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

Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 670 et seq. ), the Agricultural Marketing Service (AMS) has considered the economic impact of this action on small business entities. There are more than 800 users of the PVP, of whom about 100 may file applications in a given year. Some of these users are small business entities under the criteria established by the Small Business Administration (13 CFR 121.201). The AMS has determined that this action would not have a significant economic impact on a substantial number of these small business entities.

The Plant Variety Protection (PVP) Office administers the PVP Act of 1970 (7 U.S.C. 2321 et seq., ), and issues Certificates of Protection that provide intellectual property rights to developers of new varieties of plants. A Certificate of Protection is awarded to an owner of a variety after examination indicates that it is new, distinct from other varieties, genetically uniform, and stable through successive generations. This action will raise the fee charged to users of plant variety protection. The AMS estimates that the rule will yield an additional $270,000 during fiscal year (FY) 2003. The costs to private and public business entities will be proportioned to their use of the service, and shared equitably. The costs to individual users will be increased by 35 percent, or about $1,059.00 per application. Plant Variety Protection is a voluntary service. Any decision by developers to discontinue to the use of plant variety protection will not hinder private and public entities from marketing their varieties in commercial markets.

Every year, AMS reviews it user fee financial program to determine their fiscal condition. In the most recent review of the PVP program, the cost analysis indicated that the existing fee schedule will not generate sufficient revenues to cover program services and obligations while maintaining an adequate program reserve balance. From 1995 and through 2002, the PVP Office absorbed accumulated national and locality salary increases for Federal employees totaling 36 and 19 percent, respectively. These costs were offset by a fee increase of only 10 percent in September 2000.

AMS calculated the new fee schedule by projecting FY 2002 revenues of $903,000 and program obligations of $1,231,000. This indicates a projected loss to the program of $328,000 for FY 2003. At this rate, the trust fund balance would be nearly depleted by the end of FY 2004. With a fee increase of 35 percent, FY 2003 revenues and expenditures are projected to be $1,041,000 and $1,189,000, respectively. The trust fund balance is expected to be maintained at the FY 2003 level of $853,000, which satisfies Agency requirements.

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This action is not intended to have retroactive effect, nor will it preempt any state or local laws, regulations, or policies, unless they present an irreconcilable conflict with the proposed rule. There are no administrative procedures that must be exhausted prior to any judicial challenge to the provisions of the rule.

This rule does not contain any information collection or record keeping requirements that are subject to the Office of Management and Budget approval under the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35).

The PVP Program is a voluntary, user fee-funded service, conducted under the Authority of the Plant Variety Protection Act (7 U.S.C. 2321 et seq. ). The Act authorizes the Secretary of Agriculture to provide intellectual property rights that facilitate marketing of new varieties of seed-propagated crops and potatoes. The Act also requires that reasonable fees be collected from the users of the services to cover the costs of maintaining the program.

On August 2, 2000, AMS published a rule in the Federal Register (65 FR 47243) that increased Plant Variety Protection fees that became effective September 1, 2000.

In its analysis of projected costs for FY 2002, AMS identified administrative and information technology support as well as a 10 percent decrease in the number of applications submitted to the office. For FY 2002, user fee revenues and program obligations are projected to be $903,000 and $1,231,000, respectively, resulting in an estimated $328,000 program deficit. With a fee increase, FY 2003 revenues and expenditures are projected to be $1,041,000 and $1,189,000 respectively. We estimate this rule would yield an additional $270,000 during FY 2003 that will offset increased program operating costs. The program will take additional cost cutting measures to eliminate the remaining deficit.

AMS used the fees currently charged as a base for calculating the new fee schedule for FY 2003. The fees set forth in Sec. 97.175 would be increased. The application fee will be increased from $320 to $432, the search fee from $2,385 to $3,220, and the issuance fee from $320 to $432. The fees for reviving an abandoned application, correcting or re-issuance of a certificate are increased from $320 to $432. The charge for granting an extension for responding to a request is increased from $55 to $74. The hourly charge for any other service not specified will increase from $66 to $89. The fee for appeal to the Secretary (refundable if appeal overturns the Commissioner's decision) is increased from $3,050 to $4,118. Reproduction of records, drawings, certificates, exhibits or printed materials, late payment, and replenish of seeds will increase by 35 percent. These fee increases are necessary to recover the costs of this fee-funded program.

The Plant Variety Protection Advisory Board has been informed of cost increases, including anticipated salary increases, and consulted on a fee increase in November 2001. The Board recommended that fees be increased. This rule makes the minimum changes in the regulations to implement the recommended increased fees to maintain the program as a fee-funded program.

A notice of the proposed rule was published in the Federal Register (67 FR 61545) on October 1, 2002. A 30-day comment period was provided to allow interested persons the opportunity to respond to the proposal, including any regulatory and informational impact of this action on small business.

The only comment received in response to the proposed revised regulatory text questioned whether the 35 percent increase of the existing fee schedule was truly warranted. Every year, AMS reviews it's user fee financed programs to determine their fiscal condition. In the most recent review of the PVP program, the cost analysis indicated that the existing fee schedule will not generate sufficient revenues to cover program services and obligations while maintaining an adequate program reserve balance. We estimate the final rule would yield an additional $270,000 during FY 2003, offsetting increased program operating costs, salaries and benefits, and technology improvements. From October 1, 2001 to September 30, 2002, the PVP program has reduced the backlog by 21 percent. With sufficient funds to cover overall operating costs, the program will continue to improve the efficiency and turnaround time in the processing of plant variety protection requests.

The Oriental fruit fly, Bactrocera dorsalis (Hendel), is a destructive pest of citrus and other types of fruit, nuts, vegetables, and berries. The short life cycle of the Oriental fruit fly allows rapid development of serious outbreaks, which can cause severe economic losses. Heavy infestations can cause complete loss of crops.

