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 all de Havilland Model DHC-8-100, -200, and -300 series airplanes was published in the Federal Register on July 7, 1998 (63 FR 36619). That action proposed to require installation of a placard on the instrument panel of the cockpit to advise the flightcrew that positioning of the power levers below the flight idle stop during flight is prohibited. Additionally, that action proposed to require eventual installation of an FAA-approved system that would prevent such positioning of the power levers during flight. Installation of that system would eliminate the requirement for installation of the placard.

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.

Several commenters point out the following: No new incidents of beta during flight have been reported since 1996, and reports were from foreign operators. Since those previous reports, the AFM has been revised to prohibit positioning of the power levers below the flight idle stop (beta) during flight, and the pilot training syllabus on prohibition of beta during flight has been revised. The commenters further state that sufficient tactile, visual, and audio cues exist to advise the flightcrew if the propeller is in beta range. One commenter, the manufacturer, points out that the power lever triggers cannot be applied accidentally. Movement of the triggers requires purposeful “reach and lift” action to engage beta. Therefore, the manufacturer asserts that unintentional engagement of beta during flight cannot occur. Another commenter states that a mechanical system cannot preclude inappropriate operation; however, proper training of pilots can. These commenters conclude that, with the previously mentioned procedures already in place, the unsafe condition specified in the proposed rule does not exist.

The FAA does not concur that the subject unsafe condition does not exist in Model DHC-8 series airplanes. The FAA acknowledges that other safeguards currently in practice, such as AFM revisions and the revised pilot training syllabus, do provide certain tactile, visual, and audio cues. (See Comment 7 for related discussion on visual cues.) However, despite the implementation of those safeguards, the FAA has received reports of operation of the airplane with the power levers positioned below the flight idle stop during flight on de Havilland Model DHC-8 series airplanes. One report indicated that such operation resulted in significant engine damage. Therefore, the FAA considers that sufficient data exist to demonstrate that an unsafe condition exists on Model DHC-8 series airplanes. Further, the FAA has determined that positioning of the power levers below the flight idle stop could result in engine overspeed, possible engine damage or failure, and consequent reduced controllability of the airplane.

Several commenters state that the current design meets the requirements of part 25 of the Federal Aviation Regulations (14 CFR part 25.1155), and one other commenter asserts that the current design already goes beyond those requirements. One of the commenters points out that part 25 of the Federal Aviation Regulations (14 CFR part 25) only addresses unintentional or uninformed actions, and does not address intentional acts. Another commenter states that if the FAA is going beyond its statutory authority and being inconsistent in application of requirements without providing justification, the commenter would view the proposed rule as arbitrary rulemaking.

The FAA does not concur that the AD should be withdrawn. The issuance of this AD is based on the finding that an unsafe condition exists or is likely to develop in this airplane series. The FAA points out that an airplane's type design is approved only after the FAA makes a determination that it complies with all applicable part 25 (14 CFR part 25) airworthiness requirements. In adopting and maintaining those requirements, the FAA has made the determination that they establish an appropriate level of safety. However, actual in-service experience (as well as other factors, such as manufacturers' fatigue testing, etc.) may reveal problems in an airplane or its components that were not envisioned or predictable at the time of type certification. When these problems create an unsafe condition, this means that the intent of the original level of safety is no longer being achieved. When actions or procedures have been identified that will positively correct the unsafe condition and restore the airplane to its original level of safety, an AD is the appropriate vehicle for mandating that such actions be accomplished.

Several commenters state that introduction of a beta lockout system will not provide any added safety benefit, and could actually cause an unsafe condition if the beta lockout system were to fail during landing. These commenters point out that failure of the lockout system to release may prevent the selection of propeller beta pitch angles (on the ground after landing) could, in fact, cause an over run, loss of control of the airplane during landing, or an accident. This commenter also states that with an “override” function, the flightcrew is required to perform an additional task to unlock the power levers so they can select “Beta/Disking & Reverse.” Another commenter states that installation of a mechanical lockout system would require an additional cockpit procedure and associated training. That commenter points out that such an additional cockpit procedure would contribute to the crew workload during the most critical phase of flight. Further, the commenter contends that the additional cockpit procedure could result in delay in placing the airplane in the desired configuration when required.

The FAA does not concur that the installation of a beta lockout system may introduce an unsafe condition. The FAA has already required retrofit of a similar lockout system on three other turbopropeller-powered airplane models. Further, several turboprop airplanes were designed and certified with beta lockout systems. Both the retrofit and the original designed lockout systems have been operating safely for close to ten years with no adverse landing or rollout service history. No change is required to the final rule as a result of these comments.

Two commenters state that the proposed rule is premature and inconsistent, and that any rulemaking effort should wait until the Aviation Rulemaking Advisory Committee (ARAC) submits its findings and recommendations regarding a change to the Federal Aviation Regulations. One of those commenters points out that ARAC is not expected to submit its recommendations to the FAA until July 31, 2001. That commenter contends that, until changes to part 25 of the Federal Aviation Regulations have been accomplished, the proposal is premature, and, at best, shows an inconsistency by the FAA as a result of arbitrary rulemaking without explanation. Another commenter requests that the FAA delay issuance of a rule pending a detailed safety study review of the current design, with the objective of determining if the Bombardier design proposal for a beta warning horn addresses the unsafe condition.

The FAA does not consider that delaying this action until after the release of the ARAC recommendation is warranted since sufficient technology currently exists to devise and install a beta lockout system. The purpose of the ARAC task is to determine whether changes to existing design standards are appropriate. These standards would be applicable only to future designs. In tasking ARAC on this subject, the FAA never intended that ARAC address issues relating to unsafe conditions found on previously certificated designs. Further, the FAA has determined that the warning horn is not sufficient to address the unsafe condition, and does not prevent moving the power lever into the beta range during flight.

Several commenters request that the FAA require installation of a beta warning horn rather than the beta lockout modification required by paragraph (b) of the proposal. These commenters also point out that Transport Canada Civil Aviation (TCCA), which is the airworthiness authority for Canada, did not determine that a beta lockout system was necessary. Those commenters question why the FAA has determined that installation of the beta lockout system is necessary when TCCA has not mandated such an installation. One commenter, the manufacturer, states that TCCA is planning to require mandatory installation of the beta warning horn, which would be substantially less expensive than installation of a beta lockout system, and would still provide an equivalent level of safety. Some commenters state that the description of the installation specified in paragraph (b) of the proposal is not sufficient to provide actual guidelines for the development of a beta lockout system. However, another commenter states that paragraph (b) of the proposal limits how operators can comply with the requirements.

Another commenter requests that specific training for prohibiting beta during in-flight be required instead of the beta lockout system. Additionally, another commenter states that the service experience of the Model DHC-8 series airplane does not distinguish itself in comparison to other airplane models considering the fact that crews of other types of airplanes could intentionally position the power lever in the beta range.

Other commenters state that a beta lockout system still wouldn't preclude intentional use of beta during flight because of the override function. The manufacturer states that the proposal implies that installation of a beta lockout system would preclude the pilot from being able to position the power lever below flight idle during flight. However, the manufacturer points out that with an override function, intentional positioning of the power levers below the flight idle stop during flight cannot be prevented. The manufacturer concludes, therefore, that the declared unsafe condition cannot be eliminated by the installation of a beta lockout system with an override function. The manufacturer asserts that, if it can be concluded that intentional positioning of power levers below flight idle stop during flight can only be deterred, the beta warning horn provides such deterrence. The manufacturer states that a beta warning horn provides a loud, easily identifiable aural warning, which would “sound” with any movement of the power levers below the flight idle stop. The manufacturer further notes that TCCA has accepted the beta warning horn modification as an enhanced level of safety.

The FAA does not concur with the requests to revise the requirement specified in paragraph (b) of the final rule. The FAA acknowledges that additional airplane flight manual limitations and additional pilot training have enhanced the operational safety of the airplane. However, those actions have not proven to solve the long-term problem involving unsafe operation of other turbopropeller-powered airplanes with a similar throttle quadrant design and service histories involving unsafe operation. Despite the addition of those actions, reports of beta during flight continued.

Further, the FAA does not concur with the commenters' requests to require a beta warning horn in lieu of a beta lockout system. The FAA points out that it appears that certain actions taken by the flightcrew are reflexive, and, as such, the action of placing the power levers below flight idle during flight may not always be interrupted by the horn. Additional data indicate that if beta operation is attempted with a warning horn as the only safety system, it is possible that in the time it takes for the flightcrew to react and return the power levers to the flight range, an overspeed of the propeller could occur that might cause engine damage or failure, and consequent reduced controllability of the airplane. Further, the beta horn (even though distinctive) may be accompanied by an airplane overspeed warning horn, along with other warnings, which may be confusing to the flightcrew. The FAA points out that, in at least one previous accident caused by inflight beta uses on another turbpropeller-powered airplane, the pilot attempted to decelerate the airplane from an overspeed condition (airplane speed was initially above Vmo). In that case, the airspeed aural warning was already sounding at the time the inflight beta event occurred. The FAA notes that many transport category airplanes powered by turbopropeller engines are operated at or near Vmo during descent in order to maintain adequate Air Traffic Control (ATC) separation from the faster flying turbojet-powered airplanes. Therefore, the FAA considers that use of a beta warning horn could be preceded or accompanied by an airplane overspeed aural warning, and could result in confusion to the flightcrew. Although the FAA acknowledges that a beta warning horn should deter the pilot from using beta in flight, the horn does not physically keep the power levers from being placed in the beta mode during flight. As explained previously, several turbopropeller-powered airplanes were designed and certified with beta lockout systems, and the FAA has required retrofit of a similar lockout system on three other turbopropeller-powered airplane models. Both the original design lockout systems and the retrofit have been operating safely for close to ten years with acceptable landing or rollout service history.

In response to commenters that questioned why the FAA is requiring installation of a beta lockout system and TCCA has not, the FAA notes that, while the United States and Canada observe the provisions of the bilateral airworthiness agreement, it remains the responsibility of the FAA to monitor and maintain the continuing airworthiness of U.S-type certificated and -registered airplanes. The bilateral airworthiness agreement does not restrict the FAA from issuing AD's based upon its own finding of an unsafe condition, regardless of the decision relative to the same subject made by another airworthiness authority. The FAA has examined the reports of operation of the airplane with the power levers positioned below the flight idle stop during flight on Model DHC-8 series airplanes, has examined other available data, and has determined that an unsafe condition exists. Therefore, the FAA finds that AD action is necessary for airplanes of this type design that are certificated for operation in the United States.

In reponse to the commenter's statement that paragraph (b) of the proposed rule limits the ways operators can comply with the requirements, the FAA points out that the language specified in that paragraph is purposefully general in nature to allow for some flexibility by the operators in complying with the requirements of that paragraph. Further, the FAA also points out that paragraph (d) of the final rule also contains a provision for operators to request approval of an alternative method of compliance.

One commenter requests that the proposed allowance for Minimum Master Equipment List (MMEL) relief of two days, as specified in paragraph (c) of the proposal, be extended to three days. Another commenter, the manufacturer, states that, where a legitimate system failure has necessitated the use of the override system, operators should not be penalized with a mandatory maintenance action in order to dispatch the airplane. The manufacturer considers a lockout system to be a secondary non-essential system to the existing design, and, therefore, dispatching the airplane with a failed lockout system for a limited time would not jeopardize the safety of the airplane. The manufacturer further states that if a pilot chooses to use the override system just prior to touchdown during inclement weather (e.g., low visibility, contaminated runway), those conditions could be considered emergency situations. Use of an override system in such an emergency should not require maintenance action to return the airplane to dispatch configuration. For those reasons, the manufacturer requests that the proposed MMEL relief of two days be extended in accordance with criteria to be identified in the DHC-8 MMEL.

The FAA concurs that the MMEL relief specified in paragraph (c) of the proposal may be extended to three flight days. However, although use of the override system may be made available as a means to gain additional stopping performance in the event of a failed beta lockout system, the FAA does not consider low visibility or contaminated runway scenarios to constitute an emergency. Further, the override function is used only when a system failure or potentially inadequate ground/air logic is indicated while the airplane is on the ground. The FAA has determined that in those situations a maintenance action must be taken.

One commenter contends that the only action that the FAA should require is the installation of a placard. The commenter asserts that adding the placard, in combination with the current pilot training curriculum, provides an adequate level of safety. The commenter further points out that only a placard is necessary for many other airplane models.

The FAA does not concur that installation of the placard should be the only requirement of this AD. The FAA has determined that long-term continued operational safety will be better assured by design changes to remove the source of the problem, rather than by reliance upon visual cues such as placards. Such visual cues may not be providing the degree of safety assurance necessary for certain transport airplanes. This, coupled with a better understanding of the human factors associated with reliance upon visual cues, has led the FAA to consider placing less emphasis on such visual cues and more emphasis on design improvements. The required installation of a beta lockout system is consistent with these considerations.

The FAA acknowledges that installing a placard is the only requirement for some transport airplanes. Those airplanes, however, do not have the same service experience as Model DHC-8 series airplanes. As explained in Comment 6, the FAA has required the installation of a beta lockout system on other airplane models that have similar service experiences to those of Model DHC-8 series airplanes.

One commenter, the manufacturer, requests that the compliance time for the installation of the beta lockout system be revised from one year to 2 1/2 years. The manufacturer explains that a beta lockout design could be available within one year of being mandated, but cautions that a compliance time of 18 months after the design approval is necessary.

Two other commenters request that the compliance time be changed to two years to allow time for design approval and actual installation. One other commenter states that one year is not enough time, but does not suggest an alternative compliance time.

The FAA concurs that the compliance time to install the beta lockout system may be extended somewhat. The FAA has taken into consideration the complexity of accomplishing the installation of a beta lockout system and the time that will be needed to develop and approve a service bulletin, and has concluded that a two-year compliance time to install the beta lockout system may be established without adversely affecting safety. Paragraph (b) of the final rule has been revised accordingly.

One commenter, the manufacturer, considers the cost estimate provided in the proposal to be significantly lower than actual costs. The manufacturer states that it has information indicating that the lockout implementation on another airplane model is estimated at an average of $24,000 per airplane ($12,000 for parts and $12,000 for labor). The manufacturer points out that the proposal does not account for the potential loss of revenue incurred by airplane downtime for incorporation of the change. The manufacturer is concerned that the lower cost estimate of $17,800 in the proposal may be misleading to operators.

One commenter considers that the requirements of the proposal go beyond the current requirements for continued airworthiness; therefore, the costs that were disregarded in the proposal as necessary for “maintaining a safe airplane” should be attributed solely as a direct result of the AD and should be addressed as such. Another commenter requests an explanation as to why a complete cost-benefit analysis is unnecessary and redundant. That same commenter requests that the FAA provide a cost-benefit analysis before a determination is made to require actions that may be unnecessary for an airplane that is already safe.

Based on information provided by the manufacturer, the FAA concurs that the estimated cost for the installation of the beta lockout system should be adjusted, and has revised the final rule accordingly. However, the FAA does not concur that a cost-benefit analysis should be accomplished for this AD. As stated in the proposal, as a matter of law, in order to be airworthy, an aircraft must conform to its type design and be in a condition for safe operation. The type design is approved only after the FAA makes a determination that it complies with all applicable airworthiness requirements. In adopting and maintaining those requirements, the FAA has already made the determination that they establish a level of safety that is cost-beneficial. When the FAA, as in this AD, makes a finding of an unsafe condition, this means that the original cost-beneficial level of safety is no longer being achieved and that the actions are necessary to restore that level of safety. Because this level of safety has already been determined to be cost-beneficial, a full cost-benefit analysis for this AD would be redundant and unnecessary.

Several commenters request that an accurate description of the unsafe condition be provided. Other commenters request clarification as to whether the FAA is trying to prevent an unsafe condition that could be caused by unintentional pilot actions or by intentional pilot actions.

The FAA considers that an adequate description of the unsafe condition has already been presented in the Notice of Proposed Rulemaking (NPRM). The FAA has determined that operation of the airplane with power levers positioned below the flight idle stop during flight could result in engine overspeed, possible engine damage or failure, and consequent reduced controllability of the airplane. Since the FAA has received reports of those types of incidents occurring on Model DHC-8 series airplanes, the FAA has determined that such an unsafe condition exists in those models.

Regardless of whether in-flight operation in beta resulted from intentional or unintentional pilot actions, the purpose of this AD is to prevent such operation. The FAA considers a requirement to install beta lockout to be the most effective means to achieve that objective.

One commenter points out that the design of the power lever system on Model DHC-8 series airplanes is different than that of other turbopropeller-powered airplanes that are addressed by AD's similar to the proposal. Several commenters assert that there seems to be different requirements for certain similar airplanes and similar requirements for different airplanes. The commenters request that the FAA “level the playing field” to ensure requirements are consistent for all airplane models.

The FAA acknowledges that there are different requirements for certain airplane models. As discussed previously, the requirements for different airplanes are based on certain aspects of design and service history of each different airplane model. Therefore, the FAA considers that the “playing field is level” in that the basic requirements for airplanes with similar design and service histories are equivalent.

One commenter requests that a public meeting be held to discuss the proposed rule. The commenter states that the proposed beta lockout system will not improve safety. The commenter contends that since the manufacturer, operators, and TCCA do not support the proposal, a public meeting should be held to determine the most appropriate action.

The FAA does not concur that a public meeting is necessary to discuss the final rule. A Notice of Proposed Public Meeting was published in the Federal Register , and that meeting took place on June 11 and 12, 1996. Draft design criteria that the FAA was considering for use in evaluating a beta lockout system were included in that notice. The public meeting was held for the purpose of soliciting and reviewing information from the public on what type of FAA action would be appropriate to prevent future occurrences of inflight beta operation on all turbopropeller-powered airplanes. Further, a 90-day comment period was specified in the NPRM to allow an adequate period of time for commenters to respond. The fact that the final rule has been revised in response to certain information supplied by the commenters demonstrates the success of this process. For those issues on which commenters continue to disagree with the FAA's conclusions, given the extensive public participation to date, it is unlikely that yet another public meeting would resolve the issues. Therefore, further delay of this AD is inappropriate.

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 described previously. The FAA has determined that these changes will neither increase the economic burden on any operator nor increase the scope of the AD.

The FAA estimates that 185 de Havilland Model DHC-8-100, and -200, and -300 series airplanes of U.S. registry will be affected by this AD, that it will take approximately 1 work hour per airplane to accomplish the installation of the placard, and that the average labor rate is $60 per work hour. Based on these figures, the cost impact of the placard installation on U.S. operators is estimated to be $11,100, or $60 per airplane.

Since the manufacturer has not yet developed a specific system commensurate with the requirements of this AD, the FAA is unable to provide specific information as to the number of work hours or cost of parts that will be required to accomplish the installation. However, based on similar installations of such systems accomplished previously on other airplane models, the FAA can reasonably estimate that approximately 200 work hours per airplane will be necessary to accomplish the system installation. The FAA also estimates that required parts will cost approximately $12,000 per airplane. Based on these figures, the cost impact of the required system installation on U.S. operators is estimated to be $4,440,000, or $24,000 per airplane.

The cost impact figures discussed above are 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 regulations adopted herein will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 12612, it is determined that this final rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.

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 .

The Registro Aeronautico Italiano (RAI), which is the airworthiness authority for Italy, has notified the FAA that an unsafe condition may exist on Agusta AB412 helicopters with rescue hoist, part number (P/N) BL10300-60 or P/N BL10300-59, installed. The RAI advises that replacement of the retention pin and certain inspections must be accomplished in accordance with Agusta Service Bulletin 412-59, Revision A, dated May 18, 1998, to prevent loss of a rescue hoist hook assembly. Loss of the rescue hoist hook assembly could result in loss of the person on the rescue hoist. Also, with the loss of the weight of the hoist cable assembly, the rescue hoist cable could become entangled with a main rotor or tail rotor blade, and result in damage or separation of a rotor blade and subsequent loss of control of the helicopter.

The FAA has reviewed Agusta Service Bulletin 412-59, Revision A, dated May 18, 1998, which describes procedures for inspecting the rescue hoist and replacing the retention pin.

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

Since an unsafe condition has been identified that is likely to exist or develop on other Agusta Model AB412 helicopters of the same type design registered in the United States, this AD is being issued to prevent separation of the rescue hoist hook assembly from the helicopter due to failure of the retention pin. This AD requires, before further flight, replacing the retention pin, P/N BL2395, of the hook assembly, P/N S6150-61090-1, unless already accomplished. Thereafter, prior to each flight during which the rescue hoist will be operated, this AD requires:

• Inspecting the rescue hoist for oil leakage and proper electrical and mechanical connections.

• Inspecting the retention pin ring assembly for safety wire integrity;

• Inspecting the pin that is installed on the housing for absence of rotation between the housing and adapter; and

• Inspecting the rescue hoist hook to ensure it rotates freely relative to the housing (number 3 on Figure 1).

This AD also requires, at intervals not to exceed 25 hours time-in-service (TIS):

• Inspecting the rescue hoist attachment and support for cracks, wear, corrosion, damage, and security;

•Inspecting the rescue hoist cable for fraying, wear, and corrosion; and

• Inspecting the rescue hoist cable for proper routing through the guide rollers, pulley, and drum.

• Finally, this AD requires, at intervals not to exceed 12 calendar months:

• Inspecting the retention pin for scratches or deformations, and replacing the retention pin if scratches or deformations are found.

The short compliance time involved is required because the previously described critical unsafe condition can adversely affect the safe operation of the rescue hoist. Therefore, the inspections are required prior to further flight, and this AD must be issued immediately.

None of the Agusta Model AB412 helicopters affected by this action are on the U.S. Register. All helicopters included in the applicability of this rule are operated by non-U.S. operators under foreign registry; therefore, they are not directly affected by this AD action. However, the FAA considers that this rule is necessary to ensure that the unsafe condition is addressed in the event that any of these subject helicopters are imported and placed on the U.S. Register in the future.

Should an affected helicopter be imported and placed on the U.S. Register in the future, it would require approximately 2.5 work hours to accomplish all of the corrective actions (replacing the retention pin and inspecting) initially, at an average labor rate of $60 per work hour. Required parts would cost $85. Based on these figures, the cost impact of this AD would be $235 per helicopter.

Since this AD action does not affect any helicopter that is currently on the U.S. Register, it has no adverse economic impact and imposes no additional burden on any person. Therefore, notice and public procedures hereon are unnecessary and the amendment may be made effective in less than 30 days after publication in the Federal Register .

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

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

Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this rule must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. 98-SW-69-AD.” The postcard will be date stamped and returned to the commenter.

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

The FAA has determined that notice and public comment are unnecessary in promulgating this regulation; therefore, it can be issued immediately to correct an unsafe condition in aircraft since none of these model helicopters are registered in the United States. It has been determined further that this action involves an emergency regulation under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979). If it is determined that this emergency regulation otherwise would be significant under DOT Regulatory Policies and Procedures, a final regulatory evaluation will be prepared and placed in the Rules Docket. A copy of it, if filed, may be obtained from the Rules Docket at the location provided under the caption ADDRESSES .

Federal Register Document DOCID: fr10ja00-6, Airspace Docket No. 99-ASO-27, published on January 10, 2000, (65 FR 1309), amended Class D surface area airspace at Jacksonville Whitehouse NOLF, FL. An error was discovered in the amendatory language identifying the airspace description. This action corrects that error.

The FAA published this direct final rule with a request for comments in the Federal Register on December 6, 1999 (64 FR 68008). The FAA uses the direct final rulemaking procedure for a non-controversial rule where the FAA believes that there will be no adverse public comment. This direct final rule advised the public that no adverse comments were anticipated, and that unless a written adverse comment, or a written notice of intent to submit such an adverse comment, were received within the comment period, the regulation would become effective on February 24, 2000. No adverse comments were received, and thus this notice confirms that this direct final rule will become effective on that date.

This direct final rule also corrects the docket number for this action to 99-ANE-92. The docket number used for the publication of the direct final rule was previously used for another airspace action. That other action, however, was issued from FAA Headquarters, while this action was issued from the New England Region. Therefore, the FAA has determined that the error in the docket number caused no confusion to interested persons wishing to comment on this proposal and corrects the docket number in this action.

Lastly, the longitude and latitude coordinates published in the direct final rule must be updated to reflect North American Datum (NAD) 1983. The FAA has determined that neither of these corrections expands the scope of the direct final rule.

Within a 5-mile radius of Burlington International Airport. This Class E airspace is effective during the specific dates and times established in advance by a Notice to Airman. The effective dates and times will thereafter be continuously published in the Airport/Facility Directory.

FDA published a notice of intent in the Federal Register on May 21, 1990 (55 FR 20799) announcing FDA's concerns about toxic aluminum levels in TPN and requesting comments. As a result of the comments received, on January 5, 1998, FDA published a proposed rule in the Federal Register (63 FR 176) in which it proposed to: (1) Establish a maximum permissible level of aluminum in LVP's used in TPN therapy; (2) require that the maximum level of aluminum permitted in LVP's used in TPN therapy be stated on the package insert of all LVP's used in TPN therapy; (3) require that the maximum level of aluminum at expiry be stated on the immediate container label of SVP's and PBP's used in the preparation of TPN solutions; (4) require that the package insert of all LVP's and SVP's, including PBP's, contain a warning statement about aluminum toxicity in patients with impaired kidneys and neonates receiving TPN therapy; and (5) require that applicants and manufacturers develop validated assay methods for determining the aluminum content in parenteral drug products used in TPN therapy and submit the validated assay methods to FDA for approval.

FDA has become increasingly concerned about the aluminum content in parenteral drug products, which could result in a toxic accumulation of aluminum in the tissues of individuals receiving TPN therapy. FDA included specific references in the proposed rule that supported the following information about aluminum toxicity (63 FR 176). Research indicates that neonates and patient populations with impaired kidney function may be at high risk of exposure to unsafe amounts of aluminum. Many drug products used routinely for TPN may contain levels of aluminum sufficiently high to cause clinical manifestations. Generally, when medication and nutrition are administered orally, the gastrointestinal tract acts as an efficient barrier to the absorption of aluminum, and relatively little ingested aluminum actually reaches body tissues. However, parenterally administered drug products containing aluminum bypass the protective mechanism of the gastrointestinal tract and aluminum circulates, and it is deposited in human tissues.

Aluminum toxicity is difficult to identify in neonates because few reliable techniques are available to evaluate bone metabolism in premature neonates. Techniques used to evaluate the effects of aluminum on bone in adults cannot be used in premature neonates. Although aluminum toxicity is not commonly detected clinically, it can be serious in selected patient populations, such as neonates, and may be more common than is recognized.

Classic manifestations of aluminum intoxication in patients with impaired kidney function include fracturing osteomalacia, encephalopathy, and microcytic hypochromic anemia. Aluminum may prevent calcium absorption in premature neonates receiving TPN therapy. In addition, aluminum loading may be a factor in the bone disease of very ill neonates with reduced kidney function who have received long-term parenteral therapy with aluminum-contaminated fluids.

FDA received 21 comments on the proposed rule and addresses each of those comments in section III of this document. FDA is adopting this final rule as described below. The agency has also made minor edits to the final rule in response to the President's June 1, 1998, memorandum on plain language in Government writing.

FDA is implementing this final rule because of evidence linking the use of parenteral drug products containing aluminum to morbidity and mortality among patients on TPN therapy, especially premature neonates and patients with impaired kidney function.

The new regulations added to part 201 ((21 CFR 201) at § 201.323(a)) limit the aluminum content for all LVP's used in TPN therapy to 25 micrograms per liter (μg/L). This requirement applies to all LVP's used in TPN therapy, including, but not limited to, parenteral amino acid solutions, highly concentrated dextrose solutions, parenteral lipid emulsions, saline and electrolyte solutions, and sterile water for injection.

New § 201.323(b) requires the package insert for all LVP's used in TPN therapy to state that the drug product contains no more than 25 μg/L of aluminum. This statement must be included in the “Precautions” section of the labeling.

New § 201.323(c) requires the product's maximum level of aluminum at expiry to be stated on the immediate container label of SVP's and PBP's used in the preparation of TPN solutions. The statement on the immediate container label must read as follows: “Contains no more than —— μg/L of aluminum.” For those SVP's and PBP's that are lyophilized powders used in the preparation of TPN solutions, the maximum level of aluminum at expiry must be printed on the immediate container label as follows: “When reconstituted in accordance with the package insert instructions, the concentration of aluminum will be no more than —— μg/L.” The maximum level of aluminum must be stated as the highest of: (1) The highest level for the batches produced during the last 3 years; (2) the highest level for the latest five batches, or (3) the maximum historical level, but only until completion of production of the first five batches after January 26, 2001. The labeling requirement applies to all SVP's and PBP's used in the preparation of TPN solutions, including, but not limited to: Parenteral electrolyte solutions, such as calcium chloride, calcium gluceptate, calcium gluconate, magnesium sulfate, potassium acetate, potassium chloride, potassium phosphate, sodium acetate, sodium lactate, and sodium phosphate; multiple electrolyte additive solutions; parenteral multivitamin solutions; single-entity parenteral vitamin solutions, such as vitamin K injection, folic acid, cyanocobalamin, and thiamine; and trace mineral solutions, such as chromium, copper, iron, manganese, selenium, and zinc.

New § 201.323(d) requires the package insert for all LVP's, SVP's, and PBP's used in TPN to contain a warning statement. The warning statement must be included in the “Warnings” section of the labeling. The warning must contain the following language:

FDA removed the phrase “intended for patients with impaired kidney function and for neonates receiving TPN therapy” from the first sentence of § 201.323(d) because the phrase duplicated information contained in the actual warning and because the phrase made the first sentence of § 201.323(d) unclear.

New § 201.323(e) requires applicants and manufacturers to use validated assay methods to determine the aluminum content in parenteral drug products used in TPN therapy. The assay methods must comply with current good manufacturing practice regulations under part 211 (21 CFR part 211) (see § 211.194(a)). Holders of approved applications for LVP's, SVP's, and PBP's used in TPN therapy are required to submit a supplement to FDA under § 314.70(c) (21 CFR 314.70(c); see also 21 U.S.C. 356a(b)) describing the assay method used for determining the aluminum content. Applicants must submit the validation method used and the release data for several batches. In addition, manufacturers of parenteral drug products not subject to an approved application must make assay methodology available to FDA during inspections (see 21 CFR 211.160 and 211.180(c)).

New § 201.323 applies to all human drug LVP's, SVP's, and PBP's used in TPN. Licensed biological products are not covered by this rule.

FDA received 21 comments on the proposed rule from professional associations, prescription drug manufacturers, Congress, individuals on TPN, and a hospital. Most comments supported the proposed limit for aluminum content in LVP's and the labeling requirement for SVP's and PBP's. Four comments suggested changes to the proposed warning statement. A summary of the comments received and the agency's responses follow.

The agency stated in the proposed rule that it was considering setting an upper limit of 25 μg/L for LVP's used in TPN therapy. This requirement would apply to all LVP's used in TPN therapy, including, but not limited to, parenteral amino acid solutions, highly concentrated dextrose solutions, parenteral lipid emulsions, saline and electrolyte solutions, and sterile water for injection. The agency also proposed that the package insert for all LVP's used in TPN therapy state that the drug product contains no more than 25 μg/L.

1. Fifteen comments strongly supported a limit on aluminum of 25 μg/L. Two of the comments specifically supported the accompanying proposal that the package insert state that the drug product contains no more than 25 μg/L of aluminum.

FDA agrees that 25 μg/L of aluminum is a reasonable limit. As stated in the proposed rule, the 25 μg/L limit is feasible and necessary for the safe and effective use of LVP's used in TPN therapy.

Two comments, one from an LVP manufacturer and the other from a trade association, stated that 25 μg/L is not a reasonable limit for the varying reasons outlined in comments 2 through 8, in section III. A of this document.

2. These comments stated that data from production batches show potential rejections of finished batches at release if a limit of 25 μg/L is adopted. One of these comments specified that more than 10 percent of assay results exceed the proposed limit. It also stated that their current batch analysis showed a 95 percent confidence that at least 99 percent of the batch contained less than 50.37 μg/L of aluminum at release.

FDA understands that not all current batches of LVP's will meet a 25 μg/L level of aluminum. FDA will implement this rule 1 year after the date of publication to allow companies an opportunity to meet the specifications in this rule. FDA is not adopting a higher level because FDA believes a 25 μg/L level of aluminum is necessary to protect the public health.

3. The same two comments said that glass leaching over time increases aluminum levels so that initial levels cannot be established low enough to ensure batch acceptability by the end of the expiry period.

The intention of this rule is to reduce aluminum to an acceptable level in TPN products. A manufacturer can reduce toxicity by any of several routes, including using containers made of different materials.

4. One of these comments requested that FDA set the maximum level of aluminum using the procedure specified in the draft guidance entitled “Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances” (draft Q6A guidance) (62 FR 62890). This draft guidance states that a limit on impurities can be determined by (1) Determining the level at which the impurity is present in relevant batches and then (2) determining the mean plus upper confidence limit for the impurity where the upper confidence limit is three times the standard deviation of batch analysis data.

