The regulations in paragraph (a)(2) of section 351.801 of 5 CFR part 351 were published on June 8, 1993, implementing section 4433 of the National Defense Authorization Act for Fiscal Year 1993 (Pub. L. 102-484). The statute provided that Department of Defense employees who received reduction in force notices between January 20, 1993, and January 31, 1998, were entitled to a 120 day notice period if a significant number of employees were affected. Later, Public Law 103-337 was enacted. This law extended the requirement for a longer notice period until January 31, 2000. Because this section of the Public Law is expiring, OPM is deleting the regulatory material in 5 CFR part 351 that contains these requirements.

I certify that this regulation will not have a significant economic impact on a substantial number of small entities because it affects only Federal employees.

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

On November 1, 1999, the Board published a proposal to amend its rules of practice and procedure at 5 CFR 1201.21(d), regarding the notice an agency must provide when it takes an appealable action against an employee who has both a right to appeal to the Board and a right to file a grievance under a grievance procedure, and 5 CFR 1201.154(d), regarding the procedures for seeking Board review of a final decision on a grievance (64 FR 58798). The proposed rule requested public comments and allowed 60 days, until January 3, 2000, for receipt of comments.

Comments were received from the Special Counsel, a Federal agency, a labor organization representing Postal Service employees, and a private practitioner who represents appellants before MSPB. The Special Counsel, the labor organization, and the practitioner all supported the proposed rule, and the Federal agency had no objection to it.

Both the Special Counsel and the practitioner suggested that the Board further amend the requirements for agency notices at 5 CFR 1201.21(d). The practitioner suggested that the Board require agencies to spell out the options for “other elections” to “make sure that each filing option and its preclusive effect is covered in the agency notice.” The Special Counsel suggested that the Board require agencies to include notice of the right to file a prohibited personnel practice complaint with the Special Counsel and the requirement for making an election among a grievance, an appeal to MSPB, and a complaint to the Special Counsel.

Each of these suggestions would expand the proposed amendment to 5 CFR 1201.21(d) beyond what it was originally meant to do—require agencies to spell out the options available between the MSPB appeal procedure and any applicable grievance procedure, and the consequences of choosing one or the other. The proposed rule was directed at a problem with notices identified in Board cases involving Postal Service employees. The Board has not identified a pattern of cases where such problems occur with any regularity with other agencies or in situations other than where an appellant has a right to challenge an agency personnel action under both the MSPB appeal procedure and a grievance procedure.

In particular cases, statutory complaint procedures other than the MSPB appeal procedure also may be available, depending on the nature of the claims raised by the appellant. For example, an appellant who claims prohibited discrimination may be able to file a complaint under the regulations of the Equal Employment Opportunity Commission. An appellant who claims that the agency's action was the result of a prohibited personnel practice may be able to file a complaint with the Special Counsel. An appellant who claims that the action was the result of an unfair labor practice may be able to pursue the matter before the Federal Labor Relations Authority.

Imposing a generally applicable all-inclusive notice requirement that would cover all of the possible situations that could occur would place a major burden on agencies to somehow anticipate all options for all claims that an employee might raise. It would also produce more complex notices that could prove extremely confusing to appellants and result in filings under one or more statutory procedures that do not apply to the appellant's particular case. Therefore, the Board is amending 5 CFR 1201.21(d) as proposed, without change.

The Federal agency asked if the Board could provide specific language for agencies to use in their notices. We believe that the regulations sufficiently spell out the requirements for agency notices and that further advice goes beyond our adjudicatory role.

The practitioner also suggested that the references to 5 U.S.C. 7121 and 7702 in 5 CFR 1201.154(d) be expanded to include explanations of what the statutes require and how they operate. While it is impractical for the Board to spell out in detail the grievance procedures set out in 5 U.S.C. 7121, the Board agrees that 5 CFR 1201.154(d) can be clarified. This subsection is amended in the final rule to specify that it applies where an appellant, other than an employee of the Postal Service or an employee otherwise excluded from the Federal Labor-Management Relations Statute, requests Board review of a final decision on a grievance and alleges prohibited discrimination before the Board. The amendment also includes a clarifying statement that a final decision on a grievance is usually the decision of an arbitrator. As to explaining the mixed case procedures of 5 U.S.C. 7702, this is accomplished by subpart E of part 1201, of which section 1201.154 is a part.

The Board is publishing this rule as a final rule pursuant to 5 U.S.C. 1204(h).

Administrative practice and procedure, Civil rights, Government employees.

This interim final rule is issued under Marketing Agreement No. 98 and Marketing Order No. 945, both as amended (7 CFR part 945), regulating the handling of Irish potatoes grown in certain designated counties in Idaho, and Malheur County, Oregon, 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 interim final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This action is not intended to have retroactive effect. 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. A handler is afforded the opportunity for a hearing on the petition. After the hearing the Secretary would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review the Secretary's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.

Sections 945.51 and 945.52 of the order provide authority for the establishment and modification of regulations applicable to the handling of potatoes. Section 945.341 establishes minimum maturity and pack requirements for potatoes handled subject to the Idaho-Eastern Oregon potato marketing order. Current requirements provide, in part, that all potatoes packed in cartons shall be inspected and certified as meeting U.S. No. 1 grade or better. All varieties shall meet the maturity requirement of slightly skinned (except the Norgold variety from August 1-15, and the White Rose and red skinned varieties from August 1-December 31 can be moderately skinned). During other periods of the year, the White Rose and red skinned varieties are not subject to maturity requirements. Size shall be conspicuously marked on all cartons (except when used as a master container). The grade requirements are based on the U.S. Standards for Grades of Potatoes (7 CFR 51.1540-51.1566), and the size must be marked consistent with § 51.1545 of the standards.

This rule will relax pack requirements to allow handlers to ship U.S. No. 2 grade potatoes in one-piece 50-pound fiberboard cartons of natural kraft color provided the carton is permanently and conspicuously marked as to grade. This will enable handlers to ship a substantial amount of U.S. No. 2 potatoes in cartons, thus meeting customer demands and maximizing producer returns.

The Idaho-Eastern Oregon Potato Committee, the agency responsible for local administration of the marketing order, met on January 18, 2000, and again by telephone on February 3, 2000, and unanimously recommended the relaxation of pack requirements to allow handlers to ship U.S. No. 2 or better grade potatoes in one-piece 50-pound fiberboard cartons of natural kraft color provided the cartons are permanently and conspicuously marked as to grade.

To meet the needs of the food service industry, the Committee recommended the relaxation of pack requirements to allow handlers to ship U.S. No. 2 grade potatoes in one-piece 50-pound fiberboard cartons of natural kraft color that are permanently and conspicuously marked as to grade. Currently, potatoes packed in cartons are required to grade at least U.S. No. 1. At its meeting on January 18, 2000, the unanimous consensus of the Committee was that pack requirements should be relaxed. The Committee then conducted a telephone vote on February 3, 2000, and unanimously passed a motion to relax the pack requirements.

Customers have been requesting U.S. No. 2 grade potatoes in 50-pound cartons because of difficulties encountered in handling the currently used 50-pound burlap or paper bags. The burlap bags are messy, difficult to handle, and do not stack well on pallets. The paper bags often tear and are equally difficult to handle or stack. Warehouses that use electronic bar codes have reported less administration and recordkeeping problems with cartons than bags because the codes are more legible on cartons.

Many customers now purchase potatoes from other areas where U.S. No. 2 potatoes are packed in 50-pound cartons. The Committee would like to respond to these changing market conditions so that handlers will remain competitive with the other areas and not lose sales.

The Committee also recognized the need to distinguish these U.S. No. 2 grade potatoes in cartons from the industry's traditional premium U.S. No. 1 grade pack in cartons. Without such a distinction, buyers might become confused and the U.S. No. 2 grade potatoes in cartons might have a price depressing effect on the premium U.S. No. 1 grade pack in cartons. The Committee was also concerned that buyers not have the opportunity to re-lid cartons with misleading or erroneous information on the pack and grade of the potatoes. Therefore the Committee included in their recommendation that the fiberboard cartons be of one-piece construction, of a natural kraft color, and permanently and conspicuously marked to grade.

Pursuant to the requirements set forth in the Regulatory Flexibility Act (RFA), the Agricultural Marketing Service (AMS) has considered the economic impact of this action 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 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 63 handlers of Idaho-Eastern Oregon potatoes who are subject to regulation under the marketing order and about 1,600 potato producers in the regulated area. Small agricultural service firms, which include potato handlers, have been defined by the Small Business Administration (13 CFR 121.201) as those having annual receipts of less than $5,000,000, and small agricultural producers are defined as those whose annual receipts are less than $500,000. A majority of these handlers and producers may be classified as small entities.

This rule would relax pack requirements to allow handlers to ship U.S. No. 2 grade potatoes in one-piece 50-pound fiberboard cartons of natural kraft color provided the cartons are permanently and conspicuously marked as to grade. This would enable handlers to ship a substantial amount of U.S. No. 2 potatoes in cartons, thus meeting customer demands and maximizing producer returns.

The Idaho-Eastern Oregon Potato Committee, the agency responsible for local administration of the marketing order, met on January 18, 2000, and again by telephone on February 3, 2000, and unanimously recommended the relaxation of pack requirements.

The relaxation of pack requirements to allow handlers to ship U.S. No. 2 grade potatoes in one-piece 50-pound fiberboard cartons of natural kraft color provided the cartons are permanently and conspicuously marked as to grade is expected to allow the industry to ship more potatoes. Currently, potatoes packed in cartons are required to grade at least U.S. No. 1. At its meeting on January 18, 2000, the unanimous consensus of the Committee was that pack requirements should be relaxed. The Committee then conducted a telephone vote on February 3, 2000, and unanimously passed the pack relaxation motion.

Customers have been requesting U.S. No. 2 grade potatoes in 50-pound cartons because of difficulties experienced in handling the currently used 50-pound burlap or paper bags. The burlap bags are messy, difficult to handle, and do not stack well on pallets. The paper bags often tear and are equally difficult to handle or stack. Warehouses that use electronic bar codes have reported less administration and recordkeeping problems with cartons than bags because the codes are more legible on cartons.

Many customers now purchase potatoes from other areas where U.S. No. 2 potatoes are packed in 50-pound cartons. The Committee would like to respond to these changing market conditions so that handlers will remain competitive with other areas and not lose sales.

The Committee also recognized the need to distinguish the U.S. No. 2 grade potatoes in cartons from this industry's traditional premium U.S. No. 1 grade pack in cartons. Without such a distinction, buyers might become confused and the U.S. No. 2 grade potatoes in cartons might have a price depressing effect on the premium U.S. No. 1 grade pack in cartons. The Committee was also concerned that buyers not have the opportunity to re-lid cartons with misleading or erroneous information on the pack and grade of the potatoes. Therefore, the Committee included in its recommendation that the fiberboard cartons be of one-piece construction, of a natural kraft color, and be permanently and conspicuously marked to grade.

At the meetings the Committee discussed the impact of allowing U.S. No. 2 potatoes in one-piece 50 pound cartons. The Committee believes that the recommendation should increase the sale of U.S. No. 2 grade potatoes to the food service industry. Information from the Committee indicates that during an average season, approximately 10 percent of the fresh potato shipments from the production area are of U.S. No. 2 grade, and that approximately 20 percent of the potatoes going to the food service industry are of U.S. No. 2 grade. This action is expected to further increase shipments to the food service industry, and help the Idaho-Eastern Oregon potato industry benefit from the increased growth in the food service industry.

The relaxation of pack requirements allowing handlers to ship U.S. No. 2 grade potatoes in cartons might require the purchase of new equipment that can handle one-piece cartons. However, these costs are expected to be minimal and would be offset by the benefits of being able to ship U.S. No. 2 grade potatoes in that manner. The benefits of this rule are not expected to be disproportionately greater or lesser for small entities than large entities.

