On October 5, 1999, President Clinton signed S. 1059, the National Defense Authorization Act for Fiscal Year 2000, Public Law 106-65. Section 651 of this Act repeals section 5532 of title 5, United States Code, effective retroactively to October 1, 1999. This action ended two reductions in retired or retainer pay previously required of retired members of a uniformed service who are employed in civilian offices or positions of the U.S. Government. This repeal affects positions in the legislative, executive, and judicial branches of the Government of the United States (including Government corporations, nonappropriated fund instrumentalities under the jurisdiction of the armed forces, and the U.S. Postal Service).

This repeal ends the following two reductions in military retired pay that applied to some Federal employees who had retired from a uniformed service:

1. The pay cap that limited the combined total of Federal civilian basic pay plus military retired pay to $110,700 (Executive Level V) for all Federal employees who retired from a uniformed service; and

2. The partial reduction in retired pay required of retired officers of a regular component of a uniformed service.

The Guide to Processing Personnel Actions (GPPA) prior to January 2, 2000 required sending a copy of the Notification of Personnel Action (SF-50) for retired members of a uniformed service to the appropriate uniformed service finance center for all covered personnel actions. OPM and the Department of Defense agreed that this Act eliminated the statutory basis for sending a copy of personnel actions effective on or after October 1, 1999. Accordingly, OPM eliminated this requirement in GPPA Update 33, dated January 2, 2000. Agencies should not send covered personnel actions for military retirees with effective dates on or after October 1, 1999.

The repeal of 5 U.S.C. 5532 does not repeal two other parts of the Dual Compensation Act of 1964. This Act adopted a “fresh start” policy for military retirees and established limits on service credit and veterans' preference to ensure that military retirees did not receive unfair advantages in pay and tenure over civilian employees, including other veterans. As a result, unlike other former service members, retired members of a uniformed service generally cannot count their service time as creditable service for retention (RIF), annual leave accrual, and retirement purposes (see 5 U.S.C. 3501(a), 3502(a), 6303(a) and 8411(c)). On the other hand, retirement does not change a service member's entitlement to veterans' preference in the employment process.

This repeal does not affect the reduction in salary required of reemployed civilian annuitants under the Civil Service Retirement System (CSRS) and Federal Employees' Retirement System (FERS). Agencies may continue to request waivers of these reductions when appropriate under criteria in 5 CFR 553 and 5 U.S.C. 8344 or 8468.

The uniformed services finance centers are responsible for making all adjustments in military retired or retainer pay. Employee questions regarding restoration of retired pay should be directed to the appropriate uniformed service finance center. These finance centers are identified in Chapter 8, of the Guide to Processing Personnel Actions, page 8-19, issued February 26, 1999 [http://www.opm.gov/feddata/GPPA/Gppa.htm].

Pursuant to 5 U.S.C. 553(b)(3)(B), I find that good cause exists for waiving the general notice of proposed rulemaking because it would be contrary to the public interest to delay access to benefits provided by law. Also, pursuant to 5 U.S.C. 553(d)(3), I find that good cause exists to waive the effective date and make this amendment effective in less than 30 days in order to implement immediately statutory language in Sec. 651 of the National Defense Authorization Act for Fiscal Year 2000, Public Law 106-65, that is effective retroactively to October 1, 1999.

I certify that these regulations will not have a significant economic impact on a substantial number of small entities (including small businesses, small organizational units, and small governmental jurisdictions) because the regulations apply only to appointment procedures for certain employees in Federal agencies.

This interim rule has been reviewed by the Office of Management and Budget in accordance with Executive Order 12866.

This rule is issued under Marketing Agreement No. 148 and Order No. 932, both as amended (7 CFR part 932), regulating the handling of olives grown in California, hereinafter referred to as the “order.” The marketing agreement and order are effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”

The Department is issuing this rule in conformance with Executive Order 12866. This rule has been reviewed under Executive Order 12988, Civil Justice Reform. Under the marketing order now in effect, California olive handlers are subject to assessments. Funds to administer the order are derived from such assessments. It is intended that the assessment rate as issued herein will be applicable to all assessment olives beginning on January 1, 2000, and continue until amended, suspended, or terminated. This rule will not preempt any State or local laws, regulations, or policies, unless they present an irreconcilable conflict with this rule.

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

This rule continues the decrease in the assessment rate established for the Committee for the 2000 and subsequent fiscal years from $26,18 per ton to $21.73 per ton of olives handled.

The California olive marketing order provides authority for the Committee, with the approval of the Department, to formulate an annual budget of expenses and collect assessments from handlers to administer the program. The members of the Committee are producers and handlers of California olives. They are familiar with the Committee's needs and with the costs for goods and services in their local area and are thus in a position to formulate an appropriate budget and assessment rate. The assessment rate is formulated and discussed in a public meeting. Thus, all directly affected persons have an opportunity to participate and provide input.

For the 1999 and subsequent fiscal years, the Committee recommended, and the Department approved, an assessment rate that would continue in effect from fiscal year to fiscal year unless modified, suspended, or terminated by the Secretary upon recommendation and information submitted by the Committee or other information available to the Secretary.

The Committee met on December 9, 1999, and unanimously recommended fiscal year 2000 expenditures of $2,472,235 and an assessment rate of $21.73 per ton of olives. In comparison, last year's budgeted expenditures were $1,845,185. Recommended budget expenditures for research are significantly higher this year because of higher anticipated research expenses. The higher research budget of $868,550 is needed to fund: (1) Continued research and development of the mechanical olive harvester and (2) scientific studies to develop chemical or biological defenses to counteract a potential threat from the olive fruit fly in the California production area.

The following table compares major budget expenditure recommendations for the 2000 fiscal year with those from last year.

The assessment rate recommended by the Committee was derived by considering anticipated expenses, an estimated assessable tonnage, and additional pertinent factors. The estimate of assessable olives for the 2000 fiscal year is 113,750 tons. This compares to an assemble tonnage of 67,990 for fiscal year 1999. The increase in fiscal year 2000, due in large part to the alternate-bearing nature of olives, allowed the Committee to lower the assessment rate from $26.18 to $21.73 per ton, a decrease of $4.45. Income derived from handler assessments, interest, and carryover of reserve funds will be adequate to cover budgeted expenses. Funds in the reserve at the end of fiscal year 2000 will be less than the maximum permitted by § 932.40 of the order (approximately one fiscal year's expenses).

The assessment rate will continue in effect indefinitely unless modified, suspended, or terminated by the Secretary upon recommendation and information submitted by the Committee or other available information.

Although this assessment rate is effective for an indefinite period, the Committee will continue to meet prior to or during each fiscal year to recommend a budget of expenses and consider recommendations for modification of the assessment rate. The dates and times of Committee meetings are available for the Committee or the Department. Committee meetings are open to the public and interested persons may express their views at these meetings. The Department will evaluate Committee recommendations and other available information to determine whether modification of the assessment rate is needed. Further rulemaking will be undertaken as necessary. The Committee's fiscal year 2000 budget and those for subsequent fiscal years will be reviewed and, as appropriate, approved by the Department.

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

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

There are approximately 1,200 producers of olives in the production area and 3 handlers subject to regulation under the marketing order. Small agricultural producers have been defined by the Small Business Administration (13 CFR 121.201) as those having annual receipts less than $500,000, and small agricultural service firms are defined as those whose annual receipts are less than $5,000,000. None of the olive handlers may be classified as small entities, while the majority of olive producers may be classified as small entities.

This rule continues the decrease in the assessment rate established for the Committee and collected from handlers for the 2000 and subsequent fiscal years from $26.18 per ton to $21.73 per ton of olives. The Committee unanimously recommended fiscal year 2000 expenditures of $2,472,235 and an assessment rate of $21.73 per ton. The assessment rate of $21.73 is $4.45 lower than the 1999 rate. The estimated quantity of assessable olives for the 2000 fiscal year is 113,750 tons. Thus, the $21.73 rate should be adequate to meet this year's budgeted expenses, when combined with funds from the authorized reserve and interest income.

The following table compares major budget expenditure recommendations for the 2000 fiscal year with those from last year.

The higher research budget of $868,550 is needed to fund: (1) Continue research and development of the mechanical olive harvester and (2) scientific studies to develop chemical and scientific defenses to counteract a potential threat from the olive fruit fly in the California production area.

A lower assessment rate was recommended for fiscal year 2000 because the estimated 2000 fiscal year assessable tonnage is approximately 40 percent larger than last fiscal years tonnage, due in large part to the alternate bearing nature of the crop. A comparison of assessable tonnage for fiscal year 2000 with the two previous fiscal years is listed below:

The Committee reviewed and unanimously recommended fiscal year 2000 expenditures of $2,472,235, which reflects increases in the research, market development, and administrative budgets. Prior to arriving at this budget, the Committee considered information from various sources, such as the Committee's Executive Subcommittee, the Research Subcommittee, and the Marketing Subcommittee. Alternate spending levels were discussed by these groups, based upon potential reductions in the funding of various research and marketing projects. The Committee determined it was not necessary to increase the assessment rate to cover these expenses because the increased estimated tonnage will provide sufficient funds to cover anticipated expenses. The assessment rate of $21.73 per ton of assessable olives was derived by considering anticipated expenses, as estimated assessable tonnage of olives, and additional pertinent factors.

A review of historical and preliminary information pertaining to the current fiscal year indicates that the grower revenue for the 1999-2000 crop year will approximate $64,126,725. With an assessment rate of 421.73 per ton and assessable tonnage totaling 113,750 tons, the Committee's assessment revenue for fiscal year 2000 will be $2,471,788, or approximately 3.9 percent of grower revenue.

This action continues to decrease in the assessment obligation imposed on handlers for fiscal year 2000 by $506,187. Assessments are applied uniformly on all handlers, and some of the costs may be passed on to producers. However, decreasing the assessment rate reduces the burden on handlers, and may reduce the burden on producers. In addition, the Committee's meeting was widely publicized throughout the California olive industry and all interested persons were invited to attend the meeting and participate in Committee deliberations on all issues. Like all Committee meetings, the December 9, 1999, meeting was a public meeting and all entities, both large and small, were able to express views on this issue.

This action imposes no additional reporting or recordkeeping requirements on California olive handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.

The Department has not identified any relevant Federal rules that duplicate, overlap, or conflict with this rule.

An interim final rule concerning this action was published in the Federal Register on January 19, 2000 (65 FR 2839). Copies of that rule were also mailed or sent via facsimile to all commodity handlers. Finally, the interim final rule was made available through the Internet by the Office of the Federal Register. A 60-day comment period was provided for interested persons to respond to the interim final rule. The comment period ended on March 20, 2000, and no comments were received.

A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at the following web site: http://www.ams.usda.gov/fv/moab. html. Any questions about the compliance guide should be sent to Jay Guerber at the previously mentioned address in the FOR FURTHER INFORAMTION CONTACT section.

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

The National Aeronautics and Space Administration published a Final Rule to revise its Freedom of Information Act (FOIA) regulations on July 22, 1999 (64 FR 39404), in accordance with the EFOIA of 1996 as amended by Public Law 104-231. This amendment provides clarification of an inconsistency in that Final Rule. This amendment removes § 1206.610(e)(4) so that § 1206.610(e) is consistent with the provisions of § 1206.610(d).

Public Law 104-251 (110 Stat. 3161), commonly known as the Railroad Unemployment Insurance Act Amendments of 1996, amended the Railroad Unemployment Insurance Act (RUIA) to shorten the waiting period for receipt of unemployment and sickness benefits payable under that statute, to change the method of computing the daily benefit rate, and to eliminate certain extended payments of benefits, and the Board amends its regulations under the RUIA to conform to those amendments.

Section 325.1 is amended to reflect the change in the waiting period for unemployment benefits from 14 days to seven days. As amended, § 325.1 would provide that unemployment benefits are payable to any qualified employee for each day of unemployment in excess of seven in his or her first two-week registration period, and then for up to ten days of unemployment in any subsequent registration period within the same period of continuing unemployment. However, if the unemployment is the result of a strike, no benefits are payable for the first day 14 days of unemployment. For purposes of applying the seven-day waiting period, a period of continuing unemployment would end when an employee exhausts his or her unemployment benefits for a benefit year. Section 325.1 would also be amended to incorporate a definition of “period of continuing unemployment”, a concept added by the 1996 amendments. The concept of a period of continuing unemployment was added to the RUIA so as to permit the continued payment of benefits from one benefit year to the next without a new waiting period if the period of unemployment runs from one year to the next. Finally, § 325.1 is amended to provide that if an employee's earnings in a registration period exceed the monthly compensation base for the applicable base year, then no unemployment benefits are payable in that registration period. For example, for benefit year 2000 the base year is calendar year 1999 in which the monthly compensation base was $970. No benefits are payable for any days of unemployment in the benefit year beginning July 1, 2000, for any registration period in which the employee earns more than $970. An employee who declines suitable work during a registration period is treated as having earned the amount of earnings he would have received had he not declined employment.

Section 330.2 is amended to provide that the maximum daily benefit rate under the RUIA is the monthly compensation base, as computed under 20 CFR part 302, multiplied by 5%, rounded down to the nearest $1. This change is the result of a change in the RUIA enacted under the 1996 amendments. The Board will publish the maximum daily benefit rate for the upcoming benefit year by June 1 of each year.

Section 335.6 is revised to reflect the same changes with respect to the waiting period for sickness benefits that the amendments to § 325.1 make with respect to unemployment benefits.

Finally, § 336.13 is revised, and § 336.14 is amended to reflect a change in the payment of extended benefits made by the 1996 amendments. Under the RUIA, as amended, an employee with ten or more years of service will receive a maximum of 65 days of extended unemployment or sickness benefits after the employee has exhausted his or her normal 130 days of unemployment or sickness.

The Board published this rule as a proposed rule on December 3, 1999 (64 FR 67811), and invited comments by February 1, 2000. No comments were received.

The Board, with the concurrence of the Office of Management and Budget, has determined that this is not a significant regulatory action under Executive Order 12866; therefore no regulatory impact analysis is required. There are no information collections associated with these rules.

In the Federal Register of November 23, 1983 (48 FR 53023), FDA published a final rule classifying into class III (premarket approval) the penile inflatable implant, a medical device. Section 876.3350 (21 CFR 876.3350) of FDA's regulations setting forth the classification of the penile inflatable implant applies to: (1) Any penile inflatable implant that was in commercial distribution before May 28, 1976, and (2) any device that FDA has found to be substantially equivalent to a penile inflatable implant in commercial distribution before May 28, 1976.

In the Federal Register of April 28, 1993 (58 FR 25902), FDA published a proposed rule, under section 515(b) of the act (21 U.S.C. 360e(b)), to require the filing of PMA's or PDP's for the classified penile inflatable implant and all substantially equivalent devices (hereinafter referred to as the April 1993 proposed rule). In accordance with section 515(b)(2)(A) of the act, FDA included in the preamble, the agency's proposed findings regarding: (1) The degree of risk of illness or injury designed to be eliminated or reduced by requiring the device to meet the premarket approval requirements of the act, and (2) the benefits to the public from use of the device.

The preamble also provided an opportunity for interested persons to submit comments on the proposed rule and the agency's proposed findings. Under section 515(b)(2)(B) of the act, it also provided an opportunity for interested persons to request a change in the classification of the device based on new information relevant to its classification. Any petition requesting a change in the classification of the penile inflatable implant was required to be submitted by May 13, 1993. The comment period initially closed on June 28, 1993. In the Federal Register of July 1, 1993 (58 FR 35416), FDA extended the comment period for 60 days to August 27, 1993, to ensure that there was adequate time for preparation and submission of comments on the proposed rule.

The agency received 32 comments in response to the April 1993 proposed rule. These comments were from physicians and other health care providers, professional organizations, physician groups, manufacturers, and consumers and other individuals. Most of the comments supported the proposed rule.

This regulation is final upon publication and requires PMA's or notices of completion of a PDP for all penile inflatable implants classified under § 876.3350 and all devices that are substantially equivalent to them. PMA's or notices of completion of a PDP for these devices must be filed with FDA within 90 days of the effective date of this regulation. (See section 501(f)(1)(A) of the act (21 U.S.C. 351(f)(1)(A)).) This regulation does not include the penile rigidity implant (21 CFR 876.3630).

(Comment 1) FDA received 23 comments from individual physicians and 2 comments from professional medical organizations. Although the majority of these comments did not object to the proposed call for PMA's or PDP's, they voiced the following common concerns: (1) Erectile dysfunction is a serious medical problem affecting tens of millions of American men and their partners, (2) removal of this device from the U.S. market would be detrimental to public health, and (3) citing the 25 years of use of the device, sufficient historical data exist to evaluate the safety and effectiveness of the penile inflatable implant. This last concern was also noted in two comments from penile inflatable implant manufacturers, which stated that the decades of medical literature regarding the risks and benefits of this device provide sufficient evidence of its safety and effectiveness. Several comments remarked that FDA has overstated the risks of the inflatable penile implant.

FDA agrees that erectile dysfunction is a significant medical problem that negatively affects the lives of more than 10 million men in the United States. Furthermore, since penile inflatable implants represent an important option in the treatment of erectile dysfunction, FDA agrees with these comments that removal of the penile inflatable implant from the market would negatively impact public health. As a result of this concern, FDA has taken the following steps to promote the continued availability of the penile inflatable implant during the call for PMA's or PDP's: (1) FDA issued the guidance document entitled “Draft Guidance for Preparation of PMA Applications for Penile Inflatable Implants” in March 1993 (the 1993 guidance document) to provide industry with detailed recommendations on the content of PMA's; (2) FDA has communicated closely with each penile inflatable implant manufacturer to address the concerns identified in the proposed rule using least burdensome methods, as well as provided recommendations on the design of preclinical and clinical studies; and (3) FDA intentionally postponed the call for PMA's or PDP's to allow manufacturers to collect sufficient data to support the filing of a PMA or PDP.

FDA agrees with the comments that there is a significant amount of information in the published and unpublished literature regarding the penile inflatable implant. However, to FDA's knowledge, these studies are neither sufficiently detailed nor properly designed to perform a statistically valid evaluation of the safety and effectiveness of any of the specific device models currently on the market. As recommended in the 1993 guidance document, PMA's or PDP's should contain safety and effectiveness information on the specific device model(s) proposed in the application. Although a large body of historical data exists regarding the clinical outcomes of models of penile inflatable implants that are no longer marketed, there is less information available regarding the safety and effectiveness of currently-marketed models. However, if sufficient historical information exists to document the safety and effectiveness of a particular penile inflatable implant model that a manufacturer desires to market, or if data about earlier models are directly relevant to a particular device, FDA encourages the use of these data in support of a PMA or PDP for that model.

While FDA agrees that the April 1993 proposed rule may have overstated the risks of some of the specific penile inflatable implant models that are currently on the market, we believe that the information in the proposed rule represents a reasonable estimate of the risks and benefits of the entire category of penile inflatable implants. As noted in many of these comments, manufacturers have made numerous design modifications to improve the reliability of the penile inflatable implant and the medical community continues to improve the patient selection criteria, patient counseling information, operative technique, and postoperative care to reduce the incidence of complications. Therefore, FDA expects the rates of complications reported in PMA's or PDP's for particular penile inflatable implants to be lower than estimated from a review of the literature on the entire device category. However, in writing the proposed call for PMA's or PDP's, FDA must consider the risks and benefits of all penile inflatable implants that currently have legally marketed status in the United States.

(Comment 2) FDA received one comment from a penile inflatable implant recipient, who is supportive of the proposed call for PMA's or PDP's. This consumer has received a total of four devices to date, and his most recent device has failed, requiring replacement. He states that the penile inflatable implant affects both his quality of life and manhood.

FDA agrees that the potential benefits of a penile inflatable implant include improvements in quality of life and self-image, and notes that these secondary benefits of penile inflatable implant implantation were cited in the proposed call for PMA's or PDP's. Furthermore, FDA believes that requiring the submission of PMA's or PDP's for the penile inflatable implant will allow FDA to assess the risks and benefits of specific devices in order to determine whether there is reasonable assurance of their safety and effectiveness.

(Comment 3) One comment stated that FDA's assessment of the risks of penile inflatable implants is inconsistent with FDA's assessment of the risks of class II silicone prostheses such as the bone cap (21 CFR 888.3000), chin prosthesis (21 CFR 878.3550), the ear prosthesis (21 CFR 878.3590), and the finger joint prosthesis (21 CFR 888.3230).

FDA is aware of the existence of information on silicone and silicone-containing prostheses, and expects that applicants may include such information in their submissions to support the safety and effectiveness of the penile inflatable implant. However, FDA does not believe that the existing information on silicone and silicone-containing prostheses can be used as the sole basis of establishing the safety and effectiveness of the penile inflatable implant, and believes that a determination of safety and effectiveness of the penile inflatable implant must be made, at least in part, on data collected on each particular device for which a PMA or PDP is submitted. FDA will consider all information contained in PMA's and PDP's in determining whether there is reasonable assurance of safety and effectiveness of this device.

(Comment 4) Many comments noted that FDA was incorrect in stating that some penile inflatable implant models contain silicone gel. These comments concluded, therefore, that the risks of silicone gel do not apply to the penile inflatable implant.

FDA disagrees with the comments that no penile inflatable implant contains silicone gel. Although silicone gel has never been used as a penile inflatable implant inflation medium, FDA is aware of at least one device model, no longer marketed in the United States, that contained silicone gel within its cylinder tip. FDA agrees with the comments that the potential risks of silicone gel are not applicable to penile inflatable implants that do not contain silicone gel.

The agency would not expect PMA's or PDP's for those devices to address the risks related to silicone gel.

(Comment 5) One comment objected that Congress never intended “old” preamendments medical devices to undergo the same scrutiny as “new” postamendments medical devices.

FDA does not believe that Congress intended to differentiate between “old” preamendments devices and “new” postamendments device with respect to the requirement that valid scientific evidence is needed to support PMA approval. Neither section 513(a)(3) (21 U.S.C. 360c(a)(3)) nor section 515(d) of the act makes any distinction between “old” and “new” devices with regard to any aspect of the requirement for PMA approval.

(Comment 6) One comment stated that FDA should allow an appropriate timeframe prior to issuance of the call for PMA's or PDP's for the following reasons: (1) FDA needs sufficient time to develop additional guidance on the data requirements for PMA's and PDP's; (2) since several of the main suppliers of silicone and polyurethane raw materials have announced a planned withdrawal of these products from the market, penile inflatable implant manufacturers need sufficient time to qualify and test new materials; and (3) device manufacturers need sufficient time to collect the preclinical and clinical data recommended by FDA.