FDA is not using the procedures specified in the draft Q6A guidance because it is not appropriate to use current product aluminum levels to determine upper limits when the goal is to reduce aluminum levels to at or below the limit defined as safe. Further, the guidances entitled “Q3A: Impurities in New Drug Substances,” (January 1996) and “Q3B Impurities in New Drug Products,” (November 1997) address the issue of quantification of impurities. These guidances state that limits should be set no higher than the level that can be justified by safety data. The guidances also state that, for impurities known to be unusually potent or to produce toxic or unexpected pharmacological effects, the quantitation and detection limit of the analytical methods should be commensurate with the level at which the impurities must be controlled. FDA's primary concern in enacting this rule is ensuring the safety of the patient population and limiting exposure to the impurity. FDA has determined that the 25 μg/L limit is necessary for the safe and effective use of LVP's in TPN therapy.

5. These comments also stated that current assay methods cannot reliably distinguish between 25 μg/L and 30 μg/L. The comment did not provide supporting data or evaluation of the specific methods claimed to lack the required accuracy.

FDA understands that methods are currently available that are capable of detecting aluminum concentrations at 25 μg/L levels. In particular, FDA is aware that graphite furnace atomic absorption spectrometometry can be a sufficiently accurate validation method. However, FDA will accept any validated analytical method to assay aluminum content in TPN.

6. One of these comments suggested that FDA should require labeling of LVP's with an average and a range of aluminum values at expiry, obtained from five production scale batches, instead of requiring a limit of 25 μg/L of aluminum in LVP's. The labeling would state “Approximate average aluminum value— μg/L. Approximate aluminum range —— μg/L to — μg/L.” The same comment requested that FDA apply the same labeling standards to LVP's, SVP's, and PBP's, under the rationale that some LVP's are identical in composition to PBP's.

FDA notes that if a manufacturer makes a PBP specifically for LVP use, the PBP should not contain more than 25 μg/L of aluminum so that the LVP manufactured from the PBP does not contain more than 25 μg/L of aluminum. FDA is implementing the 25 μg/L limit for LVP's rather than permitting an average or a range of aluminum levels to be stated for LVP's because the agency believes that it is more appropriate to set a maximum level due to the large volume of use of these products. FDA has determined that the 25 μg/L limit is necessary for the safe and effective use of LVP's used in TPN therapy. FDA's basis for not requiring SVP's and PBP's to be labeled with an average and a range of aluminum levels is discussed in response to comment 11 in section III. B of this document.

7. This same comment stated that establishing a 25 μg/L limit on LVP's would not have the desired effect of reducing aluminum levels in TPN because the majority of aluminum contamination is due to SVP's, not LVP's. A different comment requested that FDA narrow coverage of the rule to only those products that contribute significant amounts of aluminum to TPN: Calcium gluconate, calcium gluceptate, potassium phosphates, and sodium phosphates. The comment stated that calcium gluconate alone can contribute 88 percent of the total aluminum present in a TPN formulation.

FDA recognizes that numerous factors contribute to aluminum contamination in TPN therapy. Therefore, FDA is addressing the problem in several different ways in an effort to reduce aluminum contamination, rather than reducing aluminum from one source.

8. Another comment noted that the United States Pharmacopeia (USP) has limited aluminum levels in monographs for substances used in hemodialysis, including: Calcium acetate, calcium chloride, magnesium chloride, potassium chloride, sodium acetate, sodium bicarbonate, and sodium chloride. The comment stated that additional steps could be taken to limit aluminum levels in monographs of substances used in the manufacture of TPN solutions. Although FDA believes USP's limits add a valuable contribution to limiting aluminum contamination, FDA believes the additional measures set forth in this final rule are needed to prevent an unsafe level of aluminum in TPN.

In the proposed rule, FDA proposed requiring that the maximum level of aluminum at expiry be stated on the immediate container label of SVP's and PBP's used in the preparation of TPN solutions. FDA proposed that the statement on the immediate container label read as follows: “Contains no more than —— μg/L of aluminum.” For those SVP's and PBP's that are lyophilized powders used in the preparation of TPN solutions, FDA proposed that the maximum level of aluminum at expiry be printed on the immediate container label as follows: “When reconstituted in accordance with the package insert instructions, the concentration of aluminum will be no more than—— μg/L.” FDA proposed that the maximum level of aluminum must be expressed as the highest of: (1) The highest level for the batches produced during the last 3 years; (2) the highest level for the latest five batches; or (3) the maximum historical level, but only until completion of production of the first five batches after the rule takes effect.

9. Two comments supported FDA's proposal. One comment requested that FDA further specify limitations on aluminum content for SVP's.

FDA plans to implement the labeling requirements for SVP's and PBP's as proposed. FDA does not consider it appropriate to consider SVP's as a single category because SVP's are used for many indications other than TPN and in target populations where aluminum toxicity is not an issue.

10. One comment asked that FDA set a minimum level below which the amount of aluminum would not need to be declared.

FDA believes it is important for health care practitioners to know as much as possible about the aluminum levels being consumed by their patients. FDA believes the knowledge that a product has a low level of aluminum is just as important as the knowledge that a product contains high levels of aluminum. This labeling requirement permits health care professionals administering the drug to be able to calculate the total aluminum exposure the patient receives from multiple sources, and to be able to make appropriate substitutions to prepare “low aluminum” parenteral solutions for use in patients who are in high risk groups. Therefore, FDA believes all LVP's, SVP's, and PBP's used in TPN should be labeled with their aluminum levels.

11. One comment stated that information about the average amount of aluminum and its range at expiration for LVP's and SVP's is more useful than the maximum historical value at expiration, since otherwise a physician may overestimate the amount of aluminum being delivered to the patient. Another comment proposed that FDA require labeling of SVP's and PBP's with an average and a range of aluminum values at expiry, obtained from five production scale batches, such that the labeling would state “Approximate average aluminum value —— μg/L. Approximate aluminum range —— μg/L to—— μg/L.”

The agency believes that information about the maximum concentration of aluminum potentially present at expiry is more useful to the practitioner. FDA's intention is to limit exposure to aluminum, and the use of average values or range at expiration would not achieve this goal as effectively.

In the proposed rule, FDA stated that licensed biological products were not covered by the proposal.

12. Twelve comments stated that biologics, specifically albumin, plasminate, and any other colloidal volume expanders, should be regulated. The Center for Biologics Evaluation and Research at the FDA is currently considering whether to regulate the levels of aluminum in licensed biological products. However, such regulation is outside the scope of this final rule.

FDA proposed requiring a statement regarding the maximum daily aluminum intake recommended for patients. FDA sought comment on whether adding the language “Patients should receive no more than 4 to 5 μg/kg/day of aluminum” to the warning statement was appropriate and on whether a 4 to 5 μg/kilogram (kg)/day level is reasonable and adequate to protect the public health.

13. Two comments stated that FDA should include definitions of safe, unsafe, and toxic levels of aluminum. Three comments said that FDA should provide health professionals with a best estimate as to what constitutes a toxic aluminum load.

One comment stated that proposing to limit aluminum to 4 to 5 μg/kg/day would either make TPN formulations unavailable to neonates or expose doctors to liability, because it is a difficult level to meet. Another comment said that 4 to 5 μg/kg/day is too low and may not allow patients to receive adequate amounts of calcium and phosphates. One comment noted that parenteral limits are much lower than oral limits, and expressed the belief that the proposed language did not offer guidance with respect to combined oral and parenteral daily limits. Another comment noted that the proposal does not provide a therapeutic alternative to too high aluminum levels, and asked that FDA include in the statement a definition of the populations truly at risk.

One comment stated that it would be difficult for health care professionals to calculate total aluminum intake, particularly for neonates receiving multiple intravenous infusions. Another comment stated that the factors that affect plasma aluminum clearance  1 can influence sensitivity to aluminum load  2 at any concentration of aluminum infused, and therefore aluminum concentration in TPN cannot be correlated directly to aluminum plasma levels.

Two comments recommended alternative statements. One suggested using the following language: “Daily parenteral intake of greater than 4 to 5 μg/kg/day of aluminum has been associated with central nervous system and bone toxicity.” Another suggested using the following warning: “No aluminum toxicity to the brain or bone of premature neonates has been documented with intakes below 5 μg/kg/day; however, tissue loading may still occur at that rate of administration to preterm infants.”

One comment requested that FDA require such a warning statement only for those SVP's for which aluminum is a significant problem.

Based on these comments, FDA revised the warning to include a statement on current findings rather than a statement about maximum safe levels. FDA included specific references in the proposed rule (63 FR 176).

FDA proposed permitting applicants and manufacturers to have the discretion and flexibility to develop their own validated assay methods as long as the methods are in compliance with current good manufacturing practices requirements. Holders of approved applications for LVP's, SVP's and PBP's used in TPN therapy would be required to submit a supplement under part 314 (21 CFR part 314) in § 314.70(c) that described the method used for determining aluminum content. Holders of pending applications would be required to submit an amendment under § 314.60 or § 314.96. For SVP's not subject to approved applications, manufacturers would be required to maintain records for examination by FDA during inspections.

14. One comment stated that the USP provides an established system and procedure for the development of uniform analytical methods. The comment asked that FDA request that U.S.P. develop assay methods for determining aluminum content in parenterals rather than requiring individual companies to do so.

FDA believes that more than one analytical method may be suitable or necessary to assay aluminum content in different TPN products. Once FDA has reviewed several methods, it may evaluate whether it is appropriate to develop uniform analytical procedures. Individual companies may provide their validated analytical methods to USP for publication. Through this process, USP may establish a uniform analytical method for determining aluminum content in parenterals. FDA will accept any method that is validated and in compliance with current good manufacturing practice requirements.

15. One comment supported FDA's proposal. The comment also stated that analytical methods should be those in general use, such as flameless atomic absorption spectroscopy with a graphite furnace, and the method should be sufficiently sensitive to detect aluminum at the μg/L and not the milligram (mg) per liter level.

Again, FDA will accept any method that is validated and in compliance with current good manufacturing practice requirements. Any analytical method must be sensitive enough to detect aluminum at the μg/L and not the mg/L level, because the aluminum limits for LVP's and the required labeling statements for LVP's, SVP's, and PBP's are measured in μg/L.

FDA proposed that any final rule that issued based on its proposed rule would become effective 1 year after the final rule's date of publication in the Federal Register . After that date, new drug applications (NDA's) submitted under § 314.50 and abbreviated new drug applications (ANDA's) submitted under 21 CFR 314.94 would have to comply with the new requirements under § 201.323.

16. One comment proposed an implementation date of 4 years after publication of the final rule in the Federal Register to account for the time necessary to collect and analyze data. Another comment suggested an implementation date of 31/2 years after publication of the final rule, or whenever data from five batches of product became available and the supplement was approved. This comment stated that the additional time is necessary to collect aluminum levels at expiry by an appropriate and validated method, since companies do not presently have such data.

Under the final rule, a manufacturer may use: (1) The highest level for the batches produced during the last 3 years; (2) the highest level for the latest five batches, or (3) the maximum historical level, but only until completion of production of the first five batches after this rule takes effect. This means that if expiry data under (1) and (2) of comment 16 in section III. F of this document are not available within 1 year, data available for the product during that year can be used under (3) of comment 16. As a manufacturer accrues additional data, it can then also use methods (1) and/or (2) of comment 16.

17. One comment asked whether FDA expects supplements to be submitted and approved and labeling changed within 1 year of publication of the final rule, or simply for supplements to be submitted within 1 year of publication of the final rule.

FDA expects supplements to be submitted and labeling to be changed within 1 year of publication of this final rule. Under current regulations (§ 314.70(c)) and the Food and Drug Administration Modernization Act of 1997 (21 U.S.C. 356a(b)), a manufacturer can file a changes being effected supplement for immediate implementation of this change. Thus, FDA believes implementation should take place in 1 year.

FDA estimated in the proposed rule that the annualized cost to amino acid suppliers to implement the proposed rule would be $1,416,622. This figure includes first year or one-time costs estimated at $20 million.

18. One comment stated that wholesale raw material amino acids for intravenous use is a fraction of the $109 million market cited by FDA, and is actually much closer to $40 million. The comment went on to state that this market is shrinking and will continue to do so for the foreseeable future. The comment estimated that, in light of these figures, the annual cost of compliance would represent 3 percent of sales, almost as much as the 4 percent spent by the industry on research and development. Another comment stated that the proposed rule underestimated the cost for compliance because validation without USP guidance would be difficult and because the number of worker hours required to test products is large.

FDA believes that the benefits of removing the health hazard outweigh costs to industry. FDA provides additional economic analysis based on these comments in section VII of this document.

19. The same comment stated that for LVP manufacturers, costs are even higher. The comment stated that the Eastern Research Group (ERG) study “grossly underestimated the expense associated with label copy changes, non-compliant raw materials, finished product, and did not consider product recalls, which are inevitable, given the technically unfeasible 25 μg/L limit.”

FDA has reanalyzed these expenses in section VII of this document.

FDA's rule to regulate the aluminum content of certain parenteral drug products and to require aluminum content to be stated in the labeling of certain drug products is authorized by the Federal Food, Drug, and Cosmetic Act (the act). Section 502(a) of the act (21 U.S.C. 352(a)) prohibits false or misleading labeling of drugs, including, under section 201(n) of the act (21 U.S.C. 321(n)), failure to reveal material facts relating to potential consequences under customary conditions of use. Section 502(f) of the act requires drug labeling to have adequate directions for use, adequate warnings against use by patients where its use may be dangerous to health, as well as adequate warnings against unsafe dosage or methods or duration of administration, as necessary to protect users. In addition, section 502(j) of the act prohibits the use of drugs that are dangerous to health when used in the manner suggested in their labeling. Drug products that do not meet the requirements of section 502 of the act are deemed to be misbranded.

In addition to the misbranding provisions, the premarket approval provisions of the act authorize FDA to require that prescription drug labeling provide the practitioner with adequate information to permit safe and effective use of the drug product. Under section 505 of the act (21 U.S.C. 355), FDA will approve a new drug application (NDA) only if the drug is shown to be safe and effective for its intended use under the conditions set forth in the drug's labeling. Section 701(a) of the act (21 U.S.C. 371(a)) authorizes FDA to issue regulations for the efficient enforcement of the act.

Part 201 sets out FDA's general labeling regulations. Under § 201.100(d), prescription drug products must bear labeling that contains adequate information by which licensed practitioners can use the drugs safely and for their intended purposes. Section 201.57 describes specific categories of information, including information for drug use in selected subgroups of the general population and warnings on adverse reactions and potential safety hazards that must be present to meet the requirements of § 201.100. In addition, under 21 CFR 314.125, an NDA will not be approved unless there is adequate safety and effectiveness information for the labeled uses and the product complies with the requirements of part 201.

Any drug product not in compliance with § 201.323 is misbranded under section 502 of the act and an unapproved new drug under section 505 of the act.

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

This final rule is effective on January 26, 2001. After that date, NDA's submitted under § 314.50 and abbreviated new drug applications (ANDA's) submitted under § 314.94 must comply with the labeling requirements under § 201.323. Holders of approved NDA's or ANDA's must meet the requirements of proposed § 201.323 by submitting supplements under § 314.70 or § 314.97. Applicants for LVP's used in TPN therapy and SVP's used as additives in TPN solutions are required to submit a supplement under § 314.70(c) that describes the assay method for determining the aluminum content. Applicants must submit validation of the method used and release data for several batches. Manufacturers of parenteral drug products not subject to an approved application must make assay methodology available to FDA during inspections. Holders of pending applications must submit an amendment under § 314.60 or § 314.96.

FDA has examined the impact of the final rule under Executive Order 12866, under the Regulatory Flexibility Act (5 U.S.C. 601-612), and under the Unfunded Mandates Reform Act (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 Regulatory Flexibility Act requires agencies to examine regulatory alternatives for small entities, if the rule may have a significant impact on a substantial number of small entities. The Unfunded Mandates Reform Act requires agencies to prepare an assessment of anticipated costs and benefits before enacting any rule that may result in an expenditure in any one year by State, local and tribal governments, in the aggregate, or by the private sector, of $100,000,000 (adjusted annually for inflation). The expected aggregate costs of this final rule, and the anticipated impact of the rule on small entities, are described in the analysis below. FDA concludes that this final rule is consistent with the regulatory philosophy and the principles set forth in the Executive Order and in these two statutes.

In this final rule, FDA is amending its regulations by establishing a maximum permissible aluminum limit for LVP's used in TPN, as well as requiring certain label and package insert information for aluminum content in LVP's and SVP's used in TPN. The agency is issuing this rule to lower the risk of aluminum toxicity in light of evidence linking the use of parenteral drugs containing aluminum to morbidity and mortality among patients on TPN therapy. FDA estimates total annualized compliance costs for the final rule at about $23.8 million. Further, for reasons explained elsewhere in this section of the document, the agency certifies that this rule will not have a significant economic impact on a substantial number of small entities. FDA has not identified any other Federal rules that duplicate, overlap, or conflict with this final rule.

In the preamble to the proposed rule, FDA relied on the report of its contractor, ERG, for its estimates of compliance cost burdens of the proposed rule. Total annualized compliance costs were estimated at $20.1 million. This was composed of a one time cost of $63.8 million annualized at $9.8 million (over 10 years at a 7 percent discount rate) plus recurring annual costs of $10.3 million. Over 50 percent of the total costs would be due to actions undertaken to manufacture LVP solutions and their components that would comply with the aluminum limit requirements.

In response to the proposed rule, FDA received many comments, some of which referred to the cost estimates contained in the ERG report. As a result of these comments, ERG reanalyzed areas of concern specified in the comments and made some modifications to its original analysis of compliance costs. These changes are included in an addendum to the initial compliance cost analysis (available in the docket). As a result, FDA concludes that the final rule will impose annualized compliance costs of about $23.8 million on the affected industries, an increase of $3.7 million from its cost estimate for the proposed rule. This is composed of a one time cost of $67.3 million annualized at $10.6 million (over 10 years at a 7 percent discount rate) plus recurring annual costs of $13.2 million. The remainder of this section summarizes the addendum and responds to other comments concerning economic issues mentioned earlier in this preamble.

One comment to the proposal stated that FDA had underestimated the costs of label copy changes, noncompliant raw materials, finished product, and product recalls. As a result, ERG contacted industry to gain more information and data, where possible, to improve the accuracy of these estimates. ERG's new research into pharmaceutical labeling costs shows that compliance costs for the label changes, including inventory losses occurring at the changeover, are higher for this rule than previously estimated. Accordingly, FDA has increased its labeling change estimate to about $588,000 annually.

The original ERG report estimated compliance costs for final release testing for aluminum in finished LVP products and their raw material inputs at about $4.5 million annually. After subsequent discussions with industry, ERG recognized that some LVP production lots will fail to meet the required aluminum limit, but noted that this loss of finished product will be reduced by measures to lower the aluminum level of the raw material inputs. Similarly, ERG found that the cost of product recalls will be low due to the final release testing of LVP products, but it could not predict the likely frequency of such recalls.

The same comment also suggested that dextrose suppliers would incur compliance costs because some dextrose products contain aluminum at a level that might exceed the proposed limit. Upon further consideration of the possible existence of noncompliant raw materials, including dextrose and amino acids, and discussions between industry and ERG, FDA adjusted its original cost estimate to include an additional $2.72 million annually due to losses from noncompliant raw materials.

Another comment stated that FDA had underestimated laboratory assay method validation costs. Following ERG's review of its original analysis and further discussions with industry, FDA agrees with the comment as it relates to LVP manufacturers and has increased one-time assay method validation costs for this sector from $737,000 to $2.1 million. Further research into current compliance rates across all industry sectors, however, resulted in lowering assay method validation costs for some other sectors. The net result is a slight increase in total annualized assay method validation costs to about $1.72 million. Further, the estimate of annualized equipment purchase costs has been increased by $350,000.

Another comment referred to a statistic FDA used to show the relative size of the expected cost impact on amino acid suppliers. Specifically, the comment disagreed with the FDA statement that annual compliance costs for raw material amino acid suppliers would represent only 0.09 percent of sales, having been derived from $1.4 million in compliance costs and $1.6 billion in total amino acid sales. The comment proceeded with its own estimate of the relative size of the compliance cost for these suppliers, calculating it to be 3 1/2 percent of the $40 million in amino acid sales to TPN solution manufacturers, a level roughly equivalent to total research and development costs. Upon further analysis, FDA reaffirms its estimate of the average annual compliance cost per amino acid manufacturing establishment of about $1.4 million. However, because there are approximately nine supplier establishments, the total cost would be about $12.75 million, which equates to an even greater percentage of total sales of amino acids to TPN solution manufacturers, about 32 percent, than the comment suggested. The costs, nevertheless, amount to only about 0.09 percent of the total $1.6 billion in sales of amino acids to all industries as stated in the proposal.

As in its original analysis, ERG discussed but could not reliably forecast the likelihood that some suppliers of amino acids and possibly dextrose would abandon the TPN solution market, due to the relatively small percentage of total amino acid and dextrose sales to TPN manufacturers. Because the industry currently uses nine different suppliers, FDA does not anticipate product shortages. Nevertheless, the agency will remain alert to the possibility.

Any professional skills necessary for implementation of this final rule should already exist within the firms and should not need to be newly acquired.

If a rule has a significant impact on a substantial number of small entities, the Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize the significant economic impact of such a rule on small entities. In the proposed rule, FDA relied on the estimated compliance costs by type of establishment as projected by ERG. That analysis determined that very few of the affected companies are considered small by the standards of the Small Business Administration (SBA). 3 Therefore, the agency certified that the proposed rule would not have a significant economic impact on a substantial number of small entities.

The agency received no comments specifically directed at this certification. Nevertheless, due to comments on other aspects of its estimates and modifications to the original analysis, FDA has reanalyzed the small business impacts of the final rule.

Fewer than 8 of the 24 companies identified in the ERG report as a manufacturer or supplier of TPN products or their inputs are small businesses according to the SBA definitions. No more than four SVP manufacturers are small under the SBA definitions. Moreover, since the average annualized cost for these establishments is estimated at about $51,000 each, the estimated annualized compliance costs for these companies are expected to account for less than one percent of their annual revenues. FDA further identified one amino acid supplier that may be a small business; but again, the annualized compliance costs for this firm would be less than 1 percent of annual revenues. The size of one dextrose supplier and one electrolyte supplier could not be confidently determined due to the scarcity of data. Therefore, it was not possible to determine whether the compliance costs of these firms would represent more than 1 percent of their revenues. Based on the very few small firms that might incur a significant impact, the Commissioner of Food and Drugs certifies under section 605(b) of the Regulatory Flexibility Act 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.

The Unfunded Mandates Reform Act requires (in section 202) that agencies prepare an assessment of anticipated costs and benefits before establishing any rule that requires expenditures by State, local, and tribal governments, in the aggregate, or by the private sector of $100 million (adjusted annually for inflation, or about $108 million in 1999) in any one year. The publication of this final rule concerning the regulation of TPN containing aluminum is not expected to result in expenditures of funds by State, local, or tribal governments, or the private sector in excess of $100 million annually. Because the agency estimates the largest 1-year expenditure to be about $80.5 million (representing the sum of one-time expenditures and annual expenditures), no further analysis is warranted according to the Unfunded Mandates Reform Act.

This final rule contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). A description of these provisions is given below with an estimate of the annual reporting burden. Included in this estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information.

Title: Aluminum in Large and Small Volume Parenterals Used in Total Parenteral Nutrition.

Description: FDA is amending its regulations to add certain labeling requirements for aluminum content in LVP's, SVP's and PBP's used in TPN. FDA is also specifying an upper limit of aluminum permitted in LVP's and requiring manufacturers to submit to FDA for approval validated assay methods for determining aluminum content in parenteral drug products. The agency is adding these requirements because of evidence linking the use of parenteral drug products containing aluminum to morbidity and mortality among patients on TPN therapy, especially premature neonates and patients with impaired kidney function.

Based on data concerning the number of applications for LVP's, SVP's, and PBP's used in TPN received by the agency, FDA estimates that the labeling for approximately 200 products will be changed under § 201.323(b), (c), and (d). FDA estimates that it will take approximately 14 hours to prepare and submit to FDA each labeling change. Based on data collected by the Eastern Research Group (Ref. 1) concerning the number of affected manufacturers, FDA estimates that approximately 65 respondents will each submit one validated assay method annually under § 201.323(e). FDA estimates that it will take approximately 14 hours to prepare and submit to FDA each validated assay.

Description of Respondents: Persons and businesses, including small businesses and manufacturers.

FDA did not receive any comments on the paperwork reduction aspects of the proposed rule.

The information collection provisions of this final rule have been submitted to OMB for review.

Before this rule becomes effective, FDA will publish a notice in the Federal Register announcing OMB's decision to approve, modify, or disapprove the information collection provisions in this final rule. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the information collection displays a current OMB control number.

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 federalism implications as defined in the order and, consequently, a Federalism summary impact statement is not required.

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

1. Eastern Research Group, Addendum to Compliance Cost Analysis for a Regulation for Parenteral Drug Products Containing Aluminum, April 15, 1999.

2. U.S. Small Business Administration, Table of Size Standards, 1996.

Elanco Animal Health, A Division of Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285, filed NADA 140-863 that provides for use of Paylean® (ractopamine hydrochloride) Type A medicated article to make Type B and Type C medicated swine feeds. The Type C medicated finishing swine feeds must contain at least 16 percent crude protein. Feeds containing 4.5 grams per ton (g/t) ractopamine hydrochloride are used for increased rate of weight gain, improved feed efficiency, and increased carcass leanness. Feeds containing 4.5 to 18 g/t ractopamine hydrochloride are used for improved feed efficiency and increased carcass leanness. The NADA is approved as of December 22, 1999, and the regulations in part 558 (21 CFR part 558) are amended by adding § 558.500 to reflect the approval. The basis for approval is discussed in the freedom of information summary.

Furthermore, § 558.4(d) is amended in the “Category I” table by adding an entry for “ractopamine” to provide for the assay limits for Type A medicated articles and Type B/C medicated feeds and the maximum Type B medicated feed level.

In addition, part 556 (21 CFR part 556) is amended by adding § 556.570 to establish an ADI for total ractopamine and tolerances for residues of ractopamine in edible tissues of treated swine.

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

Under section 512(c)(2)(F)(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(i)), this approval for food-producing animals qualifies for 5 years of marketing exclusivity beginning December 22, 1999, because no active ingredient (including any ester or salt of the active ingredient) has been previously approved for any other application filed under section 512(b)(1).

The agency has carefully considered the potential environmental effects of this action. FDA has concluded that the action will not have a significant impact on the human environment, and that an environmental impact statement is not required. The agency's finding of no significant impact and the evidence supporting that finding, contained in an environmental assessment, may be seen in the Dockets Management Branch (address above) between 9 a.m. and 4 p.m., Monday through Friday.

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

Animal drugs, Foods.

Animal drugs, Animal feeds.

In the Federal Register of September 14, 1984 (49 FR 36326), FDA issued medical device reporting regulations for manufacturers and importers under the act and the Medical Device Amendments of 1976 (the 1976 amendments) (Public Law 94-295). To correct weaknesses noted in the 1976 amendments, and to better protect the public health by increasing reports of device-related adverse events, Congress enacted the Safe Medical Devices Act of 1990 (the SMDA) (Public Law 101-629), which required medical device user facilities and distributors to report certain device-related adverse events.

Distributor reporting requirements became effective on May 28, 1992, following the November 26, 1991 (56 FR 60024), the publication of those provisions in a tentative final rule. In the Federal Register of September 1, 1993 (58 FR 46514), FDA published a notice announcing that the proposed distributor reporting regulations had become final by operation of law and were now codified in part 804 (21 CFR part 804).

On June 16, 1992, the President signed into law the Medical Device Amendments of 1992 (the 1992 amendments) (Public Law 102-112) amending certain provisions of section 519 of the act (21 U.S.C. 360i) relating to reporting of adverse device events. Among other things, the 1992 amendments amended section 519 of the act to modify the requirements for manufacturer and importer reporting. Under the regulations issued under the SMDA and the 1992 amendments, importers are required to report as manufacturers if they are engaged in manufacturing activities or to report as distributors if they are engaged solely in distribution activities.

On November 21, 1997, the President signed FDAMA (Public Law 105-115) into law. FDAMA made several changes regarding the reporting of adverse experiences related to devices. On May 12, 1998, FDA published a proposed rule (63 FR 26129) (hereinafter referred to as the May 1998 proposal) and a direct final rule (63 FR 26069) (hereinafter referred to as the May 1998 direct final rule) to implement the amendments to the Medical Device Reporting (MDR) provisions. FDA received at least one significant adverse comment on the direct final rule. Accordingly, consistent with FDA's procedures on direct final rulemaking, FDA is withdrawing the May 1998 direct final rule and is addressing the comments in this final rule based upon the May 1998 proposal.

The May 1998 proposal was intended to amend the medical device reporting requirements to implement the following changes made by FDAMA:

1. Section 213(a) of FDAMA revised section 519(a) of the act to eliminate distributors as an entity required to report adverse device events. Importers are still required to report under section 519(a) of the act.

2. Section 213(a) of FDAMA also amended section 519(a) of the act to clarify that existing requirements for distributors to keep records concerning adverse device events and make them available to FDA upon request continue to apply.

3. Section 213(a)(2) of FDAMA revoked section 519(d) of the act, which required manufacturers, importers, and distributors to submit to FDA an annual certification concerning the number of reports filed under section 519(a) in the preceding year. As a result, certification requirements are eliminated.

4. Section 213(c)(1)(A) of FDAMA revised section 519(b)(1)(C) of the act to require that device user facilities submit an annual rather than a semiannual summary of their reports to FDA.

5. Section 213(c)(1)(B) of FDAMA eliminated section 519(b)(2)(C) of the act. This section had required FDA to disclose, upon request, the identity of a device user facility making a report under section 519(b) of the act if the identity of the device user facility was included in a report required to be submitted by a manufacturer, distributor, or importer. As a result of this change by FDAMA, FDA now may disclose the identity of a device user facility only: in connection with an action concerning a failure to report or false or fraudulent reporting; in a communication to the manufacturer of the device; or to the employees of the Department of Health and Human Services, the Department of Justice, and duly authorized committees and subcommittees of Congress.

6. Section 422 of FDAMA states that FDA's regulatory authority under the act, relating to tobacco products, tobacco ingredients, and tobacco additives shall be exercised under the act as in effect on the day before the date of enactment of FDAMA. The proposal stated that, under this rule of construction, the reporting requirements for manufacturers and distributors (including distributors who are importers) of cigarettes or smokeless tobacco would remain unchanged.

Furthermore, along with the substantive changes to the MDR provisions required by FDAMA, the agency proposed certain nonsubstantive changes to the organization of the provisions contained in parts 803 (21 CFR part 803) and 804. These organizational changes did not affect any reporting burdens; rather, the changes were made for the sake of clarity and consistency within the CFR.

The agency received nine comments submitted by medical device manufacturers, importers, distributors, and trade associations.

1. Four comments stated that the agency did not follow Congress' direction that FDA consider changing the distributor recordkeeping requirements. The Congressional Conference Committee (the Conference Committee) recommended that FDA consider limiting the length of time that distributors are required to retain records to a period of 6 years (the current requirement is a minimum of 2 years, or the expected life of the product). The Conference Committee also recommended that FDA consider providing for electronic retention of records.

The agency disagrees that it did not properly follow Congress' direction or intent. The Conference Committee recommended that the agency consider changes to the distributor recordkeeping requirements. However, FDAMA contained no provisions that required any specific changes to the requirements.

The agency carefully considered the recommendations of the conference committee. The agency determined that the protection of the public health would not be adequately served if distributor recordkeeping was limited to a period of 6 years. Under the new quality system regulations contained in part 820 (21 CFR part 820), manufacturers (including initial distributors of foreign manufacturers) must retain records for a period equal to the design and expected life of the device (but no less than 2 years). The agency believes it is appropriate to require distributors to retain records for the same time period. This is especially important because distributors are no longer required to report any adverse event information to the agency, and the agency's primary access to the distributor complaint information is through its periodic inspection and examination of the distributor records.

FDA also considered electronic retention of distributor records. Prior to FDAMA and the proposed rule, the agency had not prohibited the electronic retention of records, nor did it intend to prohibit electronic recordkeeping based upon the proposal. When the distributor recordkeeping requirements were shifted from part 804 to part 803, the language remained largely unchanged. However, in order to avoid further confusion regarding electronic retention of records, the agency is modifying proposed § 803.18(d)(1) to clarify that distributor records may be either written or electronic.

