The Immigration and Nationality Act (Act) provides for the admission of various classifications of nonimmigrant aliens who are foreign nationals having a residence in a foreign country which they have no intention of abandoning, and who are seeking temporary admission to the United States. The purpose of the nonimmigrant alien's intended stay in the United States determines his or her proper nonimmigrant classification.

F-1 nonimmigrant aliens, as defined in section 101(a)(15)(F) of the Act, are foreign students who have been admitted to the United States to pursue a full course of study in a college, university, seminary, conservatory, academic high school, private elementary school, other academic institution, or language training program in the United States that has been approved by the Service to enroll foreign students. For the purposes of this rule, the term “school” refers to all of these types of Service-approved institutions.

An F-2 nonimmigrant alien is a foreign national who has been admitted to the United States as the spouse or qualifying child (under the age of 21) of an F-1 nonimmigrant alien.

M-1 nonimmigrant aliens, as defined in section 101(a)(15)(M) of the Act, are foreign nationals who have been admitted to the United States to pursue a full course of study at a Service-approved vocational school or other recognized nonacademic institution (other than in language training programs) in the United States. The term “school” for the purposes of this interim rule also encompasses all institutions approved for attendance by M-1 students. An M-2 nonimmigrant alien is a foreign national who is the spouse or qualifying child (under the age of 21) of an M-1 nonimmigrant alien.

Recognizing the unique nature of border communities and the need to serve the educational interests of students living on both sides of the U.S./Canada and U.S./Mexico borders, this rule expands the circumstances under which a border commuter student who is a national of Canada or Mexico may be admitted as an F-1 or M-1 nonimmigrant alien to engage in a full course of study, albeit with a reduced course load.

Historically, the Service has not officially sanctioned such part-time study for border commuter students. First, the statutory definition of the B nonimmigrant visitor classification, in section 101(a)(15)(B) of the Act, precludes admission of an individual coming to the United States to study. Moreover, the Service has always interpreted the statutory definitions of the F and M classifications, relating to students pursuing a full course of study, to require enrollment on a full-time basis as defined in the regulations, which did not cover part-time border commuter students.

However, this regulatory scheme has aligned poorly with the realities of the border communities, effectively creating a “Catch-22” situation for bona fide part-time border commuter students. This has resulted in uneven application of this policy on the border. In fact, it has become commonplace for aliens residing in Canada or Mexico to enroll part-time in border institutions and enter the United States as visitors on a daily basis to pursue part-time study.

The response to the terrorist attacks of September 11, 2001, has resulted in increased scrutiny at ports-of-entry and in renewed focus on the integrity of our immigration system. There has been particular attention to the proper use of the B visitor classification. When the principal purpose for entering the United States is to attend school, the immigration laws intend that aliens be classified as nonimmigrant students, not as B visitors for business or pleasure.

Therefore, the purpose of this rule is to recognize the special relationship between the United States and its neighbors and to legitimize such study by border commuter students, while placing it within a regulated, controlled process. As nonimmigrant students, they will be authorized to attend only schools approved by the Service to accept foreign students. A border commuter student is subject to all requirements applicable to the F or M nonimmigrant classification and will be processed through the existing framework for these classifications. This includes, among other things, obtaining the appropriate Form I-20, Certificate of Eligibility for Nonimmigrant Student Status, and obtaining the appropriate visa, unless exempt. The schools will be required to comply with the same reporting and recordkeeping requirements for these part-time border commuter students as for full-time F-1 or M-1 students.

This rule will prevent the significant disruption of part-time study that has become an accepted fact of life along the border and a settled expectation. For example, it is reported that the El Paso Community College has an enrollment of some 2,400 part-time border commuter students, who generate approximately $700,000 in tuition. The loss of these students would cause the school, and other similarly-situated schools, to lose state funding based on enrollment levels, thus affecting all of the remaining students. In Detroit, it is reported that Wayne State University stands to lose approximately 500 students and $1 million in fees and tuition. Media reports show that enrollment in the University of Texas at Brownsville's English language program dropped 50% over the summer, costing the institution $150,000. In Washington State, media reports state that Bellingham Technical College stands to lose $100,000 in tuition this year. Niagara University in Lewiston, New York, reportedly stands to lose $250,000 in tuition revenue, and D'Youville College in Buffalo could lose up to $900,000 in the next year. These are only a few examples of the extent to which the practice of part-time study by commuter students is woven into life on the border.

As noted, the statutory definitions of the F-1 and M-1 classifications relate to foreign students coming to the United States temporarily and solely for the purpose of pursuing a full course of study at an approved school. The Service's current regulations at 8 CFR 214.2(f)(6) and (m)(9) set forth specific requirements for defining a “full course of study” in various contexts.

However, the regulations at 8 CFR 214.2(f)(6)(iii) also permit a school to authorize a student to engage in a reduced course load under certain circumstances while still maintaining status as a student enrolled in a “full course of study”. The school's designated school official (DSO) may approve a reduced course load due to initial difficulties with the English language or reading requirements, unfamiliarity with American teaching methods, or improper course level placement, or because of illness or medical reasons.

Moreover, there is another context in which the Service has authorized DSOs to approve a reduced course load in special circumstances for students who still wish to pursue a full course of study. In 1998, several Asian countries experienced a severe devaluation of their currencies, which caused a hardship upon nonimmigrant students in the United States dependent on currency from those countries for support. In response, the Service amended its regulations, 8 CFR 214.2(f)(6)(i)(F), allowing the Commissioner to publish a Federal Register notice authorizing affected F-1 aliens to accept employment in excess of the ordinary 20-hour per week maximum, in cases of severe economic hardship, and to drop below the usual course load in order to pursue the additional employment.

This rule adds an additional provision permitting certain border commuter students to enroll in an approved school with a lesser course load than is otherwise required for F and M students, on account of their unique educational circumstances. Specifically, for a nonimmigrant alien who meets all other requirements applicable to the F or M classification and who is commuting to a school in the United States within 75 miles of the border, the school's DSO may approve the student's attendance with a course load below that otherwise required under the general rules. However, the student must still be enrolled in a “full course of study” at the school, that is, a course of study that leads to the attainment of a specific educational, professional, or vocational objective, as prescribed in the introductory language in § 214.2(f)(6)(i) and (m)(9)(i), although at a reduced course load for each semester or term.

This reflects the special and unique relationship the United States shares with its bordering neighbors and is consistent with the numerous statutory and regulatory provisions that accommodate the special demands in regulating the flow of Canadian and Mexican nationals across our borders. For example, under section 101(a)(6) of the Act, provision is made for border crossing cards to be issued to aliens resident in foreign contiguous territory in order to facilitate the lawful crossing of our borders.

Although there is no border crossing card currently issued to Canadian nationals, the Service, together with the Department of State, has implemented procedures to issue border crossing cards to Mexican nationals consistent with the Act as amended by section 104 of the Illegal Immigration Reform and Immigrant Responsibility Act of 1996 (IIRIRA), Public Law 104-208, Div. C (Sept. 30, 1996) and section 601 of the Enhanced Border Security and Visa Entry Reform Act of 2002, Public Law 107-173 (May 14, 2002). Mexican nationals presenting a valid, unexpired Border Crossing Card may be admitted to the United States without other documentation for a period not to exceed 72 hours to visit within 25 miles of the border, or in the case of visits to certain areas in the State of Arizona, within 75 miles of the border. See 8 CFR 235.1(f)(1)(iii) and (f)(1)(v).

Another example, section 212(d)(4)(B) of the Act authorizes the Attorney General and the Secretary of State, on the basis of reciprocity, to waive the passport and visa requirements of nationals of foreign contiguous territory and adjacent islands.

The special relationship between the United States and its border neighbors is also reflected in the special procedures contained in the North American Free Trade Agreement (NAFTA) and codified under section 214(e) of the Act.

Administratively, the Service has regulated the special circumstances of frequent border crossers and made allowance for the peculiarities of daily life in border communities. In addition to regulatory provisions controlling the unique documentary requirements for admission of Canadian and Mexican nationals found at 8 CFR 212.1 and 212.6, the Service has established automated inspection services to provide access to the United States for a group of identified, low-risk border crossers. See 8 CFR 235.7. Other examples address circumstances surrounding temporary workers to the United States such as the regulatory provision found at 8 CFR 214.2( l )(12)(ii). This provision, commonly known as the “commuter L-1,” recognizes the exception to statutory limits on the period of stay for intracompany transferees who reside outside the United States and regularly commute to engage in part-time employment in this country. Another special provision in the regulations for L nonimmigrants (intracompany transferees), 8 CFR 214.2( l )(17), allows Canadian citizens to file the employer's petition for L classification at the time of applying for admission at the port-of-entry, rather than having to obtain approval of the petition in advance from a Service Center. Also, for nearly 20 years, the Service and the Department of Labor have authorized exceptions for Canadian musicians entering under the H-2B temporary worker program. These musicians, if entering the United States to perform within 50 miles of the U.S. Canada border, are pre-certified by the Secretary of Labor.

This rule is necessary to take account of the unique educational situation of bona fide commuter students seeking to attend United States schools along the U.S./Canada and U.S./Mexico borders. The Service understands that certain border states have undertaken measures to facilitate attendance by Mexican and Canadian nationals.

The Service will restrict application of this provision to schools located within 75 miles of the U.S. border. The Service believes this 75-mile zone is consistent with the general commuter travel provisions and will accommodate the needs of students and institutions. Since 1953, Mexico and the United States have agreed to make special accommodations for Mexican nationals who cross the border into the immediate border area to promote the economic stability of the region, and the United States and Canada have a longstanding accommodation for citizens to cross the common border without requiring passports or visas. The Service therefore believes this 75-mile zone, which is the maximum distance currently allowed for Mexican nationals entering the immediate border area, pursuant to 8 CFR 235.1(f)(1)(v), is consistent with the many border accommodations established over time and will meet the needs of students and institutions. The Service does not believe a larger zone is warranted to address the problem.

Canadian or Mexican nationals enrolling at a school outside this 75-mile zone, or who maintain a residence in the United States in connection with their attendance at any approved school, will remain subject to the established rules for F or M nonimmigrants student status.

This rule adds new provisions in the Service's regulations at 8 CFR 214.2(f)(18) and (m)(19) to include special provisions defining a full course of study for border commuter students. To be eligible to be authorized by a school's DSO based on the border commuter student provision, the alien must be:

• A national of Canada or Mexico who maintains an actual residence and place of abode in the alien's country of nationality;

• Attending a school located within 75 miles of the border;

• Registered as a border commuter student; and

• Matriculating in a full course of study, albeit on a part-time basis.

This interim rule also adds a new provision, 8 CFR 214.2(f)(18)(iii), to place in effect the reasonable limitation that border commuter students attending an approved school on a part-time basis as F-1 students will be admitted for a fixed admission period for each semester, quarter, or term. Under current regulations, only M-1 students are admitted for a fixed period of admission, while full-time F-1 student are admitted for “duration of status”, as provided in 8 CFR 214.2(f)(5) and (f)(7), while the student pursues a full course of study or authorized practical training. By setting a fixed period of admission for F-1 border commuter students that reflects the current semester or quarter of the school's academic calendar, the Service will be able to maintain greater control and oversight to ensure that the student does in fact remain a border commuter student. The school's DSO will be required to specify on the Form I-20 the term-by-term completion date, and a new Form I-20 will be required for each new quarter or semester that the commuter student attends at the school. Conforming amendments to paragraphs (f)(1)(i), (f)(5)(i), and (f)(7)(i) of § 214.2 further clarify that border commuter students will be admitted for a fixed period rather than for duration of status.

This rule also clarifies in § 214.2(m)(19)(iii) that the provision in § 214.2(m)(5), allowing an additional 30-day period in which to depart the United States following the completion of an M-1 student's course of study (in order to make final arrangements before departure), does not apply to border commuter students.

The Service notes that, in a separate rulemaking, 67 FR 34862 (May 16, 2002) (proposed rule), the Service is implementing section 641 of IIRIRA to establish an information collection system for nonimmigrant alien students. This system, the Student and Exchange Visitor Information System (SEVIS), will require the DSO to report when a reduced course load has been authorized for a particular student. SEVIS will enable the Service to provide more efficient oversight of this special authority for border commuter students to enroll at an approved school with a reduced course load.

Under this rule, Canadian or Mexican nationals approved as F-1 border commuter students for a part-time course load may only be authorized to accept employment in a curricular practical training program or a post-completion optional practical training program, using existing authorization procedures. The regulatory provisions governing curricular and post-completion optional practical training are contained at 8 CFR 214.2(f)(10)(i) and(f)(10)(ii)(A)( 3 ), respectively. In the case of an M-1 border commuter student, employment will only be authorized as provided for practical training as provided in existing 8 CFR 214.2(m)(14). Border commuter students admitted to pursue a course of study on a part-time basis under this rule will not be approved for any other employment in the United States (whether on-campus or off-campus) in connection with their F or M student status.

The Service believes this position is appropriate for several reasons. First, student employment (unrelated to training) often serves to help students meet living expenses while they are away from their home country and living in the United States, and that rationale does not apply to border commuter students. Also, although on-campus employment pursuant to a fellowship or scholarship would normally be available to an F-1 student, a part-time border commuter student is, by definition, not in the same situation as other F-1 students. The purpose of the F-1 and M-1 classification is completion of an educational objective, and the categories of work authorization allowed by this rule are closely related to that objective. For this reason, this rule retains the eligibility for non-resident border commuter students to engage in curricular practical training programs and post-completion optional practical training programs, but not in other types of employment in connection with their student status.

Finally, because a border commuter student admitted under this rule is maintaining his or her actual place of abode in Canada or Mexico and, by definition, would not be residing in the United States, the Service does not believe that employment in the United States is economically necessary. The alien would be able, of course, to find employment in his or her own country where the student continues to reside.

