This final rule is issued under Marketing Agreement No. 155 and Marketing Order No. 928, both as amended (7 CFR part 928), regulating the handling of papayas grown in Hawaii, 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 of Agriculture (Department) is issuing this rule in conformance with Executive Order 12866.

This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule is not intended to have retroactive effect. This action 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. A 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.

Pursuant to a recommendation of the Papaya Administrative Committee (committee or PAC), this final rule removes the suspension of three sections of the order's rules and regulations regarding grade and inspection (§ 928.313), maturity shipment exemptions (§ 928.152), and inspection waiver procedures (§ 928.150) and makes these regulations applicable until January 2, 2002. This final rule also amends § 928.160 regarding reporting requirements to require handlers to add the inspection certificate number on PAC Form 1, Papaya Utilization during the period of regulation. The removal of the suspension of the grade requirements in § 928.313 will require handlers of papayas to adhere to the minimum quality requirements that were in effect prior to their suspension on July 1, 1994, except that a 5 percent tolerance for immature papayas in Hawaii No. 1 will be removed, as recommended by the committee.

An interim final rule implementing these suspensions was published in the Federal Register on July 27, 1994 (59 FR 38102). A final rule finalizing the interim final rule was published in the Federal Register on October 18, 1994, (59 FR 52409).

Removal of the suspension of minimum quality requirements will require handlers to obtain inspection through the Federal or Federal-State Inspection Service (inspection service) prior to shipment. Removal of the suspension of the maturity exemption and related reporting requirements in § 928.152 will require handlers interested in becoming approved handlers of immature papayas to apply to the committee for approval, and to report handling of immature papayas. Immature papayas are used in a popular dish called green papaya salad and as a vegetable substitute in recipes. In addition, amendment of § 928.160 will require handlers to include the number of the inspection certificate issued by the inspection service on each PAC Form 1, Utilization Report, filed with the committee. Finally, removal of the suspension of the inspection waiver procedures in § 928.150 will allow handlers to ship papayas without inspection under certain conditions when it is not practicable for the inspection service to provide such inspection.

This rule was recommended by the committee at its meeting on February 18, 1999, by a vote of seven in favor, two opposed, and one abstention. The two dissenters believed that the cost of mandatory inspection continues to outweigh its benefits to the industry, that there are other less expensive methods of achieving quality control, and that voluntary quality control should be continued. Those in favor believed that voluntary controls have not been effective, and mandatory controls were needed to ensure that buyers receive the quality they desire and help the industry compete more effectively in the marketplace.

Section 928.52 of the papaya marketing order authorizes the establishment of grade, size, quality, maturity, and pack and container regulations for shipments of papayas. Section 928.53 allows for the modification, suspension, or termination of such regulations when warranted. Section 928.55 provides that whenever papayas are regulated pursuant to §§ 928.52 or 928.53, such papayas must be inspected by the inspection service and certified as meeting the applicable requirements. The cost of inspection and certification is borne by handlers. Section 928.54 authorizes regulation exemptions when shipping papayas for commercial processing, relief agencies, or charitable institutions. In addition, the Secretary may relieve from any or all requirements under or established pursuant to § 928.41, 928.52, 928.53, and 928.55, the handling of papayas in such minimum quantities, in such types of shipments, or for such specified purposes (including shipments to facilitate the conduct of marketing research and development projects established pursuant to § 928.45) as the committee, with the approval of the Secretary, may prescribe. Section 928.60 of the papaya marketing order authorizes handler reporting requirements.

In 1994, §§ 928.150, 928.152, and 928.313 of the order's rules and regulations were suspended. Section 928.313 established minimum grade requirements for shipments of papayas prior to its suspension. This section required that papayas grade at least Hawaii No. 1, except that not more than 5 percent of the fruit may be immature. Also, the weight requirements specified in the Hawaiian grade standards did not apply. This final rule removes the suspension of these regulations with some changes. First, paragraph (a) of § 928.313 will be amended to remove the 5 percent tolerance for immature fruit. Second, paragraph (b) of that section will be amended to correct the information regarding the name, address, and telephone number of the Department contact to obtain copies of the Hawaii papaya quality standards which are incorporated by reference. The standards for Hawaii-grown papaya are dated August 6, 1990, and replace standards dated May 29, 1981, previously incorporated.

As a result of removing the suspension of the grade regulations issued pursuant to § 928.52, mandatory inspection will also be required, except where specifically exempted.

Prior to its suspension, § 928.152 of the order's rules and regulations defined immature papayas and established the procedures for handling immature papayas exempt from regulation. This section also required handlers to apply to the PAC to become approved handlers of immature papayas and report the handling of immature papayas. This rule removes the suspension of these regulations in their entirety for 12 months, thus, affording approved handlers the opportunity to handle immature papayas, exempt from minimum grade, size, quality, and maturity regulations. PAC Form 7 (Application to be an Approved Handler of Immature Papayas) and PAC Form 7(c) (Maturity Exemption Report) will also be reinstated so the committee can approve applications of handlers who would like to handle immature papayas. Removal of the suspension will require such handlers to report their handling of immature papayas. Handlers pay assessments on such shipments.

Section 928.150 established the procedures for granting inspection waivers under certain conditions prior to its suspension. This rule removes the suspension of § 928.150 for one year, giving the inspection service the flexibility to issue inspection waivers to handlers when it is impracticable to provide inspection services during the period of regulation. For example, a handler might be in a remote location and the inspection service might not be able to provide an inspector to perform the inspection at the time and place requested.

Section 928.160 was amended in 1994 as a result of the suspension of §§ 928.150, 928.152, and 928.313. Because the quality requirements, and, thus, the requirement for mandatory inspection were suspended, § 928.160 was amended to remove the requirement to include the inspection certificate number on the PAC Form 1, Utilization Report. Since the quality and inspection requirements will be reinstituted, a change will be necessary in § 928.160 to require the inspection certificate number to be reported by the handler on the PAC Form 1. PAC Form 1 has been revised to include this additional information collection.

Minimum grade and inspection requirements were initially established to assure that only acceptable quality fruit entered fresh market channels, thereby ensuring consumer satisfaction, increasing sales, and improving returns to papaya producers. The reporting requirements were established to authorize the committee to allow approved handlers to handle immature papayas, and to aid the committee in assessment billings and program compliance.

In committee discussions on the suspension of grade, inspection, and reporting requirements in 1994, members who supported the suspension advised that the papaya industry was committed to instituting alternative quality assurance procedures in the absence of mandatory inspection. This was to be achieved by handlers providing financial incentives to producers to harvest and deliver only high quality fruit. Such a program was to be arranged with handlers by the newly formed producers' bargaining cooperative. It was anticipated that this program would provide incentives for growers to deliver high-quality fruit to handlers. However, the producer's bargaining cooperative was not as successful as hoped in implementing this program. To date, the industry has not instituted any effective alternative means of quality control. As a result, the overall quality of papayas shipped from Hawaii has declined and the industry has lost market share.

Most committee members also believed that the elimination of inspection requirements would increase producer returns because handlers would pass on to producers the savings they realized when inspection costs were eliminated. This has happened to a limited extent. Finally, the committee hoped that buyers of fresh papayas would encourage handlers to continue to ship high-quality fruit by paying premium prices for higher-quality fruit. As handlers became more aware of the price differentials between various quality levels, the committee believed that competition among handlers would ensure shipments of good quality fruit. This has not occurred as the committee had hoped.

At the time the suspension was recommended, the industry was suffering from an infestation of Papaya Ringspot Virus (PRSV), a debilitating disease that attacks papaya trees, eventually killing them. Production from the Island of Hawaii, the primary growing region, declined substantially, and the papayas produced from infected trees were of lower quality.

Since 1994, the committee has reported deteriorating wholesale buyer and consumer confidence with Hawaiian papayas, resulting in lost market share. The condition of poor quality papayas often deteriorates further during shipment, frequently requiring buyers to discard some fruit and repack the rest. This has resulted in financial losses for some buyers, decreased buyer confidence, and reduced market opportunities for handlers of Hawaii papayas. As a result, competing supplies from the Philippines, Brazil, and Mexico have made inroads into existing Hawaii papaya markets.

This is of great concern to the committee, especially because the domestic production from two PRSV-resistant papaya varieties is increasing significantly, and is expected to continue. The committee would like to regain the confidence of buyers by shipping high-quality Hawaii papayas. It believes that mandatory quality control is needed to ensure buyers the quality they prefer. Removing the suspension of the grade, inspection, and reporting requirements in place prior to July 1, 1994, is anticipated to help the industry achieve its goals and compete more effectively in the marketplace.

During its deliberations on the removal of the suspension of grade, inspection, and reporting requirements on February 18, 1999, the committee discussed the current state of the industry and what actions the committee could take to enhance the quality of shipments, improve grower and handler returns, increase wholesale buyer and consumer confidence, and regain lost market share. The committee decided that to successfully market the increasing production from the PRSV-resistant papaya varieties, the industry must reestablish a quality image for Hawaii papayas among buyers and consumers. It would be counterproductive, they noted, to utilize assessment dollars promoting a product which was not of acceptable quality.

In addition, the committee noted that reinstituting mandatory inspection will augment information available to the committee on assessments owed by handlers. Once inspections begin, a copy of each inspection certificate will be provided to the committee staff by the inspection service. This third-party information will permit the committee staff to have accurate and timely data upon which to bill each handler for papayas handled. Currently, the committee staff utilizes information gathered from transshippers (air freight and shipping companies) to augment and confirm information provided by handler's reports for assessment collection compliance purposes under § 928.31(n). This information is obtained at a significant cost of committee time and resources. While information from transshippers will continue to be used as a random check, data provided from the inspection certificates will be the primary source of third-party information for assessment billings by the committee staff.

Inspection costs to handlers will result from this action. Inspection costs incurred will total $24.24 per hour for on site inspections and mileage travel costs of 37 cents a mile round-trip from the office to the processing plant or handler's premises. For a trip less than 10 minutes or 7 miles, no travel time cost is charged, just the mileage cost. For a trip taking 10 or more minutes, or covering 7 or more miles, the travel time cost is based on the $24.24 hourly rate.

The committee members who opposed the recommendation believe that the cost of inspection will be passed on to producers, lowering overall producer returns, and that the benefits of mandatory quality control will not outweigh the costs. In addition, they believe that voluntary quality control should be given more time to work. However, most committee members favored the recommendation, as they believe the alternatives attempted have not been successful, and that prompt action is imperative to assure the long-term viability of the Hawaii papaya industry.

The committee's recommendation resulted from the efforts of a task force assigned by the committee chairman in 1998. The task force reviewed the current marketing and quality conditions affecting the Hawaii papaya industry for several months, and recommended to the committee removal of the suspension of quality control-related requirements.

Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA), AMS has considered the economic impact of this action 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 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 400 producers of papayas in the production area and approximately 60 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.

Based on a reported average f.o.b. price of $1.30 per pound of papayas, a handler would have to ship in excess of 3.85 million pounds of papayas to have annual receipts of $5,000,000. Last year, two handlers each shipped in excess of 3.85 million pounds of papayas, and, therefore, would be considered large businesses. The remaining handlers are considered to be small businesses under SBA's definition.

Based on a reported average grower price of $0.45 per pound and industry shipments of 36 million pounds, total grower revenues would be $16.2 million. Average grower revenue would, thus, be $40,500. Based on the foregoing, the majority of handlers and producers of papayas would be classified as small entities.

This rule removes the suspension of grade, inspection, and related reporting requirements under the order's rules and regulations. As a result of removing the suspension, §§ 928.150, 928.152, and 928.313 will be reinstated. This rule also amends these sections to make the requirements in these sections applicable for one year; and § 928.160 will be amended to include the requirement that inspection certificate numbers be added to the utilization reports filed by handlers during the time mandatory inspection is required.

Section 928.313 will also be amended to remove the 5 percent tolerance for immature papayas since the committee believes that the quality of papayas shipped into fresh market channels must be improved. In their recommendation to remove the 5 percent tolerance for immature papayas from the reinstated rules and regulations, the committee believed that they were tightening the quality requirements by utilizing the quality requirements in effect under the Hawaii Department of Agriculture Standards for Fruits and Vegetables (Hawaii Standards).

Under the Hawaii Standards, tolerances are applied based upon the number of samples and number of fruit in the sample that contains defects. Immaturity is considered a serious defect under the Hawaii Standards for Papaya. According to the Hawaii inspection service, in the routine application of the number of defects in a papaya sample, the average tolerance applied would generally be less than 5 percent, which would result in the increased papaya quality envisioned by the committee.

