The Merit Systems Protection Board is amending its rules of practice and procedure for review of rules and regulations of the Office of Personnel Management to reflect a change in a statutory citation. Section 6(a)(2) of the Veterans Employment Opportunities Act of 1998 (Pub. L. 105-339) redesignated 5 U.S.C. 2302(b)(11), which makes it a prohibited personnel practice to take or fail to take a personnel action that would violate any law, rule, or regulation implementing or directly concerning the merit system principles, as 5 U.S.C. 2302(b)(12). That statutory provision is cited in the Board's regulations at 5 CFR 1203.11(b)(2), which describes the additional information that must be submitted with a request for review of an OPM regulation where that prohibited personnel practice is at issue. Therefore, the Board is amending its regulations at 5 CFR 1203.11(b)(2) to conform to the redesignated statutory provision.

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.

The Agricultural Marketing Act (AMA) of 1946 (7 U.S.C. 1621 et seq. ) authorizes official voluntary grading and certification on a user-fee basis of eggs, poultry, and rabbits. The AMA provides that reasonable fees be collected from users of the program services to cover, as nearly as practicable, the costs of services rendered.

The AMS regularly reviews these programs to determine if fees are adequate and if costs are reasonable. This rule will amend the schedule for fees and charges for grading services rendered to the egg, poultry, and rabbit industries to reflect the costs currently associated with them.

A recent review of the current fee schedule, effective October 1, 1999, revealed that anticipated revenue would not adequately cover increasing program costs. Without a fee increase, FY 2001 revenues for grading services are projected at $23.7 million, costs are projected at $24.9 million, and trust fund balances would be $11.3 million. With a fee increase, FY 2001 revenues are projected at $24.3 million, costs are projected at $24.9 million, and trust fund balances would be $11.9 million.

Employee salaries and benefits account for approximately 81 percent of the total operating budget. A general and locality salary increase for Federal employees, ranging from 4.76 to 5.31 percent, depending on locality, became effective in January 2000 and has materially affected program costs. Another general and locality salary increase estimated at 3.7 percent is expected in January 2001. Also, from October 1999 through September 2001, salaries and fringe benefits of federally licensed State employees will have increased by about 6.7 percent.

The impact of these cost increases was determined for resident, nonresident, and fee services. To offset projected cost increases, the hourly resident and nonresident rate will be increased by approximately 4 percent and the fee rate will be increased by approximately 6 percent. The hourly rate for resident and nonresident service covers graders' salaries and benefits. The hourly rate for fee service covers graders' salaries and benefits, plus the cost of travel and supervision. The hourly rate for an appeal grading or review of a grader's decision covers the time required to perform such service. Due to changes in the number of Poultry Program offices and the resulting reduction in costs, administrative charges that cover the cost of supervision for resident and nonresident service will remain unchanged as shown in the table below.

The following table compares current fees and charges with the revised fees and charges for egg, poultry, and rabbit grading as found in 7 CFR parts 56 and 70:

Based on an analysis of costs to provide these services, a proposed rule to increase the fees for these services was published in the Federal Register (65 FR 37298) on June 14, 2000. Comments on the proposed rule were solicited from interested parties until July 14, 2000. The Agency received four comments during the 30-day comment period. They were from one producer, one processor, and two industry associations. All four opposed the fee increase.

The producer and the two associations expressed concern that the increase was coming at a time of economic hardship and suggested that the Agency increase efforts to reduce costs. One of the associations suggested that the increase be postponed for 6 months, then re-evaluated and re-calculated at that time. The processor indicated that it wanted to continue using the service, but could not if the cost became prohibitive.

Employee salaries and benefits account for approximately 81 percent of the total operating budget, and rates for these expenditures are set by various Federal and State governing bodies. Projected increases in these costs require the Agency to increase hourly rates to keep the programs operating on a sound financial basis. Further, as discussed earlier and shown in the previous table, while the hourly rates would increase, the administrative charges would remain unchanged. Due to changes in the number of Poultry Program offices and the resulting reduction in costs, administrative charges that cover the cost of supervision for resident and nonresident service will remain unchanged. Although the Agency seeks to minimize or negate any fee increases for the poultry, rabbit, and egg grading programs, it must operate these programs on a sound financial basis. Therefore, the Agency is implementing those increases, as proposed, to ensure the financial stability of its grading programs.

This action has been determined to be not significant for purposes of Executive Order 12866 and has not been reviewed by the Office of Management and Budget (OMB).

Pursuant to the requirements set forth in the Regulatory Flexibility Act (RFA)(5 U.S.C. 601 et seq. ), the AMS has considered the economic impact of this action on small entities. It is determined that its provisions would not have a significant economic impact on a substantial number of small entities.

There are about 400 users of Poultry Programs' grading services. These official plants can pack eggs, poultry, and rabbits in packages bearing the USDA grade shield when AMS graders are present to certify that the products meet the grade requirements as labeled. Many of these users are small entities under the criteria established by the Small Business Administration (13 CFR 121.201). These entities are under no obligation to use grading services as authorized under the Agricultural Marketing Act of 1946.

The AMS regularly reviews its user fee financed programs to determine if the fees are adequate. The most recent review determined that the existing fee schedule would not generate sufficient revenues to cover program costs while maintaining an adequate reserve balance. Without a fee increase, FY 2001 revenues for grading services are projected at $23.7 million, costs are projected at $24.9 million, and trust fund balances would be $11.3 million. With a fee increase, FY 2001 revenues are projected at $24.3 million, costs are projected at $24.9 million, and trust fund balances would be $11.9 million.

This action will raise the fees charged to users of grading services. The AMS estimates that overall, this rule will yield an additional $0.5 million during FY 2001. The hourly rate for resident and nonresident service will increase by approximately 4 percent and the fee rate will increase by approximately 6 percent. The impact of these rate changes in a poultry plant will range from less than 0.002 to 0.02 cents per pound of poultry handled. In a shell egg plant, the range will be less than 0.009 to 0.09 cents per dozen eggs handled.

This action 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. There are no administrative procedures which must be exhausted prior to any judicial challenge to the provisions of this rule.

The information collection requirements that appear in the sections to be amended by this action have been previously approved by OMB and assigned OMB Control Numbers under the Paperwork Reduction Act (44 U.S.C. Chapter 35) as follows: § 56.52(a)(4)—No. 0581-0128; and § 70.77(a)(4)—No. 0581-0127.

Pursuant to 5 U.S.C. 553, it is found and determined that good cause exists for not postponing the effective date of the action until 30 days after publication in the Federal Register . The revised fees need to be implemented on an expedited basis in order to avoid further financial losses in the grading program. The effective date of the fee increase will be set to coincide with the billing cycle that begins on the first day of the first month after date of publication in the Federal Register .

This rule is issued under Marketing Agreement and Order No. 989 (7 CFR part 989), both as amended, regulating the handling of raisins produced from grapes grown in California, hereinafter referred to as the “order.” The marketing agreement and order are effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”

The Department of Agriculture (Department) is issuing this rule in conformance with Executive Order 12866.

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

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

This rule decreases the assessment rate established for the Committee for the 2000-01 and subsequent crop years from $8.50 to $6.50 per ton of free tonnage raisins acquired by handlers, and reserve tonnage raisins released or sold to handlers for use in free tonnage outlets. The order authorizes volume control provisions that establish free and reserve percentages of raisins acquired by handlers. Free tonnage raisins may be sold by handlers to any outlet, and reserve tonnage raisins are held by handlers for the account of the Committee or released or sold to handlers for sale to free tonnage outlets. Reserve raisins held for the account of the Committee are not assessable. With projected assessable tonnage about 23,300 tons higher than last year's assessable tonnage, sufficient income should be generated at the lower assessment rate for the Committee to meet its anticipated expenses. This action was unanimously recommended by the Committee at a meeting on August 15, 2000.

Sections 989.79 and 989.80, respectively, of the order provide authority for the Committee, with the approval of the Department, to formulate an annual budget of expenses and collect assessments from handlers to administer the program. The members of the Committee are producers and handlers of California raisins. They are familiar with the Committee's needs and with the costs of goods and services in their local area and are thus in a position to formulate an appropriate budget and assessment rate. The assessment rate is formulated and discussed in a public meeting. Thus, all directly affected persons have an opportunity to participate and provide input.

A continuous assessment rate of $5.00 per ton was in effect for the 1996-97 and 1997-98 crop years. Due to short crops in 1998-99 and 1999-2000, the assessment rate for those years was raised to $8.50 per ton.

Regarding the 2000-01 crop year, the Committee recommended decreasing the assessment rate to $6.50 per ton of assessable raisins to cover recommended administrative expenditures of $2,145,000. This compares to budgeted expenses of $2,482,000 for the 1999-2000 crop year. Major expenditures include $660,500 for export program administration and related activities, $477,700 for salaries, $476,300 for contingencies, and $160,000 for compliance activities. Budgeted expenses for these items in 1999-2000 were $549,500, $425,000, $506,250, and $200,000, respectively.

The recommended $6.50 per ton assessment rate was derived by dividing the $2,145,000 in anticipated expenses by an estimated 330,000 tons of assessable raisins. The Committee recommended decreasing its assessment rate because the projected 2000-01 assessable tonnage of 330,000 tons is about 23,300 tons higher than last year's actual assessed tonnage. Thus, sufficient income should be generated at the lower assessment rate for the Committee to meet its anticipated expenses. Pursuant to § 989.81(a) of the order, any unexpended assessment funds from the crop year must be credited or refunded to the handlers from whom collected.

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

Although this assessment rate is effective for an indefinite period, the Committee will continue to meet prior to or during each crop year to recommend a budget of expenses and consider recommendations for modification of the assessment rate. The dates and times of Committee meetings are available from the Committee or the Department. Committee meetings are open to the public and interested persons may express their views at these meetings. The Department will evaluate Committee recommendations and other available information to determine whether modification of the assessment rate is needed. Further rulemaking will be undertaken as necessary. The Committee's 2000-01 budget and those for subsequent crop years will be reviewed and, as appropriate, approved by the Department.

Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA), the Agricultural Marketing Service (AMS) has considered the economic impact of this 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 20 handlers of California raisins who are subject to regulation under the order and approximately 4,500 raisin producers in the regulated area. Small agricultural firms are 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 having annual receipts of less than $500,000. Thirteen of the 20 handlers subject to regulation have annual sales estimated to be at least $5,000,000, and the remaining 7 handlers have sales less than $5,000,000, excluding receipts from any other sources. No more than 7 handlers, and a majority of producers, of California raisins may be classified as small entities, excluding receipts from other sources.

This rule decreases the assessment rate established for the Committee and collected from handlers for the 2000-01 and subsequent crop years from $8.50 to $6.50 per ton of assessable raisins acquired by handlers. The Committee unanimously recommended 2000-01 expenses of $2,145,000. Major expenditures include $660,500 for export program administration and related activities, $477,700 for salaries, $476,300 for contingencies, and $160,000 for compliance activities. Budgeted expenses for these items in 1999-2000 were $549,500, $425,000, $506,250, and $200,000, respectively. With anticipated assessable tonnage at 330,000 tons, about 23,300 tons higher than last year's actual assessed tonnage, sufficient income should be generated at the $6.50 per ton assessment rate to meet expenses. Pursuant to § 989.81(a) of the order, any unexpended assessment funds from the crop year must be credited or refunded to the handlers from whom collected.