As alternatives to this action, the Committee considered various alternatives to distinguish U.S. No. 2 grade potatoes packed in cartons from the traditional premium carton pack of U.S. No. 1 grade potatoes. The Committee decided that it was important that there be a clear distinction between the packs to ensure that the shipments of U.S. No. 2 potatoes in cartons not negatively impact the market for U.S. No. 1 potatoes in cartons.

This rule will not impose any additional reporting or recordkeeping requirements on either small or large potato handlers and importers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sectors. The Department has not identified any relevant Federal rules that duplicate, overlap, or conflict with this rule.

Further, the Committee's meetings were widely publicized throughout the potato industry, and all interested persons were invited to attend the meetings and participate in Committee deliberations. Like all Committee meetings, the January 18, 2000, meeting was a public meeting and all entities, both large and small, were able to express their views on this issue. The Committee itself is composed of eight members, of whom three are handlers and five are producers. Finally, interested persons are invited to submit information on the regulatory and informational impacts of this action on small businesses.

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

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

A 60-day comment period is provided to allow interested persons to respond to this interim final rule. All written comments timely received will be considered before a final determination is made on this matter.

Pursuant to 5 U.S.C. 553, it also is 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 action until 30 days after publication in the Federal Register because: (1) The Committee unanimously recommended this relaxation in pack requirements; (2) handlers would like to take advantage of the relaxation as soon as possible to better meet buyer needs; (3) handlers are aware of this action which was discussed by the Committee at public meetings; and (4) handlers are currently shipping U.S. No. 2 grade potatoes.

For the reasons set forth above, 7 CFR part 945 is amended as follows:

A proposal to amend part 39 of the Federal

Aviation Regulations (14 CFR part 39) by superseding AD 93-20-02, amendment 39-8709 (58 FR 53635, October 18, 1993), which is applicable to certain McDonnell Douglas Model DC-8 series airplanes, was published in the Federal Register on December 22, 1999 (64 FR 71689). The action proposed to continue to require a revision to the Airplane Flight Manual Supplement (AFMS) to ensure that the main deck cargo door is closed, latched, and locked; repetitive inspections of the wire bundle and door latch rollers to detect damage; and repair or replacement of damaged components. The action also proposed to require, among other actions, modification of the indication and hydraulic systems of the main deck cargo door, and installation of a means to prevent pressurization to an unsafe level if the main deck cargo door is not closed, latched, and locked.

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

One commenter requests that the proposed AD be revised to include a statement that any AMOC approved previously in accordance with AD 93-20-02 is acceptable for compliance with paragraph (b) of this AD. The commenter states that it has received FAA approval of an AMOC to paragraph (a) of AD 93-20-02 for an installation of a door warning system that includes an Airplane Flight Manual Supplement (AFMS) other than that approved for STC SA1802SO.

The FAA concurs. AMOC approvals to paragraph (a) or (b) of AD 93-20-02 continue to apply to paragraphs (a) and (b) of this final rule, respectively. Therefore, the FAA has revised paragraph (g) of the final rule accordingly. However, operators that received AMOC's to AD 93-20-02 must still comply with the requirements of paragraphs (c), (d), and (e) of this AD.

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

There are approximately 32 Model DC-8 series airplanes of the affected design in the worldwide fleet. The FAA estimates that 29 airplanes of U.S. registry will be affected by this AD.

The actions that are currently required by AD 93-20-02, and retained is this AD, take approximately 1 work hour per airplane to accomplish, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of the currently required actions on U.S. operators is estimated to be $1,740, or $60 per airplane, per inspection cycle.

It will take 1 work hour per airplane to accomplish the new replacement of circuit breakers, at an average labor rate of $60 per work hour. Required parts will cost approximately $265 per airplane. Based on these figures, the cost impact of this new replacement required by this AD on U.S. operators is estimated to be $9,425, or $325 per airplane.

It will take 80 work hours per airplane to accomplish the new modification of the hydraulic systems, at an average labor rate of $60 per work hour. Required parts will cost approximately $20,000 per airplane. Based on these figures, the cost impact of this new modification required by this AD on U.S. operators is estimated to be $719,200, or $24,800 per airplane.

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

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

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

The Securities and Exchange Commission (“Commission”) today is adopting new rule 17f-7 [to be codified at 17 CFR 270.17f-7], amendments to rule 17f-5 [17 CFR 270.17f-5] and conforming amendments to rule 7d-1 [17 CFR 270.7d-1] and rule 17f-4 [17 CFR 270.17f-4] under the Investment Company Act of 1940 [15 U.S.C. 80a] (the “Investment Company Act”). 1

The Commission is adopting new rule 17f-7 under the Investment Company Act and amendments to rule 17f-5, the rule that governs the custody of the assets of registered management investment companies (“funds”) with custodians outside the United States. The new rule and rule amendments will permit funds to maintain their assets in foreign securities depositories based on conditions that reflect the operations and role of these depositories. Depositories are systems for the central handling of securities in which transactions in securities are processed through adjustment of electronic account records rather than delivery of certificates.

The rule and amendments we are adopting today establish basic standards for foreign depositories that funds may use, and generally require that a fund's contract with its global custodian obligate the custodian to analyze and monitor the custody risks of using a depository, and provide information about the risks to the fund or its adviser, as well as any information regarding material changes in the risks. Unlike amended rule 17f-5, rule 17f-7 does not contain any provisions regarding the delegation of authority under the rule. Decisions to maintain assets with a depository would be made by the fund or its adviser, based upon information provided by the global custodian.

Rule 17f-5 was adopted in 1984, 2 and extensively revised in 1997 (“1997 Amendments”) to reflect significant developments in foreign investment by U.S. funds and the Commission's greater experience with foreign custody arrangements. 3 The 1997 Amendments expanded the types of foreign banks and securities depositories that may serve as custodians of fund assets, and required that the selection of a foreign custodian be based on whether the fund's assets will be subject to reasonable care if maintained with that custodian. 4 In 1998, as a result of difficulties experienced by funds, their advisers and bank custodians in applying the standards of rule 17f-5 to the use of foreign depositories, representatives of funds asked the Commission to delay the compliance date for the 1997 Amendments. 5 The Commission suspended the compliance date for most of the 1997 Amendments in May 1998. 6 Representatives of funds and bank custodians then submitted a proposal to further amend rule 17f-5 to change the standards by which foreign depositories are evaluated. 7

PDMA (Public Law 100-293) was enacted on April 22, 1988, and was modified by the PDA (Public Law 102-353, 106 Stat. 941) on August 26, 1992. The PDMA as modified by the PDA amended sections 301, 303, 503, and 801 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 331, 333, 353, 381) to, among other things, establish requirements for the wholesale distribution of prescription drugs.

Section 503(e)(1)(A) of the act states that each person who is engaged in the wholesale distribution of a prescription drug who is not the manufacturer or an authorized distributor of record for the drug must, before each wholesale distribution of a drug, provide to the person receiving the drug a statement (in such form and containing such information as the Secretary may require) identifying each prior sale, purchase, or trade of the drug, including the date of the transaction and the names and addresses of all parties to the transaction. Section 503(e)(4)(A) of the act states that, for the purposes of section 503(e), the term “authorized distributors of record” means those distributors with whom a manufacturer has established an “ongoing relationship” to distribute the manufacturer's products.

On December 3, 1999, the agency published final regulations in part 203 (21 CFR part 203) implementing these and other provisions of PDMA (64 FR 67720). Section 203.50 requires that, before the completion of any wholesale distribution by a wholesale distributor of a prescription drug for which the seller is not an authorized distributor of record to another wholesale distributor or retail pharmacy, the seller must provide to the purchaser a statement identifying each prior sale, purchase, or trade of the drug. The identifying statement must include the proprietary and established name of the drug, its dosage, the container size, the number of containers, lot or control numbers of the drug being distributed, the business name and address of all parties to each prior transaction involving the drug, starting with the manufacturer, and the date of each previous transaction. Section 203.3(b) defines “authorized distributor of record” as a distributor with whom a manufacturer has established an ongoing relationship to distribute the manufacturer's products. “Ongoing relationship” is defined in 203.3(u) to mean an association that exists when a manufacturer and a distributor enter into a written agreement under which the distributor is authorized to distribute the manufacturer's products for a period of time or for a number of shipments. If the distributor is not authorized to distribute a manufacturer's entire product line, the agreement must identify the specific drug products that the distributor is authorized to distribute.

Thus, the final rule requires unauthorized distributors (i.e., those distributors who do not have a written authorization agreement) to provide a drug origin statement to purchasers showing the entire prior sales history of the drug back to the first sale by the manufacturer. As discussed in the preamble to the final rule (64 FR 67720 at 67747), manufacturers and authorized distributors of record are not required to provide an identifying statement when selling a drug, although the agency encouraged them to do so voluntarily to permit unauthorized distributors to continue to be able to purchase products from them. 1

The provisions in the final rule related to wholesale distribution of prescription drugs by unauthorized distributors (i.e., §§ 203.3(u) and 203.50) were adopted from the provisions in the proposed rule published in the Federal Register of March 14, 1994 (59 FR 11842), and are essentially the same as the proposed provisions, except the definition for “ongoing relationship” in the proposed rule was revised to eliminate certain requirements. 2 The agency received two comments on the proposed definition of ongoing relationship and one comment on proposed § 203.50, and responded in detail to those comments in the preamble to the final rule (see 64 FR 67720 at 67727, 67728, and 67747).

Section 503(c)(3)(A) of the act states that no person may sell, purchase, or trade, or offer to sell, purchase, or trade any drug that was purchased by a public or private hospital or other health care entity. Section 503(c)(3)(B) states several exceptions to section 503(c)(3)(A), none of which are relevant to this discussion. Section 503(c)(3) also states that “[f]or purposes of this paragraph, the term ‘entity’ does not include a wholesale distributor of drugs or a retail pharmacy licensed under State law.”

In the final rule of December 3, 1999, § 203.20 provides, with certain exceptions, that no person may sell, purchase, or trade, or offer to sell, purchase, or trade any prescription drug that was purchased by a public or private hospital or other health care entity or donated or supplied at a reduced price to a charitable organization. In § 203.3(q) of the final rule, “Health care entity” is defined as meaning any person that provides diagnostic, medical, surgical, or dental treatment, or chronic or rehabilitative care, but does not include any retail pharmacy or wholesale distributor. Under both the act and the final rule, a person could not simultaneously be a health care entity and a retail pharmacy or wholesale distributor. Thus, under the final rule, blood centers functioning as health care entities could not engage in wholesale distribution of prescription drugs, except for blood and blood components intended for transfusion, which are exempt from the PDMA under § 203.1 of the final rule. Blood and blood components include whole blood, red blood cells, platelets and cryoprecipitated antihemophilic factor which are prepared by blood banks who collect blood from donors and separate out the components using physical or mechanical means. Blood derivatives are derived from human blood, plasma, or serum through a chemical fractionation manufacturing process. Examples of blood derivative products include albumin, antihemophilic factor, immune globulin, and alpha-1 anti-tripsin. As discussed in the preamble to the final rule in response to comments (64 FR 67720 at 67725, 67726, and 67727), blood derivative products are not blood or blood components intended for transfusion and therefore could not be distributed by health care entities, including full service blood centers that function as health care entities, after the final rule goes into effect.

Since publication of the final rule, the agency has received letters and petitions and has had other communications with industry, industry trade associations, and members of Congress objecting to the provisions in §§ 203.3(u) and 203.50. In early February 2000, the agency met with representatives from the wholesale industry and industry associations. The meeting participants discussed their concerns with both: (1) The requirement in § 203.3(u) that there be a written authorization agreement between a manufacturer and distributor for the distributor to be considered an authorized distributor of record under § 203.3(b), and (2) the requirement in § 203.50 that unauthorized distributors provide an identifying statement showing all prior sales going back to the manufacturer.