A border commuter student who wishes to engage in employment in the United States that is not authorized by this rule must obtain the appropriate visa, or enroll as a full-time F-1 or M-1 student, in which case the student will not be governed by the limitations of this rule.

This rule simply provides a means for certain Canadian and Mexican nationals who commute into the U.S. to attend school on a part-time basis to be able to obtain proper status as an F-1 or M-1 nonimmigrant.

The United States Government's obligations under NAFTA do not address students and this rule in no way affects the rights of Canadian or Mexican nationals to temporary entry and employment in the U.S. under NAFTA. Canadian or Mexican nationals are admitted as TN nonimmigrants, or in some cases in a different work-related nonimmigrant classification under NAFTA depending on their circumstances. If a Canadian or Mexican national has been already admitted to the United States in a work-related nonimmigrant classification pursuant to NAFTA, it is permissible for them to attend school incidental to their NAFTA-based classification, and that is not affected by this interim rule.

No. Canadian or Mexican nationals attending school in the United States on a full-time basis continue to be governed by the rules that apply to their respective classifications. A Canadian or Mexican national admitted to attend school in the United States on a full-time basis as an F-1 or M-1 student may seek authorization from a DSO for a reduced course load, but must comply with the aspects of this rule requiring residence in Canada or Mexico, or otherwise qualify for reduced course load under 8 CFR 214.2(f)(6)(iii).

Section 214(m) of the Act prohibits an F-1 student from attending a public high school for more than 12 months in the aggregate. Because of the statutory limitation, an F-1 student at a public high school can only be admitted for an aggregate of 12 months of study. Section 214(m) also requires that the alien, prior to being issued the F-1 visa, demonstrate that he or she has reimbursed the local school district for the full, unsubsidized per capita cost of providing the high school education for the period of the alien's attendance.

Also, under section 214(m) of the Act, as amended by sections 625 and 107(e)(2) of IIRIRA, a nonimmigrant may not be accorded status as an F-1 student to pursue a course of study at a public elementary school or a publicly funded adult education program.

No. Except for the change this rule makes regarding enrollment in a full course of study for border commuter students, all other requirements, processes, and procedures remain in effect. For example, a border commuter student may transfer between qualifying institutions within the 75-mile limit under the same rules as any other F-1 student. Such a student would also be able to transfer to a school outside the 75-mile limit, under the established procedures, but the student would not be eligible, at the new school, for the special part-time provision created by this rule. Similarly, a Canadian or Mexican national who is currently a full-time student may transfer to a qualifying school as a border commuter student provided that he or she meets the requirements of this rule.

The Service's implementation of this rule as an interim rule is based on the “good cause” exceptions found at 5 U.S.C. 553(b)(B) and (d)(3). The reason and necessity for the immediate promulgation of this rule are as follows:

Adherence to the notice and comment period normally required under 5 U.S.C. 553(b) by promulgation of a proposed rule prior to an interim rule would cause a disruption in studies. As noted in the supplementary information to this rule, the emphasis on the proper classification for the activity affected by this rule has led to increased enforcement and has had the effect of ceasing studies by affected students. In order to allow those students to recommence studies in a proper and regulated format in time for the upcoming fall academic term, an interim rule is necessary.

Furthermore, this rule enhances security and reduces risk because it places the activity it governs in a regulated context. As noted in this rule, the activity sanctioned by this rule has taken place on the border for some time, but has taken place in a classification, such as the B nonimmigrant classification, that is not appropriate. Thus, to avoid disruption it is necessary that this rule be designated an interim rule.

Therefore, the Service finds that it would be impractical and contrary to the public interest to adopt this rule with the prior notice and comment period normally required under 5 U.S.C. 553(b).

This rule is also made effective upon publication in the Federal Register. This action is necessary in order to avoid the disruption in the enrollment of border community students in the upcoming academic term, as discussed above. It will also facilitate the use of this provision by the affected communities as soon as possible after publication. Because this rule removes a restriction and imposes no new burdens or requirements on the public, the Service is not required to delay the effective date of this rule for 30 days under 5 U.S.C. 553(d), and concludes that it would be contrary to the public interest to do so.

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. This rule allows border community students to enroll part-time in United States schools who accept them for admission. Although some of these border-area schools may be considered as small entities as that term is defined in 5 U.S.C. 601(6), the effect of this rule would be to benefit those schools by allowing them to continue to enroll certain part-time students who commute into the United States to attend school.

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 one 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 Office of Management and Budget (OMB) for review.

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. Therefore, in accordance with section 6 of Executive Order 13132, it is determined that this rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.

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

Under the Paperwork Reduction Act of 1995, Public Law 104-13, all Departments are required to submit to the Office of Management and Budget (OMB) for review and approval any reporting requirements inherent in a final rule. This rule does not impose any new reporting or recordkeeping requirements under the Paperwork Reduction Act.

On July 23, 1992, the FAA published a Notice of Proposed Rulemaking (57 FR 32846) that would establish requirements for part 121 certificate holders to develop and comply with an FAA approved ground deicing/anti-icing program. The proposed rule was developed in response to a number of airplane accidents caused in part by icing and to recommendations from an international conference on aircraft deicing/anti-icing. Because of the urgency of the rulemaking, the FAA allowed for only a 15-day comment period.

On September 21, 1993, the FAA published proposed requirements for ground deicing procedures for parts 125 and 135 certificate holders (58 FR 49164). Under the proposal when ground icing conditions exist, parts 125 and 135 certificate holders would be required to check their airplanes for contamination prior to beginning takeoff. In addition, under the proposed changes to part 125, certificate holders would be required to provide pilot testing on ground deicing/anti-icing procedures, and under proposed changes to part 135, certificate holders would be required to provide pilot training on ground deicing/anti-icing procedures. The FAA proposed the requirements in response to part 135 accidents that were caused by pilots beginning takeoff with contamination adhering to critical airplane surfaces.

On September 29, 1992, the FAA published the part 121 interim rule (57 FR 44924) and on December 30, 1993, the FAA published the part 135 interim rule (58 FR 69620). The FAA requested comments on the interim final rules because the comment periods on the NPRMs were unusually short, and because the FAA anticipated that the first winter of implementation of the rules might provide additional information supporting either the continuation or modification of the rules. This action is in response to those comments and confirms the interim final rules as final rules.

The FAA received 22 comments on the part 121 interim rule. Generally, most commenters favor the FAA's action. Several commenters address specific requirements in the part 121 interim rule and some recommend changes in the rule language.

The most significant issues addressed by commenters on the part 121 interim rule involve holdover times, pretakeoff checks, hard-wing aircraft, and the role of aircraft dispatchers. Additional issues addressed by commenters involve applicability, training, research, type of fluid, alternate procedures, need for an approved program, and air traffic control.

The FAA received only one comment on the part 135 interim rule. This commenter made specific recommendations to delete paragraphs from parts 125 and 135 that the commenter claims are inconsistent with the “Clean Aircraft concept.”

The only comment on the part 135 interim rule states that paragraph (a)(1) of both §§ 125.221 and 135.227, which permits takeoffs when there is frost adhering to the wings, or stabilizing or controlling surfaces, if the frost has been polished to make it smooth, is inconsistent with the Clean Aircraft concept. The commenter states that if this paragraph is included in the final rule it will allow the same type large turbine aircraft to be operated with less safety under parts 125 or 135 than under part 121.

FAA Response: While the FAA has no record of an unsafe operational history with aircraft operated under the current icing regulations of 14 CFR parts 125 and 135, we believe there may be validity to this comment and we may address the clean aircraft concept in a future agency action.

The part 121 interim rule requires that a certificate holder's ground deicing/anti-icing program must include the certificate holder's holdover timetables and the procedures for the use of these tables by the certificate holder's personnel. The rule requires that takeoff after exceeding any determined holdover time is permitted only after (1) A pretakeoff contamination check determines that the wings, control surfaces, and other critical surfaces, as defined in the certificate holder's program, are free of frost, ice, or snow; or (2) it is otherwise determined by an approved alternative procedure that the wings, control surfaces, and other critical surfaces, as defined in the certificate holder's program, are free of frost, ice, or snow; or (3) the critical surfaces are redeiced and a new holdover time is determined.

Four commenters (Swissair, ALPA, Association of European Airlines (AEA), and an airline pilot) express concern with the reliability and use of holdover times. Swissair states it has always considered the holdover times as guideline and does not support the use of holdover time guidelines as the only criteria for a go/no-go decision. ALPA expresses a similar opinion. Three commenters (Canadair, ALPA, and an airline pilot) are concerned that with the wide range of holdover times pilots may mistakenly believe that a takeoff is safe, regardless of other factors, so long as it is made within the longer time limit. Swissair states that the range of holdover times cannot be considered “as a minimum/maximum value but rather more correctly as two maximums, depending on actual weather conditions.” Canadair states that it is not clear whether a “certificate holder's program is expected to quote a single holdover time for a specific situation or a range * * *” and that if a range is intended, the FAA needs to clarify the significance of the minimum time.

FAA Response: The FAA agrees with the commenters that a holdover time should not be used as the sole criteria for a go/no-go decision before the expiration of the holdover time. The FAA stated this in the preamble to the interim final rule and in paragraph 8c of Advisory Circular 120-60, Ground Deicing and Anti-Icing Program. In the part 121 interim rule the FAA cautioned that the holdover timetables are for use in departure planning only and shall be used in conjunction with pretakeoff check procedures. These tables provide only approximate time ranges. Each pilot-in-command (PIC) determines the appropriate holdover time for the type of fluid and the actual weather conditions. The fact that a determined holdover time has not yet expired would not alone justify a decision to take off if other conditions, such as the rate or type of precipitation, had worsened, or if the PIC has other information, such as expected delays, to warrant redeicing or re-inspecting the aircraft. Conversely, the final rule does not prohibit takeoff after a holdover time has expired, if certain additional actions are taken, e.g. , a pretakeoff contamination check or an alternative check that indicates the aircraft is free of contamination.

The FAA agrees that the stated range in holdover times should not be used as a minimum and maximum value. The advisory circular specifically states that generally the maximum time within the holdover time range applies in light precipitation conditions and the minimum time applies to moderate to heavy precipitation conditions. In each case the holdover time is determined from within the stated range depending on the actual weather conditions. The FAA, therefore, has determined that the advisory circular provides sufficient guidance to pilots concerning holdover time; therefore, no further changes are required.

If the determined holdover time has been exceeded, the part 121 interim final rule requires, as one alternative, a pretakeoff contamination check (§ 121.629(c)(3)(i)). A pretakeoff contamination check, as defined in § 121.629(c)(4), is a check to make sure the wings, control surfaces, and other critical surfaces, as determined in the certificate holders' program, are free of frost, ice, and snow. It must be accomplished from outside the aircraft unless the approved program specifies otherwise, and it must be completed within five minutes before takeoff.

A pretakeoff check is defined in § 121.629(c)(4) as a check of the aircraft's wings or representative aircraft surfaces for frost, ice, or snow within the holdover time. As stated in the preamble to the part 121 interim rule and to be consistent with the intended use of holdover timetables, certificate holders must accomplish a pretakeoff check whenever holdover timetables are used. Language has been added to § 121.629(c)(3) to make it clear that a pretakeoff check is integral to the use of holdover timetables.

The part 121 interim rule under § 121.629(d) also allows a certificate holder to continue to operate without a deicing program if the aircraft is checked to ensure that the wings, control surfaces, and other critical surfaces are free of frost, ice, and snow anytime conditions are such that frost, ice, or snow may reasonably be expected to adhere to the aircraft. The check must be completed within five minutes before takeoff and accomplished from outside the aircraft. This check is referred to as the “paragraph (d) outside-the-aircraft check.” As stated in the preamble to the part 121 interim rule, accomplishing this check may not be a viable option at certain airports, at certain peak departure times, and during certain weather conditions.

Twelve commenters (ALPA, NTSB, ATA, Fokker, Canadair, de Havilland, an airline pilot, AEA, Federal Express, Swissair, Association of Flight Attendants, and Aviatrends) address the issue of aircraft checks. The three sub-issues these commenters address are: (1) The adequacy of any check made from within the aircraft; (2) how the five minutes is measured; and (3) other aircraft check issues.

(1) Checks made from within the airplane. The NTSB, ALPA, de Havilland, Association Flight Attendants, Aviatrends, and an airline pilot all voice concern for the reliability of any check made from within the airplane. The NTSB expressed particular concern for visual observations involving swept-wing airplanes without leading edge devices. Aviatrends cited specific examples in which reports filed under NASA's Aviation Safety Reporting System indicated problems with checks from inside the aircraft. In one case where both Type I and Type II fluid had been applied, the first officer reported that it was impossible to see through Type II fluid on the cabin windows. A second report concluded that “the value of inspecting the wing for ice from inside the cabin, especially at night, is questionable” and the “Type II deicing fluid is the consistency of warm honey and when it covers the cabin windows very little can be seen through them.” ALPA expressed similar concerns and concluded that “the inspection from inside the aircraft is therefore turned into a presumption.”

FAA Response: Pretakeoff contamination checks, defined under § 121.629(c)(4) and required under § 121.629(c)(3)(i), must be accomplished from outside the aircraft unless the certificate holder's approved program specifies otherwise. Checks performed from inside the aircraft are not permitted unless the certificate holder has clearly defined and demonstrated procedures to allow the flight crew to assess the condition of the aircraft from inside the aircraft under various conditions ( e.g. , lighting, weather, visibility, etc. ). The certificate holder's program should emphasize that if any doubt exists as to the condition of the aircraft after conducting this check, takeoff must not be attempted. In addition, as stated in the preamble to the part 121 interim rule, the ultimate authority and responsibility for the operation of the aircraft remain with the PIC. Therefore, whenever the PIC is not fully satisfied with the reliability of a check conducted from inside the aircraft, the PIC is expected to get the aircraft redeiced or request that an additional check be conducted from outside the aircraft.

