A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) that applies to BHTC Model 407 helicopters was published in the Federal Register on July 20, 2000 (65 FR 44994). That action proposed to require visually inspecting certain brackets that attach slots to the horizontal stabilizer for a crack and replacing any slat assembly that has a cracked bracket. Also proposed was installing different part-numbered airworthy segmented slat assemblies on all affected models prior to flight after December 31, 2000.

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

The FAA estimates that 348 helicopters of U.S. registry will be affected by this AD, that it will take approximately 0.5 work hour per helicopter to perform the visual inspections, 1 work hour to replace a slat assembly, and that the average labor rate is $60 per work hour. Required parts will cost approximately $2,364 per segmented slat assembly. Based on these figures, the total cost impact of the AD on U.S. operators is estimated to be $1,697,544, assuming 1 inspection per helicopter and replacement of the 2 slat assemblies on each helicopter.

The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

For the reasons discussed above, I certify that this action (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. A final evaluation has been prepared for this action and it is contained in the Rules Docket. A copy of it may be obtained from the Rules Docket at the location provided under the caption ADDRESSES.

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an airworthiness directive (AD) that is applicable to certain Boeing Model 747-400 series airplanes was published in the Federal Register on October 6, 1999 (64 FR 54229). That action proposed to require removal of existing inertial reference units (IRU) and installation of modified IRU's.

Interested persons have been afforded an opportunity to participate in the making of this amendment. Due consideration has been given to the comments received.

One commenter supports the proposed rule.

Three commenters request that the FAA extend the proposed compliance time for the installation of modified IRU's.

The first commenter states that sending all its units back to the parts manufacturer for modification will take at least two weeks per unit. Additionally, taking the unmodified units off all of its airplanes and shipping them will delay completion of the installation required by the proposed AD until receipt of the modified units. Therefore, the proposed installation would not be accomplished until February 2002. The commenter adds that the dual inertial reference system (IRS) failure that prompted this proposal, as stated in the preamble, was caused by a short circuit in the brake system control unit (BSCU). The airplane manufacturer later determined that the short circuit was due to moisture ingested into the BSCU, and released Boeing Service Bulletins 747-25-3080, Revision 2, dated February 29, 1996 (improves the integrity of the drip shields), and 747-53-2402, dated December 21, 1995 (installs protective panels over the drip shields to protect them from damage) to address this condition. The commenter has completed these modifications, and notes that these modifications significantly reduce the likelihood of water damage to the BSCU. The commenter states that, considering these airplane modifications and the realities of the modification stated above, a two-year compliance time would be more realistic.

The second commenter states that 12 months is an unrealistic and unnecessary compliance time, and submits the following factors for consideration:

• First, the IRU part numbers addressed by the proposal are used on Boeing Model 737-300/400/500, 757, and 767 series airplanes, in addition to Model 747-400 series airplanes. Many of the 747-400 operators also operate some of the other airplane types and have common spares. The operators will either have to maintain separate spares for the Model 747-400 series airplanes, or modify all of the spares. If the operators are forced into maintaining separate spares, this will increase the quantity of spare units required.

• Second, while there is a potential for this condition to develop, the probability of occurrence is lower than implied in the proposal. The availability of standby heading and attitude systems, plus the ability of the IRU to recover heading and attitude capability, also reduce the urgency to complete all updates within 12 months. Considering the above factors, the commenter recommends the compliance time be extended from 12 months to at least 24 months, with the expectation that an extension will likely be needed for full compliance.

The third commenter requests that the compliance time be changed from 12 months to 24 months, but does not give a reason for this request.

The FAA concurs with the commenters' requests to extend the compliance time for installation of modified IRU's; however, the FAA does not concur with the length of time requested by the commenters. Following careful consideration of the comments, the FAA considers that an extension of the compliance time specified in paragraph (a) of this AD from 12 months to 18 months will not compromise safety. Paragraph (a) of this final rule has been revised accordingly.

Three commenters request that the applicability of the proposed rule be revised.

The first commenter requests that the proposed applicability be revised to apply to all Model 747-400 series airplanes, not just specific line numbers as written in the applicability section. The commenter states that some of its recent deliveries of Model 747-400 series airplanes had the upgraded IRU's installed at delivery, and those line numbers are not included in the current applicability of the proposed rule. The commenter also notes that it is possible that one or more of the upgraded IRU units were replaced with an older IRU after the airplane went into service; therefore, it is the commenter's intent to accomplish the proposed requirements on all of its Model 747-400 series airplanes.

The second commenter requests that the statement “certain Boeing Model 747-400 series airplanes,” in the preamble of the proposed rule be revised to read, “all Boeing Model 747-400 series airplanes equipped with Honeywell inertial reference systems.” The commenter notes that explicitly stating this up front in the proposed AD provides clarification of the airplanes affected by the proposal. The commenter also recommends identifying a second grouping in the applicability section to make the spares requirement [paragraph (b)] applicable to all Model 747-400 series airplanes.

The third commenter states that some Model 747-400 series airplanes not specified in the proposal may have had replacement IRU's installed that should be modified.

The FAA does not concur with the commenters' request. In response to the first and second commenters, all new 747-400 series airplanes after line number 1187 were delivered with newly designed IRU's installed, and the FAA previously disseminated instructions to operators about replacement or exchange of the new IRU's with older-type IRU's. In response to the third commenter, the FAA has addressed the intent of the commenter's request in paragraph (b) of this AD.

One commenter suggests that since the problem referenced in the proposed rule is unique to Model 747-400 series airplanes, and other IRS-equipped fleets can continue using older part numbers, the text in the spares paragraph should be revised from “any airplane” to “any 747 airplane.”

Two commenters recommend the wording in the spares paragraph be revised to read, “As of the required compliance date for this AD, no person shall install an IRU with a Boeing part number which precedes S242T101-113 on a Boeing 747-400 series airplane,” or “Subsequent to the required compliance date of this AD, no person shall install a Honeywell IRU having a Boeing part number that precedes S242T101-113 on a Boeing Model 747-400 series airplane.” The commenter states that this is to require the use of modified IRU's after the compliance date, thereby permitting the use of existing inventory during the interim period and to preclude the use of any IRU preceding part number S242T101-113 after the compliance date.

The FAA does not concur with the commenters' requests to change the words in the spares paragraph from “on any airplane” to “on any Boeing Model 747-400 airplane,” or “with a Boeing part number that precedes S242T202-113 on a Boeing Model 747-400 series airplane.” The applicability statement of all AD actions lists all models affected by that AD. All of the requirements stated in an AD are applicable only to the airplane models listed in the applicability, and based on information received from the parts manufacturer, only the IRU's having the part numbers listed in the spares paragraph are affected by the AD.

Additionally, the FAA does not concur with changing “As of the effective date * * * ” to “As of the compliance date * * * ” Removing an unsafe condition that already exists on an airplane necessarily involves performing maintenance on the airplane, and the FAA always provides some kind of “grace period” in order to minimize disruption of operations. On the other hand, prohibiting installation of spares that have been determined to create an unsafe condition does not require any additional maintenance activity; it simply requires use of one part rather than another. In general, once an unsafe condition has been determined to exist, it is the FAA's normal policy not to allow that condition to be introduced into the fleet. In developing the technical information on which every AD is based, one of the important considerations is the availability of parts that the AD will require to be installed. When it is determined that those (safe) parts are immediately available to operators, it is the FAA's policy to prohibit installation of the unsafe parts as of the effective date of the AD.

Therefore, the FAA finds that there is no justification for making the changes requested by the commenters. No change to the final rule is necessary in this regard.

One commenter requests that the unsafe condition as stated in the proposed rule be revised from “ * * * compromise the ability of the flight crew to maintain the safe flight and landing of the airplane” to “ * * * compromise the ability of the flight crew to subsequently cope with adverse operating conditions.” The commenter states that the loss of primary data to both pilots, in addition to loss of other navigational information is improbable. The commenter adds that while loss of primary data could impact operations during adverse conditions, with standby data available, loss of primary data does not impact safe flight of the airplane.

The FAA does not concur with the commenter's request. The FAA has determined that, should an airplane lose all three IRU's, which would result in operating with only one standby instrument, it would indeed impact safe flight of the airplane due to reduced controllability resulting from loss of the IRU's. No change to the final rule is necessary in this regard.

One commenter describes revisions to various sections of the preamble of the proposed rule. In the “Summary” section, the commenter revises the wording to state that the proposed AD is applicable to 747-400 series airplanes equipped with the Honeywell IRS, and to present a logical sequence for the event and the consequences. The commenter also changes the statement of unsafe condition from “ * * * maintain the safe flight and landing of the airplane” to “ * * * subsequently cope with adverse operating conditions.” In the “Discussion” and “Explanation of Relevant Service Information” sections, the commenter suggests revising the wording to ascribe the reported event specifically to a Model 747-400 series airplane equipped with the Honeywell IRS, to indicate the data loss, and to discuss attributed causes of the event. In the “Explanation of Requirements of Proposed Rule” section, the commenter revises the wording to clarify the intent of Boeing Alert Service Bulletin 747-34A2638, Revision 1, dated April 8, 1999, as applicable to multiple part numbers of Honeywell IRU's. In the “Differences Between Proposed Rule and Alert Service Bulletin” section, the commenter revises the wording to identify the time necessary to perform the required replacement as being consistent with the alert service bulletin estimate, and to identify compliance time based on initial estimates from Honeywell and operators' recommendations.

Another commenter states that actions specified in the proposal are intended to prevent loss of navigation during flight. The commenter discusses the various navigation systems and notes that it is rare that navigation data from the IRU's are used during the approach and landing phase of flight. The commenter further states that the event that prompted the NPRM included loss of primary heading and attitude data from the left and center IRU's, as well as loss of navigation data. The right IRU was still providing valid heading and attitude reference, and the standby systems were available. The commenter adds that when the voltage was removed, the faulted IRU's could have been reset to the “ATTITUDE” mode, which returns the primary heading and attitude functions.

The same commenter states that the proposal states that this condition is likely to exist on other products of the same type design. However, the commenter notes that to its knowledge, this is the only occurrence of this condition throughout the entire service life of the Model 747-400 series airplane. In addition, the commenter states that service information has been issued to address the broken or damaged drip shields, which allowed liquid to enter the BSCU and cause the electrical fault. The commenter recommends the wording in the “Explanation of Requirements of Proposed Rule” be changed to “may develop” or similar wording which better describes the low probability of occurrence for this condition.

The FAA concurs with the commenter's description of the intent of these sections; however, because only the “Summary” section is restated in the final rule, no change to the other sections, as stated above, is necessary. Additionally, the “Summary” section of this final rule only represents a brief synopsis of the AD, it is accurate as proposed, therefore, no change to the final rule is necessary.

Three commenters request that the cost information in the proposed rule be revised.

The first commenter states that the cost to U.S. operators estimated in the proposal is approximately $3,000, and reasons that the true costs involved are significantly higher for the following reasons:

• First, the cost estimate in the proposal allowed for 1 hour per airplane; however, the actual time to remove, install, and functionally check all three IRU's will be longer.

• Second, the cost estimate did not include any of the operators' costs for internal processing, shipping, and handling.

• Third, the operators may have to purchase additional spare units to support rotation of IRU's through the modification program.

• Fourth, the estimate does not include the cost to modify or update the IRU's. In addition, the commenter notes that, although there is no cost specified in the proposal for the required parts, the parts manufacturer will charge for the modification of some parts. Therefore, the statement that the manufacturer will provide parts at no cost is inaccurate and should not be included in the proposal.

The second commenter states that the estimated work hours in the cost information section should be revised from 1 work hour to 2.25 work hours to identify cost impacts consistent with the estimated time to perform the proposed replacement.

The third commenter makes no specific request for a change to the proposed rule, but states that, if the 12-month compliance time is retained, it could be faced with purchasing additional shipsets of IRS units (assuming they are available in time) in order to expedite accomplishment of the fleet campaign. The commenter notes that a shipset costs about $450,000, and two additional shipsets might be needed.

The FAA agrees with the first commenter, in that the service bulletin does not specify that the required parts will be supplied by the parts manufacturer at no cost to the operators. The service bulletin merely states that the operator can supply the parts. Information received from the parts manufacturer states that it will supply the parts for the actions required by this AD; however, any other modifications will be paid for by the operators. No change to the final rule is necessary in this regard.

The FAA does not concur with revising the work hours necessary for accomplishment of the required replacement. The cost impact information describes only the “direct” costs of the specific actions required by this AD. The number of work hours necessary to accomplish the required actions, specified as 1 work hour in the cost impact information below, was provided to the FAA by the manufacturer based on the best data available to date. This number represents the time necessary to perform only the actions actually required by this AD. The FAA recognizes that, in accomplishing the requirements of any AD, operators may incur “incidental” costs in addition to the “direct” costs. The cost analysis in AD rulemaking actions, however, typically does not include incidental costs, such as the time required to gain access and close up, planning time, or time necessitated by other administrative actions. Because incidental costs may vary significantly from operator to operator, they are almost impossible to calculate. No change to the final rule is necessary in this regard.

After careful review of the available data, including the comments noted above, the FAA has determined that air safety and the public interest require the adoption of the rule with the changes previously described. The FAA has determined that these changes will neither increase the economic burden on any operator nor increase the scope of the AD.

There are approximately 429 Model 747-400 series airplanes of the affected design in the worldwide fleet. The FAA estimates that 50 airplanes of U.S. registry will be affected by this AD, that it will take approximately 1 work hour per airplane to accomplish the required replacement, and that the average labor rate is $60 per work hour. Required parts will be supplied by the parts manufacturer at no cost to the operators. Based on these figures, the cost impact of the AD on U.S. operators is estimated to be $3,000, or $60 per airplane.

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

The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

For the reasons discussed above, I certify that this action (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. A final evaluation has been prepared for this action and it is contained in the Rules Docket. A copy of it may be obtained from the Rules Docket at the location provided under the caption ADDRESSES.

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) which applied to the ECF Model AS332C, L, and L1 helicopters was published in the Federal Register on July 14, 2000 (65 FR 43720). That action proposed to require inspecting any spar tube installed on certain horizontal stabilizers for corrosion, hardness, cracks, or scratches. Replacing the spar tube and bushing, as necessary, with an airworthy spar tube and bushing was also proposed.