The meeting participants asserted that manufacturers are unwilling to enter into written authorization agreements with the majority of smaller wholesalers so that these wholesalers cannot become authorized distributors of record for the drugs they sell and, hence, must provide an identifying statement for these drugs. The meeting participants also said that smaller wholesalers cannot obtain an identifying statement showing all prior sales of the drugs they purchase for sale because a large portion of these drugs are purchased from authorized distributors who are not required to provide identifying statements and are unwilling to voluntarily provide them. The meeting participants asserted that authorized distributors will not voluntarily provide identifying statements when they sell drugs to unauthorized distributors because it would require them to change their warehouse and business procedures, which would entail additional effort and expense.

The meeting participants asserted that implementation of the final rule will prevent over 4,000 smaller, unauthorized distributors from distributing drugs to their customers and may put them out of business, at least with respect to their prescription drug wholesale business. They also asserted that because many of their customers are smaller retail outlets that are not served by larger distributors, implementation of the final rule may leave certain markets for prescription drugs, and ultimately consumers for prescription drugs, underserved.

In addition to the meeting discussed above and other informal communications that FDA has had with industry, industry associations, and Congress, FDA received a petition for stay of action requesting that the relevant provisions of the final rule be stayed until October 1, 2001. The agency also received a petition for reconsideration from the Small Business Administration (SBA) requesting that FDA reconsider the final rule and suspend its effective date based on the projected severe economic impact it would have on over 4,000 small businesses. The petitions argued that the requirement for a written agreement in § 203.3(u) is unreasonable because manufacturers are not willing to enter such agreements with the majority of smaller distributors. The petitions also asserted that authorized wholesalers are not now able and could not provide, at a reasonable cost, an identifying statement to their unauthorized distributor customers that meets the requirements of § 203.50 of the final rule. The SBA petition asserted that, if the effective date of the final rule is not stayed, drug products now in the inventory of wholesalers will have to be cleared and new orders will have to cease or be severely limited in order to comply with the final rule's December 4, 2000 effective date, with corresponding disruptions in the distribution of drugs possible by summer, 2000.

Since the time of the proposed rule, FDA has received 2 letters, one from a large blood center and the other from an association representing the blood center industry, and has held several meetings to discuss the implications of the regulations on blood centers that distribute blood derivative products and provide health care as a service to the hospitals and patients they serve. The blood center industry asserts that the regulations and, particularly the definition of “health care entity,” will severely inhibit their ability to provide full service care to the detriment of client hospitals and the patients they serve, and may disrupt the distribution of these products to the public. The agency has also received a letter from a member of Congress on this issue. Although the agency was aware of this issue at the time the final rule was published, we believed that application of § 203.3(q) to blood centers would not result in a disruption in the distribution of blood derivative products. However, comments and information provided by representatives of the blood center industry have persuaded us that the final rule could disrupt the availability of blood derivative products to the public.

Based on the concerns expressed by industry, industry associations, and Congress about implementing §§ 203.3(u) and 203.50 by the December 4, 2000, effective date, the agency has decided to delay the effective date for those sections of the final rule until October 1, 2001. Additionally, the agency has decided to delay the applicability of § 203.3(q) to wholesale distribution of blood derivatives by health care entities, until October 1, 2001. All other provisions of the rule will become effective on December 4, 2000. This action should not be construed to indicate that FDA necessarily agrees with or has made decisions about the substantive arguments made in the petitions and other submissions related to implementation of §§ 203.3(u) and 203.50 or § 203.3(q), as it applies to wholesale distribution of blood derivatives by health care entities.

The agency believes that providing additional time before these are to become effective is appropriate to permit the agency to obtain more information about the possible consequences of implementing these provisions, to further evaluate the issues involved, and to seek a legislative resolution to these issues, if necessary. Therefore, the agency is reopening the administrative record to receive additional comments on these provisions from interested individuals. Regarding §§ 203.3(u) and 203.50, the agency is especially interested in gaining further insight into the potential impact of the provisions on the wholesale distribution system generally, and on the ability of smaller pharmacies and other prescription drug retailers to obtain prescription drugs. In addition, the agency is seeking comments on the potential economic impact of the provisions on smaller wholesale distributors that are not authorized distributors of record. Regarding § 203.3(q), the agency also invites comment on the economic and public health impact of including full service blood centers under the definition of “health care entity,” thereby prohibiting the wholesale distribution of blood derived products by such entities.

Interested persons may submit to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, written comments regarding this proposal by July 3, 2000. Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

This action is being taken under FDA's authority under 21 CFR 10.35(a). The Commissioner of Food and Drugs finds that this delay of the effective date is in the public interest.

Global Pharmaceutical Corp., Castor and Kensington Aves., Philadelphia, PA 19124, has informed FDA of a change of sponsor's name and address to IMPAX Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544. Accordingly, the agency is amending the regulations in 21 CFR 510.600(c)(1) and (c)(2) to reflect the change of sponsor's name and address.

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.

This document is available as an electronic file on The Federal Bulletin Board the day of publication in the Federal Register. By modem, dial 202/512-1387 and type “/GO FAC,” or call 202/512-1530 for disk or paper copies. This file is available for downloading without charge in ASCII and Adobe Acrobat® readable (*.PDF) formats. For Internet access, the address for use with the World Wide Web (Home Page), Telnet, or FTP protocol is: fedbbs.access.gpo.gov. This document and additional information concerning the programs of the Office of Foreign Assets Control are available for downloading from the Office's Internet Home Page: http://www.treas.gov/ofac, or in fax form through the Office's 24-hour fax-on-demand service: call 202/622-0077 using a fax machine, fax modem, or (within the United States) a touch-tone telephone.

On March 17, 2000, Secretary of State Madeleine K. Albright announced that economic sanctions against Iran would be eased to allow Americans to purchase and import carpets and food products such as dried fruits, nuts, and caviar from Iran. To implement this policy, the Treasury Department's Office of Foreign Assets Control (“OFAC”) is amending the Iranian Transactions Regulations, 31 CFR part 560 (the “Regulations”), to authorize, by general license, the importation into the United States of, and dealings in, certain Iranian-origin foodstuffs and carpets and related transactions.

Section 560.534(a) of this final rule authorizes the importation into the United States of Iranian-origin foodstuffs intended for human consumption that are classified under chapters 2-23 of the Harmonized Tariff Schedule of the United States (“HTS”). Items that are classified in chapters 2-23 of the HTS that are not foodstuffs intended for human consumption are not authorized for importation into the United States by this section. This final rule also authorizes the importation into the United States of Iranian-origin carpets and other textile floor coverings and carpets used as wall hangings that are classified under chapter 57 or heading 9706.00.0060 of the HTS. Items that are classified under heading 9706.00.0060 (“Antiques of an age exceeding one hundred years/Other”) that are not carpets and other textile floor coverings or carpets used as wall hangings are not authorized for importation into the United States by this section.

Section 560.534(b) of this rule authorizes U.S. persons, wherever located, to engage in transactions or dealings in such Iranian-origin foodstuffs and carpets, provided that such transactions or dealings do not involve a prohibited exportation to Iran or the Government of Iran. Section 560.534(c) sets forth the effect of this rule on open and closed enforcement actions initiated by the U.S. Government prior to the effective date of this final rule.

Transactions ordinarily incident to the transactions authorized in § 560.534 and necessary to give effect thereto also are authorized as set forth in § 560.405. Section 560.405 is amended to exclude from the scope of permitted incidental transactions letter of credit services relating to transactions authorized in § 560.534. See § 560.405(e). Those letter of credit services that are authorized are set forth separately in § 560.535. Forms of financing other than letters of credit are permitted as incidental transactions as set forth in § 560.405, provided that such forms of financing do not involve a debit or credit to an account of a person in Iran or of the Government of Iran maintained on the books of a U.S. depository institution. See § 560.534(d). Brokering services relating to transactions authorized by this final rule also are authorized. See § 560.535(c). Examples of transactions permitted under this final rule are set forth in §§ 560.534(e) and 560.535(e).

Technical changes are made to § 560.405, to clarify that loading of licensed cargo in Iran is a permitted incidental transaction, and to § 560.524, to clarify that the importation into the United States of qualifying household goods and personal effects is permitted regardless of the time elapsed since the importer's arrival in the United States from Iran.

Because the Regulations involve a foreign affairs function, Executive Order 12866 and the provisions of the Administrative Procedure Act (5 U.S.C. 553) (the “APA”) requiring notice of proposed rulemaking, opportunity for public participation, and delay in effective date, are inapplicable. Because no notice of proposed rulemaking is required for this rule, the Regulatory Flexibility Act (5 U.S.C. 601-612) does not apply.

The collections of information related to the Regulations are contained in 31 CFR part 501 (the “Reporting and Procedures Regulations”). Pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), those collections of information were previously approved by the Office of Management and Budget (“OMB”) under control number 1505-0164. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid control number.

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B) and 553(d)(3), the Coast Guard finds that good cause exists for not publishing an NPRM and making these regulations effective less than 30 days after the Federal Register publication. Publishing an NPRM and delaying the effective date would be contrary to national safety interests since immediate action is needed to minimize potential danger to the public as there will be numerous spectator craft in the area, the event date is scheduled for May 20, 2000, and the permit request was only recently received.

These regulations are required to provide for the safety of life on navigable waters because of the inherent danger of the storage and launching of fireworks in the vicinity of spectator craft in Charleston Harbor, Charleston, SC. These regulations prohibit non-participating vessels from entering the area surrounding the two fireworks barges.

This proposal is not a “significant regulatory action” under section 3(f) of Executive Order 12866 and does not require an assessment of potential costs and benefits under section 6(a)(3) of that order. The Office of Management and Budget has not reviewed it under that order. It is not “significant” under the regulatory policies and procedures of the Department of Transportation (DOT) (44 FR 11040: February 26, 1979). The Coast Guard expects the economic impact of this proposal to be so minimal that a full Regulatory Evaluation under paragraph 10(e) of the regulatory policies and procedures of DOT is unnecessary. The regulated area will only be in effect for approximately 1 1/2 hours.

Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ), the Coast Guard must consider whether this rule will have a significant economic effect upon a substantial number of small entities. “Small entities” include small business, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities as the regulations will only be in effect for 1 1/2 hours in a limited area and the event will be highly publicized.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-221), we offer to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process. Small entities may contact the person listed under FOR FURTHER INFORMATION CONTACT for assistance in understanding and participating in this rulemaking. We also have a point of contact for commenting on actions by employees of the Coast Guard. Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247).

This rule calls for no new collection of information requirements under the Paperwork Reduction Act (44 U.S.C. 3501 et seq. ).

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

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

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

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

We have analyzed this 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 safety that may disproportionately affect children.

The Coast Guard has considered the environmental impact of this action and has determined pursuant to Figure 2-1, paragraph 34(h) of Commandant Instruction M16475.1C, that this action is categorically excluded from further environmental documentation.

The Quincy Weymouth SR3A Bridge has a vertical clearance of 33 feet at mean high water and 43 feet at mean low water. The existing regulations for the bridge in 33 CFR 117.621 require the bridge to open on signal, except that; from 6:30 a.m. to 9 a.m. and 4:30 p.m. to 6:30 p.m., Monday through Friday, except holidays observed in the locality, the draw need not be opened. The draw shall open on signal at all times for self-propelled vessels greater than 10,000 gross tons.

The bridge owner, the Massachusetts Highway Department (MHD), asked the Coast Guard to allow the bridge to remain closed on May 6, 2000, from 8 a.m. to 12 p.m. to facilitate electrical repairs at the bridge.

In accordance with 33 CFR 117.35(c), this work will be performed with all due speed in order to return the bridge to normal operation as soon as possible. This deviation is authorized under 33 CFR 117.35.

The Sara Long (Route 1 Bypass) Bridge has a vertical clearance of 10 feet at mean high water and 18 feet at mean low water. The existing regulations for the bridge in 33 CFR 117.531(c) require the bridge to open on signal, except that; from 15 May through 31 October, from 7 a.m. to 7 p.m., the draw need be opened only at quarter of and quarter after the hour for recreational vessels and commercial vessels less than 100 gross tons except as provided in paragraph (a)(1). Paragraph (a)(1) states that vessels over 100 gross tons, inbound ferry service vessels and inbound commercial fishing vessels shall be passed through the draw as soon as possible without delay at any time.