(2) How the 5 minutes is measured. Several commenters (Swissair, ATA, Fokker, and AEA) question the intent of the rule language that requires that the pretakeoff contamination check must “be conducted” and the paragraph (d) check must “occur” within five minutes prior to beginning takeoff. These commenters point out that if this check can take five to fifteen minutes to accomplish, as the FAA stated in the preamble to the part 121 interim rule, the rule would be impractical unless it is interpreted to mean that the takeoff must occur within five minutes of completion of the check. While seeking clarification of the five-minute time requirement, AEA states that a measurement of five minutes after completing the checks would be problematic and could be dangerous unless there is a differentiation based on the type of fluid used.

FAA Response: The FAA's intent was that the pretakeoff contamination check and the paragraph (d) outside-the-aircraft check must be completed within five minutes prior to beginning takeoff. The FAA believes that a pretakeoff contamination check or a paragraph (d) outside-the-aircraft check completed within no more than five minutes prior to beginning takeoff is sufficiently close to takeoff, in most weather conditions, to ensure absence of contamination. Five minutes is a maximum time. The FAA expects PICs to use good judgment when weather conditions might dictate a shorter time.

(3) Other pretakeoff check issues. Canadair states that there is still a possibility of confusion between the two similarly worded terms “pretakeoff check” and “pretakeoff contamination check” and recommends that the latter be renamed “external contamination check.” AEA states its concern that since holdover times are only guidelines, they should not be used as “criteria to establish whether a more thorough check (pretakeoff contamination check) is required.”

FAA Response: The FAA believes that the aviation industry has become familiar with the distinction between the two checks. As stated under item (1) above, a holdover time is never the sole criteria in determining whether a takeoff should be attempted or whether another check is warranted. The PIC's evaluation of all the relevant factors and his or her exercise of good judgment are expected.

The part 121 interim rule does not contain any specific additional requirements for hard wing aircraft ( i.e. aircraft without wing leading edge devices). The NPRM preamble stated that the FAA has issued Airworthiness Directives (AD) requiring a tactile check of specific hard wing aircraft in ground icing conditions. The FAA stated in the preamble to the part 121 interim rule that it would continue to deal with aircraft specific requirements by using ADs.

Five commenters (NTSB, Fokker, de Havilland, the Air Transport Association, and Embraer) comment on the issue of ground deicing as it affects aircraft commonly referred to as hard wing aircraft. The NTSB believes that special operational procedures are justified for hard wing aircraft. Conversely, the other four commenters state that the FAA does not have any valid basis for imposing additional requirements ( e.g. a tactile check) on hard wing aircraft with aft-mounted engines. Of these commenters, only Fokker offers specific evidence to support its position. Primarily, Fokker disputes the NASA report that served as a partial basis for the FAA's conclusions concerning hard wing aircraft. Fokker maintains that the NASA report is inaccurate and that data produced in subsequent tests conducted by NASA and earlier tests conducted in Sweden do not support the need for applying any additional procedures to hard wing aircraft.

FAA Response: The part 121 interim rule imposed no special requirements for hard wing aircraft; however, the FAA has issued AD 92-03-01 and AD 92-03-02, which require special procedures for certain model DC-9 and MD-80 airplanes. These special procedures are based on the fact that these airplanes have a wing design that is particularly susceptible to loss of lift due to wing icing. Minute amounts of ice or other contaminates on the leading edge of these hard wings can cause an increase in stall speed of up to 30 knots. This increased stall speed may be well above the stall warning activation speed. Because of this phenomena, special guidance applicable to hard wing aircraft have been included in Advisory Circular (AC) 120-60.

The part 121 interim rule addresses the duties and responsibilities of the PIC and the aircraft dispatcher in determining whether a takeoff can be safely accomplished (§ 121.629(b) and (c)).

Three commenters address the proper roles of PICs and aircraft dispatchers. Swissair agrees with the FAA that the ultimate responsibility for determining if the aircraft is airworthy is with the PIC once the aircraft is released from ground personnel. Two commenters, both aircraft dispatchers, believe that § 121.629, as amended in the part 121 interim rule, does not give proper recognition to what they believe are joint responsibilities of aircraft dispatcher and pilot-in-command as reflected in §§ 1221.395, 121.533, 121.593, 121.599(a), 121.601(a), 121.605, and 121.627(a). Both commenters state that the cited sections indicate a joint responsibility between the aircraft dispatcher and the PIC for the safety of a flight and that the dispatcher's responsibility does not end with the release of the aircraft by the dispatcher. Rather, the dispatcher continues to be involved in the operational control of the aircraft throughout the flight. One of these commenters recommends that § 121.629 should be revised to specifically state that the aircraft dispatcher is involved with the PIC in the operational control of the aircraft and that this control includes dispatcher concurrence in computing or revising a holdover time and dispatcher initiation of an exterior tactile contamination check.

FAA Response: The FAA agrees that operational control of the aircraft is a joint responsibility between the PIC and the aircraft dispatcher. As stated in the preamble to the part 121 interim rule, a certificate holder's program may include holdover time coordination with the aircraft dispatcher; however, the real-time information required to determine or update the proper holdover time may be available only to the PIC. In this situation the PIC safety responsibility may require him or her to determine a holdover time without coordinating with the dispatcher. The FAA believes that the part 121 interim rule language does not diminish, and is consistent with, the traditional role of the aircraft dispatcher as stated in the sections cited above and therefore no change is made in the part 121 interim rule language.

The part 121 interim rule applied to part 121 certificate holders only; however, the preamble for the interim final rule stated that the FAA would continue to study part 125 and 135 operations to determine if future rulemaking is required. Three comments address applicability. The NTSB reiterates its concern that the interim rule does not address part 125 and part 135 certificate holders. Empire Airlines states that, based on its experience as an operator under both parts 121 and 135, it believes a part 121-type program should not be imposed on part 135 operators. Canadair states that part 91 aircraft should also be included in any further study.

FAA Response: The FAA issued an interim final rule tailored to part 125 and 135 operators on December 30, 1993 (58 FR 69620). Presently, the FAA plans no part 91 rulemaking; however, guidance for part 91 operators on ground deicing/anti-icing practices and procedures is available in AC 120-58, Pilot Guide for Large Aircraft Ground Deicing, and AC 135-17, Pilot Guide for Small Aircraft Ground Deicing.

The part 121 interim rule requires initial and recurrent ground training and testing for flight crewmembers and qualification for all other affected personnel. The training, testing, and qualifications must cover the use of holdover times, aircraft deicing/anti-icing procedures, contamination, types and characteristics of deicing/anti-icing fluids, cold weather preflight inspection procedures, and techniques for recognizing contamination.

Four commenters (NTSB, Fokker, Trans World Express and Finnair) address the issue of training. The NTSB states that the required recurrent training for flight crewmembers and involved ground personnel is “equally applicable to the FAA personnel involved in overseeing the airline programs.” Fokker believes that flight crew training is most important in preventing ground icing accidents and recommends that the “FAA should emphasize training in the use of rotation techniques suited to conditions where ground icing can be anticipated.” Trans World Express states that vendors ( e.g. contract personnel who may work for several certificate holders) are required to receive the generic training over and over when the vendors really need it only once and recommends that the certificate holder be permitted to accept another certificate holder's qualification program for vendors as it pertains to deicing/anti-icing fluid application and dispersal. Finnair states that training is the most important short-term safety measure and should emphasize the overall picture of the conditions affecting the aircraft and not concentrate on any one item such as holdover timetables.

FAA Response: The FAA agrees with the NTSB regarding the need for FAA inspector ground deicing/anti-icing training. This training was provided to all Principal Aviation Safety Inspectors (Operations and Maintenance) before the part 121 interim rule was published.

The FAA agrees with Finnair and Fokker regarding their comments on training except to the extent that Fokker believes that pilots should be trained to use a different aircraft rotation technique during takeoff that, in its view, is more suited to conditions where ground icing can be anticipated. Training pilots in the proposed techniques, however, undermines the “clean aircraft” concept since the premise for using such techniques is that the PIC may be unsure of whether the aircraft is free of contamination. If contamination is adhering to critical surfaces of the aircraft, the takeoff would not comply with § 121.629(a), and the techniques recommended by Fokker are not a safe alternative to that compliance.

Conceptually, the FAA agrees with Trans World Express that redundant training is neither necessary nor useful for the trainee. On the other hand, the FAA cannot permit a certificate holder to use another certificate holder's or a vendor's deicing/anti-icing procedures unless those procedures have been approved by the principal inspectors of the certificate holder that wishes to use them.

In the part 121 interim rule preamble, the FAA stated that further research is needed on issues such as the effects of airplane design on wing contamination and how this would affect pilot flying techniques. The preamble states that additional study is needed to assess the value of aircraft type specific pilot training for use in ground icing conditions. The NTSB and the Federal Express Corporation state support for further research of the type the FAA indicated in the part 121 interim rule preamble. Federal Express states support for further research on the use of holdover times and on the effects of airplane design and their interaction with contaminants, particularly for hard wing aircraft. The NTSB states that the highest research priority should be given to determining the possible contaminating effects of Type II fluids on runway friction. The NTSB also strongly supports continuing initiatives for the development of technical solutions to wing contaminant detection.

FAA Response: Within the past few years research has been initiated on several different areas related to the ground deicing problem. The FAA has published a report which describes ongoing research, entitled “Aircraft Ice Detectors and Related Technologies for Onground and Inflight Application.” It is available to the public through the National Technical Information Service, Springfield, VA 22161. The FAA is continuing to analyze holdover times in an effort to make them a more precise tool for determining an aircraft's contamination status. The FAA and the United States Air Force are cooperating with NASA Ames Research Center in the development of a new more environmentally friendly deicing/anti-icing fluid. Many different corporations and individual entrepreneurs are developing detection systems that might be used to detect contamination on an aircraft's critical surfaces. The FAA's Technical Center has completed initial studies that indicate Type II fluids do not have a significant effect on runway friction.

The part 121 interim rule does not require using any specific deicing/anti-icing fluid. The ground deicing AC 120-60 gives guidance in the use of deicing/anti-icing fluids, stating the advantages and disadvantages of Type I and Type II fluids. Two commenters (Fokker and Technoshield) address the question of Type II fluids. Fokker states that the FAA Advisory Circular incorrectly suggests that there may be disadvantages to Type II fluids with respect to decreasing the runway coefficient of friction. Technoshield suggests that the entire rulemaking will have the effect of precluding the use of Type I fluids.

FAA Response: As stated in the preamble to the part 121 interim rule, each type fluid has its benefits and intended usage. Each certificate holder, not the FAA, determines the type(s) of fluid to be used in its operations. Recent studies by the FAA indicate that no degradation of runway frictions greater than that occurring with water covered runway surfaces occurs with the use of Type II fluids.

The FAA does not believe that the rule affects the choice of fluid. Weather conditions and certificate holder practice will continue to determine the choice of fluid.

Canadair suggests that it would be useful if the FAA issues advisory material on how to design, develop, and verify an alternative procedure for determination that critical surfaces are free of frost, ice, or snow, as is authorized under § 121.629(c)(3)(ii).

FAA Response: As was stated in the preamble to the part 121 NPRM, the “otherwise determined by an alternative procedure” language was included to cover changes in ambient conditions or industry development of approved new technologies. The FAA believes that certificate holders should take the initiative to develop such alternative procedures and submit them to the FAA for approval.

ALPA states its belief that each carrier operating under part 121 should have an approved program and that, for the reasons stated in its earlier comments on the ground deicing NPRM, § 121.629(d) should be deleted.

FAA Response: The FAA believes that the only certificate holders under part 121 who do not have an approved ground deicing/anti-icing program are those who conclude it would be more cost effective to operate without such a program. These certificate holders might have to delay or cancel flights in icing conditions because the outside-the-aircraft check required under § 121.629(d) is not a viable option during certain weather conditions and at certain airports. If a certificate holder is able to conduct an outside-the-aircraft check and that check ensures that the aircraft is free of contamination, the FAA believes the check is an adequate substitute for an approved program.

The NTSB referenced several of its previous recommendations that are not directly related to this rulemaking action but that are related to achieving more efficient planning for ground operations. The recommendations, if implemented, would reduce the probability that airplanes will exceed their deicing holdover times.

FAA Response: The FAA has undertaken a number of related actions, including, as part of certain airports' ground deicing plans, gate hold procedures (NTSB Recommendation A-93-19) and procedures that limit the time an aircraft spends on the ground after deicing (NTSB Recommendation A-93-20). These procedures have contributed to both improved safety during ground icing conditions and enhanced the overall departure and arrival rates during these conditions.

These rules are federal actions that are subject to the National Environmental Police Act (NEPA). Under applicable guidelines of the President's Council on Environmental Quality and agency procedures implementing NEPA, the FAA normally prepares an environmental assessment (EA) to determine the need for an environmental impact statement (EIS) or whether a finding of no significant impact (FONSI) would be appropriate. (40 CFR 1501.3; FAA Order 1050.1D appendix 7. par. 3(a)). In the NPRMs the FAA invited comments on any environmental issues associated with the proposed rule, and specifically requested comments on the following: (1) Whether the proposed rule will increase the use of deicing fluids, (2) whether the proposed part 121 rule will encourage the use of Type II deicing fluid, (3) the impact, if any, of using these deicing fluids on taxiways “just prior to takeoff,” and (4) containment methods currently used that can be adapted to other locations on an airport. Only a few commenters to the part 121 NPRM addressed these environmental issues and most of these commenters focused more on the effect of Federal, state, and local environmental requirements and the lack of local facilities, than on the questions of the potential environmental impact of deicing fluids. A summary of the comments received, the FAA's response, and the findings of the FAA's Environmental Assessment appear in the preamble to the part 121 interim rule.

