This notice has been determined to be significant and was reviewed by OMB under Executive Order 12866.

The title and number of the Federal Assistance Program, as found in the Catalog of Federal Domestic Assistance, to which this rule applies, are Commodity Loans and Purchases—10.051.

This final rule has been reviewed in accordance with Executive Order 12988. The provisions of this rule do not preempt State laws, are not retroactive, and do not involve administrative appeals.

It has been determined that the Regulatory Flexibility Act is not applicable to this final rule since neither the Farm Service Agency (FSA) nor the Commodity Credit Corporation (CCC) is required by 5 U.S.C. 553 or any other provision of law to publish a notice of proposed rulemaking with respect to the subject of these determinations.

The amendments to 7 CFR parts 723 and 1464 set forth in this final rule do not contain information collections that require clearance by the Office of Management and Budget under the provisions of 44 U.S.C. chapter 35.

This rule contains no Federal mandates under the regulatory provisions of Title II of the Unfunded Mandate Reform Act of 1995 (UMRA), for State, local, and tribal governments or the private sector. Thus, this rule is not subject to the requirements of sections 202 and 205 of the UMRA.

This final rule is issued pursuant to the provisions of the 1938 Act and the 1949 Act.

On March 1, 1999, the Secretary determined and announced the national marketing quotas and price support levels for the 1999 crops of fire-cured (type 21), fire-cured (types 22-23), dark air-cured (types 35-36), Virginia sun-cured (type 37), and cigar-filler and binder (types 42-44 and 53-55) tobaccos. A number of related determinations were made at the same time which this final rule affirms. On the same date, the Secretary also announced that a referendum would be conducted by mail with respect to cigar-filler and binder (types 42-44 and 53-55) tobacco.

During March 15-19, 1999, eligible producers of cigar-filler and binder (types 42-44 and 53-55) tobacco voted in a referendum to determine whether such producers approved marketing quotas for the 1999, 2000, and 2001 marketing years (MY) for this tobacco. Of the producers voting, 77.7 percent favored marketing quotas for cigar-filler and binder (types 42-44 and 53-55) tobacco. Accordingly, quotas and price support for cigar-filler and binder (types 42-44 and 53-55) tobacco are in effect for the 1999 through 2001 MYs.

In accordance with section 312 of the 1938 Act, for tobaccos other than flue-cured tobacco and burley tobacco, the Secretary of Agriculture is required to proclaim not later than March 1 of any MY a national marketing quota for those tobaccos for which marketing quotas have been approved in the prior three years. There is a vote on quotas for each kind in a 3-year cycle. For cigar-filler and binder (types 42-44 and 53-55) tobacco, the 1998 MY was the last year of 3 consecutive years of quota. Accordingly, marketing quotas for cigar-filler and binder (types 42-44 and 53-55) were proclaimed for each of the 3 MYs beginning October 1, 1999; October 1, 2000, and October 1, 2001, but subject to producer approval. As indicated, cigar-filler and binder (types 42-44 and 53-55) producers approved quotas in the referendum. Quotas for the other tobaccos covered by this notice were approved in referenda which are still effective.

Because of producer approval of quotas, sections 312 and 313 of the 1938 Act required that the Secretary also announce the reserve supply level and the total supply of fire-cured (type 21), fire-cured (types 22-23), dark air-cured (types 35-36), Virginia sun-cured (type 37), and cigar filler and binder (types 42-44 and 53-55) tobaccos for the MY beginning October 1, 1998. The Secretary also announced the amounts of the national marketing quotas, national acreage allotments, national acreage factors for apportioning the national acreage allotments (less reserves) to old farms, and the amounts of the national reserves and parts thereof available for (1) new farms and (2) making corrections and adjusting inequities in old farm allotments.

Under the 1949 Act, price support is required to be made available for each crop of a kind of tobacco for which marketing quotas are in effect or for which marketing quotas have not been disapproved by producers. With respect to the 1999 crops of the kinds of tobacco that are the subject of this notice, the respective maximum levels of price support for these kinds of tobacco is determined in accordance with section 106 of the 1949 Act. Announcement of the price support levels for these five kinds of tobacco are normally made before the planting seasons. Under the provisions of Section 1108 (c), of Pub. L. No. 99-272, the price support level announcements do not require prior rulemaking. For the 1999 crops, the price support announcements were made on March 1, 1999, at the same time the quota announcements were made. Quota and price support determinations for burley and flue-cured tobacco are made separately and are the subject of separate notices.

Section 312(b) of the 1938 Act provides, in part, that the national marketing quota for a kind of tobacco is the total quantity of that kind of tobacco that may be marketed such that a supply of such tobacco equal to its reserve supply level is made available during the MY.

Section 313(g) of the 1938 Act provides that the Secretary may convert the national marketing quota into a national acreage allotment for apportionment to individual farms. Since producers of these kinds of tobacco generally produce considerably less than their respective national acreage allotments allow, a larger quota is necessary to make available production equal to the reserve supply level. Further, under section 312 (b) of the 1938 Act, the amount of the national marketing quota may, not later than the following March 1, be increased by not more than 20 percent over the straight formula amount if the Secretary determines that such increase is necessary in order to meet market demands or to avoid undue restriction of marketings in adjusting the total supply to the reserve supply level.

Section 301(b)(14)(B) of the 1938 Act defines “reserve supply level” as the normal supply, plus 5 percent thereof, to ensure a supply adequate to meet domestic consumption and export needs in years of drought, flood, or other adverse conditions, as well as in years of plenty. “Normal supply” is defined in section 301(b)(10)(B) of the 1938 Act as a normal year's domestic consumption and exports, plus 175 percent of a normal year's domestic use and 65 percent of a normal year's exports as an allowance for a normal year's carryover.

Normal year's domestic consumption is defined in section 301(b)(11)(B) of the 1938 Act as the average quantity produced and consumed in the United States during the 10 MYs immediately preceding the MY in which such consumption is determined, adjusted for current trends in such consumption. Normal year's exports is defined in section 301(b)(12) of the 1938 Act as the average quantity produced in and exported from the United States during the 10 MYs immediately preceding the MY in which such exports are determined, adjusted for current trends in such exports.

Also, under section 313(g) of the 1938 Act, the Secretary is authorized to establish a national reserve from the national acreage allotment in an amount equivalent to not more than 1 percent of the national acreage allotment for the purpose of making corrections in farm acreage allotments, adjusting for inequities, and for establishing allotments for new farms. The Secretary has determined that the national reserve, noted herein, for the 1999 crop of each of these kinds of tobacco is adequate for these purposes.

On February 26, 1999, a proposed rule was published in the Federal Register (64 FR 9452) in which interested persons were requested to comment with respect to setting quotas for the tobacco kinds addressed in this notice.

Fourteen written responses were received during the comment period which ended March 1, 1999. A summary of these comments by kind of tobacco follows:

(1) Fire-cured (type 21) tobacco. Two comments were received, recommending no change in 1999 quotas.

(2) Fire-cured (types 22-23) tobacco. Five comments were received. Four recommended a five percent deduction in 1999 quotas, while one other recommended a 10 percent decrease.

(3) Dark air-cured (types 35-36) tobacco. Five comments were received. Four recommended a 10 percent increase in the quota, while one favored a five percent increase.

(4 ) Virginia sun-cured (type 37) tobacco. Two comments were received, recommending no change in quota.

(5) Cigar-filler and binder (types 42-44 and 53-55) tobacco. No comments were received.

The tobacco program is, through assessments, operated at no net cost to taxpayers other than the costs common to all price support operations. Accordingly, producer comments are given considerable weight in this review. Based on a review of the comments received and the latest available statistics of the Federal Government, which appear to be the most reliable data available, the following determinations were made for the five subject tobacco kinds:

The average annual quantity of fire-cured (type 21) tobacco produced in the United States that is estimated to have been consumed in the United States during the 10 MYs preceding the 1998 MY was approximately 19.3 million pounds. The average annual quantity produced in the United States and exported from the United States during the 10 MYs preceding the 1998 MY was 2.0 million pounds (farm sales weight basis). Both domestic use and exports have trended downward. Because of these considerations, a normal year's domestic consumption has been determined to be 0.7 million pounds, and a normal year's exports have been determined to be 1.5 million pounds. Application of the formula prescribed by section 301(b)(14)(B) of the 1938 Act results in a reserve supply level of 4.6 million pounds.

Manufacturers and dealers reported stocks held on October 1, 1998, of 2.4 million pounds. The 1998 crop is estimated to be 2.4 million pounds. Therefore, total supply for the 1998 MY is 4.8 million pounds. During the 1998 MY, it is estimated that disappearance will total approximately 2.3 million pounds. Deducting this disappearance from total supply results in a 1999 MY beginning stock estimate of 2.8 million pounds.

The difference between the reserve supply level and the estimated carryover on October 1, 1999, is 2.5 million pounds. This represents the quantity that may be marketed that will make available during the 1999 MY a supply equal to the reserve supply level. More than 95 percent of the announced national marketing quota is expected to be produced. Accordingly, it has been determined that a 1999 national marketing quota of 2.116 million pounds is necessary to make available production of 2.1 million pounds. As permitted by section 312(b) of the 1938 Act, it was further determined that the 1999 national marketing quota should be increased by 20 percent over the normal formula amount in order to avoid undue restriction of marketings. This determination took into account the size of last year's quota, the comments, the long storage time for this tobacco and the possibility of changes in demand over expected demand. Thus, the national marketing quota for the 1999 crop is 2.6 million pounds.

In accordance with section 313(g) of the 1938 Act, dividing the 1999 national marketing quota of 2.6 million pounds by the 1994-98, 5-year national average yield of 1,600 pounds per acre results in a 1999 national acreage allotment of 1,625.00 acres.

Pursuant to the provisions of section 313(g) of the 1938 Act, a national acreage factor of 1.0 is determined by dividing the national acreage allotment for the 1999 MY, less a national reserve of 7.61 acres, by the total of the 1999 preliminary farm acreage allotments (previous year's allotments). The preliminary farm acreage allotments reflect the factors specified in section 313(g) of the 1938 Act for apportioning the national acreage allotment, less the national reserve, to old farms.

The average annual quantity of fire-cured (types 22-23) tobacco produced in the United States that is estimated to have been consumed in the United States during the 10 MYs preceding the 1998 MY was approximately 19.3 million pounds. The average annual quantity produced in the United States and exported during the 10 MYs preceding the 1998 MY was 15.5 million pounds (farm sales weight basis). Domestic use has trended upward while exports have varied. Because of these considerations, a normal year's domestic consumption has been determined to be 29.7 million pounds, and a normal year's exports have been determined to be 18.4 million pounds. Application of the formula prescribed by section 301(b)(14)(B) of the 1938 Act results in a reserve supply level of 117.7 million pounds.

Manufacturers and dealers reported stocks held on October 1, 1998, of 84.8 million pounds. The 1998 crop is estimated to be 40.4 million pounds. Therefore, total supply for the 1998 MY is 125.2 million pounds. During the 1998 MY, it is estimated that disappearance will total approximately 40.0 million pounds. Deducting this disappearance from total supply results in a 1999 MY beginning stock estimate of 85.2 million pounds.

The difference between the reserve supply level and the estimated carryover on October 1, 1999, is 32.5 million pounds. This represents the quantity that may be marketed that will make available during the 1999 MY a supply equal to the reserve supply level. About 95 percent of the announced national marketing quota is expected to be produced. Accordingly, it has been determined that a 1999 national marketing quota of 34.5 million pounds is necessary to make available production of 32.5 million pounds.

Utilizing section 312(b) of the 1938 Act, it was further determined for the same reason as with fire-cured (type 21) tobacco, that the 1999 national marketing quota should be increased by 20 percent over the normal formula amount in order to avoid undue restriction of marketings. Thus, the national marketing quota for the 1999 crop is 41.4 million pounds.

In accordance with section 313(g) of the 1938 Act, dividing the 1999 national marketing quota of 41.4 million pounds by the 1994-98, 5-year average yield of 2,577 pounds per acre results in a 1999 national acreage allotment of 16,065.19 acres.

Pursuant to the provisions of section 313(g) of the 1938 Act, a national acreage factor of 0.95 is determined by dividing the national acreage allotment for the 1999 MY, less a national reserve of 53.30 acres, by the total of the 1999 preliminary farm acreage allotments (previous year's allotments). The preliminary farm acreage allotments reflect the factors specified in section 313(g) of the 1938 Act for apportioning the national acreage allotment, less the national reserve, to old farms.

The average annual quantity of dark air-cured (types 35-36) tobacco produced in the United States that is estimated to have been consumed in the United States during the 10 MYs preceding the 1998 MY was approximately 9.0 million pounds. The average annual quantity produced in the United States and exported from the United States during the 10 MYs preceding the 1998 MY was 1.4 million pounds (farm sales weight basis). Both domestic use and exports have been erratic. Because of these considerations, a normal year's domestic consumption has been determined to be 10.2 million pounds, and a normal year's exports have been determined to be 1.4 million pounds. Application of the formula prescribed by section 301(b)(14)(B) of the 1938 Act results in a reserve supply level of 31.9 million pounds.

Manufacturers and dealers reported stocks held on October 1, 1998, of 22.4 million pounds. The 1998 crop is estimated to be 10.1 million pounds. Therefore, total supply for the 1998 MY is 32.5 million pounds. During the 1998 MY, it is estimated that disappearance will total approximately 10.5 million pounds. Deducting this disappearance from total supply results in a 1999 MY beginning stock estimate of 22.0 million pounds.

The difference between the reserve supply level and the estimated carryover on October 1, 1999, is 9.9 million pounds. This represents the quantity that may be marketed that will make available during the 1999 MY a supply equal to the reserve supply level. Over 90 percent of the announced national marketing quota is expected to be produced. Accordingly, it has been determined that a national marketing quota of 10.67 million pounds is necessary to make available production of 9.9 million pounds. In accordance with section 312(b) of the 1938 Act, it has been further determined that the 1999 national marketing quota should be increased by 20 percent over the normal formula amount in order to avoid undue restriction of marketings. This determination took into account the same factors as with fire-cured (type 21) tobacco and industry preferences. This results in a national marketing quota for the 1999 MY of 12.8 million pounds. Otherwise, the quota would be below the level for the 1998 crop.