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

The FAA estimates that 3 helicopters of U.S. registry will be affected by this AD, that it will take approximately 40 work hours per helicopter to accomplish the required actions, and that the average labor rate is $60 per work hour. Required parts will cost approximately $1,000 per helicopter. Based on these figures, the total cost impact of the AD on U.S. operators is estimated to be $10,200.

The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

For the reasons discussed above, I certify that this action (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. A final evaluation has been prepared for this action and it is contained in the Rules Docket. A copy of it may be obtained from the Rules Docket at the location provided under the caption ADDRESSES .

Airworthiness Directive (AD) 2000-11-08, amendment 39-11756, applicable to certain Boeing Model 747 and 767 series airplanes, was published in the Federal Register on June 1, 2000 (65 FR 34935). That AD supersedes AD 98-08-23, amendment 39-10472 (63 FR 18817, April 16, 1998) to require revising the FAA-approved Airplane Flight Manual (AFM) to prohibit the use of certain fuels; and either replacing an existing placard with a new placard, or replacing all dribble flow fuel nozzles (DFFN) with standard fuel nozzles, which terminates the requirements for the new placard and AFM revision. That AD also includes identical requirements applicable to airplanes on which standard fuel nozzles are not installed.

As published, AD 2000-11-08 contains an erroneous fuel specification in paragraphs (a)(1)(i) and (c)(1) of that AD. Those paragraphs incorrectly reference MIL-T-83113, which is a specification that does not exist. The correct reference is MIL-T-83133.

Since no other part of the regulatory information has been changed, the final rule is not being republished.

In the Federal Register of October 26, 1989 (54 FR 43766), FDA published a final rule which, among other things, amended its menstrual tampon labeling regulation to standardize the existing absorbency terms (“junior”, “regular”, “super”, and “super plus”) to correspond with the following four absorbency ranges: Less than 6 g; 6 to 9 g; 9 to 12 g; and 12 to 15 g of fluid, as measured by the syngyna test. The 1989 final rule did not include terms for tampons with absorbency in the 15 to 18 g range. Tampon manufacturers have asserted that many women need tampons with this higher level of absorbency to manage their heavy menstrual flow. See 54 FR 43766 to 43769.

Tampons are currently classified into class II (special controls) at 21 CFR 884.5460 and 884.5470. Any person who is required to register under section 510 of the act (21 U.S.C. 360) and part 807 (21 CFR part 807) and who intends to begin the introduction or delivery for introduction into interstate commerce of a tampon for commercial distribution is required to submit a premarket notification to FDA at least 90 days before making such introduction or delivery in accordance with section 510(k) of the act and subpart E of part 807. Under § 807.87(e), a 510(k) premarket notification for a menstrual tampon must contain, among other thing, the proposed labeling for the tampon. Section 801.430 (21 CFR 801.430) spells out the specific labeling required for tampons with 15 g or less of absorbency, including standardized terms for absorbency as determined by testing with the specified syngyna methodology. Because the regulation currently provides no uniform labeling term for tampons that absorb 15 to 18 g of fluid with the syngyna test, the agency is requiring that such tampons be labeled as “ultra” absorbency. FDA has recently cleared a menstrual tampons product in this absorbency range, and they are available to women in the United States. FDA believes that designating a standard term for this absorbency range will improve consumer understanding of tampons across brands and allow for better adherence to advice in the tampon labeling about toxic shock syndrome (TSS).

In the Federal Register of January 21, 1999 (64 FR 3255 through 3257), FDA published a proposed rule to add the term “ultra” to describe tampons with a 15 to 18 g absorbency as measured by the syngyna test. The 90-day comment period closed on April 21, 1999.

The agency received nine comments from individuals, tampon manufacturers, one trade association, and one from a member of the U.S. Congress. Besides comments specific to use of the term “ultra”, other comments addressed FDA's 1995 draft guidance document on the preparation of 510(k) premarket notifications for menstrual tampons (Ref. 1). Several comments recommended changing the currently used term for tampon absorbency less than 6 g, from “junior” to “light”. A summary of the written comments and FDA's response to the comments is provided in section III of this document.

1. Two comments from manufacturers supported the term “ultra”. They noted that the term “ultra” is defined in Webster's Dictionary (and others) as “going beyond what is usual or ordinary” and “going beyond others”. These comments also noted that menstrual tampons with this absorbency are called “Ultra Plus” in Canada. Comments from two other manufacturers did not favor the term “ultra” for this tampon absorbency. They argued that “ultra” implies the product is more compact in size, more concentrated, more environmentally sound, or possibly superior. The comments noted that “ultra” is a proprietary term carrying one or more of these meanings for a variety of other household products, such as dishwashing detergents and sanitary napkins. These manufacturers proposed the terms “extra” or “extra plus”.

FDA concludes that the term “Ultra” is suitable to identify the absorbency of tampons in the range of 15 to 18 g. FDA believes that the term “Ultra” fits more clearly within the current scheme of tampon absorbency terminology than the terms “extra” or “extra plus”. The term “ultra” better conveys to the consumer absorbency abilities that are beyond “Super” and “Super Plus” and is less confusing to consumers than the terms “extra” or “extra plus”.

Manufacturers must now define this absorbency in their labeling along with the other absorbency categories to help consumers understand the meaning of this new term. As before, labeling will continue to be required to inform consumers that they should use the lowest absorbency suitable for their needs, as well as alternating use of tampons with use of menstrual pads. FDA does not permit manufacturers to promote tampons for a wear time longer than 8 hours.

2. Five comments suggested changes in tampon labeling related to the wording of the consumer information on TSS. At present, under § 801.430(d)(2), the tampon labeling regulation requires that TSS incidence be reported in the package insert as 1 to 17 cases of TSS per 100,000 menstruating women and girls per year. These five comments requested that this labeling be revised to reflect more recent data that indicate the rate of TSS has declined. There were also various comments on FDA's draft guidance document on preparing 510(k) premarket notifications on menstrual tampons, dated May 25, 1995 (Ref. 1).

These comments were beyond the scope of the proposed rule. FDA recognizes that TSS incidence in the United States has dropped since this labeling regulation was issued in 1989. See response to comment number 6. FDA will consider these suggestions for revisions to the labeling regulation to update the TSS incidence information. Regarding the second set of comments, FDA is currently working to improve the 1995 510(k) guidance document, and the suggested changes will be considered during that process. FDA intends to issue a draft updated guidance document within a few months.

3. Five comments suggested changing the absorbency term “junior”, used for tampons with the lowest absorbency (less than 6 g), to “light”. They suggested that the term “junior” implied such tampons were only for young teenagers.

This comment also was beyond the scope of this rulemaking. However, FDA agrees that the term “light” is more appropriate than “junior” for tampons with absorbency less than 6 g. A proposed rule to change the term “junior” to “light” appears elsewhere in this issue of the Federal Register .

4. One comment asked why FDA did not propose a new term for tampon absorbency in the 15 to 18 g range when the other terms were issued in the regulation in 1989.

The intent of the 1989 regulation was to standardize terms currently in use so that consumers had clear information to make the best choices regardless of which brand they purchased. Although the absorbencies varied across brands, most manufacturers had no more than four different absorbencies of tampons on the market. Most companies chose to modify their products to match the standardized absorbency categories and keep the established terms. Immediately prior to issuance of the labeling regulation in 1989, only one marketed tampon was in the 15 to 18 g range. The manufacturer of this tampon chose to reduce its absorbency to 12 to 15 g and continue to use the term “super plus”. In the preamble to the final regulation standardizing absorbency terms, FDA stated that anyone who wished to market a tampon that absorbs more than 15 g of fluid would be required to submit a 510(k). The agency would then determine whether the labeling submitted for the device was appropriate and whether the tampon required premarket approval under section 515 of the act (21 U.S.C. 360e). FDA did receive and clear a 510(k) for such a product earlier this year.

5. One comment asked how FDA would institute monitoring procedures for tracking the potential risk of increase in TSS cases.

FDA requires laboratory testing for all tampon products, as appropriate, depending on changes to materials or design. The agency already has in place Mandatory Device Reporting (MDR) requirements for manufacturers to identify and monitor reports of serious events related to device use, including menstrual TSS. In 510(k) premarket notifications, manufacturers of tampons with 15 to 18 g absorbency will provide FDA with their specific plans for monitoring trends in TSS complaints with use of their own tampon brands. The manufacturer of the product already cleared has such a plan in place. In the postmarket setting and as part of its regular MDR Program and User Facility Reporting Program, FDA will actively review any reports received on adverse events, as well as the Centers for Disease Control and Prevention (CDC) reports on menstrual-TSS.

CDC has tracked TSS reports in the United States for 20 years, and produces periodic morbidity/mortality reports. CDC recently has published a TSS surveillance update, reviewing reports from 1979 to 1996 (Ref. 2). These reports show a marked drop in TSS cases in the early 1980's with a relatively flat, extremely low number of TSS reports since approximately 1986. For instance, in 1996, there were five definite and four probable menstrual-related TSS cases reported to CDC.

The agency also notes that tampons with an absorbency as high as 18 g are currently marketed in other countries with very low TSS rates (Ref. 3). It appears that a number of factors may play a role in the etiology and risk of menstrual-related TSS, including tampon materials, continuous tampon use versus alternating use between tampons and menstrual pads, the presence of oxygen in the vaginal environment, and awareness of TSS symptoms and seeking early treatment. Standardized absorbency terms are intended to minimize the risk of menstrual-TSS with tampon use. This rule is consistent with purpose of the 1989 regulation, which is to ensure that standardized labeling gives women the information they need to make appropriate choices among all brands. FDA does not believe that this final rule will increase the risk of TSS for women who use tampons in accordance with the labeling.

6. One comment asked about the steps that might be taken to improve consumer decisionmaking about choosing the appropriate tampon absorbency.

FDA agrees that women should have a good understanding about tampon absorbency in order to make the best possible choice when purchasing tampons. In the United States, there are several public awareness initiatives in place. For nearly 20 years, FDA, CDC, and tampon manufacturers have all played a part in this process. Education programs at the local level have been contributing partners, as well. FDA believes that the current low TSS rates in the United States are a reflection of these highly effective public awareness initiatives. FDA expects that these programs, coupled with good tampon labeling, will ensure continued good choice patterns among tampon users in the United States.

The agency has determined under 21 CFR 25.30 (k) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

FDA has examined the impacts of the final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), as amended by subtitle D of the Small Business Regulatory Fairness Act of 1996 (Pub. L. 104-121), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this final rule is consistent with the regulatory philosophy and principles identified in the Executive Order.

The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. There currently are no small entities marketing a tampon of this absorbency. Any small entity that decided to enter the market with this product would incur no additional costs because of this rule because the small entity would already be required to identify the absorbency ranges of its tampons.

The agency therefore certifies that the final rule will not have a significant economic impact on a substantial number of small entities. Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement of anticipated costs and benefits before proposing any rule that may result in an expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million in any one year (adjusted annually for inflation). The Unfunded Mandates Reform Act does not require FDA to prepare a statement of costs and benefits for the final rule, because the final rule is not expected to result in any 1-year expenditure that would exceed $100 million adjusted for inflation.

FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that have substantial direct effect on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the agency has concluded that the rule does not contain policies that have federalism implications as defined in the order and, consequently, a federalism summary impact statement is not required.

This final rule does not contain information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). Although the agency submitted the proposed labeling for public comment as an information collection in the proposed rule, FDA now concludes that the labeling requirement is not subject to review by OMB because it does not constitute a “collection of information” under the PRA. Rather, the proposed labeling is a “public disclosure of information originally supplied by the Federal Government to the recipient for the purpose of disclosure to the public” (5 CFR 1320.3(c)(2)).

The following references have been placed on display in the Docket Management Branch (address above) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under the authority delegated to the Commissioner of Food and Drug, 21 CFR part 801 is amended as follows:

Under section 513 of the Federal Food, and Drug, and Cosmetic Act (the act) (21 U.S.C. 360c), FDA must classify devices into one of three regulatory classes: Class I, class II, or class III. The FDA classification of a device is determined by the amount of regulation necessary to provide a reasonable assurance of safety and effectiveness. Under the Medical Device Amendments of 1976 (the 1976 amendments (Public Law 94-295)), as amended by the Safe Medical Devices Act of 1990 (the SMDA (Public Law 101-629)), devices are to be classified into class I (general controls) if there is information showing that the general controls of the act are sufficient to ensure safety and effectiveness; into class II (special controls), if general controls, by themselves, are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide such assurance; and into class III (premarket approval), if there is insufficient information to support classifying a device into class I or class II and the device is a life-sustaining or life-supporting device or is for a use that is of substantial importance in preventing impairment of human health, or presents a potential unreasonable risk of illness or injury.

Most generic types of devices that were on the market before the date of the 1976 amendments (May 28, 1976) (generally referred to as preamendments devices) have been classified by FDA under the procedures set forth in section 513(c) and (d) of the act through the issuance of classification regulations into one of these three regulatory classes. Devices introduced into interstate commerce for the first time on or after May 28, 1976, (generally referred to as postamendments devices) are classified through the premarket notification process under section 510(k) of the act (21 U.S.C. 360(k)). Section 510(k) of the act and the implementing regulations, 21 CFR part 807, require persons who intend to market a new device to submit a premarket notification report (510(k)) containing information that allows FDA to determine whether the new device is substantially equivalent within the meaning of section 513(i) of the act to a legally marketed device that does not require premarket approval.

On November 21, 1997, the President signed into law FDAMA (Public Law 105-115). Section 206 of FDAMA, in part, added a new section 510(m) to the act. Section 510(m)(1) of the act requires FDA, within 60 days after enactment of FDAMA, to publish in the Federal Register a list of each type of class II device that does not require a report under section 510(k) of the act to provide reasonable assurance of safety and effectiveness. Section 510(m) of the act further provides that a 510(k) will no longer be required for these devices upon the date of publication of the list in the Federal Register . FDA published that list in the Federal Register of January 21, 1998 (63 FR 3142).