FDA believes there has been sufficient time for PMA and PDP sponsors to develop data and address the issues identified as potential risks. Section 515(b) of the act does not require the agency to provide guidance on the contents of specific PMA's. However, FDA issued the 1993 guidance document to provide industry with detailed recommendations on the appropriate data to be included in PMA's and PDP's for penile inflatable implants. The 1993 guidance document is available from the Internet at www.fda.gov/cdrh/ode/oderp810.html. In order to receive the 1993 guidance document via your fax machine, call the CDRH Facts-On-Demand (FOD) system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the system and then enter the document number (810) followed by the pound sign (#). Follow the remaining voice prompts to complete your request. While the 1993 guidance document continues to remain in effect, FDA plans to revise this document in the near future to incorporate many of the comments subsequently received from the industry and public. Furthermore, the agency encourages penile inflatable implant manufacturers to meet with FDA before submitting a PMA or PDP to obtain additional guidance regarding the recommended data to submit to demonstrate the safety and effectiveness of each specific device model proposed for market approval.

In addition, the period of time between the classification of the device in 1983 and the date by which PMA's must be filed is more than 16 years. Thus, FDA believes that sufficient time and guidance have been provided to allow sponsors to develop the data for a PMA submission.

FDA agrees that dialogue with industry and with the scientific community and medical community is important. To elicit early public discussion on the 1993 guidance document and the agency's plans to call for PMA's or PDP's for the penile inflatable implant, FDA called a meeting of the Gastroenterology and Urology Devices Advisory Panel on April 15, 1993, to discuss these topics. Following publication of the proposed call for PMA's or PDP's, FDA communicated closely with each penile inflatable implant manufacturer to address the concerns identified by FDA in the April 1993 proposed rule, as well as provide recommendations on the design of preclinical and clinical studies for their particular device models. Furthermore, FDA staff have been and continue to be accessible to discuss PMA and PDP content information with industry and the scientific and medical community.

(Comment 7) One comment stated that FDA was incorrect in its determination that the penile inflatable implant has a high priority for initiating a proceeding to require premarket approval due to inappropriate comparison to potential adverse effects of silicone gel breast implants and due to the volume of Medical Device Reports (MDR's) received to date for penile inflatable implants. The comment further noted that an early call for PMA's or PDP's is unwarranted since the penile inflatable implant was not included in the January 6, 1989 (54 FR 550), list of 31 “high priority” preamendments class III devices.

FDA believes the call for PMA's or PDP's for this device cannot be considered an “early” call in light of its classification in 1983 and the proposed call for PMA's in 1993.

By adding section 515(i) to the act in the Safe Medical Devices Act of 1990 (Public Law 101-629), Congress made it clear that it expected FDA to move forward expeditiously to either require premarket approval or notices of completion of PDP for all preamendments class III devices or to reclassify them into class I or class II. Therefore, FDA believes that it is appropriate to issue this final rule at this time.

(Comment 8) There were 19 comments on the risk of infection. Several comments stated that the incidence of infection associated with the implantation of penile inflatable implants is not any higher than it is for other implantation surgeries. Many of these comments further stated that the risk of infection is minimized by proper patient selection, meticulous attention to sterile technique during device implantation, and adherence to appropriate postoperative precautions. Several comments stated that infection, if it occurs, often can be successfully controlled without the need for device removal if it is recognized early and treated with appropriate aggressive antibiotic therapy with or without drainage and wound irrigation. One comment added that infections of penile inflatable implants only rarely result in an inability to replace the device due to corporeal fibrosis and cavernositis.

FDA agrees that the risk of infection can be minimized by proper patient selection, surgical precautions, and postoperative care. However, FDA believes that it is important for studies submitted in a PMA or PDP to provide accurate information on the incidence and consequences of infection associated with the implantation of the penile inflatable implant. As noted in the 1993 guidance document, FDA is requesting information on the incidence of infection for this device.

(Comment 9) There were 13 comments regarding the risks of migration and extrusion. These comments stated that migration and extrusion of penile inflatable implants occur infrequently, are directly related to infection or excessive pressure of the prosthesis on surrounding tissues, and are minimized by properly placing an appropriately sized device using appropriate surgical techniques. For these reasons, several comments stated that migration and extrusion should not be labeled as “significant risks” of implantation of the device.

While FDA agrees that migration and extrusion can be minimized by proper device sizing and placement, insufficient information is available to determine the frequency of this event or its effects. Therefore, FDA believes that it is important for studies submitted in a PMA or PDP to provide accurate information on the incidences of migration and extrusion associated with the implantation of the penile inflatable implant.

FDA disagrees with the comment that migration and extrusion are not significant risks. Migration and extrusion of the penile inflatable implant can lead to surgical intervention, making them serious risks to health. As noted in the 1993 guidance document, FDA is requesting information to address the incidences of migration and extrusion for this device.

(Comment 10) There were 13 comments regarding the risk of erosion. These comments stated that, similar to migration and extrusion, erosion of penile inflatable implants occurs infrequently, is directly related to infection or excessive pressure of the prosthesis on surrounding tissues, and is minimized by properly placing an appropriately sized device using appropriate surgical techniques. For these reasons, several comments stated that erosion should not be labeled as a “significant risk” of implantation of the device.

While FDA agrees that the risk of erosion can be minimized by proper device sizing and placement, insufficient information is available to determine the frequency of this event or its consequences. Therefore, FDA believes that it is important for studies submitted in a PMA or PDP to provide accurate information on the incidence of erosion associated with the implantation of the penile inflatable implant.

FDA disagrees with the comment that erosion is not a significant risk. Erosion of the penile inflatable implant can require surgical intervention, making it a serious risk to health. As noted in the 1993 guidance document, FDA is requesting information to address the incidence of erosion for this device.

(Comment 11) FDA received 15 comments regarding the risk of fibrous capsule formation. Most of these comments stated that fibrous capsule formation is part of the body's normal reaction to an implanted device, and is not harmful to the patient. One comment stated that fibrous capsule formation does not adversely affect the function of the penile inflatable implant, while several others acknowledged that the fibrotic capsule can keep the reservoir or other device components from completely filling, thus hindering the ability of the device to fully inflate or deflate. Many of the comments regarding the effect of fibrous capsule formation upon inflation and deflation of the penile inflatable implant further stated that this risk can be minimized by leaving the device deflated during the healing period so that the capsule formed around the reservoir minimally impedes refilling. One comment further stated that FDA was wrong to refer to fibrous capsule formation as a “foreign body reaction,” since fibrotic reactions are not only related to the material of the implant but also to other factors such as loading forces on the implant and the patient's biological tendency to form a scar. Two comments stated that fibrous capsule formation is only problematic with static prostheses, such as breast implants, and, therefore, is not a concern with penile inflatable implants.

FDA agrees that fibrous capsule formation is part of the body's normal reaction to all implanted devices including penile inflatable implants, and is usually not life-threatening. Also, FDA recognizes that the severity of this risk to health is dependent upon multiple factors other than foreign body reaction. Furthermore, FDA agrees that the risk of inflation/deflation difficulties secondary to fibrous capsule formation around the reservoir can be minimized by proper postoperative care. However, FDA believes that fibrous capsule formation can affect the function of the penile inflatable implant and is potentially serious. Severe fibrous capsule formation has been reported to impede the ability of the penile inflatable implant to operate as it is designed, which reduces or eliminates the benefit of the device. In addition, the recipient may then elect to have his implant surgically explanted and have a second device implanted. This additional surgery makes fibrous capsule formation a potentially serious adverse event. As noted in the 1993 guidance document, FDA is requesting information to address the incidence of fibrous capsule formation for this device.

(Comment 12) There were 14 comments regarding the risk of mechanical malfunction. All of these comments stated that while early models of penile inflatable implants were associated with high rates of mechanical malfunction, improvements in device design and implantation technique have steadily decreased the failure rate. Several of these comments added that the mechanical malfunction rate of current device designs ranges from “rare” to 1 to 3 percent. One comment added that FDA's statement that a penile inflatable implant “should not be considered a lifetime implant” is inaccurate, since prostheses may be expected to endure indefinitely with the proviso that there is a risk of mechanical failure.

FDA agrees that the mechanical malfunction rate of the penile inflatable implant has significantly decreased as compared to early models. Despite this observed trend, however, insufficient information is available to determine the frequency of this event for each of the particular device models that manufacturers intend to market following the effective date of this regulation. Therefore, FDA believes that it is important for studies submitted in a PMA or PDP to provide accurate information on the incidence of mechanical malfunction associated with the implantation of the penile inflatable implant.

FDA disagrees with the comment that the penile inflatable implant can be considered a lifetime implant. As complex mechanical devices, penile inflatable implants are subject to wear over time and, therefore, have finite lifetimes. The fact that each device carries the risk of mechanical failure, as acknowledged in the comment, underscores the need to inform patients that the device should not be expected to function indefinitely.

(Comment 13) FDA received 11 comments regarding the risk of iatrogenic disorders. These comments stated that iatrogenic disorders occur infrequently, are minimized with proper operative technique and surgeon experience, are not directly related to the device, and are medical issues outside the domains of clinical testing and premarket review.

FDA agrees that iatrogenic disorders are infrequent events which are reduced through adherence to proper surgical technique. FDA also agrees that the medical community has had a major role in defining these surgical practices in an effort to minimize the incidence of iatrogenic disorders. However, FDA believes that iatrogenic disorders are, in part, device related, since issues of sizing, device assembly, and implantation technique are influenced by the specific device design being implanted. As a result, FDA believes that iatrogenic disorders should be evaluated in the clinical testing and premarket review of penile inflatable implants so that the product-specific information obtained from such testing is appropriately incorporated into the labeling of that device model. As noted in the 1993 guidance document, FDA is requesting information to address the incidence of iatrogenic disorders for this device.

(Comment 14) There were 14 comments regarding the risk of patient dissatisfaction. These comments stated that patient dissatisfaction is infrequent and is only rarely the primary cause for reoperation. Additionally, many comments stated that patient dissatisfaction is the result of the patient having unrealistic expectations regarding the postimplantation appearance and function of his penis, and that this situation can be minimized by requiring thorough preoperative counseling regarding the realistic outcomes of device implantation. One physician comment stated that none of his patients had ever asked him to have a penile inflatable implant removed due to dissatisfaction.

FDA agrees that the majority of patients who receive penile inflatable implants report satisfaction with their device. Additionally, FDA concurs with the comments that patient dissatisfaction is typically the result of the patient having unrealistic expectations regarding the implant, and can be minimized by patient educational measures such as patient labeling and physician counseling. However, since patient dissatisfaction can ultimately require surgical intervention, FDA considers patient dissatisfaction a risk that should be addressed by manufacturers. Furthermore, since implantation of a penile inflatable implant may destroy any latent erectile capability the patient may have had, as well as make other, more conservative forms of treatment for erectile dysfunction difficult or impossible, dissatisfied patients are left with few recourses. To assess and optimize the adequacy of information materials available to potential implant recipients, FDA believes it is essential to evaluate the frequency of this event and its consequences. Therefore, FDA believes it is important for studies submitted in a PMA or PDP to provide accurate information on the incidence of patient dissatisfaction associated with the implantation of the penile inflatable implant.

(Comment 15) Sixteen comments were received regarding the risk of human carcinogenicity. These comments stated that there is no evidence in the medical literature that the penile inflatable implant is associated with the development of cancer. Furthermore, nine of these comments were from physicians, who stated that they had not observed carcinogenicity in their personal experiences with these devices. One physician comment added that while carcinogenicity has not been proven to occur with the penile inflatable implant, further research is necessary to rule out this potential complication. Several comments stated that silicone causes solid state tumors in rodents, a phenomenon thought to be restricted to rodents and not applicable to humans. These comments also stated that epidemiological studies have not found that women with silicone breast implants, which contain silicone elastomers similar or identical to those used in the penile inflatable implant, are at an increased risk for cancer. Several comments stated that human carcinogenicity should be removed from the list of significant risks associated with the penile inflatable implant.

FDA believes that the potential carcinogenicity for this device remains unknown. The agency continues to believe that carcinogenicity is a potential risk that must be assessed in a PMA or PDP.

(Comment 16) There were 16 comments related to human reproductive and teratogenic effects. These comments stated that there is no evidence that the penile inflatable implant is teratogenic. Nine comments from physicians stated that they had not observed reproductive and teratogenic effects in their personal experiences with these devices, one of whom added that further research is necessary to rule out this potential complication. Two comments stated that since most implant patients are beyond the age of fathering children, the risks of reproductive problems and teratogenic effects are not significant concerns. Furthermore, the small numbers of patients who do receive a device during their reproductive ages would not warrant a prospective study. Several comments stated that human reproductive and teratogenic effects should be removed from the list of significant risks associated with the penile inflatable implant.

FDA agrees that there are no published studies showing that penile inflatable implants are associated with toxic reproductive effects or teratogenic effects. However, FDA believes that the reproductive and/or teratogenic effects of these products remain potential risks that should be assessed in a PMA or PDP.

(Comment 17) There were 16 comments regarding the risks of immune related connective tissue disorders and immunological sensitization. These comments stated that there is no evidence that the penile inflatable implant causes either immune related connective tissue disorders or immunological sensitization. Nine comments from physicians stated that they had not observed connective tissue disorders and other immunological effects in their personal experiences with these devices. Two comments stated that further research is necessary to rule out this potential complication. Several comments stated that no definitive link between silicone and autoimmune diseases has been established. Furthermore, several comments stated that since the diseases most frequently associated with autoimmune responses occur at a lower frequency in men than women, it may be impossible to extrapolate the findings from any study of silicone breast implants to the penile inflatable implant. Several comments stated that immune related connective tissue disorders and immunological sensitization should be removed from the list of significant risks associated with the penile inflatable implant.

FDA agrees that no definitive causal relationship has been established between immunological effects and/or connective tissue disorders and the penile inflatable implant. Epidemiological data published within the last several years (Refs. 3, 4, and 5) addressing the relationship between silicone breast prostheses and autoimmune diseases or connective tissue diseases indicate that silicone breast prostheses have not caused a large increase in the incidence of connective tissue disease in women with breast implants. However, the possibility of a smaller, increased risk of immunological effects among men with penile inflatable implants, or of an atypical, as yet undefined, syndrome or disease, cannot be eliminated based on these data. FDA is aware that differences in the incidence of such disorders between men and women make extrapolation of the results of breast implant studies to the outcome of the penile inflatable implant difficult. In the 1993 guidance document, FDA recommends that a cohort of penile inflatable implant recipients be regularly monitored for the occurrence of such adverse events as part of an active surveillance program for a minimum of 5 years postimplantation. FDA continues to believe that adverse immune related connective tissue disorders and immunological sensitization remain potential risks that must be assessed in a PMA or PDP, but FDA does not believe that 5 years of prospective data collection on a specific product will be necessary before PMA approval or PDP completion.

(Comment 18) Five comments stated that fumed amorphous silica is so tightly bound in the silicone elastomer components of the penile inflatable implant that the fumed amorphous silica is biologically inactive. For that reason, these comments believed that the presence of fumed amorphous silica is not a risk to health of the penile inflatable implant. Two other comments stated that complications related to the release of silica from the penile inflatable implant have not been observed, although one of these comments added that further research is necessary to rule out this potential complication.

FDA does not believe there is sufficient information to eliminate fumed amorphous silica as a potential risk to health associated with the penile inflatable implant, particularly since the amount of fumed amorphous silica is varied in order to achieve the desired physical characteristics of the device's components. Consequently, the agency believes that this potential risk to health should be addressed in a PMA or PDP.

(Comment 19) There were seven comments regarding the risk of silicone particle shedding. Four of these comments stated that small, but clinically insignificant, quantities of silicone particles have been noted in the periprosthetic tissues and inguinal lymph nodes of some penile inflatable implant recipients. Two comments stated that there is no evidence of silicone particle shedding from the penile inflatable implant. One comment stated that minimal, if any, silicone particle shedding occurs with this device. Several of these comments concluded that silicone particle shedding is not a risk of the penile inflatable implant.

Based upon information presented in the comments, FDA agrees that silicone particle shedding is not a risk to health of the penile inflatable implant. Although silicone particle shedding and subsequent migration have been reported with penile inflatable implants (Ref. 1), the quantity of such particles was minimal and no deleterious effects were associated with this finding. Furthermore, subsequent research published after the proposed call for PMA's and PDP's was unable to document evidence of silicone particle migration (Ref. 2). FDA, therefore, does not believe silicone particle shedding is a risk that needs to be addressed in PMA's or PDP's for these devices.

(Comment 20) Several comments stated that silicone gel leakage and migration are not risks to health of this device since there are no penile inflatable implants that contain silicone gel.

FDA disagrees with the comments that no penile inflatable implant contains silicone gel. As stated in response to comment 4 of this document, FDA is aware of at least one device model, no longer marketed in the United States, that contained silicone gel within its cylinder tip. FDA agrees with the comments that the potential risks of silicone gel leakage and migration are not applicable to penile inflatable implants that do not contain silicone gel.

(Comment 21) There were three comments regarding the risk of polyurethane elastomer degradation. These comments stated that: (1) Currently marketed penile inflatable implants do not use polyurethane as a surface material, (2) in vitro testing regarding the degradation of polyurethane may not be predictive of degradation in vivo, and (3) there is no evidence in the literature of the release of either methylene diamine or toluene diamine in vivo from polyurethane.

FDA is aware of at least two penile inflatable implant models that have polyurethane elastomer as one of their surface materials; therefore, the agency does not agree with the comment that this material is not used. Furthermore, since the available information regarding the degradation of polyurethane elastomer is inconclusive, FDA does not believe there is sufficient information to eliminate it as a potential risk to health associated with the penile inflatable implant. Consequently, the agency believes that this potential risk to health should be addressed in a PMA or PDP. FDA believes that this potential risk is only applicable to penile inflatable implants that employ polyurethane elastomer as a surface, patient-contacting material.

(Comment 22) Several comments were received regarding the “other reported complications” of the penile inflatable implant (i.e., hematoma, chronic pain, erythema, edema, ulceration, necrosis, scarring, and urinary retention). These comments stated that these complications either occur infrequently, are transient, or are not judged by patients or physicians to be severe.

FDA believes that insufficient information is available to determine the frequency of these events or their consequences. Therefore, FDA believes that it is important for studies submitted in a PMA or PDP to provide accurate information on the incidence of all complications associated with the implantation of the penile inflatable implant.

(Comment 23) Many comments were received regarding FDA's description of the benefit of the penile inflatable implant. Several comments objected to FDA's statement that “device implantation is a discretionary surgical procedure performed for reasons related to quality of life, rather than medical reasons.” One comment stated that the benefits of the penile inflatable implant include penile reconstruction, in addition to quality of life improvement. This comment added that while many patients benefit with an improved quality of life, medical necessity and need are important indications for the use of penile inflatable implants. Another comment noted that the penile inflatable implant is, in fact, used to correct a medical problem—erectile dysfunction. A third comment argued that restoration of erectile function is analogous to surgical procedures to restore vision or hearing, or to salvage a limb, all of which could potentially be regarded as discretionary surgical procedures to improve quality of life.

Lastly, several comments stated that the benefits of the penile inflatable implant include improvement of quality of life, and the psychological benefits of the device should not be underestimated or undervalued. Furthermore, a comment from a penile inflatable implant recipient stated that the device impacts his “quality of life and manhood.”

As stated in the proposed call for PMA's or PDP's, FDA believes that the penile inflatable implant is designed to provide sufficient penile rigidity to permit sexual intercourse. The proposed rule further states that this device is intended for the treatment of erectile dysfunction resulting from many medical conditions, such as diabetes mellitus, spinal cord injury, Peyronie's disease, and pelvic surgery. FDA continues to believe that device implantation is usually elective in nature, and the agency agrees with the comments that the primary benefit of the penile inflatable implant is restoration of erectile function. As noted by these comments, however, many implant recipients also benefit with an improved quality of life and FDA does not intend to underestimate or undervalue this benefit.

(Comment 24) Three comments objected to FDA's reference to improved fertility as being an intended benefit of the penile inflatable implant. One comment agreed with the April 1993 proposed rule, noting that a benefit of the device is the restoration of the ability for young men with erectile dysfunction to father children naturally.

FDA agrees that restoration of male fertility should not be listed as a benefit of the penile inflatable implant. Although this device may have provided an opportunity for a small number of patients to father children naturally, the agency acknowledges that this consequence of the device should not be listed as a benefit of the penile inflatable implant for the following reasons: (1) The primary reason for device implantation is the treatment of erectile dysfunction; (2) no penile inflatable implant manufacturer promotes their device with the claim of restoration of fertility; and (3) the majority of penile inflatable implant candidates are beyond the age of which they desire to father children. The agency's response to these comments is consistent with the recommendations provided at an April 15, 1993, meeting of the Gastroenterology and Urology Devices Advisory Panel.

(Comment 25) Two comments objected to FDA's proposal that PMA's and PDP's analyze the prior treatment history and presurgical workup of penile inflatable implant recipients. They stated that it is physicians, in consultation with patients, who should decide the choice of treatment for erectile dysfunction, and that devices should not be treated any differently in this respect than pharmaceuticals where a physician has many different drugs available to treat a disorder and chooses the appropriate one based on the patient's needs.

FDA agrees that it should not interfere with the practice of medicine. However, the agency believes that manufacturers have a responsibility to report the circumstances of use of their device in the product's labeling, especially due to the potential for irreversible effects following implantation of a penile inflatable implant. Consequently, FDA believes that information regarding the prior treatment history and presurgical workup of penile inflatable implant recipients should be reported in a PMA or PDP to ensure that labeling for the product will provide reasonable assurance of safe and effective use.

(Comment 26) Three comments stated that quality of life and psychological evaluations are not useful to judge the effectiveness of the penile inflatable implant since the primary goal of device implantation is restoration of erectile function. Two of these comments added that: (1) Manufacturers do not make claims regarding psychological benefit, (2) it is inappropriate for FDA to require a manufacturer to demonstrate this benefit, (3) there are no accepted tests for measuring the psychological impact of the penile inflatable implant, and (4) existing tests for psychological well-being and self-esteem are confounded by multiple life variables, including the patient's and partner's general health, sexual functioning, and understanding of the potential complications when making the decision to have a penile inflatable implant. One comment stated that assessment of psychological benefit would likely require large clinical studies.

FDA agrees that the primary benefit derived from implantation of a penile inflatable implant is restoration of erectile function. However, FDA continues to believe that the potential quality of life and psychological benefits offered by the device are important, albeit secondary, components of the device's effectiveness. Although FDA agrees that designing studies to assess the psychological benefit of implantation with a penile inflatable implant may be difficult, FDA believes the psychological impact of the device can and should be assessed in a PMA or PDP as a secondary effectiveness measure. The agency will accept a variety of types of scientific evidence in support of a PMA or PDP, as long as the data constitute valid scientific evidence within the meaning of 21 CFR 860.7(c)(2) (e.g., a validated quality of life patient questionnaire can provide data to address this issue).