Section 928.313 will also be amended to correct the name and address of Department references for obtaining copies of the Hawaii papaya quality standards, which are incorporated by reference. References to Department contacts are outdated, as is the mailing address listed in that section. The quality standards for Hawaii-grown papayas have been revised as of August 6, 1990, and will replace the standards dated May 29, 1981, currently incorporated by reference.

During its deliberations, the committee discussed the current state of the industry with the advent of the two PRSV-resistant papaya varieties. Production is increasing and overall production levels of Hawaii papayas are expected to reach pre-1994 levels by the 2001-2002 fiscal year, and then continue growing. Such increasing production could reduce handler and producer returns if the quality of papayas shipped is not improved.

Since the suspension of the grade and inspection requirements in 1994, the quality of Hawaii papayas in the marketplace has been deteriorating. The condition of poor quality fruit has often deteriorated further during shipment, requiring buyers to discard some fruit and repack the remaining fruit. This has resulted in financial losses for some buyers and caused decreased buyer confidence in Hawaii papaya quality, resulting in reduced market share.

With the new varieties, the industry is now in a position to provide ample supplies of good quality fruit, and restore wholesale buyer and consumer confidence in Hawaii papayas. Ample supplies of good quality fruit will allow the industry to regain its market share; and, thus, improve returns to handlers and producers.

The committee discussed continuing the suspension as an alternative to this change. However, the committee believed that removing the suspension of the grade, inspection, and reporting requirements will benefit producers and handlers by enhancing the market quality of papayas grown in Hawaii.

The committee estimated that the increased cost of inspection will be offset by the increased market value of the inspected papayas. Inspection costs incurred will total $24.24 per hour for on site inspections and mileage travel costs of 37 cents a mile round-trip from the office to the processing plant or handler's premises. For a trip of less than 10 minutes or 7 miles, no travel time cost is charged, just the mileage cost. For a trip taking 10 or more minutes, or covering 7 or more miles, the travel time cost is based on the $24.24 hourly rate. The majority of committee members agreed that removing the suspension of the grade, inspection, and reporting requirements is in the long-term best interests of the industry.

Improved quality of Hawaii papayas is expected to result in increased consumer satisfaction and repeat purchases, thereby improving handler and producer returns. The increased handling costs due to mandatory inspection are expected to be offset by the aforementioned benefits. In addition, greater information collection authority may result in enhanced assessment collections, permitting the committee to utilize more funds to promote a larger and higher-quality crop, if they deem it appropriate.

This action imposes additional reporting requirements on an estimated five papaya handlers by requiring handlers to file PAC Form 7, the Application to be an Approved Handler of Immature Papayas, and PAC Form 7(c), Maturity Exemption Report. It also requires including the inspection certificate number on PAC Form 1. PAC Form 7 is estimated to take 15 minutes to complete, and PAC Form 7(c) is estimated to take less than 10 minutes to complete. There is no additional measurable reporting burden estimated for PAC Form 1. In all, requiring both forms will result in an estimated additional reporting burden to the previously mentioned five handlers of 9.25 annual hours. The current burden is approximately 1,000 hours. The benefits of the additional reporting requirements are expected to outweigh the costs. Handlers will be able to utilize exemptions to the grade and inspection requirements, and the committee will have additional information to aid in assessment collections and program compliance. In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the information collection requirements that are contained in Part 928 have been previously approved by the Office of Management and Budget (OMB) and have been assigned OMB No. 0581-0102.

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.

As noted in the initial regulatory flexibility analysis, the Department has not identified any relevant Federal rules that duplicate, overlap, or conflict with this final rule. However, as previously stated, handlers of Hawaii papayas will be required to obtain inspection prior to shipment, except under certain conditions when it is not practicable for the inspection service to provide such inspection, apply for approval to handle immature papayas, and report handling of immature papayas. In addition, changes to PAC Form 1 will require handlers to include the number of the inspection certificate issued by the inspection service.

In addition, the committee's meeting was widely publicized throughout the papaya industry and all interested persons were encouraged to attend the meeting and participate in committee deliberations on all issues. Like all committee meetings, the February 18, 1999, meeting was a public meeting and all entities, both large and small, were encouraged to express views on this issue. The committee itself is comprised of 13 members, of whom nine are producers and three are handlers. The committee also includes a public member who does not represent an agricultural interest nor have a financial interest in papayas.

A proposed rule concerning this action was published in the Federal Register on February 18, 2000 (65 FR 8313). Copies of the rule were mailed or sent via facsimile to all committee members and handlers. Finally, the rule was made available on the Internet by the Office of the Federal Register. A 60-day comment period, ending April 18, 2000, we provided to allow interested persons to respond to the proposal.

One comment, signed by eight persons, was received in response to the proposal. The commenters collectively opposed the removal of the suspension of grade and inspection requirements, citing that the current economic condition of the papaya industry did not warrant reinstatement of these requirements. The commenters also noted that production of papayas, which they estimate at only 29 million pounds, is not yet adequate to warrant minimum grade and inspection requirements and that further market study should have been done prior to the committee recommendation. Also, according to the comment, papaya trees that are not PRSV-resistant still continue to be lost due to PRSV, and the Hawaii Department of Agriculture (HDOA) has not put forth a plan to clear abandoned papaya fields. Finally, the comment indicated that reinstating minimum grade and inspection requirements would be detrimental to small growers, handlers, and marketers.

It is anticipated that the reinstatement of the grade and inspection requirements will have a positive effect on the industry. These requirements would ensure that higher-quality papayas are offered for sale, thus enhancing the overall image of Hawaii papayas. Such an increase in quality is also likely to stimulate consumer confidence and lead to repeat purchases, and, thus, improve grower prices. Improved grower prices should, in turn, improve the general economic condition of the industry. Accordingly, such action would not be detrimental to growers, handlers, and marketers, small or large.

Regarding the comment about additional market studies, this recommendation was the result of nearly one year's work by a task force assigned by the committee chairman in 1998. The task force reviewed the current marketing and quality conditions affecting the industry for several months prior to making a recommendation to the committee. As a result of the work and recommendation of the task force, the committee made its recommendation to the Department after a thorough discussion on February 18, 1999. Discussions of the recommendation continued at a subsequent committee meeting held on September 23, 1999. At that meeting, a thorough analysis of the current condition of the industry and the potential effects of reinstating minimum grade and inspection requirements was held. It should be noted that the committee did not change its original recommendation at that time.

In response to the comment that the production of papayas is only 29 million pounds, the PAC estimated the 1999-2000 production of papayas to be 40 million pounds. This estimate was discussed and approved by the PAC at its April 22, 1999, meeting. The fiscal year ended June 30, 2000, and the PAC's final production figure for 1999-2000 is 35.8 million pounds. An estimate of production for the 2000-2001 fiscal year is not yet available.

In any event, the size of a crop alone is not an adequate reason to forego reinstating minimum grade and inspection requirements. Minimum grade and inspection requirements serve other purposes for an industry. The benefits have been previously outlined herein.

Further, the commenters note that grade and inspection requirements should not be reinstated until the HDOA puts forth a plan to clear abandoned papaya fields. While a plan to clear abandoned papaya fields would likely address the continued infection of non-resistant papayas trees, nothing in this action jeopardizes any plan which HDOA may put forth in the future. Regardless of the variety of papayas being produced and marketed, quality control measures are important to the industry in terms of increased consumer confidence and acceptance, repeat purchases, and the overall improved image of Hawaii papayas.

The cost of inspection may be an additional cost to handlers. However, the cost is borne by all handlers, and the benefits of inspection in terms of increased sales, improved marketability, and other factors, are expected to outweigh the costs.

The comment period was reopened with a notice published in the Federal Register on June 5, 2000 (65 FR 35590). Copies of the notice were mailed or sent via facsimile to all committee members and handlers. Finally, the notice was made available on the Internet by the Office of the Federal Register. A 15-day comment period, ending June 20, 2000, was provided to allow interested persons to respond to the notice for additional written comments. One comment was received as the result of the comment period reopening.

The comment was filed on behalf of the committee, which discussed the proposal at its meeting on May 25, 2000. According to the comment, at the meeting the committee clarified its intent regarding the removal of the 5 percent tolerance for immature papayas. Based upon additional information that was gathered, evaluated, and considered by the committee at the meeting, the committee unanimously reaffirmed its 1999 recommendation that the maximum percentage tolerances for immature papayas be based upon the Hawaii No. 1 standard, as established by the State of Hawaii. As noted previously, this would generally limit tolerances to less than 5 percent for immature papayas, in part because this is scored as a serious defect. Thus, this applied tolerance would result in the increased papaya quality envisioned by the committee.

According to the proponents of this action, the voluntary quality control measures anticipated following the 1994 suspension action have not been effective and the quality of papayas has been dropping. This has had an adverse impact on industry shipments and returns. They believe that reinstatement of quality control is in the long term interest of the industry because it will help the industry reestablish a quality image for Hawaii papayas among buyers and consumers, help increase shipments, augment information available to the committee on assessments owed by handlers, and facilitate program compliance. These are compelling reasons for reinstating quality control under the marketing order.

However, taking into account the views of some in the industry that the benefits of mandatory inspection will not outweigh the costs, and that alternative methods of quality control should continue to be explored and developed in helping the industry solve its marketing problems, and the length of time the requirements have been suspended (1994), we believe that it is preferable to reestablish the mandatory inspection and related requirements and make them applicable for a 12-month period, rather than on a continuing basis. This regulatory approach will require the committee to evaluate the results of mandatory quality control near the end of the regulatory period. The committee will have to decide then whether mandatory inspection should be continued beyond the 12-month regulatory period, and report the basis for its determination and recommendation. This will require the committee to closely assess the benefits of mandatory inspection in the short term which should be of assistance in helping producers and handlers make long term plans.

Changes to the regulatory text as proposed have been made below to implement mandatory quality control only for one year from the effective date of this final rule.

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 INFORMATION CONTACT section.

After consideration of all relevant matter presented, including the information and recommendation submitted by the committee, the comment received, 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.

Bovine tuberculosis is a contagious, infectious, and communicable disease caused by Mycobacterium bovis. It affects cattle, bison, deer, elk, goats, and other species, including humans. Bovine tuberculosis in infected animals and humans manifests itself in lesions of the lung, bone, and other body parts, causes weight loss and general debilitation, and can be fatal.

At the beginning of the 20th century, bovine tuberculosis caused more losses of livestock than all other livestock diseases combined. This prompted the establishment of the National Cooperative State/Federal Bovine Tuberculosis Eradication Program for bovine tuberculosis in livestock.

Federal regulations implementing this program are contained in 9 CFR part 77, “Tuberculosis” (referred to below as the regulations), and in the “Uniform Methods and Rules Bovine Tuberculosis Eradication” (UMR), which is incorporated by reference into the regulations. The regulations restrict the interstate movement of cattle, bison, and captive cervids to prevent the spread of tuberculosis. In this interim rule, we are amending the regulations to establish two tuberculosis classification zones in Texas.

Under §§ 77.3 and 77.4 of the regulations, in order to qualify for zone classification by the Animal and Plant Health Inspection Service (APHIS), the State must meet the following requirements:

1. The State must have adopted and must be enforcing regulations that impose restrictions on the intrastate movement of cattle, bison, and captive cervids that are substantially the same as those in place in part 77 for the interstate movement of those animals.

2. The designation of part of a State as a zone must otherwise be adequate to prevent the interstate spread of tuberculosis.

3. The zones must be delineated by the animal health authorities in the State making the request for zone recognition and must be approved by the APHIS Administrator.

4. The request for zone classification must demonstrate that the State has the legal and financial resources to implement and enforce a tuberculosis eradication program and has in place an infrastructure, laws, and regulations that require and ensure that State and Federal animal health authorities are notified of tuberculosis cases in domestic livestock or outbreaks in wildlife.

5. The request for zone classification must demonstrate that the State maintains, in each intended zone, clinical and epidemiological surveillance of animal species at risk of tuberculosis, at a rate that allows detection of tuberculosis in the overall population of livestock at a 2 percent prevalence rate with 95 percent confidence. The designated tuberculosis epidemiologist must review reports of all testing for each zone within the State within 30 days of the testing.

6. The State must enter into a memorandum of understanding with APHIS in which the State agrees to adhere to any conditions for zone recognition particular to that request.