The industry considered various alternative assessment rates prior to arriving at the $6.50 per ton recommendation. The Committee's Audit Subcommittee met on August 8, 2000, to review preliminary budget information. The subcommittee considered keeping the assessment rate at $8.50 per ton. However, this would have generated a projected $1 million in excess funds. The subcommittee considered reducing the rate to $7.50 per ton and ultimately recommended that rate to the Committee at its meeting on August 15, 2000. Other options were discussed at the Committee meeting, including decreasing the rate to $5.00 per ton. After much deliberation, the Committee voted to decrease the assessment rate to $6.50 per ton.

A review of statistical data on the California raisin industry indicates that assessment revenue has consistently been less than one percent of grower revenue in recent years. Although no official estimates or data are available for the upcoming season, it is anticipated that assessment revenue will likely continue to be less than one percent of grower revenue in the 2000-2001 crop year, especially with the 24 percent decrease in the assessment rate.

Regarding the impact of this action on affected entities, this action decreases the assessment rate imposed on handlers. Assessments are applied uniformly on all handlers, and some of the costs may be passed on to producers. However, decreasing the assessment rate reduces the burden on handlers, and may reduce the burden on producers.

In addition, the Audit Subcommittee's meeting on August 8, 2000, and the Committee's meeting on August 15, 2000, where this action was deliberated were public meetings widely publicized throughout the raisin industry. All interested persons were invited to attend the meetings and participate in the industry's deliberations. Finally, all interested persons are invited to submit information on the regulatory and information impact of this action on small businesses.

This rule imposes no additional reporting or recordkeeping requirements on either small or large raisin handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sectors agencies. Finally, the Department has not identified any relevant Federal rules that duplicate, overlap, or conflict with this rule.

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

After consideration of all relevant 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.

Pursuant to 5 U.S.C. 553, it is also found and determined upon good cause that it is impracticable, unnecessary, and contrary to the public interest to give preliminary notice prior to putting this rule into effect, and that good cause exists for not postponing the effective date of this rule until 30 days after publication in the Federal Register because: (1) The 2000-01 crop year began on August 1, 2000, and the order requires that the rate of assessment for each crop year apply to all assessable raisins acquired during the year; (2) this action decreases the assessment rate; (3) handlers are aware of this action which was unanimously recommended at a public meeting and is similar to other assessment rate actions issued in past years; and (4) this rule provides a 60-day comment period, and all comments timely received will be considered prior to finalization of this rule.

The Service published an interim rule in the Federal Register on September 6, 2000, at 65 FR 53889. In the interim rule there is a reference to “§ 204(n) of this chapter” the reference should have been to “§ 204.12(a) of this chapter.”

The Transport Canada Civil Aviation (TCCA), which is the airworthiness authority for Canada, recently notified the FAA that an unsafe condition may exist on certain Bombardier Model CL-600-2B19 series airplanes. The TCAA advises that it has received reports of stiffness of the aileron controls following take-off from a snow and slush covered runway. It is suspected that water, ice, or slush accumulated on the aileron quadrants and control cable pulleys in the wheel bay of the main landing gear (MLG) during the ground roll, and then froze during the climb to cruise altitude. Upon descent to lower altitude, normal aileron control was restored and the airplane landed safely.

Such accumulation of water, ice, or slush on the aileron quadrants and control cable pulleys in the wheel bay of the main landing gear could result in reduced controllability of the airplane.

Bombardier has issued Service Bulletin 601R-27-104, dated October 15, 1999, which describes procedures for the installation of splash shields for the aileron quadrants in the wheel bay of the MLG. Accomplishment of the action specified in the service bulletin is intended to adequately address the identified unsafe condition. The TCAA classified this service bulletin as mandatory and issued Canadian airworthiness directive CF-2000-28, dated August 28, 2000, in order to assure the continued airworthiness of these airplanes in Canada.

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

Since an unsafe condition has been identified that is likely to exist or develop on other airplanes of the same type design registered in the United States, this AD is being issued to prevent the accumulation of water, ice, and slush on the aileron quadrants and control cable pulleys in the wheel bay of the MLG, which could result in reduced controllability of the airplane. This AD requires accomplishment of the actions specified in the service bulletin described previously.

This AD differs from the parallel Canadian AD in that it requires the installation of the splash shields within 30 days after the effective date of this AD, rather than within 90 days as specified in the Canadian AD. The FAA finds that a 90-day compliance time will not ensure that the installation is accomplished in a timely manner. In developing an appropriate compliance time for the installation of the splash shields, the FAA considered not only the TCAA's recommendation, but also the degree of urgency associated with addressing the subject unsafe condition. The FAA finds that installation of the splash shields within 30 days of the effective date of this AD to be warranted, in that this represents an appropriate amount of time allowable for affected airplanes to continue to operate without compromising safety.

Since a situation exists that requires the immediate adoption of this regulation, it is found that notice and opportunity for prior public comment hereon are impracticable, and that good cause exists for making this amendment effective in less than 30 days.

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

Submit comments using the following format:

• Organize comments issue-by-issue. For example, discuss a request to change the compliance time and a request to change the service bulletin reference as two separate issues.

• For each issue, state what specific change to the AD is being requested.

• Include justification ( e.g., reasons or data) for each request.

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

Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this rule must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket Number 2000-NM-312-AD.” The postcard will be date stamped and returned to the commenter.

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

The FAA has determined that this regulation is an emergency regulation that must be issued immediately to correct an unsafe condition in aircraft, and that it is not a “significant regulatory action” under Executive Order 12866. It has been determined further that this action involves an emergency regulation under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979). If it is determined that this emergency regulation otherwise would be significant under DOT Regulatory Policies and Procedures, a final regulatory evaluation will be prepared and placed in the Rules Docket. A copy of it, if filed, may be obtained from the Rules Docket at the location provided under the caption ADDRESSES .

We use the Listings in appendix 1 to subpart P of part 404 at the third step of the sequential evaluation process to evaluate claims filed by adults and children for benefits based on disability under the Social Security and SSI programs. The Listings are divided into parts A and B. We use the criteria in part A to evaluate the impairments of adults. We use the criteria in part B to evaluate impairments of children. If those criteria do not apply, then we will apply the medical criteria in part A.

As a result of medical advances in disability evaluation and treatment, and program experience, we periodically review and update the Listings. When we last published the respiratory body system listings on October 7, 1993 (58 FR 52346), we established October 7, 2000, as the date on which the respiratory body system listings would no longer be effective unless they were extended or revised and promulgated again.

In this final rule, we are extending until July 2, 2002, the date on which the respiratory body system listings (3.00 and 103.00) will no longer be effective. We are extending this date because we do not expect to develop revised listings criteria for this body system by the current expiration date. However, we are reviewing the respiratory body system listings and we plan to publish proposed and final rules over the course of the next two years.

We believe that the requirements in these listings are still valid for our program purposes. Specifically, if we find that an individual has an impairment that meets the statutory duration requirement and that meets or equals the Listings, we will find that the individual is disabled at the third step of the sequential evaluation process.

Pursuant to section 702(a)(5) of the Social Security Act, 42 U.S.C. 902(a)(5), we follow the Administrative Procedure Act (APA) rulemaking procedures specified in 5 U.S.C. 553 in the development of our regulations. The APA provides exceptions to its notice and public comment procedures when an agency finds there is good cause for dispensing with such procedures on the basis that they are impracticable, unnecessary, or contrary to the public interest. We have determined that, under 5 U.S.C. 553(b)(B), good cause exists for dispensing with the notice and public comment procedures for this rule. Good cause exists because this final rule only extends the date on which the respiratory body system listings will no longer be effective. It makes no substantive changes to the listings. The current regulations expressly provide that the listings may be extended, as well as revised and promulgated again. Therefore, we have determined that opportunity for prior comment is unnecessary, and we are issuing this regulation as a final rule.

In addition, we find good cause for dispensing with the 30-day delay in the effective date of a substantive rule provided by 5 U.S.C. 553(d). As explained above, we are not making any substantive changes in the respiratory body system listings. However, without an extension of the expiration date for the respiratory body system listings, we will lack regulatory criteria for assessing respiratory impairments at the third step of the sequential evaluation process after the current expiration date of the listings. In order to ensure that we continue to have regulatory criteria for assessing respiratory impairments under the listings, we find that it is in the public interest to make this rule effective upon publication.

We have consulted with the Office of Management and Budget (OMB) and determined that this final rule does not meet the criteria for a significant regulatory action under Executive Order 12866. Thus, it was not subject to OMB review. We have also determined that this final rule meets the plain language requirement of Executive Order 12866 and the President's memorandum of June 1, 1998 (63 FR 31885).

We certify that this final regulation will not have a significant economic impact on a substantial number of small entities. Therefore, a regulatory flexibility analysis as provided in the Regulatory Flexibility Act, as amended, is not required.

This final regulation imposes no reporting/recordkeeping requirements necessitating clearance by OMB.

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(8), the Coast Guard finds that good cause exists for not publishing an NPRM. Good cause exists for not publishing an NPRM due to the fact that the safety zone is required due to an unforeseen oil spill. Any delay encountered in this regulation's effective date would be unnecessary and contrary to public interest since immediate action is needed to close the waterway and protect the recovery personnel and vessels in the vicinity of oil spill recovery operations.

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 . This is due to the following reasons: It is an unforeseen oil spill and is needed to protect the recovery personnel and vessels in the vicinity of the oil spill recovery operations.

There was an oil spill in the vicinity of the Naval Weapons Station, Earle, NJ on September 14, 2000. The Coast Guard is establishing a temporary safety zone to provide safety to personnel engaged in recovery operations and to vessels in the area. The safety zone is in effect from 7 p.m. (e.s.t.) on September 14, 2000, until 7 a.m. (e.s.t.) on Monday, September 25, 2000. The effective times of this safety zone may be extended or shortened depending on the time required to conduct the oil spill recovery. The safety zone prevents vessels from transiting a portion of Lower New York and Sandy Hook Bays. The safety zone includes all waters of Lower New York and Sandy Hook Bays bound by the following points: 40°27.449′ N, 074°08.224′ W onshore at Point Comfort, NJ, thence to Old Orchard Shoal Light (LLNR 35395), thence to Chapel Hill South Channel Lighted Bell Buoy 10 (LLNR 35235), thence to 40°28.656′ N, 074°01.076′ W onshore at Sandy Hook Point, thence to Atlantic Highlands Breakwater Light (LLNR 35595). Marine traffic will not be allowed within this safety zone without authorization from the Captain of the Port New York. The size and duration of this zone may be expanded or contracted as required for oil spill recovery activities. Public notifications will be made by facsimile and broadcast notice to mariners as required.

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, 1979).

The Coast Guard expects the economic impact of this final rule to be so minimal that a full Regulatory Evaluation under paragraph 10e of the regulatory policies and procedures of DOT is unnecessary. This finding is based on the minimal time that vessels will be restricted from the zone, and the unforeseen nature of the oil spill.

The size of this safety zone was determined using the predicted tides and currents for the area affected by the oil spill.

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.

This rule will affect the following entities, some of which may be small entities: The owners or operators of vessels intending to transit or anchor in a portion of Lower New York and Sandy Hook Bays during the times this zone is activated.

This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: It is due to an unforeseen oil spill. The size and duration of the zone may be expanded or contracted due to oil spill recovery operations.

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

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 zone will only be in effect for the time required to complete the oil spill recovery operations.

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 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 Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

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

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not concern an environmental risk to health or 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 34(g), of Commandant Instruction M16475.1C, this rule is categorically excluded from further environmental documentation. This rule fits paragraph 34(g) as it establishes a safety zone. A “Categorical Exclusion Determination” is available in the docket for inspection or copying where indicated under ADDRESSES.