Section 510(m)(2) of the act provides that 1 day after date of publication of the list under section 510(m)(1), FDA may exempt a device on its own initiative or upon petition of an interested person, if FDA determines that a 510(k) is not necessary to provide reasonable assurance of the safety and effectiveness of the device. This section requires FDA to publish in the Federal Register a notice of intent to exempt a device, or of the petition, and to provide a 30-day comment period. Within 120 days of publication of this document, FDA must publish in the Federal Register its final determination regarding the exemption of the device that was the subject of the notice. If FDA fails to respond to a petition under this section within 180 days of receiving it, the petition shall be deemed granted.

There are a number of factors FDA may consider to determine whether a 510(k) is necessary to provide reasonable assurance of the safety and effectiveness of a class II device. These factors are discussed in the guidance the agency issued on February 19, 1998, entitled “Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff.” That guidance can be obtained through the Internet on the CDRH home page at http://www.fda.gov/cdrh or by facsimile through CDRH Facts-on-Demand at 1-800-899-0381 or 301-827-0111. Specify “159” when prompted for the document shelf number.

On April 26, 2000, FDA received a petition requesting an exemption from premarket notification for the triiodothyronine test system. The triiodothyronine test system is currently classified under 21 CFR 862.1710. In the Federal Register of July 11, 2000 (65 FR 42706), FDA published a notice announcing that this petition had been received and provided an opportunity for interested persons to submit comments on the petition by August 10, 2000. FDA received no comments. FDA has reviewed the petition and has determined that the triiodothyronine test system intended for measuring the hormone triiodothyronine in serum and plasma does meet the criteria for exemption from the notification requirements. This is the only type of triiodothyronine test system of which FDA presently has any knowledge. The exemption is limited to triiodothyronine test systems of the type described and is also subject to the general limitations on exemptions from premarket notification for clinical chemistry and clinical toxicology devices as described in 21 CFR 870.9. For example, the exemption will not apply to devices of this type that present new indications, novel designs, or alternative materials. The exemption also will not apply if the device is intended for over-the-counter use.

The agency has determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

FDA has examined the impacts of the final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612) (as amended by subtitle D of the Small Business Regulatory Fairness Act of 1996 (Public Law 104-121)), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this final rule is consistent with the regulatory philosophy and principles identified in the Executive Order. In addition, the final rule is not a significant regulatory action as defined by the Executive Order and so is not subject to review under the Executive Order.

The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this rule will relieve a burden and simplify the marketing of these devices, the agency certifies that the final rule will not have a significant economic impact on a substantial number of small entities. Therefore, under the Regulatory Flexibility Act, no further analysis is required.

FDA concludes that this final rule contains no collections of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the agency has concluded that the rule does not contain policies that have federalism implications as defined in the order and, consequently, a federalism summary impact statement is not required.

A Notice of Proposed Rule Making (NPRM) was not published for this regulation. In keeping with 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. In keeping with the requirements of 5 U.S.C. 533(d)(3), the Coast Guard also finds good cause exists for making this regulation effective less than 30 days after publication in the Federal Register . U.S. Army Corps of Engineers, Philadelphia District, informed the Coast Guard on September 13, 2000 that dredging operations would commence on October 1, 2000. Publishing a NPRM and delaying its effective date would be contrary to the public interest, since immediate action is needed to protect mariners against potential hazards associated with the dredging operations in the Marcus Hook Range Ship Channel and to modify the anchorage regulations to facilitate vessel traffic.

The U.S. Army Corps of Engineers (ACOE) notified the Coast Guard that it needed to conduct dredging operations on the Delaware River, in the vicinity of the Marcus Hook Range Ship Channel. The dredging is needed to maintain the project depth of the channel. Similar dredging is conducted each year. This period of dredging begins October 1, 2000 and is anticipated to end on November 30, 2000.

To reduce the hazards associated with dredging the channel, vessel traffic that would normally transit through the Marcus Hook Range Ship Channel may divert through a portion of anchorage 7 to maintain a 150 foot radius around dredging operations. This necessitates additional requirements/restrictions on the use of Anchorage 7. For the protection of mariners transiting in the vicinity of dredging operations, the Coast Guard is also establishing a safety zone around the dredging vessel Essex. The safety zone will ensure mariners remain a safe distance from the potentially dangerous dredging equipment.

33 CFR 110.157(b)(2) allows vessels to anchor for up to 48 hours in the anchorages listed in § 110.157(a), which includes Anchorage 7. However, because of the limited anchorage space available in Anchorage 7 during dredging operations, the Coast Guard is adding a temporary paragraph in 33 CFR 110.157(b)(11) to provide additional requirements and restrictions on vessels utilizing Anchorage 6, 7 and 9.

Vessels desiring to use the Marcus Hook Anchorage (Anchorage 7) must seek permission from the Captain of the Port at least 24 hours in advance. Only one vessel will be allowed to anchor in Anchorage 7 at one time, and the Captain of the Port will grant permission on a “first come, first serve basis.” A vessel desiring to use anchorage 7 will be directed to a location within the anchorage, and no vessel may remain in the anchorage beyond twelve hours.

The Coast Guard expects that vessels normally permitted to anchor in Anchorage 7 will use Anchorage 6 off Deepwater Point or Anchorage 9 near the entrance to Mantua Creek, because they are the closest anchorages to Anchorage 7. To control access to Anchorages 6 and 9, the Coast Guard is requiring any vessel 700 feet or greater in length to obtain advance permission from the Captain of the Port before anchoring. The Coast Guard is also concerned that the holding ground in Anchorages 6 and 9 is not as good as in Anchorage 7. As larger vessels do not typically use these anchorages, any vessel 700 to 750 feet in length is required to have one tug standing alongside while at anchor, and any vessel of over 750 feet in length must have two tugs standing alongside. The tug(s) must have sufficient horsepower to prevent the vessel they're attending from swinging into the channel.

The Coast Guard is also establishing a safety zone within a 150-yard radius of the dredging operations being conducted in the Marcus Hook Range Ship Channel in the vicinity of Anchorage 7 by the dredge vessel Essex. The safety zone will protect mariners transiting the area from the potential hazards associated with dredging operations. Vessels transiting the Marcus Hook Range Ship Channel will have to divert from the main ship channel through Anchorage 7, and must operate at the minimum safe speed necessary to maintain steerage. No vessel may enter the safety zone unless it receives permission from the Captain of the Port.

This temporary final rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866 and does not require an assessment of potential costs and benefits under section 6(a)(3) of that order. The Office of Management and Budget has exempted it from review under that order. It is not significant under the regulatory policies and procedures of the Department of Transportation (DOT) (44 FR 11040; February 26, 1979). The Coast Guard expects the economic impact of this proposal to be so minimal that a full Regulatory Evaluation under paragraph 10e of the regulatory policies and procedures of DOT is unnecessary.

Although this regulation requires certain vessels to have one or two tugs alongside while at anchor, the requirement only applies to vessels 700 feet or greater in length, that choose to anchor in Anchorages 6 and 9. Alternate anchorages, such as Anchorage A (Breakwater) and Anchorage 1 (Big Stone) in Delaware Bay, are also reasonably close and generally available. Vessels anchoring in Anchorage A and 1 are not required to have tugs alongside, except when specifically directed to do so by the Captain of the Port because of a specific hazardous condition. Furthermore, few vessels 700 feet or greater are expected to enter the port during the effective period. The majority of vessels expected are less than 700 feet and thus will not be required to have tugs alongside.

Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ), the Coast Guard considered whether this temporary final rule will have a significant economic impact on a substantial number of small entities. “Small Entities” include small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. This regulation's greatest impact is on vessels greater than 700 feet in length which choose to anchor in Anchorages 6 and 9 and will have virtually no impact on any small entities. Therefore, the Coast Guard certifies under section 605(b) of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) that this temporary final rule will not have a significant economic impact on a substantial number of small entities.

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

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

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

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

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

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

We considered the environmental impact of this rule and concluded that, under figure 2-1, paragraphs (34)(f) and (g), of Commandant Instruction M16475.1C, this rule is categorically excluded from further environmental documentation.

On June 30, 2000, we published in the Federal Register the final rule titled “Response Plans for Marine Transportation-Related Facilities Handling Non-Petroleum Oils” (USCG-1999-5149)[65 FR 40820]. In the preamble to that rule, on page 40822, we stated that higher volume port areas were designated based on the availability of response equipment on hand in those ports. After that publication, the Coast Guard received comments from the affected public requesting clarification of our high volume ports discussion.

We previously addressed this topic in an interim final rule, “Response Plans for Marine Transportation-Related Facilities” (58 FR 7330), that was published in the Federal Register on February 5, 1993. As stated in the interim rule, higher volume ports were actually designated based on the volume of all types of oil transported through those ports. Faster response times were established for those ports to encourage vessel and facility plan holders to concentrate larger quantities of response equipment as close as possible to locations having the highest probability of a significant spill incident. Over time, the industry has responded by stockpiling larger quantities of response equipment in those ports practicable for all plan holders regardless of the type of oil cargo carried.

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a NPRM. The sponsor of the event did not provide the Coast Guard with the final details for the event in sufficient time to publish a NPRM or a final rule 30 days in advance. The delay encountered if normal rulemaking procedures were followed would effectively cancel the event. Cancellation of this event is contrary to the public interest since the fireworks display is for the benefit of the public.

The New York State Office of Parks, Recreation and Historic Preservation is sponsoring an Air Show display on Long Island Sound, Governor Alfred E. Smith/Sunken Meadow State Park, Kings Park, NY. The Air Show display will occur on October 28 & 29, 2000. The safety zone covers all waters of the Long Island Sound within a 3,000 foot by 12,000 foot area which will be located in approximate position: Northeast corner; 40°-55.0.5′N, 073°-16.40′W, Northwest corner; 40°-55.0.5′N, 073°-14.40′W, Southeast corner; 40°-54.55′N, 073°-16.40′W, Southwest corner; 40°-54.55′N, 073°-14.40′W, (NAD 1983). This zone is required to protect the maritime community from the safety dangers associated with this display. Entry into or movement within this zone will be prohibited unless authorized by the Captain of the Port or his on-scene representative.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866 and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Transportation (DOT) (44 FR 11040, February 26, 1979). The Coast Guard expects the economic impact of this proposal to be so minimal that a full Regulatory Evaluation under paragraph 10e of the regulatory policies and procedures of DOT is unnecessary. This safety zone involves only a portion of Long Island Sound and entry into this zone will be restricted for 6 hours on October 28 and 29, 2000. Although this regulation prevents traffic from transiting this section of Long Island Sound, the effect of this regulation will not be significant for several reasons: the duration of the event is limited; all vessel traffic may safely pass around this safety zone; and extensive, advance maritime advisories will be made.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses not-for-profit organizations that are independently owned and operated are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

The Coast Guard certifies under 5 U.S.C. 605 (b) that this rule will not have a significant impact on a substantial number of small entities. This rule will affect the following entities, some of which may be small entities: the owners or operators of vessels intending to transit or anchor in a portion of Long Island Sound from 10:30 a.m. until 4:30 p.m. on October 28 and 29, 2000. This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: The duration of the event is limited; all vessel traffic may safely pass around this safety zone; and extensive, advance maritime advisories will be made.

Under subsection 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 [Pub. L. 104-121], the Coast Guard wants to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process. If your small business or organization would be affected by this rule and you have any questions concerning its provisions or options for compliance, please call Chief Chris Stubblefield at (203) 468-4428. Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247).

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

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

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

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

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

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

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

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. We were notified of the oil pollution booming test in the Cape May Harbor with insufficient time to publish an NPRM, allow for comments, and publish a final rule.

Under 5 U.S.C. 553 (d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . We were informed on September 7, 2000 that a strategic booming test would take place in the Cape May Harbor. Delaying the effective date of the rule would be contrary to the public interest, since immediate action is needed to protect mariners against potential hazards associated with the temporary placement of boom across the north end of the Cape May Harbor.

The strategic booming exercise is in response to a 1996 oil spill that fouled the New Jersey shoreline from Manasquan to Cape May. The New Jersey Department of Environmental Protection commissioned a project to develop potential protection strategies for each tidal inlet occurring along the Atlantic Coast of New Jersey.

The thirteen tidal inlets along New Jersey's coastline are actually channels that divide the barrier islands into segments. The inlets are subject to reversing tidal currents, and are conduits for the volume of water that flows in and out of the bay/estuarine system during a tidal cycle called the tidal prism. It is through these conduits that oil spilled on open ocean waters could reach the sensitive resources, such as salt marshes, that occur along the bay/estuarine shorelines. Coastal tidal inlets are therefore focal points for designing strategies to protect these vital resources from spilled oil.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866 and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Transportation (DOT) (44 FR 11040; February 26, 1979).

We expect the economic impact of this temporary final rule to be so minimal that a full Regulatory Evaluation under paragraph 10e of the regulatory policies and procedures of DOT is unnecessary.

The primary impact of these regulations will be on vessels wishing to transit the affected waterways during the booming exercise on October 19, 2000. Although this regulation prevents traffic from transiting portions of the Cape May Harbor during the event, that restriction is limited in duration, affects only a limited area, and will be well publicized to allow mariners to make alternative plans for transiting the affected area. In addition, there is an alternate route out of the harbor through the Cape May Canal.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small business, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

This rule will affect the following entities, some of which may be small entities: the owners or operators of fishing or recreational vessels intending to transit the north end of the Cape May Harbor.

The rule will not have a significant impact on a substantial number of small entities for the following reasons: the restrictions are limited in duration, affect only limited areas, and although the safety zone will apply to the entire width of the navigable channel, traffic will be able to exit the north end of the Cape May Harbor via the Cape May Canal. The oil spill prevention exercise has been well publicized by the New Jersey Department of Environmental Protection, which distributed flyers to the marinas and boaters located in the north end of the Cape May Harbor. In addition, before the effective period, the Coast Guard will issue maritime advisories to allow mariners to make alternative plans for transiting the affected areas.

Under section 213 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we are willing to assist small entities in understanding the rule so that they can better evaluate its effects on them and participate in the rulemaking process.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsmen and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small businesses. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247).