In our October 23, 2000, final rule, we classified the entire State of Texas as modified accredited advanced with regard to cattle and bison and as modified accredited with regard to captive cervids. However, we have received from the State of Texas a request for zone recognition in which State animal health officials demonstrate that Texas meets the requirements listed above for zone recognition. Therefore, in this interim rule, we are recognizing two zones in Texas as described below.

1. The smaller of the two zones is bounded as follows: Beginning at the point where the Hudspeth-El Paso County line intersects U.S. Highway 62; then west along U.S. Highway 62 to its intersection with the El Paso city limits; then southwest along the El Paso city limits to the Rio Grande River; then southeast along the Rio Grande River to the Fort Hancock-El Porvenir Bridge; then northeast along an imaginary line to Interstate 10; then northwest along Interstate 10 to its intersection with the Hudspeth-El Paso County line; then north along the Hudspeth-El Paso County line to the point of beginning.

2. The second zone in Texas consists of the rest of the State.

With regard to cattle and bison, State animal health officials in Texas have demonstrated to APHIS that, except for the smaller zone, Texas meets the criteria for accredited-free status set forth in the definition of accredited-free State or zone in § 77.5 of the regulations. In accordance with these conditions, Texas has demonstrated that the larger zone has zero percent prevalence of affected cattle or bison herds and has had no findings of tuberculosis in any cattle or bison herds for the past 5 years. Additionally, the State complies with the conditions of the UMR.

State animal health officials in Texas have demonstrated that the smaller zone meets the criteria for modified accredited advanced status for cattle and bison set forth in the definition of modified accredited advanced State or zone in § 77.5 of the regulations. According to those criteria, the Administrator, upon his or her review, may classify a State or zone as modified accredited advanced—depending on the veterinary infrastructure, livestock demographics, and tuberculosis control and eradication measures in the State or zone—if the State or zone has fewer than 30,000 herds total and, of those, no more than 3 are affected herds for each of the most recent 2 years. Within the smaller zone in Texas, there are a total of approximately 17 cattle herds and no bison herds. Of those cattle herds, two are known to be affected with tuberculosis, and Texas is conducting an aggressive program to eradicate the disease in the zone. There are no known affected herds in the remainder of the State. Under those conditions, the Administrator has determined that the smaller zone in Texas qualifies for modified accredited advanced status with regard to cattle and bison.

With regard to captive cervids, because both of the zoned areas in Texas continue to qualify as modified accredited, in § 77.26 we continue to list Texas in its entirety as a modified accredited State.

We are amending § 77.9(b) to correct an omission in our October 23, 2000, final rule. Section 77.9 contains provisions pertaining to modified accredited advanced States and zones. In § 77.9(b), the word “advanced” was omitted. We are adding the word “advanced” to § 77.9(b).

This rulemaking is necessary on an emergency basis to establish two zones with separate tuberculosis risk classifications in Texas with regard to cattle and bison. Failure to provide “split-State status” in Texas with regard to tuberculosis on an emergency basis could increase the likelihood of the spread of that disease by reducing the incentive for Texas to stringently restrict movement of tuberculosis-susceptible animals from high-risk areas within the State and to implement effective containment and eradication measures. Under these circumstances, the Administrator has determined that prior notice and opportunity for public comment are contrary to the public interest and that there is good cause under 5 U.S.C. 553 for making this rule effective less than 30 days after publication in the Federal Register .

We will consider comments that are received on or before January 22, 2001. After the comment period closes, we will publish another document in the Federal Register . The document will include a discussion of any comments we receive and any amendments we are making to the rule as a result of the comments.

This rule has been reviewed under Executive Order 12866. For this action, the Office of Management and Budget has waived its review process required by Executive Order 12866.

Bovine tuberculosis is a communicable disease of cattle, bison, cervids and other species, including humans, and results in losses in meat and milk production among infected animals. As part of the Cooperative State/Federal Tuberculosis Eradication Program, which has virtually eliminated bovine tuberculosis from the Nation's livestock populations, the regulations classify each State according to its tuberculosis risk and place certain restrictions on the movement of cattle and bison from States with high-risk classifications. In this interim rule, we are dividing Texas into two separate zones for the purpose of tuberculosis risk classification. One of these zones will be classified as accredited-free with regard to cattle and bison; the other will be classified as modified accredited advanced. We discuss below the projected effects of this regulatory action.

In 1999, the total number of cattle in the United States was approximately 99.115 million, valued at approximately $58.833 billion. There were 1,095,960 U.S. operations with cattle. Over 99 percent of these operations were small businesses with annual gross receipts of less than $500,000. There were about 112,700 bison held as livestock in the United States, valued at about $169 million, on 1,150 premises.

Under the regulations in part 77, each State is assigned one of five risk classifications: Accredited-free, modified accredited advanced, modified accredited, accreditation preparatory, or nonaccredited. In our October 23, 2000, final rule, we classified the entire State of Texas as modified accredited advanced with regard to cattle and bison. In this interim rule, we are classifying most of Texas as accredited-free with regard to cattle and bison and a portion of El Paso and Hudspeth Counties, TX, as modified accredited advanced. We analyze below the expected effect of changing Texas from one statewide classification of modified accredited advanced with regard to cattle and bison to two separate zone classifications—one of accredited-free and one of modified accredited advanced.

Under the three-tier classification that remains in effect until the November 22, 2000, effective date of the October 23, 2000, final rule, the entire State of Texas is classified as modified accredited, which means that cattle not known to be infected with or exposed to tuberculosis may be moved interstate from anywhere in Texas without restriction. Although the October 23, 2000, final rule classifies the State of Texas as modified accredited advanced, this interim rule, which classifies most of the State of Texas as an accredited-free zone, also becomes effective on November 22, 2000. Because cattle or bison that originate in an accredited-free zone may be moved interstate without restriction, there will be, for all practical purposes, no change in the restrictions that apply to the interstate movement of cattle and bison from the accredited-free zone established in this interim rule. Additional testing and identification requirements will, however, apply to the interstate movement of certain cattle and bison that originate in the modified accredited advanced zone that we are establishing in El Paso and Hudspeth Counties, TX. Specifically, for interstate movement of cattle or bison from a modified accredited advanced State or zone, the regulations require sexually intact cattle and bison not from an accredited herd to have one negative test within 60 days prior to being moved interstate and also require that they be officially identified. Additionally, sexually intact heifers moved to an approved feedlot, steers, and spayed heifers must be either officially identified or identified to a premises of origin before they can be moved interstate.

As of January 1999, there were about 153,000 cattle herds in Texas with 14.9 million cattle, valued at $7.1 billion. (In addition, there were 40 operations with bison, with a total of 1,370 animals.) In the portion of El Paso and Hudspeth Counties, TX, that we are establishing as a modified accredited advanced zone in this interim rule, there are approximately 17 cattle herds totaling approximately 12,000 to 13,000 head. There are no bison herds. Of the cattle in this zone, only approximately 1,000 are expected to require testing to be moved interstate. Another 120 are expected to require identification but no testing.

The approximate per-animal testing cost is $4.30, compared to an average sale value of approximately $600 for a head of cattle. The cost of official identification by applying an eartag is about $0.50 per head.

Applying the unit testing and identification costs to the number of animals that are likely to require testing and identification, or simply identification, to be eligible for movement from the modified accredited advanced zone yields the approximate economic effect of this interim rule. The testing cost is projected to be no more than $4,300 annually, and the identification cost is projected to be no more than $560, for a total estimated annual testing and identification cost in Texas of no more than $4,860. This cost is relatively small when compared to the total size and significance of the cattle and bison industry in Texas and in the United States overall.

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

This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 7 CFR part 3015, subpart V.)

This interim rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule: (1) Preempts all State and local laws and regulations that are in conflict with this rule; (2) has no retroactive effect; and (3) does not require administrative proceedings before parties may file suit in court challenging this rule.

This interim rule contains no new information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

The tracking and reporting of government-to-government obligations attached to nuclear material or equipment is essential to fulfilling U.S. Government commitments under various agreements for cooperation in the peaceful uses of nuclear energy pursuant to Section 123 of the Atomic Energy Act (AEA). “Obligations” include controls, peaceful end-use assurances, and other conditions placed on the transfer of equipment or material. The U.S. Government is required to report to the governments of other countries the inventory of subject nuclear material held in the United States. To meet this requirement, NRC must keep adequate records showing obligations to countries that have exported nuclear material to the U.S., and track any nuclear material produced through the use of that material. The U.S. must also obtain consent before releasing obligated material to a third party.

For the past ten or more years, the situation has become more complicated, reflecting the growing complexity of the nuclear fuel cycle. To ensure that information regarding obligations is reported to the government in advance of shipments, in accordance with NRC's need to obtain prior consent for the retransfer of obligated material, this rulemaking institutes a change from solely reporting the country of origin of nuclear material to reporting all obligations attached to the material on NRC license applications. This rule extends the required prior notice on shipments of Canadian and Australian origin material to all shipments of obligated material, including, but not limited to, EURATOM and Japan.

This rulemaking is clear that as obligations are commitments made by the U.S. Government to another government on behalf of NRC licensees, the U.S. Government maintains the responsibility for informing industry of obligations attached to imported material and for approving changes to obligations on material while it is in the U.S.

Section 110.1 is amended by adding a paragraph to clarify that bond shipments, or shipments which are only passing through the U.S., do not require an NRC import or export license; however, they must comply with the Department of Transportation/IAEA packaging, and state transportation requirements.

Section 110.2 is amended to add definitions on subjects on which the NRC receives many public inquiries. These definitions are taken from the Atomic Energy Act (AEA), or are defined by the Executive Branch and the multilateral export control regimes of which the U.S. is a member, including the Nuclear Suppliers Group and the Zangger NPT Exporters Committee. They include byproduct material, depleted uranium, dual-use, heels, natural uranium, nuclear reactor internals, obligations, restricted destinations and source material. A citation in the definition of “Nuclear Referral List” is corrected, and the definition of “Source material” is revised.

In § 110.6, additional information is inserted on retransfers to satisfy prior consent reporting obligations on nuclear equipment and material subject to agreements for cooperation.

In § 110.7, paragraph (b) is updated to include § 110.23.

In § 110.8, reference to a new Appendix N on lithium isotope separation plant equipment and components and reference to a new Appendix O on fuel fabrication plant equipment and components are added. Plants for the conversion of plutonium are added to paragraph (f). A new paragraph is added on plants for the production of special nuclear material using accelerator-driven subcritical assembly systems capable of continuous operation above 5 MWe thermal.

In § 110.10, the reference to the completion of rulemaking proceedings is deleted in the interest of procedural efficiency.

In § 110.21, a new paragraph is added to indicate that uranium, enriched to less than 20 percent in U-235, in the form of UF6 heels in cylinders being returned to suppliers in EURATOM will no longer require a specific NRC license, but is subject to an NRC general license.

In § 110.22, a new paragraph is added to permit the export of uranium, enriched to less than 20 percent in U-235, in the form of UF6 heels in cylinders being returned to suppliers in EURATOM under an NRC general license. The specific license required previously is revoked.

In § 110.23, the export of byproduct material, californium-253 and -254, and neptunium-235 are added to bring NRC's regulations into conformance with NSG Guidelines. Yearly reporting requirements on exports of americium and neptunium are added to this section to fulfill a U.S. commitment to the IAEA on the voluntary tracking of these byproduct materials. Also, this section is clarified in an effort to make it more readable to the public.

In § 110.26 a paragraph is added to indicate that a general license for the export of nuclear reactor components, in final or semi-fabricated form, is amended to clarify that it covers components solely of U.S. origin. Also, this section is revised to include additional countries to which exports may go under a general license. The U.S. has received broad generic assurances from these countries under section 109(b) of the AEA that these components will not be used for explosive purposes or retransfered to a third country without U.S. permission. These countries include Bulgaria, Czech Republic, Latvia, Lithuania, New Zealand, and Romania. The NRC is revoking the general license for the export of nuclear reactor components to research reactors capable of continuous operation above 5MWe thermal, whether in final or semi-fabricated form, to conform 10 CFR part 110 with 10 CFR part 810. A new paragraph is added to indicate that the general license for the export of nuclear reactor components does not authorize the export of components to research reactors, in final or semi-fabricated form, capable of continuous operation above 5 MWe thermal, and that a specific license is required for these exports.

Section 110.27 is revised by adding the words “NRC or Agreement State” after the word “specific” to clarify the fact that a consignee must have a general or specific domestic license to possess the material before it can be imported to the U.S.

In § 110.28, “Sudan” is added to the list of embargoed destinations for which a U.S. trade embargo is in effect.