2. Three comments stated that in describing distributor recordkeeping, reference to the quality system regulations, specifically § 820.198 (Complaint files), is inappropriate because § 820.198 applies only to manufacturers.

The agency agrees with this comment in part. The section being revoked (804.35) references § 820.198 because many of the recordkeeping requirements in § 820.198 would apply to all distributors. However, for the sake of clarity, the agency is revising § 803.18(d) to remove the reference to § 820.198, and is substituting language to identify the relevant requirements from § 820.198 that apply to distributors who are not importers.

3. Two comments suggested that the requirement that importers submit adverse event reports within 10 days be changed to allow 30 days for reporting.

The agency agrees and is modifying the regulation accordingly. Prior to the SMDA, importers were subject to the same reporting timeframes as manufacturers under the 1984 MDR regulation. Consistent with the requirements of the SMDA, the 10-day reporting requirement was imposed on distributors and, because part 804 defined distributors to include importers, the 10-day reporting requirement was imposed on importers as well. Under FDAMA, distributors are no longer required to submit adverse event reports, but the reporting requirements continue to apply to importers. Because importers are subject to many of the same requirements as manufacturers under the new quality system regulations contained in part 820, the agency will allow importers the same 30 days it provides manufacturers to gather information and submit reports.

4. One comment stated that the fields to be filled out on FDA Form 3500A (MEDWATCH reporting form) should be specifically identified for importers. The comment also requested clarification regarding whether the agency's definition of “importer” for the purpose of MDR includes firms who sell directly to the ultimate user.

The agency agrees that the fields to be filled out by importers on FDA Form 3500A should be specified within the regulation. Because the requirements and burdens would not be affected by revising the style and format of § 803.43, the agency is modifying the section to be consistent with §§ 803.32 and 803.52, which describe the information to be submitted on the MEDWATCH form. Furthermore, proposed § 803.43 was inadvertently misnumbered. For the sake of consistency in numbering, the final rule will renumber this section as § 803.42.

The agency notes that, because “distributors” had previously been defined to include “importers,” FDA Form 3500A does not specifically address importer information and does not use the term “importers.” However, block F of the MEDWATCH form is identified for use by device user facilities and distributors. An importer should continue to complete blocks A, B, D, E, and F until the form is revised to remove references to “distributor” and replace them with “importer.”

The agency clarifies that firms who purchase products from a foreign manufacturer and sell directly to the ultimate user are considered retailers and not importers under part 803 and are not required to report.

5. One comment stated that distributor reporting is important for the protection of the public health. The comment recommended, as an alternative to distributor reporting, a modification to the medical device labeling requirements to require that manufacturer contact information be included in the labeling for all devices in order to ensure proper adverse event reporting.

The agency agrees that consumers are likely to contact medical device distributors with their device complaints. Without distributor reporting, it is possible that the agency will not receive information regarding some complaints. However, under FDAMA, the agency no longer has the authority to require distributor reporting.

Although distributors are no longer under an obligation to report adverse device events, the agency continues to encourage distributors to provide manufacturers with adverse event information so that consumer complaints may be appropriately investigated and reported.

The alternative suggestion that manufacturer contact information be included in device labeling would be likely to increase the amount of information the manufacturer and the agency receives from the consumer. However, implementing this type of change to the medical device labeling regulation is beyond the scope of this rule. The agency is currently reviewing its medical device labeling regulation and considering certain modifications. The question of manufacturer contact information appearing on device labeling will be considered as part of that regulatory effort.

6. One comment stated that the agency erroneously interpreted section 422 of FDAMA, regarding the regulation of tobacco products, tobacco ingredients, or tobacco additives. The comment stated that section 422 simply provides that nothing in FDAMA shall affect the question of whether or not FDA has authority to regulate such products. The comment suggests that, if FDA has the authority to regulate such products, they should be regulated in the same manner as other medical devices.

The agency disagrees with this comment. Section 422 of FDAMA states that “Nothing in this Act or the amendments made by this Act shall be construed to affect the question of whether the Secretary of Health and Human Services has any authority to regulate any tobacco product, tobacco ingredient, or tobacco additive.” Although this language may suggest that FDAMA is simply silent regarding the agency's authority to regulate tobacco, section 422 goes on to state that “Such authority, if any, shall be exercised under the Federal Food, Drug, and Cosmetic Act as in effect on the day before the date of the enactment of this act.” Beyond the question of whether the agency has authority to regulate tobacco, this language directs the agency as to how it should exercise any such authority once pending litigation is resolved.

Under section 422 of FDAMA, therefore, Congress neither affirms nor denies the agency's authority to regulate tobacco, but it does direct the agency to continue regulating tobacco as it had been doing prior to FDAMA (if authority to regulate tobacco exists). Prior to FDAMA, distributor reporting and manufacturer and distributor certification were required under the act. If the agency were to exercise its authority under the act “as in effect on the day before the date of the enactment of [FDAMA],” distributor reporting and manufacturer and distributor certification requirements would continue to apply to manufacturers and distributors of cigarettes and smokeless tobacco products.

However, while the agency disagrees with the comment's interpretation of section 422 of FDAMA, FDA finds persuasive the comment's arguments that tobacco manufacturers and distributors should be exempt from the requirement of annual certification of MDR's and that distributors should be exempt from MDR reporting requirements under the residual authority of the act. The agency has authority under section 519(c) of the act to exempt, by regulation, any class of persons from the medical device reporting requirements upon a finding that such reporting by that class is not necessary to “assure that a device is not adulterated or misbranded or * * * otherwise to assure its safety and effectiveness” (21 U.S.C. 360i(c)). The agency finds that the statutory criteria for exemption are met because reasonable assurances will be provided by the remaining medical device reporting requirements, that is, reporting and recordkeeping required by manufacturers and importers and recordkeeping required by distributors.

7. On its own initiative, FDA has revised § 803.22(b)(2) to make clear that importers who receive reportable information about a device not imported by them need not submit a report to FDA but, instead, must forward the information to FDA along with a cover letter explaining that they do not import the device in question.

8. On its own initiative, FDA has determined that it is not necessary for importers to submit supplemental reports under § 803.56 as proposed. Instead, FDA will require importers to submit additional information only when requested by FDA under § 803.15. No change to § 803.15 is necessary.

9. Also on its own initiative, FDA has made some nonsubstantive changes to the definitions in § 803.3 in order to integrate the requirements for importer reporting into part 803.

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 this 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. The Office of Management and Budget (OMB) has determined that this final rule is a significant regulatory action 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. The rule codifies the elimination of reporting by distributors, continues reporting by importers as they have been doing to date with an extension of the time for reporting, increases protection from disclosure of the identity of device user facilities that have submitted reports, reduces summary reporting by device user facilities from semiannual to annual, eliminates annual certification for manufacturers and distributors (including importers) of medical devices, and makes other nonsubstantive changes. The agency certifies that this final rule will not have a significant negative economic impact on a substantial number of small entities. This final rule also does not trigger the requirement for a written statement under section 202(a) of the Unfunded Mandates Reform Act because it does not impose a mandate that results in an expenditure of $100 million or more by State, local, or tribal governments in the aggregate, or by the private sector, in any one year.

This final rule contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The title, description, and respondent description of the information collection provisions are shown below with an estimate of the annual reporting burden. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information.

Title: Reporting and recordkeeping requirements for manufacturers, importers, user facilities, and distributors of medical devices under the FDA Modernization Act (FDAMA)—General Requirements.

Description: FDAMA contained provisions that affect medical device reporting in a variety of ways. Section 213 of FDAMA eliminated the reporting requirements for medical device distributors (but not for importers), as well as the certification requirements for medical device manufacturers and distributors. This section of FDAMA also modified the summary reporting requirements for user facilities to require annual, rather than semiannual, reporting, and increased confidentiality of user facility identities.

This final rule amends FDA's regulations in part 803 and revokes part 804 to reflect the changes to medical device reporting made by FDAMA. The final rule has also been amended to implement the exemptions for manufacturers and distributors of cigarettes and smokeless tobacco products discussed below.

In accordance with 5 CFR 1320.8(d), on May 12, 1998, requests for public comment were published in the Federal Register (see 63 FR 26069 and 63 FR 26129). Several comments were received in response to the proposed rule and are discussed in detail previously in this final rule.

Four comments objected that FDA did not follow the congressional recommendation in the conference report on FDAMA that FDA limit the time that distributors be required to keep records to a maximum of 6 years. The direct final rule required that distributors keep records for 2 years or the expected life of the device, whichever is greater.

FDA carefully considered the recommendations of the conference committee. The agency determined that the protection of the public health would not be adequately served if distributor recordkeeping was limited to a period of 6 years. Under the new quality system regulations contained in part 820, manufacturers (including initial distributors of foreign manufacturers) must retain records for a period equal to the design and expected life of the device (but no less than 2 years). The agency believes it is appropriate to require distributors to retain records for the same time period. This is especially important because distributors are no longer required to report any adverse event information to the agency, and the agency's primary access to the distributor complaint information is its periodic inspection and examination of the distributor records.

FDA considered electronic retention of distributor records. Prior to FDAMA and the May 1998 proposal, the agency had not prohibited the electronic retention of records, nor did it intend to prohibit electronic recordkeeping based upon the May 1998 proposal. When the distributor recordkeeping requirements were shifted from part 804 to part 803, the language remained largely unchanged. However, in order to avoid further confusion regarding electronic retention of records, the agency is modifying proposed § 803.18(d)(1) to clarify that distributor records may be either written or electronic.

Three comments stated that it is inappropriate to refer to the quality systems regulations (§ 820.198) in describing distributor recordkeeping because § 820.198 does not apply to distributors.

FDA agrees and has revised § 803.18(d) accordingly to remove the reference to § 820.198. FDA is substituting language to identify the relevant requirements from § 820.198 that apply to distributors who are not importers. FDA notes, however, that § 820.198 does apply to importers of devices.

Two comments suggested that the reporting timeframe for importers should be changed to 30 days from 10 days.

FDA agrees with these comments and has revised the final rule. Previously, importers were included in part 804 with the reporting requirements for distributors. Because distributors are no longer required to report, part 804 is eliminated and importers are included in part 803 with manufacturers. The 30-day timeframe is consistent with the timeframe for manufacturers.

One comment suggested that the form for reporting adverse events (FDA Form 3500A) should be revised to refer specifically to importers. Another comment asked for clarification as to whether a person who sells directly to the ultimate user may be considered an “importer”.

The agency agrees that the fields to be filled out by importers on FDA Form 3500A should be specified within the regulation. Because the requirements and burdens would not be affected by revising the style and format of § 803.43, the agency is modifying the section to be consistent with §§ 803.32 and 803.52, which describe the information to be submitted on the MEDWATCH form. Furthermore, proposed § 803.43 was inadvertently misnumbered. For the sake of consistancy in numbering, the final rule will renumber this section as § 803.42.

The agency notes that, because “distributors” had previously been defined to include “importers,” FDA Form 3500A does not specifically address importer information and does not use the term, “importers.” However, block F of the MEDWATCH form is identified for use by device user facilities and distributors. An importer should continue to complete blocks A, B, D, E, and F until the form is revised to remove references to “distributor” and replace them with “importer.” The agency clarifies that firms who purchase products from a foreign manufacturer and sell directly to the ultimate user are considered retailers and not importers under part 803 and are not required to report.

One comment suggested that distributor reporting is important for the protection of the public health and recommended that, as an alternative to distributor reporting, FDA should require manufacturer contact information on the labeling to assure proper adverse event reporting.

The agency agrees that consumers are likely to contact medical device distributors with their device complaints. Without distributor reporting, it is possible that the agency will not receive information regarding some complaints. However, under FDAMA, the agency no longer has the authority to require distributor reporting. Although FDA cannot require distributor reporting, FDA encourages distributors to report adverse event information to manufacturers so that they may investigate and report it as appropriate. The suggestion that FDA require manufacturer contact information on the labeling is beyond the scope of this rule and FDA will consider it separately.

One comment objected that FDA incorrectly interpreted section 422 of FDAMA regarding the regulation of tobacco products, tobacco ingredients and tobacco additives. The comment stated that section 422 only means that nothing in FDAMA shall affect whether FDA has the authority to regulate tobacco products. The comment further said that section 422 of FDAMA does not mean, as FDA believes, that the requirements, such as MDR reporting, for manufacturers and distributors of tobacco products are unchanged by FDAMA.

The agency disagrees with this comment. Section 422 of FDAMA states that “Nothing in this Act or the amendments made by this Act shall be construed to affect the question of whether the Secretary of Health and Human Services has any authority to regulate any tobacco product, tobacco ingredient, or tobacco additive.” Although this language may suggest that FDAMA is simply silent regarding the agency's authority to regulate tobacco, section 422 of FDAMA goes on to state that “Such authority, if any, shall be exercised under the Federal Food, Drug, and Cosmetic Act as in effect on the day before the date of the enactment of this act.” Beyond the question of whether the agency has authority to regulate tobacco, this language directs the agency as to how it should exercise such authority once pending litigation is resolved.

Under section 422 of FDAMA, therefore, Congress neither affirms nor denies the agency's authority to regulate tobacco, but it does direct the agency to continue regulating tobacco as it had been doing prior to FDAMA (if authority to regulate tobacco exists). Prior to FDAMA, distributor reporting and manufacturer and distributor certification were required under the act. If the agency were to exercise its authority under the act “as in effect on the day before the date of the enactment of [FDAMA],” distributor reporting and manufacturer and distributor certification requirements would continue to apply to manufacturers and distributors of cigarettes and smokeless tobacco products.

However, while the agency disagrees with the comment's interpretation of section 422 of FDAMA, FDA finds persuasive the comment's arguments that tobacco manufacturers should be exempt from the requirement of annual certification of MDR's and that distributors should be exempt from MDR reporting requirements under the residual authority of the act. The agency has authority under section 519(c) of the act to exempt, by regulation, any person from the medical device reporting requirements upon a finding that such reporting is not necessary to “assure that a device is not adulterated or misbranded or * * * otherwise to assure its safety and effectiveness” (21 U.S.C. 360i(c)). The agency finds that the statutory criteria for exemption are met in light of the fact that Congress has repealed the requirements for manufacturer and distributor annual certification and distributor reporting. A reasonable assurance of the safety and effectiveness of tobacco products will be provided by the remaining medical device reporting requirements, that is, reporting and recordkeeping required of manufacturers and importers and recordkeeping required of distributors.

FDA estimates the burden for this collection of information as follows:

The collection of information contained in these final regulations has been reviewed and approved by the Office of Management and Budget in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507) under control number 1545-0771. Responses to this collection of information are required in order to deduct certain business expenses or exclude from income certain reimbursed business expenses of employees.

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

The estimated annual burden per respondent or recordkeeper varies from 10 minutes to 20 hours, depending on individual circumstances, with an estimated average of 1.3 hours.

Comments concerning the accuracy of this burden estimate and suggestions or reducing this burden should be sent to the Internal Revenue Service, Attn: IRS Reports Clearance Officer, OP:FS:FP, Washington, DC 20224, and to the Office of Management and Budget, Attn: Desk Officer for the Department of the Treasury, Office of Information and Regulatory Affairs, Washington, DC 20503.

Books or records relating to this collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.

On November 6, 1985, the IRS published in the Federal Register (50 FR 46006) temporary regulations (TD 8061) adding § 1.274-5T regarding substantiation of expenses with documentary evidence under section 274(d) of the Code. A notice of proposed rulemaking (LR-145-84, 1985-2 C.B. 809) cross-referencing the temporary regulations was published in the Federal Register (50 FR 46087) for the same day. The notice of proposed rulemaking invited comments on only those portions of the temporary regulations under § 1.274-5T that amended § 1.274-5 (now designated § 1.274-5A) to reflect contemporaneous legislation.

On March 25, 1997, the IRS published in the Federal Register (62 FR 13988) temporary regulations (TD 8715) amending paragraphs (c)(2)(iii)(B) and (f)(4) of § 1.274-5T. The amendments raised the receipt threshold from $25 to $75 and authorized the Commissioner to prescribe rules modifying the substantiation requirements for an adequate accounting by an employee to an employer. Under the amendment, the Commissioner could publish rules defining the circumstances (including the use of specified internal controls) under which an employee may make an adequate accounting to his employer by submitting an expense account alone, without the necessity of submitting documentary evidence (such as receipts). A notice of proposed rulemaking (REG-209785-95, 1997-1 C.B. 753) cross-referencing the temporary regulations was published in the Federal Register (62 FR 14051) for the same day.

On October 1, 1998, the IRS published a notice of proposed rulemaking (REG-122488-97, 1998-42 I.R.B. 19) in the Federal Register (63 FR 52660), proposing amendments to the Income Tax Regulations (26 CFR part 1) under sections 62(c) and 274(d) of the Code regarding substantiation of expenses using mileage and per diem rates. Specifically, the amendments removed the limitation in § 1.274(d)-1(a)(3) that provides that mileage allowances prescribed in rules by the Commissioner are available only to the owner of a vehicle. On that date the IRS also published temporary Income Tax Regulations (TD 8784, 1998-42 I.R.B. 4) under section 62(c) and 274(d) of the Code in the Federal Register (63 FR 52600), relating to the substantiation of expenses under a reimbursement or other expense allowance arrangement.

Comments were received in response to the 1985 proposed regulations, and a public hearing was held on March 3, 1986. Few of the written comments, and none of the comments at the hearing, relate to the provisions in this Treasury Decision. Written comments were also received with respect to the 1997 proposed regulations, but no public hearing was requested or held. No comments were received, and no hearings were requested or held, with respect to the 1998 proposed regulations.

This Treasury Decision incorporates the suggestions made in the written comments with some exceptions. With respect to the 1985 regulations, one commentator suggested that the definition of an adequate accounting in § 1.274-5T(f)(4), in the case of automobile expense reimbursements, should be satisfied by a reimbursement based on data on the type of automobile and local operating and fixed costs. Although this suggestion has not been specifically adopted in the final regulations, the standard mileage rate revenue procedure provides for this type of substantiation. See, e.g., section 8 of Rev. Proc. 98-63, 1998-52 I.R.B. 25.

Another commentator suggested, inter alia, (1) adding exceptions to the documentary evidence requirements under § 1.274-5T(c)(2)(iii) and (2) providing that the Commissioner, in establishing a meal allowance under § 1.274-5T(j), may allow a specific dollar allowance per meal. These suggestions are not adopted because the intent of the regulations is to give the Commissioner the discretion to make these practical decisions.

Similarly, with respect to the 1997 regulations, commentators made suggestions regarding the specific content of the guidance to be issued under the proposed regulations at § 1.274-5(f)(4). We did not incorporate these suggestions because the regulations are designed to describe appropriate published guidance of general applicability, not the specific provisions of such guidance. However, all of the comments will be taken into consideration by the Commissioner in issuing published guidance.

This Treasury Decision adopts the revision to § 1.62-2(e)(2) proposed in REG-122488-97, with minor changes. This Treasury Decision also adopts §§ 1.274-5(c)(2)(iii), (f)(4), (g), (j), and (m) as proposed by LR-216-84, modified by REG-209785-95 and REG-122488-97, and removes and reserves the corresponding provisions in § 1.274-5T. Finally, this Treasury Decision adopts the proposal in REG-122488-97 to remove §§ 1.62-2T, 1.274(d)-1, and 1.274(d)-1T.

It has been determined that this Treasury decision is not a significant regulatory action as defined in EO 12866. Therefore, a regulatory assessment is not required. It also has been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to these regulations. Sections 1.274-5(c)(2)(iii) and (f) were originally proposed by a notice of proposed rulemaking (LR-145-84) that was issued on November 6, 1985. Therefore, the Regulatory Flexibility Act (5 U.S.C. chapter 6) does not apply with respect to those collections of information. With respect to the collection of information in § 1.274-5(c)(iii)(B) as proposed by REG-209785-95 on March 25, 1997, it is hereby certified that these regulations will not have a significant economic impact on a substantial number of small entities. This certification is based on the fact that, by increasing the receipt threshold from $25 to $75, these regulations reduce the existing recordkeeping requirements of taxpayers, including small entities. The regulations do not otherwise significantly alter the reporting or recordkeeping duties of small entities. Therefore, a Regulatory Flexibility Analysis under the Regulatory Flexibility Act (5 U.S.C. chapter 6) is not required. Pursuant to section 7805(f) of the Internal Revenue Code, the IRS submitted the notices of proposed rulemaking preceding these regulations to the Chief Counsel for Advocacy of the Small Business Administration for comment on its impact on small business.

The principal author of these final and temporary regulations is Edwin B. Cleverdon, Office of the Assistant Chief Counsel (Income Tax and Accounting). However, personnel from other offices of the IRS and Treasury Department participated in their development.

The notice of proposed rulemaking was published on Wednesday, October 13, 1999, vol. 64, No. 197, pages 55441—55442. Pursuant to its authorities in Sections 4, 7, and 28 of the Rivers and Harbors Act of 1917 (40 Stat. 266; 33 U.S.C. 1) and Chapter XIX of the Army Appropriations Act of 1919 (40 Stat. 892; 33 U.S.C. 3), the Corps is amending its regulations in 33 CFR Part 207.718(v), (w)(1), (w)(4), (w)( 5), (w)(6), (w)(7), and (w)(8). Paragraph (v) is deleted since the area below the dams at McNary, Ice Harbor, Lower Monumental, Little Goose, and Lower Granite is changed from “hazardous” to “restricted”. Signs mark the restricted areas. The redesignation of the downstream area from “hazardous” to “restricted” is to prohibit vessels, except government vessels, from entering the area. Under a hazardous designation, vessels could enter at their own risk. An increase in fishing vessels into the hazardous area in pursuit of adult salmon and steelhead is of great concern, since the electrical generators and spillway gates are operated remotely from Portland. There are no personnel at the dam to warn boaters of an immediate release of water. Paragraph (w)(1) is amended to provide an additional margin of safety for recreational boaters operating above and below Bonneville Lock and Dam during the discharge of water from the Juvenile Bypass System outfall structures. Paragraphs (w)(4), (w)(5), (w)(6), (w)(7), and (w)(8) are amended to provide a greater margin of safety for recreational boaters from sudden dangerous currents, turbulence and whirlpools caused by the operation of spillways, electrical generators, and navigation locks. Operation of the electrical generators and spillway gates are remotely controlled from Portland, Oregon. The regulation governing the navigation locks and approach channels, Columbia and Snake Rivers, Washington and Oregon, 33 CFR 207.718 was adopted on January 23, 1978 (43 FR 3115). The last amendment to 33 CFR 207.718 was April 4, 1991 (56 FR 13765). This final rule is not a major rule for the purposes of Executive Order 12866. As required by the Regulatory Flexibility Act, the Corps of Engineers certifies that this final rule would not have a significant impact on small business entities.

No comments were received to the October 13, 1999, Federal Register notice of proposed rulemaking. However, there was an error in the proposed upstream restricted area boundaries at Ice Harbor Lock and Dam, Lower Monumental Lock and Dam, and Little Goose Lock and Dam. The Corps Walla Walla District issued a public notice on December 16, 1988, regarding proposed changes to restricted area boundaries at McNary, Ice Harbor, Lower Monumental and Little Goose Locks and Dams. However, the restricted area boundaries in the October 13, 1999, Federal Register contained errors in direction and distances from the December 16, 1988 public notice. The revised restricted upstream boundary at Ice Harbor Dam provides a greater distance from the dam to protect boaters. The revised restricted upstream boundary at Lower Monumental Dam shifts the north boundary waterward to place the boat ramp outside the restricted area. The upstream restricted area boundary line at Little Goose Dam that runs on an angle of 345° 26′ true for a distance of 620 yards to the north shore is amended to delete the distance, since the shore line is subject to change by lake level fluctuations and natural causes.

Throughout this document wherever “we”, “us”, or “our”, are used we mean EPA. This Supplementary Information section is organized as follows:

In today's action, EPA is approving the Lake and Porter Counties, Indiana Post-1996 Rate of Progress (ROP) Plan, including a 1990 inventory adjustment, as a revision to the State Implementation Plan (SIP). IDEM submitted these items on December 17, 1997, and January 22, 1998.

The Post-1996 ROP Plan satisfies the requirements of the Clean Air Act. Specifically, the plan:

• Revises the 1990 base year emission inventory,

• Identifies control measures to achieve a projected 9% VOC emission reduction in Lake and Porter Counties,

• Documents the 9% reductions to occur by November 15, 1999, and,

• Identifies a 1999 mobile source emissions budget for VOC.

EPA found that the Post-1996 ROP Plan contains 77,660 pounds VOC/day of emission reductions in Lake and Porter Counties that are creditable. This exceeds the required reduction of 77,366 pounds VOC/day. The Act requires these reductions because VOC emissions combine with oxides of nitrogen in the atmosphere to form ground-level ozone, a pollutant which can cause inflammation of the lungs, decrease lung capacity, and aggravate asthma.

Section 182(c)(2)(B) of the Act requires submittal of a demonstration that the SIP will result in a 9% emission reduction by November 15, 1999. This 9% needs to be in addition to the emission reduction requirement for a 15% reduction by November 15, 1996. Indiana submitted the demonstration as part of the Post-1996 ROP Plan.

The Post-1996 ROP Plan refers to various emission control regulations which IDEM estimates will achieve the 9% emission reductions for Lake and Porter Counties. The regulations, both Federal and State, impact a wide variety of industries and businesses. For the most part, these regulations have already been implemented. All of them have already been approved into the SIP or promulgated by EPA. Today's approval does not establish any new requirements. The plan identifies and documents how existing SIP and Federal regulations achieve the necessary 9% emission reductions. The plan, by documenting emission reductions, demonstrates the progress being made toward cleaner air for the people that live and work in Lake and Porter Counties, Indiana.

A Post-1996 ROP Plan documents the control strategies a State is implementing to reduce emissions of ozone precursors by 9% from 1990 baseline emissions. Section 182(b)(1) of the Act requires States to develop these Post-1996 ROP Plans for ozone nonattainment areas which have been classified as serious and above. Lake and Porter Counties are classified as severe nonattainment for ozone. To be approvable, a State must show that the 9% emission reduction will occur by November 15, 1999.

The Plan is called a “Post-1996” ROP Plan because the Act also requires that by November 15, 1996, the States implement control strategies achieving 15% emission reduction for ozone nonattainment areas classified as moderate and above. The Post-1996 ROP Plan continues the 3% per year reductions from November 16, 1996, through November 15, 1999.

The IDEM Post-1996 ROP Plan identifies VOC control strategies. VOC emissions combine with oxides of nitrogen in the atmosphere to form ground-level ozone. Ozone can cause inflammation of the lungs, decrease lung capacity, and aggravate asthma.

IDEM's Post-1996 ROP Plan is applicable to the severe ozone nonattainment area of Lake and Porter Counties, Indiana. Lake and Porter Counties are part of the Chicago-Gary-Lake County ozone nonattainment area, which is classified as severe nonattainment for ozone.

Lake and Porter Counties are classified as severe nonattainment for ozone. For that reason, section 182(c)(2)(B) of the Act requires that these areas reduce emissions of ozone precursors by 3% per year, and that the State submit a Post-1996 ROP Plan to identify and document those reductions.

On December 17, 1997, Indiana submitted to EPA the Lake and Porter Counties Indiana Post-1996 ROP Plan. EPA found this submittal to be complete in a letter to IDEM dated December 30, 1997.

The ROP Plan contains documentation and control strategies for both the 9% reduction requirement and 3% contingency measures, as well as a revision to the 1990 VOC emission inventory. The contingency measures include agreed orders for Keil Chemical and United States Steel Gary Works. EPA will address the contingency measures and these agreed orders in a subsequent rulemaking action.

The submittal also contains a mobile source emission budget for VOC. IDEM supplemented its submittal on January 22, 1998, to clearly identify the mobile source emission budget.

IDEM supplemented its submittal on January 22, 1998 to clearly identify a 1999 mobile source budget for VOCs of 40,897 pounds VOC per summer day, as contained in Table 16 of the Post-1996 ROP Plan.

At the time that EPA received this submittal, the transportation rules (62 FR 43780) required EPA to review mobile source budgets within 45 days of submittal. After receiving the supplemental submittal regarding the budget on January 22, 1998, EPA completed that review of the budget. EPA found the 1999 VOC budget of 40,897 pounds VOC per summer day adequate in a February 2, 1998, letter. Since that time, Lake and Porter Counties have been required to restrict their 1999 modeled mobile source VOC emissions to below that budget.

On October 13, 1997, IDEM published a notice of public hearing for the Post-1996 ROP Plan and opened a public comment period through December 1, 1997. IDEM held a public hearing on the proposed ROP Plan on November 13, 1997. The submittal summarizes the public comments and IDEM's responses to those comments.

On April 3, 1997, EPA proposed approval and solicited public comment on Indiana's 15% ROP plan. EPA finalized approval of the 15% ROP plan on July 18, 1997 (62 FR 38457). The 15% ROP plan was designed to reduce VOC emissions in Lake and Porter Counties by 68,242 pounds per day.

IDEM has revised the 1990 Lake and Porter Counties base year VOC emissions inventory. The revision increases the base year VOC emissions inventory by 195,349 pounds/day, a 46% increase. The resulting 1990 VOC emissions inventory for Lake and Porter Counties is 620,070 pounds/day (typical weekday emissions during the period of June through August).

Both the 15 percent ROP plan and the Post-1996 ROP Plan depend on the level of the 1990 base year VOC emissions. EPA has encouraged the States to update the 1990 base year emissions as needed, and to make appropriate changes in ROP plans. EPA recognizes that the base year emissions estimates (or the estimated emissions for any other year) are not fixed over time and that new data can improve these estimates. Such is the case in this ROP submittal.

In July and August 1993, the United States Steel Corporation (US Steel) commented to IDEM on the 1990 base year inventory. US Steel stated that the 1990 base year emissions inventory underestimated VOC emissions from the US Steel coke oven by-product recovery plant. When IDEM received these comments, it was in the final stages of preparing the base year emissions inventory and did not have time to further investigate US Steel's claim prior to submitting the inventory to the EPA.

EPA approved IDEM's 1990 base year emissions inventory for Lake and Porter Counties on January 4, 1995 (60 FR 375). The rulemaking suggested that IDEM give further consideration to the comments of US Steel and acknowledged that IDEM would need extra time to consider relevant data prior to amending the base year emissions inventory, if warranted.

After taking a more detailed look at the emissions from the coke oven by-product recovery sector, IDEM concluded that it was appropriate to revise the 1990 base year emissions inventory. Both State rule 326 IAC 14-9 and the Federal National Emission Standard for Hazardous Air Pollutants (NESHAP) regulate benzene emissions from coke oven by-product recovery plants. The rules were implemented in 1991 and not 1990, as assumed in the original 1990 base year emissions inventory. IDEM is now correcting this assumption, resulting in the need to increase the 1990 base year emissions.

To accurately reflect the overall emissions from this category, IDEM increased the resolution of the emissions inventory for the emissions from coke oven by-product recovery plants. These enhanced emission calculations provided the context for the compliance data from US Steel, allowing IDEM to more accurately determine the correct 1990 emissions level.

IDEM concluded that the 1990 base year emissions were significantly higher than the base year inventory originally adopted and has requested that the 1990 SIP base year inventory be adjusted accordingly.

In determining what control measures a State can use in its Post-1996 ROP Plan strategy, emission reductions from control measures are creditable to the extent they occur before November 15, 1999. The General Preamble for the Implementation of Title I of the Act also interprets and clarifies the Act's requirements for crediting control strategies. The Preamble provides that all credited emission reductions must be real, permanent, and enforceable, and discusses how these criteria can be met with specific strategies (57 FR 13497). EPA has explained these requirements in more detail in the guidance documents listed in this Federal Register .

To achieve the required 9% VOC emission reduction requirement, IDEM reviewed and chose the following emission control measures.

Coke Oven By-Product Recovery Plants NESHAP. This Federal NESHAP at 40 CFR Part 61, Subpart L, applies to all furnace and foundry coke oven by-product recovery plants. The NESHAP requires the use of gas blanketing to control emissions from tar intercepting sumps, process vessels, and naphthalene processing operations. The NESHAP also covers controlling emissions from equipment leaks, coolers, and light oil processes.

As noted above, Indiana promulgated rule 326 IAC 14-9 in 1988, covering some of the emissions for this source category. It was scheduled for implementation in 1990, but was actually implemented in 1991. EPA approved the rule as part of the State's Reasonably Available Control Technology (RACT) SIP on September 17, 1992 (57 FR 42889).

IDEM has requested credit in its Post-1996 ROP Plan for reductions from coke oven by-product recovery plants that went beyond rule 326 IAC 14-9. EPA believes this approach is consistent with EPA guidance which provides that only the emission reductions from NESHAPS that go beyond RACT rules in existence before November 15, 1990, can be credited in ROP plans. Based on this guidance, the State determined the emission reduction resulting from the NESHAP that went beyond that of rule 326 IAC 14-9.