In accordance with section 313(g) of the 1938 Act, dividing the 1999 national marketing quota of 12.8 million pounds by the 1994-98, 5-year average yield of 2,291 pounds per acre results in a 1999 national acreage allotment of 5,587.08 acres.

Pursuant to the provisions of section 313(g) of the 1938 Act, a national acreage factor of 1.10 is determined by dividing the national acreage allotment for the 1999 MY, less a national reserve of 45.60 acres, by the total of the 1999 preliminary farm acreage allotments (previous year's allotments). The preliminary farm acreage allotments reflect the factors specified in section 313(g) of the 1938 Act for apportioning the national acreage allotment, less the national reserve, to old farms.

The average annual quantity of Virginia sun-cured (type 37) tobacco produced in the United States that is estimated to have been consumed in the United States during the 10 MYs preceding the 1998 MY was approximately 90,000 pounds. The average annual quantity produced in the United States and exported from the United States during the 10 MYs preceding the 1998 MY was approximately 100,000 pounds (farm sales weight basis). Both domestic use and exports have shown a sharp downward trend. Because of these considerations, a normal year's domestic consumption has been determined to be 64,000 pounds, and a normal year's exports have been determined to be 20,000 pounds. Application of the formula prescribed by section 301(b)(14)(B) of the 1938 Act results in a reserve supply level of 219,000 pounds.

Manufacturers and dealers reported stocks held on October 1, 1998, of 50,000 pounds. The 1998 crop is estimated to be 140,000 pounds. Therefore, total supply for the 1998 MY is 190,000 pounds. During the 1998 MY, it is estimated that disappearance will total approximately 190,000 pounds. Deducting this disappearance from total supply results in a 1999 MY beginning stock estimate of 90,000 pounds.

The difference between the reserve supply level and the estimated carryover on October 1, 1998, is 129,000 pounds. This represents the quantity that may be marketed that will make available during the 1998 MY a supply equal to the reserve supply level. Less than three-quarters of the announced national marketing quota is expected to be produced. Accordingly, it has been determined that a 1999 national marketing quota of 171,000 pounds is necessary to make available production of 129,000 pounds. Thus, the national marketing quota for the 1999 crop is 171,000 pounds which is greater than the preceding quota by about 5 percent and should not unduly restrict marketings.

In accordance with section 313(g) of the 1938 Act, dividing the 1999 national marketing quota of 171,000 pounds by the 1994-98, 5-year average yield of 1,466 pounds per acre results in a 1999 national acreage allotment of 116.64 acres.

Pursuant to the provisions of section 313(g) of the 1938 Act, a national acreage factor of 1.0 is determined by dividing the national acreage allotment for the 1999 MY, less a national reserve of 0.35 acres, by the total of the 1999 preliminary farm acreage allotments (previous year's allotments). The preliminary farm acreage allotments reflect the factors specified in section 313(g) of the 1938 Act for apportioning the national acreage allotment, less the national reserve, to old farms.

The average annual quantity of cigar-filler and binder (types 42-44 and 53-55) tobacco produced in the United States that is estimated to have been consumed in the United States during the 10 MYs preceding the 1998 MY was approximately 10.9 million pounds. The average annual quantity produced in the United States and exported from the United States during the 10 MYs preceding the 1998 MY was less than 100,000 pounds (farm sales weight). Domestic use has trended downward and exports are very small. Thus, a normal year's domestic consumption has been determined to be 5.9 million pounds, and a normal year's exports have been determined to be zero pounds. Application of the formula prescribed by section 301(b)(14)(B) of the 1938 Act results in a reserve supply level of 17.0 million pounds.

Manufacturers and dealers reported stocks held on October 1, 1998, of 16.2 million pounds. The 1998 crop is estimated to be 4.2 million pounds. Therefore, total supply for the 1998 MY is 20.4 million pounds. During the 1998 MY, it is estimated that disappearance will total about 7.0 million pounds. Deducting this disappearance from total supply results in a 1999 MY beginning stock estimate of 13.4 million pounds.

The difference between the reserve supply level and the estimated carryover on October 1, 1999, is 3.6 million pounds. This represents the quantity that may be marketed that will make available during the 1999 MY a supply equal to the reserve supply level. About 80 percent of the announced national marketing quota is expected to be produced. Accordingly, it has been determined that a 1999 national marketing quota of 4.5 million pounds is necessary to make available production of 3.6 million pounds. This results in a 1999 national marketing quota of 4.5 million pounds. This determination reflects that there are short reserve supplies and takes into account possible changes in expected demand and the fact that even with this adjustment the 1999 quota will be less than the 1998 crop quota.

In accordance with section 313(g) of the 1938 Act, dividing the 1999 national marketing quota of 4.5 million pounds by the 1994-98, 5-year average yield of 2,054 pounds per acre results in a 1999 national acreage allotment of 2,190.84 acres.

Pursuant to the provisions of section 313(g), of the 1938 Act, a national factor of 0.65 is determined by dividing the national acreage allotment for the 1999 MY, less a national reserve of 2.31 acres, by the total of the 1999 preliminary farm acreage allotments (previous year's allotments). The preliminary farm acreage allotments reflect the factors specified in section 313(g) of the 1938 Act for apportioning the national acreage allotment, less the national reserve, to old farms.

Because of the results of the producer referendum, marketing quotas shall be in effect for the 1999 MY for cigar-filler and binder (types 42-44 and 53-55) tobacco. In referenda held March 15-19, 1999, 77.7 percent of cigar filler and binder producers voted in favor of quotas.

This rule is issued under Marketing Agreement No. 141 and Order No. 931 (7 CFR part 931), regulating the handling of fresh Bartlett pears grown in Oregon and Washington 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 rule has been reviewed under Executive Order 12988, Civil Justice Reform. Under the marketing order now in effect, fresh Bartlett pear handlers are subject to assessments. Funds to administer the order are derived from such assessments. It is intended that the assessment rate as issued herein will be applicable to all assessable fresh Bartlett pears beginning July 1, 2000, and continuing until modified, suspended, or terminated. This rule will not preempt any State or local laws, regulations, or policies, unless they present an irreconcilable conflict with this rule.

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

This rule decreases the assessment rate established for the Committee for the 2000-2001 and subsequent fiscal periods from $0.025 to $0.02 per standard box of fresh Bartlett pears handled.

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

For the 1999-2000 and subsequent fiscal periods, the Committee recommended, and the Department approved, an assessment rate that would continue in effect from fiscal period to fiscal period indefinitely unless modified, suspended, or terminated by the Secretary upon recommendation and information submitted by the Committee or other information available to the Secretary.

The Committee met on June 1, 2000, and unanimously recommended 2000-2001 expenditures of $81,060 and an assessment rate of $0.02 per standard box of fresh Bartlett pears handled. In comparison, last year's budgeted expenditures were $77,231. The assessment rate of $0.02 is $0.005 less than the rate now in effect and will reduce the financial burden on handlers. At the current rate of $0.025 per standard box and with estimated 2000-2001 fresh Bartlett pear shipments of 3,200,000 standard boxes, the projected reserve on June 30, 2001, would exceed the level the Committee believes to be adequate to administer the program. The Committee discussed lower assessment rates, but decided that an assessment rate of less than $0.02 would not generate the income necessary to administer the program with an adequate reserve. The decreased assessment rate is expected to result in an operating reserve of $19,261 on June 30, 2001.

Major expenses recommended by the Committee for the 2000-2001 fiscal period include $44,468 for salaries, $4,847 for office rent, and $3,891 for health insurance. Budgeted expenses for these items in 1999-2000 were $40,433, $5,323, and $4,048, respectively.

The Committee based its recommended assessment rate on the 2000-2001 crop estimate, the 2000-2001 fiscal period expenditures estimate, and the current and projected balance of the operating reserve. With fresh Bartlett pear shipments for 2000-2001 estimated at 3,200,000 standard boxes, the $0.02 per standard box assessment rate should provide $64,000 in assessment income. Income derived from handler assessments, along with $13,060 from the Committee's authorized reserve (currently $32,321) and miscellaneous income ($3,000), will be adequate to cover budgeted expenses. Funds in the reserve (estimated to be $19,261 at the end of the 2000-2001 fiscal period) will be kept within the maximum permitted by the order (approximately one fiscal year's operational expenses; § 931.42).

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

Although this assessment rate is effective for an indefinite period, the Committee will continue to meet prior to or during each fiscal period to recommend a budget of expenses and consider recommendations for modification of the assessment rate. The dates and times of Committee meetings are available from the Committee or the Department. Committee meetings are open to the public and interested persons may express their views at these meetings. The Department will evaluate Committee recommendations and other available information to determine whether modification of the assessment rate is needed. Further rulemaking will be undertaken as necessary. The Committee's 2000-2001 budget and those for subsequent fiscal periods will be reviewed and, as appropriate, approved by the Department.

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

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

There are approximately 1,800 producers of fresh Bartlett pears in the production area and approximately 65 handlers subject to regulation under the marketing order. Small agricultural producers are 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.

Currently, about 98.5 percent of the fresh Bartlett pear handlers ship under $5,000,000 worth of fresh Bartlett pears and 1.5 percent ship over $5,000,000 worth on an annual basis. In addition, based on acreage, production, and producer prices reported by the National Agricultural Statistics Service, and the total number of fresh Bartlett pear producers, the average annual producer revenue is approximately $9,800. In view of the foregoing, it can be concluded that the majority of fresh Bartlett pear producers and handlers may be classified as small entities, excluding receipts from other sources.

This rule decreases the assessment rate established for the Committee and collected from handlers for the 2000-2001 and subsequent fiscal periods from $0.025 to $0.02 per standard box of fresh Bartlett pears handled. The Committee unanimously recommended 2000-2001 expenditures of $81,060 and an assessment rate of $0.02 per standard box of fresh Bartlett pears handled. In comparison, last year's budgeted expenditures were $77,231. The assessment rate of $0.02 is $0.005 less than the rate currently in effect. At the rate of $0.025 per standard box and with 2000 fresh Bartlett pear shipments estimated at 3,200,000 standard boxes, the projected reserve on June 30, 2001, would exceed the level the Committee believes to be adequate to administer the program. The assessment rate reduction would also lessen the financial burden on handlers. The Committee decided that an assessment rate of less than $0.02 would not generate the income necessary to administer the program with an adequate reserve.

Major expenses recommended by the Committee for the 2000-2001 fiscal period include $44,468 for salaries, $4,847 for office rent, and $3,891 for health insurance. Budgeted expenses for these items in 1999-2000 were $40,433, $5,323, and $4,048, respectively.

With fresh Bartlett pear shipments for 2000-2001 estimated at 3,200,000 standard boxes, the $0.02 rate of assessment should provide $64,000 in assessment income. Income derived from handler assessments, along with $13,060 from the Committee's authorized reserve (currently $32,321) and miscellaneous income ($3,000), will be adequate to cover budgeted expenses. Funds in the reserve (estimated to be $19,261 at the end of the 2000-2001 fiscal period) will be kept within the maximum permitted by the order (approximately one fiscal year's operational expenses; 931.42).

Recent price information indicates that the grower price for the 2000-2001 marketing season will range between $8.60 and $11.30 per standard box of fresh Bartlett pears. Therefore, the estimated assessment revenue for the 2000-2001 fiscal period as a percentage of total grower revenue will range between 0.18 and 0.23 percent.

This action decreases the assessment obligation imposed on handlers. While assessments impose some additional costs on handlers, the costs are minimal and uniform on all handlers. Some of the additional costs may be passed on to producers. However, decreasing the assessment rate reduces the burden on handlers and may reduce the burden on producers.

In addition, the Committee's meeting was widely publicized throughout the fresh Bartlett pear industry and all interested persons were invited to attend the meeting and participate in Committee deliberations on all issues. Like all Committee meetings, the June 1, 2000, meeting was a public meeting and all entities, both large and small, were able to express views on this issue. Finally, interested persons are invited to submit information on the regulatory and informational impacts of this action on small businesses.

This action will not impose any additional reporting or recordkeeping requirements on either small or large fresh Bartlett pear handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.

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

A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: 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 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.

Pursuant to 5 U.S.C. 553, it is also found and determined upon good cause that it is impracticable, unnecessary, and contrary to the public interest to give preliminary notice prior to putting this rule into effect, and that good cause exists for not postponing the effective date of this rule until 30 days after publication in the Federal Register because: (1) This action reduces the current assessment rate for fresh Bartlett pears; (2) the 2000-2001 fiscal period begins on July 1, 2000, and the marketing order requires that the rate of assessment for each fiscal period apply to all assessable fresh Bartlett pears handled during such fiscal period; (3) handlers are aware of this action which was unanimously recommended by the Committee at a public meeting and is similar to other assessment rate actions issued in past years; and (4) this interim final rule provides a 60-day comment period, and all comments timely received will be considered prior to finalization of this rule.

On March 10, 2000 the OCC published a final rule titled “Financial Subsidiaries and Operating Subsidiaries.” 65 FR 12905. The final rule amended 12 CFR 5.36, “Other equity investments,” to provide a streamlined, after-the-fact notice procedure for national banks making non-controlling investments in enterprises engaging in specified activities. As part of the notice process, the applicant must certify that it has satisfied the standards and conditions that the OCC applies to investments of this type. 1 These standards and conditions are established by OCC precedents approving non-controlling investments. 2

The final rule omitted from the notice procedure one standard contained in these precedents. In order to clarify that all of the standards and conditions contained in OCC precedent approving non-controlling investments apply to non-controlling investments that are eligible for the after-the-fact notice procedure, we are amending § 5.36(e) to conform the requirements of the notice procedure with those of the precedents on which it is based. Accordingly, this rule adds the requirement that a national bank certify that its loss exposure is limited, as a legal and accounting matter, and that the bank does not have open-ended unlimited liability for the obligations of the enterprise. The rule is published in final form and takes effect immediately upon publication in the Federal Register .