The bridge owner, the New Hampshire Department of Transportation, asked the Coast Guard to allow the bridge to remain closed for 5 hours, 12 p.m. through 5 p.m., on May 17, 2000, to facilitate electrical repairs at the bridge.

In accordance with 33 CFR 117.35(c), this work will be performed with all due speed in order to return the bridge to normal operation as soon as possible. This deviation is authorized under 33 CFR 117.35.

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. Publishing an NPRM is impracticable because we received notice of this event very recently, not leaving time for both a NPRM and a delayed effective date. Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register .

On Sunday, May 21, 2000, the National Medical Center and Beckman Research Institute will be hosting their first annual 5K Run/Walk. Beginning at Trinity Park at 7:30 a.m., the run/walk participants will head south on Flagler Drive then head east on the Royal Park Bridge (estimated time of closure 7:25 a.m. to 7:45 a.m.), then the route will continue east on Royal Palm Way, turn north on Coconut Palm Way, then east on Royal Poinciana then head east on Flagler Bridge (estimated time of closure 7:25 a.m. until 8:15 a.m.) this provides the walkers from 7:32 a.m. until 8:15 a.m. to clear the final bridge.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866 and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Transportation (DOT) (44 FR 11040, February 26, l979) and the bridges will only remain closed for a maximum of 50 minutes and there will be less traffic because this is a Sunday morning.

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

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities as the bridges will only remain closed to traffic for a maximum of 50 minutes.

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

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

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

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

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

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

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

The Coast Guard considered the environmental impact of this rule and concluded that under figure 2-1, paragraph (32)(e), of Commandant Instruction M16475.lC, this rule is categorically excluded from further environmental documentation. A “Categorical Exclusion Determination” is available in the docket for inspection or copying where indicated under ADDRESSES.

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-300989. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

In the Federal Register of January 24, 2000 (65 FR 3682) (FRL-6399-6), and August 5, 1998 (63 FR 41835) (FRL-6017-1), EPA issued notices pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170) announcing the filing of pesticide petitions (PP) 9E6025 and 6F4754 for tolerances by the Interregional Research Project Number 4, New Jersey Agricultural Experiment Station, Rutgers University, New Brunswick, NJ 08903, and Novartis Crop Protection Inc., 18300 Greensboro, NC 27419-8300, respectively. These notices included a summary of petitions prepared by Novartis Crop Protection Inc., the registrant. There were no comments received in response to the notice of filing.

These petitions requested that 40 CFR 180.462 be amended by establishing tolerances for combined residues of the herbicide pyridate, [ O -(6-chloro-3-phenyl-4-pyridazinyl)- S -octyl-carbonothioate and the metabolite CL-9673 (6-chloro-3-phenyl-pyradazine-4-ol), and conjugates of CL-9673], in or on peppermint tops and spearmint tops at 0.20, Brassica, head and stem subgroup, and collards at 0.03 parts per million (ppm).

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. * * *”

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, and to make a determination on aggregate exposure, consistent with section 408(b)(2), for tolerances for combined residues of pyridate on peppermint tops and spearmint tops at 0.20 ppm, Brassica, head and stem subgroup, and collards at 0.03 ppm. EPA's assessment of the dietary exposures and risks associated with establishing the tolerances follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by pyridate are discussed in Unit II.A. of the Final Rule on Pyridate Pesticide Tolerance published in the Federal Register on October 7, 1998 (63 FR 53837) (FRL 6036-2).

1. Acute toxicity . The acute dietary endpoint selected for the acute dietary risk assessment was 20 milligrams/kilogram/day (mg/kg/day) based on the subchronic (90-day) dog study with a no observed adverse effect level (NOAEL) of 20 mg/kg/day. The lowest observed adverse effect level (LOAEL) was 60 mg/kg/day based on ataxia and emesis observed within 1-3 hours of dosing beginning on the first day. An uncertainty factor of 100 (10X for interspecies extrapolation and 10X for intraspecies variations) was used to determine the acute Reference Dose (RfD) of 0.2 mg/kg/day. The acute Population Adjusted Dose (aPAD) is equal to the acute RfD divided by the FQPA Safety Factor. Since the FQPA Safety Factor was reduced to 1X, the aPAD is equal to the acute RfD.

2. Chronic toxicity . EPA has established the chronic RfD for pyridate at 0.11 mg/kg/day. This RfD is based on a NOAEL of 10.8 mg/kg/day from the chronic/carcinogenicity study in rats where decreased body weight gain was reported at the LOAEL of 67.5 mg/kg/day. This dose was supported by the results of the 3-generation reproduction toxicity study. The NOAEL was 10.8 mg/kg/day based on the reported decrease in pup weights at 67.5 mg/kg/day on postnatal day 14 and 21 in both generations. An uncertainty factor of 100 (10X for interspecies extrapolation and 10X for intraspecies variation) was used to determine the chronic Reference Dose (cRfD) of 0.11 mg/kg/day. The chronic Population Adjusted Dose (cPAD) is equal to the chronic RfD divided by the FQPA Safety Factor. Since the FQPA Safety Factor was reduced to 1X, the cPAD is equal to the chronic RfD.

3. Carcinogenicity . Pyridate is not carcinogenic in either the rat or the mouse. Therefore, no carcinogenic endpoint was selected.

1. From food and feed uses . Tolerances have been established (40 CFR 180.462) for the combined residues of pyridate, in or on a variety of raw agricultural commodities. Permanent tolerances are established for combined residues of pyridate, the metabolite CL-9673, and conjugates of CL-9673 in/on cabbage, corn, and peanut at 0.03 ppm. Risk assessments were conducted by EPA to assess dietary exposures from pyridate as follows:

i. Acute exposure and risk . 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. Tier 1 acute dietary exposure analyses from food for pyridate were performed with the Dietary Exposure Evaluation Model (DEEM TM ) using published and proposed tolerance level residues and 100% crop treated (CT) for all commodities. Therefore, the acute risk was analyzed at the 95th percentile. The acute dietary risk estimates from food are less than 1% of the aPAD for the general U.S. population and all population subgroups. The results of the analyses indicate that the acute dietary risks from food associated with the existing and proposed uses of pyridate do not exceed EPA's level of concern for the U.S. population or any population subgroup.

ii. Chronic exposure and risk . Tier 1 chronic dietary exposure analyses from food for pyridate were performed with the DEEM TM using published and proposed tolerance level residues and 100% CT for all commodities. The chronic dietary risk from food estimates are less than 1% of the cPAD for the general U.S. population and all population subgroups. The results of the analyses indicate that the chronic dietary risks from food associated with the existing and proposed uses of pyridate do not exceed EPA's level of concern for the U.S. population or any population subgroup

2. From drinking water . Although pyridate does not possess the environmental fate parameters associated with a compound that could leach to ground water, the fate parameters of its degradate CL-9673 seem to indicate that it has the potential to leach to ground water especially in soils of low organic matter. In unusual conditions such as flooding, where an aerobic conditions exist in the top soil layers for up to 60 days, CL-9673 could persist and possibly leach to ground water or run off to surface water. Pyridate is not listed in the EPA Pesticides in Ground Water Database, nor is there an EPA Maximum Contaminant Level or health advisory.

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 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 run off 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 the estimates environmental concentration (EECs) from these models to quantify drinking water exposure and risk as a %RfD or %PAD. Instead drinking water levels of comparisons (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 pyridate, they are further discussed in the aggregate risk sections below.

EPA has calculated DWLOCs for both acute and chronic risks. To calculate the DWLOC for acute exposure relative to an acute toxicity endpoint, the acute dietary food exposure (from DEEM was subtracted from the aPAD to obtain the acceptable acute exposure to pyridate in drinking water. To calculate the DWLOC for chronic (non-cancer) exposure relative to a chronic toxicity endpoint, the chronic dietary food exposure (from DEEM) was subtracted from the cPAD to obtain the acceptable chronic (non-cancer) exposure to pyridate in drinking water. DWLOCs were then calculated using default body weights and drinking water consumption figures.

i. Acute exposure . Based on the GENEEC and SCI-GROW models the EECs of pyridate in drinking water for acute exposures are estimated to be 97 parts per billion (ppb) for surface water and 5 ppb for ground water.

ii. Chronic exposure . Based on the GENEEC and SCI-GROW models the EECs in drinking water for chronic exposures are estimated to be 25 ppb for surface water and 5 pbb for ground water.

3. From non-dietary exposure . There are no residential or non- occupational uses for pyridate; therefore, residential exposures are not expected.

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 pyridate 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, pyridate 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 pyridate 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. Acute risk . A high-end exposure estimate from residues in food was calculated for the general U.S. population and all population subgroups. The acute dietary exposure from food for all populations subgroups (<1% aPAD) is below EPA's level of concern. The maximum EECs of pyridate in surface and ground water are less than EPA's DWLOCs for pyridate as a contribution to acute aggregate exposure (Table 1).

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-300996. 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 June 24, 1998 (63 FR 34304) (FRL-5797-5), 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 time-limited tolerance for the residues of fludioxonil in or on apricots, nectarines, peaches and plums at 5.0 ppm, with an expiration date of December 31, 1999. EPA established the tolerances 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 fludioxonil on apricots, nectarines, peaches and plums for this year's growing season due to the continuation of the existing emergency conditions in California and South Carolina. These states requested the use of fludioxonil to control brown rot, gray mold rot, and rhizopus rot on these commodities. These fungal pathogens cause latent infection during the period from shuck fall through harvest. When a fruit matures, its disease resistance declines and latent fungal infection turns into a fruit lesion. Lesioned fruit becomes unmarketable. Harvested fruit were treated with the systemic fungicide iprodione up until 1996, when the manufacturer canceled the post-harvest use on stone fruit. During 1997, left over iprodione stock was used, however, many packing houses packed the fruit without a fungicide treatment, which resulted in significant yield and quality losses of the produce. Significant economic losses are expected to growers without the use of fludioxonil. After having reviewed the submission, EPA concurs that emergency conditions exist. EPA has authorized under FIFRA section 18 the use of fludioxonil on apricots, nectarines, peaches, and plums for control of brown rot, gray mold rot, and Rhizopus rot in California and South Carolina.

EPA assessed the potential risks presented by residues of fludioxonil in or on apricots, nectarines, peaches and plums. 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 June 24, 1998 (63 FR 34304). Based on that data and information considered, the Agency reaffirms that re-establishment of the time-limited tolerances will continue to meet the requirements of section 408(l)(6). Therefore, the time-limited tolerances are re-established for an additional 2-year period. EPA will publish a document in the Federal Register to remove the revoked tolerances from the Code of Federal Regulations (CFR). Although these tolerances will expire and are revoked on December 31, 2001, under FFDCA section 408(l)(5), residues of the pesticide not in excess of the amounts specified in the tolerances remaining in or on apricots, nectarines, peaches, and plums 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 these tolerances 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-300996 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 July 3, 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, Ariel Rios Bldg., 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, Ariel Rios Bldg., 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, Ariel Rios Bldg., 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-300996, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, Ariel Rios Bldg., 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 re-establishes time-limited tolerances 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 tolerances 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).

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-300998. 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 (CM #2), 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

In the Federal Register of August 5, 1998 (63 FR 41828) (FRL-5799-6) and August 24, 1999 (64 FR 46191) (FRL-6069-6), EPA issued notices pursuant to section 408 of FFDCA, 21 U.S.C. 346a as amended by FQPA (Public Law 104-170) announcing the filing of a pesticide petition (PP 8F4941) for tolerance by K-I Chemical U.S.A. Inc., Westchester Financial Center, 11 Martine Avenue, 9th Floor, White Plains, NY, 10606. These notices included a summary of the petition prepared by K-I Chemical U.S.A. Inc., the registrant. There were no comments received in response to the notices of filing.