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

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

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

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

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

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

We considered the environmental impact of this rule and concluded that, under figure 2-1, paragraph (34)(g), of Commandant Instruction M16475.1C, this rule is categorically excluded from further environmental documentation.

In 1999, the Coast Guard conducted a Port Access Route Study (PARS), which we announced in a document published in the Federal Register on March 11, 1999 (63 FR 12140). A PARS was needed to evaluate the effects of port improvement projects for the ports of Los Angeles and Long Beach on navigational safety and vessel traffic management efficiency, and to recommend any necessary changes to existing routing measures. The Coast Guard completed the study in July 1999 and announced the results of this study in a Notice published in the Federal Register on May 19, 2000 (65 FR 31856). Among other things, this study recommended modifications to the precautionary areas, existing TSS's, and aids to navigation.

On July 21, 2000, we published a notice of proposed rulemaking (NPRM) entitled Regulated Navigation Area; San Pedro Bay, California, in the Federal Register (65 FR 45328). The comment period ended September 5, 2000. We did not receive any comments on the proposed rule. No public hearing was requested, and none was held.

During the drafting of this Final Rule, a few minor changes were made to items discussed in the NPRM. The Coast Guard expects that these minor changes from the content of the NPRM will not impose a burden on the public.

1. In the Discussion of Regulation section of the NPRM, it correctly states that the length of the Long Beach Pilot area will be expanded approximately 1.7 nm to the south. Subsequently, in the same section, it states incorrectly that the Long Beach Pilot Area will be expanded to the south approximately 1.6 nm. This error in the NPRM is corrected in this final rule to reflect that the length of the Long Beach Pilot Area will be expanded approximately 1.7 nm to the south.

2. The second change corrects an error in the last paragraph of the Discussion of Regulation section of the NPRM. The sentence, “When a vessel drawing more than 50 feet * * *” is corrected to read, “When a vessel 50 feet and greater * * *”

3. The third change deals with the nomenclature used to designate the geographical coordinates of the RNA, Pilot Areas, Deep Water Routes, and the Middle Breakwater Area. The format used in the NPRM described the latitudes and longitudes in degrees, minutes and seconds. In contrast, the format used in the final rule describes latitudes and longitudes in degrees, minutes, and tenths of minutes. The format used in the final rule is easier to read and the NAD 1983 datum is accounted for throughout the regulation. Also, describing the coordinates for the RNA in this manner is consistent with the way the coordinates are published in the Los Angeles/Long Beach Traffic Separation Scheme. See 65 FR 53,911 (Sep. 6, 2000) (to be codified at 33 CFR pt. 167).

4. The fourth and final change deals with the terms of the Proposed Regulation at § 165.1109(e)(5). The NPRM published “No vessel may enter the waters between Commercial Anchorage G and the Middle Breakwater * * *” This Final Rule now refers to the specific vessels described in paragraph (d), General Regulations, which may not enter the waters between Commercial Anchorage G and the Middle Breakwater.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . On September 6, 2000 the Coast Guard amended the Los Angeles/Long Beach Traffic Separation Scheme (TSS) to route commercial vessels farther offshore for safety and environmental protection reasons in the San Pedro Bay area. See 65 FR 53911. One of the amendments to the TSS expanded the Precautionary Area to match the shifted coordinates of the western and southern traffic lanes. This new Precautionary Area also coincides with the expanded coordinates for the RNA.

The RNA and the Precautionary Area establish the manner in which vessels transit through San Pedro Bay. As explained in the NPRM, the RNA has specific vessel operation requirements which are necessary because of hazardous conditions in the area. In order to enforce such requirements within the RNA, which now must have the expanded boundaries to match the TSS amendments, we are making this rule effective on the date of publication so that the RNA is in place as close as possible to the effective date of the TSS.

Also, because of these changes to the TSS and the RNA, a complete update of several local charts is required. Chart publication cannot occur until the RNA rule becomes final. Since these charts are essential to safe navigation in San Pedro Bay and the approaches of the Ports of Los Angeles—Long Beach, there is good cause to implement this final rule upon publication in the Federal Register .

The Commander, Eleventh Coast Guard District is modifying the San Pedro Bay RNA. As previously discussed, this change makes the RNA geographically the same as the precautionary area. A Precautionary Area is an internationally recognized routing measure comprising an area within defined limits where ships must navigate with particular caution. By itself, a precautionary area does not impose specific maneuvering requirements on vessels. A Regulated Navigation Area (RNA) is a regulatory measure that defines an area, in which the Coast Guard has imposed specific vessel operating requirements because of the existence of hazardous conditions. Due to the quantity of vessel traffic and diversity of types of vessels transiting the approach to Los Angeles and Long Beach harbors, the Coast Guard thinks that the general guidance of a Precautionary Area is insufficient to ensure safe transit of the area. Therefore, in addition to establishing the Precautionary Area, the Coast Guard is also establishing an RNA, which covers the same area of waters and includes specific vessel operating procedures.

The following is a summary of the specific changes to the RNA:

• The southern boundary of the RNA is moved to the south approximately 2.2 nm to align with the new western traffic separation scheme. The southeastern corner of the RNA is shifted to the west approximately 1.8 nm on a bearing on 220 degrees T from the easterly most point of the existing Precautionary Area, to align with the new southern traffic separation scheme.

• The Los Angeles Pilot Area is expanded approximately 0.4 nm to the south-southeast.

• The Long Beach Pilot Area is expanded approximately 1.7 nm to the south.

• A Deep Water Traffic Lane approximately 3.27 nm long is established in the Los Angeles approach channel.

• A Deep Water Traffic Lane approximately 1.9. nm long is established in the Long Beach approach channel.

• A Deep Water Pilot Area is established just south of the Los Angeles Deep Water Traffic Lane. It is centered on position 33°39.00N, 118°13.19W, approximately 0.5 nm south of the southern terminus of the Los Angeles Channel and will be 1.0 nm in diameter.

In addition, this rule codifies the amended RNA into Title 33 Part 165 of the Code of Federal Regulations.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866 and did not require an assessment of potential costs and benefits under section 6(a)(3) of that order. It has been exempted from review by the Office of Management and Budget under that order. It is not significant under the regulatory policies and procedures of the Department of Transportation (44 FR 11040; February 26, 1979). The economic impact of this rule is so minimal that a full Regulatory Evaluation under paragraph 10(e) of the regulatory policies and procedures of Department of Transportation was unnecessary.

Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ), the Coast Guard considered whether this rule will have a significant economic impact on a substantial number of small entities. “Small entities” may include small businesses and not-for-profit organizations that are not dominant in their respective fields, and governmental jurisdictions with populations less than 50,000. For the same reasons set forth in the above Regulatory Evaluation, the Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on any substantial number of entities, regardless of their size.

In accordance with § 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), the Coast Guard offered to assist small entities in understanding this rule so that they can better evaluate its effects on them and participate in the rule making process. No concerns or questions from small businesses were brought to our attention on this rule.

This regulation contains no collection of information requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

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

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

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

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

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This proposed rule does not concern an environmental risk to safety disproportionately affecting children.

The Coast Guard has considered the environmental impact of this regulation and concluded that under Chapter 2.B.2. of Commandant Instruction M16475.1C, Figure 2-1, paragraph (34)(g), it has no significant environmental impact and it is categorically excluded from further environmental documentation.

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 EPA 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.

Under section 307(d) of the CAA, we are required to promulgate designations of areas identifying their status with respect to attainment of the ambient standards described previously. We are required to determine whether each area is attaining the standard, not attaining the standard, or cannot be designated based on available information. Once an area is designated as nonattainment for a standard, it cannot be redesignated to attainment until the requirements of section 107(d)(3)(E) of the CAA are met. These requirements are discussed below, and include a revision to the SIP to show how the state, in which the area is located, plans to maintain the standards in the future in the area to be redesignated to attainment.

We are redesignating the nonattainment area in western Iron County, Missouri, to attainment for lead and taking final action to approve the submission for the Doe Run Resource Recycling Facility near Bixby, Missouri, as an amendment to the SIP.

We are also taking final action to approve the revision to rule 10 CSR 10-6.120, Restriction of Emissions of Lead From Specific Lead Smelter-Refinery Installations, as an amendment to the SIP.

The basis for our approval of the rule is described in this notice, and in more detail in the technical support document (TSD) prepared for this action. The TSD is available at the address identified above.

The purpose of the submittal is to meet the criteria under section 107(d)(3) of the Clean Air Act Amendments (CAAA) for redesignation of the nonattainment area in western Iron County to attainment for the lead standard.

The area was designated as nonattainment for lead in November 1991, effective January 6, 1992. The boundaries of the nonattainment area follow the Dent Township in western Iron County, Missouri. The major source of lead emissions in this nonattainment area is the Doe Run Resource Recycling Facility, near Bixby, Missouri.

Primary smelting of lead began at this location in 1968, but the current facility ceased operation as a primary smelter in 1988 and has been operating as a secondary smelter and resource recovery operation since 1991.

Section 107(d)(3) of the CAAA establishes the five requirements to be met before we can designate an area from nonattainment area to attainment. These are:

A. The area has attained the NAAQS;

B. The area has a fully approved SIP under section 110(k) of the act;

C. We have determined that the improvement in air quality is due to permanent and enforceable emissions reductions;

D. We have determined that the maintenance plan for the area has met the requirements of section 175A of the Act and;

E. The state has met all requirements applicable to the area under section 110 and part D.

The state submittal provided ambient air monitor data showing that this area has consistently shown compliance with the NAAQS for lead since the second quarter of 1988. The NAAQS for lead is 1.5 micrograms per cubic meter (1.5 μg/m 3 , maximum quarterly average. A quarterly average is considered a violation of the standard if it is at least 1.6 μg/m 3 when rounded to the tenths from the hundredths place when monitored.

Air dispersion modeling using the ISCST Version 3 dated June 24, 1999, was used to evaluate the concentration of lead resulting from operations at the Doe Run Resource Recycling Facility. The maximum concentration predicted by the model was a value of 0.73 μg/m 3 which is in compliance with the lead standard.

Missouri submitted part D nonattainment SIPs for the Doe Run Resource Recycling Facility and its predecessor in 1980 and in 1993 and 1994. The SIPs established emission, operational and work practice standards. These requirements included enforceable throughput and emission point limits, identified emission control projects that the facility would have to complete prior to processing lead concentration and producing primary lead, and established contingency measures to reduce fugitive emissions for the secondary process. The 1980 part D nonattainment SIP was approved on April 27, 1981, (46 FR 23412) and the 1993/1994 submission was fully approved under section 110(k) of the CAA, as a revision to the Missouri SIP on August 4, 1995 (60 FR 39851). A detailed discussion of the latter SIP revision can be found in the August 4, 1995, Federal Register notice.

The permanent and enforceable emission reductions at the Doe Run Resource Recycling Facility include implementation of the part D nonattainment SIP, permanent closure of the primary lead smelting operation, controls on the secondary lead smelting operation, and the installation of reasonably available control technology and reasonably available control measures.

The revision to rule 10 CSR 10-6.120, Restriction of Emissions of Lead From Specific Lead Smelter-Refinery Installations, ensures the permanent and enforceable emission reductions by clarifying the emissions limits for the facility and removing the text which could have allowed this facility to resume operation as a primary smelter. Because no violations of the lead standard have occurred since the facility ceased operation as a primary smelter in 1988, we believe that this clarification will make enforceable the operating scenario which has led to air quality improvements and attainment of the standard.

The maintenance plan submitted as part of the SIP revision provides for maintenance of the relevant NAAQS in the area for at least ten years after the approval of redesignation to attainment.

The maintenance plan for the Doe Run Resources Recycling Facility addresses the monitoring network, the emission inventory, the maintenance demonstration, and verification of continued attainment, as described in more detail in the TSD. The plan also includes contingency measures, which require additional paving and roadway sweeping, and improvements to baghouse controls, to be implemented if monitored violations occur in the future. The contingency measures are specified in the consent order which was approved by MDNR and Doe Run.

Eight years after the redesignation, the state has committed to submit a revised maintenance plan demonstrating attainment for ten years following the initial ten-year period.

The state has met these requirements by submitting and implementing the nonattainment plan to bring the area back into attainment and subsequently by submitting an appropriate maintenance plan to keep the area in attainment, as described previously in this notice and in the TSD.

The revision to rule 10 CSR 10-6.120, Restriction of Emissions of Lead From Specific Lead Smelter-Refinery Installations, is an important part of the redesignation process for this nonattainment area. The changes to the rule include revising the emissions limits for the Doe Run Resource Recycling Facility and removing all text which could have allowed this facility to resume operation as a primary smelter. Another significant change modifies the title of the rule, consistent with the changes in the body of the rule, so that the rule applies to “specific” lead smelters (including secondary smelters) rather than addressing only “primary” lead smelters.

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 TSD which is part of this document, the revision meets the substantive SIP requirements of the CAA, including section 110 and implementing regulations. The state submittal also meets the criteria for redesignation to attainment in section 107(d)(3) of the CAA, as explained above and in the TSD.

We are taking final action to approve the submission for the Doe Run Resource Recycling Facility near Bixby, Missouri, as an amendment to the SIP and redesignate the nonattainment area in western Iron County, Missouri, to attainment for lead.

We are also taking final action to approve the revision to rule 10 CSR 10-6.120, Restriction of Emissions of Lead From Specific Lead Smelter-Refinery Installations, as an amendment to the SIP.

We are processing this action as a final action because the revisions make routine changes to the existing rules which are noncontroversial, and because the area has been attaining the lead standard since 1988 based on monitored data. Therefore, we do not anticipate any adverse comments.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). This rule approves preexisting requirements under state law. In addition, the redesignation is an action which affects the status of a geographic area but does not impose any new requirements on governmental entities or sources. Therefore, it 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 (Public Law 104-4). For the same reason, this rule also does not significantly or uniquely affect the communities of tribal governments, as specified by Executive Order 13084 (63 FR 27655, May 10, 1998). This rule will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the CAA. This rule also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing SIP submissions, our role is to approve state choices, provided that they meet the criteria of the CAA. In this context, in the absence of a prior existing requirement for the state to use voluntary consensus standards (VCS), we have no authority to disapprove a 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. As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this rule, we have taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct. EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the Executive Order. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. We will submit a report containing this rule and other required information to the United States Senate, the United States House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 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 December 18, 2000. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

This is a synopsis of the Commission's Report and Order, MM Docket No. 99-278, adopted September 20, 2000, and released September 29, 2000. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC Reference Information Center (Room CY-A257), 445 12th Street, SW., Washington, DC. The complete text of this decision may also be purchased from the Commission's copy contractors, International Transcription Service, Inc., (202) 857-3800, 1231 20th Street, NW., Washington, DC 20036.