Pursuant to section 553(b)(B) of the Administrative Procedure Act (APA), 5 U.S.C. 553(b)(B), the OCC finds good cause for dispensing with the requirements for notice and an opportunity for public comment that the APA would otherwise require. This technical correction conforms the rule with the governing standards that have been available in published OCC precedent for some time. By removing an apparent inconsistency with the precedents in this area, the rule avoids the confusion, and the potential for the filing of incomplete notices, that may otherwise occur when banks compare the requirements of the rule with those in the precedents.

The APA generally requires that a final rule take effect 30 days after publication in the Federal Register . 5 U.S.C. 553(d). Similarly, section 302 of the Riegle Community Development and Regulatory Improvement Act of 1994 (CDRI Act) generally requires that a final rule issued by a Federal banking agency take effect on the first day of the first calendar quarter that begins on or after the date on which the regulation is published in final form. 12 U.S.C. 4802(b)(1). Both requirements are subject to a good cause exception.

For the reasons previously explained, the OCC finds good cause for making this amendment to 12 CFR 5.36(e) effective immediately upon publication. Delaying the effective date of the amendment will delay national banks' ability to rely with certainty on the notice process for non-controlling investments and thus impede the rule's purpose of facilitating national banks' ability to make non-controlling investments that comport with the standards the OCC has adopted in its published precedents.

The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) does not apply to a rulemaking where a general notice of proposed rulemaking is not required. 5 U.S.C. 603 and 604. As noted previously, the OCC has determined that it is not necessary to publish a notice of proposed rulemaking for this final rule. Accordingly, the RFA's requirements relating to an initial and final regulatory flexibility analysis are not applicable. In any event, however, since this final rule merely adds one additional element to the notice that the rule permits a national bank to file, this final rule does not have a significant economic impact on a substantial number of small entities.

The Comptroller of the Currency has determined that this final rule is not a significant regulatory action for purposes of Executive Order 12866.

The Unfunded Mandates Reform Act of 1995, Public Law 104-4, 109 Stat. 48 (UMA), applies only when an agency is required to issue a general notice of proposed rulemaking or a final rule for which the agency published a general notice of proposed rulemaking (2 U.S.C. 1532). As noted previously, the OCC has determined, for good cause, that notice and comment is unnecessary. Accordingly, the UMA does not require a budgetary impact analysis.

Nevertheless, the OCC has determined that this final rule will not result in expenditures by State, local, and tribal governments, or by the private sector, of $100 million or more in any one year. Accordingly, the OCC has not prepared a budgetary impact statement or specifically addressed the regulatory activities considered.

For the reasons set forth in the preamble, the OCC amends chapter I of title 12 of the Code of Federal Regulations as follows:

On February 23, 2000, the Finance Board approved a proposed rule to implement provisions of the Gramm-Leach-Bliley Act, Public Law 106-102, 133 Stat. 1338, 1453 (Nov. 12, 1999) (GLB Act) regarding the term of office of Bank directors. 65 FR 17458 (April 3, 2000). The GLB Act amended Section 7(d) of the Federal Home Loan Bank Act (Bank Act) to establish uniform three-year terms for the appointed and elected directors of the Banks and required that the terms of those directors first elected or appointed after enactment of the GLB Act be adjusted as necessary to stagger the board of each Bank into three classes of approximately equal size. 12 U.S.C. 1427(d), as amended . Under prior law the appointed directors had served for four-year terms and the elected directors had served for two-year terms. Because the GLB Act amendments took effect upon enactment, they had the effect of extending the terms of all incumbent elected directors by one year. As a result of the extension of the terms of office by the GLB Act, on January 1, 2000, when the two-year terms of the elected directors otherwise would have expired, there were no open elected directorships at any of the Banks. During 1999, each Bank had conducted elections in which the members voted to elect approximately one-half of the elected directors of the Bank, but the candidates elected could not assume office on January 1, 2000 as a consequence of the GLB Act amendments. In previously addressing the effect of the GLB Act on the terms of Bank directorships, the Finance Board expressed its intent to authorize the board of directors of each Bank to decide whether to conduct new elections in 2000 or to adopt the tabulation of votes cast in the 1999 elections for use in the 2000 elections. 1 The Finance Board indicated that it would establish the criteria by which the board of each Bank could make that decision, which was one issue that the Finance Board had addressed in the proposed rulemaking. The proposed rule also addressed the manner in which the terms of the directors assuming office after November 12, 1999 were to be adjusted in order to achieve the one-third staggering required by the GLB Act. The final rule addresses both of those issues, substantially as proposed.

The location of the new facility (previously named Gwinn) is located on the Sawyer International Airport. Therefore, in accordance with standard procedures the facility is renamed Sawyer. On May 21, 2000, the FAA proposed to amend several VOR Federal airways in the vicinity of Sawyer, MI, due to the decommissioning of the Marquette VOR/DME and the commissioning of the Sawyer VOR/DME (65 FR 21682). During the flight check of V-316 it was determined the route between the Sawyer VOR/DME and the Sault Ste Marie VORTAC was unsatisfactory. As a result, the FAA altered V-316 to the south approximately 3 NM to the Newberry VOR/DME.

Interested parties were invited to participate in this rulemaking proceeding by submitting written comments on the proposal to the FAA. No comments were received. Except for editorial changes, the name change of the facility from “Gwinn” to “Sawyer” and the change to V-316 to include the Newberry VOR/DME, this amendment is the same as that proposed in the notice.

This amendment to part 71 of the Federal Aviation Regulations (14 CFR part 71) realigns five Federal airways due to the decommissioning of the Marquette VOR/DME and the commissioning of the new Sawyer VOR/DME. Specifically, V-7, V-133, V-224, V-316, and V-341 are realigned from their former routes to the Sawyer VOR/DME. The Sawyer VOR/DME is located approximately 15 NM southeast of the former Marquette location. In addition, as a result of an unsatisfactory flight check the FAA is amending V-316 to include the Newberry VOR/DME. Additionally, in accordance with standard procedures the facility is renamed Sawyer. The FAA is taking this action to manage the navigable airspace and support navigational requirements in the vicinity of Marquette, MI.

Domestic VOR Federal airways are published in Section 6010(a) of FAA Order 7400.9G dated September 1, 1999, and effective September 16, 1999, which is incorporated by reference in 14 CFR 71.1. The Federal airways 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. It, therefore—(1) is not a significant regulatory action“ under Executive Order 12866; (2) is not a significant rule” under Department of Transportation (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.

This amendment to part 95 of the Federal Aviation Regulations (14 CFR part 95) amends, suspends, or revokes IFR altitudes governing the operation of all aircraft in flight over a specified route or any portion of that route, as well as the changeover points (COPs) for Federal airways, jet routes, or direct routes as prescribed in part 95.

The specified IFR altitudes, when used in conjunction with the prescribed changeover points for those routes, ensure navigation aid coverage that is adequate for safe flight operations and free of frequency interference. The reasons and circumstances that create the need for this amendment involve matters of flight safety and operational efficiency in the National Airspace System, are related to published aeronautical charts that are essential to the user, and provide for the safe and efficient use of the navigable airspace. In addition, those various reasons or circumstances require making this amendment effective before the next scheduled charting and publication date of the flight information to assure its timely availability to the user. The effective date of this amendment reflects those considerations. In view of the close and immediate relationship between these regulatory changes and safety in air commerce, I find that notice and public procedure before adopting this amendment are impracticable and contrary to the public interest and that good cause exists for making the amendment effective in less than 30 days.

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. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

On February 9, 2000, the Federal Energy Regulatory Commission (Commission) issued Order No. 637 amending its regulations in response to the development of more competitive markets for natural gas and the transportation of natural gas. 1 These changes included expanding reporting requirements for the Index of Customers in order to provide shippers with a more useful picture of the structure of the market for decisionmaking and monitoring purposes.

The Commission added the following new reporting requirements to the Index of Customers data collection: the receipt and delivery points held under the contract and the zones or segments in which the capacity is held; the common transaction point codes; the contract number; a shipper identification number, such as DUNS; an indication whether the contract includes negotiated rates; the names of any agents or asset managers that control capacity in a pipeline rate zone; and any affiliate relationship between the pipeline and the holder of capacity. 2

The Commission issues an Instruction Manual for Electronic Filing of the Index of Customers explaining how pipelines are to report Index of Customer data. This Manual has been revised to incorporate the new reporting requirements.

The revised Instruction Manual for Electronic Filing of the Index of Customers is attached to this notice as an Appendix. 3 The revised manual can be found at the following electronic address: http://www.ferc.fed.us/public/elec req.htm. The manual also is available in the Commission's Public Reference Room and on CIPS and RIMs. As indicated in Order No. 637, pipelines are required to implement these new reporting requirements by September 1, 2000.

In a notice published in the Federal Register of April 16, 1998 (63 FR 18920), FDA announced that a color additive petition (CAP 8C0256) had been filed by Cyanotech Corp., <73-4460 Queen Kaahumanu Hwy., #102, Kailua-Kona, HI 96740. The petition proposed to amend the color additive regulations to provide for the safe use of haematococcus algae meal as a color additive in salmonid fish feeds.

Haematococcus algae meal consists of the comminuted and dried cells of the alga Haematococcus pluvialis (also known as H . lacustris ). The major components of haematococcus algae meal are proteins, carbohydrates, and lipids produced by the alga cells. The primary coloring substance in haematococcus algae meal is astaxanthin (3,3′-dihydroxy-β,β-carotene-4,4′-dione), which exists primarily in esterified forms (Ref. 1). One published (Ref. 2) and several unpublished studies included in the petition showed that haematococcus algae meal satisfactorily pigmented the flesh of the fish when it was fed to salmonid fish.

In the Federal Register of April 13, 1995 (60 FR 18736), the agency published a final rule that listed astaxanthin in § 73.35 (21 CFR 73.35) for use in the feed of salmonid fish (hereinafter referred to as the April 1995 final rule). In the preamble to that rule, the agency stated that the new regulation for astaxanthin did not specify the source of astaxanthin or the manufacturing process, because the agency had made its safety determination based on the chemical similarity of synthetic astaxanthin to astaxanthin from natural sources. The agency concluded that any source could be used to produce the color additive as long as the astaxanthin meets the identity, specifications, and stability requirements defined in § 73.35, and it is manufactured in accordance with good manufacturing practice. Furthermore, the agency stated in the astaxanthin rule that the specifications were listed to convey the fact that FDA had evaluated only a particular form of the color additive. The agency also stated that it was concerned that deleterious materials not found in the habitat of salmonids may be included in fish feed from biomass products that contain only a small amount of astaxanthin with the rest of the material being residues from the producing organisms. Thus, the agency said that interested parties should submit information in the form of a new color additive petition if they wish to market a biomass product containing astaxanthin.

Haematococcus algae meal is a biomass product that contains a relatively small amount of astaxanthin with the rest of the material being proteins, carbohydrates, and lipids. In addition, the agency determined that haematococcus algae meal would not meet the specifications in § 73.35(b) for solubility in chloroform, absorption maximum wavelength, and residue on ignition, because some of the algal components in haematococcus algae meal would interfere with the test methods. Furthermore, the petitioner specified the astaxanthin content of haematococcus algae meal to be not less than 1.5 percent, whereas the corresponding specification for astaxanthin in § 73.35(b) is not less than 96 percent. Therefore, the agency concludes that a new regulation is necessary to list haematococcus algae meal.

In the April 1995 final rule, the agency concluded that 80 milligrams per kilogram (mg/kg) of astaxanthin in fish feed would result in adequate pigmentation of the flesh of salmonids. Therefore, in § 73.35(c)(2) the agency limited the astaxanthin content of finished feed to not more than 80 mg/kg. However, the agency now notes that astaxanthin in the feed of farm-raised salmonid fish may come not only from the color additive astaxanthin meeting the specifications of § 73.35, but also from the color additive haematococcus algae meal and other color additives that are sources of astaxanthin the agency may list in the future. Therefore, new § 73.185(c)(2) requires that the quantity of astaxanthin in finished feed, from haematococcus algae meal when used alone or in combination with other astaxanthin color additive sources listed in part 73 (21 CFR part 73), shall not exceed 80 mg/kg (72 grams per ton) of finished feed.

In evaluating the safety of the use of haematococcus algae meal in fish feed, the agency considered: (1) The safety of astaxanthin in haematococcus algae meal to humans and fish; and (2) the safety of the other components in haematococcus algae meal to humans and fish.

Astaxanthin is the principal pigment that imparts the pink or red coloring characteristic of the flesh of wild salmonids. These fish obtain astaxanthin from the crustaceans that constitute a significant portion of their diet (Ref. 3). A similar flesh color may be obtained in aquacultured salmonids by feeding them a diet supplemented with astaxanthin. In the April 1995 final rule, the agency concluded that astaxanthin was safe for use in the feed of salmonid fish. This conclusion was based on the following facts: (1) The petitioned use of astaxanthin would result in deposition of a very small amount of astaxanthin in salmonid flesh; (2) astaxanthin that was the subject of the April 1995 final rule, differed from astaxanthin present in the flesh of wild salmon only in its optical isomeric distribution; (3) human exposure to astaxanthin from consumption of aquacultured salmon fed synthetic astaxanthin is comparable to the exposure to astaxanthin from wild salmon. In addition, the results of the toxicity studies submitted by the petitioner supported the conclusion that there was reasonable certainty of no harm from the petitioned use of astaxanthin.