In § 110.30, “Belarus”, “Cyprus”, “Latvia”, “Slovenia”, and “Turkey” are added as new NSG members.

In § 110.31, the title of the person with whom specific license applications are to be filed is updated.

In § 110.32, the information required in an application for a specific license (NRC Form 7) is clarified to satisfy reporting obligations on imported or exported nuclear equipment and material incurred by the U.S. Government pursuant to agreements for cooperation with other countries.

In § 110.44, the physical security standards are being revised to incorporate by reference the update and recommendations contained in the IAEA document, INFCIRC/225/Rev.4, June 1999, “The Physical Protection of Nuclear Material and Nuclear Facilities.” The standard that NRC continues to apply is that physical protection in recipient countries is sufficient to protect against the proliferation of nuclear weapons. Although the IAEA has included “radiological sabotage” as a distinct consideration of physical security, it is commonly understood in the international community to involve radiological health and safety rather than nuclear non-proliferation concerns. NRC is not required to consider foreign health and safety in its export licensing decisions. Also, the title of the person to whom communications are to be addressed, and specific license applications are to be filed, is updated.

In § 110.50, the title of the notifying official is updated to Deputy Director. A requirement is added that licensees must notify the Deputy Director of the Office of International Programs (OIP) in writing at least 40 days before the export of foreign-origin nuclear material or equipment, and may not ship this material or equipment until authorized by the Deputy Director, OIP. This information is needed to satisfy U.S. Government obligations under various agreements for cooperation with other countries, as defined in § 110.2, which require prior consent for shipment of foreign-origin nuclear material or equipment. Foreign-origin material and equipment exports subject to such obligations include, but are not limited to, those going to Australia, Canada, EURATOM, and Japan.

In § 110.70, an exception is inserted for exports of heavy water to Canada.

In § 110.82, the length of time to file hearing requests and intervention petitions after receipt of license applications in the Public Document Room is expanded from 15 to 30 days in the interest of procedural efficiency.

In appendix A to part 110, a correction is made to delete “specially designed”, and insert “especially designed.”

In appendix B to part 110, an editorial error in the power range of 50-100 volt amps is corrected to read 50-1000 volt amps. The corresponding power range in the NSG Trigger List is 50-1000 volts amps.

In appendix J to part 110, the heading is revised to add plutonium. Following the Note, a subheading (a) on uranium conversion plant equipment is added and a new paragraph on especially designed or prepared systems for the conversion of UO 2 to UCl 4 as feed for electromagnetic enrichment and plants for plutonium conversion to bring part 110 into conformance with current NSG guidelines. Also, a note, subheading (b) on plutonium conversion plant equipment, and two paragraphs are added to cover especially designed or prepared plant equipment for the conversion of plutonium from one chemical species to another, including PuO 2 to PuF 4 and of PuF 4 to plutonium metal.

In Appendix K to Part 110, a paragraph is added on complete heavy water upgrade systems or columns.

In appendix L to part 110, the radio nuclides “californium-253” and “californium-254”, and “neptunium-235” are added to bring Part 110 into conformance with current NSG guidelines.

Appendix N to part 110 is added to illustrate the entry in § 110.8(c) on plants for the separation of the isotopes of lithium and especially designed or prepared assemblies and components for these plants.

Appendix O to part 110 is added to illustrate the entry in § 110.8(e) on plants for the fabrication of nuclear reactor fuel elements, and especially designed or prepared equipment and components for these plants.

Because the substance of this rule involves a foreign affairs function of the United States, the notice and comment provisions of the Administrative Procedure Act do not apply (5 U.S.C. 553(a)(1)). In addition, solicitation of public comments would delay United States conformance with its international obligations, and would be contrary to the public interest (5 U.S.C. 553(b)).

In accordance with the Small Business Regulatory Enforcement Fairness Act of 1996, the NRC has determined that this action is not a major rule and has verified this determination with the Office of Information and Regulatory Affairs of OMB. The rule is necessary to conform the nuclear non-proliferation policies of the United States with international export guidelines.

The NRC has determined that this final rule is the type of action described in categorical exclusion 10 CFR 51.22(c)(1) and (c)(2). Therefore, neither an environmental impact statement nor an environmental assessment has been prepared for this final rule.

This final rule increases the burden on exporters of americium and neptunium to submit an annual reports of shipments made. The public burden for this information collection is estimated to average .5 hour(s) per request. Because the burden for this information collection is insignificant, Office of Management and Budget (OMB) clearance is not required. Existing requirements were approved by OMB approval number 3150-0036.

If a means used to impose an information collection does not display a currently valid OMB control number, the NRC may not conduct or sponsor, and a person is not required to respond to, the information collection.

As required by the Regulatory Flexibility Act of 1980 (5 U.S.C. 605(b)), the Commission certifies that this rule does not have a significant impact on a substantial number of small entities. This rule is necessary to reflect the nuclear non-proliferation policies of the executive branch and U.S. Government obligations under nuclear agreements for cooperation, and to update the export controls of the United States in respect to the multilateral export control recommendations of the Nuclear Non-proliferation Treaty Exporters Committee (Zangger Committee) and the Nuclear Suppliers Group (NSG), of which the United States is a member.

The National Technology Transfer Act of 1995, Pub. L.104-113, requires that Federal agencies use technical standards that are developed or adopted by voluntary consensus standards bodies unless the use of such a standard is inconsistent with applicable law or otherwise impractical. The changes in this rulemaking are not inconsistent with any voluntary consensus standard.

The NRC has determined that the backfit rule, 10 CFR 50.109, does not apply to this final rule and a backfit analysis is not required, because these amendments do not involve any provisions that would impose backfits as defined in 10 CFR 50.109. The rule does not constitute a backfit because it does not propose any changes or additions to requirements for existing structures, systems, components, procedures, organizations or designs associated with the construction or operation of a facility.

(a) * * *

On October 27, 1999, the Board published a final rule codifying at Chapter 4, Title 13, Code of Federal Regulations (CFR), regulations implementing the Program, as established in Chapter 1 of Public Law 106-51, the Emergency Steel Loan Guarantee Act of 1999 (64 FR 57932). Since those initial regulations were published the Board has made a number of changes to the regulations meant to conform the regulations to the Guarantee Agreement between the government and the lender and to allow for participations in unguaranteed tranches of loans guaranteed under the Program. Today the Board is making additional changes designed to harmonize certain program requirements with commercial lending practices, streamline program operation, and to open a second period for the submission of applications. In addition, several non-substantive changes are being made to change addresses and allow for certain delegations of authority.

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

This rule is exempt from the rulemaking requirements contained in 5 U.S.C. 553 pursuant to authority contained in 5 U.S.C. 553(a)(2) as it involves a matter relating to loans. As such, prior notice and an opportunity for public comment and a delay in effective date otherwise required under 5 U.S.C. 553 are inapplicable to this rule.

Because this rule is not subject to a requirement to provide prior notice and an opportunity for public comment pursuant to 5 U.S.C. 553, or any other law, the analytical requirements of the Regulatory Flexibility Act, 5 U.S.C. 601 et seq., are inapplicable.

This rule has been determined to be not major for purposes of the Congressional Review Act, 5 U.S.C. 801 et seq.

No intergovernmental consultations with State and local officials are required because the rule is not subject to the provisions of Executive Order 12372 or Executive Order 12875.

This rule contains no Federal mandates, as that term is defined in the Unfunded Mandates Reform Act, on State, local and tribal governments or the private sector.

This rule does not contain policies having federalism implications requiring preparation of a Federalism Summary Impact Statement.

This rule does not contain policies that have takings implications.

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an airworthiness directive (AD) that is applicable to all Lockheed Model 188A and 188C series airplanes was published in the Federal Register on August 30, 2000 (65 FR 52677). That action proposed to require a revision of the Airplane Flight Manual to add procedures for donning the flightcrew oxygen masks when the cabin altitude warning horn is activated.

Interested persons have been afforded an opportunity to participate in the making of this amendment. No comments were submitted in response to the proposal or the FAA's determination of the cost to the public.

The FAA has determined that air safety and the public interest require the adoption of the rule as proposed.

There are approximately 75 Model 188A and 188C series airplanes of the affected design in the worldwide fleet. The FAA estimates that 32 airplanes of U.S. registry will be affected by this AD, that it will take approximately 1 work hour per airplane to accomplish the required actions, and that the average labor rate is $60 per work hour. Based on these figures, the cost impact of the AD on U.S. operators is estimated to be $1,920, or $60 per airplane.

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

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

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

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an airworthiness directive (AD) that is applicable to certain Saab Model SAAB SF340A and SAAB 340B series airplanes was published in the Federal Register on September 19, 2000 (65 FR 56507). That action proposed to require inspecting the connector on the refuel/defuel panel and the electrical connector on the illuminated placard to detect signs of fluid ingression or corrosion, and corrective actions.

Interested persons have been afforded an opportunity to participate in the making of this amendment. No comments were submitted in response to the proposal or the FAA's determination of the cost to the public.

The FAA has determined that air safety and the public interest require the adoption of the rule as proposed.

The FAA estimates that 289 Model SAAB SF340A and SAAB 340B series airplanes of U.S. registry will be affected by this AD, that it will take approximately 4 work hours per airplane to accomplish the required actions, and that the average labor rate is $60 per work hour. Based on these figures, the cost impact of the AD on U.S. operators is estimated to be $69,360, or $240 per airplane.

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

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

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

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) by superseding AD 98-08-11, amendment 39-10491 (63 FR 20066, April 23, 1998), which is applicable to certain McDonnell Douglas Model MD-11 and MD-11F series airplanes, was published in the Federal Register on July 13, 2000 (65 FR 43265). The action proposed to continue to require opening the circuit breaker of the pneumatic sense line heater tape, installing an inoperative ring, and coiling and stowing the electrical wire to the circuit breaker of the pneumatic sense line heater tape. The action also proposed to require repetitive inspections of the subject area and corrective actions, if necessary, and would provide for an optional terminating modification(s) for the repetitive inspection requirements.

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

The commenter states no objection to the proposed rule.

After careful review of the available data, including the comment noted above, the FAA has determined that air safety and the public interest require the adoption of the rule as proposed.

There are approximately 174 Model MD-11 and MD-11F series airplanes of the affected design in the worldwide fleet. The FAA estimates that 67 airplanes of U.S. registry will be affected by this AD.

The modification that is currently required by AD 98-08-11, and retained in this AD, takes approximately 1 work hour per airplane to accomplish, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of the currently required actions on U.S. operators is estimated to be $4,020, or $60 per airplane.

The new inspection required by this AD action will take approximately 1 work hour per airplane to accomplish, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of the new inspection required by this AD on U.S. operators is estimated to be $4,020, or $60 per airplane, per inspection cycle.

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

Should an operator elect to accomplish the optional terminating action provided by paragraph (d)(1) of this AD, it would take approximately 4 work hours to accomplish, at an average labor rate of $60 per work hour. The cost of required parts would be approximately $4,500 per airplane. Based on these figures, the cost impact of this optional terminating action would be $4,740 per airplane.

Should an operator elect to accomplish the optional terminating action provided by paragraph (d)(2) of this AD, it would take approximately 1 work hour to accomplish, at an average labor rate of $60 per work hour. The cost of required parts would be approximately $50 per airplane. Based on these figures, the cost impact of this optional terminating action would be $110 per airplane.

Should an operator elect to accomplish the optional terminating action provided by paragraph (d)(3) of this AD, it would take approximately 2 work hours to accomplish, at an average labor rate of $60 per work hour. The cost of required parts would be approximately $2,500 per airplane. Based on these figures, the cost impact of this optional terminating action would be $2,620 per airplane.

Should an operator elect to accomplish the optional terminating action provided by paragraph (d)(4) of this AD, it would take approximately 4 work hours to accomplish, at an average labor rate of $60 per work hour. The cost of required parts would be approximately $50 per airplane. Based on these figures, the cost impact of this optional terminating action would be $290 per airplane.

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

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

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an airworthiness directive (AD) that is applicable to certain Saab Model SAAB 340B series airplanes was published in the Federal Register on March 15, 2000 (65 FR 13921). That action proposed to require a one-time inspection to detect discrepancies of the flight idle stop override mechanism, and corrective action, if necessary.

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

One commenter, an operator, states that mandating the inspection proposed in this AD has no value and will not contribute to safety. The commenter offers several reasons, described below, for this assertion.