The purpose of this final rule is to establish the Department's policy on the reimbursement of contractor settlement, award and defense costs associated with contractor employee whistleblower actions. This policy will cover the Department's cost reimbursement contractors and subcontractors with a contract amount in excess of $5,000,000. Costs associated with whistleblower actions filed by an employee in Federal and state courts, and with Federal agencies under 29 CFR Part 24, 48 CFR Subpart 3.9, 10 CFR Part 708 or 42 U.S.C. 7239 will be subject to the reimbursement provisions of the new regulation.

This action grows out of rulemaking notices published on January 5, 1998 (63 FR 386) and March 24, 1999 (64 FR 14206). The first notice published for comment a proposed rule to create a whistleblower costs clause. The second notice reopened the comment period for an alternate proposal using a cost principle approach.

The alternate proposal was the result of a number of factors, including: (1) The Department's experience in a few high profile whistleblower actions; (2) further review of the practices of the rest of the Federal Government with this cost category; (3) a Department effort to reduce the number of cost clauses in DEAR Part 970 in favor of a cost principle approach (notice of proposed rule published June 14, 2000 (65 FR 37335)); and (4) the comments received in response to the initial proposed rule.

For the reasons stated below, the Department has now concluded that the cost principle approach, which provides contracting officers with greater flexibility in making determinations on a case-by-case basis, is the best approach for the circumstances facing the Department and its facility management contractors. However, the Department has modified its initial cost principle proposal in response to some of the comments received concerning that proposal.

Two sets of comments were received in response to the January 5, 1998, notice of proposed rulemaking and five sets of comments were received in response to the March 24, 1999, notice to reopen the comment period. Except for one set of comments from another Federal agency, all comments were from the Department's contractors.

Both sets of comments on the proposed cost clause pointed out that the result of the proposal to reimburse settlement costs, while excluding costs where an adverse determination is made, would provide a financial incentive for the Department's contractors to settle any employee claim of retaliation, no matter how lacking in merit, rather than risk an adverse determination and the disallowance of costs. The comments also asserted that such a liberal policy for settlement of questionable claims would encourage frivolous claims.

It was, in part, as a result of these comments that the Department proposed the alternate cost principle approach providing contracting officers with greater flexibility in making case-by-case determinations based on the facts of each case. In a case-by-case approach, costs resulting from unlawful or egregious contractor conduct would be disallowed, while costs resulting from the exercise of prudent business judgment by the contractor would be allowable.

Three of the contractors commented that the alternate proposal would create an administrative burden and unnecessary and unallowable expense, and they urged that the final regulation not be expanded to labor cases beyond whistleblower retaliation claims. All of the contractor comments argued that the existing contract clauses and cost principle regulations provided sufficient coverage for labor settlements and litigation costs.

The Department agrees that the regulation should not be expanded to cover all labor cases and the final regulation covers only employee whistleblower actions alleging a retaliatory act.

The final rule creates a cost principle regulation to be added to 48 CFR (DEAR) Part 931 and incorporated by reference in 48 CFR (DEAR) Subpart 970.31. Contractors and subcontractors covered by this regulation are those with contracts for an amount in excess of $5,000,000. The regulation requires contracting officers to determine allowability of defense, settlement and award costs on a case-by-case basis after considering the terms of the contract, relevant cost regulations, and relevant facts and circumstances, including federal law and policy prohibiting reprisal against whistleblowers, at the conclusion of the employee whistleblower claim. The cost principle addresses only the costs associated with whistleblower retaliation claims filed in Federal and state courts and with Federal agencies under 29 CFR Part 24, 48 CFR subpart 3.9, 10 CFR Part 708 or 42 U.S.C. 7239.

The Department recognizes that a potential disadvantage of a case-by-case approach is unwarranted variation in cost allowability determinations in cases involving similar circumstances. Therefore, in order to promote an evenhanded approach and to avoid unwarranted variation, the Department will name a member of the Office of General Counsel who will consult with representatives from the Office of Procurement and Assistance Management, the Office of Environment, Safety and Health, and other Headquarters program offices on whistleblower costs. The Department's contracting officers will be required to report their final allowability determinations, and the analysis or basis for their determinations, to the Office of Procurement and Assistance Management, which will collect that information to determine whether additional guidance to the field is necessary. The collected information will also be a resource for providing advice to contracting officers. Internal guidance is being issued to establish procedures and points of contact for consulting and reporting purposes.

This cost principle will be effective in contracts awarded or executed by the Department after the effective date of this regulation. Whistleblower costs clauses already contained in current contracts will continue to be effective unless a contract modification is executed deleting the clause in favor of cost principle coverage.

Since the Department published the January 5, 1998, notice and the March 24, 1999, notice, the National Defense Authorization Act for FY 2000 (Pub.L. 106-65) reorganized the Department. Consistent with that Act, the Department has amended the authority citation for 48 CFR (DEAR) Parts 931 and 970 to include the citation for that Act.

Today's regulatory action has been determined not to be a “significant regulatory action” under Executive Order 12866, “Regulatory Planning and Review,” (58 FR 51735, October 4, 1993). Accordingly, this final rule was not subject to review under that Executive Order by the Office of Information and Regulatory Affairs of the Office of Management and Budget (OMB).

With respect to the review of existing regulations and the promulgation of new regulations, section 3(a) of Executive Order 12988, “Civil Justice Reform,” 61 FR 4729 (February 7, 1996), imposes on Executive agencies the general duty to adhere to the following requirements: (1) Eliminate drafting errors and ambiguity; (2) write regulations to minimize litigation; (3) provide a clear legal standard for affected conduct rather than a general standard; and (4) promote simplification and burden reduction. With regard to the review required by section 3(a), section 3(b) of Executive Order 12988 specifically requires that Executive agencies make every reasonable effort to ensure that the regulation: (1) Clearly specifies the preemptive effect, if any; (2) clearly specifies any effect on existing Federal law or regulation; (3) provides a clear legal standard for affected conduct while promoting simplification and burden reduction; (4) specifies the retroactive effect, if any; (5) adequately defines key terms; and (6) addresses other important issues affecting clarity and general draftsmanship under any guidelines issued by the Attorney General. Section 3(c) of Executive Order 12988 requires Executive agencies to review regulations in light of applicable standards in section 3(a) and section 3(b) to determine whether they are met or it is unreasonable to meet one or more of them. DOE has completed the required review and determined that, to the extent permitted by law, this regulation meets the relevant standards of Executive Order 12988.

The Regulatory Flexibility Act of 1980 (5 U.S.C. 601 et seq. ) requires preparation of an initial regulatory flexibility analysis for any rule that by law must be proposed for public comment unless the agency certifies that the rule will not have a “significant economic impact on a substantial number of small entities.” DOE is not required by the Administrative Procedure Act (5 U.S.C. 553) or any other law to propose this procurement rule for public comment. Accordingly, the Regulatory Flexibility Act requirements do not apply to this rulemaking, and no regulatory flexibility analysis has been prepared.

No new information or record keeping requirements are imposed by this rulemaking. Accordingly, no OMB clearance is required under the Paperwork Reduction Act (44 U.S.C. 3501 et seq. ).

DOE has concluded that promulgation of this rule falls into a class of actions which would not individually or cumulatively have significant impact on the human environment, as determined by DOE's regulations (10 CFR part 1021, subpart D) implementing the National Environmental Policy Act (NEPA) of 1969 (42 U.S.C. 4321 et seq. ). Specifically, this rule is categorically excluded from NEPA review because the amendments to the DEAR would be strictly procedural (categorical exclusion A6). Therefore, this rule does not require an environmental impact statement or environmental assessment pursuant to NEPA.

Executive Order 13132 (64 FR 43255, August 10, 1999) requires agencies to develop an accountable process to ensure meaningful and timely input by State and local officials in the development of regulatory policies that have “federalism implications.” Policies that have federalism implications are defined in the Executive Order to include regulations that have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. DOE has examined this rule and has determined that it would not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. No further action is required by Executive Order 13132.

The Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) generally requires a Federal agency to perform a detailed assessment of costs and benefits of any rule imposing a Federal Mandate with costs to State, local or tribal governments, or to the private sector, of $100 million or more. This rulemaking, which provides guidance on the reimbursement of certain contractor legal defense costs, does not impact any state, local or tribal government.

As required by 5 U.S.C. 801, DOE will report to Congress promulgation of this final rule prior to its effective date. The report will state that it has been determined that the rule is not a “major rule” as defined by 5 U.S.C. 804(2).

Gaura neomexicana ssp. coloradensis was initially described as G . coloradensis by Rydberg (1904) based on material collected near Fort Collins, Colorado, in 1895. Munz (1938) transferred G . coloradensis to G . neomexicana and reduced it to variety coloradensis. This taxon is now recognized as G . n . ssp. coloradensis (Raven and Gregory 1972).

Gaura neomexicana ssp. coloradensis is a perennial herb that lives vegetatively for several years before bearing fruit once and then dying. It has one or a few reddish, hairy stems that are 50-80 centimeters (cm) (2-3 feet (ft)) tall. The lower leaves are lance-shaped with smooth or wavy-toothed margins and average 5-15 cm (2-6 inches (in.)) long, while those on the stem are smaller and reduced in number. Flowers are arranged in a branched, elongate pattern above the leaves. Only a few flowers are open at any one time and these are located below the rounded buds and above the mature fruits. Individual flowers are 5-14 millimeters ( 1/4 - 1/2 in.) long with four reddish sepals (modified leaves surrounding the flower) and four white petals that turn pink or red with age. The hard, nutlike fruits are 4-angled and have no stalk. Nonflowering plants consist of a stemless, basal rosette of oblong, hairless leaves 3-18 cm (1-7 in.) long (Marriott 1987; Fertig 1994; Fertig et al . 1994).

Gaura neomexicana ssp. coloradensis occurs on subirrigated, alluvial (stream deposited) soils on level or slightly sloping floodplains and drainage bottoms at elevations of 1,524-1,951 meters (5,000-6,400 ft). Colonies are often found in low depressions or along bends in wide, active, meandering stream channels a short distance upslope of the actual channel. The plant requires early-to mid-succession riparian (river bank) habitat. It commonly occurs in communities dominated by Agrostis stolonifera (redtop) and Poa pratensis (Kentucky bluegrass) on wetter sites, and Glycyrrhiza lepidota (wild licorice), Cirsium flodmanii (Flodman's thistle), Grindelia squarrosa (curlytop gumweed), and Equisetum laevigatum (smooth scouring rush) on drier sites. Both these habitat types are usually intermediate in moisture between wet, streamside communities dominated by sedges ( Carex spp.), rushes ( Juncus spp.), and cattails ( Typha spp.), and dry, upland shortgrass prairie. Typical G . n . ssp. coloradensis habitat is open, without dense or overgrown vegetation. Salix exigua (coyote willow) and Cirsium arvense (Canada thistle) may become dominant in G . n . ssp. coloradensis habitat that are not periodically flooded or otherwise disturbed. The plant occurs on soils derived from conglomerates, sandstones, and tuffaceous mudstones and siltstones of the Tertiary White River, Arikaree, and Oglalla Formations (Love and Christiansen 1985). These soils are common in eastern Colorado and Wyoming.

Gaura neomexicana ssp. coloradensis is an early successional plant (although probably not a pioneer) adapted to use stream channel sites that are periodically disturbed. Historically, flooding was probably the main cause of disturbances in the plant's habitat, although wildfire and grazing by native herbivores also may have been important. Although flowering and fruiting stems may undergo increased mortality because of these events, vegetative rosettes appear to be little affected (Mountain West Environmental Services 1985). However, the survival rate of the vegetative rosettes appears to be very dependent on available soil moisture. In wet years, such as the past few years, a large number of rosettes have survived; however, in dry years or during extended droughts, fewer rosettes appear to survive to reach the size necessary for flowering and fruiting. Because the long-term viability of this taxa relies on successful flowering and fruiting, as well as the difficulty in identifying small rosettes, only the flowering plants are counted to estimate population size and trends. The establishment and survival of seedlings appears to be enhanced at sites where tall and dense vegetation has been removed by some form of disturbance. In the absence of occasional disturbance, the plant's habitat can become choked out by dense growth of willows ( Salix spp.), grasses (including red top ( Agrostis stolinifera )), baltic rush ( Juncus balticus ), and exotic plants (such as Canada thistle ( Cirsium arvense ) and leafy spurge ( Euphorbia esula )), which prevents new seedlings from becoming established and replacing plants that have died (Floyd 1995a; Fertig 1996).

Little is known about the historical distribution of Gaura neomexicana ssp. coloradensis . Prior to 1984, no extensive documentation of the plant's range had been conducted. The plant was known from several historical (and presumably extirpated (Fertig 1994)) locations in southeastern Wyoming, and at least four historical (and presumably extirpated (Fertig 1994)) locations in northern Colorado; and from three extant populations in Laramie County, Wyoming, and Weld County, Colorado. In 1979, the total known population size was estimated in the low hundreds (Dorn 1979). Intensive range-wide surveys from 1984 to 1986 resulted in the discovery or confirmation of more than 20 populations in Wyoming, Colorado, and Nebraska, containing approximately 20,000 flowering individuals (Marriott 1987). Additional surveys since 1992 have resulted in the discovery of additional populations in Wyoming and Colorado (Fertig 1994; Floyd 1995b).

All currently known populations are within a small area (6,880 hectares (ha) or 17,000 acres (ac)) in southeastern Wyoming, western Nebraska, and north-central Colorado. Two of the populations occur on F.E. Warren Air Force Base in Cheyenne, Wyoming, and five small populations on State land (Chambers Preserve, CO; Oliver Reservoir State Recreation Area, NE; and state school trust land, WY). One population occurs on the Meadow Springs Ranch, northern Colorado (owned by City of Fort Collins). The remaining populations occur on private lands.