(Comment 27) FDA received two extensive comments on the types of manufacturing information, preclinical testing, and clinical data that should be required in a PMA for a penile inflatable implant, as well as several general comments on the appropriate contents of a PMA. Additionally, FDA received one comment proposing detailed modifications to the quality of life, satisfaction, and psychological evaluation recommendations stated in the proposed call for PMA's and PDP's.

FDA agrees with many of the points raised in these comments. Although the 1993 guidance document describes the general types of manufacturing, preclinical, and clinical data that FDA believes can support approval of a PMA for a penile inflatable implant, the agency realizes that other, scientifically sound methods exist for addressing the identified risks and benefits of the device and encourages manufacturers to document the safety and effectiveness of their device using the least burdensome approaches. In fact, FDA has agreed to the use of many of these alternative approaches for the collection and analysis of data in its past interactions with penile inflatable implant manufacturers. Furthermore, FDA intends to revise the 1993 guidance document to incorporate many of these comments.

Infection is a risk associated with any surgical implant procedure, including the penile inflatable implant. Compromised device sterility and surgical techniques may be a major contributing factor to this risk. Infection may result in the removal of the implant and may result in an inability to replace the device due to corporeal fibrosis and scarring.

Migration refers to the movement of the components of the penile inflatable implant within the body. In some cases, a portion of the implant migrates externally (“extrusion”). The cylinders and pump can migrate either proximally or distally, leading to inadequate support of the glans penis, difficulty in manipulating the pump, or pressure necrosis with subsequent erosion. Extrusion is usually associated with wound dehiscence at the site of incision, but can also occur secondary to erosion. Factors contributing to migration and extrusion include implantation of a device that is too large, iatrogenic injury to the surrounding tissues, and infection. Migration and extrusion of the penile inflatable implant can lead to surgical intervention.

Erosion is the breakdown of tissue adjacent to the device. The cylinders can erode through the distal urethra, the pump can erode through the scrotal wall, and, rarely, the reservoir can erode through the bladder or bowel. Factors contributing to erosion include implantation of a device that is too large, iatrogenic injury to the surrounding tissues, and infection. Erosion may lead to device extrusion, and can require surgical intervention.

The formation of a fibrous capsule around the components of the penile inflatable implant is a risk associated with this device. Fibrous capsule formation around the reservoir and/or pump may either cause spontaneous inflation of the cylinders or prevent the cylinders from completely deflating. Significant fibrous capsular formation may be corrected by device manipulation, corrective surgery, or surgical removal of the device and adjacent tissues. The effects of fibrous capsule formation vary from reduced satisfaction with the implant to explantation.

As with other prosthetic devices intended to restore a physiologic function, penile inflatable implants may mechanically malfunction. Reported types of mechanical malfunctions include leakage, cylinder rupture, cylinder aneurysm, spontaneous inflation/deflation, tubing kinks, and pump valve failure. Mechanical malfunctions may be caused by improper device handling or improper surgical technique, or problems with the device's design or manufacturing process. Surgical intervention to remove or replace the device is required if the patient desires a functional prosthesis.

Improper device handling, inadequate or vigorous dilatation, aggressive dissection, malpositioning of the device, cylinder suturing, and cylinder missizing are among the preventable complications caused as a result of surgical technique. Iatrogenic disorders may be responsible for various adverse conditions necessitating device removal and/or replacement.

If patients are not provided information and counseling regarding the risks and benefits of the penile inflatable implant prior to implantation, they may not have realistic expectations of the physical, psychological, and functional outcomes of the device. Uninformed patients may be dissatisfied with the device due to complications such as unresolved pain, as well as disappointment in cosmetic appearance, concealability, rigidity/firmness, and penile sensation. Some dissatisfied patients have elected to have the device surgically removed because the implant did not meet their expectations.

The potential for developing cancer as a result of the long-term implantation of the penile inflatable implant cannot be eliminated as a potential risk associated with this device.

Although FDA is not aware of data indicating that the penile inflatable implant is associated with reproductive and teratogenic effects, the potential for teratogenicity and other reproductive adverse effects as a result of long-term implantation of the device cannot be eliminated as a possible risk to health.

The potential for developing immunological effects and/or connective tissue disorders as a result of long-term exposure to the penile inflatable implant remains uncertain. Since the publication of the proposed rule 6 years ago, new epidemiological data (Refs. 3, 4, and 5) addressing the relationship between silicone breast prostheses and autoimmune diseases or connective tissue diseases indicate that silicone breast prostheses have not caused a large increase in the incidence of connective tissue disease in women with breast implants. However, the possibility of a smaller, increased risk of immunological effects among men with penile inflatable implants, or of an atypical, as yet undefined, syndrome or disease, cannot be eliminated based on these data.

Amorphous fumed silica is bound to the silicone in the elastomer of the penile inflatable implant. Silica presents a potential risk which should be addressed in a PMA or PDP.

Small quantities of silicone gel are present in at least one model of penile inflatable implant. Silicone gel leakage and associated migration are potential risks which should be addressed in a PMA or PDP for any device that contains this material.

Polyurethane elastomer materials, which have been used as surface materials in some penile inflatable implants, may degrade over time and release degradation products which are potential carcinogens in animals. When present, polyurethane elastomer degradation is a potential risk that should be addressed in a PMA or PDP.

Other reported complications associated with implantation of the penile inflatable implant include hematoma, chronic pain, erythema, edema, ulceration, necrosis, scarring, and urinary retention, which should be addressed in a PMA or PDP.

The penile inflatable implant is intended to restore the ability to have an erection in men with erectile dysfunction. It has the potential to be an effective treatment for erectile dysfunction. Implant recipients may also benefit from an improved quality of life.

Under section 515(b)(3) of the act, FDA is adopting the findings as published in the preamble to the April 1993 proposed rule and is issuing this final rule to require premarket approval of the generic type of device, the penile inflatable implant, by revising § 876.3350(c).

Under the final rule, a PMA or a notice of completion of a PDP is required to be filed on or before July 11, 2000, for any penile inflatable implant that was in commercial distribution before May 28, 1976, or that has been found by FDA to be substantially equivalent to such a device on or before July 11, 2000. An approved PMA or a declared completed PDP is required to be in effect for any such device on or before 180 days after FDA files the application.

Any other penile inflatable implant that was not in commercial distribution before May 28, 1976, or that has not been found by FDA to be substantially equivalent to such a device on or before July 11, 2000, is required to have an approved PMA or a declared completed PDP in effect before it may be marketed.

If a PMA or a notice of completion of a PDP for a penile inflatable implant is not filed on or before the 90th day past the effective date of this regulation, that device will be deemed adulterated under section 501(f)(1)(A) of the act (21 U.S.C. 351(f)(1)(A)), and commercial distribution of the device will be required to cease immediately. The device may, however, be distributed for investigational use, if the requirements of the investigational device exemption (IDE) regulations (part 812) (21 CFR part 812) are met.

Under § 812.2(d) of the IDE regulations, FDA hereby stipulates that, on the effective date of this rule, the exemptions from the IDE requirements in § 812.2(c)(1) and (c)(2) will no longer apply to clinical investigations of the penile inflatable implant. Further, FDA concludes that investigational penile inflatable implants are significant risk devices as defined in § 812.3(m) and advises that, as of the effective date of this rule, the requirements of the IDE regulations regarding significant risk devices will apply to any clinical investigation of a penile inflatable implant. For any penile inflatable implant that is not the subject of a timely filed PMA or PDP, an IDE must be in effect under § 812.20 on or before 90 days after the effective date of this regulation or distribution of the device must cease. FDA advises all persons presently sponsoring a clinical investigation involving the penile inflatable implant to submit an IDE application to FDA no later than 60 days after the effective date of this final rule to avoid the interruption of ongoing investigations.

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

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

FDA expects that only two manufacturers will submit a PMA or PDP for the penile inflatable implant. FDA does not believe that two companies are a significant number of small entities. FDA estimates that it costs up to $1 million to develop and submit a PMA or PDP for this type of device. As noted previously, the penile inflatable implant was classified into class III on November 23, 1983, and FDA published a proposed rule to require a PMA or PDP for this device on April 28, 1993. Thus, manufacturers have long been aware of the need to develop information in support of a PMA or a PDP. The cost of developing the data, therefore, has been spread over the past several years. Moreover, since the publication of the proposed rule, FDA has been working closely with both manufacturers to assist them in preparing for the submission of a PMA or a PDP, and one has successfully completed a PDP for two device models. FDA estimates based on such information as is publicly available, that these two companies have annual revenues in excess of several hundred million dollars. FDA, therefore, believes that this final rule will not be an undue burden on these manufacturers. The agency therefore certifies that the final rule will not have a significant economic impact on a substantial number of small entities. Therefore, under the Regulatory Flexibility Act, no further analysis is required.

This proposed rule contains information collection provisions that are subject to review by OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3530). The burden hours required for § 876.3350(c) are reported and approved under OMB Control No. 0910-0231.

The following references have been placed on display in the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. These references may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

In a final rule published in the Federal Register on February 15, 2000 (65 FR 7437), VA redesignated certain sections in 38 CFR part 8. This document makes changes regarding cross-references to reflect these redesignations.

Since this document makes only non-substantive changes, we are dispensing with prior notice and comment and delayed effective date provisions of 5 U.S.C. 552 and 553.

The Catalog of Federal Domestic Assistance Program number for this regulation is 64.103.

Citizens concerned with water quality in Rhode Island, Vermont, Kansas, the District of Columbia and Idaho may be interested in this rulemaking. Entities discharging toxic pollutants to waters of the United States in these States could be affected by this rulemaking since criteria are used in determining NPDES permit limits. Potentially affected categories and entities include:

This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be potentially affected by this action. This table lists the types of entities that EPA is now aware could potentially be affected by this action. Other types of entities not listed in the table could also be affected. To determine whether your facility is affected by this action, you should carefully examine the applicability criteria in § 131.36 of title 40 of the Code of Federal Regulations. If you have any questions regarding the applicability of this action to a particular entity, consult the appropriate person(s) listed in the preceding FOR FURTHER INFORMATION CONTACT section.

In 1992, EPA promulgated a final rule (known as the “National Toxics Rule”, or “NTR”) to establish numeric water quality criteria for 12 States and two Territories (hereafter “States”) that had failed to comply fully with section 303(c)(2)(B) of the Clean Water Act (“CWA”) (57 FR 60848). The criteria, codified at 40 CFR 131.36, became the applicable water quality standards in those 14 jurisdictions for all purposes and programs under the CWA effective February 5, 1993.

When a State adopts criteria that meet the requirements of the CWA, EPA will issue a rule amending the NTR to withdraw its criteria. Section 553 of the Administrative Procedure Act, U.S.C. 533(b)(B) provides that, when an agency for good cause finds that notice and public procedure are impracticable, unnecessary or contrary to the public interest, the agency may issue a rule without providing notice and opportunity for public comment. EPA has determined that there is good cause for making today's rule final without prior proposal and opportunity for comment because EPA has determined that, if the State's criteria are no less stringent than the Federal regulations, additional comment on the criteria is unnecessary. EPA finds that this constitutes good cause for issuing this final rule without notice and comment. EPA has determined that the States criteria are no less stringent than the NTR criteria because they are identical, identical when rounded using conventional rounding techniques, or more stringent. For the same reason, and because this rule relieves a restriction, EPA has determined that good cause exists to waive the requirement for a 30-day period before the amendment becomes effective and therefore, the amendment will be immediately effective.

On August 6, 1997, Rhode Island adopted revisions to its surface water quality standards (Regulation EVM 112-88.97-1), regarding human health criteria. Rhode Island adopted human health criteria for toxic pollutants contained in the NTR. EPA Region 1 approved the State's human health criteria on January 15, 1999, because Rhode Island's numeric criteria for the protection of human health were consistent with the CWA and EPA's implementing regulations at 40 CFR Part 131. By adoption of numeric criteria, Rhode Island complied with the requirements of Section 303(c)(2)(b) of the CWA to have numeric criteria for toxic pollutants. EPA Region 1 requested that the Agency withdraw the Federal criteria applicable to Rhode Island for which the State now has numeric criteria.

In today's action, EPA is withdrawing Rhode Island from the NTR for those criteria that the State has adopted that are no less stringent than the Federal criteria in the NTR. Rhode Island adopted, and EPA approved, a human health (organisms only) criterion of 50 μg/l for arsenic. The value promulgated in the NTR for this criterion is 0.14 μg/l. Rhode Island will remain in the NTR for this criterion. In a separate, upcoming action, EPA will propose to remove Rhode Island from the NTR for this criterion and provide for public comment. Additionally, Rhode Island adopted, and EPA approved, human health criteria of 18 mg/l and 59 mg/l (water and organisms, and organisms only, respectively) for bis(2)ethylhexyl pthalate. The values promulgated in the NTR are 18 μg/l and 59 μg/l, respectively. Rhode Island will remain in the NTR for these criteria.

On July 12, 1994, Vermont adopted revisions to its surface water quality standards (Appendix C, Vermont Water Quality Standards, effective August 1, 1994). EPA Region 1 approved the State's adoption of criteria for all toxics contained in the NTR on December 5, 1996, because they are consistent with the CWA and EPA's implementing regulations at 40 CFR Part 131. EPA Region 1 requested that the Agency withdraw the Federal criteria applicable to Vermont for which the State now has numeric criteria.

In today's action, EPA is withdrawing Vermont from the NTR for certain human health and aquatic life criteria where the State adopted criteria that are no less stringent than the Federal criteria. Vermont adopted, and EPA approved, a human health (organisms only) criterion of 1.5 μg/l for arsenic. The value promulgated in the NTR for this criterion is 0.14 μg/l. Vermont will remain in the NTR for this criterion. In a separate, upcoming action, EPA will propose to remove Vermont from the NTR for this criterion and provide for public comment. Additionally, Vermont adopted and EPA approved, an aquatic life criterion continuous concentration (CCC) of 0.8 μg/l for gamma-BHC. The value promulgated for this criterion in the NTR was 0.08. Vermont will remain in the NTR for this criterion.

On March 4, 1994, the District of Columbia adopted revisions to its surface water quality standards [amended Chapter 11 of Title 21 DCMR pursuant to the authority set forth in Section 5 of the Water Pollution Control Act of 1984, D.C. Law 5-188, effective March 16, 1985, D.C. Code Section 6-924 (1988) and Mayor's Order 85-152, September 12, 1985], adopting human health criteria to protect from effects related to fish consumption. EPA Region 3 approved these revisions on November 4, 1996, because the District's numeric criteria are consistent with section 303(c)(2)(B) of the Clean Water Act and EPA's implementing regulations at 40 CFR Part 131. EPA Region 3 requested that the Agency withdraw the Federal human health (organism only) criteria applicable to the District for which the District now has numeric criteria.

In today's action, EPA is withdrawing the District of Columbia from the NTR for those human health “organism only” criteria that the District has adopted that are no less stringent than the Federal criteria in the NTR. The District remains in the NTR for organism + water human health criteria. The District removed the drinking water use for the only water body in the District designated for that use. EPA approved the removal of this use and, in a separate upcoming action, EPA will propose to remove the District from the NTR for organism + water human health criteria and will provide for public comment.

On June 29, 1994, Kansas adopted revisions to its water quality standards (K.A.R. 28-16-28) regarding both human health and aquatic life criteria, and submitted them to EPA Region 7 for review and approval on October 31, 1994. On February 19, 1998, EPA Region 7 approved certain new or revised water quality criteria for the protection of human health and aquatic life because they are consistent with section 303(c)(2)(B) of the CWA and EPA's implementing regulations at 40 CFR 131, and requested that the Agency withdraw the Federal criteria applicable to Kansas for which the State now has numeric criteria. Additionally, on June 29, 1999, Kansas adopted new and revised ambient water quality criteria for additional pollutants. They were submitted to EPA for review and approval on August 10, 1999. On January 19, 2000, EPA Region 7 approved these additional criteria because they are also consistent with section 303(c)(2)(B) of the CWA and EPA's implementing regulations at 40 CFR 131, and requested that the Agency withdraw the Federal criteria applicable to Kansas for which the State now has numeric criteria.

In today's action, EPA is removing Kansas from the NTR for certain human health and aquatic life criteria because the State's adopted criteria are no less stringent than the Federal criteria. Kansas remains in the NTR for arsenic (human health—organisms only) and cadmium (acute and chronic aquatic life). For these pollutants, Kansas adopted criteria that are less stringent than the Federal rule. In a separate, upcoming action, EPA will propose to withdraw the NTR criteria for these pollutants and provide for public comment. In addition, Kansas remains in the NTR for certain other toxic pollutants for which it has not yet adopted numeric criteria.

In addition, EPA is modifying the NTR for Kansas to reflect the State's adoption of a 10 − 6 risk level for carcinogens and a change in nomenclature for one of the State's use classifications.

On August, 24, 1994, Idaho adopted revisions to its surface water quality standards (Title 1, chapter 2, Section 250 of the Idaho Administrative Code). For all aquatic life toxic pollutants, Idaho adopted the NTR criteria by reference. On June 25, 1996, EPA Region 10 approved the criteria because they were identical to the Federal criteria. EPA Region 10 requested that the Agency withdraw the Federal criteria applicable to Idaho for which the State now has numeric criteria.

In today's action, EPA is withdrawing Idaho from the NTR for all aquatic life criteria because the State adopted criteria that are identical to the Federal criteria.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and is therefore not subject to review by the Office of Management and Budget. Because the agency has made a “good cause” finding that this action is not subject to notice-and-comment requirements under the Administrative Procedure Act or any other statute, it is not subject to the regulatory flexibility provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ), or to sections 202 and 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). In addition, this action does not significantly or uniquely affect small governments or impose a significant intergovernmental mandate, as described in sections 203 and 204 of UMRA. This rule also does not significantly or uniquely affect the communities of tribal governments, as specified by Executive Order 13084 (63 FR 27655, May 10, 1998). This rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This rule also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant.

This action does not involve technical standards; thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. The rule also does not involve special consideration of environmental justice related issues as required by Executive Order 12898 (59 FR 7629, February 16, 1994). This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

The Congressional Review Act (5 U.S.C. 801 et seq. ), as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. Section 808 allows the issuing agency to make a rule effective sooner than otherwise provided by the CRA if the agency makes a good cause finding that notice and public procedure is impracticable, unnecessary or contrary to the public interest. This determination must be supported by a brief statement. 5 U.S.C. 808(2). As stated previously, EPA made such a good cause finding, including the reasons therefore, and established an immediate effective date of April 12, 2000. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804 (2).

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

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

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

2. In person . The Agency has established an official record for this action under docket control number OPP-300973A. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

In the Federal Register of May 26, 1999 (64 FR 28480) (FRL-6081-3), EPA issued a notice pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the Food Quality Protection Act (FQPA) (Public Law 104-170) announcing the filing of a pesticide tolerance petition (PP 8E4950) by Omnichem S.A, Industrial Research Park, 1348 Louvain-La-Neuve, Belgium. This notice included a summary of the petition prepared by the petitioner, including a statement of the number average molecular weight of the range of polymers. There were no comments received in response to the notice of filing.

In the Federal Register of February 28, 2000 (65 FR 10401) (FRL-6491-3), EPA issued a rule establishing an exemption from the requirement of a tolerance for residues of a range of polymers α-alkyl (C 12 -C 15 )- ω -hydroxypoly (oxypropylene)poly (oxyethylene)copolymers (where the poly(oxypropylene) content is 3-60 moles and the poly(oxyethylene) content is 5-80 moles in or on growing crops, when applied to raw agricultural commodities after harvest, or to animals when used as an inert ingredient (surfactant). The number average molecular weight, which is routinely included in the tolerance exemption expression, was inadvertently omitted from the tolerance exemption expression in § 180.1001(c) and (e). This rule corrects the tolerance exemption to include the molecular weight as a limitation.

Section 553 of the Administrative Procedure Act (APA), 5 U.S.C. 553(b)(B), provides that, when an agency for good cause finds that notice and public procedure are impracticable, unnecessary or contrary to the public interest, the agency may issue a rule without providing notice and an opportunity for public comment. EPA has determined that there is good cause for making today's rule final without prior proposal and opportunity for comment, because EPA is amending the tolerance exemption expression that was previously issued to include the number average molecular weight. The preamble to the previously published Final Rule discussed how the number average molecular weeight was one of the criteria for identifying low risk polymers. Thus, notice and public procedure are unnecessary. EPA finds that this constitutes good cause under 5 U.S.C. 553(b)(B).

No. This final rule implements a technical amendment to the Code of Federal Regulations to reflect a technical correction to a previously issued Final Rule, and it does not otherwise impose or amend any requirements. As such, the Office of Management and Budget (OMB) has determined that a technical correction is not a “significant regulatory action” subject to review by OMB under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Nor does this rule contain any information collection requirements that require review and approval by OMB pursuant to the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501 et seq.).

Because this action is not economically significant as defined by section 3(f) of Executive Order 12866, this action is not subject to Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action will not result in environmental justice related issues and does not, therefore, require special consideration under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994). Since the Agency has made a “good cause” finding that this action is not subject to notice-and-comment requirements under the Administration Procedure Act or any other statute (see Unit IV), this action is not subject to provisions of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), or to sections 202 and 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). In addition, this action does not significantly or uniquely affect small governments or impose a significant intergovernmental mandate, as described in sections 203 and 204 of UMRA. Nor does this action significantly or uniquely affect the communities of tribal governments as specified by Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments (63 FR 27655, May 10, 1998). This rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). This action does not involve any technical standards that require the Agency's consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). In issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct, as required by section 3 of Executive Order 12988, entitled Civil Justice Reform (61 FR 4729, February 7, 1996). EPA has complied with Executive Order 12630, entitled Governmental Actions and Interference with Constitutionally Protected Property Rights (53 FR 8859, March 15, 1988), by examining the takings implications of this rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the Executive Order.

For information about the applicability of the regulatory assessment requirements to the final rule that was issued on February 28, 2000 (65 FR 10401) (FRL-6491-3), please refer to the discussion in Unit XII of that document.

Yes. The Congressional Review Act (CRA), 5 U.S.C. 801 et seq ., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. Section 808 allows the issuing agency to make a rule effective sooner than otherwise provided by the CRA if the agency makes a good cause finding that notice and public procedure is impracticable, unnecessary or contrary to the public interest. This determination must be supported by a brief statement. (5 U.S.C. 808(2)). EPA has made such a good cause finding for this final rule, and established an effective date of April 12, 2000. Pursuant to 5 U.S.C. 808(2), this determination is supported by the brief statement in Unit III. of this document. 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 is not a “major rule” as defined by 5 U.S.C. 804(2).