IDEM has determined that the NESHAP has resulted in additional VOC emission reductions of 45,300 pounds/day at the US Steel mill and 10,071 pounds/day at the Bethlehem Steel mill, for a total additional VOC emission reduction of 55,371 pounds/day.

Furthermore, EPA has determined that while the reductions from 326 IAC 14-9 are not creditable toward the 9% reduction requirements, they should be removed from the baseline emission inventory before determining the required reductions for the ROP purposes. This approach acknowledges that while these reductions were not actually made before 1990, they are also not part of the 1990 Act's ROP process.

Inland Steel Coke Oven Battery Shutdowns. Indiana rule 326 IAC 6-1-10.1(k)(5) (adopted by the State in March 1993), required Inland Steel Flat Products to shut down coke batteries numbers 6 through 11 before November 1996. Inland Steel no longer holds a valid operating permit for these coke batteries. In addition, based on a consent decree between the State and Inland Steel, Inland Steel cannot bank the VOC emission reductions from these coke battery closures for future use. IDEM considers them to be permanent emission reductions.

IDEM notes that, since it found emissions from the coke oven by-products recovery to be higher than was originally reported in the 1990 base year inventory, additional emission reduction credits are available. Note that IDEM increased the 1990 base year VOC emissions in this source category, as discussed above.

To calculate the emission reduction credit for this source, IDEM had to take into account emission reduction credits already applied in prior submittals, in particular in the 15 percent ROP plan, to avoid double counting. IDEM increased the resolution of the emissions inventory for this source so that it could consider the impacts of the previously implemented rule 326 IAC 14-9 and previously credited controls.

IDEM found that it could credit an additional VOC emission reduction (beyond that credited in the 15 percent ROP plan) of 6,666 pounds/day to the Inland Steel coke oven battery shutdowns. The IDEM submittal credits 6,288 pounds/day to the 9 percent ROP emission reduction requirement, and 378 pounds/day to the 3 percent contingency requirement. However, EPA is today crediting the full 6,666 pounds VOC/day toward the 9% requirement. This excess reduction accounts for discrepancies identified in other sections of IDEM's submittal.

IDEM had credited a VOC emission reduction of 3,984 pounds/day for this source closure in prior air quality plan submittals, and is not taking credit for that portion in the 9 percent post-1996 ROP Plan.

Effects of Reformulated Gasoline on Small, Non-Road Engines. The emission reduction for this source category applies to 2-stroke and 4-stroke non-road engines. The emission reduction results from the implementation of the Act's requirement for the use of reformulated gasoline in ozone nonattainment areas classified as severe and above.

To determine the emission reduction credit, IDEM used August 1993 guidance from EPA to calculate the emission reduction by engine type. The emission reductions only apply to exhaust and evaporative emissions. Based on the EPA guidance, IDEM did not account for emission reductions resulting from changes in refueling emissions.

Tables 1 and 17 of the Post-1996 ROP Plan, document a VOC emission reduction of 1,292 pounds/day for this source category. However, the detailed emissions summary contained in Appendix C-1 of the submittal calculates a VOC emission reduction of 575 pounds per day. The emission reductions achieved by the use of reformulated gasoline in small, non-road engines and the regulation for new small engines need to be calculated together, since both affect small engines. A calculation error was made when disaggregating the results of that analysis. In Tables 1 and 7, 715 pounds VOC/day were inadvertently shifted from the emissions listed for the “new small engine standards” to the emissions reduction credited for “effects of reformulated gasoline on small, non-road engines.” This approval corrects that error and credits the effects of reformulated gasoline on small, non-road engines with a 575 pound VOC/day emission reduction.

When this error was made, an additional 2 pounds VOC/day were added to the effects of reformulated gasoline on small, non-road engines. This 2 pound deficit will be made up by the excess credit for the Inland Steel coke oven battery shutdowns. In IDEM's submittal, it only took credit for Inland Steel coke oven battery shutdowns for 6,288 out of a total 6,666 pounds VOC/day. This approval more than makes up the 2 pound deficit by applying all 6,666 pounds VOC/day to the Post-1996 9% reduction.

New Small Engine Standards. IDEM calculated the impact of new federal standards codified at 40 CFR Part 90 for small engines by following November 28, 1994, EPA guidance titled “Future Non-road Emission Reduction Credits for Court-Ordered Non-Road Standards”. IDEM determined the emission impacts for each equipment type and engine type in Lake and Porter Counties. Appendix C-2 of the Post-1996 ROP Plan submittal specifies the emission reduction for each equipment and engine type combination by county. IDEM calculated emission impacts after removing the impacts of reformulated gasoline, as specified in the EPA guidance.

IDEM determined, as demonstrated in Appendix C-2 of the Post-1996 ROP Plan, that the small engine standards would reduce 1999 emissions by 6,034 pounds VOC/day. However, tables 1 and 18 of the Post-1996 ROP submittal document a VOC emission reduction from this control category equaling only 5,319 pounds/day.

As noted above, IDEM inadvertently shifted 715 pounds VOC/day to reformulated gasoline when listing the measures in the tables. EPA has made this correction to the tables in today's Federal Register . The new small engine standard is being credited at 6,034 pounds VOC/day reduction.

Volatile Organic Liquid Storage Reasonably Available Control Technology. The VOC impact of this control is based on the calculated impacts of State rule 326 IAC 8-9, adopted by the Indiana Air Pollution Control Board on May 3, 1995 and approved by EPA on January 17, 1997 (62 FR 2593). This rule became effective in Indiana on October 1, 1995, and was to be phased in over several years, with most sources needing to comply by May 1, 1996. The rule applies to storage vessels with a capacity greater than 39,000 gallons that are used to store volatile organic liquids with a maximum true vapor pressure of 1.52 pounds per square inch or greater.

The rule requires the use of internal floating roofs with vapor-mounted primary and secondary seals with controlled fittings in fixed roof tanks. It also requires the replacement of vapor-mounted primary seals with liquid-mounted primary seals or shoe seals and installation of secondary seals with controlled fittings in external floating roof tanks.

The emission reduction total for this control measure assumes a VOC emission reduction of 96 percent in fixed roof tanks, 29 percent in internal floating roof tanks, and 65 percent for external floating roof tanks. The emission reduction calculation also assumes an 80 percent rule effectiveness level.

All external floating roof tanks have to comply with the State rule by May 1, 1996. Existing internal floating roof tanks have up to 10 years to comply with the rule. IDEM only claims an emission reduction credit for external floating roof tanks and fixed roof tanks.

This approval credits a VOC emission reduction of 2,700 pounds VOC/day for this source control measure in 1999, documented in Table 21 and Appendix C-5 of the Post-1996 ROP submittal.

Coke Oven Batteries NESHAP. The coke oven batteries NESHAP, promulgated by EPA on October 27, 1993, and codified at 40 CFR Part 63, Subpart L, applies to all coke oven batteries in existence prior to December 4, 1992, including by-product and nonrecovery coke oven batteries, and to all new coke oven batteries constructed on or after December 4, 1992. The rule mandates emission limits and/or controls for door leaks, topside port leaks, offtake system leaks, visible emissions, and charging systems.

IDEM calculated the emission reductions based on EPA guidance in the preamble to the 1993 NESHAP (58 FR 57898). Appendix C-4 of the ROP Plan submittal documents in detail the individual source calculations used by IDEM to calculate the total VOC emission reduction. This approval credits a total VOC reduction of 6,314 pounds/day.

EPA has developed a number of guidelines specifically addressing the review of Post-1996 ROP Plans. In addition, EPA guidelines concerning the review of 15 percent ROP plans (1996 ROP plans) address many issues of relevance in the review of the Post-1996 ROP Plans. These documents address such topics as: (1) the requirements of the Act; (2) development of baseline and target emission estimates; (3) emission inventory projection procedures; and, (4) recommended emission reduction levels for various emission control measures.

The 15% plan target emission level needed to be recalculated because IDEM has revised the 1990 VOC emission inventory. The Post-1996 ROP Plan uses the 15% plan's 1996 target level as a starting point. IDEM calculated the 1999 target emission level directly from this 1996 target level. IDEM then subtracted the 1999 target emission level from the projected 1999 inventory to determine how much VOC emission reductions are needed. In this manner, instead of revisiting the 15% plan, the Post-1996 ROP Plan has to provide for ample reductions to meet the 1999 target.

To determine the 1990 adjusted base year inventory, IDEM started with the 1990 base year emission inventory approved by EPA on January 4, 1995 (60 FR 375), which EPA found met the requirements of sections 172(c)(3) and 182(a)(1) of the Act for Lake and Porter Counties. IDEM then revised the inventory as described earlier. The revision resulted in total 1990 adjusted base year emissions of 620,070 pounds VOC/day. IDEM subtracted biogenic emissions and emissions from outside Lake and Porter Counties from the 1990 base year inventory to determine that the 1990 ROP inventory level is 577,190 pounds VOC/day.

IDEM used EPA's Mobile Source Emissions Model (MOBILE) 5a to calculate the emission reductions from the pre-1990 FMVCP and 1990 RVP regulations; IDEM then subtracted these reductions and the emission reductions from coke oven by-product recovery plants from the 1990 ROP inventory level to find the 1990 adjusted base year inventory level of 389,599 lbs VOC/day.

IDEM then multiplied the adjusted base year emissions by 15% resulting in a required reduction of 58,440 pounds VOC/day. To obtain the 1996 emission target level, IDEM subtracted the 15% required emission reductions from the 1990 ROP emissions resulting in a 1996 target level of 331,159 pounds VOC/day.

The Post-1996 ROP Plan satisfies the requirements of the Clean Air Act. Specifically, the plan:

• Revises the 1990 base year emission inventory,

• Identifies control measures to achieve a projected 9% VOC emissions reductions in Lake and Porter Counties,

• Documents the 9% reductions to occur by November 15, 1999, and,

• Identifies a 1999 mobile source emissions budget for VOC.

The Post-1996 ROP Plan projects reductions in VOC emissions in Lake and Porter Counties of 77,660 pounds VOC/day. This exceeds the required reduction of 77,366 pounds VOC/day. Indiana can use the excess reduction of 294 pounds VOC/day toward meeting future ROP emission reduction requirements.

Section 182(c)(2)(B) of the Act requires submittal of a demonstration that the SIP will result in a 9% emission reduction by November 15, 1999. This 9% needs to be in addition to the emission reduction requirement for a 15% reduction by November 15, 1996. Indiana submitted the demonstration as part of the Post-1996 ROP Plan.

EPA approves Indiana's Post-1996 ROP Plan, including the 1990 inventory adjustments, submitted December 17, 1997, and January 22, 1998, for Lake and Porter Counties, as a revision to the SIP. Final approval of the Post-1996 ROP Plan also approves the 1999 mobile source emission budget of 40,897 pounds VOC per summer day.

This action will be effective on March 27, 2000.

EPA is publishing this action without prior proposal because EPA views this as a noncontroversial revision and anticipates no adverse comments. However, in a separate document in this Federal Register publication, EPA is proposing to approve the SIP revision should adverse written comments be filed. This action will be effective without further notice unless EPA receives relevant adverse written comment by February 25, 2000. Should the Agency receive such comments, it will publish a withdrawal informing the public that this action will not take effect. Any parties interested in commenting on this action should do so at this time. If no such comments are received, this action will be effective on March 27, 2000.

The Office of Management and Budget (OMB) has exempted this regulatory action from Executive Order (E.O.) 12866, entitled “Regulatory Planning and Review.”

Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), applies to any rule that: (1) is determined to be “economically significant” as defined under E.O. 12866, and (2) concerns an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, the Agency must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the Agency.

This rule is not subject to E.O. 13045 because it does not involve decisions intended to mitigate environmental health or safety risks.

Under E.O. 13084, EPA may not issue a regulation that is not required by statute, that significantly affects or uniquely affects the communities of Indian tribal governments, and that imposes substantial direct compliance costs on those communities, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by the tribal governments. If the mandate is unfunded, EPA must provide to the Office of Management and Budget, in a separately identified section of the preamble to the rule, a description of the extent of EPA's prior consultation with representatives of affected tribal governments, a summary of the nature of their concerns, and a statement supporting the need to issue the regulation.

In addition, E.O. 13084 requires EPA to develop an effective process permitting elected and other representatives of Indian tribal governments “to provide meaningful and timely input in the development of regulatory policies on matters that significantly or uniquely affect their communities.” Today's rule does not significantly or uniquely affect the communities of Indian tribal governments. Accordingly, the requirements of section 3(b) of E.O. 13084 do not apply to this rule.

Federalism (64 FR 43255, August 10, 1999) revokes and replaces E.O. 12612 (Federalism) and E.O. 12875 (Enhancing the Intergovernmental Partnership). E.O. 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the E.O. 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.” Under E.O. 13132, EPA may not issue a regulation that has federalism implications, that imposes substantial direct compliance costs, and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by State and local governments, or EPA consults with State and local officials early in the process of developing the proposed regulation. EPA also may not issue a regulation that has federalism implications and that preempts State law unless the Agency consults with State and local officials early in the process of developing the proposed regulation.

This final 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 E.O. 13132, 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 Clean Air Act. Thus, the requirements of section 6 of the E.O. do not apply to this rule.

The Regulatory Flexibility Act (RFA) generally requires an agency to conduct a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small not-for-profit enterprises, and small governmental jurisdictions.

This final rule will not have a significant impact on a substantial number of small entities because SIP approvals under section 110 and subchapter I, part D of the Clean Air Act do not create any new requirements but simply approve requirements that the State is already imposing. Therefore, because the Federal SIP approval does not create any new requirements, I certify that this action will not have a significant economic impact on a substantial number of small entities.

Moreover, due to the nature of the Federal-State relationship under the Clean Air Act, preparation of flexibility analysis would constitute Federal inquiry into the economic reasonableness of state action. The Clean Air Act forbids EPA to base its actions concerning SIPs on such grounds. Union Electric Co., v. U.S. EPA, 427 U.S. 246, 255-66 (1976); 42 U.S.C. 7410(a)(2).

Under Section 202 of the Unfunded Mandates Reform Act of 1995 (“Unfunded Mandates Act”), signed into law on March 22, 1995, EPA must prepare a budgetary impact statement to accompany any proposed or final rule that includes a Federal mandate that may result in estimated annual costs to State, local, or tribal governments in the aggregate; or to the private sector, of $100 million or more. Under Section 205, EPA must select the most cost-effective and least burdensome alternative that achieves the objectives of the rule and is consistent with statutory requirements. Section 203 requires EPA to establish a plan for informing and advising any small governments that may be significantly or uniquely impacted by the rule.

EPA has determined that the approval action promulgated does not include a Federal mandate that may result in estimated annual costs of $100 million or more to either State, local, or tribal governments in the aggregate, or to the private sector. This Federal action approves pre-existing requirements under State or local law, and imposes no new requirements. Accordingly, no additional costs to State, local, or tribal governments, or to the private sector, result from this action.

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This rule is not a “major” rule as defined by 5 U.S.C. 804(2).

Section 12 of the National Technology Transfer and Advancement Act (NTTAA) of 1995 requires Federal agencies to evaluate existing technical standards when developing a new regulation. To comply with NTTAA, EPA must consider and use “voluntary consensus standards” (VCS) if available and applicable when developing programs and policies unless doing so would be inconsistent with applicable law or otherwise impractical.

EPA believes that VCS are inapplicable to this action. Today's action does not require the public to perform activities conducive to the use of VCS.

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by March 27, 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).)

The following sections: Background, Analysis of the State's Submittal, and Final Action, provide additional information concerning the revisions to the enhanced I/M portion of the Georgia SIP.

On December 13, 1996 (61 FR 65496), EPA published a notice of proposed rulemaking (NPR) for the State of Georgia. The NPR proposed conditional interim approval of Georgia's enhanced I/M program, for the Atlanta ozone nonattainment area, submitted to satisfy the applicable requirements of both the CAA and the NHSDA. The formal SIP revision, submitted on March 27, 1996, by the Georgia Environmental Protection Division (EPD) of the Department of Natural Resources, contained plans to implement the program in two phases. The plan for Phase 1 described how the program would be expanded from the four counties in the previous program to the 13 ozone nonattainment counties. Phase 1 implemented a two speed idle (TSI) test and a gas cap pressure check for all vehicles that were subject to an emissions inspection. The implementation of Phase 2 required an ASM test for vehicles older than six model years, while newer vehicles continued to be subject to the TSI test. Phase 2 also implemented minor changes in software. The program was conditionally approved because it lacked ASM test method specifications and a requirement to implement the program in a timely manner. Subsequently, on January 31, 1997, the EPD submitted the necessary ASM test method, satisfying one of the conditions for program approval. These specifications were largely based upon EPA's specifications for the ASM test. Therefore, on August 11, 1997 (62 FR 42916) EPA noted the test specifications condition of the December 13, 1996, proposal was met and removed, and final interim approval was given to the program.

Additional detailed discussion of the Georgia enhanced I/M SIP and the rationale for EPA's action are explained in the proposal notice published December 13, 1996, reference above and in the final interim approval notice published on August 11, 1997 (62 FR 42916), and will not be restated here.

On November 4, 1998, EPD submitted a revision to the SIP that modified portions of the enhanced I/M program. Specifically, the submission deleted emergency rules contained in the “Emission Inspection Procedures,” and the “Inspection Station Requirements” for the Georgia I/M regulation. These emergency rules were adopted when the ASM portion of the program could not be implemented on schedule due to delays in the delivery of hardware and software. The emergency rules allowed stations to check vehicle emissions on the TSI through December 1, 1998. However, the required hardware and software were delivered prior to the expected date, allowing ASM testing to start earlier than anticipated. Additionally, the “Certificate of Emissions Inspection” was changed to require a telephone number for tracking purposes. The details of the modifications requested in the November 1998 submittal are discussed below.

Paragraph 7 in the Emission Inspection Procedures (Georgia Rule 391-3-20-.04) is deleted entirely, removing the provision that allowed older vehicles to be tested with the TSI procedure.

Sections (1)(a)(3) and (1)(c)(3) are deleted from Georgia Rule 391-3-20-.09, thereby removing the provisions that allowed certain newer vehicle only inspection stations or fleet inspection stations to test older vehicles with the TSI procedure.

A new subparagraph (2)(b) of Georgia Rule 391-3-20-.13 completely replaces the former subparagraph, requiring a telephone number in addition to the other information previously required on the repair information form.

On December 4, 1998, the EPD submitted additional revisions to the SIP to modify portions of the enhanced I/M program. Specifically, the submission updates the I/M Test Manual definition so that it refers to the version of the Enhanced I/M Test Equipment, Procedures and Specifications—Phase II dated September 10, 1998; extends the $200 waiver expenditure requirement through December 31, 1999; and extends the $25.00 fixed test fee and the issuing of an administrative fee credit of $6.30 to an inspection station owner for each ASM test performed through June 30, 1999. The details of the modifications requested in the December 1998 submittal are discussed below.

The State updated the I/M Test Manual definition so that it refers to the most recent version of the Enhanced I/M Test Equipment, Procedures and Specifications—Phase II dated September 10, 1998.

The revision extended the $200 waiver expenditure requirement through December 31, 1999. This extension reflects a change in EPA's policy which will mandate the $450 wavier amount (plus an increase for inflation) to be implemented after January 1, 2000. EPA is approving the State's request to extend the deadline for the full implementation of the cost waiver including the CPI adjustment until January 1, 2000. This allows the State to complete one full cycle of testing with the $200 cost waiver and also allows the State to complete a full cycle of testing with the full $450 plus the annual CPI adjustment made retroactively to 1989 cost waiver before January 1, 2002, which is the performance standard modeling evaluation date. EPA believes, that consistent with its interpretation that the start dates and evaluation dates have been extended by approximately two years by the NHSDA, the full implementation of the waiver can also be extended by two years.

The revision extended the $25.00 fixed test fee and the issuing of an administrative fee credit of $6.30 to an inspection station owner for each ASM test performed through June 30, 1999.

The revision delayed implementation of the final emissions standards for the dynamometer tests through December 31, 1999. This allows one year of ASM testing at the phase in cut points. The delay in implementing the final ASM standards was caused by the delay in starting Phase 2, the ASM portion, of the Georgia I/M program due to ASM hardware and software delivery problems.

EPA is approving the aforementioned changes to the SIP. The Agency has reviewed this request for revisions of the Federally approved SIP for conformance with provisions of the CAA and EPA guidance and has determined that these requests conform to those requirements. Therefore, this action revises the State's enhanced I/M program as presented in the Analysis of State's Submittal section of this document.

The EPA is publishing this rule without prior proposal because the Agency views these as noncontroversial submittals and anticipates no adverse comments. However, in the proposed rules section of this Federal Register publication, EPA is publishing a separate document that will serve as the proposal to approve the SIP revisions should adverse comments be filed. This rule will be effective March 27, 2000 without further notice unless the Agency receives adverse comments by February 25, 2000.

If the EPA receives such comments, then EPA will publish a document withdrawing the final rule and informing the public that the rule will not take effect. All public comments received will then be addressed in a subsequent final rule based on the proposed rule. The EPA will not institute a second comment period. Parties interested in commenting should do so at this time. If no such comments are received, the public is advised that this rule will be effective on March 27, 2000 and no further action will be taken on the proposed rule.

The Office of Management and Budget has exempted this regulatory action from review under Executive Order (E.O.) 12866, entitled “Regulatory Planning and Review.”

Federalism (64 FR 43255, August 10, 1999) revokes and replaces E.O. 12612 (Federalism) and E.O. 12875 (Enhancing the Intergovernmental Partnership). E.O. 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the E.O. 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.” Under E.O. 13132, EPA may not issue a regulation that has federalism implications, that imposes substantial direct compliance costs, and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by State and local governments, or EPA consults with State and local officials early in the process of developing the proposed regulation. EPA also may not issue a regulation that has federalism implications and that preempts State law unless the Agency consults with State and local officials early in the process of developing the proposed regulation.

This final 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 E.O. 13132. Thus, the requirements of section 6 of the E.O. do not apply to this rule.

Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), applies to any rule that: (1) Is determined to be “economically significant” as defined under E.O. 12866, and (2) concerns an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, the Agency must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the Agency.

This rule is not subject to E.O. 13045 because it does not involve decisions intended to mitigate environmental health or safety risks.

Under E.O. 13084, EPA may not issue a regulation that is not required by statute, that significantly affects or uniquely affects the communities of Indian tribal governments, and that imposes substantial direct compliance costs on those communities, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by the tribal governments. If the mandate is unfunded, EPA must provide to the Office of Management and Budget, in a separately identified section of the preamble to the rule, a description of the extent of EPA's prior consultation with representatives of affected tribal governments, a summary of the nature of their concerns, and a statement supporting the need to issue the regulation.

In addition, E.O. 13084 requires EPA to develop an effective process permitting elected and other representatives of Indian tribal governments “to provide meaningful and timely input in the development of regulatory policies on matters that significantly or uniquely affect their communities.” Today's rule does not significantly or uniquely affect the communities of Indian tribal governments. Accordingly, the requirements of section 3(b) of E.O. 13084 do not apply to this rule.

The Regulatory Flexibility Act generally requires an agency to conduct a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small not-for-profit enterprises, and small government jurisdictions.

This final rule will not have a significant impact on a substantial number of small entities because SIP approvals under section 110 and subchapter I, part D of the CAA do not create any new requirements but simply approve requirements that the State is already imposing. Therefore, because the Federal SIP approval does not create any new requirements, I certify that this action will not have a significant economic impact on a substantial number of small entities.

Moreover, due to the nature of the Federal-State relationship under the CAA, preparation of a flexibility analysis would constitute Federal inquiry into the economic reasonableness of state action. The CAA forbids EPA to base its actions concerning SIPs on such grounds. Union Electric Co. v. U.S. EPA, 427 U.S. 246, 255-66 (1976); 42 U.S.C. 7410(a)(2).

Under Section 202 of the Unfunded Mandates Reform Act of 1995 (“Unfunded Mandates Act”), signed into law on March 22, 1995, EPA must prepare a budgetary impact statement to accompany any proposed or final rule that includes a Federal mandate that may result in estimated costs to State, local, or tribal governments in the aggregate; or to private sector, of $100 million or more. Under Section 205, EPA must select the most cost-effective and least burdensome alternative that achieves the objectives of the rule and is consistent with statutory requirements. Section 203 requires EPA to establish a plan for informing and advising any small governments that may be significantly or uniquely impacted by the rule.

EPA has determined that the approval action promulgated does not include a Federal mandate that may result in estimated costs of $100 million or more to either State, local, or tribal governments in the aggregate, or to the private sector. This Federal action approves pre-existing requirements under State or local law, and imposes no new requirements. Accordingly, no additional costs to State, local, or tribal governments, or to the private sector, result from this action.

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

Section 12 of the National Technology Transfer and Advancement Act (NTTAA) of 1995 requires Federal agencies to evaluate existing technical standards when developing a new regulation. To comply with NTTAA, EPA must consider and use “voluntary consensus standards” (VCS) if available and applicable when developing programs and policies unless doing so would be inconsistent with applicable law or otherwise impractical.

The EPA believes that VCS are inapplicable to this action. Today's action does not require the public to perform activities conducive to the use of VCS.

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 March 27, 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).)

The Commission has received six petitions for further reconsideration of its Report and Order on Reconsideration, MM Docket, 97-217, 64 FR 63727. The petitions were filed by: Wireless Cable Association International, et al .; the Catholic Television Network; BellSouth; the Archdiocese of Los Angeles; IPWireless, Inc.; and the National ITFS Association. In the Report and Order on Reconsideration , the Commission made changes to the rules adopted in previous order which enabled licensees in the Multipoint Distribution Service (“MDS”) and Instructional Television Fixed Service (“ITFS”) to engage in fixed two-way transmissions. The petitioners seek further changes. The full text of the petitions for further reconsideration are available for inspection and copying during normal business hours in the FCC Reference Room, Room CY-A257, Portals II, 445 12th Street, SW, Washington, DC, and also may be purchased from the Commission's copy contractor, International Transcription Services, Inc. (“ITS”), Portals II, 445 12th Street, SW Room CY-B402, Washington, DC 20554.

This is a summary of the Commission's Third Report and Order (Third R&O) in CC Docket No. 88- 57; FCC 99-405, adopted December 21, 1999, and released January 10, 2000. The complete text of this Third R&O is available for inspection and copying during the weekday hours of 9 a.m. to 4:30 p.m. in the FCC Reference Center, Room CY-A257, 445 12th Street, SW, Washington, DC 20554, or copies may be purchased from the Commission's copy contractor, International Transcription Services, Inc., 445 12th Street, SW., Suite CY-B400, Washington, D.C. 20554, phone (202) 314-3070.

1. In the Review of §§ 68.104 and 68.213 of the Commission's Rules Concerning Connection of Simple Inside Wiring to the Telephone Network and Petition for Modification of § 68.213 of the Commission's Rules filed by the Electronic Industries Association, Order on Reconsideration, Second Report and Order and Second Further Notice of Proposed Rulemaking, CC Docket No. 88-57, RM-5643, 12 FCC Rcd 11897, (1997), 62 FR 36476, the Commission included a Second Further Notice of Proposed Rulemaking requesting comment on proposed modifications to the demarcation point rule, BICSI's proposed enhanced wire quality standards, and the gold or gold equivalent standard.

2. In this Order, we adopt material standards for copper, twisted pair wire used in new, simple inside wiring installations. We introduce this standard into our regulations to identify a “standard industry practice.” This action will benefit consumers and small businesses using legacy voice telecommunications services as well as those seeking to access broadband services. We envision that consumers may enforce this rule by prosecuting claims against builders and contractors that have utilized inferior wiring in new construction. For example, an aggrieved consumer or building owner, beset by problems caused by poor quality inside wire, may make a civil claim against a builder or contractor for breach of implied warranty of merchantability or fitness for a particular purpose. We also anticipate that telecommunications wiring standards will be adopted by building industry organizations, and reflected in local building codes.

3. Poor-quality, non-twisted pair inside wiring can cause network harm in the form of “cross-talk,” resulting in a loss of privacy, interference with digital transmission, and disruption of telephone conversations. The presence of inferior wiring may not be immediately apparent to homeowners and homebuyers, since the potential for future problems may be difficult to detect. Once a problem is discovered, homeowners often must rewire the affected premises to rectify the problem, at a cost substantially higher than the cost of initially installing quality inside wiring.

4. A primary cause of this troublesome situation is that the simple inside wiring market does not function correctly because homebuyers are shut out of the inside wire selection process. Building contractors and developers generally select telecommunications wire long before the homebuyer has entered the picture, and that this situation allows builders to prioritize lower cost over quality when purchasing wire to be used for simple inside wiring. When homeowners become aware of the problem, such as when they attempt to install an additional line or experience audible cross-talk, it is often too late to seek reparations from the builder or contractor. Thus, since the “purchasing entity,” in this case the builder or contractor, is not held accountable for the problems caused by its least-cost-based decision, market forces will not protect the consumer's interest in quality inside wiring. Thus, we establish a wire quality standard to correct this market malfunction.

5. We find that it is in the public interest to adopt inside wiring quality standards in order to protect consumers and the PSTN from such harm. Thus, we amend § 68.213(c) of the Commission's rules to adopt enhanced wire quality standards for simple inside wiring. Specifically, we require that copper inside wiring installed July 24, 2000, shall be, at a minimum, solid, 24 gauge or thicker, twisted pairs, marked to indicate compliance with the electrical specifications for Category 3, as defined in the ANSI/EIA/TIA Building Wiring Standards. Inside wiring material exceeding the minimum requirements specified in § 68.213(c) as amended by this Order may be used and should be marked to indicate those characteristics. We note that the inside wiring requirements that we adopt in this Order apply only to copper conductor specifically installed for use as simple inside wiring for telecommunications service. We define the scope of this regulation specifically to avoid precluding the development and use of other transmission media that may be able to function in place of twisted pair copper inside wiring.

6. We emphasize that the inside wiring quality standards we adopt in this do not imply that inferior materials may be used instead of copper. Under § 68.108 of our rules, carriers are afforded certain self-help privileges enabling them to take necessary actions to protect the PSTN, such as temporarily disconnecting or refusing to connect inside wiring or CPE that is likely to cause harm to the PSTN.

7. We also establish that wire must be marked for compliance with the Commission's inside wiring quality standard at one-foot intervals, as described in § 68.213(c)(3) of our rules as amended by this Third Report and Order. The new standard will become effective July 24, 2000.

8. The growing market presence of communications equipment and technology, such as facsimiles, modems, and ISDN, that have low tolerance for transmission anomalies and interference, such as those caused by poor connectors, indicates that the public interest will be served by supporting industry initiatives that pursue improved telecommunications transmission quality. Furthermore, the current standard has been in place for more than a year and has not been the subject of any criticism. Consequently, we decline to further revise § 68.500 with respect to the gold or gold equivalent standard.

9. In the 1997 Rulemaking, the Commission proposed that schools, hospitals and other similar facilities be considered multiunit premises under the Commission's demarcation point rule. Nothing in the record evinces difficulties in this area or indicates that case-by-case resolution of this issue would be problematic. Thus, we decline to determine that schools, hospitals, and similar facilities should be classified as multiunit premises under the demarcation point rule.

10. In the 1997 Rulemaking , the Commission requested comment identifying a reasonable time for telephone companies to respond to requests for disclosure of information regarding the wiring layout of buildings, including information about inside wiring on the customer's side of the demarcation point. The record does not indicate uncertainty or problems in this area. Thus, we decline to identify a specific period as reasonable for the purposes of customer requests for inside wiring information.

11. It appears that record keeping would not increase or significantly decrease as a result of the Commission's affirmation and clarification of the demarcation point definition gold and gold equivalence standard, and modification of the inside wiring material requirements rules. No new skills are necessary to comply with this amendment by telephone companies, wire maintenance and installation companies, and wire manufacturers.

12. As required by the Regulatory Flexibility Act (RFA) the Commission has prepared this Final Regulatory Flexibility Analysis (FRFA) of the expected significant economic impact on small entities by the policies and rules proposed in the Order on Reconsideration, Second Report and Order, and Second Notice of Proposed Rulemaking. See 5 U.S.C. 603(a).

13. The Commission, in compliance with section 1 and Title II of the Communications Act of 1934, as amended in the Telecommunications Act of 1996, promulgates rules in this Third Report and Order by amending § 68.213 of its rules to establish minimum standards for simple inside wiring to be connected to the public switched telecommunications network. This rule change will benefit consumers and small businesses by ensuring that telecommunications wiring in new installations will be capable of accommodating clear telecommunications and digital transmissions. Consumers and small businesses will also benefit from the decreased necessity for the expensive replacement of poor quality simple inside wiring, as may be required to accommodate extra lines for additional telephones, personal computers, fax machines, and ISDN or xDSL services. Furthermore, this rule change will staunch the increasing incidence of cross-talk and the risk of network harm associated with the installation of poor quality inside wiring.