The Environmental Assessment (EA) which supported a Finding of No Significant Impact (FONSI) is included in the docket for this rulemaking. Except for the NTSB suggestion that the FAA conduct further research on runway contaminants, no further comments on environmental issues associated with this rulemaking were received following publication of the part 121 and part 135 interim rules. Nonetheless, as part of its long term efforts, the FAA will continue to work with certificate holders and with airport operators to monitor the actual and potential environmental effects of this rule and will take appropriate steps as necessary.

After consideration of the comments submitted in response to the interim final rules, the FAA has determined that no further rulemaking action is necessary. The interim final rule amending part 121 of title 14 of the Code of Federal Regulations, Amendment No. 121-231, entitled Aircraft Ground Deicing and Anti-Icing Program, published at 57 FR 44924 on September 29, 1992, is adopted as a final rule. The interim final rule amending parts 125 and 135 of title 14 of the Code of Federal Regulations, Amendment Nos. 125-18 and 135-46, entitled Training and Checking in Ground Icing Conditions, published at 58 FR 69620 on December 30, 1993, is adopted as a final rule.

The Census Bureau has developed standard procedures and pricing policies regarding the certification process.

Over the years, the volume of requests for certified Census Bureau documents has steadily increased. Title 13, Section 8, allows the Census Bureau to provide certain statistical materials upon payment of costs for this service. With the release of Census 2000 data, the volume of requests for certified documents is expected to continue increasing. The price structure includes a preset service fee plus the cost of the resources used in fulfilling the requests, according to the kind of certification requested and its level of difficulty (easy, moderate, or difficult). The two types of certification available are (1) “Impression,” that is, impressing the Census Bureau seal on a document and (2) “Attestation,” a signed statement by Census Bureau officials, attesting to the authenticity, accompanying a document onto which the Census Bureau seal has been impressed.

A certification may be needed for many reasons. For example, parties in a legal proceeding may wish to obtain a copy of a Census Bureau table or map that they wish to introduce into evidence.

In order to create consistent certification rules, the Census Bureau is making the following amendment to Title 15, Code of Federal Regulations (CFR), part 50:

• Add new Section 50.50 containing the Census Bureau's certification process.

• Establish a consistent pricing structure.

• Require requests for certifications to contain information on Form BC-1868(EF), Request for Official Certification. (See the Census Bureau's Web site, <http://www.census.gov/mso/www/certification/>. )

On June 4, 2002, the Census Bureau published in the Federal Register a notice of proposed rulemaking and request for comments on this program (67 FR 38445). The Census Bureau received no comments on the proposed rule.

A notice of final rulemaking is not required by Title 5, United States Code (U.S.C.), section 553, or any other law, because this rule is procedural in nature and involves a matter relating to public property, loans, grants, benefits, or contracts. Accordingly, it is exempt from the notice and comment provisions of the Administrative Procedure Act under 5 U.S.C. 553(a)(2) and 5 U.S.C.(b)(A). Therefore, the analytical requirements of the Regulatory Flexibility Act are not applicable (5 U.S.C. 601, et seq. ). As a result, a Regulatory Flexibility Analysis is not required and none has been prepared.

This rule has been determined not to be significant for purposes of Executive Order 12866. This rule does not contain policies with federalism implications sufficient to warrant preparation of a federalism assessment under Executive Order 12612.

Notwithstanding any other provision of law, no person is required to respond to, nor shall a person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the Paperwork Reduction Act (PRA), Title 44, U.S.C., Chapter 35, unless that collection of information displays a current Office of Management and Budget control number. This notice does not represent a collection of information and is not subject to the PRA's requirements. The form referenced in the rule, Form BC-1868(EF), collects only information necessary to process a certification request. As such, it is not subject to the PRA's requirements (5 CFR 1320.3(h)(1)).

As described in section 764.3 of the Export Administration Regulations (15 CFR 764.3), the Bureau of Industry and Security (BIS) has the authority to issue an order that restricts the ability of persons named in it to engage in export or reexport transactions of items subject to the Export Administration Regulations (EAR) and restricts their access to items subject to the regulations. These orders may also prohibit all persons from taking certain actions specified in the order because those actions could circumvent the restrictions imposed on the denied person by the order. BIS publishes notices of such orders in the Federal Register to provide notice to all persons of the provisions of the order. BIS maintains unofficial compilations of such denial orders, for the convenience of the public, in a “Denied Persons List” included in the unofficial version of the EAR and on a Web site. Because these compilations are not included in the Code of Federal Regulations, this rule removes references to the “Denied Persons List” from the EAR in parts 732, 736, 758, 764, 766 and 772. References to the “Denied Persons List” in part 752 of the EAR will be removed in a separate rule.

This rule also replaces the word “immediately” with “[date]” in the last sentence of the pro forma standard denial order, because a standard order need not be effective as of the date of signing. This rule does not change the scope of any order denying export privileges, nor does it change the rights or duties of any person with respect to the Export Administration Regulations.

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

2. Notwithstanding any other provision of 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 Paperwork Reduction Act, unless that collection of information displays a currently valid Office of Management and Budget Control Number. This rule does not involve a collection of information subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq. ).

3. This rule does not contain policies with Federalism implications as that term is defined in Executive Order 13132.

4. Pursuant to 5 U.S.C. 553(b)(A), the provisions of the Administrative Procedure Act requiring a notice of proposed rulemaking and the opportunity for public comment are waived, because this regulation involves a rule of agency procedure. No other law requires that a notice of proposed rulemaking and an opportunity for public comment be given for this rule.

Additionally, pursuant to 5 U.S.C. 553(d)(2), the 30 day delay in effectiveness is waived for the same reason. Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this rule under the Administrative Procedure Act or by any other law, the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) are not applicable. Therefore, this regulation is issued in final form. Although there is no formal comment period, public comments on this regulation are welcome on a continuing basis. Comments should be submitted to William Arvin, Office of Exporter Services, Bureau of Industry and Security, Department of Commerce, P.O. Box 273, Washington, D.C. 20044.

Pharmacia and Upjohn Co., 7000 Portage Rd., Kalamazoo, MI 49001-0199, filed supplements to NADA 135-940 that provides for use of ANTIROBE (clindamycin hydrochloride) Aquadrops Liquid and to NADA 120-161 for ANTIROBE (clindamycin hydrochloride) Capsules. Supplemental NADA 135-940 provides for an expanded dose range for the use of clindamycin hydrochloride in both dogs and cats for the treatment of certain infections associated with bacteria susceptible to clindamycin hydrochloride. Supplemental NADA 120-161 provides for the same expanded dose range in dogs and for use of a 300-mg strength capsule. The supplemental applications are approved as of May 13, 2002, and the regulations are amended in §§ 520.446 and 520.447 (21 CFR 520.446 and 520.447) to reflect these approvals. The basis of these approvals is discussed in the freedom of information summaries. Sections 520.446 and 520.447 are also being revised to reflect a current format.

In accordance with the freedom of information provisions of 21 CFR part 20 and 514.11(e)(2)(ii), summaries of safety and effectiveness data and information submitted to support approval of these applications may be seen in the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

FDA has determined under 21 CFR 25.33(d)(1) that these actions are of a type that do not individually or cumulatively have a significant effect on the human environment. Therefore, neither environmental assessments nor environmental impact statements are required.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

1. The authority citation for 21 CFR part 520 continues to read as follows:

(a) Specifications —(1) Each capsule contains the equivalent of 25, 75, 150, or 300 milligrams (mg) clindamycin as the hydrochloride salt.

(2) Each capsule contains the equivalent of 25, 75, or 150 mg clindamycin as the hydrochloride salt.

(3) Each tablet contains the equivalent of 25, 75, or 150 mg clindamycin as the hydrochloride salt.

(b) Sponsors . See sponsors in § 510.600(c) of this chapter as follows:

(1) No. 000009 for use of capsules described in paragraph (a)(1) of this section as in paragraphs (d)(1)(i) and (d)(2)(i) of this section.

(2) No. 059130 for use of capsules described in paragraph (a)(2) of this section as in paragraphs (d)(1)(ii) and (d)(2)(ii) of this section.

(3) No. 059079 for use of tablets described in paragraph (a)(3) of this section as in paragraphs (d)(1)(ii) and (d)(2)(ii) of this section.

(c) Special considerations . Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(d) Conditions of use in dogs —(1) Amount —(i) Wounds, abscesses, and dental infections: 2.5 to 15 mg per pound (/lb) of body weight every 12 hours for a maximum of 28 days. Osteomyelitis: 5.0 to 15 mg/lb of body weight every 12 hours for a minimum of 28 days.

(ii) Wounds, abscesses, and dental infections: 2.5 mg/lb of body weight every 12 hours for a maximum of 28 days. Osteomyelitis: 5.0 mg/lb of body weight every 12 hours for a minimum of 28 days.

(2) Indications for use —(i) For the treatment of skin infections (wounds and abscesses) due to susceptible strains of coagulase-positive staphylococci ( Staphylococcus aureus or S. intermedius) , deep wounds and abscesses due to susceptible strains of Bacteroides fragilis , Prevotella melaninogenicus , Fusobacterium necrophorum , and Clostridium perfringens , dental infections due to susceptible strains of S. aureus , B. fragilis , P. melaninogenicus , F. necrophorum , and C. perfringens , and osteomyelitis due to susceptible strains of S. aureus , B. fragilis , P. melaninogenicus , F. necrophorum , and C. perfringens .

(ii) For the treatment of soft tissue infections (wounds and abscesses), dental infections, and osteomyelitis caused by susceptible strains of S. aureus , soft tissue infections (deep wounds and abscesses), dental infections, and osteomyelitis caused by or associated with susceptible strains of B. fragilis , P. melaninogenicus , F. necrophorum , and C. perfringens .

(a) Specifications . Each milliliter of solution contains the equivalent of 25 milligrams (mg) clindamycin as the hydrochloride salt.

(b) Sponsors . See sponsors in § 510.600(c) of this chapter as follows:

(1) No. 000009 for use as in paragraphs (d)(1)(i)(A), (d)(1)(ii)(A), (d)(2)(i)(A), and (d)(2)(ii)(A) of this section.

(2) No. 059130 for use as in paragraphs (d)(1)(i)(B), (d)(1)(ii)(B), (d)(2)(i)(B), and (d)(2)(ii)(B) of this section.

(c) Special considerations . Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(d) Conditions of use —(1) Dogs —(i) Amount —(A) Wounds, abscesses, and dental infections: 2.5 to 15 mg per pound (/lb) of body weight every 12 hours for a maximum of 28 days. Osteomyelitis: 5.0 to 15 mg/lb of body weight every 12 hours for a minimum of 28 days.

(B) Wounds, abscesses, and dental infections: 2.5 mg per pound (/lb) of body weight every 12 hours for a maximum of 28 days. Osteomyelitis: 5.0 mg/lb of body weight every 12 hours for a minimum of 28 days.

(ii) Indications for use —(A) For the treatment of skin infections (wounds and abscesses) due to susceptible strains of coagulase-positive staphylococci ( Staphylococcus aureus or S. intermedius ), deep wounds and abscesses due to susceptible strains of Bacteroides fragilis , Prevotella melaninogenicus , Fusobacterium necrophorum , and Clostridium perfringens , dental infections due to susceptible strains of S. aureus , B. fragilis , P. melaninogenicus , F. necrophorum , and C. perfringens , and osteomyelitis due to susceptible strains of S. aureus , B. fragilis , P. melaninogenicus , F. necrophorum , and C. perfringens .

(B) For the treatment of soft tissue infections (wounds and abscesses), dental infections, and osteomyelitis caused by susceptible strains of S. aureus and for soft tissue infections (deep wounds and abscesses), dental infections, and osteomyelitis caused by or associated with susceptible strains of B. fragilis , P. melaninogenicus , F. necrophorum , and C. perfringens .

(2) Cats—(i) Amount —(A) 5.0 to 15.0 mg/lb of body weight every 24 hours for a maximum of 14 days.

(B) 5.0 to 10.0 mg/lb of body weight every 24 hours for a maximum of 14 days.

(ii) Indications for use —(A) For the treatment of skin infections (wounds and abscesses) due to susceptible strains of S. aureus , S. intermedius , Streptococcus spp., deep wounds and abscesses due to susceptible strains of Clostridium perfringens and Bacteroides fragilis , and dental infections due to susceptible strains of S. aureus , S. intermedius , Streptococcus spp., C. perfringens , and B. fragilis .

(B) Aerobic bacteria: Treatment of soft tissue infections (wounds and abscesses) and dental infections caused by or associated with susceptible strains of S. aureus , S. intermedius , and Streptococcus spp. Anaerobic bacteria: Treatment of soft tissue infections (deep wounds and abscesses) and dental infections caused by or associated with susceptible strains of C. perfringens and B. fragilis .

Section 845 of the National Defense Authorization Act for Fiscal Year 1994, Public Law 103-160, as amended, authorizes the Secretary of a Military Department, the Director of Defense Advanced Research Projects Agency and any other official designated by the Secretary of Defense, to enter into transactions other than contracts, grants or cooperative agreements in certain situations for prototype projects that are directly relevant to weapons or weapon systems proposed to be acquired or developed by the Department of Defense. Such transactions are commonly referred to as “other transaction” agreements for prototype projects. To the extent that a particular statute or regulation is limited in its applicability to the use of a procurement contract, it would generally not apply to “other transactions” for prototype projects.

Part 3 to 32 CFR was established to codify policy pertaining to prototype “other transactions” that have a significant impact on the public and are subject to rulemaking. Additional guidance on prototype “other transactions” directed at Government officials can be found on the Defense Procurement web site at: http://www.osd.dp.mil.