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

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

1. Electronically . You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/. To access this document, on the Home Page select “Laws and Regulations ” “Regulations and Proposed Rules,” 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-301043. 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.

EPA, on its own initiative, in accordance with sections 408(e) and 408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is establishing tolerances for residues of the herbicide clopyralid, 3,6-dichloro-2-pyridinecarboxylic acid, in or on peaches and nectarines at 0.50 part per million (ppm). These tolerances will expire and are revoked on December 31, 2002. EPA will publish a document in the Federal Register to remove the revoked tolerances from the Code of Federal Regulations.

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

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

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

Plum pox virus was introduced to the United States in 1999 and has recently been found in Pennsylvania. This disease is a major threat to stone fruit production, and Delaware and New Jersey are requesting an emergency exemption for use of clopyralid since removal of broadleaf weeds that are alternate hosts for the virus, or are refugia for the green peach aphid, the vector of this virus, will enhance the effectiveness of imidacloprid which has already been exempted under section 18 of FIFRA for use to combat the aphid vector directly.

The registered alternative herbicides are not optimal for control of the weeds that clopyralid is being requested for. Most are for preemergence use on bare ground, and will not affect perennial weeds such as clover, Canada thistle, and asters. Some are non-selective and will kill the sod between tree rows, resulting in unacceptable erosion. Only 2,4-D is useful for some weeds, but for others, gives only partial control. While the use of imidacloprid to control the vectors is the major tool to contain or eradicate plum pox virus, an herbicide like clopyralid will enhance the effectiveness of imidacloprid by reducing the population of insects needing to be controlled, and the population of weeds that can serve as alternate hosts for the virus. EPA has authorized under FIFRA section 18 the use of clopyralid on peaches and nectarines for control of weeds that serve as alternate hosts for plum pox virus or are refugia for the green peach aphid in Delaware and New Jersey. After having reviewed the submission, EPA concurs that emergency conditions exist for these States.

As part of its assessment of this emergency exemption, EPA assessed the potential risks presented by residues of clopyralid in or on peaches and nectarines. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2), and EPA decided that the necessary tolerance under FFDCA section 408(l)(6) would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing this tolerance without notice and opportunity for public comment as provided in section 408(l)(6). Although these tolerances will expire and are revoked on December 31, 2002, under FFDCA section 408(l)(5), residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on peaches and nectarines after that date will not be unlawful, provided the pesticide is applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by these tolerances at the time of that application. 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.

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

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

Consistent with section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of clopyralid and to make a determination on aggregate exposure, consistent with section 408(b)(2), for time-limited tolerances for residues of clopyralid in or on peaches and nectarines at 0.50 ppm. EPA's assessment of the dietary exposures and risks associated with establishing the tolerance follows.

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

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

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

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

1. Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.431) for the residues of clopyralid, in or on a variety of raw agricultural commodities. Tolerances currently exist for residues of clopyralid on asparagus, barley, field corn, mint, oats, sugar beet tops, wheat, meat, milk and eggs. Additionally, time-limited tolerances for canola, cranberries and flax have been established. Risk assessments were conducted by EPA to assess dietary exposures from clopyralid in food as follows:

i. Acute exposure. Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. The Dietary Exposure Evaluation Model (DEEM®) analysis evaluated the individual food consumption as reported by respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: 100% crop treated was assumed for all crops and residues were assumed to be at tolerance level.

ii. Chronic exposure . In conducting this chronic dietary risk assessment the Dietary Exposure Evaluation Model (DEEM®) analysis evaluated the individual food consumption as reported by respondents in the USDA 1989-1992 nationwide CSFII and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: 100% crop treated was assumed for all crops and residues were assumed to be at tolerance level.

iii. Cancer . Clopyralid has been classified as “not likely” to be a human carcinogen. Therefore, an exposure assessment to address cancer risk is not required.

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

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

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

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

Based on the GENEEC and SCI-GROW models the EECs of clopyralid for acute exposures are estimated to be 27 parts per billion (ppb) for surface water and 9.7 ppb for ground water. The EECs for chronic exposures are estimated to be 9 ppb for surface water and 9.7 ppb for ground water.

3. From non-dietary exposure . The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Clopyralid is currently registered for use on the following residential non-dietary sites: turf and ornamentals. Applications can be made 1-2 times per year at rates up to 0.5 lb acid equivalent (ae) per acre. The current registered labels permit homeowners to mix/load/apply both liquid and granular formulations. The risk assessment was conducted using the following exposure assumptions: residential handlers may receive short-term dermal and inhalation exposure to clopyralid when mixing, loading and applying; adults and children may be exposed to clopyralid from dermal contact with residues when contacting foliage during post-application activities; and toddlers may also receive short-term oral exposure from hand-to-mouth ingestion during post-application activities.

No chemical-specific exposure or residue dissipation data for handler or post-application activities were submitted to the Agency in support of the registered lawn uses. Therefore, the Agency's Draft Standard Operating Procedures for Residential Exposure Assessments were used as the basis for all handler exposure calculations. The post-application risk assessment is based on generic assumptions as specified by the newly proposed Residential SOPs and recommended approaches by the Agency's Exposure Science Advisory Committee (ExpoSAC). Changes to the Residential SOPs have been proposed that alter the residential post-application scenario assumptions. The proposed assumptions are expected to better represent residential exposure and are still considered to be high-end, screening level assumptions. Agency management has authorized the use of the revised residential SOPs that were presented to the FIFRA SAP in September 1999. Therefore, the revised residential SOPs were used to calculate exposure estimates for the clorpyralid turf and ornamental uses.

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 clopyralid 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, clopyralid 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 clopyralid has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the final rule for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

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

ii. Developmental toxicity studies . In the developmental study in rats, the maternal toxicity LOAEL is 250 mg/kg/day based on death, reduced body weight gains, and reduced food consumption, and the maternal toxicity NOAEL is 75 mg/kg/day. The developmental toxicity NOAEL is greater than or equal to 250 mg/kg/day.

In the developmental toxicity study in rabbits, the maternal NOAEL is 110 mg/kg/day based on death, clinical signs, reduced body weight, and gastric lesions at the LOAEL of 250 mg/kg/day. The developmental NOAEL is also 110 mg/kg/day based on hydrocephalus (8 fetuses in 3 litters) at the LOAEL of 250 mg/kg/day.

iii. Reproductive toxicity study . In the 2-generation reproductive toxicity study in rats, the systemic toxicity NOAEL is 500 mg/kg/day. This endpoint is based on decreased body weights, body weight gains, and food consumption in the F 0 and F 1 males and females and slight focal hyperkeratotic changes in the gastric squamous mucosa of 1 of 30 F 0 males and 2 of 30 F 1 males at the LOAEL of 1,500 mg/kg/day. The reproductive toxicity NOAEL is 500 mg/kg bw/day. This endpoint is based on the decreased day 28 body weight of male pups of both litters of the F 1 generation and the increased relative liver weight of F 1a pups (both sexes) and F1b males of the F 1 generation at the LOAEL of 1,500 mg/kg/day.

iv. Prenatal and postnatal sensitivity. There is no evidence of qualitative or quantitative susceptibility following in utero exposure to rats or rabbits in the prenatal developmental studies or in the offspring following pre/postnatal exposure in the two generation rat reproduction toxicity study.

v. Conclusion . The FQPA 10x Safety Factor was reduced to 3x. This reduction was made because there is no quantitative or qualitative evidence of increased susceptibility following in utero exposure to rats and rabbits and/or following prenatal/postnatal exposure to rats. Additionally, the dietary (food and drinking water) and non-occupational exposure assessments will not underestimate the potential exposures for infants, children, and/or women of childbearing age. However, there was neuropathology in fetuses (hydrocephalus) in the rabbit developmental study. This study was considered a “weak trigger” for the requirement of a developmental neurotoxicity study. Therefore, the FQPA Safety Factor is 3x.

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

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

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

1. Acute risk . Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food to clopyralid will occupy 8% of the aPAD for the U.S. population, 5% of the aPAD for females 13 years and older, 9% of the aPAD for all infants less than 1 year old (the infant subpopulation at greatest exposure) and 13% of the aPAD for children 1-6 years old (the children subpopulation at greatest exposure). In addition, despite the potential for acute dietary exposure to clopyralid in drinking water, after calculating DWLOCs and comparing them to conservative model estimated environmental concentrations of clopyralid in surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the aPAD, as shown in the following Table 2:

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to clopyralid from food will utilize 14% of the cPAD for the U.S. population, 10% of the cPAD for all infants less than 1 year old (the infant subpopulation at greatest exposure) and 34% of the aPAD for children 1-6 years old (the children's subpopulation at greatest exposure). Though there are residential uses for clopyralid, based on the use pattern, chronic residential exposure is not expected. In addition, despite the potential for chronic dietary exposure to clopyralid in drinking water, after calculating the DWLOCs and comparing them to conservative model EECs of clopyralid in surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in the following Table 3:

3. Short-term risk . Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Clopyralid is currently registered for use(s) that could result in short-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and short-term exposures for clopyralid. A short-term aggregate risk assessment was conducted for adults because there is potential for inhalation exposure to the residential handler. In addition, a short-term risk assessment was conducted for infants and children because of the potential for residential post-application oral exposure. Since no short-term dermal endpoint was identified, even though there is potential for short-term dermal exposures, no short-term dermal aggregate risk assessment was conducted.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that food and residential exposures aggregated result in aggregate MOEs of 10,000 for inhalation exposure for adults, and 2,300 for children 1-6 years old and 2,400 for all infants less than 1 year old for post-application oral exposure. These aggregate MOEs do not exceed the Agency's level of concern for aggregate exposure to food and residential uses. In addition, short-term DWLOCs were calculated and compared to the EECs for chronic exposure of clopyralid in ground water and surface water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect short-term aggregate exposure to exceed the Agency's level of concern, as is shown in the following Table 4:

4. Intermediate-term risk .

Intermediate-term aggregate exposure takes into account non-dietary, non-occupational exposure plus chronic exposure to food and water (considered to be a background exposure level). Intermediate-term exposure is considered to be exposures that last for 1 week to several months. Though clopyralid is registered for use on turf and ornamentals, only 1-2 applications can be made. Therefore, intermediate-term exposure is not expected. Therefore, the short-term aggregate risk estimate discussed above, is considered protective of the aggregate exposure from non-dietary, non-occupational uses.

5. Aggregate cancer risk for U.S. population . Clopyralid has been classified as “not likely” to be a human carcinogen. Therefore, an aggregate risk assessment to address cancer risk is not required.

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

An adequate analytical method is available for enforcement of the proposed time-limited tolerance for peaches and nectarines. This method (ACR 79.5, Dow Chemical) is a Gas Chromatography method using a Hall electrolytic conductivity detector. The method has been validated for use on wheat and barley and has been submitted to FDA for publication in PAM II. The method may be requested from: Calvin Furlow, PRRIB, IRSD (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460; telephone number: (703) 305-5229; e-mail address: furlow.calvin@epa.gov.

There are no CODEX, Canadian, or Mexican Maximum Residue Limits (MRL) for clopyralid on peaches or nectarines. International harmonization is therefore not an issue for these section 18 requests.

No more than 0.375 lb clopyralid can be applied per acre per year. A 60-day preharvest interval (PHI) will be observed.

Therefore, the tolerances are established for residues of clopyralid, 3,6-dichloro-2-pyridinecarboxylic acid, in or on peaches and nectarines at 0.50 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--301043 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 November 27, 2000.