The Federal Emergency Management Agency makes the final determinations listed below of modified base flood elevations for each community listed. These modified elevations have been published in newspapers of local circulation and ninety (90) days have elapsed since that publication. The Associate Director has resolved any appeals resulting from this notification.

The modified base flood elevations are not listed for each community in this notice. However, this rule includes the address of the Chief Executive Officer of the community where the modified base flood elevation determinations are available for inspection.

The modifications are made pursuant to section 206 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq. , and with 44 CFR part 65.

For rating purposes, the currently effective community number is shown and must be used for all new policies and renewals.

The modified base flood elevations are the basis for the floodplain management measures that the community is required to either adopt or to show evidence of being already in effect in order to qualify or to remain qualified for participation in the National Flood Insurance Program.

These modified elevations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own, or pursuant to policies established by other Federal, state or regional entities.

These modified elevations are used to meet the floodplain management requirements of the NFIP and are also used to calculate the appropriate flood insurance premium rates for new buildings built after these elevations are made final, and for the contents in these buildings.

The changes in base flood elevations are in accordance with 44 CFR 65.4.

This rule is categorically excluded from the requirements of 44 CFR Part 10, Environmental Consideration. No environmental impact assessment has been prepared.

The Associate Director, Mitigation Directorate, certifies that this rule is exempt from the requirements of the Regulatory Flexibility Act because modified base flood elevations are required by the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are required to maintain community eligibility in the National Flood Insurance Program. No regulatory flexibility analysis has been prepared.

This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

This rule involves no policies that have federalism implications under Executive Order 12612, Federalism, dated October 26, 1987.

This rule meets the applicable standards of section 2(b)(2) of Executive Order 12778.

The modified base flood elevations are not listed for each community in this interim rule. However, the address of the Chief Executive Officer of the community where the modified base flood elevation determinations are available for inspection is provided.

Any request for reconsideration must be based upon knowledge of changed conditions, or upon new scientific or technical data.

The modifications are made pursuant to section 201 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq. , and with 44 CFR part 65.

For rating purposes, the currently effective community number is shown and must be used for all new policies and renewals.

The modified base flood elevations are the basis for the floodplain management measures that the community is required to either adopt or to show evidence of being already in effect in order to qualify or to remain qualified for participation in the National Flood Insurance Program.

These modified elevations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own, or pursuant to policies established by other Federal, state or regional entities.

The changes in base flood elevations are in accordance with 44 CFR 65.4.

This rule is categorically excluded from the requirements of 44 CFR Part 10, Environmental Consideration. No environmental impact assessment has been prepared.

The Associate Director, Mitigation Directorate, certifies that this rule is exempt from the requirements of the Regulatory Flexibility Act because modified base flood elevations are required by the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are required to maintain community eligibility in the National Flood Insurance Program. No regulatory flexibility analysis has been prepared.

This interim rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

This rule involves no policies that have federalism implications under Executive Order 12612, Federalism, dated October 26, 1987.

This rule meets the applicable standards of section 2(b)(2) of Executive Order 12778.

The Federal Emergency Management Agency (FEMA or Agency) makes final determinations listed below of base flood elevations and modified base flood elevations for each community listed. The proposed base flood elevations and proposed modified base flood elevations were published in newspapers of local circulation and an opportunity for the community or individuals to appeal the proposed determinations to or through the community was provided for a period of ninety (90) days. The proposed base flood elevations and proposed modified base flood elevations were also published in the Federal Register .

This final rule is issued in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part 67.

The Agency has developed criteria for floodplain management in floodprone areas in accordance with 44 CFR part 60.

Interested lessees and owners of real property are encouraged to review the proof Flood Insurance Study and Flood Insurance Rate Map available at the address cited below for each community.

The base flood elevations and modified base flood elevations are made final in the communities listed below. Elevations at selected locations in each community are shown.

This rule is categorically excluded from the requirements of 44 CFR Part 10, Environmental Consideration. No environmental impact assessment has been prepared.

The Associate Director, Mitigation Directorate, certifies that this rule is exempt from the requirements of the Regulatory Flexibility Act because final or modified base flood elevations are required by the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and are required to establish and maintain community eligibility in the National Flood Insurance Program. No regulatory flexibility analysis has been prepared.

This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

This rule involves no policies that have federalism implications under Executive Order 12612, Federalism, dated October 26, 1987.

This rule meets the applicable standards of section 2(b)(2) of Executive Order 12778.

Administrative practice and procedure, Flood insurance, Reporting and recordkeeping requirements.

This is a summary of the Commission's Report and Order (Order) released March 30, 2000 (FCC 00-114), issued in response to the Notice of Proposed Rulemaking released by the Commission on October 22, 1999 (FCC 99-301). The full text of the Order is available for inspection and copying during normal business hours in the FCC Reference Center, Room CY-A257, 445 12th Street, SW, Washington, DC 20554. The complete text also may be purchased from the Commission's copy contractor, International Transcription Service, Inc. (202) 857-3800, 1231 20th Street, NW, Washington, DC 20037. Additionally, the complete item is available on the Commission's website at <http://www.fcc.gov/Bureaus/Common_Carrier/Orders/2000/>.

Outreach Workshops: In an effort to inform respondents and answer questions regarding their filings, the Commission will hold two workshops in the Commission's Meeting Room at 445 12th Street, SW, Washington, DC 20554. The workshops will be held on April 17, 2000 and May 1, 2000. Details will be provided by Public Notice released by the Commission.

You may obtain the latest version of the form (FCC Form 477) from the Common Carrier Bureau's website at <http://www.fcc.gov/broadband/data>. The form is best accessed using Excel 97. However, other comparable spreadsheet software programs may access a version of the form that will be located at the same website.

1. In the Order summarized here, we adopt an information collection program to collect basic information about the status of local telephone service competition and the deployment of advanced telecommunications capability, also known as broadband. We conclude that we need timely and reliable information about the pace and extent of developing local competition in different geographic areas in order to evaluate the effectiveness of actions that this Commission and the states are taking to promote local competition. We also conclude that we need timely and reliable information to assess the deployment of broadband services, as required by section 706 of the Telecommunications Act of 1996.

2. Moreover, we conclude that this information would allow us to avoid “one size fits all” regulation, and, specifically, to reduce regulation wherever we can pursuant to new sections 10 and 11 of the Act. 47 U.S.C. 160, 161. The Commission adopts a simple filing that should enable it to make better informed decisions, while placing as low a burden as possible on reporting entities.

3. Throughout the Order, we explain our reasons for the conclusions we reach. We assessed commenters' proposals for alternative means of collecting the needed information. The following text represents a brief summary of conclusions adopted in the Order.

4. Types of Entities that Must Report: In the Order, we discuss the types of entities that must report data describing the extent and intensity of local competition and the extent of broadband services deployment. Based on our determination that we need comprehensive data about developing competition for local telephone service, we decide that all local exchange carriers (LECs), both incumbent and competitive, should complete the applicable portions of Form 477 if they meet our defined threshold for deployment of service. We conclude that we should require local exchange carriers to complete Parts II and V of the form for each state in which they provide 10,000 or more voice-grade equivalent lines or wireless channels. Further, we require any facilities-based provider of mobile telephony (defined here as, real time, two-way switched voice service that is interconnected with the public switched network utilizing an in-network switching facility that enables the provider to reuse frequencies and accomplish seamless handoffs of subscriber calls) to complete Part III of the form for each state in which it has 10,000 or more subscribers.

5. We next turn to a consideration of those entities that should report data on deployment of broadband services. The Order concludes that given our broad statutory mandate under section 706 of the Telecommunications Act of 1996, to evaluate the deployment of broadband services, regardless of the transmission media or technology employed, we should collect data from a wide range of broadband providers. More specifically, we require providers of what we term “one-way broadband” and “full broadband” services to complete the applicable portions of Form 477, to the extent that they exceed the broadband reporting threshold. For purposes of the data collection, “full broadband” service is defined, consistent with the Advanced Telecommunications Report , as having an information carrying capacity of over 200 Kilobits per second (Kbps) in each direction, simultaneously. An Inquiry Concerning the Deployment of Advanced Telecommunications Capabilities to All Americans in a Reasonable and Timely Fashion , 14 FCC 2d 2398, paragraphs 20 through 25 ( Advanced Telecommunications Report ). “One-way broadband” service is defined as having an information carrying capacity of over 200 Kilobits per second (Kbps) in only one direction. Actual or potential providers of broadband services may include: LECs (incumbent and competitive), cable television companies, utilities, MMDS/MDS/”wireless cable” carriers, other fixed wireless providers, mobile wireless carriers (both terrestrial and satellite-based), government entities, and others. We believe that only by casting our net wide enough to include all such entities can we discern progress, or the lack of it, in meeting the goals stated in the Advanced Telecommunications Report . We thus conclude that any entity that provides at least 250 full or one-way broadband service lines (or wireless channels) or has at least 250 full or one-way broadband customers in a state should be required to complete Parts I and V of Form 477 for that state.

6. Frequency of Reports: We decide that we can best balance our need for timely information with our desire to minimize the reporting burden on respondents by requiring providers to report data on a semi-annual basis. Given our desire to collect data to be used in the second Advanced Telecommunications Report, we direct that all respondents should file their end-of-year 1999 data on May 15, 2000. Thereafter, entities will report end-of-year data on March 1st and data as of June 30th on September 1st.

7. Definition of Reporting Area: To minimize the burden the reporting requirement places on reporting entities, we conclude that information should be reported by state. To aid our understanding of developments within a given state, we also require the reporting entity to provide the Commission with a list of Zip Codes in which they have at least one subscriber.

8. Confidentiality of Data: We continue to believe that the value of this data collection is significantly enhanced by making as much information as possible available to the public. At the same time, we conclude that we can achieve this goal in a manner that ensures the non-disclosure of confidential provider-filed data. We discuss, below, our affirmative policies for handling this information and we believe that these policies will allay commenter concerns that legitimately protectible information would be released to the public. We do not, in this Order, make findings about whether the data elements requested in the reporting form would satisfy the Commission's articulated standard for non-disclosure of competitively sensitive information, but we do make clear that our rules for requesting non-disclosure of confidential information will be available to all filers of the FCC Form 477. Moreover, for purposes of this information collection, we take steps to simplify the procedures for requesting confidential treatment of data. Our rules for requesting non-disclosure of competitively sensitive information afford sufficient protection to providers and appropriately balance the concerns of parties submitting information with the interests of the public in obtaining access to that information. We also make clear that we will not release information that is the subject of non-disclosure requests until persons requesting confidential treatment are afforded all of the procedural protections provided by our confidentiality rules. We expect that these policies will allow us to accomplish our goal of making as much information as possible available to the public while ensuring that service providers can file data with confidence that any information found to be competitively sensitive under our rules will not be disclosed.

9. We note that several commenters express concern over the potential for competitive harm that release of the gathered data could cause and, in particular, about the ability of competitors to take the data submitted and tailor market strategies to quash nascent competition, protect areas that are being subjected to increased competition, or deploy facilities to defend strongholds. Again, we believe that our confidentiality rules afford appropriate protection of legitimately protectible information, but we take additional steps to clarify our existing rules for treatment of competitively-sensitive data because we expect that some of the respondents to this form may be less familiar with Commission practices. The Commission's policy on confidential treatment of information submitted pursuant to a survey or study is to “allow survey and study respondents to request confidential treatment pursuant to Section 0.459 to the extent they can show by a preponderance of the evidence a case for non-disclosure consistent with the Freedom of Information Act (FOIA).” Assessment of the confidentiality of the information is made on a case-by-case basis and action on confidentiality requests is routinely deferred until a request for inspection is made.

10. We also recognize that there is considerable diversity in the way that individual service providers handle the data pertaining to their operations. Indeed, it is our understanding that some providers release considerable data about the nature of their operations, while others more closely safeguard such data, including the type of data that we request in the reporting form. We anticipate that providers will request confidential treatment for data filed where they deem it appropriate. In these cases, and in accordance with the Commission's rules, we will honor all parties' requests for confidential treatment of information that they identify as competitively sensitive until persons requesting confidential treatment are afforded all of the procedural protections provided by our confidentiality rules. Moreover, in such cases, we agree with those commenters who suggest that we can aggregate much of the data—for example, by carrier class and to the state level—so that it does not identify the individual provider in our regularly published reports.

11. We also take an additional step to reduce provider concerns about the release of information identified as competitively sensitive by making it easier for providers to request confidential treatment of their data. In particular, we place a check-box on the first page of the FCC Form 477 that allows providers to request non-disclosure of all or portions of their submitted data without filing at this point in the process the detailed confidentiality justification required by our rules. Thus, where parties seek confidential treatment, they need only check the well-marked box on the first page of the form and provide a completed and a redacted version of the form, as explained fully in the instructions to the Form 477. If the Commission receives a request for, or proposes disclosure of, the information contained in the Form 477, the provider will be notified and required to make the full showing under our rules. Given the unique nature of this data collection, these streamlined procedures for requesting non-disclosure should greatly improve the ability of smaller providers and providers that are less familiar with the Commission's rules to request confidential treatment of their data. We expect that this will lead to a greater level of compliance with this information collection and will give providers confidence that protectible data will not be published in our regular reports.

12. Part I: Broadband Data. Without making a prospective decision about whether these data elements would satisfy the Commission's standard for non-disclosure, we state our intention not to publish in our publicly-available reports individual provider-filed data for the broadband (Part I) portion of the form, even where providers do not seek non-disclosure of this data. At this time, we do not have sufficient evidence in the record to make a universally applicable decision about the competitive sensitivity of all of the Part I Broadband information for all providers, but we do agree to aggregate this information in a way that does not identify the individual provider data in our reports because commenters have made at least an initial showing that all or most of the data filed in these sections is typically held confidential by providers of these services. Our decision not to publish individual provider submissions from the Part I Broadband section reflects the particular and limited purposes of this data collection and our desire to maximize the level of voluntary compliance with the information collection. While this is a mandatory collection, we wish to collect as much, and as accurate, information as possible about the status of broadband deployment in a short period of time. We also, as part of this information collection, encourage service providers that are below the reporting thresholds to report data on a voluntary basis. Moreover, particularly with respect to the Part I broadband data, we conclude that we can achieve substantially the same public benefits by releasing this information in an aggregated fashion without any potential risk of competitive harm on the part of respondents. Given the unique nature of this information collection, we believe that this extra step will improve compliance, thus enhancing our understanding of the broadband market, without any material diminution in value of the information collection. Thus, we agree to publish in our regular reports data from Part I of the form only once it has been aggregated, for example by provider class, regardless of whether parties request confidential treatment on the broadband portion of the form.

13. Parts II and III: Local Competition Data. With respect to the data filed in Parts II and III of the form concerning wireline and wireless local telephone service, we will also report data in a manner that aggregates and does not identify the identity of providers where providers have requested non-disclosure of the data. We do not decide in advance to publish all of the data filed in Part II of the form in an aggregated fashion, however, because it is our experience that portions of this data are already made publicly available by the individual companies or from other sources. We note, for example, that the local competition market is characterized by incumbent firms that routinely make available their line count data, similar to that reported in Part II of the form. Similarly, competitive LECs in some states are required to submit line count data and this information is routinely made publicly available. We expect that such providers reporting data in Part II of the form will not request non-disclosure of data that has already been made publicly available and that the Commission will be able to publish this data in our reports. Concerning the Part III mobile telephony data, we recognize that mobile telephony providers argue that state-by-state subscriber counts are not routinely made publicly available. We do not, however, have sufficient evidence to make an across-the-board finding at this time. Accordingly, providers submitting data concerning these services may check the box on Form 477 to request confidential treatment of their data, which will afford them the protection of the Commission's confidentiality rules.

14. We emphasize that apart from publicly available information, which we anticipate reporting, we intend to publish the local competition data in our local competition reports only to the level of detail necessary to provide an understanding of how local competition is developing. We therefore agree with those commenters who suggest that we can aggregate much of the data—for example, by carrier class and to the state level—so that it does not identify the individual provider in our regularly published reports. This reporting approach, as well as providers' ability to request confidential treatment under our rules, should maximize the level of voluntary compliance with the information collection.

15. Part V: Zip Code Data. In the particular case of Zip Code data ( i.e. , the lists of Zip Codes where service is offered), the Commission intends to report information on Zip Codes served, but it will not release the identity of specific providers in a given Zip Code. Public release of Zip Code data in this manner is appropriate, we believe, because it does not reveal information about the actual subscribership levels for any particular provider, but only indicates the presence of one or more providers in the given Zip Code. Although we think it unlikely that any provider would consider this limited release to reveal competitively sensitive information, we do not limit parties' ability to seek non-disclosure of such data under the Commission's rules.

16. Sharing data with State Commissions. Finally, because we wish to maximize the value of this information collection for states, we conclude that the Chief of the Common Carrier Bureau may release the information collected under this program to the state commissions, subject to certain conditions. A state commission may view all data submitted on a carrier specific basis, by entities filing data for that commission's state, provided that the state has appropriate protections in place (which may include confidentiality agreements or designation of information as proprietary under state law) that would preclude disclosure of any confidential information. However, where state laws afford less protection than federal FOIA laws, the higher federal standard will prevail. We are aware that there are two states that have “open records” statutes that may prevent the state from providing confidential protection for sensitive provider information. In these situations, we will work with these state commissions to enable them to obtain access to such information in a manner that addresses the state's need for this information and also protects the confidential nature of the provider's sensitive information. We anticipate that these actions will give state commissions a valuable and unique view into the state of local competition and broadband deployment in their states. In addition, we hope that this will further our goal of reducing the overall reporting burdens placed on entities in these markets by minimizing the need for additional information collection programs at the state level.

17. We conclude that these policies, taken as a whole, most effectively balance provider concerns with our broader goals for this proceeding. As stated in the Notice, by making the information available, consumers, investors, and policy makers will be better able to make informed decisions on the development of these markets. Such information has value because a better-informed marketplace promotes a more efficient marketplace. Also, by allowing public release of as much of the information as possible, associations, scholars, and others will be able to use the information in their independent analyses of Commission policies, thereby aiding the Commission in crafting regulations that address specific market problems and eliminating those regulations that have outlived their usefulness.

18. Electronic Filing: We adopt the method proposed in the Notice for collection of the information through electronic filing except to modify the allowable methods of submission. Specifically, the form will be made available to reporting entities on the Common Carrier Bureau's website at <www.fcc.gov/broadband/data> and will utilize Excel 97 software, as well as other comparable spreadsheet software programs. Carriers and other entities that must comply with this requirement may submit their completed forms to a specified e-mail address or forward to the Commission diskette copies. Regardless of whether the reporting entity e-mails its submission or mails diskette copies, an officer of the reporting entity must submit a “Certification Statement” to the Commission attesting to the truthfulness of the data submitted. We conclude that this filing system will ensure, for both the reporting entities and the Commission, that the burdens of the program are minimized and that unnecessary expenditures for compliance are not incurred. Also, by allowing diskette submissions, reporting parties seeking confidential treatment can further ensure that the information submitted is protected.

19. To ensure that this information collection program does not outlive its usefulness, the reporting requirement adopted in the Order will terminate in five years, unless the Commission takes affirmative steps to preserve it.

20. Data to be Reported: We describe, in the Order, the specific items set out in the data collection form. A brief description of the data collection form follows, with greater detail found in the complete Order.

21. Part I of the form collects information about the number of broadband lines in service to consumers. This includes information about both “full broadband” lines, with information carrying capacity in excess of 200 Kbps in both directions, simultaneously, and asymmetric “one way broadband” lines, with information carrying capacity in excess of 200 Kbps in one direction but not both.

22. Part II of the form collects information from incumbent LECs and competitive LECs about the number of voice-grade equivalent lines and fixed wireless channels in service to provide local exchange or exchange access service. We also require respondents to provide information about the extent to which they use their own facilities in providing these lines or wireless channels, and the extent to which they use the facilities or services of other LECs in doing so.

23. Part III of the form collects information about mobile telephony subscribership.

24. As required by the Paperwork Reduction Act of 1995, the Local Competition and Broadband Deployment Notice invited the general public and the Office of Management and Budget (OMB) to comment on the proposed information collection requirements contained in the Notice. On December 22, 1999, OMB approved the proposed information collection, as submitted to OMB.  1 In this Order, we adopt the proposed Local Competition and Broadband Reporting form, but modify our proposal to reflect comments received from OMB and other commenters. The revised Local Competition and Broadband Reporting has been approved by OMB. The OMB Control Number is 3060-0816.

25. As required by the Regulatory Flexibility Act, 5 U.S.C. 603 (RFA), an Initial Regulatory Flexibility Analysis (IRFA) was incorporated into the Notice issued in this proceeding, FCC 99-301, October 22, 1999. The Commission sought written comment in the Notice, including comments on the IRFA. The Commission's Final Regulatory Flexibility Analysis (FRFA) in this Order conforms to the RFA, as amended by the Contract With America Advancement Act of 1996 (CWAAA), Public Law 104-121, 110 Stat. 847 (1996).

26. The Commission initiated this proceeding to determine whether it should require certain providers of communications services to report a limited amount of information about the development of local telephone competition and the deployment of broadband services as mandated by the Telecommunications Act of 1996. In this Order, we adopt rules to collect basic information about two important aspects of communications: the status of local telephone service competition and the deployment of “advanced telecommunications capability.” The 1996 Act—in particular, sections 251 and 271—tasked the Commission and the states with important roles in opening local telephone markets to competition. Moreover, the Commission needs timely and reliable information on broadband deployment given that section 706 of the 1996 Act requires the Commission to issue periodic reports on the state of broadband deployment. The information collected pursuant to this program will materially improve our ability to develop, evaluate, and revise policy in these critical areas and will provide valuable benchmarks not only for this Commission but for other policy makers and consumers. Further, the information collection program adopted in this Order is the least burdensome means available to fulfill these statutory obligations.

27. In the IRFA, we stated that we would seek to minimize the burden imposed on smaller entities by establishing thresholds for reporting that balanced the needs of the Commission to receive data on the development of local competition and deployment of broadband against the burden such reporting places on smaller entities. In response to the Notice, the Commission received comments from 37 parties and held a series of ex parte meetings with potential respondents to the information collection adopted in this Order. Among those parties, only the Office of Advocacy, United States Small Business Administration (SBA) and the Organization for the Promotion and Advancement of Small Telecommunications Companies (OPASTCO), commented specifically on the IRFA. We note that many other commenters raised issues about the proposed rules and we encourage readers of this FRFA to consult the complete text of this Order, which describes in detail our analysis of commenter proposals.