14. We have reviewed the general comments to identify issues that may have significant economic impact on small businesses, and find that no issues were raised in direct response to the IRFA. Furthermore, all commenters addressing the issue of amending Part 68 our rules to provide enhanced standards for inside wiring supported the proposed amendment.

15. The RFA directs the Commission to provide a description of and, where feasible, an estimate of the number of small entities that will be affected by the proposed rules. The RFA defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small business concern” under section 3 of the Small Business Act. A small business concern is one that (1) is independently owned and operated; (2) is not dominant in its field of operation, and (3) satisfies any additional criteria established by the SBA. SBA has defined a small business for Standard Industrial Classification (SIC) category 4813 (Telephone Communications, except Radiotelephone) to be a small entity when it has no more than 1,500 employees. We first discuss generally the total number of small telephone companies falling within both of these SIC categories. We then discuss the number of small businesses within the two subcategories, and attempt to refine further those estimates to correspond with the categories of telephone companies that are commonly used under our rules. Finally, we discuss the number of electrical contractors that may be affected by the proposed rules, and the extent to which they may be affected.

16. Consistent with our prior practice, we here exclude small incumbent local exchange carriers (LECs) from the definition of “small entity” and “small business concern.” While such a company may have 1,500 or fewer employees and thus fall within the SBA's definition of a small telecommunications entity, such companies are either dominant in their field or operation or are not independently owner and operated. Out of an abundance of caution, however, for regulatory flexibility analysis purposes, we will consider small incumbent LECs within this present analysis and use the term “small incumbent LECs” to refer to any incumbent LEC that arguably might be defined by the SBA as a small business concern.

17. Total Number of Telephone Companies Affected. Many of the decisions and rules adopted herein may have a significant effect on a substantial number of the small telephone companies identified by the SBA. The United States Bureau of the Census (“the Census Bureau”) reports that, at the end of 1992, there were 3,497 firms engaged in providing telephone services, as defined therein, for at least one year. This number contains a variety of different categories of carriers, including local exchange carriers, interexchange carriers, competitive access providers, cellular carriers, mobile service carriers, operator service providers, pay telephone operators, PCS providers, covered SMR providers and resellers. It seems certain that some of those 3.497 telephone service firms may not qualify as small entities or small incumbent LECs because they are not “independently owned and operated.” For example, a PCS provider that is affiliated with an interexchange carrier having more than 1,500 employees would not meet the definition of a small business. It seems reasonable to conclude, therefore, that fewer than 3,497 telephone service firms are small entity telephone service firms or small incumbent LECs that may be affected by this Third Report and Order .

18. Wireline Carriers and Service Providers. SBA has developed a definition of small entities for telephone communications companies other than radiotelephone (wireless) companies. The Census Bureau reports that there were 2,321 such telephone companies in operation for at least one year at the end of 1992. According to the SBA's definition, a small business telephone company other than a radiotelephony company is one employing fewer than 1,500 persons. All but 26 of the 2,321 non-radiotelephone companies listed by the Census Bureau were reported to have fewer than 1,000 employees. Thus, even if all 26 of those companies had more than 1,500 employees, there would still be 2,295 non-radiotelephone companies that might qualify as small entities or small incumbent LECs. Although it seems certain that some of these carriers are not independently owned and operated, we are unable at this time to estimate with greater precision the number of wireline carriers and service providers that would qualify as small businesses under the SBA's definition. Consequently, we estimate that there are fewer than 2,295 small entity telephone communications companies other than radiotelephone companies that may be affected by the decisions and rules adopted in this Third Report and Order .

19. Local Exchange Carriers. Neither the Commission nor SBA has developed a definition of small providers of local exchange services (LECs). The closest applicable definition under SBA rules is for telephone communications companies other than radiotelephone (wireless) companies. The most reliable source of information regarding the number of LECs nationwide of which we are aware appear to be the data that we collect annually in connection with the Telecommunications Relay Service (TRS). According to our most recent data, 1,347 companies reported that they were engaged in the provision of local exchange services. Although it seems certain that some of these carriers are not independently owned and operated, or have more than 1,500 employees, we are unable at this time to estimate with greater precision the number of LECs that would qualify as small business concerns under the SBA's definition. Consequently we estimate that there are fewer than 1,347 small incumbent LECs that may be affected by the decisions and rules adopted in this Third Report and Order.

20. Manufacturers of Telecommunications Equipment. The Commission has not developed a definition for small manufacturers of telecommunications terminal equipment. The closest applicable definition under SBA rules is for manufacturers of telephone and telegraph apparatus (SIC 3661) which defines a small manufacturer as one having 1,000 or fewer employees. According to 1992 Census Bureau data, there were 479 such manufacturers, and of those, 436 had 999 or fewer employees, and seven had between 1,000 and 1,499 employees. Consequently, we estimate that there are fewer than 443 small manufacturers of telecommunications terminal equipment that may be affected by the decision and rules proposed in this Third Report and Order .

21. Electrical Contractors . Electrical Contractors in this category (SIC 1731) are primarily engaged in electrical work at the construction site. This category includes establishments engaged in the installation of telecommunication equipment, sound equipment, burglar alarms, fire alarms, and telephones. According to the 1997 Economic Census there are 61,414 electrical contractors. Of that number, 61,405 electrical contractors have fewer than 1000 employees, and 61,375 have fewer than 500 employees. Consequently, we estimate that up to 61,405 small electrical contractors may be affected by the decision and rules proposed in this Third Report and Order.

22. Telecommunications Wiring Manufacturers. Manufacturers in this category (SIC 3357B) are primarily engaged in manufacturing telephone and telegraph wire and cable. This category includes establishments engaged in the manufacture of inside wiring cable. According to the 1997 Economic Census there are 28 telephone and telegraph wire and cable manufacturers, of which 18 are involved in the manufacture of inside wiring cable. The Small Business Administration has determined that manufacturing establishments in this category with fewer than 750 employees qualify as small manufacturers. Consequently, we estimate that no more than 18 inside wiring cable manufacturers may be affected by the decision and rules proposed in this Third Report and Order .

23. Reporting. None.

24. Recordkeeping. It appears that recordkeeping would not increase or significantly decrease as a result of our affirmation and clarification of our demarcation point definition gold and gold equivalence standard, and modification of our inside wiring material requirements rules. We anticipate that no new skills are necessary to comply with this amendment by telephone companies, wire maintenance and installation companies, and wire manufacturers.

25. Other Compliance Requirements. None.

26. We have considered the effect of enhanced wiring requirements on the building industry in general, and specifically with regard to the following entities: General Contractor, Single Family Houses (SIC 1521); General Contractor, Residential Buildings, Other than Single Family (SIC 1522); General Contractors, Nonresidential Buildings (SIC 1542), and Building Construction Trade Contractors, Electrical (SIC 1731), and find that these rule modifications will not cause significant negate impact. To the extant that enhanced wire quality standards for simple inside wiring may adversely affect small building contractor, it appears to be an insignificant cost in comparison to the value and public interest in the elimination of cross-talk interference to the service of third party customers that is directly attributable to the use of low-quality telephone inside wiring.

27. None.

28. The Commission will include a copy of this Final Regulatory Flexibility Analysis, along with this Third Report and Order, in a report to Congress pursuant to the Small Business Regulatory Enforcement Fairness Act of 1996, 5 U.S.C. 801(a)(1)(A). A copy of this FRFA (or summary thereof) will also be published in the Federal Register .

29. Accordingly pursuant to the authority contained in Sections 1, 4(I) and (j), 11, 201-205, 218, 220, 256, and 405 of the Communications Act as amended, 47 U.S.C. sections 151, 154(I), 151(j), 161, 201-205 and 218, 220, 256, and 405, and 5 U.S.C. 552 and 553, this Third Report and Order and Order on Reconsideration is adopted , and part 68 of the Commission's Rules is amended as set forth. Sections 1, 4, 405, and 710 of the Communications Act of 1934, as amended, 47 U.S.C. 151, 154, 405 and 610, part 68 of the Commission's rules is amended as set forth.

30. That the rule amendments set forth shall be effective July 24, 2000.

For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR Part 68 as follows:

The woundfin ( Plagopterus argentissimus ) and Virgin River chub ( Gila seminuda ) are currently listed as endangered pursuant to the Endangered Species Act (Act) of 1973, as amended (16 U.S.C. 1531 et seq. ). In the subsequent text, we refer to the woundfin and Virgin River chub as “listed fishes.” The Virgin River originates in south-central Utah, running in a southwest direction to northwestern Arizona, and southeastern Nevada for approximately 320 km (200 mi) before emptying into Lake Mead. Prior to the completion of Boulder (Hoover) Dam in 1935, the Muddy River in southeastern Nevada joined the Virgin River before the latter emptied into the Colorado River. These two rivers now flow separately into the Overton Arm of Lake Mead. The Virgin River chub and woundfin have declined in numbers due to the cumulative effects of dewatering from numerous diversion projects; proliferation of nonnative fishes; and alterations to natural flow, temperature, and sediment regimes.

Based on early records, the original range of the woundfin extended from near the junction of the Salt and Verde Rivers at Tempe, Arizona, to the mouth of the Gila River at Yuma, Arizona (Gilbert and Scofield 1898; Minckley 1973). Woundfin were also found in the mainstem Colorado River from Yuma (Jordan and Evermann 1896; Meek 1904; Follett 1961) upstream to the Virgin River in Nevada, Arizona, and Utah and into La Verkin Creek, a tributary of the Virgin River in Utah (Gilbert and Scofield 1898; Snyder 1915; Miller and Hubbs 1960; Cross 1975). However, because no barriers or habitat considerations exist that would have precluded woundfin from existing further upstream in these rivers, we believe that the woundfin likely occurred further upstream in the Verde, Salt, and Gila Rivers in Arizona.

Except for the mainstem of the Virgin River, woundfin are extirpated from most of their historical range. Woundfin presently range from Pah Tempe Springs (also called La Verkin Springs) on the mainstem of the Virgin River and the lower portion of La Verkin Creek in Utah, downstream to Lake Mead. A single specimen was taken from the middle Muddy (Moapa) River, Clark County, Nevada, in the late 1960s. However, no additional specimens have been collected from that drainage since that time (Deacon and Bradley 1972).

Adult and juvenile woundfin inhabit runs and quiet waters adjacent to riffles with sand and sand/gravel substrates. Adults are generally found in habitats with water depths between 0.15 and 0.43 meters (m) (0.5 and 1.4 feet (ft)) with velocities between 0.24 and 0.49 meters per second (m/s) (0.8 and 1.6 feet per second (ft/s)). Juveniles select areas with slower and deeper water, while larvae are found in backwaters and stream margins which are often associated with growths of filamentous algae. Spawning takes place during the period of declining spring flows.

The Virgin River chub was first described as a full species ( Gila seminuda ) in 1875 (Cope and Yarrow 1875). Later, Ellis (1914) considered this chub to be an intermediate between the roundtail chub ( G. robusta ) and bonytail chub ( G. elegans ), and reduced it to a subspecies ( G. robusta seminuda ) of the roundtail chub. The fish was believed to be restricted to the Virgin River between Hurricane, Utah, and its confluence with the Colorado River.

In a recent taxonomic study of the genus Gila using morphological and genetic characters, DeMarais et al. (1992) concluded that the prior treatment of the Virgin River chub as a subspecies of roundtail chub was inappropriate and arbitrary. The authors asserted that full species status ( Gila seminuda ) was warranted for the Virgin River chub, which likely arose through introgressive hybridization involving G. robusta and G. elegans (DeMarais et al, 1992). Moreover, DeMarais et al. (1992) concluded that the chub found in the Muddy (=Moapa) River, a Virgin River tributary, was also G. seminuda, although the Muddy River population was “distinctive.” Prior to this conclusion, this geographically isolated population of Virgin River chub was considered a separate, unnamed subspecies of roundtail chub ( G. robusta spp. ), and was referred to as the Moapa roundtail chub (Minckley 1973, Smith et al. 1977). We, along with the American Fisheries Society and American Society of Ichthyologists and Herpetologists Fish Names Committee (Mr. Joseph S. Nelson, American Fisheries Society, in litt. 1993) have accepted the taxonomic revisions of Gila.

In past candidate notices of review, we considered the Muddy River population of Virgin River chub to be a category 2 candidate species (December 30, 1982, 47 FR 58455; January 6, 1989, 54 FR 556; November 21, 1991, 56 FR 58804). At that time, category 2 candidate species were those species for which we had information indicating that listing may be appropriate, but did not have enough information on file to support issuance of a proposed rule to list. In our February 28, 1996, candidate notice of review (61 FR 7596), we discontinued the designation of category 2 candidates. The final rule listing the Virgin River chub as an endangered species (August 24, 1989; 54 FR 35305) specifically excluded the Muddy River population, because at the time it was classified as an undescribed subspecies. The Muddy River is not included in this final rule designating critical habitat for the Virgin River chub because at the time that the proposed critical habitat designation and economic analysis were prepared, we did not consider the Muddy River population to be listed. Therefore, in order to respond in a timely manner and make a final determination with regard to critical habitat for the Virgin River chub, this final rule encompasses only the mainstem Virgin River. A separate listing determination, which will include analyses on the status of the species and whether listing the fish in the Muddy River is warranted, will be prepared for this population and made available for public review and comment. The prudency and determinability of critical habitat for the Muddy River population will be addressed at that time.

The Virgin River chub was first collected in the 1870s from the Virgin River near Washington, Utah. Historically, it was collected in the mainstem Virgin River from Pah Tempe Springs, Utah, downstream to the confluence with the Colorado River in Nevada (Cope and Yarrow 1875; Cross 1975), though it may have occurred upstream of that point. Presently, the Virgin River chub occurs within the mainstem Virgin River from Pah Tempe Springs, Utah, downstream to at least the Mesquite Diversion, located near the Arizona-Nevada border.

Adult and juvenile Virgin River chub select deep runs or pools with slow to moderate velocities containing boulders or other instream cover over a sand substrate. Generally, larger fish occupy deeper habitats; however, there is no apparent correlation with velocity. Chub are generally found in velocities ranging up to 0.76 m/s (2.5 ft/s).

Preservation of the river channel alone is not sufficient to ensure the survival and recovery of the woundfin and Virgin River chub. The Virgin River floodplain is integral to preserving the integrity of the primary constituent elements (defined below) and maintaining the natural dynamics of the Virgin River. Components of a healthy river system needed for these fish include the mainstem channel, where water is maintained most or all of the year, and upland habitats that are inundated during spring flows. Studies of the major floodplain rivers of the world have documented the value of flooded bottomlands and uplands for fish production (Welcomme 1979). For example, loss of floodplain habitats in the Missouri River Basin has reduced fish biomass production as much as 98 percent (Karr and Schlosser 1978). These seasonally flooded habitats contribute to the biological productivity of the river system by producing allochthonous (humus, silt, organic detritus, colloidal matter, and plants and animals produced outside the river and brought into the river) organic matter which provides nutrients and terrestrial food sources to aquatic organisms (Hesse and Sheets 1993). The Virgin River contains little aquatic vegetation and contains a minimum amount of autochthonous (produced within the river) organic matter. Thus, the fauna of the Virgin River is heavily dependent on allochthonous energy inputs from the floodplain that provides or supports much of the food base. This rich, terrestrial food source may enhance fish growth, fecundity, and/or survival.

Use of these inundated floodplain areas increases the energy available for spawning and is necessary for reproductive success in some species (Finger and Stewart 1987). In many cyprinid fishes, including these listed fishes, spawning is associated with seasonal rains and flooding of rivers. Flood-related changes in the river environment induce spawning for many species, while the loss of these seasonal changes due to water withdrawals and channel constrictions may be a contributing factor limiting recruitment for these fish (Hontele and Stacey 1990).

Protection of floodplain areas also provides the spatial and temporal scope for natural physical processes, including flooding, to occur (National Research Council 1992). These processes over time shape and reshape the river, constantly redefining the physical habitat and complexity of the river. Large flow events allow the river to meander, thereby creating and recreating the mosaic of habitats necessary for the survival and recovery of the listed fishes. As long as this physical reshaping occurs, the habitat complexity and biological productivity associated with river-floodplain systems necessary for the survival and recovery of the listed fishes will be maintained.

Inundation of floodplain habitats during spring flows also provides areas with warmer water temperatures, lower water velocity habitat used for resting, and cover from predation. Recent studies in the Colorado River system show that the life histories and welfare of native riverine fishes are linked to the maintenance of a natural or historical flow regime ( i.e., hydrological pattern of high spring and low autumn and winter flows that vary in magnitude and duration depending on annual precipitation patterns and runoff from snowmelt) (Tyus and Karp 1989, 1990). Minckley and Meffe (1987) suggest that loss of flooding will result in extirpation of many of the native fish species in the Colorado River system.

We listed the woundfin as endangered on October 13, 1970 (35 FR 16047), and proposed critical habitat on November 2, 1977 (42 FR 57329). However, on March 6, 1979, we withdrew the proposal for critical habitat (44 FR 12382) due to the 1978 amendments to the Act, which required proposals to be withdrawn if not finalized within 2 years. A Woundfin Recovery Plan was originally approved in July 1979 and subsequently revised on March 1, 1984.

On August 23, 1978, we proposed listing the Virgin River chub as endangered and designating critical habitat (43 FR 37668). We also withdrew this proposal (45 FR 64853; September 30, 1980), due to the 1978 amendments to the Act. On June 24, 1986, we again proposed the listing as endangered and the designation of critical habitat for the Virgin River chub (51 FR 22949). The final rule to list the Virgin River chub as endangered was published on August 24, 1989 (54 FR 35305). We postponed the designation of critical habitat to allow time to undertake an analysis of the economic and other impacts of the designation as required by section 4(b)(2) of the Act. When the Virgin River chub was listed, the Muddy River form was specifically excluded because it was believed to be a separate, unnamed subspecies of roundtail chub (Moapa roundtail chub= Gila robusta ssp.).

On March 18, 1994, the U.S. District Court, Colorado (Court) ordered us to designate critical habitat for the Virgin River chub, woundfin, and Virgin spinedace ( Lepidomeda mollispinis mollispinis ) (if it became listed under the Act before December 31, 1994). The Court ordered that critical habitat be proposed no later than April 1, 1995, and be finalized by December 1, 1995. We proposed the Virgin spinedace for listing as a threatened species on May 18, 1994 (59 FR 25875), but did not include critical habitat in that proposed rule because we believed that all three fish species would receive greater conservation benefit if critical habitat for all three was designated simultaneously. We published a proposed rule designating critical habitat for the three fishes on April 5, 1995 (60 FR 17296). On April 11, 1995, we entered into the Virgin Spinedace Conservation Agreement and Strategy with other Federal, State, and private local entities to eliminate or reduce impacts threatening the continued existence of the Virgin spinedace. A Virgin River Fishes Recovery Plan, including the woundfin, Virgin River chub, and Virgin spinedace, was finalized on April 19, 1995. Because of the conservation efforts being implemented on behalf of the Virgin spinedace, we withdrew the proposed listing and critical habitat designation of the Virgin spinedace on February 6, 1996 (61 FR 4401). Therefore, the Virgin spinedace is no longer included in this critical habitat designation.

Prior to publication of a final rule designating critical habitat for the woundfin and Virgin River chub, Congress enacted a moratorium on final listing actions and we postponed further actions to finalize critical habitat. Disruptions in the listing budget beginning in Fiscal Year 1995 and the moratorium on certain listing actions, including critical habitat designations, during parts of Fiscal Years 1995 and 1996 remained in effect until April 26, 1996, when President Clinton approved the Omnibus Budget Reconciliation Act of 1996 and exercised the authority that the Act gave him to waive the moratorium. By that time, we had accrued a serious backlog of listing actions. To deal with this backlog, we developed and published Interim (61 FR 9651) and Final (61 FR 24722) Listing Priority Guidelines for Fiscal Year 1996. The guidelines described a multi-tiered approach to working through the listing backlog and identified critical habitat designations as our lowest listing priority. On December 5, 1996, we published our Final Listing Priority Guidance for Fiscal Year 1997 (61 FR 64475), which maintained this prioritization.

On May 8, 1998, we published our Final Listing Priority Guidance for Fiscal Years 1998 and 1999 (63 FR 25502). The designation of critical habitat remained our lowest priority. However, in December 1998, the 10th Circuit Court ruled that we could no longer use this justification for not designating critical habitat and ordered us to designate critical habitat for the Rio Grande silvery minnow ( Hybognathus amarus ). Shortly after that decision, the plaintiffs in the Virgin River fishes case filed a motion requesting that we be ordered to finalize critical habitat designation for the woundfin and Virgin River chub. On August 27, 1999, the U.S. District Court of Colorado ordered us to finalize critical habitat designation for the woundfin and Virgin River chub by January 20, 2000.

Section 4(a)(3) of the Act and implementing regulations (50 CFR 424.12) require that, to the maximum extent prudent and determinable, the Secretary of the Interior (Secretary) designate critical habitat at the time the species is determined to be endangered or threatened. As explained above, critical habitat was delayed for a variety of reasons. With this final rule, however, critical habitat is now designated for the woundfin and Virgin River chub in the Virgin River.

Critical habitat is defined in section 3(5)(A) of the Act as: (i) 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 (I) essential to the conservation of the species and (II) which may require special management considerations or protection and; (ii) specific areas outside the geographical area occupied by a species at the time it is listed, upon a determination that such areas are essential for the conservation of the species.” The term “conservation,” as defined in section 3(3) of the Act, means “to use and the use of all methods and procedures which are necessary to bring any endangered species or threatened species to the point at which the measures provided pursuant to this Act are no longer necessary” ( i.e., the species is recovered and removed from the list of endangered and threatened species).

We are required to base critical habitat decisions upon the best scientific and commercial information available (50 CFR 424.12) after taking into account economic and other impacts of such designation. In designating critical habitat for the woundfin and Virgin River chub, we have reviewed the overall approaches to the conservation of the woundfin and Virgin River chub undertaken or proposed by local, State, and Federal agencies operating within the Virgin River basin and the identified steps necessary for the species recovery outlined in the Virgin River Fishes Recovery Plan. We also have reviewed available information that pertains to the geographic range of the species in the Virgin River and the habitat requirements of each species. That information includes that received during the public comment periods associated with this rulemaking (described 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. Regulations implementing this interagency cooperation provision 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 a listed species or to destroy or adversely modify its critical habitat. If a Federal action may affect a listed species or its critical habitat, the responsible Federal agency must enter into formal consultation with us.

The designation of critical habitat is one of several measures available to assist in the conservation and recovery of a species. Critical habitat may help focus conservation activities by identifying areas that contain essential habitat features (primary constituent elements) regardless of whether the areas are currently occupied by the listed species. Such designation may alert Federal agencies, States, the public, and other organizations to the areas' importance. Critical habitat also identifies areas that may require special management considerations or protection.

The designation of critical habitat directly affects only Federal agencies, by prohibiting actions they fund, authorize, or carry out from destroying or adversely modifying critical habitat. Individuals, firms, and other non-Federal entities are not affected by the designation of critical habitat so long as their actions do not require support by permit, license, funding, or other means from a Federal agency.

An understanding of the interplay of the jeopardy and adverse modification standards is necessary to evaluate the likely outcomes of both consultation under section 7 and the environmental, economic and other impacts of any critical habitat designation. Implementing regulations (50 CFR part 402) define “jeopardize the continued existence of” (a species) and “destruction or adverse modification of” (critical habitat) in virtually identical terms. “Jeopardize the continued existence of” means to engage in an action “that reasonably would be expected * * * to reduce appreciably the likelihood of both the survival and recovery of a listed species.” “Destruction or adverse modification” means a direct or indirect alteration that “appreciably diminishes the value of critical habitat for both the survival and recovery of a listed species.”

Common to both definitions is an appreciable detrimental effect on both survival and recovery of a listed species. Thus, for most species, actions likely to result in destruction or adverse modification of critical habitat are nearly always found to jeopardize the species concerned. Only in a few instances might an action be found to adversely modify critical habitat without also being found to jeopardize the continued existence of the species. This situation might occur in unoccupied habitat or occupied habitat that may become unoccupied in the future. In most cases, the existence of a critical habitat designation does not materially affect the outcome of consultation. This reality is often in contrast to the public perception (and the assumption used in the previous economic analysis as described in this final rule) that the adverse modification standard sets a lower threshold than the jeopardy standard in all instances. The similar nature of the jeopardy and adverse modification standards and the application of the standards is true for the listed Virgin River fishes as well. The area of the river system being designated as critical habitat in this final rule is occupied by the listed fishes.

Section 4(b)(8) of the Act requires us to describe in any proposed or final regulation that designates critical habitat, those activities involving a Federal action that may adversely modify such habitat or those activities that may be affected by such designation. Activities that may destroy or adversely modify critical habitat include those that alter the primary constituent elements (defined below) to an extent that the value of designated critical habitat for both the survival and recovery of a listed species is reduced appreciably.

Federal activities in the Virgin River basin that may adversely modify critical habitat include actions that reduce the volume and timing of water flows, destroy or eliminate access to spawning and nursery habitat, prevent recruitment, appreciably impact food sources, contaminate the river, or significantly increase predation and competition by nonnative fishes (Table 1). Examples of such activities may include construction and operation of hydroelectric facilities, additional irrigation diversions, flood control structures, bank stabilization structures, oil and gas drilling, golf courses, and resort facilities, as well as mining, grazing, additional pumping to meet municipal water demands, and stocking or introduction of nonnative fishes.

These types of activities have already been examined during formal and informal consultations with us since the listing of the species as endangered. No additional restrictions to these activities as a result of critical habitat designation are anticipated. For example, existing Federal activities in the area include the Pah Tempe Pipeline, Halfway Wash Project, Lake Powell Pipeline, water wheeling, water leasing, Washington Fields Pumpback, and dewatering of springs for municipal and industrial purposes.

Areas outside of critical habitat, containing one or more of the primary constituent elements, may still be important for the conservation of a species. Some areas do not contain all of the constituent elements and may have those missing elements restored in the future. Such areas may be important for the long-term recovery of the species even if they are not designated critical habitat because they may serve to maintain ecosystem integrity, thereby indirectly contributing to recovery.

In summary, designation of critical habitat focuses on the primary constituent elements within the defined areas and their contribution to the species' recovery, and includes consideration of the species' biological needs and factors that will contribute to their recovery ( i.e., distribution, numbers, reproduction, and viability). In evaluating Federal actions, we will consider the actions' impacts on the primary constituent elements of water, physical habitat, and biological environment (discussed below). The ability of an area to provide these constituent elements into the future and to contribute to the recovery of the species will also be considered. The potential level of allowable impacts or habitat reduction in critical habitat will be determined on a case-by-case basis during section 7 consultation.

In identifying areas as critical habitat, 50 CFR 424.12 provides that we consider those physical and biological features that are essential to a species' conservation and that may require special management considerations or protection. Such physical and biological features, as outlined in 50 CFR 424.12, include, but are not limited to, the following:

(1) Space for individual and population growth, and for normal behavior;

(2) Food, water, air, light, minerals, or other nutritional or physiological requirements;

(3) Cover or shelter;

(4) Sites for breeding, reproduction, rearing of offspring, germination, or seed dispersal; and

(5) Habitats that are protected from disturbance or are representative of the historical geographical and ecological distributions of a species.

In determining critical habitat for the woundfin and Virgin River chub, we focused on the primary physical and biological elements essential to the conservation of each species. Prior to designating an area as critical habitat, we assessed the area for all applicable constituent elements.

The primary constituent elements of critical habitat determined necessary for the survival and recovery of these Virgin River fishes are water, physical habitat, and biological environment. The desired conditions for each of these elements are further discussed below.

Water—A sufficient quantity and quality of water (i.e., temperature, dissolved oxygen, contaminants, nutrients, turbidity, etc.) that is delivered to a specific location in accordance with a hydrologic regime that is identified for the particular life stage for each species. This includes the following:

(1) Water quality characterized by natural seasonally variable temperature, turbidity, and conductivity;

(2) Hydrologic regime characterized by the duration, magnitude, and frequency of flow events capable of forming and maintaining channel and instream habitat necessary for particular life stages at certain times of the year; and

(3) Flood events inundating the floodplain necessary to provide the organic matter that provides or supports the nutrient and food sources for the listed fishes.

Physical Habitat—Areas of the Virgin River that are inhabited or potentially habitable by a particular life stage for each species, for use in spawning, nursing, feeding, and rearing, or corridors between such areas:

(1) River channels, side channels, secondary channels, backwaters, and springs, and other areas which provide access to these habitats;

(2) Areas inhabited by adult and juvenile woundfin include runs and pools adjacent to riffles that have sand and sand/gravel substrates;

(3) Areas inhabited by juvenile woundfin are generally deeper and slower. When turbidity is low, adults also tend to occupy deeper and slower habitats;

(4) Areas inhabited by woundfin larvae include shoreline margins and backwater habitats associated with growths of filamentous algae.

(1) River channels, side channels, secondary channels, backwaters, and springs, and other areas which provide access to these habitats; and

(2) Areas with slow to moderate velocities, within deep runs or pools, with predominately sand substrates, particularly habitats which contain boulders or other instream cover.

Biological Environment—Food supply, predation, and competition are important elements of the biological environment and are considered components of this constituent element. Food supply is a function of nutrient supply, productivity, and availability to each life stage of the species. Predation and competition, although considered normal components of this environment, are out of balance due to nonnative fish species in many areas. Fourteen introduced species, including red shiner ( Cyprinella lutrensis ), black bullhead ( Ameiurus melas ), channel catfish ( Ictalurus punctatus ), and largemouth bass ( Micropterus salmoides ), compete with or prey upon the listed fishes. Of these, the red shiner is the most numerous and has been the most problematic for the listed fishes. Red shiners compete for food and available habitats and are known to prey on the eggs and early life stages of the listed fishes. Components of this constituent element include the following:

(1) Seasonally flooded areas that contribute to the biological productivity of the river system by producing allochthonous (humus, silt, organic detritus, colloidal matter, and plants and animals produced outside the river and brought into the river) organic matter which provides and supports much of the food base of the listed fishes; and

(2) Few or no predatory or competitive nonnative species in occupied Virgin River fishes' habitats or potential reestablishment sites.

Woundfin—The area designated as critical habitat for the woundfin is the mainstem Virgin River and its 100-year floodplain (as defined below), extending from the confluence of La Verkin Creek, Utah, to Halfway Wash, Nevada, and includes 59.6 km (37.3 mi) of the mainstem Virgin River in Utah, 50.6 km (31.6 mi) in Arizona, and 29.9 km (18.6 mi) in Nevada (Table 2). This designation totals 140.1 km (87.5 mi) of the mainstem Virgin River, which represents approximately 12.5 percent of the woundfin's historical habitat. Due to the lack of historical data on the distribution of the woundfin in Arizona, this percentage is only an estimate. The area of the Virgin River designated as critical habitat consists of the remaining occupied habitat for the woundfin, and this portion of the Virgin River flows through both public and private lands (Table 3).

Virgin River Chub—The area designated as critical habitat for the Virgin River chub is the mainstem Virgin River and its 100-year floodplain (as defined below), extending from the confluence of La Verkin Creek to Halfway Wash and is identical to the designation for the woundfin (Table 2). The designation for this species represents approximately 65.8 percent of the Virgin River chub's historical habitat within the Virgin River Basin. The area of the Virgin River designated as critical habitat consists of the remaining occupied habitat for the Virgin River chub, which flows through both public and private lands (Table 3).

The designation of critical habitat for both listed fishes includes the mainstem Virgin River currently occupied by the species. The 100-year floodplain of the Virgin River is included in the designation of critical habitat for both species, but we are designating only those portions of the 100-year floodplain that contain at least one of the primary constituent elements for critical habitat. We chose the 100-year floodplain for several reasons. First, the implementing regulations of the Act require that critical habitat be defined by reference points and lines as found on standard topographic maps of the area. The 100-year floodplain, as defined by the Federal Emergency Management Agency (FEMA), while not included on standard topographic maps, is an area of land that would be inundated by a flood having a one percent chance of occurring in any given year. It is the Federal standard for protection of life and property and is delineated and readily available on FEMA floodplain maps. This boundary, rather than some other delineation, was primarily chosen for two reasons: (1) The biological integrity and natural dynamics of the river system are maintained within this area ( i.e., allowing the river to meander within its main channel in response to large flow events, thereby recreating the mosaic of habitats necessary for the survival and recovery of Virgin River endangered fishes); and (2) conservation of the 100-year floodplain also helps protect the riparian areas and provide essential nutrient recharge to the Virgin River, which contributes to successful spawning and recruitment of endangered fishes.