The facts upon which the agency concluded, in the April 1995 final rule, that astaxanthin was safe for use in the feed of salmonid fish, are similar to the facts upon which the agency is basing its conclusion that astaxanthin from the petitioned use of haematococcus algae meal is safe for use in the feed of salmonid fish. During the review of the present petition, the agency determined that in both crustaceans and H . pluvialis , astaxanthin is mainly in esterified forms that are converted to free astaxanthin during digestion and deposited as such in fish flesh (Ref. 4). The agency also determined that free astaxanthin from H . pluvialis differed from astaxanthin present in the flesh of wild salmon only in its optical isomeric distribution and that the petitioned use of astaxanthin would result in deposition of a very small amount of astaxanthin in salmonid flesh. Furthermore, the agency determined that the astaxanthin from haematococcus algae meal will substitute for the fish feed uses of astaxanthin listed in § 73.35, and that the petitioned use of haematococcus algae meal will not increase the estimated daily intake of astaxanthin in humans, which is comparable to the exposure to astaxanthin from wild salmon. Therefore, the agency concludes that astaxanthin from the petitioned use of haematococcus algae meal is safe for use in the feed of salmonid fish.

Based on the data in the petition and other relevant material, the agency determined that: (1) Consumers will not be directly exposed to haematococcus algae meal, but to astaxanthin remaining in fish that have consumed the yeast in their diet; (2) there is no evidence that any constituents other than astaxanthin will accumulate in fish maintained on diets supplemented with haematococcus algae meal; (3) the results of studies during which rats and salmon were fed haematococcus algae meal and bacterial mutagenicity tests did not reveal any adverse effects, indicating the absence of toxic impurities in the algae; (4) a literature search uncovered no reports of pathogenicity or toxicogenicity of H . pluvialis ; and (5) algae are commonly used as feed components in fish aquaculture with no deleterious effects on fish health. Based on this information, FDA concludes that the petitioned use of haematococcus algae meal is safe (Ref. 5).

Based on the results of stability studies of haematococcus algae meal submitted by the petitioner, FDA concludes that to minimize chemical changes that would result in loss of color of astaxanthin, haematococcus algae meal must be added to fish feed only in the form of a stabilized color additive mixture. Therefore, new § 73.185(a)(2) requires that haematococcus algae meal be added to fish feed only as a component of a stabilized color additive mixture.

All color additives, in accordance with § 70.25 (21 CFR 70.25), require sufficient information to assure their safe use and to allow a determination of compliance with any limitations imposed by the agency in other applicable regulations. Therefore, the labeling of the color additive, haematococcus algae meal, and any mixture prepared therefrom, is subject to the requirements of § 70.25.

According to § 70.25(a)(4), an expiration date for a color additive must be stated on its label if stability data require it. FDA finds that because of the instability of astaxanthin in haematococcus algae meal, an expiration date must be stated on the label of sealed and open containers, in accordance with § 70.25(a)(4). FDA also finds that declaration of the expiration date constitutes a material fact that must be disclosed on the label of the color additive mixture under sections 201(n) and 403(a)(1) of the act (21 U.S.C. 321(n) and 343(a)(1)) because failure to do so would constitute a failure to reveal facts material in light of the representations made on the label and material with respect to consequences that may result from the use of the color additive. The use of haematococcus algae meal requires the declaration of expiration dates because astaxanthin in haematococcus algae meal can decompose to products that would not be coloring agents and thus would not affect the color of salmonid flesh.

In addition to the requirements for labeling the color additive or color additive mixture, the ingredient list on fish feed, to which haematococcus algae meal is added, must identify the presence of the color additive under § 501.4 (21 CFR 501.4). New § 73.185(d)(2) references § 501.4 to ensure that the presence of haematococcus algae meal as a color additive in the fish feed will be declared on the ingredient label.

Finally, the presence of the color additive must be declared on the label of any food, including salmonid fish, containing added haematococcus algae meal and food containing such salmonid fish as an ingredient. Section 101.22(b) (21 CFR 101.22(b)) requires a food that bears or contains artificial coloring, such as salmon artificially colored with haematococcus algae meal, to bear labeling even though such food is not in package form. Section 101.22(c) requires that label statements of artificial coloring be “likely to be read by the ordinary person under customary conditions of purchase and use of such food.”

Furthermore, § 101.22(k)(2) requires, in the statement of ingredients for a food to which any coloring has been added, and for which the coloring is not subject to certification, a declaration that makes it clear that a color additive has been used in the food. In addition, the presence of a color additive must be declared on any bulk container of food containing a color additive that is held at a retail establishment under the provisions in § 101.100(a)(2) (21 CFR 101.100(a)(2)). The ingredient label would prevent economic fraud in salmonid fish containing added haematococcus algae meal because the ingredient label would notify the consumer that the fish is artificially colored. Without such ingredient labeling, food comprising salmonid fish with added haematococcus algae meal would be deemed to be misbranded under section 403(k) of the act, which states that: “A food shall be deemed to be misbranded * * * If it bears or contains any artificial flavoring, artificial coloring, or chemical preservative, unless it bears labeling stating that fact * * *.”

Therefore, in accordance with §§ 101.22(b), (c), and (k)(2), and 101.100(a)(2), labeling on any salmonid fish containing haematococcus algae meal is required to declare the presence of the color additive or color additive mixture. New § 73.185(d)(3) references §§ 101.22(b), (c), and (k)(2), and 101.100(a)(2) to ensure that, at the retail level, the presence of haematococcus algae meal as a color additive in the fish will be declared, and that the labeling of the bulk fish container, including a list of ingredients, will be displayed on the container or on a counter card with similar information.

In the future, the agency also intends to propose to amend § 73.35(d)(3) to include references to § 101.22(b) and (c).

Based on the data in the petition and other relevant material, FDA concludes that the petitioned use of haematococcus algae meal as a color additive in fish feed to color the flesh of salmonid fish is safe, the additive will achieve its intended technical effect, and therefore, part 73 should be amended as set forth below. In addition, based upon the factors listed in 21 CFR 71.20(b), the agency concludes that certification of haematococcus algae meal is not necessary for the protection of the public health.

In accordance with § 71.15 (21 CFR 71.15), the petition and the documents that FDA considered and relied upon in reaching its decision to approve the petition are available for inspection at the Center for Food Safety and Applied Nutrition by appointment with the information contact person listed above. As provided in § 71.15, the agency will delete from the documents any materials that are not available for public disclosure before making the documents available for inspection.

The agency has previously considered the environmental effects of this rule as announced in the notice of filing for CAP 8C0256. No new information or comments have been received that would affect the agency's previous determination that there is no significant impact on the human environment and that an environmental impact statement is not required.

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

Any person who will be adversely affected by this regulation may at any time file with the Dockets Management Branch (address above) written objections by August 7, 2000. Each objection shall be separately numbered, and each numbered objection shall specify with particularity the provisions of the regulation to which objection is made and the grounds for the objection. Each numbered objection on which a hearing is requested shall specifically so state. Failure to request a hearing for any particular objection shall constitute a waiver of the right to a hearing on that objection. Each numbered objection for which a hearing is requested shall include a detailed description and analysis of the specific factual information intended to be presented in support of the objection in the event that a hearing is held. Failure to include such a description and analysis for any particular objection shall constitute a waiver of the right to a hearing on the objection. Three copies of all documents are to be submitted and are to be identified with the docket number found in brackets in the heading of this document. Any objections received in response to the regulation may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

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

1. Renstrom, B., G. Borch, O. M. Skulberg, and S. Liaaen-Jensen, “Optical Purity of (3S,3′S)-Astaxanthin from Haematococcus pluvialis ,” Phytochemistry , 20:2561-2564, 1981.

2. Sommer, T. R., W. T. Potts, and N. M. Morrissy, “Utilization of Microalgal Astaxanthin by Rainbow Trout ( Oncorhynchus mykiss ),” Aquaculture , 94:79-88, 1991.

3. Kitahara, T., “Carotenoids in the Pacific Salmon During the Marine Period,” Comprehensive Biochemistry and Physiology , 78B:859-862, 1984.

4. Mori, T., K. Makabe, K. Yamaguchi, S. Konosu, and S. Arai, “Comparison Between Krill Astaxanthin Diester and Synthesized Free Astaxanthin Supplemented to Diets in Their Absorption and Deposition by Juvenile Coho Salmon ( Oncorhynchus kisutch ),” Comprehensive Biochemistry and Physiology , 93B:255-258, 1989.

5. Johnson, C. B., Memorandum entitled “ Haematococcus pluvialis Algae Meal for Use in Feed for Salmonids: Final Toxicology Review” from the Division of Health Effects Evaluation (HFS-225) to the Division of Petition Control (HFS-215), Center for Food Safety and Applied Nutrition, FDA, August 12, 1999.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 73 is amended as follows:

In a notice published in the Federal Register of November 19, 1997 (62 FR 61823), FDA announced that a color additive petition (CAP 8C0252) had been filed by Archer Daniels Midland Co., P.O. Box 1470, Decatur, IL 62525. The petition proposed to amend the color additive regulations to provide for the safe use of astaxanthin from Phaffia rhodozyma as a color additive in salmonid fish feeds. During its review of the petition, the agency determined that the subject color additive is more accurately described as a dried preparation of the yeast P. rhodozyma that contains astaxanthin. Therefore, the agency is establishing phaffia yeast as the common or usual name of the color additive.

Phaffia yeast consists of the cells of the yeast P. rhodozyma that are produced by pure culture fermentation and subsequently killed by heat and dried. P. rhodozyma is the asexual form of the yeast species Xanthophyllomyces dendrorhous (Ref. 1). The major components of phaffia yeast are proteins, carbohydrates, and lipids produced by the yeast cells. The primary coloring substance in phaffia yeast is astaxanthin (3,3′-dihydroxy-β,β-carotene-4,4′-dione) (Ref. 2). One published (Ref. 3) and several unpublished studies included in the petition showed that phaffia yeast satisfactorily pigmented the flesh of the fish when it was fed to salmonid fish.

In a final rule published in the Federal Register of April 13, 1995 (60 FR 18736), the agency listed astaxanthin in § 73.35 (21 CFR 73.35) for use in the feed of salmonid fish. In the preamble to that rule, the agency stated that the new regulation for astaxanthin did not specify the source of astaxanthin or the manufacturing process, because the agency had made its safety determination for astaxanthin based on the chemical similarity of synthetic astaxanthin to astaxanthin from natural sources. The agency concluded that any source could be used to produce the color additive as long as the astaxanthin meets the identity, specifications, and stability requirements defined in § 73.35, and it is manufactured in accordance with good manufacturing practice. Furthermore, the agency stated in the astaxanthin rule that the specifications were listed to convey the fact that FDA had evaluated only a particular form of the color additive. The agency also stated that it was concerned that deleterious materials not found in the habitat of salmonids may be included in fish feed from biomass products that contain only a small amount of astaxanthin with the rest of the material being residues from the producing organisms. Thus, the agency said that interested parties should submit information in the form of a new color additive petition if they wish to market a biomass product containing astaxanthin.

Phaffia yeast is a biomass product that contains a relatively small amount of astaxanthin with the rest of the material being proteins, carbohydrates, and lipids. In addition, the petitioner indicated that phaffia yeast would not meet the specifications in § 73.35(b) for solubility in chloroform, absorption maximum wavelength, and residue on ignition, because some of the yeast components in phaffia yeast would interfere with the test methods. Furthermore, the petitioner specified the astaxanthin content of phaffia yeast to be not less than 0.4 percent, whereas the corresponding specification for astaxanthin in § 73.35(b) is not less than 96 percent. Therefore, the petitioner requested that a new regulation be established for phaffia yeast as a source of astaxanthin. The agency agrees with the petitioner that a new regulation is necessary to list phaffia yeast.

During the fish feeding studies, phaffia yeast was mixed with fish feed in such quantities that the amount of astaxanthin in finished feeds did not exceed 80 milligrams per kilogram. The agency based its safety determination on this amount of astaxanthin and the petitioner requested that this level be specified in the listing regulation. However, the agency notes that astaxanthin in the feed of farm-raised salmonid fish may come not only from phaffia yeast, but also from the use of the color additive astaxanthin meeting the specifications of § 73.35 and other color additives that are sources of astaxanthin the agency may list in the future. Therefore, newly added § 73.355(c)(2) (21 CFR 73.355(c)(2)) requires that the quantity of astaxanthin in finished feed, from phaffia yeast when used alone or in combination with other astaxanthin color additive sources listed in part 73 (21 CFR part 73), shall not exceed 80 milligrams per kilogram (72 grams per ton) of finished feed.

In evaluating the safety of the use of phaffia yeast in fish feed, the agency considered: (1) The safety of astaxanthin in phaffia yeast to humans and fish, and (2) the safety of the other components in phaffia yeast to humans and fish.

Astaxanthin is the principal pigment that imparts the pink or red coloring characteristic of the flesh of wild salmonids (Ref. 3). These fish obtain astaxanthin from the crustaceans that constitute a significant portion of their diet. A similar flesh color may be obtained in aquacultured salmonids by feeding them a diet supplemented with astaxanthin. In the final rule of April 13, 1995, the agency concluded that astaxanthin was safe for use in the feed of salmonid fish. This conclusion was based on the following facts: (1) The petitioned use of astaxanthin would result in deposition of a very small amount of astaxanthin in salmonid flesh; (2) astaxanthin that was the subject of the final rule of April 13, 1995, differed from astaxanthin present in the flesh of wild salmon only in its optical isomeric distribution; (3) human exposure to astaxanthin from consumption of aquacultured salmon fed synthetic astaxanthin is comparable to the exposure to astaxanthin from wild salmon. In addition, the results of the toxicity studies submitted by the petitioner supported the conclusion that there was reasonable certainty of no harm from the petitioned use of astaxanthin.

In the final rule of April 13, 1995, the facts upon which the agency concluded that astaxanthin was safe for use in the feed of salmonid fish are similar to the facts upon which the agency is basing its conclusion that astaxanthin from the petitioned use of phaffia yeast is safe for use in the feed of salmonid fish. During the review of the present petition, the agency determined that astaxanthin from phaffia yeast differed from astaxanthin present in the flesh of wild salmon only in its optical isomeric distribution and that the petitioned use of astaxanthin would result in deposition of a very small amount of astaxanthin in salmonid flesh. Furthermore, the agency determined that the astaxanthin from phaffia yeast will substitute for the fish feed uses of astaxanthin listed in § 73.35, and that the petitioned use of phaffia yeast will not increase the estimated daily intake of astaxanthin in humans, which is comparable to the exposure to astaxanthin from wild salmon. Therefore, the agency concludes that astaxanthin from the petitioned use of phaffia yeast is safe for use in the feed of salmonid fish.