A proposed rule was published in the Federal Register for public comment on November 21, 2001 (66 FR 58422-58425). A notice of public meeting was published in the Federal Register on March 4, 2002 (67 FR 9632) and held on March 27, 2002. The proposed rule addressed conditions on use of “other transactions” for prototype projects, the nontraditional Defense contractor definition and audit policy. Comments on the proposed rule were received from five respondents and approximately 50 representatives of Government and industry attended the public meeting. The majority of the written comments and discussion at the public meeting focused on the audit policy and will be addressed in a later rule. Only one respondent commented on the conditions of law and none commented on the definition of a nontraditional Defense contractor. The following summarizes the comments regarding the conditions of law and the disposition.

One respondent identified the use of undefined terms that are confusing (e.g., “subordinate element of the party or entities,” “awardee”) and recommended expanding upon defined terms such a business unit and segment. The respondent recommended defined terms be consistently used through out the rule or definitions be added for undefined terms.

Response: The DoD agrees. The final rule includes additional definitions and made changes to ensure consistent use throughout the rule.

One respondent(s) questioned whether the statement “As a matter of policy, these same restrictions apply any time cost sharing may be recognized when using OTA” was intended to apply to all OTAs, not just OTAs for prototype projects. The respondent recommended it be deleted from this rule and be included in a new rule that applies to all OTA.

Response: The DoD agrees the statement was confusing. The final rule establishes “Limitations on Cost-Sharing” as a separate section and clarifies that as a matter of policy, the cost-sharing limitations will also be applied to other OT agreements for prototype projects that provide for non-Federal cost-share.

It has been determined that this rule is not a significant rule as defined under section 3(f)(1) through 3(f)(4) of Executive Order 12866.

It has been certified that this rule does not contain a Federal mandate that may result in the expenditure by State, local and tribal governments, in aggregate, or by the private sector, of $100 million or more in any one year.

It has been certified that this part is not subject to the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) because it would not, if promulgated, have a significant economic impact on a substantial number of small entities. The rule does not require additional record keeping or other significant expense by project participants.

It has been certified that this rule does not impose any reporting or record keeping requirements under the Paperwork Reduction Act of 1995.

It has been certified that this rule does not have federalism implications, as set forth in Executive Order 13132.

Accordingly, part 3 of 32 CFR is amended as follows:

Throughout this document, “we,” “us” and “our” refer to EPA.

Table 1 lists the rule we are approving with the dates that it was adopted by the local air agency and submitted by the Arizona Department of Environmental Quality.

On April 12, 2002 this rule submittal was found to meet the completeness criteria in 40 CFR Part 51 Appendix V, which must be met before formal EPA review.

There is no previous version of Rule 140 in the SIP.

The purpose of Rule 140 is to provide an owner and/or operator of a source who has been charged with a violation for excess emissions with an affirmative defense to a civil or administrative enforcement penalty. To qualify for the limited affirmative defense to a penalty action, the source must demonstrate compliance with listed criteria and reporting requirements set forth in Rule 140. Moreover, the affirmative defense does not apply to a SIP provision required by federally promulgated performance standards or emission limits, such as new source performance standards (NSPS) and national emission standards for hazardous air pollutants (NESHAPS). The defense also does not apply to violations in areas where a single source has the potential to cause an exceedence of the National Ambient Air Quality Standards (NAAQS) or Prevention of Significant Deterioration (PSD) increments. The TSD has more information about this rule.

This rule contains administrative provisions and standards that apply to emission controls found in other local agency requirements. In combination with those other requirements, this rule must be enforceable (see section 110(a) of the CAA) and must not relax existing requirements (see sections 110(l) and 193). EPA policy that we used to define specific enforceability requirements includes:

• State Implementation Plans: Policy Regarding Excess Emissions during Malfunctions, Startup, and Shutdown, EPA Memorandum from Steven Herman and Robert Perciasepe to Regional Administrators, Regions I-X (September 20, 1999).

• Issues Relating to VOC Regulation Cutpoints, Deficiencies, and Deviations; Clarification to Appendix D, November 24, 1987 Federal Register Notice, (Blue Book), notice of availability published in the May 25, 1988 Federal Register.

Rule 140 excludes injunctive relief, federally promulgated emission standards or limitations, and violations in areas with single sources have the potential to exceed the NAAQS from the rule's affirmative defense to enforcement penalties. Rule 140 excludes any violation of standards and limitations included in a permit to meet requirements for pollutant significance levels in adjacent nonattainment areas where primary or secondary ambient air quality standards are being violated. These exclusions assure that Rule 140 will not interfere with the NAAQS and PSD increments, as required by sections 110(a) and (l) of the CAA.

We believe Rule 140 is consistent with the relevant policy and guidance regarding enforceability, SIP relaxations, and EPA's policy regarding excess emissions. The TSD has more information on our evaluation.

As authorized in section 110(k)(3) of the CAA, EPA is fully approving the submitted rule because we believe it fulfills all relevant requirements. We do not think anyone will object to this approval, so we are finalizing it without proposing it in advance. However, in the Proposed Rules section of this Federal Register , we are simultaneously proposing approval of the same submitted rule. If we receive adverse comments by September 26, 2002, we will publish a timely withdrawal in the Federal Register to notify the public that the direct final approval will not take effect and we will address the comments in a subsequent final action based on the proposal. If we do not receive timely adverse comments, the direct final approval will be effective without further notice on October 28, 2002. This will incorporate this rule into the federally enforceable SIP.

Section 110(a) of the CAA requires states to submit regulations that control volatile organic compounds, oxides of nitrogen, particulate matter, and other air pollutants which harm human health and the environment. This rule was developed as part of the local agency's program to control these pollutants.

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. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). 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 pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).

This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action 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, “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing SIP submissions, EPA's 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), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP 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. 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. 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 . 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 October 28, 2002. 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. 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:

Section 110 of the Clean Air Act (CAA) requires states to develop air pollution regulations and control strategies to ensure that state air quality meets the national ambient air quality standards established by EPA. These ambient standards are established under section 109 of the CAA, and they currently address six criteria pollutants. These pollutants are: Carbon monoxide, nitrogen dioxide, ozone, lead, particulate matter, and sulfur dioxide.

Each state must submit these regulations and control strategies to us for approval and incorporation into the Federally-enforceable SIP.

Each Federally-approved SIP protects air quality primarily by addressing air pollution at its point of origin. These SIPs can be extensive, containing state regulations or other enforceable documents and supporting information such as emission inventories, monitoring networks, and modeling demonstrations.

In order for state regulations to be incorporated into the Federally-enforceable SIP, states must formally adopt the regulations and control strategies consistent with state and Federal requirements. This process generally includes a public notice, public hearing, public comment period, and a formal adoption by a state-authorized rulemaking body.

Once a state rule, regulation, or control strategy is adopted, the state submits it to us for inclusion into the SIP. We must provide public notice and seek additional public comment regarding the proposed Federal action on the state submission. If adverse comments are received, they must be addressed prior to any final Federal action by us.

All state regulations and supporting information approved by EPA under section 110 of the CAA are incorporated into the Federally-approved SIP. Records of such SIP actions are maintained in the Code of Federal Regulations (CFR) at Title 40, Part 52, entitled “Approval and Promulgation of Implementation Plans.” The actual state regulations which are approved are not reproduced in their entirety in the CFR outright but are “incorporated by reference,” which means that we have approved a given state regulation with a specific effective date.

Enforcement of the state regulation before and after it is incorporated into the Federally-approved SIP is primarily a state responsibility. However, after the regulation is Federally approved, we are authorized to take enforcement action against violators. Citizens are also offered legal recourse to address violations as described in section 304 of the CAA.

On May 30, 2002, we received a request from the Missouri Department of Natural Resources (MDNR) to amend the Missouri SIP. This request pertained to rule 10 C.S.R. 10-6.060, Construction Permits Required. This rule defines sources which are required to obtain permits to construct and establishes requirements to be met prior to construction or modification of any of these sources.

Prior to this revision, this rule applied to all incinerators. However, on May 28, 2000, the MDNR was notified by the state Attorney General's office that the authority to regulate these types of incinerators was limited by state statute to the University of Missouri Extension Service.

On the recommendation of the Attorney General's office, the MDNR has revised this rule to add an exemption for this type of incinerator. Specifically, subparagraph (O) was added to subsection (1)(D)(1)—Exempt Emission Units. This exemption reads: “Noncommercial incineration of dead animals, the on-site incineration of resident animals for which no consideration is received or commercial profit is realized, as authorized in section 269.020.6, RSMo 2000.”

The MDNR has submitted emission inventory information which confirms that emissions from these sources is minimal (for example, particulate emissions are approximately one ton per year, or less), and that this exemption is not likely to have an adverse impact on ambient air quality. These sources will continue to be constructed and operated in accordance with the requirements of the University of Missouri Extension Service. Thus, we are taking action to approve this revision to the Missouri SIP.

The state submittal has met the public notice requirements for SIP submissions in accordance with 40 CFR 51.102. The submittal also satisfied the completeness criteria of 40 CFR part 51, appendix V. In addition, as explained above and in more detail in the technical support document which is part of this document, the revision meets the substantive SIP requirements of the CAA, including section 110 and implementing regulations.

We are processing this action as a final action because the revisions make routine changes to the existing rules which are noncontroversial. Therefore, we do not anticipate any adverse comments. Please note that if EPA receives adverse comment on part of this rule and if that part can be severed from the remainder of the rule, EPA may adopt as final those parts of the rule that are not the subject of an adverse comment.

Final action: EPA is approving as an amendment to the Missouri SIP revisions to rule 10 C.S.R. 10-6.060, Construction Permits Required, pursuant to section 110 of the CAA.

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. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). 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 pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).

This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action 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, “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing SIP submissions, EPA's 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), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP 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. 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. 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 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. 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 October 28, 2002. 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:

Section 110 of the Clean Air Act (CAA) requires states to develop air pollution regulations and control strategies to ensure that state air quality meets the national ambient air quality standards established by EPA. These ambient standards are established under section 109 of the CAA, and they currently address six criteria pollutants. These pollutants are: Carbon monoxide, nitrogen dioxide, ozone, lead, particulate matter, and sulfur dioxide.

Each state must submit these regulations and control strategies to us for approval and incorporation into the Federally-enforceable SIP.

Each Federally-approved SIP protects air quality primarily by addressing air pollution at its point of origin. These SIPs can be extensive, containing state regulations or other enforceable documents and supporting information such as emission inventories, monitoring networks, and modeling demonstrations.

In order for state regulations to be incorporated into the Federally-enforceable SIP, states must formally adopt the regulations and control strategies consistent with state and Federal requirements. This process generally includes a public notice, public hearing, public comment period, and a formal adoption by a state-authorized rulemaking body.

Once a state rule, regulation, or control strategy is adopted, the state submits it to us for inclusion into the SIP. We must provide public notice and seek additional public comment regarding the proposed Federal action on the state submission. If adverse comments are received, they must be addressed prior to any final Federal action by us.

All state regulations and supporting information approved by EPA under section 110 of the CAA are incorporated into the Federally-approved SIP. Records of such SIP actions are maintained in the Code of Federal Regulations (CFR) at Title 40, Part 52, entitled “Approval and Promulgation of Implementation Plans.” The actual state regulations which are approved are not reproduced in their entirety in the CFR outright but are “incorporated by reference,” which means that we have approved a given state regulation with a specific effective date.

Enforcement of the state regulation before and after it is incorporated into the Federally-approved SIP is primarily a state responsibility. However, after the regulation is Federally approved, we are authorized to take enforcement action against violators. Citizens are also offered legal recourse to address violations as described in section 304 of the CAA.

On April 26, 2002, we received a request from the Missouri Department of Natural Resources to amend the Missouri SIP. This request pertained to rule 10 CSR 10-6.280, Compliance Monitoring Usage. The purpose of this rule is to establish acceptable alternate compliance certification methods for sources submitting compliance certifications and to establish credible evidence of compliance.

Prior to this revision, the state rule made reference to rule 10 CSR 10-6.290, Enhanced Monitoring, which was to be adopted in the future. This rule was never developed. The state decided instead to reference the monitoring methods in 40 CFR part 64 as one of the methods available to sources needing to submit a compliance certification and to establish credible evidence of compliance. Therefore, the state rule has been revised in two places to delete the reference to 10 CSR 10-6.290, and to add the reference to 40 CFR part 64.

Specifically, paragraph 1 of subsections (A) and (B), section (3) General Provisions, was revised to read as follows, “Monitoring methods outlined in 40 CFR part 64.”

Since this revision corrects the reference to a non-existing rule and now references the federal monitoring methods, we are taking action to approve this revision to the Missouri SIP.

The state submittal has met the public notice requirements for SIP submissions in accordance with 40 CFR 51.102. The submittal also satisfied the completeness criteria of 40 CFR part 51, appendix V. In addition, as explained above and in more detail in the technical support document which is part of this document, the revision meets the substantive SIP requirements of the CAA, including section 110 and implementing regulations.

We are processing this action as a final action because the revisions make routine changes to the existing rules which are noncontroversial. Therefore, we do not anticipate any adverse comments. Please note that if EPA receives adverse comment on part of this rule and if that part can be severed from the remainder of the rule, EPA may adopt as final those parts of the rule that are not the subject of an adverse comment.

Final action: EPA is approving as an amendment to the Missouri SIP, revisions to rule 10 CSR 10-6.280, Compliance Monitoring Usage, pursuant to section 110 of the CAA.

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. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). 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 pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).

This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action 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, “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing SIP submissions, EPA's 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), EPA has no authority to disapprove an SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews an SIP submission, to use VCS in place of an SIP 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. 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. 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 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. 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 October 28, 2002. 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, “we,” “us,” and “our” refer to EPA.