1. The commenter states that the cable that originally stuck [prompting issuance of a related FAA AD, AD 98-08-16, amendment 39-10465 (63 FR 18118, April 14, 1998)], along with the uplock switch and knob, is fully contained within the control quadrant installed on each airplane, and the quadrants are interchangeable among airplanes. The commenter considers it extremely doubtful that the same quadrants are still installed in the airplanes that are specified in the applicability of the proposed AD.

2. The commenter states that the proposed AD does not cover quadrants installed in airplanes with serial numbers above 413, nor does it cover quadrants installed in airplanes that were listed in the original applicability of AD 98-08-16. Yet those quadrants, although not covered in that AD, have the same flight idle stop override mechanism as those installed on airplanes specified in the applicability of the proposed AD, and the commenter asserts that the same safety concern should exist on those airplanes as well.

3. Additionally, the commenter notes the issuance of two other FAA AD's, AD 99-21-31, amendment 39-11377 (64 FR 56426, October 20, 1999), and AD 99-27-08, amendment 39-11489 (65 FR 209, January 4, 2000), that also address the control quadrants. In order to comply with the terminating action for those AD's, operators must remove the quadrant from the airplane, and the quadrant must be modified or replaced. The commenter therefore asserts that a quadrant installed on an airplane when AD 98-08-16 was issued would no longer be installed in its original, unmodified condition.

4. The commenter also states that a Maintenance Review Board (MRB) task already exists to perform a periodic operational check of the flight idle stop override mechanism on all airplanes. The commenter states that this check would find any stiff or frozen cables in the override system; therefore, the intent of the proposed AD is already being met.

The FAA infers that the commenter is requesting that the proposed AD be withdrawn. The FAA does not concur, for the reasons set forth below. Further, the FAA considers that reiteration of the requirements for compliance with airworthiness directives is necessary. After the compliance time specified in an AD has passed, all corrective actions required by that AD must have been accomplished in order to correct the unsafe condition. If an airplane is returned to a configuration that allows the unsafe condition to exist, that airplane is being operated contrary to the requirements of the AD, which is prohibited per section 39.3 of the Federal Aviation Regulations (14 CFR 39.3). The FAA provides specific responses below to each of the commenter's assertions (numbered to correspond with the commenter's issues).

1. AD 98-08-16 refers to Saab Service Bulletin 340-76-041, dated May 29, 1997, and Revision 01, dated July 2, 1997, as the appropriate source of service information for the actions required by that AD. That service bulletin specifies that certain control quadrants (including those held as spares) are to be inspected, and repaired if necessary. Therefore, although control quadrants may have subsequently been interchanged among airplanes, the inspection and corrective actions required by AD 98-08-16 should have been accomplished for all affected quadrants. Additionally, the compliance time for that AD has already passed. If a quadrant is installed on an affected airplane after that date, and the quadrant has not been inspected per the requirements of AD 98-08-16, the airplane is being operated contrary to the requirements of that AD. No change to the final rule is necessary in this regard.

2. The FAA does not concur that additional airplanes are subject to the identified unsafe condition. Saab Service Bulletin 340-76-041 lists airplanes only through serial number (S/N) 413 in the effectivity; airplanes having higher S/N's did not need to be included in this effectivity because they were delivered with correctly functioning control quadrants installed. And, as stated above, for airplanes having higher S/N's that were affected by the requirements of AD 98-08-16, any quadrant installed after the compliance time should have been inspected according to the requirements of that AD. No change to the final rule is necessary in this regard.

3. The FAA acknowledges that other existing AD's may have required replacement of control quadrants with other quadrants. However, as stated above, after the compliance time for each AD has passed, the required corrective actions specified in each AD must have been accomplished for the affected airplanes, and for control quadrants subsequently installed on those airplanes. The FAA acknowledges that the one-time inspection required by this AD may have been previously accomplished as part of compliance with other AD's. In those cases, the requirements of this AD have been complied with, and no further action is required. No change to the final rule is necessary in this regard.

4. The FAA does not concur that the existing MRB task alone is adequate to address the unsafe condition identified in this AD, because the compliance time in the AD is much shorter than the time interval specified for the task in the MRB. However, the FAA has determined that the procedures specified in the MRB task for the operational check may also be used for compliance with the requirements of this AD. A Note has been added to the AD to give credit to operators that may have accomplished the MRB task prior to the effective date of this AD.

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

The FAA estimates that 31 airplanes of U.S. registry will be affected by this AD, that it will take approximately 1 work hour per airplane to accomplish the required actions, and that the average labor rate is $60 per work hour. Based on these figures, the cost impact of the AD on U.S. operators is estimated to be $1,860, or $60 per airplane.

The cost impact figure discussed above is based on assumptions that no operator has yet accomplished any of the requirements of this AD action, and that no operator would accomplish those actions in the future if this AD were not adopted.

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

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

On April 25, 2000, the FAA proposed to revise the published effective times for the Shaw AFB Class C airspace area (65 FR 24136). Because the Shaw AFB ATCT has reduced its hours of operation, it is necessary to revise the Class C airspace effective times to coincide with the times that Class C air traffic control services are available.

Interested parties were invited to participate in this rulemaking proceeding by submitting comments on the proposal to the FAA. No comments objecting to the proposal were received. However, an error was discovered in coordinates for Sumter Municipal Airport as published in the legal description. Except for the correction to those coordinates, this amendment is the same as that proposed in the notice.

This action amends 14 CFR part 71 by revising the legal description of the Shaw AFB Class C airspace area located at Shaw AFB, SC. This action revises the hours of operation for the Class C airspace area to align them with current airfield operations. The Shaw AFB Class C airspace area is designated effective during the specific days and hours of operation of the Shaw AFB ATCT as established in advance by NOTAM. This action is a technical amendment to the legal description and does not change the actual dimensions, configuration, or operating requirements of the Shaw AFB Class C airspace area. During the times that Shaw ATCT is not operational, the airspace reverts to Class E airspace since one of the requirements for Class C airspace is an operational ATCT. The radar approach control operating hours remain unchanged. Jacksonville Center assumes the airspace when Shaw radar approach control closes. In addition, this amendment corrects the coordinates, as published in the notice of proposed rulemaking for this action, for the Sumter Municipal Airport, which were inadvertently listed in error in the legal description for the Shaw AFB, SC, Class C airspace area.

The coordinates for this airspace docket are based on North American Datum 83. Class C airspace areas are published in paragraph 4000 of FAA Order 7400.9H, dated September 1, 2000, and effective September 16, 2000, which is incorporated by reference in 14 CFR 71.1. The Class C airspace area listed in this document will be published subsequently in the Order.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this regulation: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Act.

A review of the controlled airspace for Meridian NAS—McCain Field revealed the existence of an extension to the Class D surface area airspace, although there are no longer SIAPs requiring such an extension. Therefore, the Class E4 airspace area must be removed. This rule will become effective on the date specified in the DATES section. Since this action eliminates the impact of controlled airspace on users of the airspace in the vicinity of the Meridian NAS—McCain Field, notice and public procedure under 5 U.S.C. 553(b) are unnecessary. Class E4 airspace designations for airspace areas designated as an extension to a Class D airspace area are published in FAA Order 7400.9H, dated September 1, 2000, and effective September 16, 2000, which is incorporated by reference in 14 CFR 71.1. The Class E designation listed in this document will be published subsequently in the Order.

This amendment to Part 71 of the Federal Aviation Regulations (14 CFR Part 71) removes Class E4 airspace at Meridian NAS—McCain Field, MS.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore, (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

On August 28, 2000, the FAA proposed to amend part 71 of the Federal Aviation Regulations (14 CFR part 71) by establishing Class D airspace at New Bern, NC, (65 FR 52375) as a Federal Contract Tower has opened. This action will provide Class D airspace designated as surface area to accommodate IFR operations at Craven County Regional Airport when the control tower is open. Therefore, the Class E2 airspace at New Bern, NC, must be amended from continuous to part time. Class E airspace designations are published in Paragraph 6002 of FAA Order 7400.9H, dated September 1, 2000, and effective September 16, 2000, which is incorporated by reference in 14 CFR 71.1, dated September 1, 1999. The Class E airspace designations listed in this document will be published subsequently in the Order.

This amendment to Part 71 of the Federal Aviation Regulations (14 CFR part 71) amends Class E2 airspace at New Bern, NC.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore, (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

On June 28, 2000, the FAA proposed to amend Title 14 of the Code of Federal Regulations part 71 (part 71) to establish VOR Federal Airway, V-457, in Alaska (65 FR 39834). Interested parties were invited to participate in this rulemaking proceeding by submitting written comments on the proposal to the FAA. No comments objecting to the proposal were received.

This action amends part 71 by establishing VOR Federal Airway V-457 in Alaska. Presently, there is an uncharted nonregulatory route using the same routings as the V-457 which becomes effective January 25, 2001. The FAA is establishing V-457 for the following reasons: (1) The conversion of this uncharted nonregulatory route to a VOR Federal airway adds to the IFR airway and route infrastructure in Alaska; (2) pilots will be provided with minimum en route altitudes and minimum obstruction clearance altitudes information; (3) this amendment establishes controlled airspace, thus eliminating some of the commercial IFR operations in uncontrolled airspace; and (4) the addition of this route improves the management of air traffic operations and thereby enhance safety.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this regulation: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Alaskan VOR Federal airways are published in paragraph 6010(b) of FAA Order 7400.9H dated September 1, 2000, and effective September 16, 2000, which is incorporated by reference in 14 CFR 71.1. The Alaskan VOR Federal airway listed in this document will be published subsequently in the order.

In accordance with section 513(f)(1) of the act (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976, the date of enactment of the Medical Device Amendments of 1976, generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless and until the device is classified or reclassified into class I or II or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the act, to a predicate device that does not require premarket approval. The agency determines whether new devices are substantially equivalent to previously marketed devices by means of premarket notification procedures in section 510(k) of the act (21 U.S.C. 360(k)) and 21 CFR part 807 of the FDA regulations.

Section 513(f)(2) of the act provides that any person who submits a premarket notification under section 510(k) of the act for a device that has not previously been classified may, within 30 days after receiving an order classifying the device in class III under section 513(f)(1) of the act, request FDA to classify the device under the criteria set forth in section 513(a)(1) of the act. FDA shall, within 60 days of receiving such a request, classify the device by written order. This classification shall be the initial classification of the device. Within 30 days after the issuance of an order classifying the device, FDA must publish a notice in the Federal Register announcing such classification.

In accordance with section 513(f)(1) of the act, FDA issued an order on July 11, 2000, classifying the QUANTA Lite TM ASCA ( S . cerevisiae ) IgG ELISA in class III, because it was not substantially equivalent to a device that was introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, or a device which was subsequently reclassified into class I or class II. On July 18, 2000, FDA filed a petition submitted by INOVA Diagnostics, Inc., requesting classification of the QUANTA Lite TM ASCA ( S . cerevisiae ) IgG ELISA into class II under section 513(f)(2) of the act.

After review of the information submitted in the petition, FDA determined that the INOVA Diagnostics QUANTA Lite TM ASCA ( S . cerevisiae ) IgG ELISA can be classified in class II with the establishment of special controls. This device is intended for use in the semi-quantitative in vitro determination of anti- Saccharomyces cerevisiae ( S . cerevisiae ) antibodies (ASCA) in human serum as an aid in the diagnosis of Crohn's disease. FDA believes that class II special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device.

In addition to the general controls of the act, the INOVA Diagnostics QUANTA Lite TM ASCA ( S . cerevisiae ) IgG ELISA is subject to a special control guidance document entitled “Guidance for Industry and FDA Reviewers: Class II Special Control Guidance for Anti- Saccharomyces cerevisiae ( S . cerevisiae ) Antibody (ASCA) Premarket Notifications.”

Section 510(m) of the act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the act, if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. FDA has determined that premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of this type of device and, therefore, the device is not exempt from the premarket notification requirements. The test is used in the diagnosis of Crohn's disease and FDA review of data sets and labeling ensure that minimum levels of performance are obtained before marketing and are subject to impartial external quality control before labeling is put into place. Thus, persons who intend to market this device must submit to FDA a premarket notification submission containing information on the anti- Saccharomyces cerevisiae ( S . cerevisiae ) antibody (ASCA) test system before marketing the device.