The yeast P. rhodozyma naturally produces astaxanthin (Refs. 2 and 3). The parent strain of P. rhodozyma used by the petitioner was originally obtained from a natural source. From this parent strain a new strain that produces more astaxanthin was derived using classical mutagenesis (nonrecombinant deoxyribonucleic acid (DNA)) techniques.

Based on the data in the petition and other relevant material, the agency determined that: (1) consumers will not be directly exposed to phaffia yeast, but to astaxanthin remaining in fish that have consumed the yeast in their diet; (2) there is no evidence that any constituents other than astaxanthin will accumulate in fish maintained on diets supplemented with phaffia yeast; (3) the results of studies during which rats and fish were fed phaffia yeast and bacterial mutagenicity tests did not reveal any adverse effects on these organisms, indicating the absence of toxic impurities in the yeast; (4) a literature search uncovered no reports of pathogenicity or toxicogenicity of P. rhodozyma ; and (5) various yeasts are commonly used as feed in fish aquaculture with no deleterious effects on fish health. Based on this information, FDA concludes that the petitioned use of P. rhodozyma is safe (Ref. 4).

Based on the results of stability studies of phaffia yeast submitted by the petitioner, FDA concludes that to minimize chemical changes that would result in loss of color of astaxanthin, phaffia yeast must be added to fish feed only in the form of a stabilized color additive mixture. Therefore, newly added § 73.355(a)(2) requires that phaffia yeast be added to fish feed only as a component of a stabilized color additive mixture.

All color additives, in accordance with § 70.25 (21 CFR 70.25), require sufficient information to assure their safe use and to allow a determination of compliance with any limitations imposed by the agency in other applicable regulations. Therefore, the labeling of the color additive, phaffia yeast, and any mixture prepared therefrom, is subject to the requirements of § 70.25.

According to § 70.25(a)(4), an expiration date for a color additive must be stated on its label if stability data require it. FDA finds that because of the instability of astaxanthin in phaffia yeast, an expiration date must be stated on the label of sealed and open containers, in accordance with § 70.25(a)(4). FDA also finds that declaration of the expiration date constitutes a material fact that must be disclosed on the label of the color additive mixture under sections 201(n) and 403(a)(1) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321(n) and 343(a)(1)) because failure to do so would constitute a failure to reveal facts material in light of the representations made on the label and material with respect to consequences which may result from the use of the color additive. The use of phaffia yeast requires the declaration of expiration dates because astaxanthin in phaffia yeast can decompose to products that would not be coloring agents and thus would not affect the color of salmonid flesh.

In addition to the requirements for labeling the color additive or color additive mixture, the ingredient list on fish feed, to which phaffia yeast is added, must identify the presence of the color additive under 21 CFR 501.4. New § 73.355(d)(2) references § 501.4 to ensure that the presence of phaffia yeast as a color additive in the fish feed will be declared on the ingredient label.

Finally, the presence of the color additive must be declared on the label of any food, including salmonid fish, containing added phaffia yeast and food containing such salmonid fish as an ingredient. Section 101.22(b) (21 CFR 101.22(b)) requires a food that bears or contains artificial coloring, such as salmon artificially colored with phaffia yeast, to bear labeling even though such food is not in package form. Section 101.22 requires that label statements of artificial coloring be “likely to be read by the ordinary person under customary conditions of purchase and use of such food.”

Furthermore, § 101.22(k)(2) requires, in the statement of ingredients for a food to which any coloring has been added, and for which the coloring is not subject to certification, a declaration that makes it clear that a color additive has been used in the food. In addition, the presence of a color additive must be declared on any bulk container of food containing a color additive that is held at a retail establishment under the provisions in § 101.100(a)(2) (21 CFR 101.100(a)(2)). The ingredient label would prevent economic fraud in salmonid fish containing added phaffia yeast because the ingredient label would notify the consumer that the fish is artificially colored. Without such ingredient labeling, food comprising salmonid fish with added phaffia yeast would be deemed to be misbranded under section 403(k) of the act, which states that: A food shall be deemed to be misbranded “If it bears or contains any artificial flavoring, artificial coloring, or chemical preservative, unless it bears labeling stating that fact * * *.”

Therefore, in accordance with §§ 101.22(b), (c), and (k)(2), and 101.100(a)(2), labeling on any salmonid fish containing phaffia yeast is required to declare the presence of the color additive or color additive mixture. New § 73.355(d)(3) references §§ 101.22(b), (c), and (k)(2), and 101.100(a)(2) to ensure that, at the retail level, the presence of phaffia yeast as a color additive in the fish will be declared, and that the labeling of the bulk fish container, including a list of ingredients, will be displayed on the container or on a counter card with similar information. In the future, the agency also intends to propose to amend § 73.35(d)(3) to include references to § 101.22(b) and (c).

Based on the data in the petition and other relevant material, FDA concludes that the petitioned use of phaffia yeast as a color additive in fish feed to color the flesh of salmonid fish is safe, the additive will achieve its intended technical effect, and therefore, part 73 should be amended as set forth below. In addition, based upon the factors listed in 21 CFR 71.20(b), the agency concludes that certification of phaffia yeast is not necessary for the protection of the public health.

In accordance with § 71.15 (21 CFR 71.15), the petition and the documents that FDA considered and relied upon in reaching its decision to approve the petition are available for inspection at the Center for Food Safety and Applied Nutrition by appointment with the information contact person listed above. As provided in § 71.15, the agency will delete from the documents any materials that are not available for public disclosure before making the documents available for inspection.

The agency has previously considered the environmental effects of this rule as announced in the notice of filing for CAP 8C0252 (November 19, 1997, 62 FR 61823). No new information or comments have been received that would affect the agency's previous determination that there is no significant impact on the human environment and that an environmental impact statement is not required.

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

Any person who will be adversely affected by this regulation may at any time file with the Dockets Management Branch (address above) written objections by August 7, 2000. Each objection shall be separately numbered, and each numbered objection shall specify with particularity the provisions of the regulation to which objection is made and the grounds for the objection. Each numbered objection on which a hearing is requested shall specifically so state. Failure to request a hearing for any particular objection shall constitute a waiver of the right to a hearing on that objection. Each numbered objection for which a hearing is requested shall include a detailed description and analysis of the specific factual information intended to be presented in support of the objection in the event that a hearing is held. Failure to include such a description and analysis for any particular objection shall constitute a waiver of the right to a hearing on the objection. Three copies of all documents are to be submitted and are to be identified with the docket number found in brackets in the heading of this document. Any objections received in response to the regulation may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday. FDA will publish notice of the objections that the agency has received or lack thereof in the Federal Register .

1. Golubev, W. I., “Perfect State of Rhodomyces dendrorhous (Phaffia rhodozyma) ,” Yeast , 11:101-110, 1995.

2. Andrewes, A. G., H. J. Phaff, and M. P. Starr, “Carotenoids of Phaffia rhodozyma , a Red-Pigmented Fermenting Yeast,” Phytochemistry , 15:1003-1007, 1976.

3. Johnson, E. A., D. E. Conklin, and M. J. Lewis, “The Yeast Phaffia rhodozyma as a Dietary Pigment Source for Salmonids and Crustaceans,” Journal of the Fishers Research Board of Canada , 34:2417-2421, 1977.

4. Johnson, C. B., memorandum entitled “Astaxanthin from Phaffia rhodozyma: Final Toxicology Review” from the Division of Health Effects Evaluation (HFS-225) to the Division of Petition Control (HFS-215), Center for Food Safety and Applied Nutrition, FDA, August 12, 1999.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 73 is amended as follows:

Fort Dodge Animal Health, a 1Division of American Cyanamid Co., P.O. Box 1339, Fort Dodge, IA 50501, is the sponsor of NADA 32-319 for Furox (furazolidone) aerosol powder for use in dogs, horses, ponies, and cattle. The sponsor filed a supplemental NADA requesting removal of topical ocular use of the product in cattle. The supplemental NADA is approved as of November 29, 1999, and the regulations are amended in 21 CFR 524.1005(b)(1), (c)(2)(iii), and (c)(3) to reflect the approval.

The regulations in § 524.1005(b)(1) (21 CFR 524.1005(b)(1)) indicate that Pfizer, Inc., is sponsor of NADA 32-319 for use of a 10 percent furazolidone aerosol powder in dogs, horses, and cattle. The NADA had been acquired by Fort Dodge Animal Health, a Division of American Cyanamid Co. At this time, the regulation is amended in § 524.1005(b) to reflect the sponsor change.

Approval of this supplemental NADA provides for removal of a cattle use. It does not affect the safety or effectiveness data in the application. Therefore, a freedom of information summary is not required.

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

Therefore, under the Federal Food, Drug, and Cosmetic Act and under the authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 524 is amended as follows:

Hoechst Roussel Vet, Perryville Corporate Park III, P.O. Box 4010, Clinton, NJ 08809-4010, filed a supplement to NADA 128-620 that provides for use of Safe-Guard® (fenbendazole) 10% Suspension for Cattle and Panacur® (fenbendazole) 10% Suspension for Cattle. The supplement provides for establishing a tolerance for parent fenbendazole in cattle muscle. The supplement is approved as of May 9, 2000, and the regulations in § 556.275 (21 CFR 556.275) are amended to reflect the approval. The basis of approval is discussed in the freedom of information summary.

In addition, FDA is reviewing information in the application and it is establishing a tolerance for parent fenbendazole in goat muscle. The regulations are further amended in § 556.275 to reflect this action.

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

The agency has determined under 21 CFR 25.33(a)(1) 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.

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

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 556 is amended as follows:

Alpharma, Inc., One Executive Dr., P.O. Box 1399, Fort Lee, NJ 07024, filed NADA 141-144 that provides for use of BMD® (10, 25, 30, 40, 50, 60, or 75 grams per pound (g/lb) bacitracin methylene disalicylate) and SafeGuard® (18.1, 36.2, or 90.7 g/lb fenbendazole) Type A medicated articles to make combination Type B and C medicated feeds for growing and finishing swine and pregnant sows.

For growing and finishing swine, the Type A medicated articles are used to make combination Type B medicated feeds that contain 300 to 1,780 grams per ton (g/ton) of bacitracin methylene disalicylate and 300 to 17,740 g/ton of fenbendazole and combination Type C medicated feeds that contain 10 to 30 g/ton of bacitracin methylene disalicylate and 10 to 300 g/ton of fenbendazole. The combination Type C medicated feeds are used for increased rate of weight gain and improved feed efficiency; and for the removal of adult-stage lungworms ( Metastrongylus apri and M. pudendotectus ); adult and larvae (L3, 4 stages—liver, lung, and intestinal forms) large roundworms ( Ascaris suum ); adult-stage nodular worms ( Oesophagostomum dentatum , O. quadrispinulatum ); small stomach worms ( Hyostrongylus rubidus ); adult and larvae (L2, 3, 4 stages—intestinal mucosal forms) whipworms ( Trichuris suis ); and adult and larvae kidneyworms ( Stephanurus dentatus ).

For growing and finishing swine and for pregnant sows, the Type A medicated articles are used to make Type B medicated feeds that contain 7,460 to 14,837 g/ton of bacitracin methylene disalicylate and 300 to 17,740 g/ton of fenbendazole and Type C medicated feeds that contain 250 g/ton of bacitracin methylene disalicylate and 10 to 300 g/ton of fenbendazole.

The combination Type C medicated growing and finishing swine feeds are used for the control of swine dysentery associated with T. hyodysenteriae in growing and finishing swine on premises with a history of swine dysentery but where signs of disease have not yet occurred, or following an approved treatment of the disease; and for the removal of adult-stage lungworms ( M. apri and M. pudendotectus ); adult and larvae (L3, 4 stages—liver, lung, and intestinal forms) large roundworms ( A. suum ); adult-stage nodular worms ( O. dentatum , O. quadrispinulatum ); small stomach worms ( H. rubidus ); adult and larvae (L2, 3, 4 stages—intestinal mucosal forms) whipworms ( T. suis ); and adult and larvae kidneyworms ( S. dentatus ).

The combination Type C medicated sow feeds are used for the control of clostridial enteritis in suckling pigs caused by C. perfringens ; and for the removal of adult stage lungworms ( M. apri and M. pudendotectus ); adult and larvae (L3, 4 stages—liver, lung, and intestinal forms) large roundworms ( A. suum ); adult-stage nodular worms ( O. dentatum , O. quadrispinulatum ); small stomach worms ( H. rubidus ); adult and larvae (L2, 3, 4 stages—intestinal mucosal forms) whipworms ( T. suis ); and adult and larvae kidneyworms ( S. dentatus ).

The NADA is approved as of April 7, 2000, and 21 CFR 558.76 and § 558.258 (21 CFR 558.258) are amended to add new entries to reflect the approval. The basis for approval is discussed in the freedom of information summary.

Also, § 558.258 is amended to redesignate paragraph (c) as paragraph (d) and add paragraph (c) to reflect a newer format.

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

The agency has determined under 21 CFR 25.33(a)(2) 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.

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

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is amended as follows:

Pursuant to 5 U.S.C. 553, a notice of proposed rulemaking has not been published for this regulation and good cause exists for making it effective less than 30 days from date of publication in the Federal Register . Due to complex planning and coordination requirements, the Coast Guard was not able to obtain details of the event thirty days prior to its occurrence. Because of this, following normal rulemaking procedures would be impracticable and contrary to the public interest. Prompt regulatory action is needed in order to provide for the safety of spectators and participants during the event. If normal notice and comment procedures were followed, this rule would not become effective until after the date of the event. For this reason, following normal rulemaking procedures in this case would be impracticable and contrary to the public interest.