Extensive surveys were conducted during 1998 to document the status of previously known populations at 14 sites in Wyoming and Colorado (Fertig 1998b). All 14 sites still supported populations of Gaura neomexicana ssp. coloradensis . Repeated survey information led Fertig (1998b) to conclude that 10 of these populations were either relatively stable or increasing over the long term. Fertig (1998b) estimated the entire population of this taxon to contain between 47,000 and 50,000 reproductive plants. Twelve previously known populations were not surveyed in 1998, so their current status is unknown. Three of these populations were surveyed from 1989 until 1992 and were found to contain only 807 reproductive plants (Fertig 1998b). However, four populations in Colorado and five in Wyoming identified in previous surveys had not been relocated since 1986 and may be extirpated. Thus, of 26 previously and currently known populations, 9 may be extirpated; 3 are probably small, but have not been surveyed since 1992; 4 are still extant, but declining; and 10 are stable or increasing.

Federal action on these plants began as a result of section 12 of the Endangered Species Act (Act) of 1973, as amended (16 U.S.C. 1531 et seq. ), which directed the Secretary of the Smithsonian Institution to prepare a report on those plants considered to be endangered, threatened, or extinct in the United States. This report (House Document No. 94-51) was presented to Congress on January 9, 1975, and included Gaura neomexicana spp. coloradensis. We published a notice in the July 1, 1975, Federal Register (40 FR 27823) of our acceptance of the Smithsonian Institution report as a petition within the context of section 4(c)(2) (petition provisions are now found in section 4(b)(3)) of the Act, and our intention to review the status of the reported plant species.

On June 16, 1976, we published a proposal in the Federal Register (41 FR 24523) to determine approximately 1,700 vascular plant species, including Gaura neomexicana ssp. coloradensis, to be endangered species under section 4 of the Act. General comments received in relation to the 1976 proposal were summarized in an April 26, 1978, Federal Register publication (43 FR 17909). The Act Amendments of 1978 required that all proposals over 2 years old be withdrawn. A 1-year grace period was given to those proposals already more than 2 years old. In the December 10, 1979, Federal Register (44 FR 70796), we published a notice of withdrawal of the June 16, 1976, proposal, along with four other proposals that had expired.

We published an updated Notice of Review (NOR) for plants on December 15, 1980 (45 FR 82480), which included Gaura neomexicana ssp. coloradensis as a Category 1 candidate species. Category 1 candidates were formerly defined as species for which we had on file substantial information on biological vulnerability and threats to support preparation of listing proposals, but issuance of a proposed rule was precluded by other listing activities of higher priority. This subspecies was mistakenly left out of the NOR published November 28, 1983 (48 FR 53640), but its status was republished in subsequent NORs published in the Federal Register on September 27, 1985 (50 FR 39526), February 21, 1990 (55 FR 6184), and September 30, 1993 (58 FR 51144).

On February 28, 1996, we published a NOR in the Federal Register (61 FR 7596) that discontinued the designation of category 2 species as candidates. That notice included as candidates only those species meeting the former definition of category 1. Gaura neomexicana ssp. coloradensis was included as a candidate in this notice and has retained that status in the subsequent NOR, published in the Federal Register on September 19, 1997 (62 FR 49384).

As part of a settlement agreement in Fund for Animals et al. v. Lujan et al. (D.D.C. Civ. No. 92-800), the proposed rule to list this subspecies as threatened was published in the Federal Register on March 24, 1998 (63 FR 14060). The comment period on the proposed rule to list Gaura neomexicana ssp. coloradensis was reopened in the Federal Register on May 17, 2000 (65 FR 31298), to accommodate the public notice requirement of the Act to consider any new scientific information.

On January 18, 1982, we signed a Memorandum of Understanding with the Commander of the F.E. Warren Air Force Base to ensure continued survival of the two populations of Gaura neomexicana ssp. coloradensis that occur on the base. The agreement has been updated several times since 1982. In 1990 a Research Natural Area was established to include all the known naturally occurring populations on the base. The 1992 Memorandum of Understanding also included The Nature Conservancy, supported demographic studies of the G. n. ssp. coloradensis populations on the base, and provided for ongoing protective efforts. The most recent Memorandum of Agreement (signed March 31, 1999, and effective through December 31, 2003) supports continued protection of the plant populations on the base, development of a weed control plan, and research on reproduction, genetic variability, and other ecological and biological aspects of the plant.

We have updated this rule to reflect any changes in information concerning distribution, status, and threats since the publication of the proposed rule and to incorporate information obtained through the public comment periods. This additional information did not alter our decision to list the subspecies.

In the March 24, 1998, proposed rule (63 FR 14060) and the May 17, 2000, reopening of the comment period (65 FR 31298), we requested interested parties to submit factual reports or information that might contribute to the development of a final rule. We sent announcements of the proposed rule to appropriate Federal and State agencies, county governments, scientific organizations, and other interested parties. We also published announcements of the proposed rule in three local newspapers (Fort Collins Coloradoan, the Wyoming Tribune Eagle, and the Western Nebraska Observer) on May 18 and 19, 2000, inviting public comment.

We received a total of ten comments (four from private organizations, four from agricultural operations, one from State Government, and one from a private individual) that are discussed below. Of these comments, two were provided as supplements to comments already provided during the initial comment period.

Issue 1: Two commenters suggested we take an ecosystem approach and adopt a program that would conserve several species, including Preble's meadow jumping mouse ( Zapus hudsonius preblei ), even if development of such a program leads to delays in protection for the plant. The commenter also indicated the proposed rule ignores the efforts of the Laramie County Commissioners to amend the county use plan and develop a Habitat Conservation Plan which would include Gaura neomexicana ssp. coloradensis.

Our Response: We actively support ecosystem-level conservation efforts and encourage multi-species planning efforts to avoid or reduce the need for future listing actions and facilitate recovery of listed species within designated planning areas. Our 1994 policy regarding the ecosystem approach to the Act, published in the Federal Register on July 1, 1994 (59 FR 34273), directs us to make listing decisions for groups of species where possible and implement recovery plans for multiple listed and candidate species. However, we also are required to determine whether a species is endangered or threatened within specific time frames and based on the five factors listed under section 4(a)(1) of the Act. Based on these factors, the decision to propose listing this subspecies was made in 1998. Once a listing is proposed, we have a responsibility to either finalize the listing or withdraw the proposal. After reviewing the available data and the comments received, we determined that finalizing the listing proposal was the appropriate action to take.

Although the Laramie County Habitat Conservation Plan may address the majority of Gaura neomexicana ssp. coloradensis populations, the effort is still in the early planning process with no certainty of its completion, approval, or implementation. Therefore, we are not able to consider the effectiveness of this Habitat Conservation Plan in reducing or eliminating the threats to this subspecies in the future as part of our listing decision. We must evaluate the threats to G. n. ssp. coloradensis based upon existing land-use and regulatory mechanisms, which have not always proven adequate in the past to conserve the subspecies effectively.

Issue 2: One commenter stated the proposed rule did not provide compelling reasons for not designating critical habitat.

Our Response: After further review of the available data, we found that designating critical habitat is prudent for this subspecies, but we are deferring the designation to allow ourselves to concentrate our limited resources on higher priority critical habitat (including court ordered designations) and other listing actions, while establishing protections needed for the conservation of Gaura neomexicana ssp. coloradensis without further delay.

Issue 3: Two commenters stated Gaura neomexicana ssp. coloradensis should be listed as endangered and not threatened.

Our Response: As mentioned above, extensive surveys conducted during 1998 showed populations of Gaura neomexicana ssp. coloradensis still occurring at the 14 surveyed sites, with 10 of these populations either stable or increasing over the long term. The entire population of this taxon is estimated to contain between 47,000 and 50,000 reproductive plants. Although the majority of populations occur on private land, two populations, which are considered stable, occur on F.E. Warren Air Force Base, and are protected through the Research Natural Area designation and through the current Memorandum of Agreement. Additionally, a seed bank has been established at the Nebraska State Arboretum, and experimental populations have been established at the University of Colorado and the University of Wyoming. As a result, G. n. ssp. coloradensis does not meet the definition of an endangered species under the Act, because it is not in imminent danger of extinction in the foreseeable future (see “Summary of Factors Affecting the Species” below). Therefore, listing as threatened is appropriate.

Issue 4: Three commenters discussed the value of private land in plant conservation, saying that the plant's presence on private land is an indication that those lands are being managed consistently with the conservation of the subspecies. The commenters expressed concern over the hardship landowners may have to endure as a result of the listing, and one thought conservation efforts should be voluntary without fear of fines.

Our Response: We believe private lands will be of great importance in the conservation of Gaura neomexicana ssp. coloradensis. Most riparian habitat in the geographic range of the plant is in private ownership, so it is reasonable to expect to find most suitable habitat and most populations of the plant on private lands. We acknowledge that healthy populations of G. n. ssp. coloradensis with stable or increasing long-term trends probably reflect land management practices that are compatible with the needs of the plant. We encourage the continuation of such practices. Additionally, the prohibitions outlined in section 9 of the Act are much less restrictive for threatened plants on private lands than for animals (see “Available Conservation Measures” below). Few actions are actually restricted and, therefore, there is little likelihood of landowners suffering hardships because of the presence of a listed plant on their property.

Issue 5: Three commenters stated that many agricultural practices benefit Gaura neomexicana ssp. coloradensis.

Our Response: As described above, we recognize that certain agricultural practices and disturbances, particularly those that reduce competition from late-seral stage plants while allowing Gaura neomexicana ssp. coloradensis to set seed, are beneficial to the plant. However, some agricultural practices may be harmful to the plant's survival. For example, although the plant often does well in grazed areas, certain grazing regimes and stocking levels result in poor conditions for the plant. Mowing of hay may reduce competing vegetation, but if done at the wrong time or too frequently could prevent G. n. ssp. coloradensis plants from setting seed. Development of water supply and irrigation systems may result in creation of suitable habitat in some areas, while adversely affecting existing suitable habitat through direct habitat loss and changes in hydrology. Further coordination between the Service and the agriculture industry will improve our understanding of how agriculture affects the plant and its habitat.

Issue 6: Five commenters discussed noxious weed control. Two commenters pointed out that limited or timely spraying of noxious weeds may help Gaura neomexicana ssp. coloradensis by eliminating plants that aggressively compete for resources, while late haying may allow noxious weeds to flourish. Other commenters wanted the Service to identify alternatives to herbicides to control noxious weeds.

Our Response: We recognize the need to control noxious weeds and acknowledge that competition from these subspecies may have serious negative implications for Gaura neomexicana ssp. coloradensis. However, G. n. ssp. coloradensis is highly susceptible to commonly-used herbicides when they are applied non- selectively. Alternative means of herbicide application and the use of biological control agents should continue to be investigated. Further studies at F.E. Warren Air Force Base may help identify the best methods for noxious weed control in G. n. ssp. coloradensis habitat.

Issue 7: One commenter wanted the Service to disclose what percentage of suitable habitat within the historical habitat has been surveyed and either quantify the level of habitat impacts or quantify the remaining habitat available for recovery.

Our Response: Gaura neomexicana ssp. coloradensis has a restricted geographic range and high habitat specificity (Fertig 1998b), making habitat identification straightforward. The extensive effort associated with 1984-1986 surveys is outlined by Marriott (1987), who indicated that the majority of suitable habitat had been surveyed for the presence of this plant. However, no effort has been made to precisely quantify the percentage of suitable habitat that has been surveyed or the remaining habitat available for recovery. As access to private lands is occasionally restricted and funding for surveys is minimal, our ability to identify and survey all suitable habitat or monitor habitat for impact is limited. Moreover, disturbance regimes and plant succession continually change habitat characteristics, making quantification of habitat available for recovery of limited value. Therefore, we have based our listing determination on the best available information gained from known populations and accessible suitable habitat.

Issue 8: One commenter indicated few Gaura neomexicana ssp. coloradensis plants occur in Nebraska, although many occur elsewhere within the plant's range. We interpreted this comment to indicate the commenter believed the plant should not be listed in Nebraska.

Our Response: While it is true that few Gaura neomexicana ssp. coloradensis plants occur in Nebraska, the Act does not allow for the listing of distinct populations of plants. Therefore, any listing action would cover the entire range of the subspecies. Additionally, the Nebraska plants are facing the same threats occurring elsewhere in the range. The loss of these plants would negatively affect conservation of the subspecies.

Issue 9: One commenter expressed concern that listing Gaura neomexicana ssp. coloradensis would affect their ability to sell their land. We interpret this to be an economic concern.

Our Response: Under 16 U.S.C., paragraph 1533(b)(1)(A), 50 CFR 424.11(b), and section 4(b)(1)(A) of the Act, listing decisions are made solely on the basis of the best available scientific and commercial data. Economic impacts cannot be considered when determining whether to list a species under the Act. It also should be noted that plants listed under the Act receive only minimal protection on private lands.

Issue 10: Two commenters referenced more recent data available since the proposed rule was published. Both commenters cited higher population numbers than those used in the proposed rule (especially when considering vegetative rosettes), as well as new information regarding long-term trends.

Our Response: We have used the most current information available in preparation of this rule, including those documents and studies referenced by the commenters. This rule reflects new population estimates and trends in the “Background” section. Additionally, the Service has considered the apparently large number of vegetative rosettes. However, the survival rate of the vegetative rosettes is generally low and appears to be dependent on many factors, including soil moisture, with many small and medium rosettes produced in wet years and few during dryer years. The large numbers of vegetative rosettes recently documented may merely reflect the wet springs experienced recently, rather than a meaningful increase in population sizes. It appears few vegetative rosettes survive to reach the size necessary for flowering and fruiting. For this reason, as well as the difficulty in identifying small rosettes, flowering plants have always been counted to estimate population size and trends. Limited data are available to establish any trend in number of vegetative rosettes over the years or a strong correlation between the number of vegetative rosettes and flowering plant population size. Therefore, we believe the best indicator of population size for this plant is the number of flowering plants.