28. In its comments to the IRFA, SBA expresses concern that the proposed threshold for reporting broadband data (1,000 broadband lines nationwide) may be set too low and, therefore, include a number of smaller entities that would be unduly burdened by the reporting requirement. As a result, SBA recommends that the Commission raise the reporting threshold to at least 5,000 lines nationwide or “significantly reduce the burden on the small businesses that would be replying.” OPASTCO, in its comments, commends the Commission for its efforts to exempt smaller entities and urges the Commission to adopt an existing SBA definition of small companies: those with fewer than 1,500 employees. We note that other commenters, while not in direct response to the IRFA, disagree with SBA and OPASTCO and urge the Commission to adopt its proposed reporting threshold.

29. In an effort to balance the needs of the Commission with the costs our data gathering may place on smaller entities, the Commission has modified the thresholds for reporting and the frequency of filing reports, and other aspects of the requirements. We believe that these modifications satisfy SBA's request that we significantly reduce the burdens for those small entities that must comply. For example, by adopting a state level threshold (250 broadband lines in a given state), we ensure that reporting entities have a significant presence in a given state, before having to complete the form for that state. Moreover, we conclude that this threshold is set to allow the Commission to comply with Congress' charge in section 706 of the 1996 Act to determine whether advanced telecommunications capability, commonly known as “broadband,” is being deployed to all Americans. In order to gain the comprehensive understanding—as called for in section 706—of the broadband market, particularly in rural and inner-city areas and among demographic groups that are traditionally underserved, it is necessary to gather data from entities that are most likely to serve these areas and groups, which include some smaller entities.

30. Among the other actions taken to reduce the overall burden on small entities, we decouple the broadband and local competition reporting thresholds. In the Notice, the Commission tentatively concluded that any provider meeting the threshold requirement for the broadband part of the form would be required to complete the local competition part of the form, whether or not the entity met the threshold for that part, if the entity provides services listed in that part of the form. We note that the representatives of traditionally smaller providers opposed this linkage of reporting thresholds. By eliminating this linkage, we reduce reporting burdens on these traditionally smaller providers.

31. To further reduce the potential burden this data gathering program may place on smaller entities the Commission, in this Order, has also reduced the frequency of reporting from quarterly to semi-annually. In this regard, we accept the suggestions of many commenters that reducing the frequency of reporting is a measurable way to decrease the burden placed on reporting entities. We necessarily decline SBA's invitation to adopt an annual filing basis, because we conclude that the rapidly changing nature of the local competition and broadband markets necessitate more regular data collections.

32. Supporting the proposal in the Notice, SBA further encourages the Commission to collect information on a statewide basis. In this Order, we adopt our proposal and require providers to report data on a state-by-state basis. To supplement this data, we ask providers of broadband and local exchange services to provide a list of the Zip Codes in which they serve at least one customer. We conclude that reporting scheme best balances our need to achieve geographically disaggregated information while minimizing burdens on all entities, including small entities.

33. Finally, we note SBA's suggestion that small carriers be allowed to file data on a voluntary basis. While the Commission concludes that it is necessary to adopt a mandatory reporting mechanism, we agree with SBA that smaller, exempted providers should be invited to file data on a voluntary basis. Thus, we encourage small providers to file the new FCC Form 477 even if they do not meet the reporting thresholds for mandatory reporting.

34. Overall, we believe that our approach ( e.g. , changing thresholds to the state level, decoupling the thresholds for different parts of the form, and reducing the reporting frequency to semi-annually) will result in a program that is not overly burdensome on reporting entities, and thus balances the concerns raised by SBA and other commenters with the Commission's need to gain a better understanding of developments in these markets.

35. In the IRFA, the Commission included a description and estimate of the number of small entities to which its proposed rules would apply. No commenters addressed the issue. In this Order, the Commission decides that local exchange carriers and providers of mobile telephony services that serve 10,000 or more voice-grade equivalent lines or wireless channels (or mobile telephony subscribers) in a given state and any entity that provides 250 or more full or one-way broadband lines or channels in a given state, must report data about those services provided in that state. Based on data available to it at present, the Commission estimates that approximately 200 of the nation's local exchange carriers and between 100-200 mobile telephony providers will be required to comply with the requirement. We do not have concrete data on which to base a precise estimate of the number of broadband providers that may be required to report. We set out, however, a detailed description of the types of entities that may be required to comply with the reporting requirement and we detail our understanding of the number of small entities within each of these categories.

36. To estimate the number of small entities that will be affected by the rules, we first consider the statutory definition of “small entity” under the RFA. The RFA generally defines “small entity” as having the same meaning as the term “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act, unless the Commission has developed one or more definitions that are appropriate to its activities. Under 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) meets any additional criteria established by the Small Business Administration (SBA). The SBA has defined a small business for Standard Industrial Classification (SIC) categories 4812 (Radiotelephone Communications) and 4813 (Telephone Communications, Except Radiotelephone) to be small entities when they have no more than 1,500 employees. We first discuss the number of small telephone companies falling within these SIC categories, then attempt to refine further those estimates to correspond with the categories of telephone companies that are commonly used under our rules.

37. The most reliable source of information regarding the total numbers of common carrier and related providers nationwide, as well as the numbers of commercial wireless entities, appears to be data the Commission publishes annually in its Carrier Locator report, derived from filings made in connection with the Telecommunications Relay Service (TRS). According to data in the most recent report, there are 4,144 interstate carriers. These carriers include, inter alia , local exchange carriers, wireline carriers and service providers, interexchange carriers, competitive access providers, operator service providers, pay telephone operators, providers of telephone toll service, providers of telephone exchange service, and resellers.

38. We have included small incumbent LECs in this present RFA analysis. As noted above, a “small business” under the RFA is one that, inter alia , meets the pertinent small business size standard ( e.g. , a telephone communications business having 1,500 or fewer employees), and “is not dominant in its field of operation.” The SBA's Office of Advocacy contends that, for RFA purposes, small incumbent LECs are not dominant in their field of operation because any such dominance is not “national” in scope. We have therefore included small incumbent LECs in this RFA analysis, although we emphasize that this RFA action has no effect on FCC analyses and determinations in other, non-RFA contexts.

39. Total Number of Telephone Companies Affected. 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 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 that may be affected by the decisions and rules in the Order.

40. Wireline Carriers and Service Providers. SBA has developed a definition of small entities for telephone communications companies other than radiotelephone 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 SBA's definition, a small business telephone company other than a radiotelephone company is one employing no more 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. 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 business concerns under 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 in the Order.

41. Local Exchange Carriers, Interexchange Carriers, Competitive Access Providers, Operator Service Providers, and Resellers. Neither the Commission nor SBA has developed a definition of small local exchange carriers (LECs), interexchange carriers (IXCs), competitive access providers (CAPs), operator service providers (OSPs), or resellers. The closest applicable definition for these carrier-types under SBA rules is for telephone communications companies other than radiotelephone (wireless) companies. The most reliable source of information regarding the number of these carriers nationwide of which we are aware appears to be the data that we collect annually in connection with the Telecommunications Relay Service (TRS). According to our most recent data, there are 1,560 LECs and CAPs, 171 IXCs, 24 OSPs, and 388 resellers. 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 these carriers that would qualify as small business concerns under SBA's definition. Consequently, we estimate that there are fewer than 1,410 small entity LECs, 151 IXCs, 129 CAPs, 32 OSPs, and 351 resellers that may be affected by the decisions and rules in the Order.

42. Wireless (Radiotelephone) Carriers. SBA has developed a definition of small entities for radiotelephone (wireless) companies. The Census Bureau reports that there were 1,176 such companies in operation for at least one year at the end of 1992. According to SBA's definition, a small business radiotelephone company is one employing no more than 1,500 persons. The Census Bureau also reported that 1,164 of those radiotelephone companies had fewer than 1,000 employees. Thus, even if all of the remaining 12 companies had more than 1,500 employees, there would still be 1,164 radiotelephone companies that might qualify as small entities if they are independently owned are operated. 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 radiotelephone carriers and service providers that would qualify as small business concerns under SBA's definition. Consequently, we estimate that there are fewer than 1,164 small entity radiotelephone companies that may be affected by the decisions and rules in the Order.

43. Cellular, PCS, SMR and Other Mobile Service Providers. In an effort to further refine our calculation of the number of radiotelephone companies that may be affected by the rules adopted herein, we consider the data that we collect annually in connection with the TRS for the subcategories Wireless Telephony (which includes Cellular, PCS, and SMR) and Other Mobile Service Providers. We will utilize the closest applicable definition under SBA rules—which, for both categories, is for telephone companies other than radiotelephone (wireless) companies, however, to the extent that the Commission has adopted definitions for small entities providing PCS and SMR services, we discuss those definitions. According to our most recent TRS data, 732 companies reported that they are engaged in the provision of Wireless Telephony services and 23 companies reported that they are engaged in the provision of Other Mobile 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 Wireless Telephony Providers and Other Mobile Service Providers, except as described below, that would qualify as small business concerns under SBA's definition. Consequently, we estimate that there are fewer than 732 small entity Wireless Telephony Providers and fewer than 23 small entity Other Mobile Service Providers that may be affected by the decisions and rules in the Order.

44. Broadband PCS Licensees. The broadband PCS spectrum is divided into six frequency blocks designated A through F, and the Commission has held auctions for each block. The Commission defined “small entity” for Blocks C and F as an entity that has average gross revenues of less than $40 million in the three previous calendar years. For Block F, an additional classification for “very small business” was added, and is defined as an entity that, together with its affiliates, has average gross revenues of not more than $15 million for the preceding three calendar years. These regulations defining “small entity” in the context of broadband PCS auctions have been approved by SBA. No small businesses within the SBA-approved definition bid successfully for licenses in Blocks A and B. There were 90 winning bidders that qualified as small entities in the Block C auctions. A total of 93 small and very small business bidders won approximately 40% of the 1,479 licenses for Blocks D, E, and F. However, licenses for Blocks C through F have not been awarded fully, therefore there are few, if any, small businesses currently providing PCS services. Based on this information, we estimate that the number of small broadband PCS licenses will include the 90 winning C Block bidders and the 93 qualifying bidders in the D, E, and F blocks, for a total of 183 small PCS providers as defined by SBA and the Commissioner's auction rules.

45. SMR Licensees. Pursuant to 47 CFR 90.814(b)(1), the Commission has defined “small entity” in auctions for geographic area 800 MHz and 900 MHz SMR licenses as a firm that had average annual gross revenues of less than $15 million in the three previous calendar years. The definition of a “small entity” in the context of 800 MHz SMR has been approved by the SBA, and approval for the 900 MHz SMR definition has been sought. The rules may apply to SMR providers in the 800 MHz and 900 MHz bands that either hold geographic area licenses or have obtained extended implementation authorizations. We do not know how many firms provide 800 MHz or 900 MHz geographic area SMR service pursuant to extended implementation authorizations, nor how many of these providers have annual revenues of less than $15 million. Consequently, we estimate, for purposes of this FRFA, that all of the extended implementation authorizations may be held by small entities, some of which may be affected by the decisions and rules in the Order.

46. The Commission recently held auctions for geographic area licenses in the 900 MHz SMR band. There were 60 winning bidders who qualified as small entities in the 900 MHz auction. Based on this information, we estimate that the number of geographic area SMR licensees that may be affected by the decisions and rules in the Order includes these 60 small entities. No auctions have been held for 800 MHz geographic area SMR licenses. Therefore, no small entities currently hold these licenses. A total of 525 licenses will be awarded for the upper 200 channels in the 800 MHz geographic area SMR auction. The Commission, however, has not yet determined how many licenses will be awarded for the lower 230 channels in the 800 MHz geographic area SMR auction. There is no basis, moreover, on which to estimate how many small entities will win these licenses. Given that nearly all radiotelephone companies have fewer than 1,000 employees and that no reliable estimate of the number of prospective 800 MHz licensees can be made, we conclude, for purposes of this FRFA, that all of the licenses may be awarded to small entities, some of which may be affected by the decisions and rules in the Order.

47. 220 MHz Radio Service—Phase I Licensees. The 220 MHz service has both Phase I and Phase II licenses. There are approximately 1,515 such non-nationwide licensees and four nationwide licensees currently authorized to operate in the 220 MHz band. The Commission has not developed a definition of small entities specifically applicable to such incumbent 220 MHz Phase I licensees. To estimate the number of such licensees that are small businesses, we apply the definition under the SBA rules applicable to Radiotelephone Communications companies. According to the Bureau of the Census, only 12 radiotelephone firms out of a total of 1,178 such firms which operated during 1992 had 1,000 or more employees. Therefore, if this general ratio continues to 1999 in the context of Phase I 220 MHz licensees, we estimate that nearly all such licensees are small businesses under the SBA's definition, some of which may be affected by the decisions and rules in the Order.

48. 220 MHz Radio Service—Phase II Licensees. The Phase II 220 MHz service is a new service, and is subject to spectrum auctions. In the 220 MHz Third Report and Order we adopted criteria for defining small businesses and very small businesses for purposes of determining their eligibility for special provisions such as bidding credits and installment payments. We have defined a small business as an entity that, together with its affiliates and controlling principals, has average gross revenues not exceeding $15 million for the preceding three years. Additionally, a very small business is defined as an entity that, together with its affiliates and controlling principals, has average gross revenues that are not more than $3 million for the preceding three years. An auction of Phase II licenses commenced on September 15, 1998, and closed on October 22, 1998. 908 licenses were auctioned in 3 different-sized geographic areas: three nationwide licenses, 30 Regional Economic Area Group Licenses, and 875 Economic Area (EA) Licenses. Of the 908 licenses auctioned, 693 were sold. Companies claiming small business status won: one of the Nationwide licenses, 67% of the Regional licenses, and 54% of the EA licenses. As of October 7, 1999, the Commission had granted 681 of the Phase II 220 MHz licenses won at a first auction and an additional 221 Phase II licenses won at a second auction.

49. Narrowband PCS. The Commission has auctioned nationwide and regional licenses for narrowband PCS. There are 11 nationwide and 30 regional licensees for narrowband PCS. The Commission does not have sufficient information to determine whether any of these licensees are small businesses within the SBA-approved definition for radiotelephone companies. At present, there have been no auctions held for the major trading area (MTA) and basic trading area (BTA) narrowband PCS licenses. The Commission anticipates a total of 561 MTA licenses and 2,958 BTA licenses will be awarded by auction. Such auctions have not yet been scheduled, however. Given that nearly all radiotelephone companies have no more than 1,500 employees and that no reliable estimate of the number of prospective MTA and BTA narrowband licensees can be made, we assume, for purposes of this FRFA, that all of the licenses will be awarded to small entities, as that term is defined by the SBA.

50. Rural Radiotelephone Service. The Commission has not adopted a definition of small entity specific to the Rural Radiotelephone Service. A significant subset of the Rural Radiotelephone Service is the Basic Exchange Telephone Radio Systems ( BETRS ). We will use the SBA's definition applicable to radiotelephone companies, i.e. , an entity employing no more than 1,500 persons. There are approximately 1,000 licensees in the Rural Radiotelephone Service, and we estimate that almost all of them qualify as small entities under the SBA's definition.

51. Air-Ground Radiotelephone Service. The Commission has not adopted a definition of small entity specific to the Air-Ground Radiotelephone Service. Accordingly, we will use the SBA's definition applicable to radiotelephone companies, i.e. , an entity employing no more than 1,500 persons. There are approximately 100 licensees in the Air-Ground Radiotelephone Service, and we estimate that almost all of them qualify as small entities under the SBA definition.

52. Private Land Mobile Radio (PLMR). PLMR systems serve an essential role in a range of industrial, business, land transportation, and public safety activities. These radios are used by companies of all sizes operating in all U.S. business categories. The Commission has not developed a definition of small entity specifically applicable to PLMR licensees due to the vast array of PLMR users. For the purpose of determining whether a licensee is a small business as defined by the SBA, each licensee would need to be evaluated within its own business area. The Commission is unable at this time to estimate the number of, if any, small businesses that could be impacted by the proposed rules. However, the Commission's 1994 Annual Report on PLMRs indicates that at the end of fiscal year 1994 there were 1,087,267 licensees operating 12,481,989 transmitters in the PLMR bands below 512 MHz. Because any entity engaged in a commercial activity is eligible to hold a PLMR license, the rules in this context could potentially impact every small business in the United States. We note, however, that because the vast majority of these licensees are end-users, not providers of telephony or broadband services, they would not be directly affected by the rules adopted in this Order.

53. Fixed Microwave Services. Microwave services include common carrier, private-operational fixed, and broadcast auxiliary radio services. At present, there are approximately 22,015 common carrier fixed licensees in the microwave services. The Commission has not yet defined a small business with respect to microwave services. For purposes of this FRFA, we will utilize the SBA's definition applicable to radiotelephone companies— i.e. , an entity with no more than 1,500 persons. We estimate, for this purpose, that all of the Fixed Microwave licensees (excluding broadcast auxiliary licensees) would qualify as small entities under the SBA definition for radiotelephone companies.

54. Offshore Radiotelephone Service. This service operates on several UHF TV broadcast channels that are not used for TV broadcasting in the coastal area of the states bordering the Gulf of Mexico. At present, there are approximately 55 licensees in this service. We are unable at this time to estimate the number of licensees that would qualify as small entities under the SBA's definition for radiotelephone communications.

55. Wireless Communications Services. This service can be used for fixed, mobile, radio location and digital audio broadcasting satellite uses. The Commission defined “small business” for the wireless communications services (WCS) auction as an entity with average gross revenues of $40 million for each of the three preceding years, and a “very small business” as an entity with average gross revenues of $15 million for each of the three preceding years. The Commission auctioned geographic area licenses in the WCS service. In the auction, there were seven winning bidders that qualified as very small business entities, and one that qualified as a small business entity. We conclude that the number of geographic area WCS licensees that may be affected by the decisions and rules adopted in the Order includes these eight entities.

56. Satellite Services. The Commission has not developed a definition of small entities applicable to satellite service licensees. Therefore, the applicable definition of small entity is generally the definition under the SBA rules applicable to Communications Services, Not Elsewhere Classified (NEC). This definition provides that a small entity is expressed as one with $11.0 million or less in annual receipts. According to the Census Bureau, there were a total of 848 communications services providers, NEC, in operation in 1992, and a total of 775 had annual receipts of less than $9.999 million. The Census report does not provide more precise data.

57. In addition to the estimates provided above, we consider certain additional entities that may be affected by the data collection from broadband service providers. Because section 706 requires us to monitor the deployment of broadband regardless of technology or transmission media employed, we anticipate that some broadband service providers will not provide telephone service. Accordingly, we describe below other types of firms that may provide broadband services, including cable companies, MDS providers, and utilities, among others.

58. Cable services or systems. The SBA has developed a definition of small entities for cable and other pay television services, which includes all such companies generating $11 million or less in revenue annually. This definition includes cable systems operators, closed circuit television services, direct broadcast satellite services, multipoint distribution systems, satellite master antenna systems and subscription television services. According to the Census Bureau data from 1992, there were 1,788 total cable and other pay television services and 1,423 had less than $11 million in revenue.

59. The Commission has developed its own definition of a small cable system operator for the purposes of rate regulation. Under the Commission's rules, a “small cable company” is one serving fewer than 400,000 subscribers nationwide. Based on our most recent information, we estimate that there were 1,439 cable operators that qualified as small cable system operators at the end of 1995. Since then, some of those companies may have grown to serve over 400,000 subscribers, and others may have been involved in transactions that caused them to be combined with other cable operators. Consequently, we estimate that there are fewer than 1,439 small entity cable system operators.

60. The Communications Act also contains a definition of a small cable system operator, which is “a cable operator that, directly or through an affiliate, serves in the aggregate fewer than 1 percent of all subscribers in the United States and is not affiliated with any entity or entities whose gross annual revenues in the aggregate exceed $250,000,000.” The Commission has determined that there are 66,000,000 subscribers in the United States. Therefore, we found that an operator serving fewer than 660,000 subscribers shall be deemed a small operator, if its annual revenues, when combined with the total annual revenues of all of its affiliates, do not exceed $250 million in the aggregate. Based on available data, we find that the number of cable operators serving 660,000 subscribers or less totals 1,450. We do not request nor do we collect information concerning whether cable system operators are affiliated with entities whose gross annual revenues exceed $250,000,000, and thus are unable at this time to estimate with greater precision the number of cable system operators that would qualify as small cable operators under the definition in the Communications Act. It should be further noted that recent industry estimates project that there will be a total of 66,000,000 subscribers, and we have based our fee revenue estimates on that figure.

61. Multipoint Distribution Systems (MDS): The Commission has defined “small entity” for the auction of MDS as an entity that, together with its affiliates, has average gross annual revenues that are not more than $40 million for the preceding three calendar years. This definition of a small entity in the context of MDS auctions has been approved by the SBA. The Commission completed its MDS auction in March 1996 for authorizations in 493 basic trading areas (BTAs). Of 67 winning bidders, 61 qualified as small entities.

62. MDS is also heavily encumbered with licensees of stations authorized prior to the auction. The SBA has developed a definition of small entities for pay television services, which includes all such companies generating $11 million or less in annual receipts. This definition includes multipoint distribution systems, and thus applies to MDS licensees and wireless cable operators which did not participate in the MDS auction. Information available to us indicates that there are 832 of these licensees and operators that do not generate revenue in excess of $11 million annually. Therefore, for purposes of this FRFA, we find there are approximately 892 small MDS providers as defined by the SBA and the Commission's auction rules, some which may be affected by the decisions and rules adopted in the Order.

63. Electric Services (SIC 4911): The SBA has developed a definition for small electric utility firms. The Census Bureau reports that a total of 1379 electric utilities were in operation for at least one year at the end of 1992. According to SBA, a small electric utility is an entity whose gross revenues did not exceed five million dollars in 1992. The Census Bureau reports that 447 of the 1379 firms listed had total revenues below five million dollars.

64. Electric and Other Services Combined (SIC 4931): The SBA has classified this entity as a utility whose business is less than 95% electric in combination with some other type of service. The Census Bureau reports that a total of 135 such firms were in operation for at least one year at the end of 1992. The SBA's definition of a small electric and other services combined utility is a firm whose gross revenues did not exceed five million dollars in 1992. The Census Bureau reported that 45 of the 135 firms listed had total revenues below five million dollars.

65. Combination Utilities, Not Elsewhere Classified (SIC 4939): The SBA defines this utility as providing a combination of electric, gas, and other services which are not otherwise classified. The Census Bureau reports that a total of 79 such utilities were in operation for at least one year at the end of 1992. According to SBA's definition, a small combination utility is a firm whose gross revenues did not exceed five million dollars in 1992. The Census Bureau reported that 63 of the 79 firms listed had total revenues below five million dollars.