The Coast Guard is adopting a temporary safety zone regulation on the waters of Lake Washington, Seattle, Washington, for the Seafair Blue Angels Performance. The Coast Guard has determined it is necessary to close the area in the vicinity of the air show in order to minimize the dangers that low-flying aircraft present to persons and vessels. These dangers include, but are not limited to excessive noise and the risk of falling objects from any accidents associated with low flying aircraft. In the event that aircraft require emergency assistance, rescuers must have immediate and unencumbered access to the craft. The Coast Guard, through this action, intends to promote the safety of personnel, vessels, and facilities in the area. Entry into this zone will be prohibited unless authorized by the Captain of the Port. This safety zone will be enforced by Coast Guard personnel. The Captain of the Port may be assisted by other federal, state, or local agencies.

This proposed rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866 and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not significant under the regulatory policies and procedures of the Department of Transportation (DOT)(44 FR 11040, February 26, 1979). We expect the economic impact of this proposed rule to be so minimal that a full Regulatory Evaluation under paragraph 10(e) of the regulatory policies and procedures of DOT is unnecessary. This expectation is based on the fact that the regulated area established by the proposed regulation would encompass an area near the middle of Lake Washington, not frequented by commercial navigation. The regulation is established for the benefit and safety of the recreational boating public, and any recreational boating impact is offset by the benefits of allowing the Blue Angels to fly. For the above reasons, the Coast Guard does not anticipate any significant economic impact.

Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ), the Coast Guard considered whether this rule would have a significant economic impact on a substantial number of small entities. “Small entities” include small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. This rule will affect the following entities, some of which may be small entities: the owners or operators of vessels intending to transit this portion of Lake Washington from 8:30 a.m. until 3 p.m., Pacific Daylight Time, August 3rd, 4th, 5th and 6th, 2000. The zone will not have a significant economic impact due to its short duration and small area. It is believed that the only vessels likely to be impacted will be recreational boaters and small passenger vessel operators. The event is held for the benefit and entertainment of those above categories. Because the impacts of this proposal are expected to be so minimal, the Coast Guard certifies under 605(b) of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) that this final rule will not have a significant economic impact on a substantial number of small entities.

If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see ADDRESSES ) explaining why you think it qualifies and how and to what degree this rule would economically affect it.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule so that they can better evaluate its effects on them and participate in the rulemaking. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the ( FOR FURTHER INFORMATION CONTACT ) section.

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

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

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

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

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

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

We considered the environmental impact of this proposed rule and concluded that, under figure 2-1, paragraph (34)(g) of Commandant Instruction M16475.lC, this proposed rule is categorically excluded from further environmental documentation. A Categorical Exclusion is provided for temporary safety zones of less than one week in duration. This rule establishes a temporary safety zone of limited duration which will be within the one-week timeframe.

Throughout this document, wherever “we” or “our” are used, we mean EPA. On April 21, 2000 (65 FR 21315), we published a final rulemaking action announcing our approval of the revised reorganization of the Virginia Administrative Code (VAC), including reorganization of the air pollution control regulations. The intent of the rule was to approve the revised regulatory structure of Virginia's air pollution control regulations, and to list, in chart form, those Virginia regulatory provisions which had been incorporated by reference into the Virginia SIP.

In this document, we discovered incorrect information and omissions related to entries appearing in the summary rulemaking charts published on pages 21322, 21342, and 21346. In one case, we did not clearly delineate the provisions in Virginia's compliance testing requirements (9 VAC 5-40-20) which we had historically approved, and thus incorporated by reference, as part of the Virginia SIP. In the other case, we omitted the listing of eight other Virginia air pollution control rules (either in the 9 VAC 5 or “VR” format) which EPA had incorporated by reference in past rulemaking actions into the SIP. In this action, we are publishing those entries in 40 CFR 52.2420(c) which contained incorrect information or were inadvertently omitted from the document.

At the same time, we had intended to revise the citation of Virginia's compliance testing provision which we had historically disapproved and codified at 40 CFR 52.2423(f) so that it reflects the current 9 VAC 5 citation. This action revises § 52.2423(f) to reflect the correct citation. 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. We have determined that there is good cause for making today's rule final without prior proposal and opportunity for comment because we are merely correcting an incorrect citation in a previous action. Thus, notice and public procedure are unnecessary. We find 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 as indicated in the Supplementary Information section above, 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 governments, as specified by 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 action does not involve technical standards; thus the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. The rule also does not involve special consideration of environmental justice related issues as required by Executive Order 12898 (59 FR 7629, February 16, 1994). 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, 1998) 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 Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

The Congressional Review Act (5 U.S.C. 801 et seq. ), as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. Section 808 allows the issuing agency to make a rule effective sooner than otherwise provided by the CRA if the agency makes a good cause finding that notice and public procedure is impracticable, unnecessary or contrary to the public interest. This determination must be supported by a brief statement. 5 U.S.C. 808(2). As stated previously, EPA had made such a good cause finding, including the reasons therefore, and established an effective date of July 6, 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 . The corrections to 40 CFR 52.2420(c) and 52.2423(f) for Virginia are not “major rules” as defined by 5 U.S.C. 804(2).

On May 8, 2000, the EPA published a direct final rule (65 FR 26491) and a parallel proposal (65 FR 26544) to amend portions of the NESHAP for Polyether Polyols Production; Synthetic Organic Chemical Manufacturing Industry; Epoxy Resins Production and Non-Nylon Polyamides Production; and Petroleum Refineries. The EPA stated in the direct final rule that if relevant, adverse comments were received by June 7, 2000, the EPA would publish a document to withdraw the affected portions of the direct final rule before its effective date of July 7, 2000. The EPA received an adverse comment on Amendment 6 in the direct final rule and, therefore, is withdrawing Amendment 6. This withdrawal of Amendment 6 only affects sources subject to the Petroleum Refineries NESHAP (40 CFR part 63, subpart CC). Amendment 6 would have changed the definition of equipment leak to add the term “connectors” to the equipment leak provisions in the NESHAP.

The adverse comment stated that the EPA's rationale for adding connectors to the list of equipment in the definition of equipment leak was not supported by the record of the rulemaking for the Petroleum Refineries NESHAP. It indicated that meetings with, and correspondence from, EPA and Congress supported flexibility and the New Source Performance Standard (NSPS) option without connectors. Therefore, the EPA is withdrawing this amendment and will decide the appropriate response to this comment. The 19 amendments for which we did not receive adverse comments will become effective on July 7, 2000, as provided in the May 8, 2000 direct final rule (65 FR 26491).

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

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

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

2. In person . The Agency has established an official record for this action under docket control number OPP-301008. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

EPA, on its own initiative, in accordance with sections 408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is establishing a tolerance for residues of the insecticide tebufenozide, in or on grapes at 3 parts per million (ppm). This tolerance will expire and is revoked on December 31, 2001. EPA will publish a document in the Federal Register to remove the revoked tolerance from the Code of Federal Regulations.

Section 408(l)(6) of the FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of FIFRA. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on section 18 related tolerances to set binding precedents for the application of section 408 and the new safety standard to other tolerances and exemptions.

Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”

Section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that “emergency conditions exist which require such exemption.” This provision was not amended by the Food Quality Protection Act (FQPA). EPA has established regulations governing such emergency exemptions in 40 CFR part 166.

Grapes are California's number one ranked crop in dollar value, accounting for over 90% of the grapes grown in the United States. The European export market for California wines accounts for well over $250 million. The Grape Leaf folder causes injury in the larval stages by rolling and feeding on the leaves, reducing photosynthetic function. The Omnivorous leaf roller directly reduces grape yields by injuring the flowers and developing berries it feeds on. The Omnivorous leaf roller also allows entry of bunch rot organisms that damage entire clusters which may result in rejection at the winery.

Cryolite is the registered alternative most often used to control both Grape Leaf folders and Omnivorous leaf rollers. However, for the 2000 crop year, nearly all major California wineries with export markets have advised their growers that they will not accept grapes which have been treated with cryolite or any other product which would affect the level of fluorides in wine. The European Community recently established strict tolerance levels of 1 ppm with respect to fluoride residues. There is a direct correlation between even limited use of cryolite on wine grapes which can result in fluoride levels in wine above 3 ppm. Therefore, the State claims that there is no feasible registered alternative available to wine growers to control these pests. EPA has authorized under FIFRA section 18 the use of tebufenozide on grapes for control of Omnivorous leaf roller and Grape leaf folder in California. After having reviewed the submission, EPA concurs that emergency conditions exist for wine grapes for the State. However, the Agency does not believe that an urgent and non-routine finding can be made for table grapes since growers can still use cryolite.

As part of its assessment of this emergency exemption, EPA assessed the potential risks presented by residues of tebufenozide in or on grapes. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2), and EPA decided that the necessary tolerance under FFDCA section 408(l)(6) would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing this tolerance without notice and opportunity for public comment as provided in section 408(l)(6). Although this tolerance will expire and is revoked on December 31, 2001, under FFDCA section 408(l)(5), residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on grapes after that date will not be unlawful, provided the pesticide is applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by this tolerance at the time of that application. EPA will take action to revoke this tolerance earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.

Because this tolerance is being approved under emergency conditions, EPA has not made any decisions about whether tebufenozide meets EPA's registration requirements for use on grapes or whether a permanent tolerance for this use would be appropriate. Under these circumstances, EPA does not believe that this tolerance serves as a basis for registration of tebufenozide by a State for special local needs under FIFRA section 24(c). Nor does this tolerance serve as the basis for any State other than California to use this pesticide on this crop under section 18 of FIFRA without following all provisions of EPA's regulations implementing section 18 as identified in 40 CFR part 166. For additional information regarding the emergency exemption for tebufenozide, contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT.

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

Consistent with section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of tebufenozide and to make a determination on aggregate exposure, consistent with section 408(b)(2), for a time-limited tolerance for residues of tebufenozide in or on grapes at 3 ppm. EPA's assessment of the dietary exposures and risks associated with establishing the tolerance follows.

The dose at which no observed adverse effect level (NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological endpoint. However, the dose at which the lowest observed adverse effect level (LOAEL) of concern are identified is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intraspecies differences.

For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by the appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is retained due to concerns unique to the FQPA, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA safety factor.

For non-dietary risk assessments (other than cancer) the UF is used to determine the level of concern (LOC). For example, when 100 is the appropriate UF (10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and compared to the LOC.

The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk is expressed as 1 x 10 -6 or one in a million). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non-linear approach, a “point of departure” is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOE cancer = point of departure/exposures) is calculated.

1. Dietary exposure from food and feed uses . Tolerances have been established (40 CFR 180.482) for the residues of tebufenozide, in or on a variety of raw agricultural commodities. Tolerances, listed under 40 CFR 180.482, currently exist for residues of tebufenozide on apples, berries, brassica crop group, canola, cotton, cranberries, pome fruits, pecans, mint, sugarcane, turnips, fruiting vegetables, leafy green vegetables, and walnuts. Additionally, time-limited tolerances for eggs, milk, pears, peanuts, peppers, rice, sugarcane, sweet potatoes, and livestock commodities of cattle, goats, hogs, horses, poultry and sheep have been established. Risk assessments were conducted by EPA to assess dietary exposures from tebufenozide in food as follows:

i. Acute exposure . Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1 day or single exposure. Toxicity observed in oral toxicity studies were not attributable to a single dose or 1 day exposure. Therefore, no toxicological endpoint was identified for acute toxicity and no acute dietary risk assessment is needed.

ii. Chronic exposure . In conducting this chronic dietary risk assessment the Dietary Exposure Evaluation Model (DEEM) analysis evaluated the individual food consumption as reported by respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments.

Data included in the application indicate no tebufenozide concentration in grape juice or raisins. For the chronic analysis, tolerance level residues and some percent crop treated (PCT) and some market share assumptions were used. Where market share information was available, it was used in preference over PCT data since it is the larger, more conservative number and therefore more protective of human health.

iii. Cancer . Tebufenozide is classified as Group E (no evidence of carcinogenicity in humans).

iv. Anticipated residue and PCT information . Section 408(b)(2)(F) states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if the Agency can make the following findings: Condition 1, that the data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain such pesticide residue; Condition 2, that the exposure estimate does not under estimate exposure for any significant subpopulation group; and Condition 3, if data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by section 408(b)(2)(F), EPA may require registrants to submit data on PCT.

The Agency used PCT information as follows: < 1% almonds, 2% apples, 1% dry beans/peas, 3% fresh cabbage, 2% cole crops, 4% cotton, 3% fresh spinach, 29% processed spinach, 5% sugarcane and 16% walnuts.

The Agency used Percent Market Share information as follows: 10% pome fruit, 19% cotton, 82% sugarcane, 10% fruiting vegetables, 14% leafy vegetables, 18% cole crop vegetables, and 25% blueberries.

The Agency believes that the three conditions listed above have been met. With respect to Condition 1, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. EPA uses a weighted average PCT for chronic dietary exposure estimates. This weighted average PCT figure is derived by averaging State-level data for a period of up to 10 years, and weighting for the more robust and recent data. A weighted average of the PCT reasonably represents a person's dietary exposure over a lifetime, and is unlikely to under estimate exposure to an individual because of the fact that pesticide use patterns (both regionally and nationally) tend to change continuously over time, such that an individual is unlikely to be exposed to more than the average PCT over a lifetime. The Agency is reasonably certain that the percentage of the food treated is not likely to be an under estimation. As to Conditions 2 and 3, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available information on the regional consumption of food to which tebufenozide may be applied in a particular area.

2. Dietary exposure from drinking water . The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for tebufenozide in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of tebufenozide.

The Agency uses the Generic Estimated Environmental Concentration (GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS) to estimate pesticide concentrations in surface water and screening concentration in ground water (SCI-GROW), which predicts pesticide concentrations in ground water. In general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS (a tier 2 model) for a screening-level assessment for surface water. The GENEEC model is a subset of the PRZM/EXAMS model that uses a specific high-end runoff scenario for pesticides. GENEEC incorporates a farm pond scenario, while PRZM/EXAMS incorporate an index reservoir environment in place of the previous pond scenario. The PRZM/EXAMS model includes a percent crop area factor as an adjustment to account for the maximum percent crop coverage within a watershed or drainage basin.