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

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

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

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

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

3. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VII.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.2. Mail your copies, identified by the docket control number OPP-301043, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.2. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 file format or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

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

This final rule establishes 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 exemption 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).

The Agency included in the final rule a list of those who may be potentially affected by this action. 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,” “Regulations and Proposed Rules,” 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-301041. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, 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.

A time-limited tolerance for diflubenzuron on pears was published in the Federal Register on September 29, 1999 (64 FR 52450) (FRL-6382-1). This correction will change the expiration date for the tolerance to March 31, 2001. The document originally published with this date given in the body of the text. However, the table at the end of the document incorrectly listed the expiration date as March 31, 2000. This document corrects that error.

Section 553 of the Administrative Procedure Act (APA), 5 U.S.C. 553(b)(B), provides that, when an agency for good cause finds that notice and public procedure are impracticable, unnecessary or contrary to the public interest, the agency may issue a rule without providing notice and an opportunity for public comment. EPA has determined that there is good cause for making today's rule final without prior proposal and opportunity for comment, because EPA is correcting the expiration date for the tolerance diflubenzuron to March 31, 2001, which was incorrectly given as March 31, 2000. EPA finds that this constitutes good cause under 5 U.S.C. 553(b)(B)

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

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

For information about the applicability of the regulatory assessment requirements to the final rule that was issued on September 29, 1999 (64 FR 52450), please refer to the discussion in Unit VIII. of that document.

Yes. The Congressional Review Act (CRA), 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. Section 808 allows the issuing agency to make a rule effective sooner than otherwise provided by the CRA if the agency makes a good cause finding that notice and public procedure is impracticable, unnecessary or contrary to the public interest. This determination must be supported by a brief statement. (5 U.S.C. 808(2)). EPA has made such a good cause finding for this final rule, and established an effective date of September 29, 1999. Pursuant to 5 U.S.C. 808(2), this determination is supported by the brief statement in Unit IV. of this document. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . This is not a “major rule” as defined by 5 U.S.C. 804(2).

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,” “Regulations and Proposed Rules,” 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/. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm.

2. In person . The Agency has established an official record for this action under docket control number OPP-301053. 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 10, 2000 and July 25, 2000 (65 FR 1370) (FRL-6394-6) and (65 FR 45769) (FRL-6596-4),respectively, 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) for tolerance by Monsanto Company, 600 13th Street NW., Suite 660, Washington DC 20005. In addition, in the Federal Register of August 14, 2000 (65 FR 49563) (FRL-6739-2), EPA issued a notice pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170) announcing the filing of pesticide petition (PP) for tolerance by IR-4, Technology Center of New Jersey, 681 U.S. Highway #1 South, North Brunswick, NJ 08902-3390. These notices included a summary of the petitions prepared by Monsanto Company. Comments were received from Monsanto in response to the notice of filing. Monsanto noted that the tolerance proposal for the leafy vegetable group is for residues of glyphosate at 0.2 ppm, not 2.0 ppm, and that there is no proposal for residues of glyphosate in or on poultry meat. The Agency agrees that the appropriate tolerance level for the leafy vegetable group is 0.2 ppm. Monsanto has agreed that a tolerance for poultry meat at 0.1 ppm is needed to harmonize with CODEX. There were no other comments received in response to the notices of filing.

The petitions requested that 40 CFR 180.364 be amended by establishing tolerances for residues of glyphosate, ( N -(phosphonomethyl)glycine) resulting from the application of glyphosate, the isopropylamine salt of glyphosate, the ethanolamine salt of glyphosate, and the ammonium salt of glyphosate in or on alfalfa hay at 400 ppm; grass, forage, fodder and hay group; nongrass animal feed group, kenaf forage, and leucaena forage at 200 ppm; alfalfa forage at 175 ppm; cereal grain group (except barley, field corn, grain sorghum, oats and wheat) at 100 ppm; rapeseed meal at 15, rapeseed seed at 10 ppm, flax meal at 8.0 ppm; dried hops cones, and spices subgroup at 7.0 ppm; teff grain at 5.0 ppm, flax seed at 4.0 ppm; field corn forage at 3.0 ppm; dokudami at 2.0 ppm, and Mexican oregano leaves at 2.0; perilla tops at 1.8 ppm; epazote at 1.3 ppm; betelnut. chaya, pine nut, and stevia dried leaves at 1.0 ppm; aloe vera, cactus fruit, cactus pads, okra, ugli fruit, and quinoa grain at 0.5 ppm; ambarella, globe artichoke, bambo shoots, berry group, biriba, blimbe, custard apple, feijoa, galangal roots, ginger white flower, governor's plum, gow kee leaves, herbs subgroup, ilama, imbe, imbu, juneberry, kava roots, lingonberry, mamey apple, mioga flower, palm heart, palm heart leaves, mountain papaya, pawpaw, pepper leaf (fresh leaves), pulasan, rose apple, salal, Spanish lime, star apple, strawberry, surinam cherry, ti leaves, ti roots, Brassica leafy vegetable, foliage of legume vegetable group (except soybean forage and hay), leafy vegetable group, leaves of root and tuber vegetable group (except sugar beet tops), root and tuber vegetable group (except sugar beet), wasabi root, water spinach tops, upland watercress, and wax jambu at 0.2; borage seed, crambe seed, buffalo gourd seed, egg, jojoba seed, lesquerella seed, meadowfoam seed, mustard seed, poultry meat, safflower seed, and sesame seed at 0.1 ppm.

In addition to the commodity tolerances proposed by IR-4 and Monsanto, Monsanto proposed to amend 40 CFR part 180 by revising the tolerance expression under § 180.364(a)(1) to read as follows:

§ 180.364 Glyphosate ; tolerances for residues. (a)(1) General . Tolerances are established for residues of glyphosate ( N -(phosphonomethyl)glycine) from the application of glyphosate, the ethanolamine salt of glyphosate, and the ammonium salt of glyphosate .... ”

Monsanto also proposed that the existing text in § 180.364(a)(1) by redesignated as § 180.364(a), that the tolerances in §§ 180.364(a)(2) and (a)(3) be transferred to the table in newly designated § 180.364(a), and that the introductory text of § 180.364(a)(2) and (a)(3) be deleted. Additional revisions to the table in § 180.364(a) are the deletion of duplicate commodity tolerance entries and the deletion of commodity tolerances that are superceded by the proposed crop group tolerances and the conversion of commodity terms to comply with EPA's Food and Feed Vocabulary Data Base (http://www.epa.gov/pesticides/foodfeed/). The Agency is also deleting all commodity entries under § 180.364(d)— indirect or inadvertent residues since these commodities will have tolerance established at the same or higher levels in the newly established § 180.364(a).

IR-4 proposed a tolerance for residues of glyphosate in or on the grass, forage, fodder and hay group at 200 ppm. IR-4's proposal is based on data previously reviewed by EPA in support of established tolerances for bahiagrass, bluegrass, bermudagrass, fescue, orchardgrass, ryegrass, timothy, and wheatgrass at 200 ppm. Monsanto has also proposed a grass, forage, fodder and hay tolerance; however, Monsanto has requested a tolerance level of 300 ppm. Monsanto's tolerance proposal for the grass group is based on new residue data which reflect changed use patterns and pre-grazing intervals for the grasses. In the notice filings cited above, reference was made to the 300 ppm tolerance level but not the 200 ppm level. Because the Agency has determined that the available data are adequate to support IR-4's tolerance proposal for residues of glyphosate in or on the grass, forage, fodder and hay group at 200 ppm and EPA has not completed review of Monsanto's new data supporting the 300 ppm level, EPA is establishing the tolerance for grass, forage, fodder and hay at 200 ppm. The Agency will reevaluate the grass group tolerance based on the residue data submitted by Monsanto and will make a decision on the proposed grass group tolerance at 300 ppm at a later date.

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 these tolerances for residues of glyphosate. EPA's assessment of 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 glyphosate are discussed in the following Table 1 as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies reviewed.

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

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

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

The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk is expressed as 1 × 10 -6 or one in a million). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non-linear approach, a “point of departure” is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOE cancer = point of departure/exposures) is calculated. A summary of the toxicological endpoints for glyphosate used for human risk assessment is shown in the following Table 2:

1. Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.364) for the residues of glyphosate, in or on a variety of food commodities. Tolerances are established for cattle, hog, horse and sheep kidney at 4.0 ppm and liver at 0.5 ppm. Tolerance levels for residues of glyphosate at 0.1 ppm for egg and poultry meat and 1.0 ppm for poultry meat byproducts were proposed by IR-4. Risk assessments were conducted by EPA to assess dietary exposures from glyphosate in food as follows:

i. Acute exposure . Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. An acute dietary endpoint and dose was not identified for glyphosate. A review of the rat and rabbit developmental studies did not provide a dose or endpoint that could be used for acute dietary risk purposes. Additionally, there were no data requirements for acute or subchronic rat neurotoxicity studies since there was no evidence of neurotoxicity in any of the toxicology studies at very high doses and glyphosate lacks a leaving group.

ii. Chronic exposure . In conducting this chronic dietary risk assessment the Dietary Exposure Evaluation Model (DEEM®) analysis evaluated the individual food consumption as reported by respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: The chronic dietary exposure analysis from food sources was conducted using the reference dose (RfD) of 2.0 mg/kg/day. The RfD is based on the maternal NOAEL of 175 mg/kg/day from a rabbit developmental study and an uncertainty factor of 100 (applicable to all population subgroups). The DEEM® analysis assumed tolerance level residues and 100% crop treated in/on all commodities with an existing or proposed glyphosate tolerance.

iii. Cancer . There is no evidence of carcinogenic potential.

2. Dietary exposure from drinking water . The available field and laboratory data indicate that glyphosate adsorbs strongly to soil and would not be expected to move vertically below the 6 inch soil layer. Based on unaged batch equilibrium studies glyphosate and glyphosate residues are expected to be immobile with Kd(ads) values ranging from 62 to 175. The mechanism of adsorption is unclear; however, it is speculated that it may be associated with vacant phosphate sorption sites or high levels of metallic soil cations. The data indicate that chemical and photochemical decomposition is not a significant pathway of degradation of glyphosate in soil and water. However, glyphosate is readily degraded by soil microbes to AMPA, which is degraded to CO 2 , although at a slower rate than parent glyphosate.

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

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 the Screening Concentration in Ground Water model (SCI-GROW), which predicts pesticide concentrations in groundwater. In general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS (a tier 2 model) for a screening-level assessment for surface water. The GENEEC model is a subset of the PRZM/EXAMS model that uses a specific high-end runoff scenario for pesticides. GENEEC incorporates a farm pond scenario, while PRZM/EXAMS incorporate an index reservoir environment in place of the previous pond scenario. The PRZM/EXAMS model includes a percent crop area factor as an adjustment to account for the maximum percent crop coverage within a watershed or drainage basin.

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

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

Using available environmental fate parameters and assuming two applications with a retreatment interval of 90 days at a rate of 5 lbs ai/A (3.75 lbs ai/A), the ground water EEC from glyphosate using SCI-GROW was 0.0038 parts per billion (ppb). The current label allows multiple applications of 0.37 - 5 lbs ai/A up to a maximum of 10.6 lbs ai/A/year. The ground water EECs generated by SCI-GROW are based on the largest 90-day average recorded during the sampling period. Since there is relatively little temporal variation in ground water concentrations compared to surface water, the concentrations can be considered as acute and chronic values.