The petition requested that 40 CFR 180 be amended by establishing a tolerance for residues of the plant growth regulator, prohexadione calcium (cyclohexanecarboxylic acid, 3, 5-dioxo-4-(1-oxopropyl)-, ion(1-), calcium, calcium salt) in or on the raw agricultural commodities peanut nutmeat at 1.0, peanut hay at 0.6, pome fruit at 3.0, and cattle meat byproduct (kidney) at 0.1 parts per million (ppm). EPA is editorially correcting the tolerance expressions to read prohexadione calcium (calcium 3-oxido-5-oxo-4-propionylcyclohex-3-enecarboxylate) in or on the raw agricultural commodities peanuts at 1.0 ppm, peanut hay at 0.6 ppm, pome fruit crop group at 3.0 ppm, kidney of cattle, goats, hogs, horses, and sheep at 0.10 ppm and meat byproducts except kidney of cattle, goats, hogs, horses and sheep at 0.05 ppm.

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. . . .”

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 and to make a determination on aggregate exposure, consistent with section 408(b)(2), for a tolerance for residues of prohexadione calcium (calcium 3-oxido-5-oxo-4-propionylcyclohex-3-enecarboxylate) in or on the raw agricultural commodities peanuts at 1.0 ppm, peanut hay at 0.60 ppm, pome fruit group at 3.0 ppm, kidney of cattle, goats, hogs, horses, and sheep at 0.10 ppm and meat byproducts except kidney of cattle, goats, hogs, horses and sheep at 0.05 ppm. EPA's assessment of the dietary exposures and risks associated with establishing the tolerance follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by prohexadione calcium are discussed in this unit.

1. A rat acute oral study with a lethal dose 50 (LD 50 ) greater than 5,000 milligrams (mg)/kilogram (kg) for males and females. None of the acute toxicity studies showed significant toxicity in the battery of tests (acute toxicity categories III and IV for all routes of exposure).

2. A 90-day rat feeding study with a No Observed Adverse Effect Level (NOAEL) of: 73.1 mg/kg/day for males and 80.4 mg/kg/day for females and a Lowest Observed Adverse Effect Level (LOAEL) of 734 mg/kg/day for males and 815 mg/kg/day for females based on squamous cell hyperplasia of the forestomach.

3. A 90-day mouse feeding study with a NOAEL of equal to or greater than 10,244 mg/kg/day for males and equal to or greater than 11,916 mg/kg/day for females, highest dose tested (HDT).

4. A 90-day dog dietary study with a NOAEL of 80 mg/kg/day and a LOAEL of 400 mg/kg/day based on moderate cortical areas of dilated basophilic tubules in the kidneys and decreased potassium levels.

5. A 1-year dog chronic feeding study with a NOAEL of 20 mg/kg/day and a LOAEL of 200 mg/kg/day based on histopathological changes in the kidneys and increased urinary volume and sodium concentrations.

6. A rat chronic feeding/carcinogenicity study with a NOAEL for systemic toxicity of 93.9 mg/kg/day and a LOAEL of 469 mg/kg/day based on decreased white blood cells (WBC) in males. There is no evidence of carcinogenicity under conditions of the study.

7. A mouse carcinogenicity study with a NOAEL for systemic toxicity of 279 mg/kg/day and a LOAEL of 2,847 mg/kg/day based on decreased body weight gain and food utilization and microscopic changes in the stomachs of males. There was no evidence of carcinogenicity under conditions of the study.

8. A 2-generation rat reproduction study with a parental systemic NOAEL of 35.5 mg/kg/day and parental systemic LOAEL of 385 mg/kg/day based on increased mortality and a reproductive NOAEL equal to or greater than 3,850 mg/kg/day (HDT) and an offspring NOAEL of 385 mg/kg/day and an offspring LOAEL of 3,850 mg/kg/day based on decreased pup body weight.

9. A rat developmental study with a maternal and developmental NOAEL equal to or greater than 1,000 mg/kg/day (HDT).

10. A rabbit developmental study with a maternal NOAEL of 40 mg/kg/day and a maternal LOAEL of 200 mg/kg/day based on increased mortality, abortions, and decreased maternal body weight gain and a developmental NOAEL equal to or greater than 200 mg/kg/day (HDT). A second rabbit developmental study with a maternal and developmental NOAEL equal to or greater than 150 mg/kg/day (HDT). A third rabbit developmental study with a maternal NOAEL of 100 mg/kg/day and a maternal LOAEL of 350 mg/kg/day based on premature deliveries and a developmental NOAEL equal to or greater than 350 mg/kg/day (HDT).

11. A acute neurotoxicity screening battery with a NOAEL equal to or greater than 2,000 mg/kg (HDT). A subchronic neurotoxicity screening battery with a NOAEL equal to or greater than 1,148 mg/kg/day for males and 1,348 mg/kg/day for females (HDT).

12. Prohexadione calcium was negative for mutagenic/genotoxic effects in a Bacterial reverse mutation assay (Ames test), an In vitro mammalian gene mutation assay, an In vitro mammalian chromosome aberration (Chinese hampster ovary (CHO) cells) study, an In vivo mammalian chromosome aberration (rat bone marrow cells) study, a Mammalian erythrocyte micronucleus test, an unscheduled DNA synthesis (UDS) in primary rat hepatocytes study, and a Rec assay with Bacillus subtilis study.

13. Following oral treatment of rats, prohexadione calcium was rapidly absorbed with highest tissue/carcass concentrations obtained within 30 minutes; however, absorption became saturated at the highest dose. The test material did not accumulate in the tissues. For low dose animals, renal excretion was the primary route of elimination. At the high dose, fecal excretion became the primary route of elimination. The primary excreta metabolite was identified as the free acid.

1. Acute toxicity . EPA could not identify any toxicological effects that could be attributable to a single oral exposure (dose) in any of the available toxicological studies.

2. Chronic toxicity . EPA has established the Chronic Reference Dose (cRfD) for prohexadione calcium at 0.80 mg/kg/day. This cRfD is based on both the subchronic and chronic toxicity studies in dogs. Since a similar endpoint of equal severity (minimal and moderate dilation of basophilic tubules) was observed in both studies, the results of the two studies can be evaluated using a single dose-response curve. The NOAEL of 80 mg/kg/day from the subchronic study due to the wider dose spread than in the 1-year study and an uncertainty factor of 100 (10x for interspecies extrapolation, 10x for intraspecies variability) were used to establish the cRfD. The NOAEL of 80 mg/kg/day was based on histopathological changes (dilated basophilic tubules) in the kidneys and clinical chemical changes seen at the LOAEL of 200 mg/kg/day. No additional uncertainty factor is needed because there is no increase in the severity of the lesions over time in the chronic study as compared to the subchronic study. Since an FQPA safety factor of 1x is applicable for chronic dietary risk assessment, the chronic population adjusted dose (cPAD) is equivalent to the cRfD of 0.80 mg/kg/day.

3. Carcinogenicity . The Health Effects Division HIARC has classified prohexadione calcium as “not likely to be carcinogenic to humans” based on the lack of carcinogenicity in rats and mice.

1. From food and feed uses . No tolerances have been previously established (40 CFR part 180) for the residues of prohexadione calcium, in or on raw agricultural commodities. Risk assessments were conducted by EPA to assess dietary exposures from prohexadione calcium as follows:

Chronic exposure and risk . The cPAD for prohexadione calcium is 0.8 mg/kg/day. A chronic dietary exposure analysis for prohexadione calcium was performed using the Dietary Exposure Evaluation Model (DEEM TM ). Tolerance level residues were used and 100% crop treated was assumed for all pome fruit and peanut commodities. The chronic analysis was conducted for the U.S. population and all population subgroups. The chronic exposure estimates (food only) for the U.S. population and all population subgroups were less than 5% of the cPAD.

2. From drinking water . The estimated environmental concentration (EEC) for ground water is 0.001 part per billion (ppb) (from screening concentration in ground water (SCI-GROW) modeling). The EECs for surface water (from generic expected environmental concentration (GENEEC) modeling) are 36 ppb for the acute (peak) concentration and 2.6 ppb for the 56-day value (with 3x adjustment factor).

3. From non-dietary exposure . There are no non-food uses of prohexadione calcium currently registered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended. No non-dietary exposures are expected for the general population.

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 prohexadione calcium 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, prohexadione calcium 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 prohexadione calcium 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. Acute risk . EPA could not identify any toxicological effects that could be attributable to a single oral exposure (dose) in any of the available toxicological studies.

2. Chronic risk . Using the DEEM chronic exposure assumptions described in this unit, EPA has concluded that aggregate exposure from food will utilize less than 1% of the cPAD for the U.S. population. The major identifiable subgroup with the highest aggregate exposure is all infants (< 1 year old) which utilizes 2.3% of the cPAD. EPA generally has no concern for exposures below 100% of the cPAD because the cPAD represents the level at or below which daily aggregate dietary exposure over a lifetime will not pose appreciable risks to human health. The drinking water level of comparisons (DWLOCs) for chronic exposure to prohexadione calcium in drinking water calculated for the U.S. population was 28,000 ppb, for females, 13-50 years old, was 24,000 ppb and for all infants the DWLOC was 8,000 ppb. The EEC for ground water is 0.001 ppb (from SCI-GROW modeling). The EEC for surface water (from GENEEC modeling) is 2.6 ppb for the 56-day value (with 3x adjustment factor). EPA's chronic DWLOC are well above the estimated exposures for prohexadione calcium in water for the subgroups of concern. Conservative model estimates (GENEEC and SCI-GROW) of the concentrations of prohexadione calcium in surface and ground water indicate that exposure will be minimal.

3. Short- and intermediate-term risk . Short- and intermediate-term aggregate risk assessments were not performed because there are no residential uses proposed for prohexadione calcium.

4. Determination of safety . Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result from aggregate exposure to prohexadione calcium residues.

1. Safety factor for infants and children . In assessing the potential for additional sensitivity of infants and children to residues of prohexadione calcium, EPA considered data from developmental toxicity studies in the rat and rabbit and a 2-generation reproduction study in the rat. The developmental toxicity studies are designed to evaluate adverse effects on the developing organism resulting from maternal pesticide exposure gestation. Reproduction studies provide information relating to effects from exposure to the pesticide on the reproductive capability of mating animals and data on systemic toxicity.

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 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 margin of exposure (MOE) analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. EPA believes that reliable data support using the standard uncertainty factor (usually 100 for combined interspecies and intraspecies variability) and not the additional tenfold MOE/uncertainty factor when EPA has a complete data base under existing guidelines and when the severity of the effect in infants or children or the potency or unusual toxic properties of a compound do not raise concerns regarding the adequacy of the standard MOE/safety factor.

The prenatal and postnatal toxicology data base for prohexadione calcium is adequate. The results of these studies indicated no quantitative or qualitative increase in susceptibility of rats or rabbits to in utero and/or postnatal exposure to prohexadione. No developmental effects were seen at doses up to the limit dose (1,000 mg/kg/day) in the rat developmental toxicity study or up to the highest doses tested (150, 200, and 350 mg/kg/day) in three rabbit developmental toxicity studies. In the 2-generation reproduction study in rats, the effects in the offspring were observed only at treatment levels which resulted in evidence of parental toxicity.

A developmental neurotoxicity (DNT) study is not required. No neuropathology or central nervous system (CNS) malformations were seen in the developmental toxicity studies. In the 2-generation reproduction study in rats, there were no findings in pups that were suggestive of changes in neurological development, although no functional assessment was performed. Additionally, there was no evidence of neurotoxicity in either the acute or subchronic neurotoxicity studies in rats and no evidence of neurotoxicity in other studies.

The Agency concluded that an extra safety factor to protect infants and children is not needed based on the following considerations:

i. The prenatal and postnatal toxicology data base is complete, there is no indication of increased susceptibility, and a developmental neurotoxicity study is not required.

ii. The dietary (food and drinking water) exposure assessments will not underestimate the potential exposures for infants and children from the use of prohexadione calcium (currently there are no proposed residential uses and, therefore, non-occupational exposure is not expected).