66. The very focus of this proceeding is whether the Commission should require certain providers of communications services to report a limited amount of information about the development of local telephone competition and the deployment of broadband services. The Order concludes that the Commission should undertake such a data collection and that local exchange carriers and providers of mobile telephony services that serve 10,000 or more voice-grade equivalent lines or channels statewide, and any entity that provides 250 or more full or one-way broadband lines or channels statewide, should report specifically targeted information. The Order sets out in detail the types of providers that should report, exempting smaller providers, frequency of reports, data to be reported, and method of reporting. In particular, we conclude in the Order that given the comprehensive data to be obtained from large and medium size providers, it can exempt most small providers from completing the survey without materially affecting its ability to assess the development of local telephone competition and the deployment of broadband services.

67. The most significant step taken to minimize the impact of these rules on small entities is the adoption of reporting thresholds. For example, the Commission makes specific provision to exempt most smaller carriers from the requirement to report local telephone competition data. The Commission concludes that carriers with fewer than 10,000 statewide voice-grade equivalent lines or channels (or mobile telephony subscribers, in the case of mobile telephony providers) should be exempted from the reporting requirement for that state. Based on this exemption, the Commission estimates that only approximately 200 of the nation's largest local exchange carriers would remain subject to the requirement. Similarly, the Commission exempts the smallest broadband providers by adopting a broadband reporting threshold. Thus, firms that provide fewer than 250 full or one-way broadband lines or wireless channels in a given state need not report data for that state.

68. Among significant alternatives, the Commission considered whether it might rely on publicly available data or voluntary surveys, in lieu of a mandatory data collection program. The Commission concludes other publicly available information sources present less than complete pictures of actual conditions and trends in developing local service markets and in the deployment of broadband. Further, the Commission considered the need for, and size of, its exemptions for small entities. The Commission concludes that the thresholds adopted will allow it to exempt most smaller carriers from completing the form without materially affecting its ability to assess the development of local competition and the deployment of broadband services. The Commission also accepted other suggestions that will reduce burdens on entities, including decoupling reporting thresholds, adopting a less frequent reporting schedule, and allowing providers to report on a state-by-state basis.

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

70. Accordingly, it is ordered that, pursuant to sections 1-5, 10, 11, 201-205, 215, 218-220, 251-271, 303(r), 332, 403, 502, and 503 of the Communications Act of 1934, as amended, 47 U.S.C. 151-155, 160, 161, 201-205, 215, 218-220, 251-271, 303(r), 332, 403, 502, and 503 and pursuant to section 706 of the Telecommunications Act of 1996, 47 U.S.C. 157 nt, this order, with all attachments, is hereby adopted.

71. That the requirements and regulations established in this Order shall become effective May 12, 2000. The Commission shall place a notice in the Federal Register announcing the effective date of the requirements and regulations adopted herein.

72. That providers subject to the requirements and regulation established in this Order shall complete and file the Local Competition and Broadband Reporting Form (FCC Form 477) no later than May 15, 2000 and semi-annually thereafter.

73. That the Commission's Consumer Information Bureau, Reference Information Center, shall send a copy of this Local Competition and Broadband Reporting Order, including the Final Regulatory Flexibility Analysis, to the Chief Counsel for Advocacy of the Small Business Administration in accordance with paragraph 603(a) of the Regulatory Flexibility Act, 5 U.S.C. 601 et seq. (1981).

The action contained in this Order summarized here contains a modified information collection.

OMB Approval Number: 3060-0816.

Title: “Local Competition and Broadband Reporting, CC Docket No. 99-301.”

Form Number: FCC Form 477.

Type of Review: Revision of Existing Collection.

Respondents: Business or Not-for-profit institutions, including small businesses.

Burden Estimate: Average burden per respondent—

Total Annual Burden: Up to 29,924 person-hours.

Estimated Costs per Respondent: $0.00.

Needs and Uses: The information collection will be used by the Commission to gather information on the state of the development of local competition and broadband deployment. Without such information, the Commission faces significant difficulty in assessing the development of these markets and, therefore, is less able to fulfill its statutory responsibilities in accordance with the Communications Act of 1934, as amended.

The Santa Ana sucker ( Catostomus santaanae ) is a recognized species and member of the sucker family ( Catostomidae ) (Robbins et al. 1991). The Santa Ana sucker was originally described as Pantosteus santa-anae by Snyder (1908). The genus Pantosteus was reduced to a subgenus of Catostomus, and the hyphen was omitted from the specific name in a subsequent revision of the nomenclature (Smith 1966). Smith and Koehn (1971) and Smith (1992) continued to recognize Pantosteus as a subgenus, although several authors have followed earlier usage (Miller 1959) in recognizing Pantosteus as a genus related to Catostomus (Minckley 1973; Minckley et al. 1986).

Moyle (1976a) described the Santa Ana sucker as being less than 16 centimeters (cm) (6.3 inches (in.)) in length. The species is silvery below and darker along the back, with irregular blotches and pigmented membranes connecting the rays of the tail (Moyle 1976a).

The Santa Ana sucker inhabits streams that are generally small and shallow, with currents ranging from swift (in canyons) to sluggish (in the bottomlands). All the streams are subject to periodic severe flooding (Moyle 1976a). Santa Ana suckers appear to be most abundant where the water is cool (less than 22° Celsius (72° Fahrenheit)), unpolluted, and clear, although they can tolerate and survive in seasonally turbid water (Moyle 1976a; Moyle and Yoshiyama 1992). Santa Ana suckers feed mostly on algae, diatoms, and detritus scraped from rocks and other hard substrates, with aquatic insects making up a very small component of their diet. Larger fish generally feed more on insects than do smaller fish (Greenfield et al. 1970; Moyle 1976a).

Santa Ana suckers generally reach sexual maturity in just over 1 year and typically do not live more than 3 years (Greenfield et al. 1970). Spawning generally occurs from early April to early July, with a peak in spawning activity occurring in late May and June (Greenfield et al. 1970; Moyle 1976a). The spawning period may be variable and protracted, however. Recent field surveys on the East Fork of the San Gabriel River found evidence of an extended spawning period. These surveys found small juveniles (<30 millimeters (mm) standard length (<1.2 in.)) in December (1998) and March (1999) at the San Gabriel River site (U.S. Geological Survey (USGS) data, in litt. 1999). This data indicates that spawning may be very protracted in this stream, and begin as early as November. The fecundity of the Santa Ana sucker appears to be exceptionally high for a small sucker species (Moyle 1976a). Total fecundity of six females, ranging in size from 78 mm (3.1 in.) to 158 mm (6.2 in.), ranged from 4,423 to 16,151 eggs (Greenfield et al. 1970). The combination of early sexual maturity, a protracted spawning period, and high fecundity should allow the Santa Ana sucker to quickly repopulate streams following periodic flood events that could decimate populations (Moyle 1976a).

Historically, the Santa Ana sucker appeared to be native to the rivers and larger streams of the Los Angeles Basin—the Los Angeles, San Gabriel, and Santa Ana River drainage systems in Los Angeles, Orange, Riverside, and San Bernardino Counties (Smith 1966). Although historic records are scarce, Santa Ana suckers presumably ranged from near the Pacific Ocean to the uplands of the Los Angeles and San Gabriel River systems, and to at least where Pump House #1 is now located (near the San Bernardino National Forest boundary) in the Santa Ana River (Swift et al. 1993; Camm Swift, Icthyologist Consultant, pers. comm. 1996). Although the Santa Ana sucker was described as common in the 1970s (Moyle 1976a), the species has experienced declines throughout most of its range (Moyle et al. 1995; Swift et al. 1993). The species is now restricted to three noncontiguous populations: lower Big Tujunga Creek (Los Angeles River drainage); the East, West, and North Forks of the San Gabriel River (San Gabriel River drainage); and the lower and middle Santa Ana River (Santa Ana River drainage) (Moyle et al. 1995; Swift et al. 1993). A population also occurs in portions of the Santa Clara River drainage system in Ventura and Los Angeles Counties. The Santa Clara population is presumed to be an introduced population, although this presumption is based on the absence of the species from early collections, and not on any documented records of introduction (Hubbs et al. 1943; Miller 1968; Moyle 1976a; Bell 1978). The Santa Clara River population was not included in the proposal to list the Santa Ana sucker as threatened because of its presumed introduced status (see the proposed rule, 64 FR 3915, for further details on this population). In this document, we define the native range of the Santa Ana sucker, as outlined in the proposed rule, to include populations in the Los Angeles River, San Gabriel River, and Santa Ana River drainage systems.

Although historically present, the species may now be extirpated from the Los Angeles River (Swift et al. 1993). Santa Ana suckers are still found in portions of Big Tujunga Creek (a tributary of the Los Angeles River) between Big Tujunga Dam and Hansen Dam. Surveys downstream of the Big Tujunga Dam found the species to be present but rare (fewer than 20 individuals collected at each site) just below the dam, as well as in the vicinities of Delta Flat and Wildwood. The species was found to be abundant (an estimated 200 individuals collected) near Stoneyvale (Mike Wickman, Angeles National Forest, in litt. 1996). Several thousand Santa Ana suckers were observed in a visual survey of Big Tujunga Creek in small sections from the confluence of Little Tujunga Creek to the Foothill Boulevard bridge in May 1999 (C. Swift, pers. com. 1999). Santa Ana suckers were also common in visual surveys of Big Tujunga Creek from Foothill Boulevard to the intersection of Oro Vista and Mt. Gleason Avenues in May 1999 (Glen Knowles, U.S. Fish and Wildlife Service, in litt. 1999a); however, by October 1999, this reach had dried up entirely. Santa Ana suckers were abundant in October 1999 in the approximately 1-mile-long stretch of flowing waters of Big Tujunga and Haines Canyon Creeks between the 210 Freeway and Hansen Dam, as were two other rare native fish species, arroyo chub ( Gila orcutti ) and Santa Ana speckled dace ( Rhinichthys osculus ssp.). Santa Ana suckers could not be found in other parts of the Big Tujunga Creek in October 1999, which were dry except for a few isolated shallow pools (G. Knowles, in litt. 1999a). In late summer and autumn of dry years, Big Tujunga Creek becomes a dry wash for much of its length. During these times, Santa Ana suckers may be restricted to about 1 mile of stream in the Los Angeles River Basin. We estimate that the Santa Ana sucker has lost approximately 80 percent of its historic native range in the Los Angeles River Basin. The portions of Big Tujunga Creek currently occupied by the Santa Ana sucker constitute approximately 25 percent of the total remaining native range of the species. Approximately 60 percent of the current range of the Santa Ana sucker in the Los Angeles River Basin occurs on private lands. The remaining 40 percent of the range in the Los Angeles River Basin occurs on Angeles National Forest lands managed by the U.S. Forest Service (USFS).

Santa Ana suckers were common in the San Gabriel River below Morris Dam, near Fish Canyon, until the mid-1970s (C. Swift, in litt. 1999a). However, no suckers were found in surveys conducted below Morris Dam in 1995 (Dr. Tom Haglund, University of California, Los Angeles, in litt. 1996). Santa Ana suckers were also absent from 1998 surveys in the mainstem San Gabriel River at Browns Gulch, below Morris Dam, and at Rainbow Ranch (Chambers Group 1999). Santa Ana suckers were present in 1998 Chamber Group surveys of the West Fork of the San Gabriel River (Chambers Group 1999); however, surveys conducted by California Department of Fish and Game (CDFG) in 1998 and 1999 failed to locate suckers in the West Fork (Ray Ally, CDFG, in litt. 1999; Robert C. Hight, CDFG, in litt. 1999). However, CDFG did find Santa Ana suckers in Bear Creek, a tributary of the West Fork San Gabriel River, in June 1999 (R. Ally, CDFG, in litt. 1999). Quarterly surveys indicated suckers were common in the East Fork of the San Gabriel River throughout 1999 (Mike Saiki, USGS Biological Resources Division (BRD), pers. comm. 1999). Thus, the Santa Ana sucker now appears extant only upstream of the confluence of the East, West, and North Forks of the San Gabriel River. Furthermore, the population of Santa Ana suckers in the North Fork is small, and the population in the West Fork appears to be declining. The portions of the San Gabriel River occupied by the Santa Ana sucker constitute approximately 15 percent of the total remaining native range of the species. However, data gathered during sampling indicates that the San Gabriel River may contain the most individuals of any remaining population (R. Ally, in litt. 1996; Mike Guisti, CDFG, in litt. 1996; M. Wickman, in litt, 1996; Juan Hernandez, CDFG, in litt. 1997; M. Saiki, pers. com. 1999). We estimate that the Santa Ana sucker has lost approximately 75 percent of its native range in the San Gabriel River. Approximately 15 percent of the current range of the Santa Ana sucker in the San Gabriel River Basin occurs on private lands. The remaining 85 percent of the range in the San Gabriel River Basin occurs in the Angeles National Forest. Even with the substantial decrease in the sucker's range in the San Gabriel River drainage system, Moyle and Yoshiyama (1992) considered this population of Santa Ana suckers to be the only viable population within the species' native range.

In 1986 and 1987, several hundred Santa Ana suckers were observed in the Santa Ana River downstream of Prado Dam (C. Swift, pers. comm. 1996). By 1996, a general fish survey below Prado Dam yielded only 5 suckers from a total of 271 fishes captured (M. Guisti, CDFG, in litt. 1996). In April 1987, only five suckers were found during a sampling effort above the Prado Dam from the City of Norco to about 5 kilometers (km) (3.1 miles (mi)) upstream. In addition to fish being scarce above the dam, no small individuals were observed, indicating the possibility of little or no reproduction occurring in the area (Moyle and Yoshiyama 1992). In 1991, sampling indicated that, although fishery habitat in the Santa Ana River was primarily fair to poor, Santa Ana suckers were abundant between Norco and Riverside (Chadwick and Associates 1992). Additionally, evidence suggested Santa Ana suckers were using tributaries, including Tequesquite Arroyo, Sunnyslope Channel, and Anza Park Drain, for spawning and nurseries (Chadwick and Associates 1996). Seventy-six Santa Ana suckers were taken in three collections about 2.0 km (1.2 mi) below Hamner Avenue, Anaheim County, in the summer of 1997. An extensive survey of the Santa Ana River between Weir Canyon Road and Hamner Avenue, in Anaheim County, during the summer of 1998 yielded 42 Santa Ana suckers. All were juveniles less than 70 mm (2.8 in.) long (C. Swift, in litt, 1998). However, recently, in surveys between September and November 1999, seven adult suckers were captured near River Road, Riverside—three in the main-stem Santa Ana River, and four in the diversion channel that diverts most of the river's flow into the Prado Wetlands (C. Swift, in litt. 1999). Snorkel surveys of the Santa Ana River between Mission Boulevard and Riverside Avenue in Riverside in November 1999 found several pockets of tens to hundreds of Santa Ana suckers, usually in the deepest areas of the stream (C. Swift, pers. comm. 1999). Although Chadwick and Associates (1991) collected one Santa Ana sucker in this area near Mission Boulevard in March 1991, they stated that this reach probably would not support viable populations of fishes due to elevated levels of “chlorine and unionized ammonia” in this reach and unsuitable breeding substrates. Recent surveys in September and December 1999 in the Metropolitan Water District crossing near the Van Buren Avenue bridge in Riverside captured 48 and 16 suckers, respectively, although these individuals appeared to be in poorer body condition than those in the San Gabriel River (Barbara Martin, USGS, BRD, pers. comm. 1999). Extensive surveys of the Santa Ana River at Imperial Highway in December 1998 and March, June, September, and December 1999 failed to record any Santa Ana suckers (B. Martin, pers. comm. 1999).

Chadwick and Associates (1996) noted that length-frequency analysis indicates Santa Ana suckers are naturally reproducing in the Santa Ana River system. However, they asserted that Santa Ana sucker population decreases, as evidenced by 1996 surveys, were due to high flows in the basin between 1991 and 1996 (M. Guisti, in litt., 1996). T. Haglund ( in litt. 1996) contended that a large number of suckers reported in tributaries are juveniles and may be the progeny of very few adults. The presence of juveniles in surveys at the Metropolitan Water District Crossing, in March, June, and September 1999, represent positive evidence of recruitment, despite the apparent lack of suitable spawning habitat at that site (M. Saiki, pers. comm. 1999).

Santa Ana suckers occur in the lower portions of the Santa Ana River, with current survey records from the vicinity of Weir Canyon Road in Anaheim to Riverside Avenue in Riverside, but are now apparently absent from the upper reach of the river in the San Bernardino Mountains (Moyle and Yoshiyama 1992; Swift et al. 1993). We estimate that the Santa Ana sucker has lost approximately 70 percent of its native range in the Santa Ana River. The portions of the Santa Ana River occupied by the Santa Ana sucker constitute approximately 60 percent of the total remaining native range of the species. Approximately 75 percent of the range of the species in the Santa Ana River Basin occurs on private lands. The balance is within State, county, city, and regional park lands, with a small portion, 3 percent, on military lands.

In summary, the Santa Ana sucker has declined throughout significant portions of its range. The species has lost approximately 75 percent of its native range. Recent population densities range from approximately 246 fish in 2.9 km (1.8 mi) on the East Fork of the San Gabriel River (J. Hernandez, in litt. 1997) to 16 fish in 1.6 km (1.0 mile) of the Santa Ana River in December 1999 (USGS Survey Data, in litt. 1999). This overall reduction in range, and the more localized reductions in numbers, are particularly surprising given the high fecundity and apparent broad habitat tolerances of the species. Urbanization, water diversions, dams, introduced competitors and/or predators, and other human-caused disturbances likely are playing a role in the decline of the species. These factors have also been implicated in the decline of other western suckers (Minckley et al. 1991; Scoppettone and Vinyard 1991).

The decline of the Santa Ana sucker is also part of a greater overall decline of freshwater fishes in Southern California. The Los Angeles Basin was or is home to at least seven native species of freshwater fishes that have been declining or have been extirpated since the 1930s (Swift et al. 1993). Four of these species, the steelhead ( Oncorhynchus mykiss ), the Pacific lamprey ( Lampetra tridentata ), the Pacific brook lamprey ( Lampetra cf. pacifica ), and the unarmored three-spined stickleback ( Gasterosteus aculeatus williamsoni ), have been extirpated from the Los Angeles Basin since the 1950s. Two others, the Santa Ana speckled dace ( Rhinichthys osculus ), and the arroyo chub ( Gila orcutti ), have become rare in the Los Angeles Basin (Swift et al. 1993).

On September 6, 1994, we received a petition under the Act (16 U.S.C. 1531 et seq. ) to list the Santa Ana sucker ( Catostomus santaanae ), Santa Ana speckled dace ( Rhinichthys osculus ), and Shay Creek threespine stickleback ( Gasterosteus aculeatus ) as endangered species. The petition was submitted by the Sierra Club Legal Defense Fund, Inc., on behalf of seven groups including the California-Nevada Chapter of the American Fisheries Society, The Nature School, California Sportfishing Protection Alliance, Friends of the River, Izaak Walton League of America, California Trout, and Trout Unlimited. We deferred processing this petition because of other higher priority listing actions and severe funding constraints imposed by a number of continuing resolutions between November 1995 and April 1996.

On July 9, 1996, we published a 90-day petition finding (61 FR 36021) that substantial information had been presented indicating listing may be warranted for the Santa Ana sucker. On November 26, 1996, we published a notice initiating a status review for the Santa Ana sucker (61 FR 60073). On April 3, 1997, we published a 12-month finding (62 FR 15872) that listing the Santa Ana sucker was warranted, but precluded by higher listing priorities. On January 26, 1999, we proposed threatened status for the Santa Ana sucker within its native historic range of the Los Angeles, San Gabriel and Santa Ana River Systems (64 FR 3915). After the close of the comment period, we received seven requests to reopen the comment period. These requests asked us to consider new information gained from ongoing studies on the species, and to consider the use of a special rule under section 4(d) of the Act to implement a long-term conservation program for the species in the Santa Ana River. On December 16, 1999, we reopened the comment period to satisfy the public notice requirements of the Act and our regulations (50 CFR 424.16(c)(vi)), and to consider new scientific information (64 FR 70209).

The processing of this final rule conforms with our Final 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 (Priority 3) 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 (Priority 4). The processing of this final rule is a Priority 2 action.

In the January 26, 1999, proposed rule (64 FR 3915), we requested interested parties to submit factual reports or information that might contribute to development of a final rule. The 60-day comment period closed on March 29, 1999. We contacted appropriate Federal and State agencies, county and city governments, scientific organizations, and other interested parties. We reopened the comment period on December 16, 1999, to satisfy the public notice requirements of the Act and to consider new scientific information. The reopened comment period closed on January 3, 2000. We published public notices of the proposed rule in the Los Angeles Times, the Orange County Register, and the Riverside Press Enterprise on December 17, 1999, which invited general public comment. We did not receive any requests for a public hearing.

During the public comment periods, we received written comments from 45 individuals, organizations, and State and local agencies. Of the comments received, 32 were in support of listing, 3 were opposed, and 10 were neutral. Some commenters submitted updated status information on the Santa Ana sucker and new information on possible threats to the species. This information has been incorporated in the “Background” and “Summary of Factors Affecting the Species” sections. We address all other comments received during the comment periods in the following summary of issues. Comments of a similar nature are grouped into a single issue.

Issue 1: Several commenters felt that the Santa Ana sucker should be listed as an endangered species, rather than a threatened species.

Our Response: Most of these comments did not provide additional information or criteria to justify listing the species as endangered. Those commenters who did provide a basis for endangered status identified potential habitat destruction, natural and human-induced changes in streamflows, urban development and related land-use practices, intensive recreation, the introduction of nonnative competitors and predators, and demographics associated with small populations as reasons that remaining populations were threatened with extinction. We agree that multiple factors threaten the Santa Ana sucker (see “Summary of Factors Affecting the Species” section). However, we do not believe the Santa Ana sucker meets the Act's definition of endangered, which is a species “in danger of extinction throughout all or a significant portion of its range.” The Act defines a threatened species as “any species which is likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range” (section 3(19)). Although current population estimates do not exist for any of the sucker populations, all of the currently known populations within the native range were surveyed in 1999. In each drainage, suckers were locally common in 1999, and no populations appeared to be in imminent danger of extinction. We conclude that the remaining populations that constitute the native range of Santa Ana sucker are likely to become in danger of extinction in the foreseeable future. Therefore, the Act's definition of a threatened species fits the current situation of the Santa Ana sucker best.