The GENEEC model was used to estimate surface water concentrations for glyphosate resulting from its maximum use rate on crops. GENEEC is a single event model (one runoff event), but can account for spray drift from multiple applications. GENEEC represents a 10 hectare field immediately adjacent to a 1 hectare pond that is 2 meters deep with no outlet. The pond receives a spray drift event from each application plus one runoff event. The runoff event moves a maximum of 10% of the applied pesticide into the pond. This amount can be reduced due to degradation on the field and by soil sorption. Spray drift is estimated at 5% of the application rate. The GENEEC values represent upper- bound estimates of the concentrations that might be found in surface water due to glyphosate use. Thus, the GENEEC model predicts that glyphosate surface water EECs range from a peak of 21 ppb to a 56-day average of 2.5 ppb. For comparison purposes, EPA guidance suggests dividing the 56-day GENEEC EEC value by 3 before comparison to the calculated DWLOC chronic value “Interim Guidance for Incorporating Drinking Water Exposure into Aggregate Risk Assessments,” 01-AUG-1999 (SOP 99.5). Thus, 2.5 divided by 3 or 0.83 ppb is the predicted surface water EEC value resulting from glyphosate treatment of crops.

To estimate the possible concentration of glyphosate in surface water resulting from direct application to water, EPA assumed application to a water body 6 feet deep. At an application rate of 3.75 lb ai/A, the estimated concentration is 230 ppb. Because the glyphosate water-application estimate is greater than the crop-application estimate, 230 ppb is the appropriate value to compare to the calculated DWLOC chronic value for aggregate risk considerations.

Based on the GENEEC and SCI-GROW models the EECs of glyphosate for chronic exposures are estimated to be 230 ppb for surface water and 0.004 ppb for ground water.

3. From non-dietary exposure . The term “residential exposure” is used in this document to refer to non- occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

Glyphosate is currently registered for use on the following residential non-dietary sites: ornamentals, greenhouses, residential areas, lawns, and industrial rights of way. Glyphosate is formulated in liquid and solid forms and it is applied using ground or aerial equipment. Based on the low acute toxicity and the lack of other toxicological concerns, exposures from residential uses of glyphosate are not expected to pose undue risks.

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 glyphosate 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, glyphosate 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 glyphosate has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the final rule for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

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

ii. Prenatal and postnatal sensitivity . There is no evidence of increased susceptibility in rats and rabbits to in utero and/or postnatal exposure to glyphosate.

iii. Conclusion . There is a complete toxicity data base for glyphosate and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. EPA determined that the 10X safety factor to protect infants and children should be removed. The FQPA factor is removed because:

• The toxicology data base is complete

• There is no indication of increased susceptibility of rats or rabbits to in utero and/or postnatal exposure to glyphosate (in the prenatal developmental toxicity study in rats, effects in the offspring were observed only at or above treatment levels which resulted in evidence of appreciable parental toxicity)

• The use of generally high quality data, conservative models and/or assumptions in the exposure assessment provide adequate protection of infants and children.

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

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

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

1. Acute risk . No appropriate toxicological endpoint for a single dose exposure was identified in oral toxicity studies with glyphosate. Therefore, an acute RfD was not established, and there is no expectation of acute dietary risk from food and water.

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to glyphosate from food will utilize 1.5% of the cPAD for the U.S. population, 3.1% of the cPAD for all infants less than 1 year old and 3.2% of the cPAD for children (1 to 6 years old). Based on the use pattern, chronic residential exposure to residues of glyphosate is not expected. In addition, there is potential for chronic dietary exposure to glyphosate in drinking water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in the following Table 3:

3. Short- and intermediate-term risk . Short- and intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Though residential exposure could occur with the use of glyphosate, no toxicological effects have been identified for short- or intermediate-term toxicity. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's level of concern.

4. Aggregate cancer risk for U.S. population . Glyphosate is not expected to pose a cancer risk to humans.

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

Adequate enforcement methods are available for analysis of residues of glyphosate in or on plant and livestock commodities. These methods include gas-liquid chromatography (GLC) (Method I in Pesticides Analytical Manual (PAM) II; the limit of detection is 0.05 ppm) and high-pressure liquid chromatography (HPLC) with fluorometric detection. Use of the GLC method is discouraged due to the lengthiness of the experimental procedure. The HPLC procedure has undergone successful Agency validation and was recommended for inclusion in PAM II. A gas chromatography/mass spectometry method for glyphosate in crops has also been validated by EPA's Analytical Chemistry Laboratory.

The unpublished methods may be requested from: Calvin Furlow, PRRIB, IRSD (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460; telephone number: (703) 305-5229; e-mail address: furlow.calvin@epa.gov.

Several maximum residue limits (MRLs) for glyphosate (including AMPA) have been established by CODEX in or on various commodities. Based on toxicological considerations, EPA has determined that AMPA no longer needs to be regulated and with this regulation has deleted AMPA from the tolerance expression. Thus, harmonization with the MRLs for AMPA is not possible. The existing and recommended “rape, seed” tolerance of 10 ppm is already in harmony with the CODEX MRL. The recommended “corn, forage” tolerance of 3.0 ppm is based on crop field trial data obtained when using a new strain of Roundup Ready corn and thus cannot be lowered to achieve harmonization with the CODEX MRL of 1.0 ppm for “maize, forage.” There is no conflict between the CODEX MRL of 0.1 ppm for “poultry, meat” and the recommended U.S. tolerance of 1.0 ppm for “poultry, meat byproducts” as these commodities are not the same. Finally, although the available data support a tolerance of 0.05 ppm for egg, for harmonization purposes and because no risk issues are involved, a tolerance level of 0.1 ppm for “egg” is being established.

Therefore, tolerances are established for residues of glyphosate, ( N -(phosphonomethyl)glycine) resulting from the application of glyphosate, the isopropylamine salt of glyphosate, the ethanolamine salt of glyphosate, and the ammonium salt of glyphosate, in or on the food commodities listed in this document.

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-301053 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 November 27, 2000.

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

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

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

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

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

3. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit 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-301053, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.2. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 file format or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

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

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

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

1. Electronically . You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/. To access this document, on the Home Page select “Laws and Regulations,” “Regulations and Proposed Rules,” 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-301048. 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, Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

EPA, on its own initiative, in accordance with sections 408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is establishing a tolerance for residues of the herbicide ethametsulfuron-methyl, in or on canola at 0.02 part per million (ppm). This tolerance will expire and is revoked on December 31, 2001. EPA will publish a document in the Federal Register to remove the revoked tolerance from the Code of Federal Regulations.

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

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

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

EPA has authorized under FIFRA section 18 the use of ethametsulfuron-methyl on canola for control of smartweeds in North Dakota and Minnesota. Products containing endothall had been available for use against smartweeds in the past. However, this use of endothall is no longer being supported. Therefore, after considering the situation this year, EPA determined that emergency conditions existed for the growers and permitted the use.

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

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

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

Consistent with section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of ethametsulfuron-methyl and to make a determination on aggregate exposure, consistent with section 408(b)(2), for a time-limited tolerance for ethametsulfuron-methyl in or on canola at 0.02 ppm. EPA's assessment of the dietary exposures and risks associated with establishing the tolerance follows.

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

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

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

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

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

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

1. Electronically .You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/. To access this document, on the Home Page select “Laws and Regulations,” “Regulations and Proposed Rules,” 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-301047. 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, Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

EPA, on its own initiative, in accordance with sections 408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is establishing a tolerance for residues of the pesticide bifenthrin, in or on potato at 0.05 part per million (ppm). This tolerance will expire and is revoked on December 31, 2002. EPA will publish a document in the Federal Register to remove the revoked tolerance from the Code of Federal Regulations.

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

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

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

Two-spotted spider mites have recently emerged as a major potato pest in the Pacific Northwest. This pest can reach damaging numbers as a result of spray programs to control other pests, which disrupts natural biological predators that would normally keep the spider mite populations in check. Damaging levels of spider mites have occurred in Washington and Oregon, and the registered alternatives do not provide adequate control. They are more slow acting, and lack the residual control of bifenthrin, and do not control heavier mite populations quickly enough to prevent economic damage. Significant economic losses are expected for the Pacific Northwest potato growers if this pest cannot be adequately controlled. Bifenthrin has been shown to be effective at controlling spider mites. EPA has authorized under FIFRA section 18 the use of bifenthrin on potatoes for control of spider mites in Washington and Oregon. After having reviewed the submission, EPA concurs that emergency conditions exist for these States.

As part of its assessment of this emergency exemption, EPA assessed the potential risks presented by residues of bifenthrin in or on potato. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2), and EPA decided that the necessary tolerance under FFDCA section 408(l)(6) would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing this tolerance without notice and opportunity for public comment as provided in section 408(l)(6). Although this tolerance will expire and is revoked on December 31, 2002, under FFDCA section 408(l)(5), residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on potato after that date will not be unlawful, provided the pesticide is applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by this tolerance at the time of that application. EPA will take action to revoke this tolerance earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.

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

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

Consistent with section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of bifenthrin and to make a determination on aggregate exposure, consistent with section 408(b)(2), for a time-limited tolerance for residues of bifenthrin in or on potato at 0.05 ppm. EPA's assessment of the dietary exposures and risks associated with establishing the tolerance follows.

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

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

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

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

EPA announces the deletion of the Newsom Brothers Superfund Site, Columbia, Mississippi, from the National Priorities List (NPL), which is appendix B of the National Oil and Hazardous Substances Pollution Contingency Plan (NCP). EPA identifies sites that appear to present a significant risk to public health, welfare, or the environment and it maintains the NPL as the list of those sites. Sites on the NPL may be the subject of remedial actions financed by the Hazardous Substances Superfund Response Trust Fund (Fund). Pursuant to 42 U.S.C. 9605 (40 CFR 300.425(e)(3) of the NCP), any site deleted from the NPL remains eligible for Fund-financed remedial actions in the unlikely event that conditions at the site warrant such action in the future.

EPA published a Notice of Intent to Delete the Newsom Brothers Site from the NPL on August 2, 2000 in the Federal Register (65 FR 47364-47366). The closing date for comments on the Notice of Intent to Delete was September 1, 2000. EPA received one comment and the responsiveness summary is attached to this Notice of Deletion. Deletion of a site from the NPL does not affect responsible party liability or impede agency efforts to recover costs associated with response efforts.

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, does not apply because this action is not a rule, as that term is defined in 5 U.S.C. 804(3).

The 1990s may be remembered as the beginning of a new generation of electric vehicles (EVs). In mid-decade, General Motors Corporation (GM) introduced the EV1, an electric-powered passenger car, offered for lease in selected western markets in the United States. Other manufacturers, such as Honda and Nissan, have also introduced new EVs. The primary impetus for the introduction of EVs into the marketplace appears to be the Clean Air Act Amendments of 1990 which included provisions for zero emission vehicles (ZEVs). EVs are the only known vehicles that will meet the emission requirements for ZEVs. In California, these provisions were to become effective beginning in model year 1998, and would have required automobile manufacturers to sell, collectively, 40,000 EVs in the model year. However, those provisions were delayed by the California Air Resources Board until model year 2003. At that time, car companies will be required to meet 10 percent of their sales with ZEVs. In addition, the Energy Policy Act of 1992 requires Federal and State fleets to acquire increasing percentages of alternative fueled vehicles.

On December 27, 1991, we published an advance notice of proposed rulemaking (ANPRM) on EV safety (56 FR 67038). The purpose of that notice was to help us to determine which existing Federal motor vehicle safety standards (FMVSS) may need modification to better accommodate the unique technology of EVs and what new FMVSS may need to be developed and issued to assure their safe introduction. We requested comments on a broad range of potential EV safety issues including battery electrolyte spillage and electric shock hazard. The ANPRM elicited widespread public interest and 46 comments were received.