Issue 11: One commenter indicated residential and urban development cannot be considered a threat to the plant in Laramie County, Wyoming, because of existing land use plans.

Our Response: The Laramie County Comprehensive Land Use Plan contains a variety of policies that may protect habitat in unincorporated portions of the county, if the County Commissioners choose. However, none of the policies offer specific protection for the plant or its habitat. Rather, the policies require: (1) Developers include a discussion of wildlife resources in the area in an Environmental Impact Report, (2) new subdivisions demonstrate no threats to nearby irrigators, (3) open space and recreational uses be considered the preferred uses in floodplains areas, and (4) existing natural and manmade features which affect land use be considered and evaluated prior to the approval of new subdivisions and developments. Although this guidance certainly allows the County Commissioners to be able to make decisions that would assist in conservation of various resources, the Laramie County Comprehensive Land Use Plan does not mandate conservation of resources in general or Gaura neomexicana ssp. coloradensis in particular. In fact, by allowing recreational activities such as hiking trails, community gardens, and riding arenas in the floodplain, the Laramie County Comprehensive Land Use Plan could allow adverse impacts to populations of G. n. ssp. coloradensis.

Issue 12: One commenter opposed the listing of Gaura neomexicana ssp. coloradensis, stating that the Federal government lacks the authority under the Commerce Clause of the Constitution to regulate this subspecies.

Our Response: The Federal government has the authority under the Commerce Clause of the United States Constitution to protect this subspecies, for the reasons given in Judge Wald's opinion and Judge Henderson's concurring opinion in National Association of Home Builders v. Babbitt, 130 F.3d 1041 (D.C. Cir. 1997), cert. denied, 1185 S.Ct. 2340 (1998), making it clear in its application of the test used in the United States Supreme Court case, United States v. Lopez, 514 U.S. 549 (1995), that regulation of endangered species limited to one State under the Act is within Congress' Commerce Clause power. That case involved a challenge to application of the Act's prohibitions to protect the listed Delhi Sands flower-loving fly ( Rhaphiomidas terminatus abdominalis ). Judge Wald held that application of the Act's prohibition against taking of endangered species was a proper exercise of Commerce Clause power to regulate: (1) Use of channels of interstate commerce, and (2) activities substantially affecting interstate commerce, because applying the Act in that case prevented destructive interstate competition and loss of biodiversity. Judge Henderson upheld protection of the fly because doing so prevents harm to the ecosystem upon which interstate commerce depends and regulates commercial development that is part of interstate commerce.

The Federal government also has the authority under the Property Clause of the Constitution to protect Gaura neomexicana ssp. coloradensis which occurs on the F.E. Warren Air Force Base. If this subspecies were to become extinct or extripated, the diversity of plant life on the Air Force Base would be diminished. The courts have long recognized Federal authority under the Property Clause to protect Federal resources in such circumstances. See e.g., Kleppe v. New Mexico, 429 U.S. 873 (1976); United States v. Alford, 274 U.S. 264 (1927); Camfield v. United States, 167 U.S. 518 (1897); United States v. Lindsey, 595 F.2d 5 (9th Cir. 1979).

Issue 13: Two commenters expressed concern regarding the delays in publishing a final listing decision and questioned the need to reopen the comment period. Both commenters believe the Service reopened the comment period to appease political interests. Additionally, one of the commenters indicated there was no new information that would warrant reconsideration of the proposal.

Our Response: We acknowledge our tardiness in publishing the final rule. Because of an oversight during the initial comment period for the proposed rule, the legal notices required by the Act (section 4(b)(5)(D)) were not published in any local newspapers. In order to fully comply with the Act, we reopened the comment period and published legal notices in the “Fort Collins Coloradoan,” the “Wyoming Tribune Eagle,” and “Western Nebraska Observer.” Six comment letters were received during the reopened comment period, two referencing new information regarding population sizes and trends. While our review of the new information did not ultimately change the proposed action, the Service believed the new information was significant enough to warrant consideration.

In accordance with interagency policy published in the Federal Register on July 1, 1994 (59 FR 34270), we solicited the expert opinions of three independent specialists regarding pertinent scientific or commercial data and assumptions relating to the taxonomy, population models, and supportive biological and ecological information for the taxon under consideration for listing. The purpose of this review is to ensure listing decisions are based on scientifically sound data, assumptions, and analyses, including input from appropriate experts and specialists. Two scientists responded to our request for peer review of this listing action and provided information which generally supported the biological and ecological data presented in the proposed rule.

One reviewer expressed concern regarding the timeliness of the listing. The reviewer indicated listing alone would result in only limited conservation on private lands, where most of the known populations occur. The reviewer wanted the Service to postpone the listing to allow time for a more significant effort to establish management agreements with willing land owners.

Our Response: As stated in response to Issue 1 above, we are required to determine whether a species is endangered or threatened within specific timeframes and based solely on the five factors listed under section 4(a)(1) of the Act. Therefore, the decision was made to list this subspecies at this time.

A second reviewer also felt voluntary conservation measures are more likely to protect this subspecies and its habitat than listing under the Act. The reviewer indicated that threats are clearly present, but many (such as herbicide use) can be mitigated. Additionally, the reviewer believed current management of privately-owned agricultural lands is largely compatible with the needs of the plant or could be made compatible through education. This reviewer believed listing of Gaura neomexicana ssp. coloradensis as threatened could undermine its conservation if landowners react negatively to its presence, and would do little to improve its management on Federal lands, such as F.E. Warren Air Force Base. The reviewer indicated that the section 9 protections discussed in the proposed rule were reasonable and consistent with the management needs of the subspecies.

Our Response: We have to make our listing decision based on conservation measures that are currently in place. Even if formal conservation agreements were in place, those agreements would need to be evaluated based upon the certainty of implementation and effectiveness. Many of the current threats could be minimized and mitigated through implementation of formal conservation agreements, including education programs. However, without those agreements there is not a high level of certainty that any conservation measures will be implemented. The potential for landowners to react negatively to the listing is not a factor that we can consider in making a listing decision. However, the Service will conduct outreach in association with this listing decision to try to minimize negative reactions by landowners and others. Additionally, listing the plant will give the Service additional oversight of potential adverse impacts resulting from Federal projects through section 7 consultation. This should enhance conservation of the species.

Section 4 of the Act and regulations (50 CFR part 424) issued to implement the listing provisions of the Act set forth the procedures for adding species to the Federal lists. A species may be determined endangered or threatened due to one or more of the five factors described in section 4(a)(1). These factors and their application to Gaura neomexicana ssp. coloradensis are as follows:

A. The present or threatened destruction, modification, or curtailment of its habitat or range. Gaura neomexicana ssp. coloradensis is restricted to approximately 6,880 ha (17,000 ac) running from Colorado Springs, Colorado, north to Cheyenne, Wyoming, and spreading into a small portion of southwest corner of Nebraska. Of the currently known populations of G. n. ssp. coloradensis, the vast majority occur on private lands managed primarily for agriculture. Only two populations occur on Federal land, both at F.E. Warren Air Force Base. Small populations are found in special management areas at Chambers Preserve, Colorado, and Oliver Reservoir State Recreation Area, Nebraska. At least three other populations in Wyoming are found partly or fully on state school trust lands managed mostly for agricultural uses. The Meadow Springs Ranch population in northern Colorado is owned by the City of Fort Collins and managed for municipal sewage treatment.

Haying and mowing at certain times of the year, water development, land conversion for cultivation, competition from exotic plants, non-selective use of herbicides, and loss of habitat to urban growth are the main threats to the plant on these lands (Marriott 1987; Fertig 1994). On some sites, including F.E. Warren Air Force Base, habitat degradation resulting from plant succession and noxious weed competition is the main threat to the long-term survival of populations. High recreational use by campers, motorists, and fishermen is a threat to populations on State park lands in Nebraska.

Conversion of moist, native grasslands to commercial croplands has been widespread throughout southeastern Wyoming and northeastern Colorado (Compton and Hugie 1993). Since much of the agricultural lands are irrigated hay fields, mowing of Gaura neomexicana ssp. coloradensis habitat for hay production has been suggested as a potential threat if conducted at an inappropriate time of year (Jennings et al. 1997). Although this threat can be significant if cutting occurs before the plant's fruits have ripened, if cutting is delayed until late in the growing season when a hard fruit wall is developed, the seeds are not damaged by cutting and may actually be dispersed in the process. Likewise, early season mowing (before the flower stalks have bolted) may provide some advantages to the plant by reducing the cover of competing vegetation (Fertig 1994).

Construction of stock ponds and reservoirs has inundated some Gaura neomexicana ssp. coloradensis habitat and made it unsuitable for the subspecies. The development of irrigation canals to move water to croplands may remove moisture from occupied or potentially suitable habitat leaving it in a drier, unsuitable condition. Additionally, the management of water resources for domestic and commercial uses, coupled with encroaching agricultural land use, has had a tendency to channelize and isolate water resources and fragment, realign, and reduce riparian and moist lowland habitat that could otherwise serve as potential G. n. ssp. coloradensis habitat (Compton and Hugie 1993).

Residential and urban development around the cities of Cheyenne and Fort Collins has converted areas of formerly suitable Gaura neomexicana ssp. coloradensis habitat. The high rate of development occurring from Colorado Springs, Colorado, to Cheyenne, Wyoming, has been cited as a continuing threat to remaining populations of the Preble's meadow jumping mouse, a threatened species that also occurs in riparian habitats and whose historic range overlaps much of that of G. n. ssp. coloradensis (62 FR 14093).

In nonagricultural, undeveloped areas, a significant threat to Gaura neomexicana ssp. coloradensis populations is habitat degradation resulting from succession of the plant community. Without periodic disturbance events, the semi-open habitats preferred by this subspecies can become choked by tall and dense growth of willows, grasses, and exotic weeds (Fertig 1994). Natural disturbances, such as flooding, fire, and native ungulate grazing, were sufficient in the past to create favorable habitat conditions for the plant. However, the natural flooding regime within the subspecies' floodplain habitat has been altered by construction of flood control structures and by irrigation and channelization practices. In the absence of such natural disturbances today, managed disturbance may be necessary to maintain and create areas of suitable habitat (Fertig 1994, 1996). However, many Federal programs, such as those administered by the USDA Natural Resources Conservation Service, focus on enhancing or protecting riparian areas by removing the types of disturbance the plant needs, increasing vegetative cover, and pushing the habitat into later successional stages.

B. Overutilization for commercial, recreational, scientific, or educational purposes. Given the limited range and concentration of the subpopulations, overcollection could be a problem. However, currently, there does not appear to be any commercial demand for the subspecies, nor is it anticipated that there would be any substantial threat of overcollection due to scientific or educational demands.

C. Disease or predation. There are no known diseases affecting Gaura neomexicana ssp. coloradensis populations, although the subspecies is occasionally affected by insect galls. G. n. ssp. coloradensis is highly palatable to a variety of insect and mammalian herbivores ( e.g., cattle, horses, and pronghorn ( Antilocapra americana )), but appears to compensate for herbivory by increasing branch and fruit production. Livestock grazing can be a threat at some sites if grazing pressures are high due to animals are not being rotated among pastures or concentrated use during the summer flowering period. Additionally, plants are occasionally uprooted or trampled by livestock and wildlife grazing in the vicinity. In at least one location where a population of G. n. ssp. coloradensis was divided by a fence, the heavily-grazed side of the fence had few or no G. n. ssp. coloradensis plants (J. Miller, U.S. Fish and Wildlife Service, in litt. 1987). The primary author of this rule also has observed a site adversely affected by higher-intensity grazing. However, in a similar situation, the more heavily-grazed side of the fence had numerous rosettes, but the side with no grazing had dense willow cover and no G. n. ssp. coloradensis (Walt Fertig, The Nature Conservancy, in litt. 1998). In addition to the intensity of grazing, the timing of grazing is key to G. n. ssp. coloradensis survival. Observations have shown that the plant can persist and thrive in habitats that are winter-grazed or managed on a short-term rotation cycle (Jennings et al. 1997). Light to medium grazing can provide additional benefits by reducing the competing vegetative cover and allowing G. n. ssp. coloradensis seedlings to become established.

D. The inadequacy of existing regulatory mechanisms. No Federal or State laws or regulations specifically protect Gaura neomexicana ssp. coloradensis or its habitat. The plant is listed as Sensitive by the U.S. Forest Service, although no populations are currently known from Forest Service lands (D. Hazlett, Plants and People Consulting, pers. comm, 1994). Fertig (1998b) considers the inadequacy of existing regulatory mechanisms to be the main impediment to long-term conservation of G. n. ssp. coloradensis. Although the Preble's meadow jumping mouse, a threatened species, inhabits riparian areas within the range of G. n. ssp. coloradensis, these two species prefer different stages of vegetational succession. Therefore, measures to protect habitat for the mouse may not protect G. n. ssp. coloradensis.

E. Other natural or manmade factors affecting its continued existence. The most serious threat on agricultural lands is non-selective use of broadleaf herbicides for the control of Cirsium arvense (Canada thistle), Euphorbia esula (leafy spurge), and other exotic plants (Marriott 1987). The noxious weed problem in Laramie County, Wyoming, is particularly evident on F.E. Warren Air Force Base. Although competition from these subspecies may have serious negative implications for populations of Gaura neomexicana ssp. coloradensis, the plant appears to be highly susceptible to commonly used herbicides when they are applied non-selectively. In 1983, nearly one-half of the mapped populations on F.E. Warren Air Force Base were inadvertently destroyed when sprayed with Tordon, a persistent herbicide. Additionally, herbicide use along road crossings in and adjacent to G. n. ssp. coloradensis populations also has been noted (J. Miller, U.S. Fish and Wildlife Service, in litt. 1987). Biological control agents have been used at F.E. Warren Air Force Base, but have not yet been fully effective in controlling Canada thistle or leafy spurge. Introduced gall-forming flies have slowly become established on the Base and have reduced the vigor, height, and reproductive ability of small patches of Canada thistle (Fertig 1997). The first evidence of successful establishment of flea beetles, a biocontrol agent for leafy spurge, was observed on the Base in 1997 (Fertig 1998a).