Issue 2: Some commenters expressed support for designating critical habitat and felt that we should designate critical habitat for the species at the time of listing. Other commenters offered specific recommendations for areas to list as critical habitat, or requested that we not designate critical habitat in specific stream reaches.

Our Response: In this rule, as in the proposed rule, we find that critical habitat is not determinable because the biological needs of the Santa Ana sucker are not sufficiently known to identify an area as critical habitat. When a “not determinable” finding is made, we must, within 2 years of the publication date of the original proposed rule, propose the designation of critical habitat unless such designation is found to be not prudent. For a more detailed evaluation of our critical habitat finding for the Santa Ana sucker, and an explanation of “not determinable” and “not prudent” findings, please see the “Critical Habitat” section.

Issue 3: Some commenters requested that we list the Santa Clara population as threatened or endangered. Another commenter asked if the Santa Clara River population would require any increased protection because of its possible role in the recovery of the species.

Our Response: In the proposed rule, we identified only those Santa Ana sucker populations within the native range of the species for listing as threatened. The native range of the Santa Ana sucker is considered to be the rivers and streams of the Los Angeles, San Gabriel, and Santa Ana River Basins. The Santa Clara population is presumed to be an introduced population, although this presumption is based on its absence from early collections, and not on a documented record of introduction (Hubbs et al. 1943; Miller 1968; Moyle 1976a; Bell 1978). Therefore, the Santa Clara River population was not included in the proposal to list the species.

We believe that the Santa Ana sucker has lost about 75 percent of its historic native range. Considering the total remaining range of the species as all those areas currently occupied by the Santa Ana sucker, including both native and introduced populations, the portions of the Santa Clara River occupied by the species constitute approximately 50 percent of the total remaining range of the species. In light of the current status of the Santa Ana sucker, and the portion of the remaining range that occurs in the Santa Clara River system, further evaluation of the Santa Clara population is needed to determine its role in the recovery of the species. If the Santa Clara River population is determined to be crucial to the recovery of the species, we may need to reevaluate the status of this population under the Act.

Issue 4: Several commenters expressed the opinion that recreational suction dredging actually benefits the Santa Ana sucker, and that such suction dredging should be allowed to continue in streams occupied by the species.

Our Response: Suction dredging is the use of a suction system to remove and return material at the bottom of a stream, river, or lake for the extraction of minerals. Suction dredging in California is regulated by the CDFG under section 228 of the California Code of Regulations and by the U.S. Army Corps of Engineers (USACE) under section 404 of the Clean Water Act. The USFS may also regulate this activity by closing streams to dredging on Forest Service lands. The USACE does not require a section 404 permit for holders of a CDFG 5653 Standard Dredge Permit, but does require a 404 permit for all other types of dredging. Suction dredge operators are required to obtain a permit from CDFG, which is valid for a calender year (J. Reese, USACE, in litt. 1995; CDFG, in litt. 1999). In 1999, all counties where the Santa Ana sucker naturally occur were open to suction dredging (Los Angeles, Orange, and Riverside Counties); however, the East Fork of the San Gabriel River and portions of the West Fork of the San Gabriel River are covered by special regulation. The East Fork is the only stream containing Santa Ana suckers that is commonly subject to suction dredging. CDFG issues special dredge permits for this stream with conditions to exclude dredging from April 1 to June 30. The closed period is to allow resident fish and amphibians to spawn without interference from dredging. CDFG issued approximately 200 special dredging permits in 1995 for the East Fork, the first year the stream had been dredged legally in 15 years. This number has decreased steadily to approximately 40 special dredging permits issued in 1999 (Dwayne Maxwell, CDFG, pers. comm. 1999).

Few studies exist on suction dredging and its effects on aquatic ecosystems. Of the studies conducted, most indicate that the effects of a single suction dredge on overall habitat and on benthic (bottom of the stream) aquatic insect communities are highly localized and short term, but vary with stream gradient, flow regime, and sediment load characteristics of the stream (Griffith and Andrews 1981; Harvey et al. 1982; Thomas 1985; Harvey 1986; Hall 1988; Somer and Hassler 1992). In general, suction dredging removes all substrates smaller than the diameter of the intake nozzle and deposits them as large, unstable piles just downstream from the dredge. Harvey et al. (1982) found that on the American River, Yuba River, and Butte Creek, California, settleable solids and sedimentation rate both increased within several meters of the suction dredge, but rapidly returned to ambient levels downstream. Turbidity, however, was more variable. Streams with higher clay content substrates experienced greater long-lasting changes in turbidity. As with the work by Harvey et al. (1982), Thomas (1985) found during a study on Gold Creek in Missoula County, Montana, that suction dredging had only localized, short-term effects on insects living in the soil. Just after dredging, numbers of soil-living insects were significantly reduced in the dredged area. However, within 10 meters (32.5 feet) downstream of the dredged area, insect numbers and turbidity were normal. Within a month, aquatic insect numbers had returned to normal in the dredged section of the stream (Thomas 1985). In addition, Somer and Hassler (1992) found that, while the species composition of benthic insects was altered within sections of streams adjacent to suction dredging, overall abundance remained the same.

Thomas (1985) observed cutthroat trout opportunistically feeding on invertebrates dislodged by a suction dredge. In some circumstances, habitat may be temporarily created by suction dredging. Harvey (1986) observed that fish occupying a riffle during late summer in Butte Creek, California, moved into a newly created dredge excavation, presumably seeking deeper water. Harvey found that adult fishes in general were not sensitive to dredging; however, riffle sculpin ( Cottus gulosus ), a benthic species, was displaced from suction-dredged areas, probably due to disturbance of its microhabitat. Harvey also suspected that the microhabitats of speckled dace ( Rhinichthys osculus ) would also be deleteriously altered by suction dredging.

Although the effects of recreational suction dredging on adult fishes may range from beneficial to deleterious, such dredging appears to have strong negative impacts to early life stages of fishes. Griffith and Andrews (1981) found a mortality rates of up to 100 percent for cutthroat trout ( Oncorhynchus clarki ) eggs and fry, and rainbow trout ( O. mykiss ) un-eyed eggs and sac fry that pass through a suction dredge. Harvey and Lisle (1998) noted that passing through a suction dredge would likely kill eggs, larvae, and fry of other types of fishes as well, including suckers (Catostomidae). Harvey et al. (1995) concluded that small larvae of fish such as suckers are easily damaged by physical disturbance caused by the dredge, but adults and juveniles are unlikely to be directly affected by suction dredges since they can either avoid or survive the passage through a dredge. In a review of the current literature on suction dredging, Harvey and Lisle (1998) concluded that while effects from dredging may be minor and local in some situations, fisheries managers would be prudent to consider dredging to be a harmful practice in streams that support threatened or endangered species.

No studies exist that specifically address the effects of suction dredging on Santa Ana suckers. In the proposed rule, we concluded that suction dredging may impact larvae and eggs of Santa Ana suckers, particularly if dredging is concentrated in an area containing spawning suckers. Santa Ana suckers and speckled dace, another species in the East Fork of the San Gabriel River, appear to prefer larger unconsolidated cobble substrates. These types of substrates may actually be created by suction dredging (Harvey and Lisle 1998). Also, suction dredging may provide local increases in food resources for fish (Thomas 1985). However, as stated above, suction dredging could result in mortality of eggs or larvae during spawning periods, and so should be excluded from Santa Ana sucker habitats during spawning. We will continue to evaluate the overall effects of suction dredging on Santa Ana suckers and provide specific recommendations to CDFG and the USFS based on those results.

Issue 5: We received comments that the Service should consider the application of a special rule under section 4(d) of the Act for the Santa Ana sucker in the Santa Ana River. The special rule would exempt certain activities from the take prohibitions of the Act, so long as a Service-approved Santa Ana sucker conservation plan is funded and implemented. The conservation plan would provide for the conservation of the species within the Santa Ana River watershed.

Our Response: Under section 4(d) of the Act, we have the authority to issue regulations as deemed necessary and advisable to provide for the conservation of a species listed as threatened. We are interested in pursuing collaborative, proactive efforts to conserve the Santa Ana sucker. A special rule under section 4(d) could provide an incentive for State, county, and local jurisdictions, as well as private land owners, to protect and conserve the Santa Ana sucker. This special rule could potentially provide for substantial conservation of the Santa Ana sucker. The comments we received from the County of Orange, Orange County Water District, and Santa Ana River Watershed Group provided background information to consider the possibilities of a special rule under section 4(d). If our review of this information indicates that the application of a special rule under 4(d) to facilitate the conservation of the Santa Ana sucker warrants further evaluation, we will publish in the Federal Register a notice of intent to consider such a rule.

Issue 6: Commenters expressed concerns about the effects of listing the Santa Ana sucker on the continued use of the San Gabriel Canyon Off Highway Vehicle Area (SGCOHVA), located at the confluence of the East and West Forks of the San Gabriel River in the Angeles National Forest.

Our Response: Although surveys in 1999 failed to record the Santa Ana sucker in the West Fork of the San Gabriel River (R. Ally, CDGF, in litt. 1999), the species was found within 1.6 km (1.0 mile) of the SGCOHVA during 1999 surveys of the East Fork (G. Knowles, in litt. 1999b). Therefore, we conclude that Santa Ana suckers can be expected to occur in the SGCOHVA.

The commenters stated that the use of the SGCOHVA would have minimal impact to the species because off-road vehicles are not used in streams but cross streams only to access other areas of the SGCOHVA. However, the operation of off-road vehicles in the SGCOHVA could adversely affect Santa Ana sucker habitat due to increased sedimentation to the stream from erosion, or alteration of channel morphology from the physical disturbance of crossing the stream. In addition, one recent study found that certain types of stream crossings can act as barriers to fish movement (Warren and Pardew 1998), although temporary ford crossings, such as those currently in the SGCOHVA, were not a significant barrier to fish dispersal. Since the overall impact of the SGCOHVA to Santa Ana suckers is not currently known, further evaluation is required. Under section 7 of the Act, Federal agencies are required to insure, through consultation with us, that any actions they authorize, fund, or carry out are not likely to jeopardize the continued existence of any listed species. The USFS would need to consult with us on the impacts that off-road vehicles in the SGCOHVA, or other ongoing and future activities on national forest lands, would have on Santa Ana suckers.

Issue 7: Several commenters were concerned that future efforts to repatriate the Santa Ana sucker into streams of the upper Santa Ana River Drainage would adversely impact the operation of hydroelectric facilities in the area.

Our Response: No decision has been made to reestablish Santa Ana suckers into areas formerly occupied by the species. However, considering the large amount of habitat loss (the Santa Ana sucker is believed to be extirpated from about 75 percent of its former range), reintroduction of Santa Ana suckers into formerly occupied habitats may be an important component of a recovery plan for the species. A decision to reintroduce the Santa Ana suckers to formerly occupied areas would be part of the recovery efforts for the species and would include analysis under and compliance with the Act, National Environmental Policy Act (NEPA), and other applicable Federal laws and regulations. Such analysis would include an evaluation of the impacts reintroduction would have on hydroelectric facilities and ways to minimize potential conflicts.

Issue 8: Commenters were concerned that listing the Santa Ana sucker would impair the ability of flood control districts to protect upland property from flooding. A commenter stated that the Santa Ana sucker has managed to adapt to the long history of flood control and maintenance activities in the Santa Ana River, and therefore, these activities should be allowed to continue. According to the commenters, flood control districts are willing to work with us to develop plans that would promote the recovery of the Santa Ana sucker to the “maximum extent possible.”

Our Response: The issue of flood control in Santa Ana sucker habitat is of critical importance. We disagree that the species has managed to adapt to flood control activity in the Santa Ana River. Flood control activity, such as bank stabilization, channelization, vegetation removal, drop structures, and the construction of dams, dikes, and diversions, has been implicated as a key factor responsible for the decline of not only the Santa Ana sucker but six other species of freshwater fishes native to the Los Angeles Basin (Swift et al. 1993). An example of the adverse impacts of flood control activity on this species is the Santa Ana River at Imperial Highway (State Highway 90) near Anaheim. Santa Ana suckers were common at this site in the late 1980s and early 1990s. During the last 15 years, the USACE has undertaken various flood control activities at the site. The river has been channelized, riparian vegetation removed, and banks stabilized with rip rap and concrete. Santa Ana suckers have not been recorded in this reach since 1996. Although the exact reasons for the apparent disappearance of Santa Ana suckers from this area may never be known, the drastic changes to its habitat by flood control activities are plausibly a key factor (Chadwick and Associates 1996; Robert Fisher, pers. comm. 1999; M. Saiki, pers. comm. 1999).

We commend the willingness of the flood control districts to work with us to develop a plan to recover the Santa Ana sucker. The Santa Ana River, within the jurisdiction of various flood control districts, contains some of the best remaining occupied habitat for Santa Ana suckers within this drainage, and the protection and enhancement of this habitat likely will be crucial to the recovery of the species. Certain flood control activities are regulated by the USACE under section 404 of the Clean Water Act. Under section 7 of the Act, Federal agencies are required to insure, through consultation with us, that any actions they authorize, fund, or carry out are not likely to jeopardize the continued existence of any listed species. The impacts of ongoing and future flood control activities to Santa Ana sucker would be addressed during the section 7 consultation process. In addition, we are considering proposing special regulations under the authority of section 4(d) of the Act that would promote the conservation of the Santa Ana sucker by exempting certain activities from the take prohibitions of the Act in association with implementing locally prepared, Service-approved programs that would contribute to the overall conservation of the species (see “Issue 5”).

Issue 9: Commenters expressed the concern that the listing of the Santa Ana sucker is premature because sound scientific evidence does not exist demonstrating that the species populations are decreasing, because surveys have been inadequate to document declining populations, and because apparent declines represent natural variation in population size resulting from climate cycles and not from human-induced changes to ecosystems.

Our Response: We estimate that the Santa Ana sucker has been eliminated from about 75 percent of its former native range. This loss has been caused by habitat destruction, natural and human-induced changes in streamflows, urban development and related land-use practices, and the introduction of nonnative competitors and predators (Moyle et al. 1995; Swift et al. 1993). The utilization of the rivers of the Los Angeles Basin for irrigation began as early as 1821, and was extensive by the 1880s (Miller 1961). The demands of an increasing human population in the Los Angeles area resulted in an extreme level of utilization of the Los Angeles Basin Rivers that was apparent as early as 1930, when McGlashan (1930) wrote of the Santa Ana River, “Probably no other stream of its size in the United States is made to serve greater or more varied uses.” By the 1950s, urbanization of the greater Los Angeles metropolitan area had resulted in severe declines of the native fish fauna of the Los Angeles Basin, such that four fish species had been extirpated from the basin (Swift et al. 1993). This urbanization resulted in conversion of Santa Ana sucker habitat to the concrete-lined storm drains that now constitute the lowermost reaches of the Los Angeles, San Gabriel, and Santa Ana Rivers (Mount 1995) ( see “Summary of Factors Affecting the Species” section). Moyle and Yoshiyama (1992) stated, “[e]ven though Santa Ana suckers seem to be quite generalized in their habitat requirements, they are intolerant of polluted or highly modified streams.” The impacts associated with urbanization are likely the primary cause of the extirpation of Santa Ana suckers from lower reaches of the Los Angeles, San Gabriel, and Santa Ana Rivers. We, therefore, disagree with the contention that sound scientific evidence does not exist demonstrating that the species is decreasing. The decline of the Santa Ana sucker and the destruction of its habitat are well documented (Miller 1961; Moyle 1976a; Moyle and Yoshiyama 1992; Swift et al. 1993; Moyle et al. 1995).

Issue 10: Commenters expressed the belief that the newly completed Seven Oaks Dam, upstream from the present range of Santa Ana sucker in the Santa Ana River, would not act as a barrier to upstream fish movement. The only flows connecting the upper and lower Santa Ana River Basins in the last 40 years have been extreme flood flows, which would cause Santa Ana suckers to be lost downstream. In fact, commenters felt that Seven Oaks Dam would be beneficial for the species by reducing the amount of fine particles and sand deposited downstream in flood flows, sediments that threaten Santa Ana sucker habitat in the Santa Ana River.

Our Response: We agree that the surface flows of the Santa Ana River between Riverside and Seven Oaks Dam have long been diverted to provide water for the communities in southwestern San Bernardino County and western Riverside County. We also agree that this dewatered stretch, and not the dam, is the current primary barrier to the movement of Santa Ana suckers upstream in the Santa Ana River. However, records from the 1940s indicate that Santa Ana suckers were once a common resident in the now dewatered stretch of the Santa Ana River near San Bernardino. The restoration of a more perennial flow to these areas may make these areas suitable for Santa Ana suckers. Ideally, connectivity between the upper and lower portions of the drainage would allow for gene flow throughout the population. However, even if water was returned to dry reaches of the Santa Ana River, Seven Oaks Dam would prevent movement of Santa Ana suckers between formerly occupied upstream habitats and the lower reaches they occupy now. Thus, Seven Oaks Dam represents a more permanent barrier to the movement of fishes than dewatered sections of the stream.

We agree that sediment load characteristics of the Santa Ana River have been modified downstream from Seven Oaks Dam. However, the ultimate effects on sediment characteristics of the Santa Ana River downstream of the newly completed Seven Oaks Dam are, at best, difficult to predict. In general, streams below newly closed dams are changed through narrowing and deepening of their channels and coarsening of their beds. This generally results in an armored condition of the river bed just below the dam, such that the bed is lined with relatively large particles that were mobile during high flood flows before the dam was closed but are now too heavy to be moved by the new regime (Graf 1988; Mount 1995). Also, most dams have a high trap efficiency, meaning that they trap most sediment. Only the finer sediments get through (Mount 1995). So, although we cannot know for certain what effect the newly completed Seven Oaks Dam will have on the Santa Ana River downstream, we can generally predict that it will result in a decrease of coarser materials and an increase in finer substrates delivered to downstream reaches. Seven Oaks Dam will further prevent the Santa Ana River from functioning as a natural river, a scenario that has often had numerous negative impacts on the aquatic environment (Hunt 1988; Harden 1996; McCully 1996), as well as on the resident fish populations (Miller 1961; Moyle 1976a; Minckley and Deacon 1991; Mount 1995).

In accordance with the interagency peer review policy published on July 1, 1994 (59 FR 34270), we solicited the expert opinions of 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. We requested four individuals, who possess expertise in Santa Ana sucker biology and Catostomid ecology, and whose affiliations include academia, a Federal agency, and a private company, to review the proposed rule by the close of the comment period. Two individuals responded to our request, and we have addressed their comments in the previous section of the rule, and in updating the “Background” and “Summary of Factors Affecting the Species” sections.

Section 4 of the Act and regulations (50 CFR part 424) issued to implement the listing provisions of the Act set forth the procedures for adding species to the Federal Lists. A species may be determined to be an endangered or threatened species due to one or more factors described in section 4(a)(1) of the Act. These factors and their application to the Santa Ana sucker ( Catostomus santaanae ) are as follows:

Moyle and Yoshiyama (1992) concluded that the native range of the Santa Ana sucker is largely coincident with the Los Angeles metropolitan area. Intensive urban development of the area has resulted in water diversions, extreme alteration of stream channels, changes in the watershed that result in erosion and debris torrents, pollution, and the establishment of introduced nonnative fishes. Moyle and Yoshiyama (1992) stated, “[e]ven though Santa Ana suckers seem to be quite generalized in their habitat requirements, they are intolerant of polluted or highly modified streams.” The impacts associated with urbanization are likely the primary cause of the extirpation of this species from lowland reaches of the Los Angeles, San Gabriel, and Santa Ana Rivers.

As the Los Angeles urban area expanded, the Los Angeles Basin rivers (the Los Angeles, Santa Ana, and San Gabriel Rivers) were highly modified, channelized, or moved in an effort to either capture water runoff or protect property. As Moyle (1976a) stated, “[t]he lower Los Angeles River is now little more than a concrete storm drain.” The same is true for the Santa Ana and San Gabriel Rivers. These channelized rivers and canals with uniform and altered substrates do not appear to be suitable for sustaining Santa Ana sucker populations (Swift et al. 1993; Chadwick and Associates 1996), and the species appears to persist only in reaches that remain relatively unchannelized. Past and continuing projects have resulted (or will result) in channelization of the Santa Ana River throughout most of the range of the Santa Ana sucker in Orange County. Urban development also threatens the Santa Ana sucker in the Los Angeles and Santa Ana River Basins. This urban development has also resulted in changes in water quality and quantity and the hydrologic regime of these rivers. The Santa Ana sucker is one of seven native freshwater fish species of the Los Angeles Basin that have declined drastically in the last 70 years. Four of these species, the steelhead, Pacific lamprey, Pacific brook lamprey, and the unarmored threespine stickleback have been extirpated from the Los Angeles Basin since the 1950s, and two others are very rare (Santa Ana speckled dace and arroyo chub), presumably due to the same factors that have caused the decline of the Santa Ana sucker (Swift et al. 1993) (For an example of the apparent effects of channelization on Santa Ana suckers, see “Issue 8” in the “Summary of Comments and Recommendations” section).

All three river systems have dams that isolate and fragment fish populations. These dams have likely resulted in some populations being excluded from suitable spawning and rearing tributaries. Reservoirs created by the dams also provide areas where introduced predators and competitors can live and reproduce (Moyle and Light 1996) (see factor C of this section). The newly completed Seven Oaks Dam, upstream from the present range of Santa Ana sucker in the Santa Ana River, forms a barrier for the upstream movement of fish and further isolates Santa Ana sucker populations from their native range in the headwaters of the system.

The population of Santa Ana suckers in the West Fork of the San Gabriel River is threatened by accidental high flows from Cogswell Reservoir, which have devastated this section of stream several times in the past (Moyle and Yoshiyama 1992; Haglund and Baskins 1992; T. Haglund, in litt. 1996). T. Haglund ( in litt. 1996) stated that, “[t]he West Fork population was wiped out by a sluicing event (removal of sediment by releasing a sudden flow of water) from Cogswell Dam in 1981 (anecdotal data) but recolonized from tributaries that acted as refugia. However, data (from CDFG, no date) suggest that the suckers have never returned to their former abundance.” Santa Ana suckers have biological adaptations that allow the fish to quickly repopulate streams following periodic flood events (Moyle et al. 1995). However, successive high flows could eliminate the sucker population in the West Fork of the San Gabriel River by rapidly depleting the individuals soon after they migrate into the mainstem from tributaries. Proposals for additional sluicing or other sediment removal activities from the Cogswell reservoir on the San Gabriel River system are being considered (R. C. Hight, in litt. 1999). The potential effects of the proposed sediment management project may also degrade the habitat of the Santa Ana sucker by depositing large amounts of silt on the streambed, causing a rapid increase in suspended sediments in the water column.