After reviewing the comments and information received in response to the ANPRM, we concluded in a November 18, 1992 notice (57 FR 54354) that it was premature to initiate rulemaking for FMVSSs specifically addressing EVs. In that notice, we stated that further research was needed in the areas of battery electrolyte spillage and electric shock hazard.

Shortly thereafter, in 1993, we conducted research and testing on two converted EVs. We tested these vehicles as specified in FMVSS No. 208, “Occupant Crash Protection.” Both vehicles were equipped with flooded (i.e., filled with liquid electrolyte) lead-acid batteries located in the engine and luggage compartments in the front and rear of the vehicle. One vehicle was equipped with twelve 12-volt batteries (five in the front and seven in the rear). The other vehicle was equipped with ten 12-volt batteries (four in the front and six in the rear). Both vehicles were subjected to 48 km/h frontal crashes into a fixed barrier. In both cases, the front batteries sustained significant damage, spilling large quantities of electrolyte. On one vehicle, 17.7 liters of electrolyte spilled from the front batteries as a result of the crash and in the other vehicle, 10.4 liters. In addition, electrical arcs were observed under the hood of one vehicle during the crash.

In the following year, we published a notice of request for comments (59 FR 49901, September 30, 1994 ) to help us to assess the need to regulate battery electrolyte spillage and electric shock hazard of EVs during a crash or rollover. We received 32 comments from automobile manufacturers, EV converters, and industry associations. The majority of the commenters supported some type of Federal regulation for electrolyte spillage and electric shock prevention, provided that the requirements of the regulation were performance-based and not design restrictive to the extent that they might inhibit technology development. Two manufacturers, Ford Motor Company (Ford) and Nissan, and two industry associations (Electric Vehicle Industry Association and Electric Vehicles of America) did not believe that Federal regulation was necessary because electric vehicle design was constantly changing due to technological breakthroughs. However, Ford did state that it would follow the recommendation of industry associations such as the Society of Automotive Engineers (SAE) which, at the time, was developing SAE J1766 “Recommended Practice For Electric and Hybrid Electric Vehicle Battery Systems Crash Integrity Testing.”

In 1995, we again conducted research and testing, this time on four EVs. Three vehicles were converted to run on electricity and one was built as an EV. The three converted vehicles were equipped with starved (i.e., electrolyte that is absorbed in an inert material to prevent leakage in case of rupture) lead-acid batteries and the vehicle built as an EV was equipped with flooded lead-acid batteries. We subjected three vehicles to 48 km/h frontal crashes similar to the test described in FMVSS No. 208, “Occupant Crash Protection” and a fourth to a 54 km/h side crash similar to the test specified in FMVSS No. 214,” Side Impact Protection.” Each vehicle was also subjected to pre and post-crash rollover tests to measure electrolyte spillage. The crash and rollover tests revealed that the vehicles with the starved lead-acid batteries had very little leakage (as expected because of their design), while the vehicle with the flooded lead-acid batteries leaked approximately 50 liters of electrolyte. We also performed electrical isolation tests on these vehicles before and after each of the crash tests. Two of the converted EVs maintained their electrical isolation after the crash tests. The other converted EV was the vehicle subjected to a side impact test. That EV chafed a wire which came in contact with the vehicle structure during the crash and did not maintain electrical isolation. The vehicle built as an EV was subjected to a frontal crash test. That vehicle lost electrical isolation when two of the battery connectors came in contact with the battery tunnel during the crash.

During our earlier rulemaking activities, there was not yet an industry standard in place that addressed potential safety problems in EVs. However, in February 1996, SAE published its Recommended Practice SAE J1766 “Recommended Practice for Electric and Hybrid Electric Vehicle Battery Systems Crash Integrity Testing.” The purpose of SAE J1766 is to define minimum performance standards and establish test methods which evaluate battery system spillage, retention, electrical system isolation, and liquid interaction in electric and hybrid electric vehicles during crash scenarios. The Recommended Practice covers all electric and hybrid EVs with a GVWR of 4536 kg (10,000 lbs) or less.

As the document notes, electric and hybrid EVs contain many types of battery systems. J1766 promotes the use of barriers between occupants and battery systems which are necessary to provide protection from potentially harmful factors and materials within the battery system, which can cause injury to vehicle occupants during different crash scenarios.

The potentially harmful factors and materials include:

SAE J1766 establishes certain performance criteria to be met when an EV is subjected to the frontal impact procedures of FMVSS No. 208 (including the 30-degree oblique), the side impact procedures of FMVSS 214, and the rear impact procedure of FMVSS No. 301. No spillage of electrolyte into the occupant compartment is permitted. Electrolyte spillage outside the passenger compartment is limited to 5 liters for a 30-minute period after vehicle motion ceases and throughout the post crash rollover test. Battery modules must stay restrained in the vehicle, without any component intruding into the occupant compartment. Electrical isolation between the chassis and high voltage system is at least 500 ohms per nominal volt.

On October 13, 1998, we proposed that provisions similar to those of SAE J1766 be adopted in a new FMVSS No. 305 to afford the public protection from electrolyte spillage and electric shock hazards in crashes (63 FR 54652). These provisions should help secure the safe introduction of new EVs into the marketplace.

As proposed, FMVSS No. 305 would apply to all passenger cars, and to multipurpose passenger vehicles, trucks, and buses with a GVWR of 4536 kg (10,000 lbs) or less, and to school buses with a GVWR over 4536 kg (10,000 lbs), that use more than 72 volts of electricity as propulsion power. Seventy-two volts is the equivalent of six 12-volt batteries. Under proposed FMVSS No. 305, EVs covered by the standard, other than heavy school buses, would be required to meet leakage and battery retention requirements that are essentially those of SAE J1766 after front (FMVSS No. 208), side (FMVSS No. 214), and rear impact barrier crash tests (FMVSS No. 301). A static rollover test (FMVSS No. 301) would also be conducted both before and after each of these crash tests. Heavy school buses (those with a GVWR greater than 4536 kg) would be required to meet the same performance requirements after a moving contour barrier crash test, without the pre- and post-test rollovers. The performance requirements proposed were that there shall be no electrolyte spillage in the passenger compartment, with spillage outside the compartment limited to 5 liters total in a 30-minute period following the cessation of motion after a crash test. Intrusion of the battery system components into the occupant compartment would also be prohibited. Batteries must be restrained in the vehicle in their original installations. The electric isolation value must be at least 500 ohms per nominal volt, as determined by the SAE procedure for the measurement of the insulation resistance of the propulsion battery of an EV. The standard known resistance Ro (in ohms) should be approximately 500 times the nominal operating voltage of the vehicle (in volts). The Ro is not required to be precisely this value since the equations are valid for any Ro. However, a Ro value in this range should provide good resolution for the voltage measurements.

However, FMVSS No. 305 would not apply to passenger-carrying EVs with a maximum speed of 40 km/h (25 mph) or less. We noted that we had recently issued a standard expressly for low-speed vehicles (LSVs), FMVSS No. 500 (63 FR 33194; June 17, 1998). LSVs are any 4-wheeled vehicles, other than trucks, with a maximum speed of not less than 32 km/hr nor more than 40 km/h. EVs subject to FMVSS No. 500 could include Neighborhood Electric Vehicles (NEVs) and those battery-powered golf cars within the speed range. FMVSS No. 500 does not require LSVs to meet FMVSS Nos. 208, 214, and 301, which contain some 48 and 54 km/h impact barrier tests like those proposed for FMVSS No. 305.

We received comments from the following 14 companies/organizations: Bombardier Motor Corporation of America, Navistar International Transportation Corp., Blue Bird Body Company, Infrastructure Working Council, Toyota Technical Center, USA, Inc., Ford Motor Company, Nissan North America, Inc., DaimlerChrysler Corporation, General Motors/North American Operations, Applied Safety Technologies Corporation, Mike Beebe, Honda/American Honda Motor Co., Inc., Mitsubishi Motors R & D of America Inc., and Volvo Cars of North America, Inc.

We asked for comments on six specific issues.

The first issue was the extent to which the proposed rule would necessitate expenditures by manufacturers of EVs to meet electrolyte spillage, battery retention, and electrical isolation test requirements.

Ford and DaimlerChrysler commented specifically on the cost to conform vehicles with a GVWR of 4536 kg (10,000 pounds) or less. Neither believed that there would be any additional cost since the tests for these requirements will be conducted in the course of conventional testing for existing FMVSS. Blue Bird, a manufacturer of large school buses, on the other hand, stated that the cost to conform in terms of dollars, weight, compliance tests, etc. would drastically impair, if not destroy, current research and development activities regarding electric and hybrid electric large school buses. This commenter also stated that it is not aware of any electric or hybrid electric powered school buses currently being offered on a regular production basis. It therefore appears that the cost to conform to FMVSS No. 305 will be negligible for vehicles with a GVWR of 4536 kg (10,000 lbs.) or less.

The second issue was the adequacy of the proposed spillage specification. We present and address these comments below in our discussion pertaining to the adoption of S5.1, a requirement on electrolyte spillage from propulsion batteries.

The third issue was the adequacy of the proposed specification for electrical isolation. We address these comments below on our discussion of S5.3, the specification for electrical isolation that we are adopting.

The fourth and fifth issues concerned the coverage of the proposed standard, and whether the proposed standard should apply to electric Low-Speed Vehicles. We address these issues below in our discussion on the applicability of the final rule.

Sixth, we asked about the appropriateness of a rollover test. The SAE currently recommends that the vehicle undergo a rollover test before the barrier impact test. We are concerned that damage may occur to the test vehicle during rollover that could affect the results of the barrier impact test. Accordingly, we asked for comments as to whether there should be a rollover test before the barrier impact test and as to the importance of conducting a rollover test before the barrier impact test.

None of the commenters believe that the pre-test rollover procedure is necessary. The SAE Electric Vehicle Safety Committee has revised the February 1996 standard. This revised standard was reissued in June 1998. In the revised standard, the SAE determined that it was not necessary to perform the pre-crash static rollover test. It found that no failures occurred to any of the vehicles tested using this procedure. The most significant information regarding safety was only found during a post-crash condition. We believe that the likelihood of electrolyte spillage or shock hazard without a related crash event is extremely remote. Further, we do not see any additional safety benefit in conducting the static rollover test prior to the crash tests. Therefore, this test is not included in the final rule.

We proposed that the new standard apply to vehicles that use 72 volts or more as propulsion power. However, we were unsure whether there might be vehicles or vehicle designs which are powered, in whole or in part (perhaps a hybrid electric configuration), by less than 72 volts of electricity. We asked whether there were any such and whether it would be appropriate to apply FMVSS No. 305 to them.

Navistar commented that the industry seems to have developed closer to a 50-volt segregation between high and low voltage. SAE J1673 “High Voltage Automotive Wiring Assembly Design” covers systems over 50-volts nominal. SAE J1797 “Packaging of Electric Vehicle Battery Modules” recommends against exceeding 60-volts DC in a single module during any state. This value equates to a 48-50 volt nominal battery. SAE Information Report 52232 “Vehicle System Voltage—Initial Recommendations” suggests not to exceed 65-volts during periodic ripple and 50-volts AC RMS. Again, these values equate to 48-50 volts nominal voltage.