None of these models include consideration of the impact processing (mixing, dilution, or treatment) of raw water for distribution as drinking water would likely have on the removal of pesticides from the source water. The primary use of these models by the Agency at this stage is to provide a coarse screen for sorting out pesticides for which it is highly unlikely that drinking water concentrations would ever exceed human health levels of concern.

Since the models used are considered to be screening tools in the risk assessment process, the Agency does not use estimated environmental concentrations (EECs) from these models to quantify drinking water exposure and risk as a %RfD or %PAD. Instead, drinking water levels of comparison (DWLOCs) are calculated and used as a point of comparison against the model estimates of a pesticide's concentration in water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food, and from residential uses. Since DWLOCs address total aggregate exposure to tebufenozide they are further discussed in the aggregate risk sections below.

Based on the GENEEC and SCI-GROW models the estimated environmental concentrations (EECs) of tebufenozide for chronic exposures are estimated to be 17 parts per billion (ppb) for surface water and 1 ppb for ground water.

3. From non-dietary exposure . The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Tebufenozide is not registered for use on any sites that would result in residential exposure.

4. Cumulative exposure to substances with a common mechanism of toxicity . Section 408(b)(2)(D)(v) requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

EPA does not have, at this time, available data to determine whether tebufenozide has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, tebufenozide does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that tebufenozide has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the final rule for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

1. Safety factor for infants and children —i. In general . FFDCA section 408 provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base on toxicity and exposure unless EPA determines that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans.

ii. Developmental toxicity studies . In prenatal developmental toxicity studies in rats and rabbits, there was no evidence of maternal or developmental toxicity; the maternal and developmental NOAELS were 1,000 mg/kg/day (highest dose tested).

iii. Reproductive toxicity study . In 2-generation reproduction studies in rats, toxicity to the fetuses/offspring, when observed, occurred at equivalent or higher doses than in the maternal/parental animals.

iv. Prenatal and postnatal sensitivity . The data provided no indication of increased sensitivity of rats or rabbits to in utero and/or postnatal exposure to tebufenozide. No maternal or developmental findings were observed in the prenatal developmental toxicity studies at doses up to 1,000 mg/kg/day in rats and rabbits. In the 2-generation reproduction studies in rats, effects occurred at the same or lower treatment levels in the adults as in the offspring.

v. Conclusion . There is a complete toxicity data base for tebufenozide and exposure data is complete or is estimated based on data that reasonably accounts for potential exposures. Data provided no indication of increased sensitivity of rats or rabbits to in utero and/or postnatal exposure to tebufenozide. Based on this, EPA concludes that reliable data support the use of the standard 100-fold uncertainty factor, and that the 10X safety factor to protect infants and children should be removed.

To estimate total aggregate exposure to a pesticide from food, drinking water, and residential uses, the Agency calculates DWLOCs which are used as a point of comparison against the model estimates of a pesticide's concentration in water (EECs). DWLOC values are not regulatory standards for drinking water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food and residential uses. In calculating a DWLOC, the Agency determines how much of the acceptable exposure (i.e., the PAD) is available for exposure through drinking water (e.g., allowable chronic water exposure (mg/kg/day) = cPAD—(average food + chronic non-dietary, non-occupational exposure)). This allowable exposure through drinking water is used to calculate a DWLOC.

A DWLOC will vary depending on the toxic endpoint, drinking water consumption, and body weights. Default body weights and consumption values as used by EPA to calculate DWLOCs: 2 Liter/70 kilograms (adult male), 2L/60 kg (adult female), and 1L/10 kg (child). Default body weights and drinking water consumption values vary on an individual basis. This variation will be taken into account in more refined screening-level and quantitative drinking water exposure assessments. Different populations will have different DWLOCs. Generally, a DWLOC is calculated for each type of risk assessment used: acute, short-term, intermediate-term, chronic, and cancer.

When EECs for surface water and groundwater are less than the calculated DWLOCs, EPA concludes with reasonable certainty that exposures to tebufenozide in drinking water (when considered along with other sources of exposure for which EPA has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because EPA considers the aggregate risk resulting from multiple exposure pathways associated with a pesticide's uses, levels of comparison in drinking water may vary as those uses change. If new uses are added in the future, EPA will reassess the potential impacts of tebufenozide on drinking water as a part of the aggregate risk assessment process.

1. Acute risk . No toxicological endpoint was identified for acute toxicity. Therefore, no acute aggregate risk assessment is needed.

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to tebufenozide from food will utilize 20% of the cPAD for the U.S. population, 75% of the cPAD for non-nursing infants and 51% of the cPAD for children (1-6 years old). There are no residential uses for tebufenozide that result in chronic residential exposure to tebufenozide. In addition, despite the potential for chronic dietary exposure to tebufenozide in drinking water, after calculating the DWLOCs and comparing them to conservative model estimated environmental concentrations of tebufenozide in surface and ground water. EPA does not expect the aggregate exposure to exceed 100% of the cPAD.

3. Short-term and intermediate-term risk . Short-term and Intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Tebufenozide is not registered for use on any sites that would result in residential exposure. Additionally, no toxicological effects have been identified for short-term and intermediate-term toxicity. Therefore, the aggregate risk is the sum of the risk from food and water, which were previously addressed.

5. Aggregate cancer risk for U.S. population . Tebufenozide is classified as Group E (no evidence of carcinogenicity in humans).

6. Determination of safety . Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to tebufenozide residues.

Adequate enforcement methodology (example—gas chromotography) is available to enforce the tolerance expression. The method may be requested from: Calvin Furlow, PRRIB, IRSD (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460; telephone number: (703) 305-5229; e-mail address: furlow.calvin@epa.gov.

There are no Mexican Maximum Residue Limits (MRL) for tebufenozide in or on grapes. Codex has a 1.0 ppm MRL on grapes for fat soluble tebufenozide. Canada has a tebufenozide MRL on grapes at 0.5 ppm. International harmonization is not feasible for this action.

Grapes are not rotated; therefore, a discussion of rotational crop requirements is not germane to this action.

Therefore, the tolerance is established for residues of benzoic acid, 3,5-dimethyl-1-(1,1dimethylethyl)-2-(4-ethylbenzoyl)hydrazide, tebufenozide, in or on grapes at 3 ppm.

Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA of 1996, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) provides essentially the same process for persons to “object” to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408(d), as was provided in the old FFDCA sections 408 and 409. However, the period for filing objections is now 60 days, rather than 30 days.

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket control number OPP-301008 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before September 5, 2000.

1. Filing the request . Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections (40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice.

Mail your written request to: Office of the Hearing Clerk (1900), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. You may also deliver your request to the Office of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., Washington, DC 20460. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (202) 260-4865.

2. Tolerance fee payment . If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or request a waiver of that fee pursuant to 40 CFR 180.33(m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it “Tolerance Petition Fees.”

EPA is authorized to waive any fee requirement “when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.” For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov, or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

3. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VII.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.2. Mail your copies, identified by the docket control number OPP-301008, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.2. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 file format or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).

This final rule establishes a time limited tolerance under FFDCA section 408. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq ., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any prior consultation as specified by Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments (63 FR 27655, May 19, 1998); special considerations as required by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or require OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a FIFRA section 18 petition under FFDCA section 408, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq .) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4).

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

Therefore, 40 CFR chapter I is amended as follows:

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

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

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

2. In person . The Agency has established an official record for this action under docket control number OPP-301007. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

EPA issued a final rule, published in the Federal Register of April 21, 1999 (64 FR 19484) (FRL-6073-1), which announced that on its own initiative under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170) it established a time-limited tolerance for the residues of fludioxonil in or on strawberries at 2 ppm, with an expiration date of May 31, 2000. EPA established the tolerance because section 408(l)(6) of the FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Such tolerances can be established without providing notice or period for public comment.

EPA received a request to extend the use of the product Switch 62.5 WG, containing the active ingredients fludioxonil and cyprodinil on strawberries for this year's growing season due to the urgent and non-routine situation which exists for South Carolina strawberry growers due to the cancellation of vinclozolin use on strawberries and the restriction on iprodione use to pre-bloom only; this reduces the number of fungicide applications available for season-long control below that needed, should disease pressure be heavy. After having reviewed the submission, EPA concurs that emergency conditions exist. EPA has authorized under FIFRA section 18 the use of fludioxonil on strawberries for control of gray mold in South Carolina.

EPA assessed the potential risks presented by residues of fludioxonil in or on strawberries. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2), and decided that the necessary tolerance under FFDCA section 408(l)(6) would be consistent with the safety standard and with FIFRA section 18. The data and other relevant material have been evaluated and discussed in the final rule of April 21, 1999 (64 FR 19484). Based on that data and information considered, the Agency reaffirms that extension of the time-limited tolerance will continue to meet the requirements of section 408(l)(6). Therefore, the time-limited tolerance is extended for an additional 1-year period. EPA will publish a document in the Federal Register to remove the revoked tolerance from the Code of Federal Regulations (CFR). Although this tolerance will expire and is revoked on May 31, 2001, under FFDCA section 408(l)(5), residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on strawberries after that date will not be unlawful, provided the pesticide is applied in a manner that was lawful under FIFRA and the application occurred prior to the revocation of the tolerance. EPA will take action to revoke this tolerance earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.

Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA of 1996, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) provides essentially the same process for persons to “object” to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408(d), as was provided in the old FFDCA sections 408 and 409. However, the period for filing objections is now 60 days, rather than 30 days.

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket control number OPP-301007 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before September 5, 2000.

1. Filing the request . Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections (40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice.

Mail your written request to: Office of the Hearing Clerk (1900), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. You may also deliver your request to the Office of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., Washington, DC 20460. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (202) 260-4865.

2. Tolerance fee payment . If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or request a waiver of that fee pursuant to 40 CFR 180.33(m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it “Tolerance Petition Fees.”

EPA is authorized to waive any fee requirement “when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.” For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov , or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

3. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit III.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.2. Mail your copies, identified by docket control number OPP-301007, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.2. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov . Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 file format or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).

This final rule extends a time-limited tolerance under FFDCA section 408. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. , or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any prior consultation as specified by Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments (63 FR 27655, May 19, 1998); special considerations as required by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or require OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a FIFRA section 18 petition under FFDCA section 408, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4).

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

Therefore, 40 CFR chapter I is amended as follows:

This is a summary of the Commission's Third Report and Order and Memorandum Opinion and Order (Third R&O/MO&O) in CC Docket No. 92-97; FCC 00-00-223, adopted June 20, 2000, and released June 27, 2000. The complete text of this Third R&O/MO&O is available for inspection and copying during normal business hours in the FCC Reference Information Center, Courtyard Level, 445 12th Street, S.W., Washington, DC, and also may be purchased from the Commission's copy contractor, International Transcription Services (ITS, Inc.), CY-B400, 445 12th Street, S.W., Washington, DC.

1. This Third R&O/MO&O completes the Commission's review of the Local Multipoint Distribution Service (LMDS) eligibility restriction, which prohibits incumbent local exchange carriers (LECs) and cable companies from having an attributable interest in the LMDS A block license that overlaps with ten percent or more of the population in their service area. As a result of that review, the Commission allows the scheduled sunset of that restriction to occur as of June 30, 2000. The eligibility restriction was adopted in the Second Report and Order in this proceeding (62 FR 23148, April 29, 1997), subject to an expiration date of June 30, 2000. The Commission, in adopting the restriction, noted that it would undertake a review of the restriction prior to its sunset. (47 CFR 101.1003(a).)

2. In adopting the LMDS eligibility restriction, the Commission considered four factors. First, that LMDS was a likely vehicle for the provision of local telephony, multi-channel video distribution (MVPD) service, or both. Second, the Commission found that the incumbent local exchange carriers (LECs) and incumbent cable companies were dominant in their respective markets, would have a strong incentive to obtain an LMDS license in order to prevent a new entrant from obtaining the license and competing directly in the incumbent's current market, and would have no incentive to use the LMDS spectrum to offer services that would compete with their own services. Third, the Commission determined that a short-term eligibility restriction, with an opportunity for review, would be the best means to increase competition in the local and telephony and MVPD markets, in light of the Commission's belief that there would be sufficient entity and increases in competition to permit sunset within three years. Fourth, the Commission found that efficiencies arising from ownership of an LMDS system by an incumbent LEC or incumbent cable provider had not been shown.

3. As a result of its review, the Commission first concludes that the standard for determining whether to sunset the eligibility restriction should be whether open eligibility poses a significant likelihood of substantial competitive harm in specific markets, and, if so, whether eligibility restrictions are an effective way to address that harm. The Commission determines that the record does not support a conclusion that open eligibility poses such a significant threat of substantial competitive harm in specific markets; indeed, open eligibility may improve the availability of services, especially in rural areas.

4. The Commission, as discussed more fully in the complete text of the Third R&O/MO&O, therefore finds that the LMDS eligibility restriction should be allowed to sunset because open eligibility (1) will not pose a significant likelihood of substantial competitive harm in any market; (2) is likely to provide access to additional capital to fully develop LMDS; (3) will treat LMDS similarly to substitutable spectrum; and (4) should help make services more available in rural areas.

5. This is a summary of the Final Regulatory Flexibility Analysis. The full Final Regulatory Flexibility Analysis may be found at Appendix D of the complete Third Report and Order and Memorandum Opinion and Order.

6. In order to ensure compliance with the requirements contained in the Regulatory Flexibility Act (RFA) and to alert all affected entities of the repercussions of the Commission's action, an Initial Regulatory Flexibility Analysis (IRFA) was incorporated in Appendix B of the Sixth Notice of Proposed Rulemaking (Sixth NPRM), 64 FR 71373, December 21, 1999, in this proceeding. Additionally, a Final Regulatory Flexibility Analysis was included in Appendix D of the Second Report and Order in this proceeding. The Commission sought written public comment on the proposals in the Fifth NPRM (62 FR 16514, April 7, 1997), including comment on the IRFA. The present Final Regulatory Flexibility Analysis (FRFA), contained in the Third Report and Order and Memorandum Opinion and Order (Third R&O), conforms to the RFA.