Some developed lands within the 100-year floodplain boundary are not considered critical habitat because they do not contain the primary constituent elements. These include, but are not limited to, existing paved roads, bridges, parking lots, dikes, levees, diversion structures, railroad tracks, railroad trestles, water diversion canals outside of natural stream channels, active gravel pits, cultivated agricultural land, and residential, commercial, and industrial developments. These developed areas do not contain the primary constituent elements and do not furnish habitat or biological features for the listed fishes, and generally will not contribute to the species' recovery. However, some activities in these areas (if federally funded, authorized, or carried out) may affect the constituent elements of the designated critical habitat and, therefore, may be affected by critical habitat designation, as discussed later in this final rule.

During the public comment period for the proposed rule (60 FR 17296), we received information provided by the Nevada Division of Wildlife and Bio/West, Inc. indicating that very few woundfin or Virgin River chub have ever been collected below Halfway Wash, Nevada. The backwater effect of the high water line of Lake Mead has resulted in a large amount of sand deposition below Halfway Wash. This deposition has changed the morphology of the river from a single channel to a highly braided river reach consisting of multiple rivulets, thereby reducing the gradient of the river and resulting in an extremely shallow multiple channeled habitat, not suitable for either woundfin or Virgin River chub. Based on this information, we changed the critical habitat boundary in Nevada from the highwater level of Lake Mead to Halfway Wash. This change reduced the critical habitat in Nevada by 11.6 km (7.3 mi) from what was described in the proposed rule. Additionally, critical habitat as proposed for the Virgin spinedace (60 FR 17296) was formally withdrawn on February 6, 1996 (61 FR 4401). This action further reduced the designation by 179 km (112.0 mi).

One assumption that we used in the economic analysis was that the threshold for an action to result in an adverse modification determination was less than the threshold for an action to jeopardize the continued existence of a species. The economic impacts summarized in the proposed rule were based on this assumption. Since the development of the economic analysis and subsequent proposed rule designating critical habitat in the Virgin River basin, we have determined that, in most cases, actions that are likely to result in the destruction or adverse modification of critical habitat are nearly always found to jeopardize the continued existence of the species concerned. This determination is based, in part, on numerous consultations concerning listed fish and critical habitat designated in the 100-year floodplain in the upper Colorado River basin. These consultations have demonstrated little or no difference in the results of application of the jeopardy and adverse modification standard. We further discuss the effect of this determination in the “Consideration of Economic and Other Impacts” section of this final rule.

As originally proposed, the critical habitat designation included five separate river reaches (Maddux et al. 1995). We structured the proposal this way to coincide with the economic analysis and to facilitate exclusion of areas if the economic impacts of designation of critical habitat outweighed the benefits, provided that exclusion would not result in the extinction of either species. For the final designation, we have simplified the boundaries by combining all five reaches into a single section of river.

Section 4(b)(2) of the Act requires us to consider the economic and other relevant impacts in determining whether to exclude any proposed area(s) from the final designation of critical habitat. We may exclude an area from critical habitat designation if the benefits of its exclusion outweigh the benefits of its inclusion in critical habitat, unless failure to designate the area would result in extinction of the species concerned. In 1995, we conducted an analysis on the potential economic impacts of the proposed critical habitat designation (Brookshire et al. 1995).

When we directed the economic analysis in 1995, we assessed the biological requirements for the recovery of the listed fishes and the regional economic activities as the basis of the analysis. The biological requirements needed to ensure recovery of the listed fishes include adjustments in water diversions in the Virgin River basin and/or mitigation of nonflow-related activities within the 100-year floodplain. We also took into consideration the effects of potential recovery efforts on future water depletions in the basin. The study region for the economic analysis included Washington and Iron Counties in Utah, Clark County in Nevada, and the portion of Mohave County in Arizona located north of the Colorado River.

We believed that Washington County, Utah, and Clark County, Nevada, would be directly affected by any actions taken by the Service on behalf of the listed fishes. These counties are presently among the fastest growing in the United States. From 1980 to 1990, Washington County's population grew by 52 percent, while Clark County's grew by 62.5 percent. Iron County, Utah, (north of Washington County) is a rapidly growing area that is economically closely linked to Washington County. Although the Virgin River does not flow through Iron County, any economic impacts on Washington County would be felt in Iron County as well. The Virgin River also flows through a portion of Mohave County in Arizona. This area has a very small population and a modest economic base.

In the 1995 economic analysis, we analyzed the economic impacts of insuring that the biological requirements of the listed fishes were met in the Virgin River Basin. Our analysis included impacts that were attributable to the listing itself, through the requirement that Federal agencies consult with us to ensure that their actions do not jeopardize the continued existence of the species. Habitat requirements of the listed fishes have been addressed by the jeopardy standard in each consultation we have done since the fishes were listed. Although we separately analyzed the incremental effects of the critical habitat designation above and beyond the effects of listing, that separation was based on the incorrect assumption that the threshold for an action to result in an adverse modification determination is less than the threshold for determining that the action will likely jeopardize the continued existence of a species. We now recognize that our analysis should have been restricted to the specific impacts of designating critical habitat, if any, that would occur above and beyond the economic impacts of the listing, an interpretation upheld by recent case law ( New Mexico Cattle Growers Association et al. v. United States Fish and Wildlife Service, et al., CIV No. 98-0275 BB/DJS-ACE).

In the economic analysis, we also made an assumption that as a species moves from near extinction to recovery, the likelihood that any given project will cause adverse modification remains relatively constant, while the likelihood of jeopardy decreases. While this assumption will hold true in some circumstances, it has turned out to be a more complicated situation than initially presumed. Specifically, factors that alter the likelihood of jeopardy will only alter the likelihood of adverse modification to the extent that they affect critical habitat. However, because the adverse modification determination has its foundation in the likelihood of survival and recovery, as does the jeopardy determination, factors that increase the likelihood of adverse modification should logically increase the likelihood of jeopardy as well. In other words, adverse modification determinations will generally coincide with jeopardy determinations.

After years of conducting consultations under section 7 of the Act on actions affecting both a listed species and its critical habitat, we have learned that the two thresholds are nearly identical. In fact, biological opinions which conclude that a Federal agency action is likely to adversely modify critical habitat but not to jeopardize the species for which it is designated are extremely rare historically. Although the Service has participated in thousands of formal consultations (an estimated 900 in Fiscal Year 1999 alone), no such biological opinions have been issued in recent years. The similar application of the two standards is true in the specific case of the listed Virgin River fishes as well. In this final rule we review the results of the economic analysis in light of the correct assumption (that the thresholds for adverse modification and jeopardy are usually identical.)

Because the entire economic analysis was based on our incorrect assumption that the threshold for an action to result in an adverse modification determination is less than the threshold for an action to jeopardize the continued existence of a species, we conclude that even the small potential impacts attributable to critical habitat designation as discussed in the economic analysis, and summarized in the proposed rule, were overstated and are primarily attributable to the listing of the woundfin and Virgin River chub.

We have concluded that no incremental economic impacts are associated with the critical habitat designation above and beyond the effects of listing the species. Therefore, we do not believe that any benefit results from excluding any area from designation, nor that any benefit of exclusion outweighs the benefit of critical habitat designation. Consequently, we have simplified the critical habitat boundaries originally described in the proposed rule by combining the areas described as five reaches into a single section of river.

On April 5, 1995, we published the proposed rule and notice of public hearing in the Federal Register (60 FR 17296). We solicited public comment on the proposed critical habitat designation and its associated draft economic analysis. The public comment period was open from April 5, 1995, to June 5, 1995, and was further extended by request to June 20, 1995 (60 FR 31444). During the comment period, we conducted a public hearing in St. George, Utah, on May 8, 1995. Additional notification of the public hearing and comment period was provided by letter to appropriate State agencies, county governments, Federal agencies, and other interested parties. Notice of the proposed rule, comment period, and the public hearing was also published in the Kingman Daily Miner, Desert Valley Times, Daily Spectrum, Deseret News, Salt Lake Tribune, Las Vegas Review Journal, and Las Vegas Sun. During the comment period, we received 14 written comment letters and 6 people testified at the public hearing. Copies of all comments were made available to the public at the Washington County Library, Utah.

Prior to the court order to finalize critical habitat designation, on August 9, 1999, we published in the Federal Register (64 FR 43206) a notice of availability of a draft environmental assessment on the proposed action of designating critical habitat. The public comment period was open from August 9, 1999, to September 8, 1999. Additional notification of the availability of the draft environmental assessment and comment period was provided by letter to appropriate State agencies, county governments, Federal agencies, and other interested parties. During the comment period, we received 12 written comment letters. After a review of all comments received in response to the draft environmental assessment, on November 24, 1999, we published a notice of availability of the final environmental assessment and finding of no significant impact for designation of critical habitat for the listed fishes (64 FR 66192) .

Some of the information provided during the comment periods is reflected in this final rule. A summary of the other issues raised in the written and oral comments regarding the proposed rule, economic analysis, and draft environmental assessment is provided below.

Issue 1: The critical habitat designation is based on the assumption that fish populations have declined in occupied reaches. The critical habitat designation is not warranted because numbers of individuals of these species may not have declined, although number of miles occupied has decreased.

Service Response: We disagree. At the time of listing, we determined that both the woundfin and Virgin River chub warranted protection under the Act due to a number of factors. These factors included both a decline in the occupied range of the species as well as a decline in the abundance of the species. In addition, current data, both published and unpublished, indicate that the decline in the woundfin population is continuing. Deacon (1988) showed that a substantial decline in woundfin occurred in the Virgin River above Quail Creek Reservoir and below Pah Tempe Springs between 1976 and 1993. He attributed this decline, in part, to a decrease in water quality because flows above Pah Tempe Springs were diverted at the Quail Creek Diversion. Prior to 1985, these flows had previously diluted the high saline input from Pah Tempe Springs. Holden and Zucker (1996) analyzed data from 1976-1993 that showed a very clear long-term decline of woundfin at long-term sampling stations in Utah, Arizona, and Nevada. When they plotted the data as number of woundfin caught per seining effort per year, they found a statistically significant negative trend over time (p < 0.05) at all stations except one during the fall season, indicating an overall decline in the woundfin population. Monitoring data from the Utah Division of Wildlife Resources (unpublished data, Recovery Team Meeting Minutes, April 29, 1999) show a substantial decline from 1994 (total number=456 (spring), 604 (fall)) to 1999 (total number=77 (spring), 162 (fall)).

Anecdotal, historical information suggests that Virgin River chub were very abundant before the 1900s and that the abundance and range of Virgin River chub has declined substantially throughout its range in Utah, Arizona, and Nevada since white settlement and water development. Reasons for this decline are thought to be mainly habitat destruction. Habitat is degraded through dewatering of the river system such that some areas are inundated by reservoirs and other areas are completely dewatered. Also, competition from nonnative species which may prey on young life-stages of Virgin River chub may contribute to population declines (Holden 1977).

Virgin River chub have the lowest densities of any native fish in the Virgin River (Radant and Coffeen, 1986; Hardy and Addley 1994). However, observed numbers may or may not reflect actual abundance. Because Virgin River chub occupy deep holes and habitats that are often logistically difficult to sample, catch rates can be erratic and sampling can be difficult to standardize. Based on the long-term data available, Virgin River chub show a general decline in Utah, Arizona, and Nevada, particularly since the mid-1980s. Yet in some areas (below Hurricane Bridge and below Washington Diversion) numbers are stable or within the range of variability noted in the late 1970s and early 1980s (Hardy and Addley 1994). Hardy and Addley are careful to note that declines may be due to droughts and other natural climatic changes. Natural droughts are no doubt exacerbated by water development and the human need for water during these years. More recent data are being analyzed to determine the current status of Virgin River chub and to determine if declining trends continued through the late 1990s.

Issue 2: The lower portion of La Verkin Creek should be included as critical habitat for the woundfin.

Service Response: Although woundfin are occasionally collected in this reach, we are aware of no data that indicate that this area is being used for reproduction or as a nursery or that it is essential for the conservation of the species. Therefore, it is not included in this final critical habitat designation.

Issue 3: Why did we not include the Muddy River in Nevada as critical habitat for the Virgin River chub?

Service Response: Please see our discussion of the Muddy River population in the Background section of this final rule. Because the Muddy River population was not listed, critical habitat designation is not appropriate. However, we intend to conduct a separate listing determination for the Muddy River population, which will include an analysis of the status of the species and a determination about the prudency and determinability of a critical habitat designation.

Issue 4: The area from Quail Creek Diversion to Pah Tempe Springs should be included in the critical habitat designation for the woundfin.

Service Response: While it is possible that this area was historical habitat for the Virgin River chub, woundfin have never been found in this reach. It is a high-gradient reach of the river that has gone dry annually for the past 80 years. When critical habitat was proposed, this reach of the river was left out because it was dry dammed. Since critical habitat was proposed, 3 cfs of flows have been restored to this reach of the river. However, since that time only one Virgin River chub has been collected in this reach of the Virgin River. We do not believe that this reach provides those physical or biological features essential to the conservation of either species.

Issue 5: Additional streams in Arizona should be designated as critical habitat.

Service Response: On July 24, 1985, we proposed the reintroduction of the woundfin into the Gila River drainage in Arizona and determined this population to be “nonessential experimental” in accordance with section 10(j) of the Act (50 FR 30188). The Act prohibits inclusion of nonessential experimental population areas in critical habitat designations.

Issue 6: The Virgin River in Utah was segmented into numerous reaches for designation; no segmenting was done in Nevada or Arizona.

Service Response: Please see our discussion under the “Summary of Changes to the Proposed Rule” section of this final rule.

Issue 7: How is the 100-year floodplain defined, and which parts of the floodplain are critical habitat?

Service Response: Please see the discussion under the “Critical Habitat Designation” section of this proposed rule.

Issue 8: A 10-year floodplain designation should be sufficient because the riparian community is maintained at this flow level.

Service Response: Critical habitat, among other things, is intended to identify areas that may require special management protection or consideration. Our intention in designating a portion of the floodplain as critical habitat is to encompass not only the area which provides a major source of food and nutrients to the river, but also the area within which the river meanders. Only areas that contain at least one of the primary constituent elements are considered critical habitat. Critical habitat that would encompass a 10-year floodplain would not contain these attributes. Moreover the selection of the 100-year floodplain is consistent with and supports the goals of Virgin River Management Plan (1999) and the Proposed Virgin River Resource Management and Recovery Program, both of which contain provisions for the protection and enhancement of the 100-year floodplain.

Issue 9: Critical habitat designation is not prudent because of preparation of the Virgin River Management Plan.

Service Response: As discussed in the implementing regulations at 50 CFR 424.12, critical habitat is considered not prudent when one or more of the following situation exists:

(1) The species is threatened by taking or other human activity, and identification of critical habitat can be expected to increase the degree of such threat to the species, or

(2) Such designation of critical habitat would not be beneficial to the species.

In the absence of any information that indicates that critical habitat will increase the degree of threat to a species threatened by taking or other human activity, any small benefit of designation requires that the designation be found prudent. Although we supported development of the Virgin River Management Plan (1999), this plan does not increase the degree of threat to the species nor negate any benefits that may be provided to the species from critical habitat designation. Therefore, such designation must be found prudent. The extent to which this plan will protect the Virgin River is still unknown. Additionally, this plan only covers the Utah portion of the habitat. We anticipate that the Virgin River Management Plan and critical habitat designation will complement each other.

Issue 10: The Service should do NEPA on critical habitat designation.

Service Response: Please see our discussion under the “Required Determinations” section of this final rule.

Issue 11: The designation does not give full consideration to existing and future water rights.

Service Response: Critical habitat designation for the Virgin River listed fishes does not modify nor nullify any existing State water law, compact agreement, or treaty. Impacts to water development opportunities within the States are mainly attributable to the effects of listing these species. It is our intent to fully consider State water law, interstate compact agreements, and treaties in protecting and recovering the listed fishes. As an example, we worked with the State of Utah and the WCWCD to develop a Virgin River Management Plan. This plan is intended to address both the needs for future water development and recovery of the listed fishes consistent with State water laws and other agreements.

Because the entire economic analysis was based on our incorrect assumption that the threshold for an action to result in an adverse modification determination is less than the threshold for an action to jeopardize the continued existence of a species, in this final rule we have concluded that even the small, potential impacts attributable to critical habitat designation as discussed in the economic analysis, and summarized in the proposed rule, were overstated and are primarily attributable to the listing of the woundfin and Virgin River chub. Although many of the points raised by various commentors on the economic analysis are no longer relevant given our conclusions about the economic impacts of critical habitat, we offer the following responses to the issues raised about the analysis.

Issue 12: The economic analysis incorrectly assumes that converting agriculture to secondary/culinary water will reduce current flows to the river.

Service Response: The economic analysis assumed that converting agricultural water to Municipal and Industrial (M&I) water might result in decreased river flows. The Utah State Water Plan for the Virgin River Basin reports water depletion figures for agricultural use to be 45 percent and for M&I use to be 63 percent. Therefore, converting agricultural use to M&I would result in a net decrease in water returns of 19 percent. Although return flows may be greater than those used in the economic analysis, the points at which these flows are returned to the river remain unknown.

Issue 13: The economic analysis did not assess impacts to Mohave County, Arizona.

Service Response: The majority of Mohave County's economic activity falls outside of the Virgin River study area, however, a small part of Mohave County, was included, mainly around the town of Litchfield, Arizona. There is little economic activity in this part of Mohave County, and it includes 0.39 percent of the total population of the study area. Consequently, the economic activity occurring in Mohave County was shared out of the total activity for the Virgin River area based on population. This activity was then incorporated into the Clark County analysis.

Issue 14: The Washington County Water Conservancy District's (WCWCD) water plans should have been incorporated into the economic analysis, and sensitivity analyses regarding the hydrologic assumptions should have been conducted.

Service Response: The WCWCD's water plans, as represented by the report “Population Projections and Future Water Demands”, prepared by Boyle Engineering (1994) for WCWCD, were, in fact, used in creating the baseline scenario. The hydrologic assumptions were structured such that the resulting economic analysis always yielded a worst-case set of economic impacts. Thus, sensitivity analysis would only lower the impacts presented in the report.

Issue 15: The Service's choice of the modeling methodology and the choice of discount rates used in the economic analysis were presented without explanation of why other models or discount rates were rejected.

Service Response: The Act requires the calculation of the economic impacts of critical habitat designation. The use of the contingent valuation method for inclusion in cost-benefit analysis is not germane. Our use of input-output analysis yielded both the direct and indirect impacts associated with recovery needs of the listed fishes. Regarding the discount rate, the discounting procedures and assumptions used represent the “industry standard.” The extant economic literature clearly calls for a positive discount rate for economic analyses addressing water allocation issues.

Issue 16: Private landowner effects, water right reallocations, loss of open space, and community character should have been addressed by the economic analysis.

Service Response: There are no additive impacts to private property owners from critical habitat designation that were not present when the species were listed. If Federal funding or Federal permits are required for a private action, the Federal action agency must then consult with the Service. All transactions associated with the reallocation of water are voluntary market transactions and are not impacts of this action. The extent to which the community chooses to allow the loss of open space and changes in community character is beyond the scope of the economic analysis. It should be noted, however, that the designation of critical habitat along another river-floodplain system, the 100-year floodplain of the Colorado River, has not precluded the setting aside of open space or development of parks and trails within the floodplain or adjacent to the river.

Issue 17: It was improper to attribute benefits of water conservation to critical habitat designation in the economic analysis.

Service Response: Water conservation will be realized, with or without the listed fishes or a critical habitat designation, by water management and conservation measures currently being implemented or planned in the future within the study area, in particular, Washington County. The economic analysis did not attribute the benefits of water conservation to listed fishes recovery and conservation. Rather, the water conservation scenario serves to demonstrate that the economic impacts of the listed fishes including designation of critical habitat can be mitigated with moderate conservation efforts.

Issue 18: The economic analysis did not document the gross overuse and waste of water in Washington County.

Service Response: The report “Population Projections and Future Water Demands”, prepared by Boyle Engineering (1994) for WCWCD addressed these matters. Further analysis in these regards is beyond the scope of the economic analysis.

Issue 19: Not enough weight is given in the economic analysis to the consequences of the conversions of agricultural lands in Washington County due to critical habitat.

Service Response: The agricultural lands conversions that are projected to occur during the economic analysis study period are generated by the population growth that is projected for the region, not by the needs of the listed fishes or the designation of critical habitat. These agricultural lands are, in fact, incorporated in the baseline projection of the economy without taking the fish needs into consideration. The fish needs may accelerate the retirement of agricultural water rights in order to maintain water in the Virgin River for the listed fishes and still allow for water development to occur to meet the needs of a growing human population. This incremental retirement of water and conversion of land is attributable mainly to the listing of these fishes and was incorporated into the economic analysis.

Issue 20: The time period for the economic analysis is too short and omits the long term impacts of the designation of critical habitat.

Service Response: The study period for the economic analysis (1995-2040) was selected for the reasons described previously in this rule. By the end of this period, the population of Washington County is projected to be 380,600 people. Development projections undertaken by Boyle Engineering (1994) place the maximum population of Washington County at approximately 350,000 at population density levels consistent with the present lifestyles of the area. Thus, the population will have reached a steady state by the end of the study period used in the economic analysis and further impacts are not anticipated.

The comment further assumes that water maintained to meet the flow needs of the fish in critical habitat is lost to the national economy. While the Washington County area cannot develop this water, Las Vegas, Nevada, could use it after it reaches Halfway Wash. From a national perspective, the water may well have a higher value in Las Vegas than in Washington County, Utah, because of the larger, more diverse economy in Clark County, Nevada.

Issue 21: The retirement of agricultural lands is not correctly addressed in the economic analysis. If land retirements are market driven, then the low productivity lands will be converted first and the high productivity lands last.

Service Response: This point is correct. The economic analysis uses the average (county-level) productivity to value all agricultural lands. This approach overstates the economic impacts due to the listed fishes and critical habitat designation because the discounted present value of agricultural retirements is higher when the average land value is used. This is consistent with the approach calculating the worst-case economic impacts.

Issue 22: The economic analysis does not measure the national efficiency effects of critical habitat designation.

Service Response: In accordance with the Act and the regulations that implement it, the final designation of critical habitat is made on the basis of the best available scientific data, after taking into consideration the probable economic and other impacts of the designation upon proposed or ongoing activities. The national efficiency effects are computed and reported in the economic analysis prepared by Brookshire et al. 1995 (see Chapter 8) and summarized in the proposed rule. The economic analysis discusses the conditions under which the factor payments computed from the input-output analysis may be used to value the national efficiency changes.

In accordance with Executive Order 12866, this action was submitted for review by the Office of Management and Budget. This final rule identifies the areas being designated as critical habitat for the woundfin and Virgin River chub. The designation will not have an annual economic effect of $100 million. Our summary of the economic impacts of designation is discussed earlier in this final rule. This rule will not create inconsistencies with other agencies' actions. This rule will not materially affect entitlements, grants, user fees, loan programs, or the rights and obligations of their recipients. Proposed and final rules designating critical habitat for listed species are issued under the authority of the Act. Critical habitat regulations are issued under procedural rules contained in 50 CFR part 424. Based on previous formal and informal consultations with other Federal agencies under section 7 of the Endangered Species Act, the Service has determined that there are no economic impacts of critical habitat designation above and beyond the impacts of the original listing of the species. Cases identified in the economic analysis as a potential economic impact of critical habitat designation are actions that would also result in a finding of “jeopardize the continued existence of the species” during section 7 consultation. Thus, any economic impact associated with the Virgin River chub and woundfin is one incurred by the original listing of the species, not by this critical habitat designation.

This rule will not have a significant economic effect on a substantial number of small entities as defined under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). As explained previously in this final rule, the designation will not have economic effects above and beyond those attributed to the listing of the species. This is because the prohibition against destroying or adversely modifying critical habitat is essentially duplicative of the prohibition against jeopardizing the continued existence of the species, and therefore, there are no additional economic effects that are not already incurred by the listing of the species.

This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule does not have an annual effect on the economy of $100 million or more. As explained in this rule, we do not believe that the designation will have economic effects above and beyond those attributed to the listing of the species. This rule will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions, because the designation will not have significant economic effects above and beyond the listing of the species. This rule does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises.

Based on our analysis of the economic impacts of this rule as discussed above, and in accordance with the Unfunded Mandates Reform Act (2 U.S.C. 1501 et seq. ), this rule will not significantly affect small governments because it will not place additional burdens on small (State, local, or Tribal) governments. This rule will not produce a Federal mandate of $100 million or greater in any year (i.e., it is not a significant regulatory action under the Unfunded Mandates Reform Act.)

In accordance with Executive Order 12630, the rule does not have significant takings implications. A takings implication assessment is not required. Although the critical habitat designation includes 55.9 kilometers of privately owned shoreline of the mainstem Virgin River, this final rule will not “take” private property rights and will not alter the value of private property. Critical habitat designation is only applicable to Federal lands, or to private lands if a Federal nexus exists (i.e., if a Federal agency authorizes or funds an action on private land). Private actions without a federal nexus on private land are not subject to any critical habitat prohibitions. Any private actions on private land that have a Federal nexus are already subject to consultation under section 7 of the Endangered Species Act. Because we have identified no economic effects of critical habitat designation above and beyond those that have accrued from the listing of these species, there are no takings implications.

In accordance with Executive Order 13132, this final rule will not affect the structure or role of States, and will not have direct, substantial, or significant effects on States. As previously stated, critical habitat is applicable only to Federal lands or to non-Federal lands to the extent that activities require Federal funding or permitting. Also, we have determined that additional economic impacts would not result from this critical habitat designation.

In keeping with Department of the Interior policy, we requested information from and coordinated development of the critical habitat proposal with the appropriate State resource agencies in Utah, Arizona, and Nevada. On August 9, 1999, we published in the Federal Register (64 FR 43206) a notice of availability of a draft environmental assessment on the proposed action of designating critical habitat. The public comment period was open from August 9, 1999, to September 8, 1999. Additional notification of the availability of the draft environmental assessment and comment period was provided by letter to appropriate State agencies, county governments, Federal agencies, and other interested parties. During the comment period, we received 12 written comment letters, which were considered in finalizing this rule.

It is our intent to fully consider State water law, interstate compact agreements, and treaties in protecting and recovering the listed fishes. As an example, we worked with the State of Utah and the WCWCD to develop a Virgin River Management Plan (1999). This plan is intended to address both the needs for future water development and recovery of the listed fishes consistent with State water laws and other agreements. The selection of the 100-year floodplain as the boundary for this critical habitat designation is consistent with and supports the goals of the Virgin River Management Plan and the Proposed Virgin River Resource Management and Recovery Program, both of which involve the State of Utah.

In accordance with Executive Order 12988, the Office of the Solicitor has determined that the rule does not unduly burden the judicial system and does meet the requirements of sections 3(a) and 3(b)(2) of the Order. The final designation of critical habitat for the woundfin and Virgin River chub has been reviewed extensively. Every effort has been made to ensure that the rule contains no drafting errors, provides clear standards, simplifies procedures, reduces burden, and is clearly written such that litigation risk is minimized.

This rule does not contain any information collection requirements for which Office of Management and Budget approval under the Paperwork Reduction Act is required.

It is our position that, outside the Tenth Circuit, we do not need to prepare environmental analyses as defined by the NEPA in connection with designating critical habitat under the Endangered Species Act of 1973, as amended. We published a notice outlining our reasons for this determination in the Federal Register on October 25, 1983 (48 FR 49244). This assertion was upheld in the courts of the Ninth Circuit ( Douglas County v. Babbitt, 48 F.3d 1495 (9th Cir. Ore. 1995), cert. denied 116 S. Ct. 698 (1996)). However, when the range of the species includes States within the Tenth Circuit, pursuant to the Tenth Circuit ruling in Catron County Board of Commissioners v. U.S. Fish and Wildlife Service, 75 F.3d 1429 (10th Cir. 1996), we undertake a NEPA analysis for critical habitat designation. We have completed that analysis through an Environmental Assessment and Finding of No Significant Impact.

In accordance with the President's memorandum of April 29, 1994, “Government-to-Government Relations with Native American Tribal Governments” (59 FR 22951) and procedures outlined by the Department of the Interior (512 DM 2), we recognize our responsibility to work with federally recognized Tribes on a Government-to-Government basis. Moreover, the 1997 Secretarial Order on Native Americans and the Act clearly states that Tribal lands should not be designated unless absolutely necessary for the conservation of the species. According to the Secretarial Order, “Critical habitat shall not be designated in such areas [an area that may impact Tribal trust resources] unless it is determined essential to conserve a listed species.” We are unaware of any Tribal lands containing habitat essential to the conservation of the listed fishes.

A complete list of all references cited is available upon request from the Field Supervisor, Salt Lake City Field Office (see ADDRESSES section).

The primary authors of this rule are Henry R. Maddux and Janet Mizzi, previously of our Salt Lake City Field Office, Patty Stevens of our Denver Regional Office, and Keith Rose of our Salt Lake City Field Office (see ADDRESSES section).

Delphinium bakeri (Baker's larkspur) and D. luteum (yellow larkspur) were found historically in coastal prairie, coastal scrub, or chaparral habitats. Urban development, agricultural land conversion, and livestock grazing have destroyed much of the habitat and extirpated numerous populations of these two plants in coastal Marin and Sonoma Counties in northern California. The historical range of Delphinium bakeri and D. luteum did not extend beyond coastal Marin and Sonoma Counties.

Ewan (1942) described Delphinium bakeri based on type material collected by Milo Baker in 1939 from Coleman Valley, Sonoma County, California. In the most recent treatment, Warnock (1993) retained the taxon as a full species. Historically, D. bakeri was known from Coleman Valley in Sonoma County and from a site near Tomales in Marin County. Delphinium bakeri occurs on decomposed shale within the coastal scrub plant community from 120 to 150 meters (m) (400 to 500 feet (ft)) in elevation (California Natural Diversity Database (CNDDB) 1997).

Delphinium bakeri is a perennial herb in the buttercup family (Ranunculaceae) that grows from a thickened, tuber-like, fleshy cluster of roots. The stems are hollow, erect, and grow to 65 centimeters (cm) (26 inches (in)) tall. The shallowly five-parted leaves occur primarily along the upper third of the stem and are green at the time the plant flowers. The flowers are irregularly shaped. The five sepals (outer most whorl or set of floral parts) are conspicuous, bright dark blue or purplish, with the rear sepal elongated into a spur. The inconspicuous petals occur in two pairs. The lower pair is oblong and blue-purple; the upper pair is oblique and white. Seeds are produced in several dry, many-seeded fruits, which split open at maturity on only one side ( i.e. , several follicles). Delphinium bakeri flowers from April through May (Warnock 1993).

Habitat conversion, grazing, and/or roadside maintenance activities have extirpated occurrences of Delphinium bakeri in Marin and Sonoma Counties (California Department of Fish and Game (CDFG) 1994). The CDFG (1994) also reported the species is declining. The only known remaining population, with a total of about 35 plants, is found on a steep road bank on private and county land in Marin County that is threatened by road work, overcollection, and sheep grazing. Because of its extreme range restriction and small population size, the plant is also vulnerable to extinction from random natural events, such as fire or insect outbreaks (CNDDB 1997).

Heller (1903) described Delphinium luteum based on type material collected from “grassy slopes about rocks, near Bodega Bay, along the road leading to the village of Bodega” in Sonoma County. Although Jepson (1970) reduced D. luteum to a variety of D. nudicaule , it is currently recognized as a full species (Warnock 1993). Delphinium luteum occurs on rocky areas within coastal scrub plant community, including areas with active rock slides, from sea level to 100 m (300 ft) in elevation (Guerrant 1976).

Delphinium luteum is a perennial herb in the buttercup family (Ranunculaceae) that grows from fibrous roots to 56 cm (22 in) tall. The leaves are mostly basal, fleshy, and green at the time of flowering. The flowers are cornucopia-shaped. The five conspicuous sepals are bright yellow, with the posterior sepal elongated into a spur. The inconspicuous petals occur in two pairs. The upper petals are narrow and unlobed; the lower petals are oblong to ovate. The fruit is a follicle. Delphinium luteum flowers from March to May.

Never widely distributed, historical populations of Delphinium luteum have been partially or entirely extirpated by rock quarrying activities, overcollecting, residential development, and sheep grazing, resulting in the species now being even more narrowly distributed (Guerrant 1976; CNDDB 1998; Betty Guggolz, Milo Baker Chapter, California Native Plant Society (CNPS), pers. comm. 1995). The CDFG (1994) reported the species is declining. The two remaining populations near Bodega, both on private land, total fewer than 50 plants. Development, overcollection, and sheep grazing threaten the remaining two populations. Because of its extreme range restriction and small population size, the plant is also vulnerable to extinction from random natural events, such as fire or insect outbreaks (CNDDB 1998; B. Guggolz, pers. comm. 1995).