ASTC commented that the final rule should not totally exclude vehicles which are propelled by 72 volts or less. Currently, SAE Standard J52344 JUN98 “Guidelines for Electric Vehicle Safety,” defines “potentially hazardous voltage” as 60 VDC and above. This is based on the UL standards UL 223 1 and UL 2202. Above this level, it is recommended to design with the intent to protect as one would for any high voltage system.

Mitsubishi argued that the application threshold should be set at or below 60 volts. This is the level specified by the National Electric Code (NEC, article 725) and UL as the limit above which a risk is posed to the human body by high voltage.

On the basis of these comments, we have concluded that that FMVSS No. 305 should not apply only to vehicles that use more than 72 volts as propulsion power as we proposed. It is clear from the commenters and industry standards that 60 volts DC can cause bodily injury. Further, we are not aware of any EV manufacturer which is presently producing motor vehicles propelled by 48 volts DC or less; it seems that these lower voltages are not detrimental to the safety of humans in the same manner that 60 volts DC may be. Accordingly, FMVSS No. 305 will apply to EVs that are propelled by 48 volts or more of electricity.

Although we were aware that two Low-Speed Vehicles ( LSVs) will be produced with six 12-volt batteries totaling 72 volts, the Bombardier NV and the GEM vehicle (the Trans2 NEV design upgraded from 48 volts), the proposed rule nevertheless excluded LSVs. However, we asked whether the standard ought not to apply to LSVs after all, and, if so, whether the proposed requirements would be reasonable, practicable, and appropriate for them.

Two commenters recommended against including LSVs in FMVSS No. 305. Bombardier commented that we had extensively discussed the safety features incorporated into FMVSS No. 500 based upon LSVs' design and performance characteristics and concluded in the final rule that this “rule requires safety equipment on low-speed vehicles consistent with their characteristics and operating environment.” Bombardier further commented that, in issuing FMVSS No. 500, we had concluded that LSVs, given their limited-speed capability and relatively controlled operating environments, need not be designed to meet the full range of FMVSSs, especially those incorporating dynamic crash requirements. Moreover, complying with the proposed dynamic crash test standards would require LSVs to undergo impact barrier tests at speeds of 48.3 km/h (30 mph). This speed is above the maximum speed of 40 km/h (25 mph) set forth in FMVSS No. 500 of which an LSV is capable.

Ford also argued that FMVSS No. 305 should not apply to electric-powered LSV's. Ford believes that compliance with FMVSS No. 305 would not provide appreciable additional safety benefit for LSV's beyond that provided by compliance to FMVSS No. 500 which is now required. Ford stated that the primary patterns of use for LSVs are anticipated to be Closed Community environments where it is highly unlikely they will be involved in a crash at 30 mph. Ford argued that if LSVs would have to meet the crash requirements of FMVSS No. 305, the manufacturers may be more likely to develop gasoline LSVs than develop zero emission electric-powered LSVs.

Contrary to these comments, Mitsubishi argued that it is possible that flooded lead-acid batteries may be used in LSVs and that the electrolyte leakage from LSVs's so equipped could be far greater than the proposed 5.0 liter limit, and thus pose a risk to humans and the environment. Therefore, Mitsubishi recommended that LSVs be covered by FMVSS No. 305. It is true that LSVs are not required to meet any of the crash test standards and their structures are not the equivalent in strength of conventional passenger cars, presenting the possibility of electrolyte spillage and failure of battery retention in crashes. NHTSA is developing a proposal to add performance requirements for the equipment required by FMVSS No. 500 for LSVs. We will carefully consider Mitsubishi's points about electrolyte leakage in developing that proposal. We prefer to take a comprehensive look at appropriate requirements for LSVs, instead of a piecemeal, standard-by-standard approach.

We noted that FMVSS No. 500's definition of LSV does not include trucks and asked whether trucks that are powered by less than 72 volts of electricity should be covered if their maximum speed is not more than 40 km/h (25 mph). Ford commented, in essence, that trucks should be included in the standard unless they cannot achieve a maximum speed of 25 mph regardless of their voltage. Inasmuch as load-carrying vehicles with a maximum speed that exceeds 20 mph are classified as “trucks” and therefore must meet requirements in 30 mph barrier crash tests of other FMVSS, we see no logical basis on which low-speed trucks should be excused from the barrier crash specifications of FMVSS No. 305, and therefore they are not excluded from the standard. However, we shall revisit this issue if FMVSS No. 500 is ever amended to include low-speed trucks.

We proposed that FMVSS No. 305 also apply to electric school buses with a GVWR of greater than 4356 kg (10,000 lbs). Blue Bird, Navistar and IWC commented that FMVSS No. 305 should not be applicable to large school buses. Navistar argued that it may seem logical to apply the same requirements to electric-powered school buses with a GVWR of greater than 4536 kg, but that, in reality, these vehicles can be quite different from electric-powered passenger vehicles. The electric propulsion system and components have to be much larger for school buses with a GVWR greater than 4536 kg and this creates packaging, shock hazard protection, and costs that are different from electric-powered passenger vehicles.

Blue Bird argued that the standard should not apply to large school buses until appropriate testing and research are conducted to determine if the requirements are justified, reasonable, appropriate and practicable. The school bus manufacturer commented that there currently are limited applications in which electric vehicle technology may be practical and that school bus service is one of these. It also said that the research that is currently in progress may be vitally important to the successful development of large electric-powered vehicles. Blue Bird stated that it is not aware of any electric or hybrid electric powered school buses currently being offered on a regular production basis. The few electric school buses that it currently produces contain 3636 kg (8,000 pounds) of batteries and support structure. The weight of the additional structure required to protect the battery modules could be substantial and this can only be accomplished by a reduction in capacity or an addition of a tandem axle. Blue Bird further argued that the extension of the proposed requirements to large school buses would constitute regulation of research and development activities rather than the regulation of production vehicles for consumer use.

IWC argued that it would be premature at this time to require bus manufacturers to comply with a standard which was developed without consideration for their application.

We agree that, in terms of cost and weight, FMVSS No. 305 could have a substantial effect on large school buses. Further, it is plausible that the additional weight and cost associated with applying FMVSS No. 305 to large school buses could restrict the development of electric-powered school buses. We do not believe that at this time large school buses should be covered by FMVSS No. 305 because the testing we proposed would require a massive safety cage to prevent the batteries from becoming damaged and leaking the electrolyte. Current school bus construction appears sufficient to prevent the electrolyte from entering the passenger compartment. There are many issues that must be resolved before issuing an FMVSS applicable to the crashworthiness of large electric-powered school buses, such as appropriate test procedures and the added weight of more battery containment. Accordingly, this aspect of the proposed rule has not been adopted.

We note that we do not regard electric school buses as “research and development vehicles.” They are production vehicles and certified as conforming to all applicable FMVSS. We anticipate that Blue Bird and other manufacturers developing electric school buses will take all appropriate measures to ensure the safety of school children from electrolyte spillage and electrical shock hazards even though these buses are not required to comply with FMVSS No. 305.

We proposed that:

DaimlerChrysler believes that a requirement of “no spillage” may be appropriate for a voluntary standard, but not for a regulation. In this commenter's view, during the post-test static rollover, a measurable quantity of spillage should be specified in S5.1, for example, 100 ml maximum of spillage into the passenger compartment in the first 30 minutes after the crash test.

GM agrees with the intent of this requirement, and participated in writing the provision into SAE J1766. GM also argued that this provision is appropriate in the context of an SAE Recommended Practice. The literal inability to measure zero—i.e., “no spillage”—creates a practicability problem in the context of an FMVSS. GM noted that the agency's other fuel integrity standards do allow a small non-zero amount of fuel spillage. GM recommended that proposed S5.1 be revised to allow a small non-zero amount (perhaps one deciliter) of electrolyte spillage into the passenger compartment.

Our desired goal is zero spillage, and we believe that it can be achieved with current battery technology. Although a requirement of “no spillage” would differ from the performance required of fuel systems in other FMVSS, there is a distinction: batteries are not subject to the same operating conditions as fuel tanks. Fuel tanks are filled frequently, which requires that the be opened and closed. Batteries recharge through applying electricity to the terminals and do not require opening on a regular basis. However, given the concern about the phrase “no spillage,” we are adopting the phrase “no visible trace” as a substitute which we believe is a more practicable specification.

The value of 5.0 liters derives from SAE J1766 and is based upon the amount of electrolyte that is contained in present large automotive batteries. Commenters were asked for their views on whether a different amount may be more appropriate to protect the public in EV crashes.

Ford and DaimlerChrysler commented specifically on the proposed limit. Ford argued that the 5.0 liters of electrolyte spillage should be the maximum that is allowed. DaimlerChrysler believes the 5.0 liter limit to be satisfactory and stated that, in all probability, spillage will be a blend of electrolyte and battery coolant, rather than electrolyte alone.

Navistar and Blue Bird both argued that the proposed limit of 5.0 liters is too restrictive for large school buses. Given the fact that we have decided to exclude large school buses from FMVSS No. 305, we simply note, without discussion, that these comments were submitted.

Upon review, we have replaced the words “crash” and “crash test” in S5.1 with the more accurate “barrier impact test.” For the same reason, we have also substituted “impact” for “crash” in other paragraphs of the standard.

Accordingly, S5.1 as adopted reads:

Note that we have eliminated the word “leakage” from the final rule. We used it as a synonym for “spillage” in the proposed rule. Both words indicate the escape of electrolyte from the battery. Elimination of “leakage” will avoid questions of whether we intended different meanings for these words. You will note also that rollover before a crash test has also been deleted. The reason for this is discussed in the paragraph below relating to S6.1.

We proposed that:

Navistar argued that this is too restrictive and that the wording can have a variety of meanings. It suggested adopting the wording of J1766 in which the battery modules must stay restrained to the vehicle. Blue Bird commented that the batteries or any part thereof pose no more danger or safety threat than any other part of a school bus that may become detached during a barrier crash test. Echoing Navistar, it said that the requirement that battery modules shall remain restrained in the location in which they are installed in the vehicle may not be necessary from a safety viewpoint. Mitsubishi argued that slight movement of the batteries does not necessarily pose a safety risk, and suggested modifying that the “Battery module must not separate from the battery system.” In Toyota's view, the definition of battery module includes the venting system and it is unlikely the venting system entering the passenger compartment could cause harm. Volvo argued that the proposed requirement is unnecessarily design restrictive and may prevent innovative and better (safer) solutions that would have the potential of improving occupant protection as compared to a design solution that would comply with the proposed requirement.

GM focused on the proposal that “no part of any battery system component shall enter the passenger compartment, as determined by a visual inspection.” Proposed S4 defines a battery system component as: “* * * any part of a battery module, interconnect, venting system, battery restraint device, and battery box or container which holds the individual battery modules.” GM noted that the proposed battery retention requirement should recognize the possibility that battery system components may be located inside the passenger compartment by design. GM further argued that the prohibition against the presence of the battery container inside the passenger compartment per se serves no safety purpose and that the proposed language could be interpreted as an unnecessary design restriction. GM recommended the following alternative wording for S5.2:

We note that the intent of the proposed requirements in S5.2 was to ensure that the battery modules would not become unattached and become flying projectiles in a crash or subsequent rollover. We agree with Navistar that the wording can have a variety of meanings, as is clearly shown based on the comments received. We have also concluded that the proposed language is unnecessarily design restrictive and should be modified to avoid unnecessary confusion. Further, the test procedures are located in S6 (S7 specifies the test conditions). We therefore are adopting the following wording for S5.2:

We proposed that:

Navistar and GM argued that momentary loss of isolation should not be regarded as a noncompliance. If electrical isolation measurements were made real-time during the crash test, a detected momentary loss of isolation could be interpreted as violating this requirement. In GM's opinion, paragraph 4.4.3 of SAE J1766 recognizes that, during a crash, electrical isolation may be lost momentarily and should be immediately restored.