7. The Commission allows to sunset the Local Multipoint Distribution Service (LMDS) eligibility restriction which prohibits incumbent local exchange carriers (ILECs) and cable companies from having an attributable interest in the LMDS A-block license that overlaps with ten percent or more of the population in their service areas. This restriction was initially imposed because of concern the ILECs and the cable companies would use LMDS spectrum to eliminate the threat of competitive entry in the local exchange telephone and cable markets, in which they are dominant. The Third R&O finds that the LMDS A-block eligibility restriction is no longer necessary to protect LMDS as a source of competition with ILECs and incumbent cable companies, and that the benefits of removing the restriction outweigh any benefits of retaining the restriction.

8. The central issue in this proceeding is the continued need for the eligibility restriction. The restriction was adopted subject to an expiration date of June 30, 2000. The expiration date, like the other issues in this proceeding, was the result of notice and comment procedures. The Commission received fourteen comments and eight reply comments in response to the Sixth NPRM.

9. No comments were received directly regarding the IRFA or the FRFA contained in the Second R&O. The Sixth NPRM sought comment on whether the standard for determining whether the restriction is extended should be that the incumbent LECs or cable companies continue to have substantial market power in the provision of local telephone or cable television services, or if a different standard should be used. As discussed in paragraphs 6-7 of the Third R&O, the Sixth NPRM also suggested two alternative standards. Although most of the commenters support allowing the eligibility rule to sunset, those who comment on the standard are somewhat divided. Several commenters argue in favor of using the market dominance standard to decide whether the eligibility should sunset.

10. The Commission agrees with the majority of parties who comment on the standard issue, and either urge the Commission to adopt the 39 GHz standard or at least to reject the “substantial market power” standard. Therefore, the Commission adopts the 39 GHz standard. In paragraphs 8-9 of the Third R&O, the Commission details the rationale for selecting the 39 GHz test as the appropriate standard to apply in determining whether the LMDS restriction should sunset.

11. The Sixth NPRM asked what services are likely to be provided on LMDS. The Commission agrees with the majority of commenters on this issue who contend that the LMDS A block licensees provide or are expected to provide broadband services, instead of local telephone or cable services. Because the Commission believes that the LMDS A block is not being used to provide services which are primarily local exchange or multi-channel video distribution (MVPD), the Third R&O concludes that it is unlikely that the possible use of LMDS spectrum by incumbents will result in the blocking of entry into those services, and thus allows the restriction to lapse. Commenters also generally contend that the broadband market is robust and competitive, and that incumbent cable companies and incumbent LECs could not use LMDS spectrum to dominate the broadband market. The Commission finds that an increasing number of broadband firms and technologies are providing growing competition to incumbent LECs and cable companies, apparently limiting the threat that they will be able to preclude competition in the provision of broadband services. The Commission also finds no evidence that the incumbent LECs or incumbent cable companies have the incentive to warehouse LMDS licenses in order to protect their control of these markets from competition. These issues are discussed at paragraphs 14—21 in the Third R&O.

12. Although the majority of commenters favor the sunset of LMDS eligibility restrictions, some commenters argue that it is premature to terminate the restriction because the first LMDS products are just becoming available in the United States. Paragraphs 23-33 in the Third R&O explain the Commission's rationale for rejecting this contention. Briefly, the Third R&O sunsets the LMDS eligibility restriction because open eligibility (1) will not pose a significant likelihood of substantial competitive harm in any market; (2) is likely to provide access to additional capital to fully develop LMDS; (3) will treat LMDS similarly to substitutable spectrum; and (4) should help make services more available in rural areas. Paragraphs 14-21of the Third R&O find that the record does not support a conclusion that open eligibility poses a significant threat of substantial competitive harm in specific markets, LEC or MVPD, or that eligibility restrictions are an effective way of addressing potential competitive harm. Paragraph 24 of the Third R&O discusses how removal of the restriction may result in access to capital resources to more fully develop LMDS. Paragraphs 26 and 27 detail why LMDS should be treated no differently from other substitutable spectrum.

13. Paragraphs 28-29 discuss allegations by rural commenters that the LMDS in-region eligibility restriction imposes several disadvantages on small, rural telecommunications carriers. The Third R&O, while recognizing that the eligibility restriction was initially imposed on rural markets because the Commission believed that it could stimulate competition to LEC's in these markets, now finds that this has not occurred, and that allowing the eligibility restriction to sunset will remove possible impediments to small and rural carrier LMDS deployment. The negative effects of the eligibility restriction on small and rural entities and consumers, are discussed more fully in paragraphs 28-32 of the Third R&O.

14. The RFA directs agencies to provide a description of and, where feasible, an estimate of the number of small entities that may be affected by the proposed rules, if adopted. The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. A small business concern is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the Small Business Administration (SBA). A small organization is generally “any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.” Nationwide, as of 1992, there were approximately 275,801 small organizations.

Common Carrier Services and Related Entities. According to data in the most recent Commission Carrier Locator Interstate Service Providers report, there are 3,528 interstate carriers, including inter alia, local exchange carriers, wireline carriers and service providers, interexchange carriers, competitive access providers, operator service providers, pay telephone operators, providers of telephone toll service, providers of telephone exchange service, and resellers.

The SBA has defined establishments engaged in providing “Radiotelephone Communications” and “Telephone Communications, Except Radiotelephone” to be small businesses when they have no more than 1,500 employees. The Commission discusses the total estimated number of telephone companies falling within the two categories and the number of small businesses in each, and then attempts to refine further those estimates to correspond with the categories of telephone companies that are commonly used under the rules.

The Commission includes small incumbent LECs in this present RFA analysis. The SBA's Office of Advocacy contends that, for RFA purposes, small incumbent LECs are not dominant in their field of operation because any such dominance is not “national” in scope.

Total Number of Telephone Companies Affected. The U.S. Bureau of the Census (Census Bureau) reports that, at the end of 1992, there were 3,497 firms engaged in providing telephone services, as defined therein, for at least one year. This number contains a variety of different categories of carriers, including local exchange carriers, interexchange carriers, competitive access providers, cellular carriers, mobile service carriers, operator service providers, pay telephone operators, covered specialized mobile radio providers, and resellers. The Commission finds it reasonable to conclude that fewer than 3,497 telephone service firms are small entity telephone service firms or small ILECs that may be affected by the action taken in this Third R&O.

Wireline Carriers and Service Providers. The SBA has developed a definition of small entities for telephone communications companies except radiotelephone (wireless) companies. The Census Bureau reports that there were 2,321 such telephone companies in operation for at least one year at the end of 1992. According to the SBA's definition, a small business telephone company other than a radiotelephone company is one employing no more than 1,500 persons. All but 26 of the 2,321 non-radiotelephone companies listed by the Census Bureau were reported to have fewer than 1,000 employees. Thus, even if all 26 of those companies had more than 1,500 employees, there would still be 2,295 non-radiotelephone companies that might qualify as small entities or small ILECs. The Commission is unable at this time to estimate with greater precision the number of wireline carriers and service providers that would qualify as small business concerns under the SBA's definition. Consequently, the Commission estimates that fewer than 2,295 small telephone communications companies other than radiotelephone companies are small entities or small ILECs that may be affected by the actions taken in this Third R&O.

Local Exchange Carriers, Competitive Access Providers, Competitive Local Exchange Carriers. Neither the Commission nor the SBA has developed a definition for small providers of local exchange service, competitive access providers, or competitive local exchange carriers. The closest applicable definition under the SBA rules is for telephone communications companies other than radiotelephone (wireless) companies. According to the most recent telecommunications industry revenue data, 1,348 carriers reported that they were engaged in the provision of incumbent local exchange services, and 212 carriers reported that they were providing competitive access or competitive local exchange services. The Commission is unable at this time to estimate with greater precision the number of LECs that would qualify as small business concerns under the SBA's definition. Consequently, the Commission estimates that fewer than 1,560 providers of local exchange service, or of competitive access or competitive local exchange services are small entities or small entities that may be affected by the actions taken in this Third R&O.

A-Block LMDS Providers. The total number of A-block LMDS licenses is limited to 493, one for each Basic Trading Area. The Commission has held auctions for all 493 licenses, in which it defined “very small business” (average gross revenues for the three preceding years of not more than $15 million), “small business” (more than $15 million but not more than $40 million), and “entrepreneur” (more than $40 but not more than $75 million) bidders. There have been 99 winning bidders that qualified in these categories in these auctions all of which may be affected by the actions taken in this Third R&O

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

The Commission has developed its own definition of a small cable system operator for the purposes of rate regulation. Under the Commission's rules, a “small cable company” is one serving fewer than 400,000 subscribers nationwide. Based on its most recent information, the Commission estimates that there were 1,439 cable operators that qualified as small cable system operators at the end of 1995, and that there are currently fewer than 1,439 small entity cable system operators.

The Communications Act also contains a definition of a small cable system operator, which is “a cable operator that, directly or through an affiliate, serves in the aggregate fewer than 1 percent of all subscribers in the United States and is not affiliated with any entity or entities whose gross annual revenues in the aggregate exceed $250,000,000.” The Commission has determined that there are 66 million subscribers in the United States. Therefore, the Commission found that an operator serving fewer than 660,000 subscribers shall be deemed a small operator, if its annual revenues, when combined with the total annual revenues of all of its affiliates, do not exceed $250 million in the aggregate. Based on available data, the Commission finds that the number of cable operators serving 660,000 subscribers or less totals 1,450. The Commission does not request or collect information concerning whether cable system operators are affiliated with entities whose gross annual revenues exceed $250 million, and thus are unable at this time to estimate with greater precision the number of cable system operators that would qualify as small cable operators under the definition in the Communications Act. It should be further noted that recent industry estimates project that there will be a total of 66 million subscribers.

The actions taken in the Third R&O entail no new or revised reporting, recordkeeping or other compliance requirements.

Although the Commission LMDS eligibility restriction was initially intended to stimulate competition between all sorts of entities, including small entities, only two of the 19 comments that were filed ask that the restriction be retained. The restriction was adopted with a June 30, 2000, sunset date to allow sufficient time for the Commission to conduct a thorough review of the effectiveness of the restriction. The Commission first adopts the 39 GHz approach to determine if the restriction should be extended. Two other alternative standards exist. The first alternative allows that the incumbent LECs or cable companies continue to have substantial market power in the provision of local telephone or cable television services. Two commenters urge the Commission to retain the restriction using the market dominance standard and arguing that LECs and cable companies remain dominant in their respective markets. As discussed in paragraphs 10-11 of the Third R&O, the Commission rejects continued use of the market power standard, because the substantial market power test does not address whether the incumbents are able to preclude competition in other markets which LMDS licensees wish to enter. No comments were submitted in support of the second option that would provide that the incumbent companies possess the incentive and ability to purchase the LMDS block to prevent entry of a competitor.

Thus, the Commission, in the Third R&O concludes that the 39 GHz test is the appropriate standard to apply in determining whether the LMDS eligibility should sunset. The 39 GHz test is a more discerning standard than the standard market power test in that it not only considers the broadest set of market facts and circumstances, but it also will allow the Commission to focus on the issues it needs to decide—whether the incumbents are likely to use their market power to cause substantial competitive harm by preventing the use of LMDS spectrum for services that would otherwise be provided by LMDS licensees, and whether the restrictions will prevent such actions. Paragraphs 8-9 of the Third R&O present a complete discussion of the benefits of the 39 GHz standard.

Finally, as discussed in paragraphs 22-33 of the Third R&O, the Commission has considered the benefits of allowing the eligibility restriction to expire as opposed to the benefits of extending it, and determines, with the support of the large majority of commenters, that allowing the restriction to sunset offers the most benefit to the most parties. Small businesses in particular stand to benefit from removal of the eligibility restriction. Paragraphs 28-32 of the Third MO&O, for example, discuss the effect of the LMDS eligibility restriction on small and rural carrier LMDS deployment, finding that the restriction causes undue hardship for rural carriers, of which many are small entities, possibly in violation of the Telecommunications Act of 1996. Commenters who argue against retaining the restriction contend that application of the restriction to rural telephone companies imposes significant economic and social costs, that communities served by rural ILEC's are often not sufficiently lucrative markets to attract other providers, that competitive concerns are not applicable in a rural market, and that rural carriers lack the resources to warehouse spectrum. For these reasons, the Commission believes that small businesses will benefit from allowing the LMDS eligibility restriction to sunset rather than to retain the restriction.

Report to Congress: The Commission will send a copy of this Third Report and Order and Memorandum Opinion and Order, including this FRFA, in a report to be sent to Congress pursuant to the Small Business Regulatory Enforcement Fairness Act of 1996, 5 U.S.C. 801(a)(1)(A). In addition, the Commission will send a copy of the Third Report and Order and Memorandum Opinion and Order and this FRFA to the Chief Counsel for Advocacy of the Small Business Administration.

It is ordered, that 47 CFR 101.1003 is removed. This modification shall become effective on June 30, 2000. (This rule modification may become effective on less than 30 days' notice because it relieves a restriction. See 5 U.S.C. 553((d))((1). Moreover, the Commission finds good cause to make this modification effective on less than 30 days' notice because the restriction in the previous rule terminates on June 30, 2000. See 5 U.S.C. 553(d)(3).)

The Commission's Office of Public Affairs, Reference Operations Division, shall send a copy of this MO&O and FNPRM, including the Initial Regulatory Flexibility Analysis, to the Chief Counsel for Advocacy of the Small Business Administration in accordance with section 603(a) of the Regulatory Flexibility Act of 1980, Public Law 96-354, 94 Stat. 1164, 5 U.S.C. 601-612 (1980).

Federal Communications Commission.