Federal Government actions on the two species began as a result of section 12 of the Act (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, designated as House Document No. 94-51, was presented to Congress on January 9, 1975, and included Delphinium bakeri and D. luteum as endangered. We published a notice on July 1, 1975 (40 FR 27823) of our acceptance of the report of the Smithsonian Institution 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 plant taxa named in the report. The above two taxa were included in the July 1, 1975, notice. On June 16, 1976, we published a proposal (41 FR 24523) to determine approximately 1,700 vascular plant species to be endangered species pursuant to section 4 of the Act. The list of 1,700 plant taxa was assembled on the basis of comments and data received by the Smithsonian Institution and us in response to House Document No. 94-51 and the July 1, 1975, Federal Register publication. D. bakeri and D. luteum were included in this Federal Register document.

General comments received in relation to the 1976 proposal were summarized in an April 26, 1978, notice (43 FR 17909). The Act Amendments of 1978 required that all proposals over two years old be withdrawn. A one-year grace period was given to those proposals already more than two years old. In the December 10, 1979, notice (44 FR 70796), we published a notice of withdrawal of the June 6, 1976, proposal, along with four other proposals that had expired.

We published a Notice of Review for plants on December 15, 1980 (45 FR 82480). This notice included Delphinium bakeri and D. luteum as category 1 candidates for Federal listing. Category 1 taxa were those for which we had on file substantial information on biological vulnerability and threats to support preparation of listing proposals. On November 28, 1983, we published a supplement to the Notice of Review (48 FR 53640). This supplement changed D. bakeri and D. luteum from category 1 to category 2 candidates. Category 2 taxa were those for which data in our possession indicated listing was possibly appropriate, but for which substantial data on biological vulnerability and threats were not currently known or on file to support proposed rules.

The plant notice was revised on September 27, 1985 (50 FR 39526). Delphinium bakeri and D. luteum were again included as category 2 candidates. Another revision of the plant notice was published on February 21, 1990 (55 FR 6184). In this revision D. bakeri and D. luteum were included as category 1 candidates. We made no changes to the status of the two species in the plant notice published on September 30, 1993 (58 FR 51144). On February 28, 1996, we published a Notice of Review in the Federal Register (61 FR 7596) that discontinued the use of candidate categories and considered the former category 1 candidates as simply “candidates” for listing purposes. Both species were included as candidates in the February 28, 1996, Notice of Review.

Section 4(b)(3)(B) of the Act requires the Secretary to make certain findings on pending petitions within 12 months of their receipt. Section 2(b)(1) of the 1982 amendments further requires that all petitions pending on October 13, 1982, be treated as having been newly submitted on that date. This provision applied to Delphinium bakeri and D. luteum, because the 1975 Smithsonian report had been accepted as a petition. On October 13, 1982, we found that the petitioned listing of these species was warranted but precluded by other pending listing actions, in accordance with section 4(b)(3)(B)(iii) of the Act; notification of this finding was published on January 20, 1984 (49 FR 2485). Such a finding requires the petition to be recycled, pursuant to section 4(b)(3)(C)(i) of the Act. The finding was reviewed annually in October of 1983 through 1994, and we published a proposed rule on June 19, 1997 (62 FR 33383).

The processing of this final rule conforms with our Listing Priority Guidance published in the Federal Register on October 22, 1999 (64 FR 57114). The guidance clarifies the order in which we will process rulemakings. Highest priority is processing emergency listing rules for any species determined to face a significant and imminent risk to its well-being (Priority 1). Second priority (Priority 2) is processing final determinations on proposed additions to the lists of endangered and threatened wildlife and plants. Third priority is processing new proposals to add species to the lists. The processing of administrative petition findings (petitions filed under section 4 of the Act) is the fourth priority. The processing of critical habitat determinations (prudency and determinability decisions) and proposed or final designations of critical habitat will no longer be subject to prioritization under the Listing Priority Guidance. This final rule is a Priority 2 action and is being completed in accordance with the current Listing Priority Guidance.

We have updated this rule to reflect any changes in distribution, status, and threats since publishing the proposed rule and to incorporate information obtained through the public comment period. This additional information did not alter our decision to list these species.

In the June 19, 1997, proposed rule (62 FR 33383) and associated notifications, we requested all interested parties to submit factual reports or information that might contribute to development of a final rule. A 60-day comment period closed on August 18, 1997. We contacted appropriate Federal and State agencies, county and city governments, scientific organizations, and other interested parties and requested comments. We sent copies of the proposed rule and the request for comments letter to seven local libraries for public display. We published newspaper notices in the Press Democrat and Marin Independent Journal on June 25, 1997; Sonoma County Independent on June 26, 1997; and Petaluma Argus Courier on June 27, 1997, which invited general public comment.

During the public comment period, we received written comments from five individuals or agencies. Three commenters expressed support for the listing proposal, and two commenters opposed the proposal. Supporting comments were received from the CNPS and two individuals from Washington State University. The two commenters from Washington State University sent a letter informing us of their research on the genetic variation in Delphinium luteum . Opposing comments were received by the Washington Legal Foundation and the Marin Farm Bureau. Opposing comments and other comments questioning the proposed rule were organized into specific issues. These issues and our response to each are summarized below.

Issue 1: One commenter stated that the Service should not list Delphinium bakeri and D. luteum because it has no authority to list or regulate species under the Act that are not involved in interstate commerce. This commenter further believed that Federal listing for D. bakeri and D. luteum is unnecessary since it would not confer greater protection than California State law already provides for these indigenous plants.

Our Response: The Federal Government has the authority under the Commerce Clause of the U.S. Constitution to protect these species, 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). That case involved a challenge to application of the Act's prohibitions to protect the listed Delhi Sands flower-loving fly ( Rhapimodas terminatus abdominalis ). As with Delphinum bakeri and D. luteum , the Delhi Sands flower-loving fly is endemic to only one State. Judge Wald held that application of the Act's prohibition against taking of endangered species to this fly 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 it prevented loss of biodiversity and destructive interstate competition. Judge Henderson upheld protection of the fly because doing so prevents harm to the ecosystem upon which interstate commerce depends and because doing so regulates commercial development that is part of interstate commerce.

Issue 2: One commenter urged us not to list Delphinium bakeri and D. luteum , stating that “the listing of the two larkspurs violates the Principles of Federalism,” and that “California has ample resources to regulate and protect these two larkspur species,” and (therefore) “should be able to make its own decisions regarding these plants found within its own border.” The commenter further stated that this listing has significant impacts on the rights of private property owners to make reasonable use of their property.

Our Response: As we stated in the proposed rule (62 FR 33383), existing State and local regulations are inadequate to protect these species. The Act does not prevent the State of California from protecting and regulating the two larkspur species. Federal and State regulations complement each other. As discussed further in Factor D of the “Summary of Factors Affecting the Species” section of this final rule, the California Environmental Quality Act (CEQA) and California Endangered Species Act (CESA) apply to actions on private and State lands. For plants, the Federal Endangered Species Act primarily covers Federal land and Federal actions that may affect proposed and listed species.

The listing of plants under the Federal Endangered Species Act does not necessarily restrict any uses of private land unless Federal funding, authorization, or a permit is involved. For example, such private land uses as proper livestock grazing, clearing a defensible space for fire protection around one's personal residence, landscaping (including irrigation), or fence maintenance are not affected by Federal listing of plants. If an activity is conducted, authorized, or funded by a Federal agency, the Federal action agency must consult with us when the activity may affect listed species.

Issue 3: One commenter was concerned that once an endangered species is listed, the designation of critical habitat under the Act would result in a taking of land. This commenter further stated that the “take” provision as applied to the two larkspurs will have a dramatic and disruptive impact on local land use and planning.

Our Response: As discussed in the “Critical Habitat” section of this final rule, a critical habitat determination is not being made at this time for these plants. The “take” prohibition, as defined in section 9 of the Act, generally does not apply to plants (except when such take is prohibited by state law or occurs in the course of a violation of state criminal trespass law).

Issue 4: One commenter said that we should consider the adverse economic effect that the listing would have on the local agriculture industry.

Our Response: Under section 4(b)(1)(A) of the Act, a listing determination must be based solely on the best scientific and commercial data available. The legislative history of this provision clearly states the intent of Congress to “ensure” that listing decisions are “based solely on biological criteria and to prevent non-biological considerations from affecting such decisions,” H.R. Rep. No. 97-835, 97th Cong., 2nd Sess. 19 (1982). As further stated in the legislative history, “applying economic criteria * * * to any phase of the species listing process is applying economics to the determinations made under section 4 of the Act and is specifically rejected by the inclusion of the word ‘solely’ in the legislation,” H.R. Rep. No. 97-835, 97th Cong. 2nd Sess. 19 (1982). Because we are precluded from considering economic impacts in a final decision to list a species, we cannot examine such impacts.

Issue 5: One commenter stated that the plants are in existence because of agriculture and not the opposite.

Our Response: As discussed under Factor A of the “Summary of Factors Affecting the Species” section of this final rule, historical habitat of Delphinium bakeri was eliminated by agricultural conversion. The discussion under Factor C explains that both species are limited in their range, have few individuals, and are extremely vulnerable to trampling.

In accordance with interagency peer review policy published 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 status, and supportive biological and ecological information for the taxon under consideration for listing. The purpose of such review is to ensure that listing decisions are based on scientifically sound data, assumptions, and analyses, including input of appropriate experts and specialists. The three requested reviewers concurred with the accuracy of the rule and supported listing these taxa. Information provided was incorporated and is presented in the final rule.

Section 4 of the Act and regulations (50 CFR part 424) that implement the listing provisions of the Act established the procedures for adding species to the Federal lists. A species may be determined to be an endangered or threatened species due to one or more of the five factors described in section 4(a)(1). These factors and their application to Delphinium bakeri Ewan (Baker's larkspur) and Delphinium luteum Heller (yellow larkspur) are as follows:

A. The Present or Threatened Destruction, Modification, or Curtailment of Its Habitat or Range. Of the two remaining populations of Delphinium luteum , one located at an old rock quarry site near Bodega has been partially destroyed and fragmented by historical quarry activities. The number of plants remaining at this site continues to decline. Population numbers were between 100 to 200 plants in 1978 (Ed Guerrant, Berry Botanic Garden, pers. comm. 1995), but recent counts indicate that only 30 to 40 individuals remain (B. Guggolz, pers. comm. 1995). The other extant site has fewer than 10 remaining individuals. A historical site near the town of Graton was converted to residential uses by 1987 (CNDDB 1997).

Historically, habitat of Delphinium bakeri was eliminated by agricultural conversion to grainfields (Ewan 1942). Remaining habitat may be threatened by sheep grazing (CNDDB 1997). One extirpated population was subjected to sheep grazing, but it is unknown if grazing was the primary cause of its demise. The few remaining individuals (approximately 35) are extremely vulnerable to impacts that otherwise might not be significant. Threats to the lone remaining site of D. bakeri are discussed under factors B through E. At the rock quarry site near Bodega Bay, the Bodega Harbor landowners association is proposing to build an equipment storage shed and a public trail that would be close to the remaining plants. Although the proposed storage equipment shed would be located on degraded habitat and would have no direct impact on the extant population of D. luteum , the public trail would be located adjacent to the population. The proximity of the trail to the plants would increase the threat from collection (see factor B). Urban development, and its associated recreational activities, continue to threaten the remaining population of D. luteum (B. Guggolz, pers. comm. 1995). Although the project proponents have been notified that construction of the shed and trail may be detrimental to D. luteum, we understand that the project remains proposed as is.

B. Overutilization for Commercial, Recreational, Scientific, or Educational Purposes. Overutilization is a threat for both species. In 1992, all the follicles (a single-celled cavity that acts like a many-seeded fruit, which upon drying splits open to release seeds) were collected from the plants at the only known site of Delphinium bakeri (CDFG 1993). Because these follicles contained the plants' seeds, all sexual reproduction for 1992 was lost. Were this collection to occur regularly or in conjunction with unrelated natural events ( e.g. , fire), the species may be lost. Due to its distinctive yellow flowers, which is uncommon for larkspurs, D. luteum is of considerable horticultural interest. Collecting is thought to have extirpated at least one occurrence of D. luteum located southwest of Tomales (CNDDB 1997). Additionally, some of the historical decline to D. luteum can be attributed to collecting. Delphinium luteum was offered for purchase in horticultural trade journals during the 1940's and 1950's (Michael Warnock, Sam Houston University, pers. comm. 1994). Plants can still be procured from a local nursery, although their seed source is not from the wild. Garden-grown seed is also available through an international garden society (NARGS 1998). Both populations of D. luteum are near residential areas, about 30 m (100 ft) from the nearest house, and are subject to collecting. Unrestricted collecting for scientific or horticultural purposes or excessive visits by individuals interested in seeing rare plants could result from increased publicity as a result of this rulemaking.

C. Disease or Predation. Most Delphinium species are toxic to cattle but not sheep. Ewan (1942) noted that Delphinium bakeri did not appear to be poisonous to livestock. However, its toxicity has not been tested. Sheep grazing may threaten the plant (CNDDB 1997). One extirpated population was subjected to grazing, but it is unknown if grazing was the primary cause of its demise. The few remaining individuals (approximately 35) are extremely vulnerable to impacts that otherwise might not be significant. Although D. luteum has persisted at two sites with sheep grazing for many decades, because of the very low number of individuals in the population, any loss of flowers and/or seeds could significantly reduce chances for the long-term survival of this species (see Factor E).

D. The Inadequacy of Existing Regulatory Mechanisms. The California Fish and Game Commission (CFGC) listed Delphinium bakeri and Delphinium luteum as rare species in 1979 under the California Native Plant Protection Act (CNPPA) (Div. 2 Ch. 10, Section 1900 et seq. of the Fish and Game Code). Although the “take” of State-listed plants is generally prohibited under CNPPA (See Sec. 1908), the extent of protection for State-listed plants has been a matter of some uncertainty. CNPPA limits the State's ability to regulate or prohibit the take of plants during agricultural operations, timber harvesting, or mining assessment work, or removal of plants from certain facilities and right-of-way [see Sec. 1913 (a) and (b)]. Under another provision of CNPPA, landowners in some circumstances can remove plants after providing CDFG at least 10 days advance notice [see Sec. 1913(c)]. The scope of these exceptions to CNPPA take prohibition, and consequently to the protection for plants, are unsettled and suspect. State designation as a rare, threatened, or endangered species under the CNPPA does provide for consideration of impacts by State agencies under CEQA, described below.

The CEQA (chapter 2 section 21050 et seq. of the California Public Resources Code) requires a full disclosure of the potential environmental impacts of proposed projects. The public agency with primary authority or jurisdiction over the project is designated as the lead agency and is responsible for conducting a review of the project and consulting with the other agencies concerned with the resources affected by the project. Section 15065 of the CEQA Guidelines requires a mandatory finding of significance if a project has the potential to “reduce the number or restrict the range of a rare, threatened, or endangered plant or animal.” Species that can be shown to meet the criteria for State listing and have been designated as rare, threatened, or endangered, such as D. bakeri and D. luteum , must be considered under CEQA guidelines (CEQA Section 15380). Once significant effects are identified, the lead agency has the option to require mitigation for effects through changes in the project or to decide that overriding considerations make mitigation infeasible. In a case that the lead agency decides that overriding considerations make mitigation infeasible, projects may be approved that cause significant environmental damage, such as destruction of State-listed species. Protection of listed species through CEQA is therefore dependent upon the discretion of the agency involved. In addition, revisions to CEQA guidelines have been proposed which, if implemented, may weaken protections for State-listed, rare, threatened, and endangered species.

E. Other Natural or Manmade Factors Affecting Its Continued Existence. The remaining population of Delphinium luteum at the rock quarry may be threatened by users of a trail associated with the extension of an existing golf course into the current county scenic easement that exists on the site (B. Guggolz, pers. comm. 1995). This easement is not a conservation easement with us but may offer some limited, incidental protection to the species in terms of controlling development to protect the viewshed. However, the trail's close proximity to the remaining populations of D. luteum may increase the amount of collection of the species by people using the trail.

The remaining population of Delphinium bakeri occurs on a steep road bank that is adjacent to a county road in Marin County. Some potential exists for herbicide spraying and road maintenance activities that could be detrimental to this species due to the extremely low number of individuals that remain. The degree of threat that these activities pose to the remaining population of D. bakeri is uncertain at this time.

Because few populations and/or individuals remain, both Delphinium bakeri and D. luteum are likely threatened by genetic drift (random change in particular gene frequency that may lead to preservation or extinction of certain genes and an overall reduction of genetic variability). D. bakeri has 1 population consisting of 35 plants. Delphinium luteum has 2 populations, totaling fewer than 50 plants. Small populations often are subject to increased genetic drift and inbreeding as consequences of their small populations (Ellstrand and Elam 1993). A loss of genetic variability, and consequent reduction in genetic fitness, provides less opportunity for a species to successfully adapt to environmental change (Ellstrand and Elam 1993).

The combination of few populations, small number of individuals found within each population, narrow range, and restricted habitat make these two plant species susceptible to destruction of all or a significant part of any population from random natural events, such as fire, drought, disease, or other natural occurrences (Shaffer 1981; Primack 1993). Random events causing population fluctuations or even population extirpations are not usually a concern until the number of individuals or geographic distribution become as limited as they have for both Delphinium bakeri and D. luteum (Primack 1993). Once a plant population becomes significantly reduced due to habitat destruction and fragmentation, the remnant population has a greater probability of extinction from random events.

We have carefully assessed the best scientific and commercial information available regarding the past, present, and future threats faced by these species in determining this final rule. Habitat loss and degradation, sheep grazing, inadequate regulatory mechanisms, naturally occurring events, small plant populations, road maintenance activities, and overcollection imperil the continued existence of these plants. Delphinium bakeri has 1 population with a total of 35 plants. Delphinium luteum has 2 small populations with a total of fewer than 50 plants. Both plant species are in danger of extinction throughout all of their range, and the preferred action is therefore to list D. bakeri and D. luteum as endangered. Other alternatives to this action were considered but not preferred because not listing or listing as threatened would not be consistent with the Act.

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 which may require special management considerations or protection; and specific areas outside the geographical area occupied by the 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.

In the proposed rule, we indicated that designation of critical habitat was not prudent for Delphinium bakeri and D. luteum because of a concern that publication of precise maps and descriptions of critical habitat in the Federal Register could increase the vulnerability of this species 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 endangered.

In the last few years, a series of court decisions have overturned Service determinations regarding a variety of species that designation of critical habitat 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 Delphinium bakeri and D. luteum would be prudent.

Due to the small number of populations both Delphinium bakeri and D. luteum are vulnerable to unrestricted collection, vandalism, or other disturbance. We remain concerned that these threats might be exacerbated by the publication of critical habitat maps and further dissemination of locational information. However, we have examined the evidence available for Delphinium bakeri and D. luteum and have not found specific evidence of taking, vandalism, collection, or trade of either 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 species of taking or other human activity.

In the absence of a finding that critical habitat would increase threats to a species, if there are any benefits to critical habitat designation, then a prudent finding is warranted. In the case of this species, there may be some benefits to designation of critical habitat. 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 species would not be likely to change the section 7 consultation outcome because an action that destroys or adversely modifies such critical habitat would also be likely to result in jeopardy to the species, there may be instances where section 7 consultation would be triggered only if critical habitat is designated. Examples could include unoccupied habitat or occupied habitat that may become unoccupied in the future. There may also be some educational or informational benefits to designating critical habitat. Therefore, we find that critical habitat is prudent for both Delphinium bakeri and D. luteum.

The Final Listing Priority Guidance for FY 2000 (64 FR 57114) states, “The processing of critical habitat determinations (prudency and determinability decisions) and proposed or final designations of critical habitat will no longer be subject to prioritization under the Listing Priority Guidance. Critical habitat determinations, which were previously included in final listing rules published in the Federal Register , may now be processed separately, in which case stand-alone critical habitat determinations will be published as notices in the Federal Register . We will undertake critical habitat determinations and designations during FY 2000 as allowed by our funding allocation for that year.” As explained in detail in the Listing Priority Guidance, our listing budget is currently insufficient to allow us to immediately complete all of the listing actions required by the Act. Deferral of the critical habitat designation for Delphinium bakeri and D. luteum has allowed us to concentrate our limited resources on higher priority critical habitat (including court ordered designations) and other listing actions, while allowing us to put in place protections needed for the conservation of Delphinium bakeri and D. luteum without further delay. However, because we have successfully reduced, although not eliminated, the backlog of other listing actions, we anticipate in FY 2000 and beyond giving higher priority to critical habitat designation, including designations deferred pursuant to the Listing Priority Guidance, such as the designation for this species, than we have in recent fiscal years.

We plan to employ a priority system for deciding which outstanding critical habitat designations should be addressed first. We will focus our efforts on those designations that will provide the most conservation benefit, taking into consideration the efficacy of critical habitat designation in addressing the threats to the species, and the magnitude and immediacy of those threats. We will develop a proposal to designate critical habitat for both Delphinium bakeri and D. luteum as soon as feasible, considering our workload priorities. Unfortunately, for the immediate future, most of Region 1's listing budget must be directed to complying with numerous court orders and settlement agreements, as well as due and overdue final listing determinations (like the one at issue in this case).

Conservation measures provided to species listed as endangered or threatened under the Endangered Species Act include recognition, recovery actions, requirements for Federal protection, and prohibitions against certain activities. Recognition through listing 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 State and requires that recovery actions be carried out for all listed species. 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 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 provision of the Act are codified at 50 CFR part 402. Section 7(a)(4) of the Act requires Federal agencies to confer with us on any action that is likely to jeopardize the continued existence of a proposed species or result in destruction or adverse modification of proposed critical habitat. If a species is listed subsequently, 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 such a species or to destroy or adversely modify its critical habitat. If a Federal action may affect a listed species or its critical habitat, the responsible Federal agency must enter into formal consultation with us. None of the populations of either species occur on Federal land. Although one of the populations occurs adjacent to a county road, we believe it is unlikely that any activities would occur that involve the use of Federal Highway funds. We anticipate few if any section 7 consultations for either species.

Listing these two plants would provide for development of a recovery plan (or plans) for them. Such plan(s) would bring together both State and Federal efforts for conservation of the plants. The plan(s) would establish a framework for agencies to coordinate activities and cooperate with each other in conservation efforts. The plan(s) would set recovery priorities and estimate costs of various tasks necessary to accomplish them. The plan(s) also would describe site-specific management actions necessary to achieve conservation and survival of the two plants. Additionally, pursuant to section 6 of the Act, we would be able to grant funds to the State of California for management actions promoting the protection and recovery of these species.

The Act and its implementing regulations set forth a series of general prohibitions and exceptions that apply to all endangered plants. All prohibitions of section 9(a)(2) of the Act, implemented by 50 CFR 17.61 for endangered plants, 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 and reduce to possession from areas under Federal jurisdiction any such plant. In addition, the Act prohibits 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, or in the course of a violation of State criminal trespass law. Certain exceptions to the prohibitions apply to our agents and State conservation agencies.

The Act and 50 CFR 17.62 and 17.63 also provide for the issuance of permits to carry out otherwise prohibited activities involving endangered plant species. Such permits are available for scientific purposes and to enhance the propagation or survival of the species. We anticipate that few trade permits would ever be sought or issued for the two species because they are not common in cultivation or in the wild.

As published in the Federal Register on July 1, 1994 (59 FR 34272), our policy to identify to the maximum extent practicable at the time a species is listed those activities that would or would not constitute a violation of section 9 of the Act. 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.

We believe that, based upon the best available information, the following actions will not likely result in a violation of section 9, provided these activities are carried out in accordance with existing regulations and permit requirements:

(1) Activities authorized, funded, or carried out by Federal agencies ( e.g. , livestock grazing, agricultural conversions, wetland and riparian habitat modification, flood and erosion control, residential development, recreational trail development, road construction, hazardous material containment and cleanup activities, prescribed burns, pesticide/herbicide application, pipelines or utility lines crossing suitable habitat) when such activity is conducted in accordance with consultation conducted under section 7 of the Act;

(2) Residential landscape maintenance (including irrigation) and the clearing of vegetation around one's personal residence as a firebreak.

We believe that the following actions could result in a violation of section 9; however, possible violations are not limited to these actions alone:

(1) Unauthorized collecting of the species on Federal lands; and

(2) Interstate or foreign commerce and import/export without previously obtaining an appropriate permit. Permits to conduct activities are available for purposes of scientific research and enhancement of propagation or survival of the species.

Questions regarding whether specific activities will constitute a violation of section 9 should be directed to the Field Supervisor of the Sacramento Fish and Wildlife Office (see ADDRESSES section).

Requests for copies of the regulations regarding listed species and inquiries regarding prohibitions and permits may be addressed to the U.S. Fish and Wildlife Service, Endangered Species Permits, 911 N.E. 11th Avenue, Portland, Oregon 97232-4181 (telephone 503/231-2063, facsimile 503/231-6243).

We have determined that an environmental assessment, 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, as amended. We published a notice outlining our reasons for this determination in the Federal Register on October 25, 1983 (48 FR 49244).

This rule does not contain any collections of information that require Office of Management and Budget (OMB) approval under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. An information collection related to the rule pertaining to permits for endangered and threatened species has OMB approval and is assigned clearance number 1018-0094. This rule does not alter that information collection requirement. For additional information concerning permits and associated requirements for endangered plants, see 50 CFR 17.62 and 17.63.

A complete list of all references in this document is available upon request from the Field Supervisor, Sacramento Fish and Wildlife Office (see ADDRESSES section).

Author: The primary author of this final rule is Kirsten Tarp, U.S. Fish and Wildlife Service, Sacramento Fish and Wildlife Office (see ADDRESSES section); telephone 916/414-6464.

The Hawaiian archipelago comprises eight main islands (Niihau, Kauai, Oahu, Molokai, Lanai, Kahoolawe, Maui, and Hawaii) and their offshore islets, plus the shoals and atolls of the Northwest Hawaiian Islands. The main islands and the northwestern chain were formed sequentially by basaltic lava that emerged from a crustal hot spot currently located near the southeast coast of the island of Hawaii (Stearns 1985). Hawaii is the youngest island in the chain and is characterized by gently sloping shield volcanoes and currently active lava flows. Volcanoes on the other islands are either dormant or extinct. Ongoing erosion has formed steep-walled valleys with well developed soils and stream systems throughout the chain. Kauai, the oldest and most northwesterly of the main islands, is characterized by high rainfall, deep valleys, numerous perennial streams, and luxuriant vegetation.

Four species of Lymnaeidae snails are native to Hawaii (Morrison 1968 and Hubendick 1952). Three of these species are found on two or more of the eight main islands. The fourth species, Newcomb's snail, is restricted to the island of Kauai. Newcomb's snail is unique among the Hawaiian lymnaeids in that the slender, tapering shape typically associated with the shells of lymnaeids has been completely lost. The result is a smooth, black shell formed by a single, oval whorl, 6 millimeters (mm) (0.25 inches (in.)) long and 3 mm (0.12 in.) wide. A similar shell shape is found in a Japanese lymnaeid (Burch 1968), but Burch's study of chromosome number shows that Newcomb's snail has evolutionary ties to the rest of the Hawaiian lymnaeids, all of which are derived from North American ancestors (Patterson and Burch 1978). This parallel evolution of similar shell morphology in Japan and Hawaii from two distinct lineages of lymnaeid snails is of particular scientific interest.

At the present time, there is no generally accepted nomenclature for the genera of Hawaiian lymnaeids, although each of these snail species, including Newcomb's snail, is recognized as a well defined species. Newcomb's snail was originally described as Erinna newcombi in 1855 by H. and A. Adams (Hubendick 1952). Hubendick (1952) did not feel that the distinctive shell form (described above) and reduced structures of the nervous system of Newcomb's snail warranted a monotypic genus. In fact, Hubendick included all Hawaiian lymnaeids in the genus Lymnaea . Morrison (1968) opposed Hubendick, and argued that the distinctive shell characters of Newcomb's snail supported the generic name Erinna . Burch (1968), Patterson and Burch (1978), Taylor (1988), and Cowie et al . (1995) all followed Morrison and referred to Newcomb's snail as Erinna newcombi . This scientific name is currently accepted for Newcomb's snail.

Newcomb's snail is an obligate freshwater species. While the details of its ecology are not well known, Newcomb's snail probably has a life history similar to other members of the family. These snails generally feed on algae and vegetation growing on submerged rocks. Eggs are attached to submerged rocks or vegetation, and there are no dispersing larval stages; the entire life cycle is tied to the stream system in which the adults live (Baker 1911). Dispersal of Newcomb's snail among stream systems is probably very infrequent due to their obligate freshwater habitat requirements. Historic dispersal probably relied on long-term erosional events that captured adjacent stream systems. This life history differs greatly from the freshwater Hawaiian neritid snails ( Neritina spp.), which have marine larvae that colonize streams following a period of oceanic dispersal (Kinzie 1990). Larvae of these neritid snails can likely disperse across the oceanic expanses that separate the Hawaiian Islands and colonize streams on any or all of these islands. This dispersal capacity is not available to Newcomb's snail.

The specific habitat requirements of Newcomb's snail include fast flowing perennial streams with stable overhanging rocks, springs, rock seeps, and waterfalls (Michael Kido, University of Hawaii, in litt. 1994; Stephen Miller, U.S. Fish and Wildlife Service (Service), pers. obs. 1994; Polhemus et al. (1992); Burch 1968; Hubendick 1952). Surveys of main stream channels of many of the perennial streams of Kauai indicate that Newcomb's snail is rarely found in these main channels (Adam Asquith, Service, pers. obs. 1994; Don Heacock, State of Hawaii, Department of Land and Natural Resources, in litt. 1995; M. Kido, in litt. 1994, 1995; S. Miller, pers. obs. 1994a, b; Timbol 1983). The limited occurrence of this snail in main stream channels may be due to scouring by sediment, rocks, and boulders that are moved downstream during heavy rains. Consequently, available suitable habitat is generally associated with small feeder streams, seeps, and waterfalls.

The present known range of Newcomb's snail is limited to six stream systems. Each stream supports a single population of Newcomb's snail (A. Asquith, pers. obs. 1994; M. Kido, in litt. 1994; S. Miller, pers. obs. 1994a, b; Hubendick 1952). These populations are located in the Hanalei River, Kalalau Stream, the Lumahai River, the North Fork of the Wailua River, Makaleha Stream, and Waipahee Stream. Makaleha and Waipahee Streams both flow into Kapaa Stream. The populations fall into two groups; populations first observed prior to 1925 and populations observed since 1993. Five populations were identified prior to 1925. Three of these populations (Wainiha, Hanakapiai, and Hanakoa) no longer exist. Of the two remaining pre-1925 populations, one (Waipahee) is small and the other (Kalalau) is relatively large (see below). These data indicate that the number of populations of Newcomb's snail has been greatly reduced since 1925, perhaps by as much as 60 percent.

Since 1990, surveys of at least 46 streams, tributaries and springs on Kauai have located 4 previously unknown populations of Newcomb's snail (A. Asquith, pers. obs. 1994; D. Heacock, in litt. 1995; M. Kido, in litt. 1994, 1995; S. Miller, pers. obs. 1994a, b; Timbol 1983). Three of these populations are small (see below), and the fourth population has been described as large.

No historic information is available on the population sizes of Newcomb's snail. However, recent reports indicate that two of the six known populations of Newcomb's snail are relatively large, the Kalalau and Lumahai populations. The high density of individuals in the Kalalau population may be indicative of an undisturbed natural condition. The estimated maximum density at the base of the upper permanent waterfall, including the area behind the falling water, is approximately 800 snails/square meter (m 2 ) (75 snails/square foot (ft  2 )) (S. Miller, pers. obs. 1994b). The total area occupied by these snails could not be accurately evaluated due to the extreme vertical orientation of the waterfall. Little information on specific size or area is currently available for the population of Newcomb's snail from the Lumahai River, although this population has been reported to be large (M. Kido, in litt. 1995).

The population in Makaleha Stream is divided into two subpopulations. One subpopulation is estimated at 30 snails/m 2 (2 to 3 snails/ft  2 ) distributed over 2 to 3 m 2 (21 to 32 ft2  2 ) (M. Kido, in litt. 1994). This is considerably smaller than the previously described population in Kalalau Stream. The reasons for differences in these two populations are not known with certainty, but may be due to the presence or absence of non native predators and the deliberate use by humans of one species of organism to feed on lymnaeid snails. The subpopulation that occupies Makaleha Springs covers approximately 20 to 30 m 2 (212 to 318 ft  2 ) (S. Miller, pers. obs. 1994a). Snail densities at this site are difficult to estimate but may be as high as 20 to 30 snails/m 2 (1 to 3 snails/ft  2 ) (S. Miller, pers. obs. 1994a).