On August 16, 2000, FDA issued an order to the petitioner classifying the INOVA Diagnostics QUANTA Lite TM ASCA ( S . cerevisiae ) IgG ELISA, and substantially equivalent devices of this generic type, into class II under the generic name, anti- Saccharomyces cerevisiae ( S . cerevisiae ) antibody (ASCA) test system. FDA identifies this generic type of device as an anti- Saccharomyces cerevisiae ( S . cerevisiae ) antibody (ASCA) test system, which is intended to measure Saccharomyces cerevisiae ( S . cerevisiae ) antibodies (ASCA) in human serum or plasma as an aid in the diagnosis of Crohn's disease. FDA is codifying this device by adding § 866.5785. This order also identified a special control applicable to this device entitled “Guidance for Industry and FDA Reviewers: Class II Special Control Guidance for Anti- Saccharomyces cerevisiae ( S . cerevisiae ) Antibody (ASCA) Premarket Notifications.”

The agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

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

The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. FDA knows of only one manufacturer of this type of device. Classification of these devices in class II will relieve this manufacturer of the device of the cost of complying with the premarket approval requirements of section 515 of the act (21 U.S.C. 360e) and may permit small potential competitors to enter the market place by lowering their costs. The agency, therefore, certifies that this final rule will not have a significant economic impact on a substantial number of small entities.

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

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

This final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 866 is amended as follows:

Internet users may access all comments received by the U.S. DOT Dockets, Room PL-401, by using the universal resource locator (URL): http://dms.dot.gov. It is available 24 hours each day, 365 days each year. Please follow the instructions online for more information and help.

An electronic copy of this document may be downloaded by using a modem and suitable communications software from the Government Printing Office's Electronic Bulletin Board Service at (202) 512-1661. Internet users may reach the Office of the Federal Register's home page at: http://www.nara.gov/fedreg and the Government Printing Office's database at: http://www.access.gpo.gov/nara.

The amendments in this final rule are based primarily on the notice of proposed rulemaking (NPRM) published at 65 FR 6344 on February 9, 2000 (FHWA Docket No. FHWA-99-6232). All comments received in response to this NPRM have been considered in adopting these amendments.

Present FHWA regulations regarding utility relocation and accommodation matters have evolved from basic principles established decades ago, with many of the policies remaining unchanged. The present regulations are found at 23 CFR part 645. Subpart A of this part pertains to utility relocations, adjustments, and reimbursement. Subpart B pertains to the accommodation of utilities.

The utility regulations were revised on May 15, 1985, when a final rule was published at 50 FR 20344. Three significant changes have occurred since then, on February 2 and July 1, 1988, when amendments to the regulation were published at 53 FR 2829 and 53 FR 24932; and on July 5, 1995, when a final rule was published at 60 FR 34846.

The February 2, 1988, amendment provided that each State must decide, as part of its utility accommodation plan, whether to allow longitudinal utility installations within the access control limits of freeways and if allowed under what circumstances.

The July 1, 1988, amendment clarified that costs incurred by highway agencies in implementing projects solely for safety corrective measures to reduce the hazards of utilities to highway users are eligible for Federal-aid participation.

The July 5, 1995, amendment eliminated the requirement for FHWA pre-award review and/or approval of consultant contracts for preliminary engineering; increased the ceiling for lump sum agreements from $25,000 to $100,000; clarified the meaning of the term “approved program” and the methodology to be used to compute indirect or overhead rates; required utilities to submit final billings within one year following completion of the utility relocation work; eliminated the certification of completed utility work and the requirement for evidence of payment prior to reimbursement; brought the definition of “clear zone” into conformance with the American Association of State Highway and Transportation Officials (AASHTO) “Roadside Design Guide”; and conformed the utilities regulations to the Intermodal Surface Transportation Efficiency Act of 1991 (ISTEA), Public Law 102-240, 105 Stat. 1914.

This final rule amends the regulation as follows:

• Incorporates an amendment conforming the utilities regulations to the Transportation Equity Act for the 21st Century (TEA-21), Public Law 105-178, 112 Stat. 107.

• Eliminates the $100,000 upper limit for lump-sum agreements.

• Allows reimbursement for utility relocations to be based upon unit costs.

• Clarifies the intent of the regulation requiring utilities to submit final billings within one year following completion of work.

• Deletes the provision encouraging STDs to adopt the alternate procedure for utilities.

• States that the most important consideration in determining whether a proposed facility is a utility or not, is how the STD views it under its own State laws and/or regulations.

• Eliminates a confusing provision to clarify the intent that the utility regulations are not applicable to longitudinal installations of private lines.

Interested persons were invited to participate in the development of this final rule by submitting written comments in response to the NPRM in Docket No. FHWA-99-6232 on or before April 10, 2000. Comments were received from 6 STDs and 1 utility company. A summary of the comments received relative to each proposed amendment follows.

In § 645.101, it was proposed to change the term “utility facilities” to “utilities” in an effort to more clearly set forth the intent to include utility lines and systems, as well as facilities. There was no opposition to this proposed amendment. A favorable comment was received from one STD. Even so, the FHWA has considered this comment, and other informal input, and has decided not to pursue this proposed amendment. The terms “utilities” and “utility facilities” have come to mean essentially the same thing. The Congress even uses the terms interchangeably in authorizing legislation contained in 23 U.S.C. 123.

In § 645.105, paragraph designations are removed from all definitions and all definitions are placed in alphabetical order to conform subpart A to the existing format in subpart B. Also, the definitions “State highway agency” and “Highway agency (HA)” are changed to “State transportation department” and “Transportation department,” respectively, to conform the utilities regulation to section 1212(a) of the TEA-21.

In § 645.109, paragraph (c) is amended to reflect the correct title for 23 CFR part 172. It is presently shown as “Administration of Negotiated Contracts.” It should be “Administration of Engineering and Design Related Service Contracts.” This was not addressed in the NPRM.

In § 645.113, paragraph (f) is amended to eliminate the $100,000 ceiling for using the lump sum payment arrangement for reimbursement for utility adjustments on Federal-aid and direct Federal highway projects. There was no opposition to this amendment. Favorable comments were received from four STDs and one utility. The amendment will provide the States greater flexibility in utilizing the lump sum payment arrangement should they so desire. The purpose of allowing lump sum agreements, in lieu of agreements based on an accounting of actual costs, is to reduce the administrative burden associated with utility relocation projects. Under the lump sum process, cost accounting is easier, project billings are simplified, and a final audit of detailed cost records is not required. The FHWA believes the small degree of accuracy that might be realized if more detailed cost accounting methods were followed does not justify the extra cost involved in carrying out detailed audits. This revision will increase the number of utility relocations potentially eligible for lump sum payment.

In § 645.117, paragraph (a)(3) is added in order to allow reimbursement for utility relocations to be based upon unit costs for labor, materials and supplies, equipment, and other related costs, in lieu of actual costs. There was no opposition to this amendment. Favorable comments were received from three STDs and one utility. This amendment will provide the States greater flexibility in utilizing the lump sum payment arrangement, and will also decrease unnecessary paperwork and encourage innovation.

In § 645.117, paragraph (i)(2) is amended to clarify the intent of the regulation requiring utilities to submit final billings within one year following completion of work. There was no opposition to this amendment. Favorable comments were received from three STDs and one utility. The intent is to authorize STDs to require utilities to submit final bills for utility relocation work within one year of completion of the work, and if final bills are not submitted within that time frame, to consider previous payments made to the utility to be final. This regulation is intended to be a tool to help STDs close out projects in a timely manner, but it does allow exceptions to be made. If they desire, STDs may pay bills received from utilities more than one year following completion of the work and be reimbursed with Federal-aid highway funds for eligible items.

In § 645.119, the first sentence in paragraph (c) is amended to delete the provision encouraging STDs to adopt the alternate procedure for utilities, but continues to indicate that if they want to adopt the alternate procedure, they may do so by filing a formal application to the FHWA for approval. There was no opposition to this amendment. A favorable comment was received from one STD. The alternate procedure was a forerunner of the certification acceptance process and was similar in many ways. But, with passage of the TEA-21, the States were given the option of exempting the FHWA from oversight on many Federal-aid projects under the provisions of 23 U.S.C. 106(b). As a result, there became limited interest in using the alternate procedure for utilities. The alternate procedure will remain available for STDs that want to use it, but the FHWA will no longer encourage STDs to use it.

In § 645.201, it was proposed to change the term “utility facilities” to “utilities” in an effort to more clearly set forth the intent to include utility lines and systems, as well as facilities. There was no opposition to this proposed amendment. Even so, the FHWA has decided not to pursue this proposed amendment. The terms “utilities” and “utility facilities” have come to mean essentially the same thing. Furthermore, authorizing legislation in 23 U.S.C. 109(l)(1) uses the term “utility facilities” throughout in regard to accommodating utilities on highway rights-of-way.

In § 645.203, it was proposed to add a new paragraph, paragraph (e), in order to apply the utility accommodation regulations to facilities similar to utilities ( i.e., facilities, such as fiber optics and wireless telecommunications, that are considered by the FHWA to be included in the definition of “utility facility” in this subpart, and are considered to be utilities by many, but not all, of the States). Comments were received from two STDs, one in favor of the proposed amendment and one opposed. The Minnesota DOT was opposed because it believed the amendment would serve to define wireless telecommunications as a utility and would unduly influence State policies.

The FHWA has considered these comments, and other informal input, and has decided not to pursue this proposed amendment. While it would have provided uniformity and simplicity (by avoiding fiber optics, wireless telecommunications, and similar facilities, from being accommodated under one FHWA procedure in one State and a different FHWA procedure in another State), it would have conflicted with the FHWA's longstanding policy that the most important consideration in determining whether a proposed installation is a utility or not is how the STD views it under its own State laws and/or regulations. There was also the appearance that accommodating non-utilities under regulations in this subpart might interfere with other requirements currently in effect for accommodating non-utilities, particularly in regard to fair market value, use of revenues for title 23 purposes, and the environment.

In § 645.205, it was proposed to add a new paragraph (e), in order to indicate States may charge a fee for utility use of highway rights-of-way on Federal-aid highway projects, and to suggest that if they do the proceeds should be used for title 23, U.S.C., purposes. Comments were received from four STDs and one utility company. Two STDs were in favor of this proposed amendment, but two other STDs and one utility company expressed some concern and/or requested clarification. The Arkansas Department of Transportation (DOT) indicated its State law might not allow fees to be charged for utility use of its rights-of-way. The Wisconsin DOT suggested revised wording. The Mid American Energy Company requested further clarification.

The FHWA has considered these comments, and other informal input, and has decided not to pursue this proposed amendment. It has been the FHWA's policy for many years to allow States to charge fees for utility use of highway right-of-way if they desire, and to allow them to use the proceeds as they see fit. In the past, fees charged for utility use were generally just enough to cover the cost of processing permits. Now, with the advent of fiber optics and wireless telecommunications, opportunities exist for the States to make substantial profits. In such cases, the FHWA has informally encouraged the States to use such proceeds for transportation purposes. This proposed amendment would have formally established the FHWA's desire for proceeds from fees charged for utility use of highway right-of-way to be used for transportation purposes. Although this is a valid desire, the utility regulations are probably not the best place to express it. This is because Federal law is silent on charging fees for utilities, thus leaving it to the States to decide for themselves. The FHWA considers utility use of highway right-of-way to be in the public interest. It therefore has no desire to require the charging of fees, and since Federal law does not require such, there is no real reason to try to regulate a practice that is working well. Relative to the use of fees obtained for the use of highway right-of-way, the FHWA only desires to encourage the States to use such proceeds for transportation purposes. Again, since there is no desire at this time to regulate this activity, a statement to this effect in FHWA's guidance literature is considered to be sufficient.

In § 645.207, the definitions “State highway agency” and “Highway agency” are changed to “State transportation department” and “transportation department,” respectively, to conform the utilities regulation to section 1212(a) of the TEA-21. The definition of “clear zone” is amended to remove the date of the referenced publication and to indicate that the most current edition should be used, and to remove the reference to FHWA Regional Offices. The purpose for deleting the date of the publication and making reference to “the most current edition” is to ensure the most recent information is used. Reference to FHWA Regional Offices is deleted because in a recent reorganization all FHWA Regional Offices were abolished. All utility-related responsibilities of the FHWA Regional Offices have been delegated to FHWA Division Offices. There was no opposition to these amendments. No comments were received.

In § 645.209, it was proposed to amend paragraph (d) to clarify the intent that STDs control utility use of highway right-of-way on Federal-aid highway projects within the State and its political subdivisions, but not necessarily on all Federal-aid highways. Comments were received from two STDs, one was in favor of the proposed amendment, and the other questioned the definition of the term “project.”