On July 1, 2002 (67 FR 44128), we proposed to find that the Santa Barbara County nonattainment area (“Santa Barbara area”) had attained the 1-hour ozone national ambient air quality standard (NAAQS) by the applicable deadline of November 15, 1999. We also proposed to approve under CAA section 110(k)(3) the contingency measures in Santa Barbara's 2001 Clean Air Plan, as shown below in “Table 1—Contingency Measures.''

The proposed action contains more information on the attainment finding, the Santa Barbara contingency measures, and our evaluation.

We received no public comments on the proposed action.

Under CAA section 181(b)(2)(A), we are finalizing our finding that Santa Barbara has attained the 1-hour ozone NAAQS by the applicable deadline. We are also approving the contingency measures identified in Table 1, under CAA section 110(k)(3).

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. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting federal requirements and finds that an area has attained a previously-established national ambient air quality standard based on an objective review of measured air quality data. As such, the action 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 pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).

This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal standard and finds that an area has attained applicable air quality standards, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. 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. 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. 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 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. 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 October 28, 2002. 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:

Section 110 of the Clean Air Act (CAA) requires states to develop air pollution regulations and control strategies to ensure that state air quality meets the national ambient air quality standards established by EPA. These ambient standards are established under section 109 of the CAA, and they currently address six criteria pollutants. These pollutants are: carbon monoxide, nitrogen dioxide, ozone, lead, particulate matter, and sulfur dioxide.

Each state must submit these regulations and control strategies to us for approval and incorporation into the Federally-enforceable SIP.

Each Federally-approved SIP protects air quality primarily by addressing air pollution at its point of origin. These SIPs can be extensive, containing state regulations or other enforceable documents and supporting information such as emission inventories, monitoring networks, and modeling demonstrations.

In order for state regulations to be incorporated into the Federally-enforceable SIP, states must formally adopt the regulations and control strategies consistent with state and Federal requirements. This process generally includes a public notice, public hearing, public comment period, and a formal adoption by a state-authorized rulemaking body.

Once a state rule, regulation, or control strategy is adopted, the state submits it to us for inclusion into the SIP. We must provide public notice and seek additional public comment regarding the proposed Federal action on the state submission. If adverse comments are received, they must be addressed prior to any final Federal action by us.

All state regulations and supporting information approved by EPA under section 110 of the CAA are incorporated into the Federally-approved SIP. Records of such SIP actions are maintained in the Code of Federal Regulations (CFR) at Title 40, Part 52, entitled “Approval and Promulgation of Implementation Plans.” The actual state regulations which are approved are not reproduced in their entirety in the CFR outright but are “incorporated by reference,” which means that we have approved a given state regulation with a specific effective date.

Enforcement of the state regulation before and after it is incorporated into the Federally-approved SIP is primarily a state responsibility. However, after the regulation is Federally approved, we are authorized to take enforcement action against violators. Citizens are also offered legal recourse to address violations as described in section 304 of the CAA.

On September 20, 1999, we issued updated policy regarding excess emissions during malfunctions, startup, and shutdowns. 1 This policy specifies criteria for SIPs which address periods of excess emissions due to malfunctions, startup, or shutdown.

The state of Missouri has subsequently revised its existing SIP approved rule, 10 CSR 10-6.050 Start-Up, Shutdown and Malfunction Conditions, to incorporate certain provisions of the policy which had not previously been included in the rule. In a submittal letter dated April 16, 2002, the state requested that we approve this revision as an amendment to the Missouri SIP.

The state's rule, applicable to all installations in Missouri, provides the owner or operator of an installation the opportunity to submit data regarding conditions which result in excess emissions. These submittals will be used by the MDNR director to determine whether the excess emissions were due to a start-up, shutdown or malfunction condition. These determinations will be used in deciding whether or not enforcement action is appropriate.

In revising its rule, the state incorporated, in subsection (3)(C), additional factors to be considered by the director, and added additional information requirements in subsection (3)(A) and paragraph (3)(C)2. Language was added in subsections (3)(A) and (3)(B) to set a threshold of one hour for excess emissions which require a written report. The requirement to report excess emissions on the annual Emissions Inventory Questionnaire was clarified in subsection (4)(B). Other revisions were made to make the rule consistent with Title V requirements. The definitions section was removed since all relevant definitions are contained in the state's definition rule, 10 CSR 10-6.020. Finally, the format of the rule was revised to be consistent with the state's new standard rule format. The state's revisions were effective February 28, 2002.

In summary, the revised rule is consistent with EPA's aforementioned policy. Thus, we are taking action to approve this revision in the Missouri SIP.

The state submittal has met the public notice requirements for SIP submissions in accordance with 40 CFR 51.102. The submittal also satisfied the completeness criteria of 40 CFR part 51, appendix V. In addition, as explained above and in more detail in the technical support document which is part of this document, the revision meets the substantive SIP requirements of the CAA, including section 110 and implementing regulations.

We are processing this action as a final action because the revisions make routine changes to the existing rules which are noncontroversial. Therefore, we do not anticipate any adverse comments. Please note that if EPA receives adverse comment on part of this rule and if that part can be severed from the remainder of the rule, EPA may adopt as final those parts of the rule that are not the subject of an adverse comment.

Final action: EPA is approving as an amendment to the Missouri SIP revisions to rule 10 CSR 10-6.050, “Start-Up, Shutdown and Malfunction Conditions” pursuant to section 110 of the CAA.

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. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). 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 pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).

This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action 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, “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing SIP submissions, EPA's 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), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP 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. 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. 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 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. 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 October 28, 2002. 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).)

On August 14, 2002, the Research and Special Programs Administration issued a final rule to revise the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) as they apply to the transportation of infectious substances. The published effective date was October 1, 2002.

The October 1, 2002 effective date does not provide sufficient time for all segments of the industry to come into compliance with the new requirements.

In rule document 02-20118, on page 53118 in the issue of Wednesday, August 14, 2002, make the following correction:

On page 53118 in the first column, in the DATES section, the effective dates of the final rule and the IBR approval are corrected to read as set forth above in the DATES section of this document.

Although its discovery was not formalized until 1840 (Torrey and Gray, 1840), the first recorded collection of Potentilla robbinsiana (Robbins' or dwarf cinquefoil) by Thomas Nuttall in 1824 generated a strong interest among botanists and others in this diminutive member of the rose family ( Rosaceae ). Initially, there was confusion as to its taxonomic status, and it was designated as a variety of various European cinquefoils, but it was eventually recognized as a distinct species (Rydberg, 1896).

Potentilla robbinsiana is a long-lived perennial herb. Its hairy three-part compound leaves are deeply toothed, and mature plants form a dense 2-4 centimeter (cm) (1-1.5 inch (in)) rosette. Individual plants develop a deep central taproot, which helps to anchor them and resists frost heaving. Potentilla robbinsiana is one of the first plants to bloom in the alpine zone where it is found, flowering soon after the snows recede, from late May to mid-June. Adult plants produce from 1 to 30, 5-petalled yellow flowers on individual stems. The achenes (fruits) mature by late July, and disperse on dry windy days. These seeds seldom disperse more than 20 cm (8 in) from the parent plant, which limits natural reestablishment (Kimball and Paul, 1986). The seeds remain dormant for at least one winter, and germination begins the following year during June and July. Although seed viability is generally high, seedling survival is low (Iszard-Crowley and Kimball, 1998).

Various experiments have shown that Potentilla robbinsiana produces seed asexually so that seedlings are genetically identical (Lee and Greene, 1986). This species has the chromosome number 49 that allows it to maintain itself through asexual reproduction, which partially explains the low genetic variability found within the sampled population (David O'Malley, personal communication, 2000).

Potentilla robbinsiana is endemic to the White Mountains of New Hampshire and is restricted to two small, distinct areas on lands administered by the White Mountain National Forest. Herbaria collections suggest that historically there may have been a number of small populations in close proximity to these two areas. Currently there are only two natural populations. Reports of occurrences outside of New Hampshire have been discounted (Cogbill, 1993), and records indicate that Potentilla robbinsiana has always had a very narrow geographic distribution.

The largest natural population of Potentilla robbinsiana occurs on Monroe Flats located just above treeline on a col (saddle) between Mt. Monroe and Mt. Washington in the Presidential Range. Within this small area (less than 1 hectare (ha) (2.5 acres (ac))), the population is well established with more than 14,000 plants at present. Considering its local abundance and density at this one location, we assume that some of the unique features of Monroe Flats are important habitat requirements for Potentilla robbinsiana . Monroe Flats (elev. 1,550 meters (m) (5,085 feet (ft.)) consists of an exposed low dome that is covered with alternating bands of relatively barren small-stoned terraces and thickly vegetated mats. Blowing winds keep the Monroe Flats mostly free of snow and ice throughout the winter, leaving the vegetation exposed to the abrasive action of blowing snow and ice, and desiccating winds. The moist, barren soils are also susceptible to frost disturbance from freeze-thaw cycles for much of the year. In this extreme environment of moderate solifluction (soil movement downslope) and exposed topography, Potentilla robbinsiana occupies a narrow niche: It is likely a poor competitor with other species, but is able to thrive in a harsh environment where few other species can survive (Cogbill, 1987).

The second extant natural population occurs on Franconia Ridge, 30 kilometers (km) (18.6 miles (mi)) to the west of the Monroe Flats population. Although still within the alpine zone, the habitat here is markedly different. A limited number of plants grow at a site on the south end of the Franconia Ridge in crevices along the side of a vertical cliff just below the ridgeline. Although records indicate that the Franconia population was never very large, it is likely that these few plants are the remnants of a larger population from more suitable habitat that previously existed along the top of the ridge. The habitat has long since eroded and the plants have disappeared due to hiking activity along a ridgeline trail.

Potentilla robbinsiana was listed as endangered on September 17, 1980, and critical habitat encompassing the Monroe Flats population was designated at that time. Overzealous specimen collecting and unregulated hiker disturbance were the reasons for listing. At the time, the extent of the Monroe Flats population was shrinking (Graber and Brewer, 1985), and the Franconia Ridge population was thought to be extirpated.

We approved a recovery plan for Potentilla robbinsiana in 1983 and revised it in 1991 (U.S. Fish and Wildlife Service 1991). We began recovery activities in 1979, focusing on the only known population at Monroe Flats. Important features of the recovery efforts for this species included: construction of a scree wall; signs to alert the public to stay on the trail; Educational posters at the Lake-of-the-Clouds hut; monitoring the use of the Crawford Path; and trail relocation to avoid disturbance. We subsequently rediscovered the natural Franconia Ridge population in June of 1984, which was represented by a single known plant.

Prior to listing, there had been a number of attempts to establish transplant populations at approximately 20 locations throughout the White Mountains (Graber, 1980). Although some of these efforts showed signs of initial success, all but one eventually failed due to unsuitable habitat or because patches of suitable habitat were too small to support viable populations. The Appalachian Mountain Club's Research Department reviewed these efforts, and, using the lessons learned, narrowed recovery efforts to four potential sites as outlined in the updated 1991 recovery plan: Two used in the previous transplant efforts (Camel Patch and the Viewing Garden) and two new ones (Boott's Spur and an additional Franconia Ridge population).

Of the transplant populations created prior to this species' listing, one continues to persist. Camel Patch received an unknown number of transplants by Raymond E. Gerber from the 1980s to 1991 (records unavailable). The Appalachian Mountain Club inventoried this site starting in 1984 when they located 84 plants. Only one of the transplant zones in this habitat showed viable natural reproduction occurring. This population was monitored annually from 1984 to 1992 and again in 1995, with annual monitoring beginning again in 1998. Supplementation of this population began in 1999 with 6 transplants, which boosted this population to 23 adults, 60 juveniles, and 6 new transplant adults. Since 1999, an additional 31 transplants were done, bringing the population to 40 adults and 57 juveniles. The Viewing Garden had received 19 known adult transplants from about 1980 through 1997. Though the adults survived for some time, viable natural reproduction was problematic and these individuals died out over time.

Transplant efforts to new locations began in 1986 with the introduction of 160 plants over three years at the Boott's Spur site. The site showed some initial promise, but by 1991 mortality was 100%. Although the Boott's Spur location was recognized as suboptimal habitat and had failed in a previous transplant effort, another 27 plants were transplanted in 1995, but none survived after the first year. The new Franconia population was established in 1988 with 61 plants transplanted over 2 years and an additional 108 plants through 1996, the date of the last transplant efforts. Like the natural populations, this transplant population has fluctuated over the years, but now appears well established with over 337 plants counted in 2001 and good natural recruitment occurring.

Section 12 of the Endangered Species Act of 1973 directed the Secretary of the Smithsonian Institution to prepare a report, within 1 year after passage of the Act, on those plants considered to be endangered, threatened, or extinct. This report, designated as House Document No. 94-51, was presented to Congress on January 9, 1975. On July 1, 1975, the Director of the Service published a notice in the Federal Register (40 FR 27823) of his acceptance of the report of the Smithsonian Institution as a petition within the context of section 4(c)(2) of the Act, and of his intention thereby to review the status of the plant taxa named within. On June 16, 1976, the Service published a proposed rulemaking in the Federal Register (41 FR 24523) to determine approximately 1,700 vascular plant species to be endangered species pursuant to section 4 of the Act. Comments on this proposal were summarized in the April 26, 1978, Federal Register publication of a final rule, which also determined 13 plants to be either endangered or threatened species (43 FR 17909). Potentilla robbinsiana was included in the Smithsonian's report, the July 1, 1975, notice of review, and the June 16, 1976, proposal.