The petitioners contended that suction dredge mining has increased in the Cattle Canyon tributary to the East Fork of the San Gabriel River, thereby threatening the Santa Ana sucker. A commenter indicated that no suction dredging has occurred in Cattle Canyon and suggested that the petitioners took Moyle and Yoshiyama (1992) out of context (Gerald Hobbs, Public Lands Action Committee, in litt. 1996, 1999). The CDFG (Patricia Wolf, CDFG, in litt. 1996) indicated they are not aware of suction dredging in the Cattle Canyon tributary to the East Fork of the San Gabriel River. However, they had issued nearly 200 Special Dredge Permits for the East Fork of the San Gabriel River in 1995, the first time the East Fork had been dredged in 15 years. This number has dropped to approximately 40 Special Dredge Permits issued in 1999 for the East Fork San Gabriel River (D. Maxwell, CDFG, pers. comm. 1999). Even though surveys from 1996 through 1999 indicate the East Fork of the San Gabriel River continues to maintain a healthy Santa Ana sucker population (R. Ally, in litt. 1996; J. Hernandez, in litt. 1997;, M. Saiki, pers. comm. 1999), suction dredging may impact larvae and eggs of Santa Ana suckers, particularly if dredging is concentrated in an area containing spawning suckers. Harvey and Lisle (1998) recommended that, given the uncertainty concerning the effects of suction dredging, fisheries managers would be wise to assume that suction dredging is a harmful practice in streams that support threatened or endangered species. (See “Issue 4” in the “Summary of Comments and Recommendations” section.)

Recreational activities on forest lands may also pose some threat to Santa Ana sucker habitat quality. Annually, thousands of people from the Los Angeles metropolitan area and adjacent urban communities use wilderness and nonwilderness areas within the Big Tujunga Creek and San Gabriel Forks areas of the Angeles National Forest for recreation. The impact of large numbers of people using these areas include destruction of streambank vegetation, streambank erosion, and the disposal of untreated human waste and other refuse into the creeks, all of which degrade water quality (D. Maxwell, CDFG, pers. comm. 1999). Given the projected growth of the Los Angeles metropolitan area, this threat should increase.

Although the Santa Ana sucker evolved under conditions that presumably included droughts, water diversions and management practices threaten the continued existence of the species. For example, stretches of the upper Santa Ana River have been permanently dewatered, eliminating Santa Ana sucker populations and migration through these reaches to other areas (Swift et al. 1993). As previously discussed, channelization of the rivers of the Los Angeles Basin, water quality degradation, and dam construction have all combined to degrade and eliminate historic Santa Ana sucker habitat. Future human population and urban growth of the basin will further stress the natural resources of the basin and likely exacerbate these conditions by further destruction and degradation of Santa Ana sucker habitat.

Degradation of water quality in the Santa Ana and Los Angeles Rivers may threaten the Santa Ana sucker (Moyle and Yoshiyama 1992). Suckers are common in some areas upstream from Prado Dam where several water treatment facilities discharge into the Santa Ana River (Chadwick and Associates 1992). Chadwick and Associates (1992) attributed high sucker numbers to adequate water supplies discharged by the treatment facilities and the presence of tributaries that offer spawning areas and refugia for suckers. However, they did note that the Santa Ana River between Mission Boulevard and Interstate 10 probably would not support viable populations of fishes, due, in part, to “elevated levels of chlorine and unionized ammonia.” Overall, Santa Ana sucker numbers are much reduced in the Santa Ana River, and the Santa Ana River population appears to be less healthy than populations in other rivers occupied by the species (Moyle and Yoshiyama 1992; M. Saiki, pers. comm. 1999; P. Wolf, in litt. 1996).

The small mile-long stretch of Big Tujunga and Haines Canyon Creeks that appears to provide a critical refugia for the Santa Ana sucker, as well as the arroyo chub and Santa Ana speckled dace, is threatened by the potential water quality impacts of a proposed golf course development to be built just upstream of Interstate 210 (Bill Eick, in litt. 1999). Cohen et al. (1999) reviewed studies of 36 golf courses around the United States in an effort to evaluate the impacts to water quality by golf courses. Although no toxicologically significant impacts were observed by the authors, maximum allowable concentrations of pesticides and related chemicals for aquatic organisms occasionally were exceeded. Moreover, maximum contaminant levels/health advisory levels were frequently exceeded for various pesticides and ground water nitrate-nitrogen. Although the water quality tolerances of Santa Ana suckers are unknown, in general, point and non-point source pollution ( e.g. , urban runoff, sedimentation) have significantly degraded the water quality in most of the native range of the Santa Ana sucker.

In an effort to identify what environmental variables affect the Santa Ana sucker, the Biological Resources Division of the USGS, in conjunction with the Orange County Water District, County of Orange, Los Angeles County Department of Public Works, and the Service, is nearing completion of a study of the factors affecting Santa Ana sucker abundance. Initial results from this study indicate that tissue concentrations of inorganic and organic contaminants from Santa Ana suckers from the San Gabriel and Santa Ana Rivers were not unusually high. However, measurements of electrical conductance and turbidity did show significant negative correlations with Santa Ana sucker abundance, indicating that Santa Ana suckers are less tolerant where conditions are more turbid and contain more salts (M. Saiki, pers. comm. 1999). Based on available information, we conclude that increased turbidity and associated deposition of fine particles and sand likely threaten the Santa Ana sucker population in the Santa Ana River by decreasing the availability of cobble and other hard substrates and altering the water quality preferred by the species (Moyle and Yoshiyama 1992).

We are not aware of any commercial or recreational demand for the Santa Ana sucker. Although the CDFG reported that Santa Ana suckers had been illegally caught with gill and throw nets in the Santa Ana River below Prado Dam (Lt. M. Maytorena, CDFG, pers. comm. 1997), the relative impact of illegal harvesting of the species is unknown.

Moyle and Yoshiyama (1992) concluded that introduced brown trout ( Salmo trutta ) may have caused the extirpation of the Santa Ana sucker from the upper Santa Ana River in the San Bernardino Mountains. The petitioners noted that centrarchid (sunfishes) and bullheads prey on suckers. In the Los Angeles River, such introduced predators aggregate in pools during droughts and are presumably feeding on native fishes, including Santa Ana suckers (Sierra Club Legal Defense Fund, in litt. 1994). Similar conditions exist in the Santa Ana River. Predation by introduced fishes in combination with habitat destruction has been implicated in the decline of other species of suckers in the Southwest (Minckley et al. 1991; Scoppettone and Vinyard 1991) and on native fishes in general in California (Moyle 1976b).

Initial results from the USGS study mentioned above indicate that the presence of nonnative fish species was more strongly correlated with the absence of Santa Ana suckers than any water quality variable. Strongly significant negative associations were found with common carp ( Cyprinus carpio ), largemouth bass ( Micropterus salmoides ), bluegill ( Lepomis macrochirus ), and fathead minnow ( Pimephales promelas ), indicating nonnative fishes may exclude Santa Ana suckers by competition, or eliminate suckers through predation (M. Saiki, pers. comm. 1999). Nonnative introduced fishes have long been recognized as having far-reaching negative impacts to native fishes in North America (Moyle et al. 1986). Accordingly, introduced predators and competitors likely threaten the continued existence of Santa Ana suckers throughout most of the range of the species.

Despite existing regulatory mechanisms and conservation activities accomplished to date by private, State, and Federal entities, the Santa Ana sucker has continued to decline throughout a significant portion of its range. Existing regulatory mechanisms that might provide some protection for the Santa Ana sucker if it was not listed include the California Endangered Species Act, California Environmental Quality Act (CEQA), NEPA, Clean Water Act, Federal Endangered Species Act (where the Santa Ana sucker occurs in areas where other federally listed species are located), and land management or conservation measures by Federal, State, or local agencies or by private groups and organizations.

The State of California considers the Santa Ana sucker a “species of special concern.” However, the Santa Ana sucker is not listed as endangered or threatened by the State, and “species of special concern” are afforded no protection under the California Endangered Species Act.

CEQA requires full public disclosure of the potential environmental impact of proposed projects. This law also obligates disclosure of environmental resources within proposed project areas and may enhance opportunities for conservation efforts. However, CEQA does not guarantee that such conservation efforts will be implemented. The public agency with primary authority or jurisdiction over the project is designated as the lead agency under CEQA, and is responsible for conducting a review of the project and consulting with other agencies concerned with resources affected by the project. Section 15065 of the CEQA guidelines requires a finding of significance if a project has the potential to “reduce the number or restrict the range of a rare or endangered plant or animal.” Although not currently listed under the California Endangered Species Act, the Santa Ana sucker would likely qualify as a rare species under section 15380 of the CEQA guidelines and thus would be given the same consideration under CEQA as those species that are officially listed with the State. Once significant impacts are identified, the lead agency may either require mitigation for effects through changes in the project or decide that overriding considerations justify approval of a project with significant impacts. In the latter case, projects may be approved that cause significant environmental damage, such as resulting in the loss of habitat supporting State-listed species. Protection of listed species through CEQA is, therefore, not assured.

NEPA requires an intensive environmental review of projects that may adversely affect a federally listed species, but project proponents are not required to avoid impacts to nonlisted species. The primary purpose of NEPA is to require Federal agencies to fully disclose impacts that would result from their proposed actions, and to make findings regarding the significance of those impacts. It does not require that resources be protected.

Lead agencies responsible under CEQA and/or NEPA have made determinations that have adversely affected, or would adversely affect, the Santa Ana sucker and its habitat. Examples of projects that have been completed or are currently undergoing the review process under CEQA and/or NEPA that would impact this species include the Santa Ana River Mainstem Project, containing multiple projects including Seven Oaks Dam and the raising of Prado Dam, and the continued channelization of the Santa Ana River in Orange County. The reviews for these projects have not addressed the effects of the proposed actions on the Santa Ana sucker, despite its status as a species proposed for listing. Similarly, on the San Gabriel River, proposed silt removal from Cogswell Dam may adversely affect the sucker. While projects altering a stream course are subject to review under section 1601 or 1603 of the California Fish and Game Code, such State regulations have not prevented habitat loss or sufficiently protected habitats to prevent the decline of the Santa Ana sucker.

Section 404 of the Clean Water Act currently affords some protection for the Santa Ana sucker. However, the Clean Water Act, by itself, does not provide adequate protection for the Santa Ana sucker. Although the objective of the Clean Water Act is to “restore and maintain the chemical, physical, and biological integrity of the Nation's waters” (33 U.S.C. 1251), this law contains no specific provisions to address the conservation needs of rare species. USACE is the Federal agency with primary responsibility for administering the section 404 program. Under section 404, nationwide permits may be issued for certain activities that are considered to have minimal impacts, including minor dredging and discharges of dredged material, some road crossings, and minor bank stabilization (December 13, 1996; 61 FR 65873). USACE seldom withholds authorization of an activity under nationwide permits unless the existence of a listed threatened or endangered species would be jeopardized. Activities that do not qualify for authorization under a nationwide permit, including projects that would result in more than minimal adverse environmental effects, either individually or cumulatively, may be authorized by an individual permit or regional general permit, which are typically subject to more extensive review. Regardless of the type of permit deemed necessary under section 404, rare species such as the Santa Ana sucker may receive no special consideration with regard to conservation or protection unless they are listed under the Act.

As part of the section 404 review process, we provide comments to USACE on nationwide permits and individual permits under the Fish and Wildlife Coordination Act. Our comments are only advisory, although procedures exist for elevating permit review within the agencies when disagreements between us and USACE arise concerning the issuance of a permit. In practice, the section 404 permit review process has often proven to be inadequate to protect unlisted but rare species, such as the Santa Ana sucker.

The Santa Ana sucker may receive a small amount of protection from the overlap of its habitat with two federally endangered birds, the least Bell's vireo ( Vireo bellii pusillus ) and the southwestern willow flycatcher ( Empidonax traillii extimus ). Consideration for these listed bird species protects some areas from projects that could ultimately damage Santa Ana sucker habitat. However, protection is limited because these listed bird species occupy different areas and have dissimilar ecological requirements from the Santa Ana sucker. Although the federally endangered San Bernardino kangaroo rat ( Dipodomys merriami parvus ) also occurs along the Santa Ana River, this listed mammal occurs upstream from the present range of the Santa Ana sucker. Therefore, the presence of the San Bernardino kangaroo rat will have little effect on the status or protection afforded the sucker.

USFS lands encompass approximately 15 percent of the current native range of the Santa Ana sucker. Although a small percentage of the range is within a designated wilderness area, the majority of the range on USFS lands is not under wilderness management. Wilderness designation offers no direct regulatory protection to the sucker, but it does reduce some human-induced impacts on the stream. For example, motorized equipment is excluded from these areas. This restriction reduces or eliminates all motorized recreation and mining activities within the wilderness areas. Because these types of activities may harm Santa Ana sucker populations and habitats, wilderness designation offers some indirect benefit to the species. Santa Ana sucker habitat on USFS is also not subject to the development pressures existing on private land. However, this protection likely is partially offset by the recreational impacts discussed earlier (see factor “A”).

Periodic wildfires could adversely affect Santa Ana suckers by eliminating vegetation that shades the water and moderates water temperature, or by producing silt-and-ash-laden runoff that can significantly increase the turbidity of rivers. Although recent fires, including the 1996 Biedebach Fire (near the vicinity of Prairie Fork on the East Fork of the San Gabriel River) and the 1999 Bridge Fire (adjacent to the West and North Forks of the San Gabriel River), did not burn the riparian corridor, they may have contributed increased runoff and siltation to the creek.

The high degree of fragmentation of the remaining Santa Ana sucker populations makes the species especially vulnerable to random events, environmental factors, and loss of genetic variability. A small population size increases the rate of inbreeding and may allow increased expression of deleterious recessive genes occurring in the population (known as inbreeding depression). Loss of genetic variability, through random genetic drift (random gene frequency changes in a small population due to chance), reduces the ability of small populations to respond successfully to environmental stresses. Most of the lowland river habitats have been lost, and the remaining populations of Santa Ana suckers are low in numbers, with the exception of the San Gabriel Forks populations. Although Santa Ana suckers are locally common in what remains of their native range, the total population size of any one of the remaining native populations is still relatively small. Random events, such as floods, variations of annual weather patterns, predation and associated demographic uncertainty (conditions affected by chance events, such as sex ratios, that influence survival and reproduction in small populations), or other environmental stresses and human-caused factors, such as chemical spills, may lead to the demise of the remnant populations in the Los Angeles or Santa Ana Basins.

We have carefully assessed the best scientific and commercial information available regarding the past, present, and future threats faced by this species in determining its status. Based on this evaluation, the preferred action is to list the Santa Ana sucker ( Catostomus santaanae ) as threatened. While not in immediate danger of extinction, the Santa Ana sucker is likely to become an endangered species in the foreseeable future if the present threats continue and populations decline further.

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

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

Section 4(a)(3) of the Act, as amended, and implementing regulations (50 CFR 424.12) require that, to the maximum extent prudent and determinable, the Secretary designate critical habitat at the time the species is determined to be endangered or threatened. According to Service regulations (50 CFR 424.12(a)), critical habitat is not determinable if information sufficient to perform required analysis of the impacts of the designation is lacking or if the biological needs of the species are not sufficiently well known to permit identification of an area as critical habitat. Section 4(b)(2) of the Act requires us to consider economic and other relevant impacts of designating a particular area as critical habitat on the basis of the best scientific data available. The Secretary may exclude any area from critical habitat if he determines that the economic benefits of such exclusion outweigh the conservation benefits of designation, unless to do so would result in the extinction of the species.

In designating critical habitat, we consider the following requirements of the species: Space for individual and population growth and for normal behavior; food, water, air, light, minerals, or other nutritional or physiological requirements; cover or shelter; sites for breeding, reproduction, or rearing of offspring; and, generally, habitats that are protected from disturbance or are representative of the historic geographical and ecological distributions of this species (see 50 CFR 424.12(b)). In addition to these factors, we also focus on the known physical and biological features (primary constituent elements) within the designated area that are essential to the conservation of the species and may require special management considerations or protection. The essential features for the Santa Ana sucker may include, but are not limited to, spawning sites, food resources, and water quality and quantity (see 50 CFR 424.12(b)).

We conclude that the knowledge and understanding of the biological needs and environmental limitations of the Santa Ana sucker and the primary constituent elements of its habitat are insufficient to determine critical habitat for the fish. We believe that the Santa Ana sucker is intolerant of highly polluted waters, but little information is available concerning this possible limiting factor. Furthermore, in the Santa Ana River, suckers remain extant, although rare, in the lower reaches where water quality is degraded relative to the headwaters. We need additional information on the environmental limits of the sucker to enable us to accurately designate critical habitat for the Santa Ana sucker throughout its range. The physical and biological features including but not limited to water chemistry, water temperature, instream flows, streambed substrate and structure, and fauna and flora of the aquatic environment that supports the Santa Ana sucker are the features about which we need additional information. In an effort to gain these data, the Orange County Water District, the County of Orange, Los Angeles County Department of Public Works, the National Fish and Wildlife Foundation, the Biological Resources Division of USGS, and the Service have funded and implemented research on the environmental limitations of the Santa Ana Sucker. The study is nearing completion and has already identified some environmental parameters, including water quality (e.g., turbidity and conductivity) and some biological parameters (introduced nonnative fish species) associated with variations in population densities. These correlations will help guide future research to focus on the variable(s) most likely to limit sucker populations.

When a “not determinable” finding is made, we must, within 2 years of the publication date of the original proposed rule, propose the designation of critical habitat, unless the designation is found to be not prudent. Initial results of the USGS-Santa Ana sucker study have been incorporated into this rule. A final report should be available later this year. We will use this study and other new information to reevaluate our knowledge of the species and, if determined prudent, propose critical habitat for the Santa Ana sucker. We will continue in our efforts to obtain more information on Santa Ana sucker biology and ecology, including distribution, population density, and essential habitat characteristics, particularly in regard to water quality. We will also use the information resulting from these efforts to identify measures needed to achieve conservation of the species, as defined under the Act.

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 practices. Recognition through listing encourages and results in conservation actions by Federal, State, and private agencies, groups, and individuals. The Act provides for possible land acquisition and cooperation with the States, and requires that recovery plans be carried out for all listed species. Funding may be available through section 6 of the Act for the State to conduct recovery activities. The protection required of Federal agencies and the prohibitions against certain activities involving listed plants are discussed, in part, below.

Section 7(a) of the Act, as amended, requires Federal agencies to evaluate their actions with respect to any species that is proposed or listed as endangered or threatened and with respect to its critical habitat, if any is being designated. Regulations implementing this interagency cooperation provision of the Act are codified at 50 CFR part 402. Section 7(a)(4) requires Federal agencies to confer with us on any action that is likely to jeopardize the continued existence of a species proposed for listing or result in destruction or adverse modification of proposed critical habitat. If a species is listed subsequently, 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 destroy or adversely modify its critical habitat, if designated. If a Federal action may affect a listed species or its critical habitat, the responsible Federal agency must enter into formal consultation with us, under section 7(a)(2) of the Act.

Federal agencies expected to consult with us under section 7 regarding the Santa Ana sucker include USACE and the Environmental Protection Agency because of their permitting authority under section 404 of the Clean Water Act. The USFS may consult with us on its activities on the Angeles National Forest and Los Padres National Forest. These agencies either administer lands/waters containing the Santa Ana sucker or authorize, fund, or otherwise conduct activities that may affect this species.

The Act and its implementing regulations set forth a series of general prohibitions and exceptions that apply to all endangered and threatened wildlife not covered by a special rule. These prohibitions, codified at 50 CFR 17.21 and 17.31, in part, make it illegal for any person subject to the jurisdiction of the United States to take (including harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, collect, or attempt any such conduct), 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 our agents and State conservation agencies.

Permits may be issued to carry out otherwise prohibited activities involving threatened wildlife under certain circumstances. Regulations governing permits are at 50 CFR 17.32. 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, permits also are available for zoological exhibition, educational purposes, or special uses consistent with the mission of the Act.

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

(1) Actions that may affect the Santa Ana sucker and are authorized, funded, or carried out by a Federal agency when the action is conducted in accordance with any reasonable and prudent alternatives or reasonable and prudent measures to minimize the impacts of take identified by us in accordance with section 7 of the Act; and

(2) Possession, transport within or between States, and import and export, with proper permits, of Santa Ana suckers that were legally collected prior to the date of publication in the Federal Register of the final regulation adding this species to the list of threatened and endangered species.

Activities that we believe could potentially harm the Santa Ana sucker and result in a violation of section 9 of the Act include, but are not limited to:

(1) Take of Santa Ana suckers without a permit, which includes harassing, harming, pursuing, hunting, shooting, wounding, killing, trapping, capturing, or collecting, or attempting any of these actions;

(2) Possessing, selling, delivering, carrying, transporting, or shipping illegally taken Santa Ana suckers;

(3) Unauthorized interstate and foreign commerce (commerce across State and international boundaries) and import/export;

(4) Introduction of nonnative species that compete or hybridize with, or prey on Santa Ana suckers;

(5) Unauthorized destruction or alteration of Santa Ana sucker habitat by dredging, channelization, diversion, dewatering through groundwater withdraw, in-stream vehicle operation or rock removal, or other activities that result in the destruction or significant degradation of cover, channel stability, substrate composition, water quality, water temperature, and migratory corridors; and

(6) Discharging or dumping of toxic chemicals, silt, organic waste, or other pollutants (such as may result from mining, land development or land management activities) into waters supporting Santa Ana suckers that results in death or injury to the species or results in the destruction or degradation of cover, channel stability, substrate composition, water quality, water temperature, and migratory corridors used by the species for foraging, cover, migration, and spawning.

We will review other activities not identified above on a case-by-case basis to determine if a violation of section 9 of the Act may be likely to result from such activity. We do not consider these lists to be exhaustive and provide them as information to the public.

Questions regarding whether specific activities may constitute a violation of section 9 should be directed to the Field Supervisor of the Service's Carlsbad Fish and Wildlife Office (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, Ecological Services, Endangered Species Permits, 911 N.E. 11th Avenue, Portland, Oregon 97232-4181 (telephone 503/231-6241; facsimile 503/231-6243)

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 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 rule does not contain any new collections of information other than those already approved under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. , and assigned Office of Management and Budget clearance number 1018-0094. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid control number. For additional information concerning permit and associated requirements for threatened wildlife, see 50 CFR 17.32.

A complete list of all references cited herein is available upon request from the Carlsbad Fish and Wildlife Office (see ADDRESSES section).

The primary author of this document is Glen W. Knowles, Carlsbad Fish and Wildlife Office, U.S. Fish and Wildlife Service (see ADDRESSES section).