2. Determination of safety . Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to prohexadione calcium residues.

The nature of the residue in peanuts, pome fruit crop group, and livestock is adequately understood. The residues of concern for the tolerance expression are parent. Based on the results of animal metabolism studies, tolerances established for kidney and meat byproducts will cover any secondary residues that would occur in animal commodities from the use on peanuts and pome fruits.

Adequate enforcement methodology (gas chromatography and mass selective detector) 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, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 305-5229; e-mail address: furlow.calvin@epa.gov.

The qualitative nature of the residue of prohexadione calcium in plants is adequately understood for the purpose of this petition. The metabolism of prohexadione calcium in apples and peanuts is similar. Prohexadione calcium is rapidly metabolized to prohexadione and parent-like oxidative intermediates and ultimately to tricarballylic acid (TCA), citric acid, and other natural products from the plant carbon pool. Only the parent compound needs to be included in the tolerance expression for pome fruit and peanuts and is the only compound to be included in the dietary risk assessments.

There are no Codex Alimentarius Commission (Codex), Canadian, or Mexican Maximum Residue Levels (MRLs) for prohexadione calcium.

No tolerances for inadvertent residues of prohexadione calcium are required in rotational crops at this time.

Therefore, the tolerances are established for residues of prohexadione calcium (calcium 3-oxido-5-oxo-4-propionylcyclohex-3-enecarboxylate) in or on the raw agricultural commodities peanuts at 1.0 ppm, peanut hay at 0.60 ppm, pome fruit crop group at 3.0 ppm, kidney of cattle, goats, hogs, horses, and sheep at 0.10 ppm, and meat byproducts except kidney of cattle, goats, hogs, horses and sheep at 0.05 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-300998 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 July 3, 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, Ariel Rios Bldg., 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. 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, Ariel Rios Bldg., 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, Ariel Rios Bldg., 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 VI.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-300998, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, Ariel Rios Bldg., 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 tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. 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 petition under FFDCA section 408(d), 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).

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-300984. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

In the Federal Register of September 9, 1999 (64 FR 49010) (FRL-6095-9), EPA issued a notice pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), as amended by the Food Quality Protection Act (FQPA) (Public Law 104-170) announcing the filing of a pesticide tolerance petition (PP 9F6027) by EDEN Biosciences, 11816 North Creek Parkway N., Bothell, WA 98011-8205. This notice included a summary of the petition prepared by the petitioner EDEN Bioscience Corporation. There were no comments received in response to the notice of filing.

The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of harpin protein.

New section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an exemption from the requirement for 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(c)(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. . . .” Additionally, section 408(b)(2)(D) requires that 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 performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings.

Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness, and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

Harpin exhibits no adverse effects in Tier I mammalian toxicity studies; therefore, Tier II and III studies are not required. Acute toxicity studies indicate that Messenger is a Toxicity Category IV substance. No toxicity was observed in acute oral toxicity studies conducted with Messenger. Acute oral and dermal toxicity LD 50 values for Messenger were greater than 5,000 grams/kilograms (g/kg) in the rat (Toxicity Category IV). The LC 50 for Messenger was greater than 2 milligrams/liter (mg/L) in an acute inhalation study in the rat. Messenger also showed no effect in eye and dermal irritation studies. For example, the dermal irritation index for Messenger was zero at 500 mg and no eye irritation was shown in the rabbit at 100 mg. There have been no reported incidents of Messenger-induced hypersensitivity in individuals exposed to Messenger during research, production, and/or field testing and there are no published reports indicating that harpin proteins are toxic. Further, the harpin protein has a non-toxic mode of action by eliciting a systemic acquired resistance response in plants, and it has been demonstrated that the product has no direct antimicrobial effect on bacteria and fungi, for species examined to date. For a more complete discussion, see the Harpin Registration Eligibility Document.

In examining aggregate exposure, FQPA directs EPA to take into account available information concerning dietary exposures from pesticide residues in food and drinking water and all other exposures for which there is reliable information. These other sources of exposure include such non-occupational exposures as those resulting from the use of pesticides around the home or in public areas such as parks and schools. The Agency defines acute and chronic aggregate risks to include only dietary (food and water) exposures. Short-, intermediate-, and long-term aggregate exposures are defined to include non-occupational exposures in addition to dietary exposures. Any or all of these aggregate risk assessments may be required for a pesticide depending on its registered uses.

Harpin and related harpin proteins are common constituents of plant pathogenic bacteria which are often found on fruits and vegetables. Additional dietary exposure to harpin protein resulting from labeled uses is unlikely to occur because of extremely low use rates and rapid degradation in the field. Furthermore, the lack of demonstrable toxicity in acute studies, and the natural occurrence of harpins in the environment support the establishment of an exemption from the requirement of a tolerance for harpin protein.

1. Food . Messenger is applied at very low rates of application (generally 2 to 11.5 grams of active ingredient per acre). Harpin also degrades rapidly in sunlight, high temperatures, and in the presence of chlorine. Because of the low use rates and rapid degradation in the field, no harpin residues are detectable, using available methods, on treated crops even immediately after application. Therefore, the Agency believes that dietary exposure to harpin via consumption of treated food or feed will be negligible.

2. Drinking water exposure . Because harpin protein is applied at extremely low use rates and rapidly degrades in the environment, residues are unlikely to occur in ground or surface water. In addition, harpin is highly sensitive to small amounts of chlorine, as contained in many municipal water systems. Therefore, residues of harpin protein are unlikely to occur in drinking water.

The Agency believes that the potential for non-dietary exposure and attendant risks to the general population including infants and children is minimal to non-existent, due to low use rates, the instability of harpin protein in the environment, and lack of demonstrated toxicity. In addition, the label use sites are commercial, agricultural, and horticultural, as opposed to domestic settings; thus, non-occupational exposure to the general population is expected to be minimal.

1. Dermal exposure . Harpin is a Toxicity Category IV product, and is not expected to pose any risk via the dermal route of exposure.

2. Inhalation exposure . Acute inhalation tests place harpin in Toxicity Category IV, thus risk via the inhalation route is expected to be minimal to non-existent.

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.

Consideration of a common mode of toxicity is not appropriate, given that there is no indication of mammalian toxicity of harpin protein and no information that indicates that toxic effects would be cumulative with any other compounds. Moreover, harpin does not exhibit a toxic mode of action in its target pests or diseases.

Harpin's lack of toxicity has been demonstrated by the results of acute toxicity testing in mammals in which harpin caused no adverse effects when dosed orally and via inhalation at the limit dose for each study. Thus, based on this and other information in this preamble, EPA concludes that there is a reasonable certainty that no harm to the United States population in general, or to infants or children will result from aggregate exposure to harpin residues. This includes all anticipated dietary exposures and all other exposures for which there is reliable information.

The Agency has no information regarding endocrine effects of this biochemical pesticide at this time; however, since there was no demonstrable toxicity in acute tests, there is no evidence to suggest that harpin will adversely affect the endocrine system.

Because this notice establishes an exemption from the requirement of a tolerance, no anlytical method is necessary. The Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation for the reasons enumerated in this preamble, including harpin's lack of toxicity. Accordingly, the Agency has concluded that an analytical method is not needed for enforcement purposes for harpin residues.

There are no Codex Maximum Residue Levels nor any tolerances or exemptions issued for harpin protein outside the United States.

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-300984 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 July 3, 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, Ariel Rios Bldg., 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, Ariel Rios Bldg., 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, Ariel Rios Bldg., 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 IX.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 number OPP-300984, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, Ariel Rios Bldg., 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 an exemption from the tolerance requirement under FFDCA section 408(d) in response to a petition submitted to the Agency. 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 petition under FFDCA section 408(d), such as the exemption 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).

Since January 1, 1992, Medicare has paid for physicians' services under section 1848 of the Social Security Act (the Act), “Payment for Physicians' Services.” The Act requires that payments under the fee schedule be based on national uniform relative value units (RVUs) based on the relative resources used in furnishing a service. Section 1848(c) of the Act requires that national RVUs be established for physician work and practice and malpractice expenses.

Under the formula set forth in section 1848(b)(1) of the Act, the amount paid for each service under the physician fee schedule is the product of three factors—(1) A nationally uniform relative value for the service; (2) a geographic adjustment factor (GAF) for each physician fee schedule area; and (3) a nationally uniform conversion factor (CF) for the service. The CF converts the relative values into payment amounts.

For each physician fee schedule service, there are three RVU components—(1) Physician work; (2) practice expense; and (3) malpractice expense. In addition, each RVU component has a corresponding geographic practice cost index (GPCI) for each fee schedule area. The GPCIs reflect the relative costs of practice expense and malpractice insurance, and of one quarter of the physician work in an area compared to the national average.

The general formula for calculating the Medicare fee schedule amount for a given service in a given fee schedule area is as follows:

Section 121 of the Social Security Act Amendments of 1994 (Pub. L. 103-432) required us to develop a methodology for a resource-based system for determining practice expense RVUs for each physician's service beginning in 1998.

The Balanced Budget Act of 1997 was enacted on August 5, 1997, before publication of the October 1997 final rule on the physician fee schedule (62 FR 59103). Section 4505(a) of the BBA delayed the effective date of the resource-based practice expense RVUs until January 1, 1999, while section 4505(b) provided for a 4-year transition, with resource-based practice expense RVUs becoming fully effective in 2002. In addition, section 4505(d)(1)(A) and (d)(1)(B) of the BBA required us to develop new resource-based practice expense RVUs, and section 4505(d)(1)(C) of the BBA required us to develop a refinement process to be used during each of the 4 years of the transition period.

Section 212 of the Balanced Budget Refinement Act of 1999 (BBRA) requires us to establish a process under which we will accept and use, to the maximum extent practicable and consistent with sound data practices, data collected or developed by entities and organizations to supplement the data we normally collect in determining the practice expense component of the physician fee schedule. Section 212(b) states that the process must be available for payments for the 2001 and 2002 physician fee schedules. This time period is consistent with the last years of the 4-year transition period, noted above. Therefore, we are establishing a process for submission of data in calendar years (CY) 2000 and 2001 for use in computing practice expense RVUs for CYs 2001 and 2002 physician fee schedule, respectively. Section 212(a) requires that we promulgate an interim final regulation that permits submission of data for payment rates for 2001.

Effective for services furnished beginning January 1, 1999, we established a new methodology for computing resource-based practice expense RVUs. The methodology uses practice expense data from two significant, accessible sources—HCFA's Clinical Practice Expert Panel (CPEP) data and the American Medical Association's (AMA's) Socioeconomic Monitoring System (SMS) data. Current aggregate specialty practice costs are used in the methodology to establish initial estimates of relative resources used in physicians' services across specialties and allocate them to specific procedures.

The SMS collects information on aggregate practice expenses from a random national survey of approximately 4,000 physicians who spend the greatest proportion of their time in patient care activities. The survey includes AMA member and non-AMA member physicians and office and hospital-based physicians. Actual practice expense data by specialty, derived from the 1995 through 1997 SMS survey data, were used to create six cost pools—administrative labor, clinical labor, medical supplies, medical equipment, office supplies, and all other expenses. The three steps used to create cost pools were as follows:

(1) Determination of practice expenses per hour by cost category, using the SMS survey of actual cost data. The practice expense per hour for each physician respondent's practice was calculated as the practice expenses for the practice divided by the total number of hours spent in patient care activities by the physicians in the practice.

(2) Determination of the total number of physician hours, by specialty, spent treating Medicare patients, using physician time data for each procedure code and Medicare claims data.

(3) Calculation of the practice expense pools by specialty and by cost category by multiplying the practice expenses per hour for each category by the total physician hours.

Since many specialties identified in our Medicare claims data did not correspond exactly to the specialties included in the practice expense tables from the SMS survey data, we crosswalked these specialties to the most appropriate SMS specialty category. (For a more detailed discussion of the methodology, you may refer to the June 1998 proposed rule (63 FR at 30826) and the November 1998 final rule with comment (63 FR at 58816).)