The sizes of the three other populations of Newcomb's snail have been characterized as small. The population in the Waipahee Stream is estimated to cover 5 to 10 m 2 (53 to 106 ft  2 ) with a density of approximately 50 to 80 snails/m 2 (4 to 8 snails/ft  2 ) (A. Asquith, pers. obs. 1994). The population of Newcomb's snail in the Hanalei River is divided into four subpopulations (M. Kido, in litt. 1994, 1995). One subpopulation has approximately 10 to 20 snails/m 2 (1 to 2 snails/ft  1 ) and occupies 2 to 3 m 2 (21 to 32 ft  2 ) (M. Kido, in litt. 1994). A second subpopulation supports approximately 25 snails. The two remaining subpopulations are reported to be small with very few snails (M. Kido, in litt. 1995). The population found in the North Fork of the Wailua River, is best described as short-lived.

Based on these data, we estimate that the six known populations of Newcomb's snail have a total of approximately 6,000 to 7,000 individuals. The great majority of these snails, perhaps over 90 percent, are located in the two populations at Kalalau and Lumahai.

The February 28, 1996, Federal Register Notice of Review of Plant and Animal Taxa that are Candidates for Listing as Endangered or Threatened Species (61 FR 7596) included Newcomb's snail as a candidate species. Candidates are those species for which we have on file sufficient information on biological vulnerability and threat(s) to support issuance of a proposed rule to list, but issuance of the proposed rule is precluded by other higher priority listing actions. We published a proposed rule on July 21, 1997 (62 FR 38953), to list this species as threatened.

Based on all available information including comments received in response to the proposal (see Comments and Recommendations Section of this final rule), we have now determined Newcomb's snail to be threatened. The processing of this final rule conforms with our Listing Priority Guidance published in the Federal Register on October 22, 1999 (64 FR 57114). The guidance clarifies the order in which we will process rulemakings. Highest priority is processing emergency listing rules for any species determined to face a significant and imminent risk to its well being (Priority 1). Second priority (Priority 2) is processing final determinations on proposed additions to the lists of endangered and threatened wildlife and plants. Third priority is processing new proposals to add species to the lists. The processing of administrative petition findings (petitions filed under section 4 of the Act) is the fourth priority. The processing of critical habitat determinations (prudency and determinability decisions) and proposed or final designations of critical habitat will no longer be subject to prioritization under Listing Priority Guidance. This final rule is a Priority 2 action. We have updated this rule to reflect any changes in information concerning distribution, status and threats since the publication of the proposed rule.

In the July 21, 1997, proposed rule (62 FR 38953) and associated notifications, we requested interested parties to submit factual reports or information that might contribute to a final determination. The comment period was reopened and extended until December 15, 1997, to accommodate a request for a public hearing (62 FR 60676). We sent announcements of the proposed rule and notice of public hearings to appropriate Federal and State agencies, county governments, scientific organizations, and other interested parties and requested comments. We also published announcements of the proposed rule in the Honolulu Star-Bulletin, Honolulu Advertiser (Oahu), and the Garden Island (Kauai) on August 8, 1997. We held a public hearing on December 3, 1997, in Lihue, Kauai, Hawaii. We accepted comments on the proposed rule until the extended comment period closed.

We received a total of 10 written comments on the proposed rule, 6 by mail and 4 at the public hearing. One Federal agency commented but neither supported nor opposed the proposal. Four Hawaii State agencies provided comments, two that supported the proposal, and two that were neutral. One Kauai County agency indicated support for our efforts in the identification of species habitat areas and in maintaining a census of species but was concerned that the development or maintenance of current or future water resources could be unnecessarily restricted by listing of the Newcomb's snail. The proposal was supported by one individual, one conservation organization and one scientific museum, and opposed by one nonprofit legal foundation. In addition, three commentors expressed support for the designation of critical habitat.

In accordance with our peer review policy promulgated July 1, 1994 (59 FR 34270), we solicited the expert opinions of three appropriate and independent specialists regarding pertinent scientific or commercial data and assumptions relating to the taxonomy, population models, and supportive biological and ecological information for the Newcomb's snail. The purpose of such review is to ensure listing decisions are based on scientifically sound data, assumptions, and analysis, including input of appropriate experts and specialists. We received from these experts written comments that provided additional information on numbers of populations and individuals, distribution, and editorial changes. We incorporated peer review comments into this final rule as appropriate.

A public hearing was requested by Hawaii's Department of Land and Natural Resources (DLNR). The hearing was held at the Outrigger Kauai Beach Hotel in Lihue, Kauai on December 3, 1997, with 13 attendees. Nine oral statements and four written comments were received during the hearing, and, with one exception, all commentors supported the listing. In addition, five commentors expressed support for the designation of critical habitat.

We considered all comments, including oral testimony presented at the public hearing, and also the comments from the peer reviewers who responded to our request to review the proposed rule. We grouped comments of a similar nature by issue and summarized as follows:

Issue 1: Critical habitat should be designated.

Response: This issue is addressed under the “Critical Habitat” section of this final rule.

Issue 2: Current or future water resources development or maintenance could be unnecessarily restricted by listing of the Newcomb's snail.

Response: Section 4(b)(1)(A) of the Act requires us to make listing decisions solely on the basis of the best scientific and commercial data available, without regard to economics or other similar impacts. The legislative history of this statutory provision makes clear that economic impacts may not be considered in determining whether a species should be listed as endangered or threatened: “The addition of the word “solely” is intended to remove from the process of the listing or delisting of species any factor not related to the biological status of the species. The committee strongly believes that economic considerations have no relevance to determinations regarding the status of species * * *” (H.R. Rep. No. 97-835, 97th Cong., 2d Sess. 19, (1982). Therefore, we have not considered the impacts of listing on economic development in making this listing determination.

Issue 3: Listing of Newcomb's snail is premature at this time because further research is needed to provide information on how best to protect it.

Response: We believe that listing of Newcomb's snail is warranted at this time due to the factors addressed under the “Summary of Factors Affecting the Species” section of this final rule. The requirement that section 4 listing determinations be based on the “best” scientific and commercial data available requires us to consider the best information available at the time of the listing decision. Therefore, the threats facing the species and its habitat, the limited range, and relatively small population size are good indicators that this species warrants listing. Additional information, that may be needed to determine how best to protect the species, may be developed and used in the recovery planning process.

Issue 4: There are significant water resource and habitat-related questions that should be evaluated prior to imposing blanket restrictions on development in habitat areas.

Response: Again, it is not appropriate to consider impacts on economic development in making a determination to list a species (see response to Issue 2). Further, implementing the Act would not necessarily result in blanket land use restrictions. Under section 7 of the Act, Federal actions including funding, licensing, and permitting that may affect the species will require consultation between the Federal action agency and us to insure the Federal action is not likely to jeopardize the continued existence of Newcomb's snail. Section 9 of the Act prohibits persons from “taking” listed species. Taking is defined to include significant habitat modification where it actually kills or injures the listed species. However, these provisions do not amount to “blanket” prohibitions on development. Section 10 of the Act provides for the issuance of permits for the incidental take of listed species resulting from otherwise lawful activities when sufficient protection for the species is provided.

Issue 5: One respondent asserted that listing this species would exceed the scope of the Federal commerce power under the Commerce Clause of Article I, section 8 of the U.S. Constitution.

Our Response: The Federal Government has the authority under the Commerce Clause of the U.S. Constitution to protect this species, 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). That case involved a challenge to application of the Act's prohibitions to protect the listed Delhi Sands flower-loving fly ( Rhaphiomidas terminatus abdominalis ). As with Newcomb's snail, the Delhi Sands flower-loving fly is endemic to only one State. Judge Wald held that application of the Act's prohibition against taking of endangered species to this fly 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 it prevented loss of biodiversity and destructive interstate competition. Judge Henderson upheld protection of the fly because doing so prevents harm to the ecosystem upon which interstate commerce depends, and because doing so regulates commercial development that is part of interstate commerce.

The Service routinely has solicited comments from parties interested in, and knowledgeable of, species that have been proposed for listing as threatened or endangered species. The July 1, 1994, Peer Review Policy (59 CFR 34270) established the formal requirement that a minimum of three independent peer reviewers be solicited to review the Service's listing decisions. During the July 21, 1997, to December 15, 1997, comment period, the Service solicited the expert opinions of three biologists having recognized expertise in malacology and/or conservation biology to review the proposed rule. The Service received comments from all three reviewers within the comment period. All concurred with the Service on factors relating to the taxonomy, population models, and biological and ecological information.

After a thorough review and consideration of all information available, we have determined that Newcomb's snail should be classified as a threatened species. We followed procedures found at section 4(a)(1) of the Act and regulations (50 CFR part 424) implementing the listing provisions of the Act. A species may be determined to be an endangered or threatened species due to one or more of the five factors described in section 4(a)(1). These factors and their application to Newcomb's snail ( Erinna newcombi ) are as follows:

A. The present or threatened destruction, modification, or curtailment of its habitat or range. Although modification of habitat is not an immediate threat, water development and diversion projects have been proposed within Newcomb's snail habitat in the past. For example, in 1994, a proposed water development project at Makaleha Springs (State of Hawaii 1994) threatened to destroy the population of Newcomb's snail at this site. This project was ultimately rejected by the State of Hawaii, Commission on Water Resource Management. However, the County of Kauai, Department of Water can submit a new application for future development of the water resources at Makaleha Springs.

B. Overutilization for commercial, recreational, scientific, or educational purposes. Overutilization is not known to be a factor affecting Newcomb's snail at the present time.

C. Disease or predation. Predation by the non native rosy glandina snail ( Euglandina rosea ) is a serious threat to the survival of Newcomb's snail. This predatory snail was introduced into Hawaii in 1955 (Funasaki et al. 1988), and has established populations throughout the main islands. The rosy glandina feeds on snails and slugs, and field studies have established that it will readily feed on native snails found in Hawaii (Hadfield et al. 1993). Furthermore, Kinzie (1992) demonstrated that the rosy glandina snail can fully submerge itself under water and feed on aquatic snails such as the Newcomb's snail. The rosy glandina has been observed on wet, algae-covered rocks of the Makaleha Springs Stream very near individuals of Newcomb's snail (S. Miller, pers. obs. 1994a), and is believed to prey on them. The rosy glandina snail has caused the extinction of many populations and species of native snails throughout the Pacific islands (Hadfield et al. 1993; Miller 1993; Hopper and Smith 1992; Murray et al. 1988; Tillier and Clarke 1983), and represents a significant threat to the survival of Newcomb's snail.

Predation on the eggs and adults of native Hawaiian lymnaeid snails by two non native species of Sciomyzidae flies also represents a significant threat to the survival of Newcomb's snail. Two species of marsh flies ( Sepedomerus macropus and Sepedon aenescens ) that feed on lymnaeid snails (Davis 1960) were introduced into Hawaii in 1958 and 1966, respectively, as biological control agents for a non native lymnaeid snail, Fossaria viridis (Funasaki et al. 1988). Fossaria viridis was targeted for biocontrol because it is an intermediate host of the cattle liver fluke ( Fasciola gigantica ) (Alicata 1938; Alicata and Swanson 1937). These authors misidentified Fossaria viridis as Fossaria ollula, as discussed in Morrison (1968). The non-native lymnaeid and the two biocontrol flies occur on Kauai as well as on other islands in Hawaii (Funasaki et al. 1988; Davis and Chong 1969; Davis 1960; Hubendick 1952). One of the marsh fly species has been observed at a site (Hanakoa Stream) where Newcomb's snail was historically recorded but is no longer present (S. Miller, pers. obs. 1994b). Another marsh fly was observed near the waterfall of a Kauai stream that had many dead lymnaeids in the waterfall plunge pool (S. Miller, pers. obs. 1994b). These biocontrol agents represent a significant threat to Newcomb's snail and other native lymnaeid snails.

Predation by several introduced aquatic species is also a possible threat to populations of Newcomb's snail (D. Heacock, in litt. 1997). These non native aquatic species include the green swordtail ( Xyphophorus helleri ), a fish introduced in 1922 for mosquito control; and two accidental introductions, the American bullfrog ( Rana catesbiana ), which was first recorded in 1867, and the wrinkled frog ( Rana rugosa ), which was first recorded in 1896 (State of Hawaii 1995).

D. The inadequacy of existing regulatory mechanisms. Newcomb's snail is not currently listed as an endangered or threatened species in Hawaii. When this rule becomes effective and the species is listed under the Act, the State of Hawaii Endangered Species Act (HRS, sect. 195D-4(a)) will automatically be invoked. The State statute reads “Any species of aquatic life, wildlife, or land plant that has been determined to be an endangered species pursuant to the [Federal] Endangered Species Act shall be deemed to be an endangered species under the provisions of this chapter and any indigenous species of aquatic life, wildlife, or land plant that has been determined to be a threatened species pursuant to the [Federal] Endangered Species Act shall be deemed to be a threatened species pursuant under the provisions of this chapter.” Further, the State may enter into agreements with Federal agencies to administer and manage any area required for the conservation, management, enhancement, or protection of endangered species (HRS, sect. 195D-5(c)). Funds for these activities could be made available under section 6 of the Federal Act (State Cooperative Agreements). However, without listing, none of these provisions would apply to Newcomb's snail.

Furthermore, current State and Federal regulatory mechanisms are inadequate to protect the species. All six of the known extant populations of Newcomb's snail occur in streams in conservation areas that are managed by the State of Hawaii primarily for watershed protection, including uses such as public drinking water, and cultural and agricultural activities. In 1987, the State of Hawaii established a Commission on Water Resource Management (CWRM) which, among other things, was responsible for issuing stream alteration permits for activities, such as water diversion and channelization, that impact Hawaii's streams and springs (State of Hawaii 1993). Since 1987, the State assumed control over all water in the State. Therefore, a State of Hawaii water permit is required for all aquatic activities such as withdrawal of water for public consumption, agricultural purposes ( i.e. , irrigation), and stream modifications (channelization and realignment).

Protection of the streams in which Newcomb's snail occurs is inadequate under the existing State permitting process because it lacks requirements for the protection and conservation of sensitive aquatic biota. In 1992, the Hawaii State legislature passed a resolution that called for the CWRM to finalize, adopt, and implement a stream protection system, and in 1993, the CWRM appointed the Stream Protection and Management Task Force (Sierra Club Legal Defense Fund 1994). The task force made a series of recommendations on the information that should be included in stream permit applications and the types of activities that might be allowed in streams. In addition, the task force recommended for several streams, including some of the Kauai streams in which Newcomb's snail occurs, “heritage” status, which would have provided them with additional protection. The task force recommendations have not been adopted.

Under section 404 of the Clean Water Act, the U.S. Army Corps of Engineers (Corps) regulates the discharge of fill material into waters of the United States (33 CFR parts 320-330). Waters of the United States include navigable waters and other waters, their headwaters (streams with an average annual flow of less than 5 cubic feet per second), and wetlands. Section 404 regulations require that applicants obtain a permit for projects that involve the discharge of fill material into waters of the United States. Projects may qualify for authorization under several nationwide permits if the project falls below certain thresholds, such as affecting less than 1.2 hectares (ha) (3 acres (ac)) or less than 152 linear m (500 linear ft) of stream bed. Projects meeting the criteria for a nationwide permit are normally permitted with minimal environmental review by the Corps. However, if any listed species might be affected or is in the vicinity of the project, a prospective permittee may not begin work under the nationwide permit until the Corps satisfies the requirements of the Act. No activity is authorized by any nationwide permit if that activity is likely to jeopardize the continued existence of any listed species (see 33 CFR 330.4(f)).

Individual permits are required for the discharge of fill material into wetlands above the thresholds established by the nationwide permits. The review process for the issuance of individual permits is more rigorous than for nationwide permits. Unlike nationwide permits, individual permit applications require alternative analysis and an assessment of cumulative wetland impacts is required for and there is a 30-day public review period. Resulting permits may include special conditions that require the avoidance or mitigation of environmental impacts. If a listed species is affected, the Corps must consult with us under section 7 of the Act.

Most of the Newcomb's snail populations are fairly small, and the habitat they occupy tends to be small seeps covering less than 1.2 ha (3 ac). Projects that may potentially impact this species could be permitted under the nationwide permit process with limited environmental review or notification because they generally fall under the nationwide permit thresholds. No other federally protected species found within the same or adjacent habitat would invoke a formal environmental review. Unless this species is listed, requiring the Corps to comply with section 7 of the Act, entire populations of the Newcomb's snail, or portions thereof, could conceivably be eliminated if fill material were discharged into the streams and seeps they occupy.

Federal regulations for the introductions of biocontrol agents have not adequately protected Newcomb's snail in the past. As a result, several non-native aquatic species and two non native fly species, which may be the most serious present threats to the Newcomb's snail's continued existence, were purposefully introduced by the State of Hawaii's Department of Agriculture or other agricultural agencies (Funasaki et al. 1988). Currently, our Pacific Islands Office reviews proposals to release biocontrol agents by the Hawaii State Department of Agriculture for potential effects on listed species. However, since post-release biology and host range are difficult to predict from laboratory studies (Gonzalez and Gilstrap 1992; Roderick 1992), the release or augmentation of non native species may pose threats to Newcomb's snail in the future.

E. Other natural or manmade factors affecting its continued existence. Because of the small, isolated nature of occurrences of Newcomb's snail, and the few individuals present in most of them, this species is also more susceptible to random events that may affect its continued existence. As indicated above, the six known populations of Newcomb's snail cover very small areas in settings that may be subjected to extreme effects associated with exceptionally heavy rainfall or hurricanes. Hurricanes struck the island of Kauai in 1983 and 1992. Rainfall associated with hurricanes can wash out streams (Polhemus 1993) and create landslides that can alter stream flow (Jones et al. 1984). Events such as these could destroy the habitat of Newcomb's snail or physically displace individuals into areas where they cannot survive.

Reduced stream flow due to water development projects, droughts, or other natural or human causes may have several potential negative effects on the ability of Newcomb's snail to complete its life cycle. Loss of water could reduce or eliminate the habitat of Newcomb's snail and possibly lead to increased intraspecific competition or desiccation and death. Reduced water flow could also lead to increased predation by non native predators. Low flows may allow marsh flies or the rosy glandina snail easier access to individual snails that are otherwise protected by the force of water movement. Droughts are not uncommon in the Hawaiian Islands. Between 1860 and 1986 the island of Kauai was affected by 33 droughts, 20 of which significantly affected the available water supply on the island (Giambelluca et al. 1991). The development of water resources also is a continuing issue. These projects divert water from streams, springs and aquifers that may otherwise maintain habitats for Newcomb's snail.

Intentional or accidental introductions of snail predators constitute a significant threat to Newcomb's snail. The State of Hawaii continues to carry out an active program of introductions of biological control agents. These organisms are primarily introduced to control agricultural pests, and their impacts on native species have only recently been considered in evaluating release programs. The marsh flies and the rosy glandina snail are examples of biological control agents that were introduced to Hawaii without adequate assessment of their impact on Newcomb's snail or other native Hawaiian species.

Finally, the combined effects of numerous factors can degrade stream ecosystems, leading to a decline in snail population size and an increase in the likelihood of extinction from naturally occurring or human caused events.

We have carefully assessed the best scientific and commercial information regarding the past, present, and future threats faced by this species in determining to make this rule final. Based on this evaluation, the preferred action is to list the Newcomb's snail ( Erinna newcombi ) as threatened. All populations are threatened or potentially threatened by predation by non native snails, flies, frogs, and fish; habitat destruction or modification from water development or diversion projects; habitat destruction or displacement of individuals by stream wash outs from heavy rainfall or landslides that can alter stream flow; and inadequate existing regulatory mechanisms. Currently, the 6 populations support 6,000 to 7,000 individuals but historical information indicates that the number of populations has been greatly reduced since 1925, perhaps by as much as 60 percent. Perhaps over 90 percent of the individuals are located in only two populations. The small sizes of four of the six populations and limited distribution make these populations vulnerable to extinction from reduced reproductive vigor or from random environmental events. Because this species is likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range, this species fits the definition of threatened as defined in the Act. Therefore, the determination of threatened status for Newcomb's snail is warranted.

Critical habitat is defined in section 3 of the Act as: (i) The specific areas within the geographical area occupied by the species, at the time it is listed in accordance with the Act, on which are found those physical or biological features (I) Essential to the conservation of the species and (II) That may require special management considerations or protection and; (ii) Specific areas outside the geographical area occupied by a species at the time it is listed, upon a determination 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.

In the proposed rule, we indicated that designation of critical habitat was not prudent for Erinna newcombi because of a concern that publication of precise maps and descriptions of critical habitat in the Federal Register could increase the vulnerability of this species 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 endangered.

In the last few years, a series of court decisions have overturned Service determinations regarding a variety of species that designation of critical habitat 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 Erinna newcombi would be prudent.

Due the small number of populations, Erinna newcombi is vulnerable to unrestricted collection, vandalism, or other disturbance. We remain concerned that these threats might be exacerbated by the publication of critical habitat maps and further dissemination of locational information. However, we have examined the evidence available for Erinna newcombi 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 species of taking or other human activity.

In the absence of a finding that critical habitat would increase threats to a species, if there are any benefits to critical habitat designation, then a prudent finding is warranted. In the case of this species, there may be some benefits to designation of critical habitat. 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 species would not be likely to change the section 7 consultation outcome because an action that destroys or adversely modifies such critical habitat would also be likely to result in jeopardy to the species, there may be instances where section 7 consultation would be triggered only if critical habitat is designated. Examples could include unoccupied habitat or occupied habitat that may become unoccupied in the future. There may also be some educational or informational benefits to designating critical habitat. Therefore, we find that critical habitat is prudent for Erinna newcombi .

The Final Listing Priority Guidance for FY 2000 (64 FR 57114) states, the processing of critical habitat determinations (prudency and determinability decisions) and proposed or final designations of critical habitat will no longer be subject to prioritization under the Listing Priority Guidance. Critical habitat determinations, which were previously included in final listing rules published in the Federal Register , may now be processed separately, in which case stand-alone critical habitat determinations will be published as notices in the Federal Register . We will undertake critical habitat determinations and designations during FY 2000 as allowed by our funding allocation for that year. As explained in detail in the Listing Priority Guidance, our listing budget is currently insufficient to allow us to immediately complete all of the listing actions required by the Act. Deferral of the critical habitat designation for Erinna newcombi will allow us to concentrate our limited resources on higher priority critical habitat and other listing actions, while allowing us to put in place protections needed for the conservation of Erinna newcombi without further delay.

We plan to employ a priority system for deciding which outstanding critical habitat designations should be addressed first. We will focus our efforts on those designations that will provide the most conservation benefit, taking into consideration the efficacy of critical habitat designation in addressing the threats to the species, and the magnitude and immediacy of those threats. We will develop a proposal to designate critical habitat for the Erinna newcombi as soon as feasible, considering our workload priorities.

Conservation measures provided to species listed as endangered or threatened under the Act include recognition, recovery actions, requirements for Federal protection, and prohibitions against certain activities. Recognition through listing 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. The protection required of Federal agencies and the prohibitions against taking and harm 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 listed as endangered or threatened and with respect to its critical habitat, if any is being designated. Regulations implementing this interagency cooperation provision of the Act are codified in 50 CFR part 402. Section 7(a)(4) requires Federal agencies to confer informally with us on any action that is likely to jeopardize the continued existence of a proposed species or result in destruction or adverse modification of proposed critical habitat. If a species is subsequently listed, 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 to destroy or adversely modify its critical habitat. If a Federal action may affect a listed species or its critical habitat, the responsible Federal agency must enter into formal consultation with us.

Federal agency actions that may require conference and/or consultation as described in the preceding paragraph include the Corps authorization of projects such as the construction of drainage diversions, roads, bridges, and dredging projects subject to section 404 of the Clean Water Act (33 U.S.C. 1344 et seq. ) and section 10 of the Rivers and Harbors Act of 1899 (33 U.S.C. 401 et seq. ), U.S. Environmental Protection Agency authorization of discharges under the National Pollutant Discharge Elimination System, and projects funded by U.S. Housing and Urban Development or Natural Resource Conservation Service funded projects.

The Act and its implementing regulations set forth a series of general prohibitions and exceptions that apply to all threatened wildlife. The prohibitions, codified at 50 CFR 17.31, in part, make it illegal for any person subject to the jurisdiction of the United States to take (includes harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect; or to attempt any of these), import or export, transport in interstate or foreign commerce in the course of commercial activity, or sell or offer for sale in interstate or foreign commerce any listed species. It is also illegal to possess, sell, deliver, carry, transport, or ship any such wildlife that has been taken illegally. Certain exceptions apply to agents of the Service and State conservation agencies.

The Act and 50 CFR 17.32 also provide for the issuance of permits to carry out otherwise prohibited activities involving threatened animal species under certain circumstances. Such permits are available for scientific purposes, to enhance the propagation or survival of the species, and/or for incidental take in connection with otherwise lawful activities. For threatened species, you may also obtain permits for zoological exhibition, educational purposes, or special purposes consistent with the purposes of the Act.

As published in the Federal Register on July 1, 1994 (59 FR 34272), our policy is to identify to the maximum extent practicable at the time a species is listed those activities that would or would not constitute a violation of section 9 of the Act. The intent of this policy is to increase public awareness of the effects of the listing on proposed and ongoing activities within a species' range. We believe that, based on the best available information, the following activities will not result in a violation of section 9, provided these activities are carried out in accordance with existing regulations and permit requirements:

(1) Scientific or recreational activities within the main channel of streams that support populations of Newcomb's snail, but exclusive of the specific sites known to support populations of this snail;

(2) Activities authorized, funded, or carried out by Federal agencies (if the species were found on Federal lands), (e.g., grazing management, agricultural conversions, wetland and riparian habitat modification, flood and erosion control, residential development, recreational trail development, road construction, hazardous material containment and cleanup activities, prescribed burns, pesticide/herbicide application, pipelines or utility lines crossing suitable habitat) when such activity is conducted in accordance with any reasonable and prudent measures given by the Service in a consultation conducted under section 7 of the Act;

Potential activities involving Newcomb's snail that we believe will likely be considered a violation of section 9 include, but are not limited to, the following:

(1) Release, diversion, or withdrawal of water that results in displacement, disruption of breeding or feeding, or death of individual snails;

(2) Actions that lead to the destruction or alteration of the occupied habitat of Newcomb's snail (e.g., in-stream dredging, rock removal, channelization, discharge of fill material, actions that result in siltation of the habitat, and diversion of ground water flow required to maintain the habitat).

(3) Introduction of species that are predators or competitors of aquatic snails, especially non native snails in the family Lymnaeidae and the closely related family Physidae.

(4) Interstate and foreign commerce (commerce across State lines and international boundaries) and import/export (as discussed earlier in this section).

You should direct questions regarding whether specific activities will constitute a violation of section 9 of the Act to the Manager of the Pacific Islands Ecoregion (see ADDRESSES section). Requests for copies of the regulations regarding listed wildlife and inquiries about prohibitions and permits may be addressed to the U.S. Fish and Wildlife Service, Endangered Species Permits, 911 N.E. 11th Avenue, Portland, Oregon 97232-4181 (503/231-6241; facsimile 503/231-6243).

As previously stated, Federal listing will automatically invoke listing under the State's endangered species act. State law prohibits taking of listed wildlife and plants in the State and encourages conservation of such species by State agencies and triggers other State regulations to protect the species (HRS, sect. 195AD-4 and 5).

We have determined that environmental assessments and environmental impact statements, 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. We published a notice outlining our reasons for this determination in the Federal Register on October 25, 1983 (48 FR 49244).

This rule does not contain any information collection requirements for which Office of Management and Budget (OMB) approval under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. is required. An information collection related to the rule pertaining to permits for endangered and threatened species has OMB approval and is assigned clearance number 1018-0094. For additional information concerning permits and associated requirements for threatened species, see 50 CFR 17.32.

A complete list of all references cited in this rule, as well as other references, is available upon request from the Pacific Islands Ecoregion office (see ADDRESSES section).

The primary authors of this final rule are Dr. Steve Miller and Christa Russell, with contributions from Christine Willis, at telephone 808/541-3441 or facsimile 808/541-3470 (see ADDRESSES section). Recent data on the distribution of Newcomb's snail was contributed by Dr. Adam Asquith, US Fish and Wildlife Service, Pacific Islands Ecoregion.

The 2000 fishery specifications and management measures for groundfish taken in the U.S. exclusive economic zone and state waters off the coasts of Washington, Oregon, and California, as authorized by the Pacific Coast Groundfish Fishery Management Plan, were published in the Federal Register on January 4, 1999 (65 FR 221). The specifications contained a number of errors that need to be corrected.

In rule FR Doc. 99-33966 beginning on page 221, in the issue of Tuesday, January 4, 2000 (65 FR 221), make the following corrections:

1. On page 239, in the second column, in paragraph (11), delete the paragraph and replace it with “(11) Operating in both limited entry and open access fisheries . The open access trip limit applies to any fishing conducted with open access gear, even if the vessel has a valid limited entry permit with an endorsement for another type of gear. A vessel that operates in both the open access and limited entry fisheries is not entitled to two separate trip limits for the same species. If a vessel has a limited entry permit and uses open access gear, and the open access limit is smaller than the limited entry limit, then the open access limit cannot be exceeded and counts toward the limited entry limit. If a vessel has a limited entry permit and uses open access gear, and the open access limit is larger than the limited entry limit, the smaller limited entry limit applies, even if taken entirely with open access gear”.

2. On page 241, in the first column in paragraph A(16)(c), the first sentence should read “Special provisions will be made for “B” platoon vessels later in the year so that the amount of fish made available in 2000 to both “A” and ”B” vessels is the same”

3. Table 2 starting on page 241 is corrected to read as follows:

4. On page 241, in the third column, in paragraph A(20)(b), the first sentence should read “Shelf rockfish consists of canary rockfish, shortbelly rockfish, widow rockfish ( Sebastes entomelas ,) yellowtail rockfish, bocaccio, chilipepper, cowcod, and the minor shelf rockfish species listed in Table 2”.

5. On page 247, in the second column, in paragraph D(1)(a)(i), remove “Cape Mendocino” and replace it with “40°10′ N. lat.″.

6. On page 247, in the third column, in paragraph (D)((1)(b), delete “Cape Mendocino” and replace it with “40°10′ N. lat.″.

7. On page 247, in the third column, in paragraph (D)(2), “34"” is corrected to read “34 inches”.

8. On page 248, in the third column, in paragraph B. (3), “limited” is corrected to read “limit”.

9. On page 248, in the third column, in paragraph (B)(4) the paragraph should read “Other rockfish are subject to the same trip limits as the limited entry fishery as published in this document. The limits will not change unless the tribal limits are separately changed.”

The fishery for coastal migratory pelagic fish (king mackerel, Spanish mackerel, cero, cobia, little tunny, dolphin, and, in the Gulf of Mexico only, bluefish) is managed under the Fishery Management Plan for the Coastal Migratory Pelagic Resources of the Gulf of Mexico and South Atlantic (FMP). The FMP was prepared by the Gulf of Mexico and South Atlantic Fishery Management Councils (Councils) and is implemented under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622.

Based on the Councils' recommended total allowable catch and the allocation ratios in the FMP, on February 19, 1998 (63 FR 8353), NMFS implemented a commercial quota for the Gulf migratory group of king mackerel in the Florida west coast subzone of 1.17 million lb (0.53 million kg). That quota was further divided into two equal quotas of 585,000 lb (265,352 kg) for vessels in each of two groups by gear types—vessels using run-around gillnets and vessels using hook-and-line gear (50 CFR 622.42(c)(1)(i)(A)( 2 )).

In accordance with 50 CFR 622.44(a)(2)(ii)(B), from the date that 75 percent of the subzone's hook-and-line gear quota has been harvested until a closure of the west coast subzone's hook-and-line fishery has been effected or the fishing year ends, king mackerel in or from the EEZ may be possessed on board or landed from a permitted vessel in amounts not exceeding 500 lb (227 kg) per day.

NMFS has determined that 75 percent of the hook-and-line quota for Gulf group king mackerel from the Florida west coast subzone was reached on January 23, 2000. Accordingly, a 500-lb (227-kg) trip limit applies to vessels in the commercial hook-and-line fishery for king mackerel in or from the EEZ in the Florida west coast subzone effective 12:01 a.m., local time, January 24, 2000.

The Florida west coast subzone extends from 87°31′06″ W. long. (due south of the Alabama/Florida boundary) to: (1) 25°20.4′ N. lat. (due east of the Miami-Dade/Monroe County, FL, boundary) through March 31, 2000; and (2) 25°48′ N. lat. (due west of the Monroe/Collier County, FL, boundary) from April 1, 2000 through October 31, 2000.

This action responds to the best available information recently obtained from the fishery. The reduced trip limit must be implemented immediately because 75 percent of the quota has been harvested. Any delay in implementing this action would be impractical and contrary to the Magnuson-Stevens Act, the FMP, and the public interest. NMFS finds for good cause that the implementation of this action cannot be delayed for 30 days. Accordingly, under 5 U.S.C. 553(d), a delay in the effective date is hereby waived.

This action is taken under 50 CFR 622.44(a)(2)(iii) and is exempt from review under E.O. 12866.