The FHWA has considered these comments and decided not to pursue this amendment. Upon further consideration of the existing regulations it was found that the term “highway” used in this subpart, and as defined in § 645.207, means any public way for vehicular travel constructed or improved in whole or part with Federal-aid highway funds. It was the intent of the amendment to clarify the distinction between highways actually constructed or improved using Federal-aid highway funds, and highways eligible for construction or improvement with Federal-aid highway funds. It may be a moot point. Even though STDs may only be required to regulate utility use on highways where Federal-aid highway funds have been used, as a practical matter it is difficult for them to adopt one policy for federally funded highways versus a different policy for adjoining State funded highways. As a result, STDs normally adopt a utility accommodation policy that covers highway routes under their jurisdiction as a group. Even so, the distinction in this regard between highways constructed or improved using Federal-aid highway funds, and highways eligible for construction of improvement using Federal-aid highway funds, is considered to be sufficiently covered in the existing utility regulations.

In § 645.209, paragraph (j) is amended to remove the date of the referenced publication and indicate the most current edition should be used, and to remove the reference to FHWA Regional Offices. The reasons for doing this are the same as discussed in § 645.207 above. There was no opposition to these amendments. Comments were received from one STD, and it was in favor of the changes.

In § 645.209, paragraph (m) is added to clarify existing policy that the most important consideration in determining whether a proposed installation is a utility or not is how the STD views it under its own State laws and/or regulations. There was no opposition to this amendment. A favorable comment was received from one STD. This determination is important because utilities are handled under this regulation; whereas, private lines and other non-utilities are handled under other regulations. As in many utility-related matters, the FHWA policy is broad enough in this instance to cover most situations, but nonetheless, in States where the State policy is more restrictive, and sometimes more liberal, than the FHWA policy, the FHWA will normally look upon a particular situation in the same manner the State does.

In § 645.209, we proposed to add a new paragraph (n), in order to: (1) Encourage STDs, when they intend to permit utilities to use and occupy the right-of-way on a Federal-aid highway project, to consider such potential use in determining the extent and adequacy of the right-of-way needed for the project; and (2) encourage STDs, in consultation with the utilities, to consider acquiring the right-of-way needed to accommodate the utilities, with the understanding they may keep the acquired right-of-way, or may sell, lease, or somehow convey it to the utilities. Comments were received from six STDs concerning this proposal. Two STDs were in favor of this proposed amendment, but four STDs expressed some concerns. The Oregon DOT found the proposed amendment to be very disturbing because it would conflict with State law prohibiting the use of State highway funds for utility purposes. The Wisconsin DOT was concerned about conveying property to utilities and made several suggestions for clarification and improvement of the proposed amendment. The Pennsylvania DOT recommended changing the language to indicate STDs “may,” rather than “should” take certain actions. The Minnesota DOT was unclear as to the use of some of the words in the proposed amendment.

The FHWA has considered these comments, and other informal input, and has decided not to pursue the proposed amendment in § 645.209. The intent was to encourage STDs to consider utility right-of-way needs during the development of projects, and to subsequently consider acquiring right-of-way for utilities. Many STDs are already doing these things. The FHWA would like to encourage other STDs to do the same, but has no desire at this time to require them to do so. However, within the context of a regulation, the difference between encouragement and requirements may become blurred. In addition, there are many underlying issues within the broad scope of the proposed amendments that cannot be addressed adequately in a regulation to satisfy the needs and constraints of individual States. The FHWA, therefore, deems it more appropriate to make its desires known in its guidance literature.

In § 645.211, the section heading is changed to reflect the statutory name change from “State highway agency” to “State transportation department.” The introductory paragraph is amended to remove the dates of the referenced publications and indicate that the most current editions should be used, and to remove the reference to FHWA Regional Offices. This is for the same reasons discussed in § 645.207 above. There was no opposition to these amendments. No comments were received.

In § 645.215, paragraph (d) is amended to remove all references to the approval of longitudinal installations of private lines. There was no opposition to this amendment. No comments were received. In § 645.203, it is indicated that private lines installed longitudinally on highway right-of-way are to be approved under the provisions of § 1.23(c), which covers the use of highway right-of-way, including air space, for non-highway purposes. This provision excludes longitudinal private line installations from coverage under the utility regulations. It was not originally intended for longitudinal private lines to be handled under the FHWA's right-of-way provisions, but it has become common practice to include them in this category. Not knowing this would happen when § 645.203 was written, another reference was made to longitudinal private lines in § 645.215(d)(2) relative to approvals. This reference is no longer applicable and conflicts with existing requirements for handling right-of-way items.

All comments received before the close of business on April 10, 2000, were considered in developing the final rule. The comments are available for examination using FHWA docket number 99-6232 in the docket room at the above address or via the electronic addresses provided above.

The FHWA has determined this action is not a significant regulatory action within the meaning of Executive Order 12866, nor a significant regulatory action within the Department of Transportation's regulatory policies and procedures. The amendments simply make minor changes to update the utilities regulations to conform to recent laws, regulations or guidance, and to clarify existing policies. It is anticipated that the economic impact of this rulemaking will be minimal because the amendments would only simplify or clarify procedures presently being used by STDs and utilities. Therefore, a full regulatory evaluation is not required.

In compliance with the Regulatory Flexibility Act (5 U.S.C. 601-612), the FHWA has evaluated the effects of this rule on small entities. Based on the evaluation, the FHWA certifies that this action will not have a significant economic impact on a substantial number of small entities. This is because the amendments only clarify or simplify procedures used by STDs and utilities in accordance with existing laws, regulations, or guidance.

The FHWA has also analyzed this proposed action for the purpose of the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq. ), and has determined that this action would not have any effect on the quality of the human and natural environment.

This action has been analyzed in accordance with the principles and criteria contained in Executive Order 13132, dated August 4, 1999, and it has been determined this rule does not have a substantial direct effect or sufficient Federalism implications on States that would limit the policymaking discretion of the States. Nothing in this document directly preempts any State law or regulation. This rule merely reduces the level of Federal approval actions by placing greater responsibility at the State or local level. Throughout the regulation there is an effort to keep administrative burdens to a minimum.

Catalog of Federal Domestic Assistance Program Number 20.205, Highway Planning and Construction. The regulations implementing Executive Order 12372 regarding intergovernmental consultation on Federal programs and activities apply to this program.

This rule does not impose a Federal mandate resulting in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year (2 U.S.C. 1531 et seq. ).

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501, et seq. ), Federal agencies must determine whether requirements contained in rulemakings are subject to the information collection provisions of the PRA. The FHWA has determined that this action would not constitute an information collection within the scope or meaning of the PRA. Implementation of this rule would impose no burden on the States and private entities because it merely provides clarification and more flexibility to STDs in implementing the FHWA's utilities regulations contained at 23 CFR 645. As a result, no additional information collection burdens are imposed on the States, the local governments, or the private sector.

At present, the FHWA sponsors four information collections that are related to public utilities requirements. Each of these collections is currently cleared by the Office of Management and Budget (OMB). These FHWA collections are as follows: (1) Develop and Submit Utility Accommodation Policies, OMB Control No. 2125-0514; (2) Eligibility Statement for Utility Adjustments, OMB Control No. 2125-0515; (3) Developing and Recording Costs for Utility Adjustments, OMB Control No. 2125-0519; and (4) Utility Use and Occupancy Agreements, OMB Control No. 2125-0522. The currently approved burden hours for these collections would not be affected by implementation of this rule.

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

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

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

A regulation identification number (RIN) is assigned to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. The RIN contained in the heading of this document can be used to cross reference this action with the Unified Agenda.

In consideration of the foregoing, the FHWA amends title 23, Code of Federal Regulations, part 645 as follows:

The Environmental Protection Agency (EPA), Region VII announces the deletion of the John Deere Ottumwa Works site, Ottumwa, Iowa from the NPL, Appendix B of the National Oil and Hazardous Substances Pollution Contingency Plan (NCP), 40 CFR part 300. The EPA identifies sites that appear to present a significant risk to public health, welfare, or the environment and maintains the NPL as the list of these sites. EPA and the Iowa Department of Natural Resources (IDNR) have determined that the remedial action at the Site has been successfully executed. EPA will accept comments on this notice thirty days after publication of this document in the Federal Register .

Section II of this action explains the criteria for deleting sites from the NPL. Section III discusses the procedures that EPA is using for this action. Section IV discusses the history of the John Deere Ottumwa Site and explains how the Site meets the deletion criteria. Section V states EPA's action to delete the releases of the Site from the NPL unless dissenting comments are received during the comment period.

Section 300.425(e) of the NCP provides that sites may be deleted from, or recategorized on the NPL where no further response is appropriate. In making a determination to delete a release from the NPL, EPA shall consider, in consultation with the state, whether any of the following criteria have been met:

(i) Responsible parties or other persons have implemented all appropriate response actions required;

(ii) All appropriate Fund-financed response under CERCLA has been implemented, and no further response action by responsible parties is appropriate; or

(iii) The remedial investigation has shown that the release poses no significant threat to public health or the environment and, therefore, taking of remedial measures is not appropriate.

Even if the site is deleted from the NPL, where hazardous substances, pollutants, or contaminants remain at the site above levels that allow for unlimited use and unrestricted exposure, EPA's policy is that a subsequent review of the site will be conducted at least every five years after the initiation of the remedial action at the site to ensure that the remedy remains protective of public health and the environment. A five-year review was conducted at the John Deere Ottumwa Works Site in 1998. Based on that review, EPA in consultation with the State, determined that conditions at the site remain protective of human health and the environment. As explained below, the Site meets the NCP's deletion criteria listed above. If new information becomes available which indicates a need for further action, EPA may initiate remedial actions. Whenever there is a significant release from a site deleted from the NPL, the site shall be restored to the NPL without the application of the Hazard Ranking System (HRS).

The following procedures were used for the intended deletion of the release from this Site: (1) All appropriate response under CERCLA has been implemented and no further action by EPA is appropriate; (2) The Iowa Department of Natural Resources concurred with the proposed deletion decision; (3) A notice has been published in the local newspaper and has been distributed to appropriate federal, state, and local officials and other interested parties announcing the commencement of a 30-day dissenting public review. The EPA is requesting only dissenting comments on the Direct Final Action to Delete.

For deletion of the release from the Site, EPA's Regional Office will accept and evaluate public comments on EPA's Final Notice before making a final decision to delete. If necessary the Agency will prepare a Responsiveness Summary, responding to each significant comment submitted during the public comment period. Deletion of the site from the NPL does not itself create, alter, or revoke any individual's rights or obligations. The NPL is designated primarily for informational purposes and to assist Agency management. As mentioned in Section II of this document, § 300.425(e)(3) of the NCP states that the deletion of a release from a site from the NPL does not preclude eligibility for future response actions.

The following site summary provides the Agency's rationale for the proposal to delete this site from the NPL.

The John Deere Ottumwa Works Site is located in Ottumwa, Iowa, Wapello County, and includes a 118-acre tract of land which has been used for the manufacture of farm implements since 1946. From 1911 until 1973, the company disposed of approximately 3,000 tons of solvents, paint sludges, acids, heavy metals, and cyanide on site. The site is located 200 feet from prime agricultural land. Approximately 700 people obtain drinking water from private wells located within 3 miles of the site. The main water supply for Ottumwa, population 27,000, is the Des Moines River; the intake is 4,000 feet upstream from the John Deere landfills. The river also is used for recreational activities. The city's secondary water supply, which is used intermittently throughout the year, is the Black Lake. It is located 500 feet down gradient of the on-site landfills. Low levels of various heavy metals from site disposal activities were detected in the soil, surface water, and sediments. Also, low levels of methylene chloride, a volatile organic compound (VOC), were detected in the soil and sediments. Potential risks may have existed for individuals who accidently ingested or came into direct contact with the contaminated soil and surface water.

The John Deere Ottumwa Works Site was placed on the National Priorities List (NPL) on February 21, 1990. Under EPA oversight, the John Deere Company began remedial investigation activities in 1990 to determine the type and extent of contamination. Field work was completed in late 1990, and the investigation was completed in late 1991. Based on the results of this investigation, the EPA selected a remedy requiring the John Deere Company to maintain the existing fence around the site and to continue monitoring the groundwater to ensure that it remains safe. In addition, the property and State Highway right-of-way deed restrictions now limit site use to non-residential activities. A Record of Decision (ROD) explaining the remedy selected for this site was signed by EPA on September 23, 1991.