In the June 5, 1998 proposed rule (63 FR 30818) and the November 2, 1998 final rule (63 FR 58814), we established the parameters for a refinement process and indicated that RVUs for all codes would be considered interim for CY 1999 and during the transition (through CY 2001). In the November 1998 final rule, we outlined the initial refinement process and the steps we are taking to resolve outstanding general methodological issues.

In the July 22, 1999 proposed rule (64 FR 39609), we stated that we awarded a one-year contract, beginning May 24, 1999, to The Lewin Group to provide technical assistance in evaluating various aspects of the practice expense methodology. These aspects include the following:

• Evaluation of the validity and reliability of the SMS data for specialty and subspecialty groups.

• Identification and evaluation of alternative and supplementary data from sources such as specialty and multi-specialty societies.

• Development of criteria for accepting other surveys and determination of the appropriate form of these surveys.

In the November 2, 1999 final rule (64 FR 59380), we noted the steps our contractor had taken to date, including issuance of its first draft report, “Practice Expense Methodology,” dated September 24, 1999. This report, which contains recommendations about a variety of methodology issues and use of oversampling and supplemental surveys, is discussed below. (The report has been placed on our homepage under the title “Practice Expense Methodology Report.” Our homepage can be accessed through the HCFA Internet site at ­http://www.hcfa.gov/medicare/pfsmain.htm.) Also, in the final rule, we indicated that for CY 2000 we would use supplemental survey data from thoracic surgeons to calculate practice expense because this oversample followed the SMS format and was collected by the AMA contractor, thus helping to assure data consistency.

In the September 24, 1999 report, the contractor recommended that we consider supplemental survey data furnished by physician and non-physician specialty groups that have conducted independent surveys that adhere to uniformity of format, sample frame, contractor, and data analysis of information on practice expense and hours spent in patient care. Specifically, the contractor recommended the following criteria:

• Draw the sample from the AMA Physician Masterfile when possible.

• Survey a large enough number of individuals to assure an adequate number of usable responses.

• Conduct the survey based on the SMS survey instruments and protocols, including administration and follow-up efforts.

• Use the same contractor as the SMS and field the survey during the same timeframe.

• Consistently define, throughout the SMS and all additional surveys, practice expense and hours spent in patient care.

• Assign responsibility for data editing and analysis to the AMA's SMS project team.

We are amending the Medicare regulations in § 414.22(b) (Relative value units (RVUs)) to add paragraph (b)(6) to establish criteria for physician and non-physician specialty groups for submitting practice expense surveys that may be used for establishing payments in the 2001 physician fee schedule. We use practice expense survey data to establish the specialty-specific practice expense per-hour, and we will consider supplemental data that is obtained through surveys. We are adopting the criteria recommended by The Lewin Group, with some modifications, for supplemental survey data submitted to us by August 1, 2000 for consideration for use in our computation of RVUs for the 2001 physician fee schedule. In addition, we are soliciting public comment on the criteria that we will consider for survey data submitted between August 2, 2000 and August 1, 2001 for use in computing RVUs for the 2002 physician fee schedule.

Any HCFA-designated specialty group may submit supplemental survey data. (Please see the list below for designated specialties.) However, for survey data submitted for payments in 2001, we will give priority consideration to specialties that are not represented or are underrepresented in the SMS data.

We will use several criteria for evaluating supplemental surveys submitted by August 1, 2000. Our criteria expand upon some of our contractor's recommendations, primarily by adopting more specific sampling criteria. We have not accepted several of our contractor's recommendations, but have modified them; we do not require that physician specialties use only the same contractor as the SMS, or that the AMA's SMS project team be assigned responsibility for data editing and analysis. In addition, as discussed below, it is not possible for the AMA to oversample a specialty in time to affect payments for CYs 2001 and 2002. Following are the specific criteria we will use:

• Physician groups must draw their sample from the AMA Physician Masterfile to ensure a nationally representative sample that includes both members and non-members of a physician specialty group. Physician groups must arrange for the AMA to send the sample directly to their survey contractor to ensure confidentiality of the sample; that is, to ensure comparability in the methods and data collected, specialties must not know the names of the specific individuals in the sample. (To request a sample from the Masterfile, contact Scott Birkhead of the AMA at (312) 464-2569. We understand that there is an approximate 1-week response time and a nominal charge for drawing the sample.)

• Non-physician specialties not included in the AMA's SMS must develop a method to draw a nationally representative sample of members and non-members. At a minimum, these groups must include former members in their survey sample. The sample must be drawn by the non-physician group's survey contractor, or another independent party, in a way that ensures the confidentiality of the sample; that is, to ensure comparability in the methods and data collected, specialties must not know the names of the specific individuals in the sample.

• A group (or its contractors) must conduct the survey based on the SMS survey instruments and protocols, including administration and follow-up efforts, and definitions of practice expense and hours in patient care. In addition, any cover letters or other information furnished to survey sample participants must be comparable to such information previously supplied by the SMS contractor to its sample participants. (A copy of the guidelines and procedures may be obtained by contacting Kenneth Marsalek at (410) 786-4502.)

• Use a contractor that has experience with the SMS or a survey firm with experience successfully conducting national multi-specialty surveys of physicians using nationally representative random samples.

• Submit raw survey data to us, including all complete and incomplete survey responses as well as any cover letters and instructions that accompanied the survey, by August 1, 2000 for data analysis and editing to ensure consistency. All personal identifiers in the raw data must be eliminated. (Send data to Health Care Financing Administration, Department of Health and Human Services, Attn: Kenneth Marsalek, C4-03-06, 7500 Security Boulevard, Baltimore, MD 21244-8013.)

• Raw survey data submitted to us between August 2, 2000 and August 1, 2001 will be considered for use in computing practice expense RVUs for CY 2002.

• The physician practice expense data from surveys that we use in our code-level practice expense calculations are the practice expenses per physician hour in the six practice expense categories—clinical labor, medical supplies, medical equipment, administrative labor, office overhead, and other. Supplemental survey data must include data for these categories. Ideally, we would like to calculate practice expense values with precision; however, we recognize that we must achieve a balance because conducting surveys is expensive and there is a tension between achieving large sample sizes, which increases precision, and smaller ones, which conserves costs.

Based on our review of existing physician practice expense surveys, we believe an achievable level of precision is a coefficient of variation, that is, the ratio of the standard error of the mean to the mean expressed as a percent, not greater than 10 percent, for overall practice expenses or practice expenses per hour. For existing surveys the standard deviation is frequently the same magnitude as the mean. If the standard deviation equals the mean, then a usable sample size of 100 will yield a coefficient of variation of 10 percent. For small, homogeneous subspecialties, the variations in practice expenses may be lower because a smaller sample size achieves this level of precision. Other ways of expressing precision (for example, 95 percent confidence intervals) are also acceptable if they are approximately equivalent to a coefficient of variation of 10 percent or better. We will consider surveys for which the precision of the practice expenses are equal to or better than this level of precision and that meet the other survey criteria. Also, we will require documentation regarding how the practice expenses were calculated and will verify the calculations. Of course, we have the statutory authority to determine the final practice expense RVUs.

Since the physician fee schedule is a national fee schedule, we require that the survey be representative of the target population of physicians nationwide. We can presume national representativeness if a random sample is drawn from a complete nationwide listing of the physician specialty or subspecialty and the response rate, the percent of usable responses received from the sample, is high, for example, 80 to 90 percent. If any of these conditions (random sample, complete nationwide listing, and high response rate) are not achieved, then the potential impacts of the deviations upon national representativeness must be explored and documented. For example, if the response rate is low, then justification must be furnished to demonstrate that the responders are not significantly different from non-responders with regard to factors affecting practice expense. Differential weighting of subsamples may improve the representativeness. Minor deviations from national representativeness may be acceptable.

We believe that it is impossible and impractical to set rigid cutoffs for most of these criteria, especially for national representativeness. We are attempting to be as flexible as possible consistent with our goal of obtaining new surveys of practice expense data that are scientifically sound and methodologically consistent with our existing estimates. For instance, a specialty may include different types of physician practices (for example, urban versus rural, academic versus non-academic, interventional versus non- interventional) that exhibit different patterns of practice expense. Similarly, a stratified sampling of these different types of practices may be a more efficient sampling strategy than a simple random sample of the entire specialty. We welcome surveys with more sophisticated designs and these types of survey variations if relevance to our criteria is documented.

We would need to make the supplemental survey data that we determine complies with the above criteria consistent with the SMS data we are using. Specifically, we are currently using 1994 through 1996 specialty practice expense per-hour data from the SMS. Thus, we would deflate supplemental survey data to be consistent with the timeframe of the data from other specialties from the SMS. For example, since the midpoint of the SMS data we currently use is 1995, we would deflate supplemental survey data to 1995 using the Medicare Economic Index. Therefore, any comparison between supplemental survey information and the SMS practice expense per-hour data we are currently using should take into account that the data should be deflated to 1995 costs. We will make comparable adjustments to bring future supplemental surveys into the same timeframe as SMS data used in the future.

In addition, if a specialty is represented in the SMS data, we will weight average (based on the number of survey responses) the supplemental data with the existing SMS data already being used. If the specialty is not represented in the SMS data, we will substitute the new data for the crosswalked SMS data currently being used for the specialty. Specialties may also wish to consider that under our methodology for determining practice expenses, we calculate specialty specific practice expense RVUs based on estimates of practice expenses for specific procedures in combination with the SMS data. The specialty specific practice expense RVUs are weight averaged based on the frequency of allowed services performed by a given specialty. Thus, supplemental data from a specialty that represents a small proportion of the allowed services for a given procedure code will have little influence on the procedure's final value in the weighted averaging.

Also, some practitioner services (services of certified registered nurse anesthetists, nurse practitioners, clinical nurse specialists, physician assistants, and certified nurse mid-wives) are paid based on a percentage of the physician fee schedule amount. Since the payment under the physician fee schedule for a service performed by a practitioner is required to be based on a percentage of the amount paid to a physician for a service, we are considering whether to use only physician practice expense data in determining the practice expense RVUs for each practitioner service.

The AMA has provided us with information on its plans for collecting future data on physicians' practice expenses. (We are including this information so that physician specialty groups can take it into account in their plans.) The AMA indicated that most experts agree that the optimal method of obtaining practice expense data is to survey physician practices instead of surveying individual physicians about their share of a practice's expenses, as does the SMS. In addition, the AMA has found that it has become increasingly difficult and expensive to collect practice expense data through the SMS. For example, physicians tend to relocate more frequently, are increasingly unwilling to spend 25 to 30 minutes on the telephone to complete the SMS survey, and are increasingly unlikely to have access to the detailed financial information requested in SMS. Based on these considerations, last year the AMA began developing a new practice-level survey. In designing the new practice survey, the AMA is seeking to address some of the limitations of the SMS survey and the questions regarding its appropriateness for use in developing practice expense RVUs.

Drafts of the practice expense survey have been reviewed with outside experts, potential users of the data, and representatives from specialty societies, including the AMA's Specialty Society Relative Value Update Committee and group practices. The AMA is currently conducting a limited pilot of the practice survey with physician-owned practices. The pilot excludes single specialty practices in radiology, anesthesiology, pathology, and emergency medicine. Accounting for these specialties is more complicated, and separate instrumentation will be required. Collection of practice-level data for these specialties will not be implemented in the first practice survey, unless staff from these specialty societies are able to design a survey instrument that the AMA can use. If the pilot of the survey is successful, the AMA plans to conduct the practice survey initially in 2000 and, in alternate years thereafter, the practice expense survey and the SMS survey.

If the CY 2000 practice expense survey is successful, the AMA plans to drop the expense questions from the SMS beginning with the calendar 2001 SMS survey. If the practice expense survey is unsuccessful, the AMA will reconsider its plans for CY 2001 and future years. Under those circumstances, it may be necessary to retain the expense questions in the SMS. However, cost factors may constrain the extent to which the AMA can conduct a complete SMS survey with practice expense questions in CY 2001. Regardless, there are still 2 years of data from the 1998 and 1999 SMS surveys that we can use in updating future practice expense RVUs.