We concur that S5.3 as proposed could be interpreted to mean that any loss of isolation is prohibited. In our view, momentary loss is not an undue safety risk provided that the system subsequently restores itself. We are revising S5.3 to indicate that the measurement is to be taken after each crash test. S5.3 as adopted reads:

We proposed that a vehicle must meet the requirements of S5.1, S5.2, S5.3 after being rotated on its longitudinal axis to successive increments of 90 degrees, before each crash test. Upon review, however, we are concerned that damage may occur to the test vehicle during rollover that could affect the results of the barrier impact test. Further, none of the commenters argued that the pre-impact test static rollover procedure was necessary. We also believe that the likelihood of electrolyte spillage or shock hazard without a related impact event is extremely remote. Accordingly, we have eliminated the proposed pre'impact static rollover from the final rule.

We proposed that:

Honda stated that the side impact test specified in S6.3 of proposed FMVSS 305 does not mention the installation of the test dummy in the test vehicle. Honda argued that, in order to prevent any possible misunderstanding, we should prescribe a dummy installation in the final rule that is identical to that in FMVSS No. 214.

We agree, and are so specifying. The test dummy that should be used in this and other tests is a 50th percentile male dummy as specified in subpart F of 49 CFR Part 572. To simplify the regulatory text, we are adopting that definition of “dummy” in S3. The final rule, then, revises S6.3 to read as follows:

We proposed that:

Navistar commented that it may be unrealistic to obtain 95 percent state of charge on some hybrid electric vehicles. Typically hybrid electric vehicles do not operate with batteries fully charged like fully electric vehicles. It may be more representative to test at nominal working voltage or state of charge for the system. Similarly, Toyota commented that the 95 percent requirement seems unreasonable for hybrid electric vehicles. It suggested that the test be performed with the batteries charged to the level recommended by the manufacturer. DaimlerChrysler argued that the batteries will not maintain 95 percent capacity because they are under a load at the point of impact, and will have been discharged somewhat. Honda stated that, for hybrid vehicles, the vehicle controls the batteries' state of charge with its vehicle's Electrical Control Unit. Finally, Honda reminded us that, in the final rule of FMVSS 105, we agreed to revise the proposed rule from “95 percent battery state of charge” to “manufacturer's recommended state of charge or 95 percent battery state of charge.”

We agree with the above comments and note that the June 1998 revised version of SAE J1766 changed 4.1.2 to read “The Battery system shall be fully charged prior to the crash test using the vehicle manufacturers recommended charging procedure.” We therefore are adopting the following wording:

We proposed that S7.7.1 read as follows:

GM asked that this sentence be clarified in the final rule, to avoid confusion and inconsistent interpretations of the test procedure, and state that the isolation measurement is from the battery side of the contactors or automatic disconnect system and the vehicle chassis, consistent with SAE J1766. Navistar argued that the specification that the propulsion battery be connected to the vehicle propulsion system during the electrical isolation test indicates that any safety devices such as fuses or contractors that were opened during or as a result of the crash would have to be re-closed for this test. Navistar stated that since such devices would be included in the design to provide a high degree of safety in a crash, it does not seem appropriate to require these safety features be defeated to determine if the test has met the requirements. Navistar is incorrect. The propulsion battery is connected to the vehicle propulsion system before a dynamic test. During the electrical isolation test, any safety devices such as fuses or contactors are not closed.

We agree with GM that we intended to have the voltage measurement taken from the battery side of the contactors if they are used. We do not agree with Navistar that the contactors would need to be reclosed for this test. During the SAE discussions in which the revisions to SAE J1766 were being developed, there was considerable attention focused on whether the electrical isolation measurement to chassis should be taken from the battery side or the traction side of the contactors. All agreed that the measurement is taken from the battery side of the contactors to the vehicle chassis because the procedure is meaningless if the voltage measurement is made between the output side of opened contactors and vehicle chassis, since there would likely be no voltage between those points.

GM recommended that S7.7.1 be revised to read as follows, and we have accepted that recommendation (note that the deletion of proposed S7.6 pertaining to the testing of large school buses has resulted in a renumbering of S7.7 to S7.6):

Proposed paragraph S7.7.3 (now S7.6.3) set forth a procedure for measuring voltage in Figure 1. Upon review, we have decided that only the first two sentences related to the procedure itself. We are adopting these sentences as proposed. The remaining material we set forth here, as it relates to propulsion battery voltage (Vb). We anticipate that Vb after the crash test will be approximately the same as Vb before the crash test. After the crash test, a Vb greater than zero is required in order to conduct the remainder of the procedure of S7.6.3. If Vb after the crash test is zero, this indicates that a short across the propulsion battery has occurred, which precludes the remainder of this test procedure. A short across the propulsion battery may be conspicuous by virtue of arcing, fire, and/or component meltdown.

Navistar stated S7.7.6 and S7.7.7 in the proposal specify a standard known resistance without reference to any approximate size. Navistar agrees that the magnitude of this resistor is not critical to the measurement. Navistar recommended that the word “standard” be deleted. We agree, and have eliminated it from S7.6.6 and S7.6.7. With respect to S7.6.7, we did not provide in the NPRM the background for the equation used to calculate electrical isolation for SAE J1766. We have placed a copy of the derivation in Docket No. NHTSA-98-4515.

GM called our attention to typographical or technical corrections that should be corrected in the final rule. We have done so. In Figure 1, the description is revised to “Measurement Location for Vb Voltage.” In Figure 3, the symbol within the circle is “V2” rather than “Vb.” In Figure 4, the equation for Ri is revised to:

In Figure 5, the equation for Ri is revised:

We have concluded that an effective date of approximately one year after the issuance of the final rule is sufficient for manufacturers covered by FMVSS No. 305 to comply with the proposed new safety standard. The major EV manufacturers all are using, or plan to use, battery types that are not susceptible to leaking large amounts of electrolytes. To our knowledge, all incorporate a device that would shut-off the propulsion battery current or prevent loss of electrical isolation in the event of a crash or short circuit.

Executive Order 12866 and DOT Regulatory Policies and Procedures. This document was not reviewed under Executive Order 12866. It has been determined that the rulemaking action is not significant under Department of Transportation regulatory policies and procedures.

Informal discussions with some EV manufacturers indicate that the industry is aware of SAE J1766 and that manufacturers are planning or producing EVs with batteries designed for minimal leakage, and to shut off the current or prevent loss of electrical isolation in the event of a crash. We believe that a substantial portion of the nascent EV industry is already designing its production to comport with SAE J1766. The added costs of our tests are minimal, as reflected in the comments on this issue in response to the notice of proposed rulemaking. The frontal barrier impact test of S6.1 of FMVSS No. 305 is the same test specified in FMVSS Nos. 208 and 301. The rear moving barrier impact test is the same test specified in FMVSS No. 301. The lateral moving barrier impact test is the same test specified in FMVSS No. 214. This means that there will be no additional costs imposed for testing an EV to which FMVSS Nos. 208, 214, and 301 already apply. To the extent that one or more of these standards do not apply to a specific EV type, the additional testing costs are not considered significant. The cost of a frontal impact test is $18,600 and the rollover test following, $1,500. The cost of a rear moving barrier impact test is $5,200, and the rollover test following, $1,500. The cost of a lateral moving barrier impact test is $18,000, and the rollover test following, $1,500. To this must be added the cost of the test vehicle for each test, to which we have assigned an approximate figure of $30,000. Accordingly, the impacts of the rule are so minimal as not to warrant preparation of a full regulatory evaluation.

Regulatory Flexibility Act. We have also considered the impacts of this rulemaking action in relation to the Regulatory Flexibility Act (5 U.S.C. Sec. 601 et seq. I certify that this rulemaking action does not have a significant economic impact upon a substantial number of small entities.

The following is our statement providing the factual basis for the certification (5 U.S.C. Sec. 605(b)). The technology to prevent leakage of electrolytes, battery retention, and electrical isolation in the event of the crash of a battery-powered motor vehicle is simple and has been well known for years. The specifications of the industry standard, J1766, have been settled since February 1996. As noted above, we believe that a substantial portion of the nascent EV industry is already designing its production to comport with SAE J1766. Verification of compliance with FMVSS No. 305 can be determined by rollover tests conducted after an EV is tested for compliance with the barrier impact specifications of FMVSS No. 301 and the cost of testing to this standard is not impacted, as we have discussed above. However, as noted above, if an EV is not required to comply with FMVSS No. 301, there will be the added cost of three rollover tests and a rear moving barrier impact test, plus the cost of a test vehicle, if the EV manufacturer chooses to certify its vehicle on the basis of an actual test rather than on engineering studies, computer simulations, mathematical calculations, or other means. We estimate the total costs for these tests as $38,200 for this segment of the EV industry. Since the overall economic impact is not considered to be significant, the agency has not determined formally whether the entities affected by the rules are “small businesses” within the meaning of the Regulatory Flexibility Act. In NHTSA's experience, manufacturers of motor vehicles are generally not “small businesses.” Accordingly, no regulatory flexibility analysis has been prepared.

Executive Order 13132 (Federalism). Executive Order 13132 on “Federalism” requires us 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.” The E.O. defines this phrase 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, which regulates the manufacture of certain motor vehicles, will not have 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, as specified in E.O. 13132.

National Environmental Policy Act. We have analyzed this rulemaking action for purposes of the National Environmental Policy Act. The rulemaking action will not have a significant effect upon the environment as it does not affect the present method of manufacturing motor vehicle lighting equipment.

Civil Justice Reform. This rule will not have any retroactive effect. Under 49 U.S.C. 30103(b)(1), whenever a Federal motor vehicle safety standard is in effect, a state may not adopt or maintain a safety standard applicable to the same aspect of performance which is not identical to the Federal standard. Section 30161 sets forth a procedure for judicial review of final rules establishing, amending, or revoking Federal motor vehicle safety standards. That section does not require submission of a petition for reconsideration or other administrative proceedings before parties may file suit in court.

Unfunded Mandates Reform Act of 1995. The Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires agencies to prepare a written assessment of the cost, benefits and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by State, local, or tribal governments, in the aggregate, or by the private sector, of more than $100 million annually. Because this rule will not have a $100 million effect, we have not prepared an Unfunded Mandates assessment.

National Technology Transfer and Advancement Act. Section 12(d) of the National Technology Transfer and Advancement Act (the Act) requires agencies to evaluate and use existing voluntary consensus standards in its regulatory activities unless doing so would be inconsistent with applicable law (e.g., the statutory provisions regarding our vehicle safety authority) or otherwise impractical. In meeting that requirement, we are required to consult with voluntary, private sector, consensus standards bodies. Examples of organizations generally regarded as voluntary consensus standards bodies include the American Society for Testing and Materials (ASTM), the Society of Automotive Engineers (SAE), and the American National Standards Institute (ANSI). If we do not use available and potentially applicable voluntary consensus standards, we are required by the Act to provide Congress, through OMB, an explanation for not using such standards.

As we have explained in the preamble, this final rule is based upon SAE J1766 FEB96 “Recommended Practice for Electric and Hybrid Electric Vehicle Battery Systems Crash Integrity Testing,” and is substantially similar to it in its specifications for prohibition of electrolyte spillage in front, side, and rear impacts, and batter retention during such impacts, and electrical isolation. No other voluntary consensus standards are addressed by this rulemaking.