The amendment of the Act in 1978 required that all proposals over 2 years old be withdrawn. A 1-year grace period was given to proposals already over 2 years old. On December 10, 1979, we published a notice withdrawing the June 16, 1976, proposal to list Potentilla robbinsiana (44 FR 70796).

Based on sufficient new information, we again proposed Potentilla robbinsiana for listing on March 24, 1980, and proposed its critical habitat for the first time (45 FR 19004). A public meeting was held on this proposal on April 28, 1980, in Concord, New Hampshire. On September 17, 1980, we published a final rule in the Federal Register (45 FR 61944) listing Potentilla robbinsiana as endangered and designating critical habitat.

On June 8, 2001, we proposed to remove Potentilla robbinsiana from the List of Endangered and Threatened Plants because the available data indicate that this species has recently met the goals for delisting. In our Federal Register notice (66 FR 30860), we requested that all interested parties provide information and comments on the status of this species.

As mentioned in the “Background” section, Potentilla robbinsiana is endemic to alpine areas of the White Mountain National Forest. The species is limited in its distribution as it occupies a unique habitat within the alpine zone that is very restricted geographically. There are currently four populations of the species; three are considered viable (over 50 plants), Monroe Flats, Camel Patch transplant site, and the Franconia Ridge transplant site. One site, the natural Franconia Ridge site has a very limited range of habitat. This population continues to sustain itself. However, we believe it will never reach the 50 plants needed to be considered viable due to limited suitable habitat.

Table 1 shows the Monroe Flats census counts of the species. Although counts were undertaken in 1973, 1983, and 1992, the methodology used to count the plants differed. The most reliable comparison between the three prior censuses and the most recent census (1999) is the number of plants found that were greater than 14 millimeters (mm) (0.5 in.) in stem diameter. Comparing the number of plants greater than 14 mm in diameter for censuses in 1983, 1992, and 1999 clearly demonstrates that the Monroe Flats population has dramatically increased.

Both the Camel Patch and Franconia Ridge transplant populations have persisted for more than 10 years. Both have juvenile recruitment and successful second generation seedling establishment. Transplant and/or monitoring efforts for these populations continue on a near annual basis (Kimball, 1998). The high level of soil movement throughout Camel Patch makes much of the site unsuitable for transplant efforts, nevertheless a population located along the edge of the encircling vegetation is well established. The Franconia Ridge population has increased dramatically in recent years and is now well established.

An 11-year demographic study, funded by the Service, the U.S. Forest Service, and Appalachian Mountain Club, was conducted along four permanent transects within the Monroe Flats population. The purpose of this study, in part, was to determine a minimum viable population for the transplant populations centered on the survival of each life stage of the plant at the Monroe Flats population. The study recommended a minimum viable population of 50 plants (Iszard-Crowley and Kimball, 1998). Both the Camel Patch location with a current population of 97 plants (Table 2) and the Franconia transplant location with a current population of 337 plants (Table 3) meet this criterion.

In accordance with section 4(f)(1) of the Act, the Service is responsible for the development and implementation of recovery plans for all listed species, to the maximum extent practicable. The first Robbins' Cinquefoil Recovery Plan was completed in 1983, and featured two main objectives: (1) To protect the existing Monroe Flats colony, encouraging its expansion to previously occupied habitat; and (2) to establish self-maintaining populations in at least four additional potential habitats not occupied at the time.

To accomplish the first objective, a scree wall surrounding the Monroe Flats population was constructed and posted with “closed to entry” signs, and two hiking trails that had previously traveled through the Monroe Flats population were relocated away from the population. Plants have since been successfully transplanted back into the habitat where the trails had resulted in the localized demise of the plants, primarily at the highest elevation in the Monroe Flats population. The ability of seed to move downhill from this recolonized site should benefit the Monroe Flats population. In addition, personnel from the White Mountain National Forest and Appalachian Mountain Club continue to provide stewardship, enforcement, and educational resources on site.

Several tasks were necessary to meet the second objective of establishing four additional self-maintaining transplant populations: (1) Protocols were developed to monitor the Monroe Flats population to better understand its demographic trends and natural rates of recruitment and mortality, and to collect data to model minimum viable population size; (2) the natural Franconia Ridge population (rediscovered in 1984) was annually monitored; (3) micro-habitat components were identified and used to locate unoccupied, potentially suitable habitat; and (4) effective propagation and transplant techniques were developed. Transplant techniques varied over the years. However, the most successful efforts used 2-year-old plants germinated from seed, and transplanted with the soil media intact in mid-June to early July. Each year a portion of the seed collected for use in transplants is placed in cold storage at the New England Wildflower Society to establish a seed bank for this species.

As mentioned in the “Background” section, two of the transplant sites failed, Boott's Spur and the Viewing Garden. The other two transplant sites, Franconia and Camel Patch, are both considered viable populations with 331 plants and 87 plants respectively, in 1999. As of 2001, these populations increased to 337 plants and 97 plants respectively.

The Robbins' Cinquefoil Recovery Plan: First Update, published in 1991, retained recovery criteria for the protection of existing natural populations and establishing additional transplant populations, but also contained minor changes to incorporate the rediscovered natural Franconia population, and acknowledged that suitable additional unoccupied habitat may be a limiting factor. In addition to the protection of the natural populations, this plan determined that a historically occupied zone within the Monroe Flats should be recolonized. Transplant efforts began in 1996 to meet this objective, and successful juvenile recruitment has since been observed.

To delist Potentilla robbinsiana , long-term demographic evidence must show that the Monroe Flats population is stable or increasing in size. As mentioned in the “Summary of Current Status” section, comparing the number of plants greater than 14 mm in stem diameter for censuses in 1983, 1992, and 1999 clearly demonstrates that the Monroe Flats population has dramatically increased.

While the 1991 recovery plan calls for the establishment of four transplant populations, it also recognizes that suitable habitat may be a limiting factor, and requires only two of the four transplant populations to be viable. Introduction of plants to the Boott's Spur location has subsequently been dropped due to the unsuccessful transplant efforts resulting in 100% mortality. The Viewing Garden location also showed 100% mortality in 1998. There are no plans to reestablish a population at this location because the suitable habitat is very limited and cannot support more than a few individual plants that are unlikely to persist under natural population fluctuations. Biologists familiar with this species are confident that little if any suitable habitat in the White Mountains remains to be discovered (K. Kimball, Appalachian Mountain Club, pers. comm. 2000). Therefore, given that the discovery of additional suitable habitat for the establishment of new transplant attempts is unlikely, recent efforts have focused on ensuring viable populations at the two remaining transplant locations, Camel Patch and Franconia Ridge. As stated in the “Summary of Current Status” section, research on the species has determined that a minimum viable population consists of 50 plants (Iszard-Crowley and Kimball, 1998). Both the Franconia transplant location with a current population of 337 plants and the Camel Patch location with a current population of 97 plants meet this criterion.

In the June 8, 2001, proposed rule (66 FR 30860) we requested that all interested parties provide information and comments on the status of Potentilla robbinsiana and the proposal to delist this species. The public comment period ended August 7, 2001. Announcements of the proposed rule were sent to Federal and State agencies, elected officials, interested private organizations and citizens, and local area newspapers.

We received a total of two written comments, one from an individual and one from an organization. The organization (Appalachian Mountain Club) supports the delisting proposal, while the individual did not support it. Comments are discussed below. In addition, we considered and incorporated, as appropriate, into the final rule all biological and commercial information obtained through the public comment period.

Issue 1: Both commenters mention that the more appropriate common name for the species is dwarf cinquefoil.

Our response: We agree that the current common name is dwarf cinquefoil. Throughout this document we refer to the species by using the Latin name Potentilla robbinsiana . The exception being, when referencing the recovery plans, where the formal title of the plans refers to the species as Robbins' cinquefoil. We continue to use the common name of Robbins' cinquefoil for this species since that was the common name under which this species was associated at the time of listing.

Issue 2: One commenter recommends that all future population counts should be for total population, not transect counts as suggested in the proposed rule.

Our response: We agree that a total population census using a grid sampling methodology would provide more consistent comparisons over time. For the 5-year post-delisting monitoring, a total population census will be used. However, as explained in the “Summary of Current Status” section, the most reliable comparison between the 3 prior censuses and the most recent census (1999) is the number of plants found that were greater than 14 mm (0.5 in.) in stem diameter.

Issue 3: One commenter was concerned that the proposed rule does not technically satisfy some of the downlisting and delisting criteria contained in the updated recovery plan.

Our response: As mentioned in the proposed rule, the downlisting and delisting objectives in the 1991 recovery plan update were based on the best information available at that time. The recovery plan states “that approved recovery plans are subject to modification as dictated by new findings, changes in species status, and the completion of recovery tasks.” Each recovery objective from the 1991 plan is addressed in the “ Potentilla robbinsiana Recovery ” section of this rule. This section lays out the recovery actions that have led to the decision to delist the species, even though not every objective was met. In addition, we have determined that none of the five listing factors identified in the Act remain a threat to Potentilla robbinsiana. The objectives identified during the recovery planning process provide a guide for measuring the success of recovery, but are not intended to be absolute prerequisites, and should not preclude a reclassification or delisting action if such action is otherwise warranted.

Issue 4: One commenter was concerned that the Service did not seek the review and concurrence from the ad hoc recovery group for Potentilla robbinsiana.

Our response: The ad hoc recovery group first met shortly after the listing of the species in 1980. At that time and up until the present, this group was never a formalized recovery team with members appointed by the Regional Director. This group was consulted at one time, but the Service never asked for a consensus on any matters. This group has not met in over a decade. The Service did seek scientific review and comment from all interested stakeholders during our public comment period associated with the proposed rule.

Issue 5: One commenter was concerned that the Service did not complete tasks 5.3 and 7 in the original recovery plan of 1983, and task 5.1 of the updated plan, prior to publishing the proposed rule.

Our response: We disagree. Task 5.3 of the original plan, “Develop news releases, articles and maintain contact with interested groups,” was not included in the updated plan of 1991. Task 7 of the original plan and task 5.1 of the updated plan are essentially the same: “submit an annual report on all conservation activities and research findings.” The Appalachian Mountain Club has submitted annual Potentialla robbinsiana progress reports consistently since 1984 to both the Service and the White Mountain National Forest. Additional reports including several updates on germination and transplanting of the species and a demographic analysis of Potentialla robbinsiana were also supplied to the Service and the White Mountain National Forest.

Issue 6: One commenter asked if the proposed rule received approval of the recovery team or was peer-reviewed by conservation biologists.

Our response: There is no recovery team for this species. Instead, the Service submitted the proposed rule to three organizations: the White Mountain National Forest, the Appalachian Mountain Club, and the New England Wild Flower Society, for scientific review. Scientists associated with these organizations, who are knowledgeable about Potentilla robbinsiana's status and biology, reviewed the proposed rule. Only the Research Department of the Appalachian Mountain Club chose to provide a written endorsement of the proposed rule. The State of New Hampshire's Natural Heritage Program also received a copy of the proposed rule, and has been an active participant in the recovery planning and efforts for this species.

Issue 7: One commenter was concerned that the proposed rule did not provide indication of active protection efforts from off-trail hikers at the Camel Patch population or from rock climbers at the natural Franconia Ridge population.

Our response: Surveys have yielded no evidence of trespass or disturbance to these populations. We, together with the Appalachian Mountain Club, monitor the transplant populations and the Franconia Ridge natural population on a near annual basis. It is recommended by the Appalachian Mountain Club, and the Service concurs, that the best long-term management for these populations is to manage them, but not to draw attention to them. Unlike the Monroe Flats population, these three populations are generally unknown and less accessible. Attempts to manage trespass using scree walls, signage, or other means, may call more attention to these discrete populations than the current low-key strategy.

Issue 8: One commenter noted that transplanted subpopulations at the Monroe Flats population are not necessarily viable.

Our response: We consider the Monroe Flats population to be one population and do not identify subpopulations. Task 4.5 of the updated recovery plan directs efforts to recolonize extirpated historical sites in the essential Monroe Flats habitat. Rather than ensuring additional viable subpopulations within Monroe Flats, the purpose of this task was to expand the population to its historical spatial extent where possible. Transplant efforts on Monroe Flats have focused in areas where plants had been extirpated due to trampling. Substrate directly along the now discontinued section of the Crawford Path has been heavily impacted and is no longer suitable habitat. However, impacts on either side of the discontinued trail have been less significant, and have been the focus of transplant efforts, including the high-point on Monroe Flats known as the “Dome.” This location may play an important role as seed source for downslope areas since seeds rarely migrate far from the parent plant. The past impact from substrate compression makes the habitat suitability and future status of this part of the transplant area uncertain. However, recent transplant survival has been strong, and there is seedling and juvenile recruitment in these areas, which meets the stated recovery task. Regardless of the potential for long-term reestablishment within the extirpated areas, these plants represent less than one percent of the Monroe Flats population and do not affect the viability of the Monroe Flats population.

Issue 9: One commenter was concerned with the statement that there is no suitable unoccupied habitat left for the species, and considers this as self-fulfilling and thus tautological.

Our response: As stated in the proposed rule under the “Background” section, prior to listing there had been a number of attempts to establish transplant populations at approximately 20 locations throughout the White Mountains. In 1986, with the experience gained from previous efforts, the four most appropriate transplant sites were determined, and efforts began. Of these four locations, two persist today. Given this species' unique habitat needs, the small geographic extent of such habitat, and the fact that transplanting efforts occurred at over 20 sites, we feel that locating additional suitable habitat for new transplant attempts is unlikely.

Issue 10: One commenter questioned why, if the Camel Patch population is deemed viable, we continue to supplement it.