In order for a population to sustain itself, there must be enough reproducing individuals and sufficient habitat to ensure survival of the population. It is not known if the scattered populations of Gaura neomexicana ssp. coloradensis contain sufficient individuals and diversity to ensure their continued existence over the long term.

The most recent survey information for the known populations of Gaura neomexicana ssp. coloradensis shows that only 5 of the 14 surveyed populations are large ( i.e., with at least 3,000 or more flowering individuals). Only one of these occurs on Federal lands. Seven of the surveyed populations (one of them occurring on Federal lands) are moderately sized, containing between 500 and 2,500 flowering individuals each. The remaining 2 surveyed populations are smaller, with less than 200 reproductive individuals each. These small populations are threatened by a possible reduction in vigor and fecundity (often evidenced by reduced seed set), as random genetic changes occur and genetic variability is lost as a result of inbreeding which is inevitable in small populations (Ehrlich 1981; Ledig 1986). Because of the small, isolated nature of the populations and the few individuals present in many of them, G. n. ssp. coloradensis also is more susceptible to random events, such as fires, insect or disease outbreaks, or other events that can easily cause the extirpation of a small population.

Although the plant evolved with and even depended upon the disturbance associated with these types of events, they may now pose a threat to Gaura neomexicana ssp. coloradensis. Individual plants may not survive such events, and because of low numbers and the now highly restricted range of the subspecies, events such as fires and floods pose a threat. A flood in 1983 along Crow Creek on the F.E. Warren Air Force Base impacted several populations and experimental seed plots established in 1981 (U.S. Fish and Wildlife Service, in litt. 1984). However, these populations rebounded and have been censussed annually since 1986 (Walt Fertig, The Nature Conservancy, in litt. 1998).

We have carefully assessed the best scientific and commercial information available regarding the past, present, and future threats to Gaura neomexicana ssp. coloradensis in determining to issue this final rule. While not in immediate danger of extinction, G. n. ssp. coloradensis is likely to become an endangered species in the foreseeable future if the present threats and declines continue. Although some conservation efforts are being conducted on Federal and private lands, these efforts are currently not sufficient to provide adequate protection for the subspecies. Therefore, Federal listing under authority of the Act is the only mechanism we can presently identify that will help ensure protection for G. n. ssp. coloradensis throughout its limited range.

Critical habitat is defined in section 3, paragraph (5)(A) of the Act as the specific areas within the geographical area occupied by a species, at the time it is listed in accordance with the Act, on which are found those physical or biological features essential to the conservation of the species and that may require special management considerations or protection; and specific areas outside the geographical area occupied by a species at the time it is listed in accordance with the provisions of section 4 of the Act, upon a determination by the Secretary that such areas are essential for the conservation of the species. “Conservation” means the use of all methods and procedures needed to bring the species to the point at which listing under the Act is no longer necessary.

Critical habitat designation directly affects only Federal agency actions through consultation under section 7(a)(2) of the Act. Section 7(a)(2) requires Federal agencies to ensure that activities they authorize, fund, or carry out are not likely to jeopardize the continued existence of a listed species or destroy or adversely modify its critical habitat.

Section 4(a)(3) of the Act, as amended, and our implementing regulations (50 CFR 424.12) require that, to the maximum extent prudent and determinable, we designate critical habitat at the time the species is determined to be endangered or threatened. Our regulations (50 CFR 424.12(a)(1)) state that designation of critical habitat is not prudent when one or both of the following situations exist: (1) the species is threatened by taking or other activity and the identification of critical habitat can be expected to increase the degree of threat to the species, or (2) such designation of critical habitat would not be beneficial to the species.

In the proposed rule, we indicated that designation of critical habitat was not prudent for Gaura neomexicana ssp. coloradensis because of a concern that publication of precise maps and descriptions of critical habitat in the Federal Register could increase the vulnerability of this subspecies to incidents of collection and vandalism. We also indicated that designation of critical habitat was not prudent because we believed it would not provide any additional benefit beyond that provided through listing as threatened.

In the last few years, a series of court decisions have overturned Service determinations that designation of critical habitat for a variety of species would not be prudent (e.g., Natural Resources Defense Council v. U.S. Department of the Interior 113 F. 3d 1121 (9th Cir. 1997); Conservation Council for Hawaii v. Babbitt, 2 F. Supp. 2d 1280 (D. Hawaii 1998)). Based on the standards applied in those judicial opinions, we have reexamined the question of whether critical habitat for Gaura neomexicana ssp. coloradensis would be prudent.

As with other species we list, we have the concern that unrestricted collection, vandalism, or other disturbances could be exacerbated by the publication of critical habitat maps and further dissemination of locational information. However, we have examined the evidence available for Gaura neomexicana ssp. coloradensis and have not found specific evidence of taking, vandalism, collection, or trade of this species or any similarly situated species. Consequently, consistent with applicable regulations (50 CFR 424.12(a)(1)(I)) and recent case law, we do not expect that the identification of critical habitat will increase the degree of threat to this subspecies of taking or other human activity.

In the absence of a finding that critical habitat would increase threats to a subspecies, if any benefits would result from a critical habitat designation, then a prudent finding is warranted. In the case of this subspecies, designation of critical habitat may provide some benefits. The primary regulatory effect of critical habitat is the section 7 requirement that Federal agencies refrain from taking any action that destroys or adversely modifies critical habitat. While a critical habitat designation for habitat currently occupied by this subspecies would not be likely to change the section 7 consultation outcome because an action that destroys or adversely modifies such critical habitat also would be likely to result in jeopardy to the subspecies, in certain instances, section 7 consultation might be triggered only if critical habitat is designated. Examples could include some actions in unoccupied habitat or occupied habitat that may become unoccupied in the future. Designating critical habitat may provide some educational or informational benefits. Therefore, we find that critical habitat is prudent for Gaura neomexicana ssp. coloradensis.

As explained in detail in the Final Listing Priority Guidance for Fiscal Year 2000 (64 FR 57114), our listing budget is currently insufficient to allow us to immediately complete all of the listing actions required by the Act. We focus our efforts on those listing actions that provide the most conservation benefit. Deferral of the critical habitat designation for this subspecies will allow us to concentrate our limited resources on higher priority critical habitat and other listing actions, without delaying the final listing decision for Gaura neomexicana ssp. coloradensis. We will develop a proposal to designate critical habitat for G. n. ssp. coloradensis as soon as feasible, considering our workload priorities and available funding. Unfortunately, for the immediate future, most of Region 6's listing budget must be directed to complying with numerous court orders and settlement agreements, as well as due and overdue final listing determinations.

The Nebraska State Arboretum currently maintains a seed bank of Gaura neomexicana ssp. coloradensis collected from sites along Lodgepole Creek in Nebraska (J. Locklear, Nebraska State Arboretum, pers. comm. April 15, 1997). Additional seed has been collected by the Natural Resources Conservation Service for deposit at the Bridger Plant Materials Center in Montana. Seed from other populations throughout the range of this subspecies is needed to ensure adequate genetic representation in cultivated stocks and seed banks. Additional testing is needed to determine the viability of seed after long periods of storage.

Habitat along Crow and Diamond Creeks on F.E. Warren Air Force Base has been designated as the Colorado Butterfly Plant Research Natural Area dedicated to the protection of the largest known population of Gaura neomexicana ssp. coloradensis , and a management plan has been developed (Marriott and Jones 1988). Two relatively large populations of G . n . ssp. coloradensis occur within the Colorado Butterfly Plant Research Natural Area. Under various memoranda of understanding and cooperative agreements with the Service and The Nature Conservancy, the Air Force has been conducting conservation activities for this subspecies since 1982. However, the current Memorandum of Agreement between the Service and the Air Force contains no implementation schedule, is subject to the availability of appropriated and non-appropriated funds and personnel, and can be terminated at any time (with 60 days notice). The Base is currently implementing a weed-control program with special restrictions on the spraying of pesticides in G . n . ssp. coloradensis habitat. Continued implementation of conservation actions on the Base will enhance the overall conservation of the subspecies.

In 1983 a population of Gaura neomexicana ssp. coloradensis was introduced on the Chambers Preserve near Boulder, Colorado. Although the reintroduction was initially successful, whether the population persists today is unknown. Several private landowners with natural populations of the plant have expressed interest in pursuing conservation projects; none are currently in place. Protection for these natural populations should be encouraged.

Additionally, as mentioned above, little is known of the genetic variability within or between populations. Genetic research to determine the degree of genetic variability within and between populations of the plant would enable the Service to focus conservation measures on maintaining the existing genetic diversity of Gaura neomexicana ssp. coloradensis , thus enhancing the subspecies' chances of long-term survival. The Air Force is currently funding a genetics study focused on populations of G . n . ssp. coloradensis at F.E. Warren Air Force Base.

Conservation measures provided to subspecies listed as endangered or threatened under the Act include recognition, recovery actions, requirements for Federal protection, and prohibitions against certain practices. Recognition through listing encourages and results in public awareness and conservation actions by Federal, State, and local agencies, private organizations, and individuals. The Act provides for possible land acquisition and cooperation with the States and requires that recovery actions be carried out for all listed species. Funding may be available through section 6 of the Act for the States to conduct recovery activities. The protection required of Federal agencies and the prohibitions against certain activities involving listed plants are discussed, in part, below.

Section 7(a) of the Act, as amended, requires Federal agencies to evaluate their actions with respect to any species that is proposed or listed as endangered or threatened and with respect to its critical habitat, if any is being designated. Regulations implementing this interagency cooperation of the Act are codified at 50 CFR part 402. Section 7(a)(2) of the Act requires Federal agencies to ensure that activities they authorize, fund, or carry out are not likely to jeopardize the continued existence of the listed species or destroy or adversely modify its critical habitat, if designated. If a Federal action may affect a listed species or its critical habitat, the responsible Federal agency must enter into formal consultation with us, under to section 7(a)(2) of the Act.

Federal agency actions that may require consultation as described in the preceding paragraph include altering vegetation, particularly through the use of herbicides; implementing livestock grazing management that alters vegetation during the flowering season of Gaura neomexicana ssp. coloradensis; construction of roads or hiking/biking trails along or through riparian areas; channelization and other alteration of perennial streams and their hydrological regimes for flood control and other water management purposes; permanent and temporary damming of streams to create water storage reservoirs or to alter the stream's course; construction of residential, commercial, and industrial developments, including roads, bridges, public utilities and telephone lines, pipelines, and other structures in G. n. ssp. coloradensis habitat; and sand and gravel and other types of mining activities within or upstream of G . n . coloradensis habitat. In addition, sections 2(c)(1) and 7(a)(1) of the Act require Federal agencies to utilize their authorities in furtherance of the purposes of the Act to carry out conservation programs for endangered and threatened species.

Listing of this plant as threatened would provide for the development of a recovery plan, which would identify both State and Federal efforts for conservation of the plant and establish a framework for agencies to coordinate activities and cooperate with each other in conservation efforts. The plan would set recovery priorities and describe site-specific management actions necessary to provide for the conservation and or recovery of the plant. Additionally, pursuant to section 6 of the Act, we would be able to grant funds to affected States for management actions promoting the protection and recovery of this subspecies.

The Act and our implementing regulations set forth a series of general prohibitions and exceptions that apply to all threatened plants. All prohibitions of section 9(a)(2) of the Act, implemented by 50 CFR 17.71, apply. These prohibitions, in part, make it illegal for any person subject to the jurisdiction of the United States to import or export, transport in interstate or foreign commerce in the course of a commercial activity, sell or offer for sale in interstate or foreign commerce, or remove the species to possession from areas under Federal jurisdiction. In addition, for plants listed as endangered, the Act prohibits the malicious damage or destruction on areas under Federal jurisdiction and the removal, cutting, digging up, or damaging or destroying of such plants in knowing violation of any State law or regulation, including State criminal trespass law. Section 4(d) of the Act allows for the provision of such protection to threatened species through regulation. This protection may apply to this subspecies in the future if such regulations were to be issued. Seeds from cultivated specimens of threatened plants are exempt from these prohibitions provided that their containers are marked “Of Cultivated Origin.” Certain exceptions to the prohibitions apply to agents of the Service and State conservation agencies.

The Act and 50 CFR 17.72 also provide for the issuance of permits to carry out otherwise prohibited activities involving threatened plants under certain circumstances. Such permits are available for scientific purposes and to enhance the propagation or survival of the subspecies. For threatened plants, permits also are available for botanical or horticultural exhibition, educational purposes, or special purposes consistent with the purposes of the Act. It is anticipated that few trade permits would ever be sought or issued because the subspecies is not in cultivation or common in the wild.

It is our policy, published in the Federal Register (59 FR 34272) on July 1, 1994, to identify to the maximum extent practicable those activities that would or would not be likely to constitute a violation of section 9 of the Act if a species is listed. The intent of this policy is to increase public awareness of the effect of the listing on proposed and ongoing activities within a species' range.

Collection of listed plants or activities that would damage or destroy listed plants on Federal lands are prohibited without a Federal endangered species permit. Such activities on non-Federal lands would constitute a violation of section 9 of the Act if they were conducted in knowing violation of State law or regulation, or in the course of violation of State criminal trespass law. Otherwise, such activities would not constitute a violation of the Act on non-Federal lands.

Questions regarding whether specific activities, such as changes in land use, will constitute a violation of section 9 should be directed to the Wyoming Field Supervisor (see ADDRESSES section). Requests for copies of the regulations regarding listed species and inquiries about prohibitions and permits may be addressed to: Regional Director, U.S. Fish and Wildlife Service, P.O. Box 25486, Denver Federal Center, Denver, Colorado 80225-0486.

This rule does not contain any information collection requirements that require Office of Management and Budget approval under the Paperwork Reduction Act.

The Service has determined that an environmental assessment and environmental impact statement, as defined under the authority of the National Environmental Policy Act of 1969, need not be prepared in connection with regulations adopted pursuant to section 4(a) of the Act of 1973, as amended. A notice outlining the Service's reasons for this determination was published in the Federal Register on October 25, 1983 (48 FR 49244).

A complete list of all references cited herein, as well as others, is available upon request from the Wyoming Field Office (see ADDRESSES section).

Author: The primary author of this document is Mary Jennings of the Wyoming Field Office (see ADDRESSES section).