Because of the large number of items of correspondence we normally receive on Federal Register documents published for comment, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document.

We ordinarily publish a notice of proposed rulemaking in the Federal Register and invite public comment on the proposed rule. The notice of proposed rulemaking includes a reference to the legal authority under which the rule is proposed, and the terms and substance of the proposed rule or a description of the subjects and issues involved.

In this instance, however, the need to engage in proposed rulemaking is obviated by section 212 of BBRA that requires that we promulgate this regulation on an interim final basis. We are providing a 60-day period for public comment.

Under the Paperwork Reduction Act of 1995 (PRA), we are required to provide 60-day notice in the Federal Register and solicit public comment before a collection of information requirement is submitted to the Office of Management and Budget (OMB) for review and approval. In order to fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the PRA requires that we solicit comment on the following issues:

• The need for the information collection and its usefulness in carrying out the proper functions of our agency.

• The accuracy of our estimate of the information collection burden.

• The quality, utility, and clarity of the information to be collected.

• Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.

This interim final rule requests HCFA-designated specialty groups to submit supplemental survey data to us, which meets the requirements of this section, by August 1, 2000, for consideration for payments in 2001. However, for survey data submitted for payments in 2001, we will give priority consideration to specialties that are not represented or are under represented in the SMS data. The burden associated with these requirements is the time necessary for the provider to submit the required data. However, due to the nature of the request, we estimate the number of submissions to average fewer than 10 on an annual basis. Therefore, these requirements are not subject to the PRA, as defined under 5 CFR 1320.3(c).

We have submitted a copy of this interim final rule to OMB for its' review of the information collection and requirements.

If you comment on these information collection and recordkeeping requirements, please mail copies directly to the following: Health Care Financing Administration, Office of Information Services, Information Technology Investment Management Group, Attn: John Burke, HCFA-1111-IFC, Room N2-14-26, 7500 Security Boulevard, Baltimore, MD 21244-1850, and, Office of Information and Regulatory Affairs, Office of Management and Budget, Room 10235, New Executive Office Building, Washington, DC 20503, Attn: Allison Eydt, HCFA Desk Officer, HCFA-1111-IFC.

We have examined the impacts of this interim final rule as required by Executive Order of 1993 (E.O.) 12866, the Unfunded Mandates Reform Act of 1995 (E.O.) 12875 (UMRA) (Pub. L. 104-4), and the Regulatory Flexibility Act of 1980 (RFA) (Pub. L. 96-354), and the Federalism Executive Order of 1999 (E.O.) 13132. E.O. 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). The RFA requires agencies to analyze options for regulatory relief of small businesses. For purposes of the RFA, small entities include small businesses, non-profit organizations, and government agencies. Most hospitals and most other providers and suppliers are small entities, either by non-profit status or by having revenues of $5 million or less annually. For purposes of the RFA, all physicians and non-physician providers are considered to be small entities. Individuals and States are not included in the definition of a small entity.

Section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area and has fewer than 50 beds.

Since this rule only provides criteria for physicians and non-physicians who wish to provide data to us in computing RVUs under the physician fee schedule, there are no budgetary implications arising from this rule. Furthermore, this rule is required by statute and, thus, reflects the Congress's view of appropriate agency action.

The UMRA also requires (in section 202) that agencies prepare an assessment of anticipated costs and benefits before developing any rule that may result in an expenditure by State, local, or tribal governments, in the aggregate, or by the private sector, of $100 million or more in any year. This final rule with comment will have no consequential effect on State, local, or tribal governments. We believe the private sector cost of this rule falls below these thresholds as well.

For these reasons, we are not preparing analyses for either the RFA or section 1102(b) of the Act because we have determined, and we certify, that this rule will not have a significant economic impact on a substantial number of small entities or a significant impact on the operations of a substantial number of small rural hospitals.

In accordance with the provisions of E.O. 12866, this regulation was reviewed by the Office of Management and Budget.

We have examined this rule in accordance with E.O. 13132 and have determined that this final rule will not have any negative impact on the rights, roles, or responsibilities of State, local, or Tribal governments.

This is a synopsis of the Commission's Report and Order, MM Docket No. 99-8, adopted April 5, 2000, and released April 14, 2000. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC Reference Center (Room 239), 445 12th Street, SW, Washington, DC. The complete text of this decision may also be purchased from the Commission's copy contractor, International Transcription Services, Inc., (202) 857-3800, 1231 20th Street, NW, Washington, DC 20036.

This is a synopsis of the Commission's Report and Order, MM Docket No. 99-6, adopted April 5, 2000, and released April 14, 2000. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC Reference Center (Room 239), 445 12th Street, SW, Washington, DC. The complete text of this decision may also be purchased from the Commission's copy contractor, International Transcription Services, Inc., (202) 857-3800, 1231 20th Street, NW, Washington, DC 20036.

Prohibitions to taking sea turtles are governed by regulations implementing the Endangered Species Act at 50 CFR parts 222 and 223. The incidental take of turtles during shrimp fishing in the Atlantic Ocean off the coast of the southeastern United States and in the Gulf of Mexico is excepted from the taking prohibition pursuant to sea turtle conservation regulations at 50 CFR 223.206, which include a requirement that shrimp trawlers have a NMFS-approved TED installed in each net rigged for fishing. The use of TEDs significantly reduces mortality of loggerhead, green, Kemp's ridley, and hawksbill sea turtles. Because leatherback turtles are larger than the escape openings of most NMFS-approved TEDs, use of these TEDs is not an effective means of protecting leatherback turtles.

Through a final rule (60 FR 47713 September 14, 1995), NMFS established regulations to provide protection for leatherback turtles when they occur in locally high densities during their annual, spring northward migration along the Atlantic seaboard. Within the Leatherback Conservation Zone, NMFS may close an area for 2 weeks when leatherback sightings exceed 10 animals per 50 nm (92.6 km) during repeated aerial surveys pursuant to § 223.206(d)(2)(iv)(A) through (C).

An aerial survey conducted on April 20, 2000, along the South Carolina coast documented 28 leatherback turtles over a total survey trackline of approximately 120 nm (222 km). The highest concentrations were noted in waters off the southern half of the state. Twenty-one of the 28 leatherbacks were sighted in the portion of the survey trackline just 36.3 nm (67.2 km) long, from the south end of Pritchards Island (approximately 32°16′ N. lat, 080°36′ W. long.) to the north end of Kiawah Island (approximately 32°35′ N. lat., 079°59° W. long.). In a 8.7-nm (16.1-km) section of the survey trackline flown in a northeasterly direction commencing approximately 1 nm (1.8 km) off the beach at the southern end of Edisto Island (approximately 32°28′ N. lat., 080°20′ W. long.), 7 leatherbacks were sighted. A replicate survey flown later in the flight (same course, speed, and altitude) over the same 8.7 nm section of trackline area sighted 11 leatherbacks. Fishing effort appeared minimal at the time of the survey. Only 8 vessels (7 underway shrimp trawlers and 1 stationary gillnet vessel) were observed during the survey of the South Carolina coast. The paucity of vessels is likely due to the fact that shrimping in state waters off South Carolina (and Georgia) is scheduled to remain closed until mid to late May.

The Assistant Administrator for Fisheries, NOAA (AA), has determined that all inshore waters and offshore waters within 10 nm (18.5 km) seaward of the COLREGS demarcation line, bounded by 32° N. lat. and 33° N. lat., within the Leatherback Conservation Zone are closed to fishing by shrimp trawlers required to have a TED installed in each net that is rigged for fishing, unless the TED installed has an escape opening large enough to exclude leatherback turtles, meeting the specifications at 50 CFR 223.207(a)(7)(ii)(B) or 223.207(c)(1)(iv)(B). These regulations specify modifications that can be made to either single-grid hard TEDs or Parker soft TEDs to allow leatherbacks to escape.

The regulations at 50 CFR 223.206(d)(2)(iv) also state that fishermen operating in the closed area with TEDs modified to exclude leatherback turtles must notify the NMFS Southeast Regional Administrator of their intentions to fish in the closed area. This aspect of the regulations does not have a current OMB control number, issued pursuant to the Paperwork Reduction Act. Consequently, fishermen are not required to notify the Regional Administrator prior to fishing in the closed area, but they must still meet the gear requirements.

This action has been determined to be not significant for purposes of E.O. 12866.

The AA is taking this action in accordance with the requirements of 50 CFR 223.206(d)(2)(iv) to provide protection for endangered leatherback sea turtles from incidental capture and drowning in shrimp trawls. Leatherback sea turtles are occurring in high concentrations in coastal waters in shrimp fishery statistical zone 32. This action allows shrimp fishing to continue in the affected area and informs fishermen of the gear changes that they can make to protect leatherback sea turtles.

Pursuant to 5 U.S.C. 553(b)(B), the AA finds that there is good cause to waive prior notice and opportunity to comment on this action. It would be contrary to the public interest to provide prior notice and opportunity for comment because providing notice and comment would prevent the agency from implementing the necessary action in a timely manner to protect the endangered leatherback. Notice and opportunity to comment on the leatherback closure procedures was provided through the rulemaking establishing the closure procedures (60 FR 25663, May 12, 1995).

Pursuant to 5 U.S.C. 552(d)(3), the AA finds that there is good cause not to delay the effective date of this rule for 30 days. It would be contrary to the public interest to delay this action because such delay would prevent the agency from implementing the necessary action in a timely manner to protect the endangered leatherback. Accordingly, the AA is making the rule effective April 27, 2000 through May 11, 2000. This closure has been announced on the NOAA weather channel, in newspapers, and other media. Shrimp trawlers may also call (727) 570-5312 for updated area closure information.

As prior notice and an opportunity for public comment are not required to be provided for this notification by 5 U.S.C. 553, or by any other law, the analytical requirements of 5 U.S.C. 601 et seq. , are inapplicable.

The AA prepared an Environmental Assessment (EA) for the final rule requiring TED use in shrimp trawls and the regulatory framework for the Leatherback Conservation Zone (60 FR 47713, September 14, 1995). Copies of the EA are available (see ADDRESSES ).

NMFS manages the groundfish fishery in the BSAI exclusive economic zone according to the Fishery Management Plan for the Groundfish Fishery of the Bering Sea and Aleutian Islands Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

The second seasonal apportionment of halibut bycatch mortality allowance specified for the BSAI trawl rock sole/flathead sole/“other flatfish” fishery category, which is defined at § 679.21(e)(3)(iv)(B)( 2 ), was established as 168 metric tons by the Final 2000 Harvest Specifications for Groundfish (65 FR 8282, February 18, 2000).

In accordance with § 679.21(e)(7)(v), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the second seasonal apportionment of the 2000 halibut bycatch mortality allowance specified for the trawl rock sole/flathead sole/“other flatfish” fishery in the BSAI has been caught. Consequently, the Regional Administrator is closing directed fishing for species in the rock sole/flathead sole/“other flatfish” fishery category by vessels using trawl gear in the BSAI.

Maximum retainable bycatch amounts may be found in the regulations at § 679.20(e) and (f).

This action responds to the best available information recently obtained from the fishery. It must be implemented immediately to prevent exceeding the second seasonal apportionment of the 2000 halibut bycatch mortality allowance specified for the trawl rock sole/flathead sole/“other flatfish” fishery category. Providing prior notice and an opportunity for public comment on this action is impracticable and contrary to the public interest. The fleet will soon take the apportionment. Further delay would only result in the second seasonal apportionment of the 2000 halibut bycatch mortality allowance being exceeded. NMFS finds for good cause that the implementation of this action cannot be delayed for 30 days. Accordingly, under U.S.C. 553(d), a delay in the effective date is hereby waived.

This action is required by 50 CFR 679.21 and is exempt from review under E.O. 12866.