In September 1992, the John Deere Company and the Department of Transportation entered into a Consent Decree with EPA to implement the selected remedy. Since that time, EPA has continued to conduct oversight activities, as well as reviewing and evaluating sampling data provided by the John Deere Company. In January 1998, a Five-Year Review Report was signed by EPA which defined current site conditions, remedy protectiveness, and recommendations for next steps. As one of the recommendations, EPA responded to a September 1997 Deere Company request that certain monitoring wells be abandoned in accordance with State and federal regulations. The EPA requested that one full round of sampling be conducted prior to the abandonment exercise to discern compound levels and evaluate which wells would remain as background wells to prevent off-site migration of contamination. Sampling was conducted in March 1999 at 11 monitoring wells and 2 piezometers for total arsenic, barium, cadmium, chromium, lead, VOCs, and semi-volatiles. Sampling results showed no levels above MCLs. Based on this outcome, eight (8) wells and 1 piezometer were abandoned in January 2000 in accordance with State and federal regulations.

The Five-Year Review was completed in January 1998 and indicated that remedial objectives had been met. These objectives include institutional controls which require the maintenance of an eight-foot high chain-link fence topped with barbed wire, and the lodging of deed restrictions which prevent the future development of residences or other similar exposure situations on site. Groundwater and surface water monitoring will hereby be discontinued subsequent to future Five-Year Reviews which may reveal the need for additional monitoring. The selected remedy does not reduce toxicity, mobility, or volume through treatment, however, it has been determined by EPA to represent the maximum extent required to protect human health and the environment. The remedy selection also ensures on a long-term basis that the sensitive population, children, are not exposed to site waste, thereby preventing the only potentially unacceptable exposure scenario from occurring. The Hazard Index (HI) associated with children directly contacting waste material is slightly above one. No unacceptable site-related cancer risks were identified. There were no Federal or State ARARs to be considered for this remedy.

Limited maintenance is required at this site. Long-term maintenance and groundwater monitoring have been conducted by the John Deere Ottumwa Company. This site is also an active RCRA facility and is monitored by RCRA as well as the Superfund Program.

The Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) requires five-year review of all sites where hazardous substances remain above health-based levels for unrestricted use of the site. Under CERCLA Section 121(c), a review is also conducted to ensure that the selected remedy continues to be protective of human health and the environment. The next five-year review at this site is scheduled for the year 2003.

The remedy selected for this site has been implemented in accordance with the Record of Decision. Therefore, no further response action is necessary. The remedy has resulted in the significant reduction of the long-term potential for release of contaminants, therefore, human health and potential environmental impacts have been minimized. The EPA and the Iowa Department of Natural Resources find that the remedy implemented continues to provide adequate protection of human health and the environment.

The EPA, with concurrence of the State of Iowa, has determined that the criteria for deletion of the release have been met. Therefore, EPA is deleting the site from the NPL.

This action will be effective January 22, 2001. However, if EPA receives dissenting comments by December 22, 2000, EPA will publish a document that withdraws this action.

Section 553 of the Administrative Procedure Act, 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 the corrections are non-substantive, formatting revisions. Thus, notice and public procedure are unnecessary. EPA finds that this constitutes good cause under 5 U.S.C. 553(b)(B).

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 technical correction 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). 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 (61 FR 4729, February 7, 1996). EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the executive order. This 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. ). EPA's compliance with these statutes and Executive Orders for the underlying rule is discussed in the January 27, 2000 Federal Register document.

The Congressional Review Act (5 U.S.C. 801 et seq. ), as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. Section 808 allows the issuing agency to make a rule effective sooner than otherwise provided by the CRA if the agency makes a good cause finding that notice and public procedure is impracticable, unnecessary or contrary to the public interest. This determination must be supported by a brief statement. 5 U.S.C. 808(2). As stated previously, EPA has made such a good cause finding, including the reasons therefor, and established an effective date of November 22, 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).

NASA is adopting as final, with changes, the interim rule published in the Federal Register (65 FR 37057-37061, June 13, 2000) that revised various NFS Parts to refocus on risk as a core acquisition concern as part of NASA's risk-based acquisition management initiative. Comments were received from one company and an industry association. All comments were considered in the development of the final rule. Revisions primarily affect internal procedures and include the following: (1) In section 1807.105 the reference to a NASA document is revised; (2) in section 1815.203-72, the words “and RFOs” are added after “RFPs” to make it clear that the section applies to MidRange procurements; (3) in section 1816.405-274 and new section 1849.102-71, language is added to require the contracting officer to notify the Associate Administrator for Procurement prior to the determination of a zero award fee in accordance with NFS 1816.405-274, and prior to exercising remedies under NFS clause 1852.223-75; (4) in section 1823.7001, the word at the end of paragraph (b)(1) is changed from “or” to “and”, and the word “concurrence” in paragraph (b)(2) is changed to “approval”, to enhance the role of installation safety officials in the application of the Safety and Health clause; and (5) in section 1852.223-75, the words “or mission failure” are added after “fatality” in paragraph (a), to achieve consistency with similar language in section 1816.405-274(c)(2).

NASA certifies that this final rule will not have a significant economic impact on a substantial number of small business entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) because this rule simply focuses attention on risk management, an existing business practice, and does not impose any significant new requirements which might have an economic impact.

The Paperwork Reduction Act does not apply because the changes to the NFS do not impose recordkeeping or information collection requirements, or collection of information from offerors, contractors, or members of the public which require the approval of the Office of Management and Budget under 41 U.S.C. 3501, et seq.

On February 16, 1999, NMFS published a final rule (64 FR 7529) implementing the ALWTRP. Among other measures, the final rule required gear marking in all fisheries covered by the ALWTRP by April 1, 1999.

The Atlantic Large Whale Take Reduction Team (ALWTRT) met on February 8-10, 1999, discussed the gear marking program in detail, found that the plan would not meet ALWTRT and NMFS goals and recommended by consensus that NMFS suspend the implementation of the gear marking requirement until November 1, 1999, or until a better system was designed. On April 9, 1999 (64 FR 17292), NMFS issued a final rule that suspended the gear marking program until November 1, 1999. On December 30, 1999 (64 FR 73434), NMFS extended the suspension until November 1, 2000. Because of a delay in preparing an extension of this suspension, these gear marking requirements went into effect. It was not the intent of the agency for this to happen. A new gear marking program will be implemented by an interim final rule currently in preparation. In order to spare fishermen the expense of having to adhere for a short period of time to gear marking requirements that will be modified in the near future, NMFS is removing and reserving these requirements. The other provisions of this final rule implementing the ALWTRP, including the gear marking requirements for the Southeast U.S. fisheries covered by the ALWTRP, remain in effect.

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

NMFS prepared a Supplemental Environmental Assessment (EA) for the final rule (64 FR 73434) extending the suspension of the effective dates of the gear marking requirements and found that action not to have a significant environmental impact. Since this final rule addresses an action previously analyzed in an EA, it is categorically excluded from further environmental review under section 5.05b of NOAA Administrative Order 216-6.

A biological opinion (BO) on the ALWTRP was completed on July 15, 1997. That BO concluded that implementation of the ALWTRP and continued operation of fisheries conducted under the American Lobster and Northeast Multispecies Fishery Management Plans (FMPs), and southeastern shark gillnet component of the Shark FMP, may adversely affect, but were not likely to jeopardize the continued existence of, any listed species of large whale or sea turtle under NMFS jurisdiction. NMFS conducted an informal consultation and made the determination that the April 9, 1999, final rule (64 FR 17292), did not change the basis for that BO. Therefore, NMFS also found this action does not change the basis for that BO.

Removing the ALWTRP gear marking requirement for northeast U.S. fisheries will have no adverse impacts on marine mammals. (EA, 1999) In addition, this final rule does not affect the determination that the ALWTRP will be implemented in a manner that is consistent to the maximum extent practicable with the approved coastal management programs of the Atlantic states.

The Assistant Administrator for Fisheries Noaa, (AA), for good cause, finds, under 5 U.S.C. 553(b)(B), that delaying this final rule to allow for prior notice and an opportunity for public comment would be contrary to the public interest. It would not be fair to subject fishermen to the expense of having to comply with gear marking requirements that do not meet the goals of the ALWTRP in which the agency intends to replace in the immediate near future with a new gear marking program. For the same reason, the AA finds, for good cause under 5 U.S.C. 553(d)(3) that delaying the effectiveness of this final rule for 30 days would be contrary to the public interest. Furthermore, since this final rule relieves a restriction, under 5 U.S.C. 553(d)(1) it is not subject to a 30-day delay in effective date.

Because publishing a general notice of proposed rulemaking is not required for this action by 5 U.S.C. 553 or by any other law, the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) are inapplicable.

This final rule removes a collection-of-information requirement previously approved by OMB (OMB control number: 0648-0364).

Administrative practice and procedure, Confidential business information, Fisheries, Marine Mammals, Reporting and record-keeping requirements.

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

Based on the Councils' recommended total allowable catch and the allocation ratios in the FMP on February 19, 1998 (63 FR 8353), NMFS implemented a commercial quota of 2.34 million lb (1.06 million kg) for the eastern zone (Florida) of the Gulf migratory group of king mackerel. On April 27, 2000, NMFS’ implemented final rule (65 FR 16336, March 28, 2000) divided the Florida west coast subzone of the eastern zone into northern and southern subzones and established a separate quota for the northern Florida west coast subzone of 175,500 lb (79,606 kg)(50 CFR 622.42(c)(1)(i)(A)( 2 )( ii )).

Under 50 CFR 622.43(a)(3), NMFS is required to close any segment of the king mackerel commercial fishery when its quota has been reached, or is projected to be reached, by filing a notification at the Office of the Federal Register. NMFS has determined that the commercial quota of 175,500 lb (79,606 kg) for Gulf group king mackerel in the northern Florida west coast subzone was reached on November 15, 2000. Accordingly, the commercial fishery for king mackerel in the northern Florida west coast subzone is closed at 12:01 a.m., local time, November 19, 2000, through June 30, 2001, the end of the fishing year.

The Florida west coast subzone is that part of the eastern zone south and west of 25°20.4' N. lat. (a line directly east from the Miami-Dade County, FL, boundary). The Florida west coast subzone is further divided into northern and southern subzones. The northern subzone is that part of the Florida west coast subzone that is between 26°19.8' N. lat. (a line directly west from the Lee/Collier County, FL, boundary) and 87°31'06' W. long. (a line directly south from the Alabama/Florida boundary).

NMFS previously determined that the commercial quota for king mackerel from the western zone of the Gulf of Mexico was reached and closed that segment of the fishery on August 26, 2000 (65 FR 52350, August 29, 2000). Thus, with this closure, all commercial fisheries for Gulf group king mackerel in the EEZ are closed from the U.S./Mexico border through the northern Florida west coast subzone through June 30, 2001.

Except for a person aboard a charter vessel or headboat, during the closure, no person aboard a vessel for which a commercial permit for king mackerel has been issued may fish for Gulf group king mackerel in the EEZ in the closed zones or subzones. A person aboard a vessel that has a valid charter vessel/headboat permit for coastal migratory pelagic fish may continue to retain king mackerel in or from the closed zones or subzones under the bag and possession limits set forth in 50 CFR 622.39(c)(1)(ii) and (c)(2), provided the vessel is operating as a charter vessel or headboat. Note, however, that the bag limit for an operator or crew member of a charter vessel or headboat is zero. A charter vessel or headboat that also has a commercial king mackerel permit is considered to be operating as a charter vessel or headboat when it carries a passenger who pays a fee or when there are more than three persons aboard, including operator and crew.

During the closure, king mackerel from the closed zones or subzones taken in the EEZ, including those harvested under the bag and possession limits, may not be purchased or sold. This prohibition does not apply to trade in king mackerel from the closed zones or subzones that were harvested, landed ashore, and sold prior to the closure and were held in cold storage by a dealer or processor.

This action responds to the best available information recently obtained from the fishery. The closure must be implemented immediately to prevent an overrun of the commercial quota (50 CFR 622.42(c)(1)) of Gulf group king mackerel, given the capacity of the fishing fleet to harvest the quota quickly. Overruns could potentially lead to further overfishing and unnecessary delays in rebuilding this overfished resource. Any delay in implementing this action would be impractical and contradictory to the Magnuson-Stevens Act, the FMP, and the public interest. NMFS finds, for good cause, that the implementation of this action cannot be delayed for 30 days. Accordingly, under 5 U.S.C. 553(d), a delay in the effective date is waived.

This action is taken under 50 CFR 622.43(a) and is exempt from review under Executive Order 12866.