Our Response: Seeds are collected annually from the Monroe Flats population and shipped to the New England Wild Flower Society for future germination and propagation. In the past, plants reared from these seeds were transplanted at the Camel Patch and Franconia transplant populations to help establish viable populations. They were also transplanted at the Monroe Flats population, and continue to be in an effort to reestablish adult plants at a topographic high spot so that they can act as an additional seed source for the main population at this site. Currently, the only plants that are transplanted at the Camel Patch population are extra plants intended for the Monroe Flats annual transplant effort. These plants are strategically placed to allow seed to flow downhill of the habitat in an effort to physically expand this population.

Section 4 of the Act and regulations (50 CFR part 424) promulgated to implement the listing provisions of the Act, set forth the procedures for listing, reclassifying, and delisting species on the Federal lists. A species may be listed if one or more of the five factors described in section 4(a)(1) of the Act threatens the continued existence of the species. A species may be delisted according to 50 CFR 424.11(d), if the best scientific and commercial data available substantiate that the species is neither endangered nor threatened (1) because of extinction, (2) because of recovery, or (3) because the original data for classification of the species were in error.

After a thorough review of all available information, we determined that substantial Potentilla robbinsiana recovery has taken place since listing in 1980. We have also determined that none of the five factors identified in section 4(a)(1) of the Act, and discussed below, are currently affecting the species in such a way that the species is endangered (in danger of extinction throughout all or a significant portion of its range) nor threatened (likely to become endangered in the foreseeable future throughout all or a significant portion of its range). These factors and their application to Potentilla robbinsiana are as follows:

Potentilla robbinsiana utilizes a substrate described as shallow loamy sand topped with a stony, pavement-like surface. This stony surface layer protects the soil from being either blown or washed away. The 1980 final listing rule determined that the plant and its habitat were damaged by trampling from hikers. Hiking through the habitat is unimpeded due to the lack of most vegetation. Because the plants are small, it is easy for hiker boots to crush adult, juvenile, and seedling plants.

Since listing, the threat from trampling has been reduced by rerouting trails and protecting habitat. The section of the Appalachian Trail that bisected the Monroe Flats population is referred to locally as the Crawford Path, named after Abel Crawford who constructed the path in 1819. In 1915, the Appalachian Mountain club constructed Lake of the Clouds Hut, 270 m (295 yards (yd)) to the north of the trail. The Crawford Path was relocated at this time to bring the trail by the Hut, and although the trail was no longer directly bisecting Potentilla robbinsiana habitat, it still went through the northwest corner of the critical habitat. In 1983, the Crawford Path and Dry River Trails were rerouted a second time in response to the Federal listing, to move the trails outside of the plant's critical habitat. A low scree wall was constructed in conjunction with the trail relocation, around the critical habitat, and has been particularly effective in places where the trail abuts critical habitat. Signs posted around the Monroe Flats population notify hikers that there is a federally listed species present and no admittance is allowed without a permit. These signs are replaced as needed. Hiker traffic and trespassers into the critical habitat were recorded by pressure plates during 1985 to assess the effectiveness of hiker management. The plates were operated from June through October 1985 and checked several times weekly. Of 4,286 hikers counted over 115 days the counters were functional, the trespass rate was 2 percent (Kimball and Paul, 1986). The target compliance level established by the 1983 recovery plan was 95 percent of the hikers not trespassing into the critical habitat, an objective that has been maintained or exceeded since 1981. Outreach has also been a strong recovery component for ensuring hiker compliance of no trespassing into the Potentilla robbinsiana habitat. A naturalist is stationed at the Lake of the Clouds Hut throughout the summer. The Hut naturalist is available during the day to answer questions and give interpretive talks regarding Potentilla robbinsiana. The naturalist and other Hut staff are also instrumental in monitoring the Monroe Flats population for human disturbance.

In 1973, prior to listing, the Monroe Flats population contained approximately 1,801 individual plants larger than 14 mm (0.55 in). As of 1999, this population included approximately 4,575 individuals of similar size. This represents a greater than 250% increase in this population. Counting plants of all sizes (seedlings to adults) in 1999, the established population size was 14,195 individuals.

The second natural population is near the Appalachian Trail on Franconia Ridge. The locations of this population and the two transplant populations have been purposefully kept undisclosed and are presently out of the way of the average hiking public. Attempts to manage trespass using scree walls, signage, or otherwise, may call more attention to this population than the current low-key strategy.

Records indicate that the extant natural Franconia Ridge population was never very large. Nevertheless, it is considered to be a reproducing population, with 11 individual plants consisting of 3 adults and 8 juveniles as of 2001, and is being monitored regularly by the Appalachian Mountain Club.

The protection efforts in effect for the Monroe Flats population, the existence of two viable transplant populations, and the strategy to manage these two populations and the natural Franconia Ridge population, demonstrate that there is no longer a threat to the habitat of Potentilla robbinsiana.

The 1980 final listing identified that the collecting of specimens for herbaria probably contributed to the loss of Potentilla robbinsiana and possibly the cause for the extirpation of one of the Franconia sites (Steele, 1964). It was noted that over 40 herbarium sheets containing nearly 100 plants (6 percent of the known mature population at the time of listing) were counted in various New England herbaria (Graber, 1980). Cogbill's more recent paper (1993) documents the collection of over 850 plants in herbaria collections worldwide, which represents one of the most extensive collections known for a single species. In the late 1800s some collectors were selling alpine plants, specifically including Potentilla robbinsiana, to other collectors for 10 cents per sheet (Cogbill, 1993). However, commercial trade in the species has not occurred since the early 1900s and is not expected to occur in the future; import or export of this species also is not anticipated. Collection of material for herbaria has declined significantly due to scientists becoming more aware of the impacts of collecting on rare species. Monitoring of these sites does not indicate a problem with overcollection. Therefore, taking of Potentilla robbinsiana for these purposes is not considered to be a threat.

This species is not known to be threatened by disease or predation.

Potentilla robbinsiana is currently afforded limited protection by the Endangered Species Act. Section 9 of the Act prohibits the removal and possession of endangered plants from lands under Federal jurisdiction and the malicious damage and destruction of endangered plants in such areas, and the damage or destruction of endangered plants from any other area in knowing violation of any State law or regulation, or in the course of a violation of State criminal trespass law. Section 7 of the Act requires Federal agencies to ensure that their actions do not jeopardize the continued existence of listed species or destroy or adversely modify designated critical habitat.

Section 7(a)(1) of the Act requires Federal agencies to carry out programs for the conservation of threatened and endangered species. The entire range of Potentilla robbinsiana occurs on Forest Service lands. Forest Service regulations prohibit removing, destroying, or damaging any plant that is classified as a threatened, endangered, rare or unique species (36 CFR 261.9). Currently the species is classified as a G1 species (critically imperiled because of extreme rarity) by the State of New Hampshire's Natural Heritage Program, and appears on the Forest Service's Region 9 (Northeast) list of “species of concern.” These rankings will not change once the species is delisted, thus the Forest Service regulations will remain in effect. On December 2, 1994, we and the Forest Service's White Mountain National Forest signed a Memorandum of Understanding (MOU) for the conservation of Potentilla robbinsiana. The MOU states that the Forest Service agrees to carry out specific management measures, with our assistance, both through the recovery period, and if and when Potentilla robbinsiana is removed from the list of endangered and threatened plants.

Potentilla robbinsiana does appear on the New Hampshire State list of endangered and threatened species, although State legislation currently offers it no protection. However, since this species is endemic to Federal lands administered by the White Mountain National Forest, which has committed to continuing its ongoing program to provide for the long-term conservation of this species, we have determined that there is adequate existing protection in place for this species.

Recovery efforts have been directed toward protection and environmental education. A number of approaches have been used to educate the hiking community, the scientific community, and the public about Potentilla robbinsiana . Providing information to the public regarding the species' biology and management satisfies their curiosity and increases their willingness to participate in protection of this species. These efforts include a permanent display and presentations about Potentilla robbinsiana by the seasonal Appalachian Mountain Club naturalist at Lake of the Clouds Hut.

The 1980 final listing rule mentioned that Potentilla robbinsiana is vulnerable to the harsh climate in which it lives. The weather regime experienced by the species is highly variable from year to year. During demographic studies over the past 16 years, it has been observed that late frosts in June have the potential to damage flowers and greatly reduce the seed crop for that year. By virtue of a deep taproot, the species appears to be adapted to a moderate level of frost-heaving, a stress that may limit competing species. At the same time, it cannot tolerate frost-induced movement of more than 18 mm/yr (.71 in/yr), or frost action sufficient to produce stone stripes or other patterned ground (Cogbill, 1987). Overall, however, this species is now thriving in a very localized part of the alpine zone of the White Mountains, and adapts to the harsh climate conditions, where few other species survive.

In summary, we have carefully reviewed all available scientific and commercial data and conclude that the threats that caused the population of Potentilla robbinsiana to decline no longer pose a risk to the continued survival of the species. This determination is based on the best available data indicating that Potentilla robbinsiana has recovered, primarily as a result of the following: (1) The two natural existing populations are protected from human disturbance, and the Monroe Flats population is considered viable and increasing; (2) the two transplant populations are considered viable; and (3) the Forest Service's commitment to continue ongoing programs to provide for the long-term conservation of this species regardless of its standing under the Endangered Species Act. This recovery indicates that the species is no longer endangered or likely to become endangered in the foreseeable future throughout all or a significant portion of its range. Therefore, the species no longer meets the Act's definitions of endangered or threatened. Under these circumstances, removal from the List of Endangered and Threatened Plants is appropriate.

This final rule will remove the protections afforded to Potentilla robbinsiana under the Act. Furthermore, the critical habitat for this plant, one location in the White Mountain National Forest, New Hampshire (50 CFR 17.96(a)), will be removed. The prohibitions and conservation measures provided by the Act will no longer apply to this species. Therefore, taking, interstate commerce, import, and export of Potentilla robbinsiana will no longer be prohibited under the Act. In addition, Federal agencies will no longer be required to consult with us under section 7 of the Act to insure that any action they authorize, fund, or carry out, is not likely to jeopardize the continued existence of Potentilla robbinsiana or destroy or adversely modify designated critical habitat.

The take and use of Potentilla robbinsiana must comply with appropriate Forest Service regulations, since the entire population lies within the White Mountain National Forest in New Hampshire.

Section 4(g)(1) of the Act requires that the Secretary of the Interior, through the Service, implement a monitoring program in cooperation with the States for not less than 5 years for all species that have been recovered and delisted. The purpose of this requirement is to develop a program that detects the failure of any delisted species to sustain itself without the protective measures provided by the Act. If at any time during the 5-year monitoring program, data indicate that protective status under the Act should be reinstated, we can initiate listing procedures, including, if appropriate, emergency listing.

Our Northeast Region will coordinate with the Forest Service, the Appalachian Mountain Club, and State resource agencies to implement an effective 5-year monitoring program to track the population status of Potentilla robbinsiana . We will annually evaluate the effectiveness of ongoing conservation programs, including education, monitoring, and enforcement efforts, in order to detect and assess any new threats to the populations. To detect any changes in the status of Potentilla robbinsiana , we will use, to the fullest extent possible, information routinely collected by the Appalachian Mountain Club's Research Department and the Forest Service. During the fifth year of the 5-year monitoring period, a total population census of the Monroe Flats population will be conducted using a grid to further evaluate the stability and health of this population.

We believe that the two transplanted sites have reached viable population status. However, during the required 5-year monitoring period, transplanting at the Camel Patch site will continue when excess plants are available from the New England Wild Flower Society. The transplants will be used to fill sparse areas and expand the population.

If we determine at the end of the mandatory 5-year monitoring period, which shall include data from the fifth year population census of Monroe Flats, that recovery is complete, and factors that led to the listing of Potentilla robbinsiana , or any new factors, remain sufficiently reduced or eliminated, monitoring may be reduced or terminated. If data show that the species is declining or if one or more factors that have the potential to cause a decline are identified, we will continue monitoring beyond the 5-year period and may modify the monitoring program based on an evaluation of the results of the initial 5-year monitoring program, or reinitiate listing if necessary.

This rule was not reviewed by the Office of Management and Budget (OMB) under Executive Order 12866.

The OMB regulations at 5 CFR part 1320, which implement provisions of the Paperwork Reduction Act, require Federal agencies to obtain approval from OMB before collecting information from the public. The OMB regulations at 5 CFR 1320.3(c) define a collection of information as the obtaining of information by or for an agency by means of identical questions proposed to, or identical reporting, record keeping, or disclosure requirements imposed on, 10 or more persons. Furthermore, 5 CFR 1320.3(c)(4) specifies that “ten or more persons” refers to the persons to whom a collection of information is addressed by the agency within any 12-month period. For purposes of this definition, employees of the Federal Government are not included.

This rule does not include any collection of information that requires approval by OMB under the Paperwork Reduction Act. Potentilla robbinsiana occurs entirely on lands administered by the Forest Service and only in one State, New Hampshire. The information needed to monitor the status of Potentilla robbinsiana following delisting will be collected primarily by a limited number of personnel from the Forest Service and the Appalachian Mountain Club. We do not anticipate a need to request data or other information from 10 or more persons during any 12-month period to satisfy monitoring information needs. If it becomes necessary to collect information from 10 or more non-Federal individuals, groups, or organizations per year, we will first obtain information collection approval from OMB.

We have determined that we do not need to prepare an Environmental Assessment, as defined under the authority of the National Environmental Policy Act of 1969, in connection with regulations adopted pursuant to section 4(a) of the Endangered Species Act as amended. We published a notice outlining our reasons for this determination in the Federal Register on October 25, 1983 (48 FR 49244).

A complete list of all references cited herein is available upon request from our Northeast Regional Office (see ADDRESSES section).

The primary author of this rule is Diane Lynch, Endangered Species Biologist (see ADDRESSES section). Doug Weihrauch, staff scientist for the Appalachian Mountain Club Research Department, provided assistance with the summary of the biological record for this species.