The Oriental fruit fly regulations, contained in 7 CFR 301.93 through 301.93-10 (referred to below as the regulations), were established to prevent the spread of the Oriental fruit fly into noninfested areas of the United States. Section 301.93-3(a) provides that the Administrator will list as a quarantined area each State, or each portion of a State, in which the Oriental fruit fly has been found by an inspector, in which the Administrator has reason to believe that the Oriental fruit fly is present, or that the Administrator considers necessary to regulate because of its proximity to the Oriental fruit fly or its inseparability for quarantine enforcement purposes from localities in which the Oriental fruit fly has been found. The regulations impose restrictions on the interstate movement of regulated articles from the quarantined areas. Quarantined areas are listed in § 301.93-3(c).

Less than an entire State will be designated as a quarantined area only if the Administrator determines that: (1) The State has adopted and is enforcing restrictions on the intrastate movement of the regulated articles that are substantially the same as those imposed on the interstate movement of regulated articles and (2) the designation of less than the entire State as a quarantined area will prevent the interstate spread of the Oriental fruit fly.

Recent trapping surveys by inspectors of California State and county agencies and by inspectors of the Animal and Plant Health Inspection Service reveal that a portion of Los Angeles and Orange Counties, CA, is infested with the Oriental fruit fly.

State agencies in California have begun an intensive Oriental fruit fly eradication program in the quarantined area in Los Angeles and Orange Counties. Also, California has taken action to restrict the intrastate movement of regulated articles from the quarantined area.

Accordingly, to prevent the spread of the Oriental fruit fly into noninfested areas of the United States, we are amending the regulations in § 301.93-3 by designating a portion of Los Angeles and Orange Counties, CA, as a quarantined area for the Oriental fruit fly. The quarantined area is described in the rule portion of this document.

This rulemaking is necessary on an emergency basis to prevent the Oriental fruit fly from spreading to noninfested areas of the United States. Under these circumstances, the Administrator has determined that prior notice and opportunity for public comment are contrary to the public interest and that there is good cause under 5 U.S.C. 553 for making this rule effective less than 30 days after publication in the Federal Register .

We will consider comments we receive during the comment period for this interim rule (see DATES above). After the comment period closes, we will publish another document in the Federal Register . The document will include a discussion of any comments we receive and any amendments we are making to the rule.

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

This rule amends the Oriental fruit fly regulations by adding a portion of Los Angeles and Orange Counties, CA, to the list of quarantined areas. The regulations restrict the interstate movement of regulated articles from a quarantined area.

Within the quarantined area there are approximately 389 small entities that may be affected by this rule. These include 351 fruit sellers, 3 growers, 33 nurseries, 1 certified farmers' market, and 1 swapmeet. These 389 entities comprise less than 1 percent of the total number of similar entities operating in the State of California. Additionally, these small entities sell regulated articles primarily for local intrastate, not interstate movement, so the effect, if any, of this regulation on these entities appears to be minimal.

The effect on those few entities that do move regulated articles interstate will be minimized by the availability of various treatments that, in most cases, will allow these small entities to move regulated articles interstate with very little additional cost.

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

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

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

An environmental assessment and finding of no significant impact have been prepared for this interim rule. The site-specific environmental assessment provides a basis for the conclusion that the implementation of integrated pest management to eradicate the Oriental fruit fly will not have a significant impact on human health and the natural environment. Based on the finding of no significant impact, the Administrator of the Animal and Plant Health Inspection Service has determined that an environmental impact statement need not be prepared.

The environmental assessment and finding of no significant impact were prepared in accordance with: (1) The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq. ), (2) regulations of the Council on Environmental Quality for implementing the procedural provisions of NEPA (40 CFR parts 1500-1508), (3) USDA regulations implementing NEPA (7 CFR part 1b), and (4) APHIS’ NEPA Implementing Procedures (7 CFR part 372).

Copies of the environmental assessment and finding of no significant impact are available for review in our reading room (information on the location and hours of the reading room is listed under the heading ADDRESSES at the beginning of this notice). In addition, copies may be obtained by calling or writing to the individual listed under FOR FURTHER INFORMATION CONTACT . The environmental assessment and finding of no significant impact may also be viewed on the Internet at http://www.aphis.usda.gov/ppd/es/ppq/lamiroff.pdf.

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

This rule is issued under Marketing Agreement and Order No. 906, as amended (7 CFR part 906), regulating the handling of oranges and grapefruit grown in the Lower Rio Grande Valley in Texas, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”

USDA 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, orange and grapefruit handlers in the Lower Rio Grande Valley in Texas 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 oranges and grapefruit beginning on August 1, 2002, and continue until amended, suspended, or terminated. This rule will not preempt any State or local laws, regulations, or policies, unless they present an irreconcilable conflict with this rule.

The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA 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 USDA 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 USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.

This rule continues to decrease the assessment rate established for the Committee for the 2002-03 and subsequent fiscal periods from $0.12 to $0.11 per 7/10-bushel carton of oranges and grapefruit.

The Texas orange and grapefruit marketing order provides authority for the Committee, with the approval of USDA, 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 Texas oranges and grapefruit. They are familiar with the Committee's needs and with the costs for goods and services in their local area and are thus in a position to formulate an appropriate budget and assessment rate. The assessment rate is formulated and discussed in a public meeting. Thus, all directly affected persons have an opportunity to participate and provide input.

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

The Committee met on May 30, 2002, and unanimously recommended 2002-03 expenditures of $1,226,022 and an assessment rate of $0.12 per 7/10-bushel carton of oranges and grapefruit. The Committee met again on August 28, 2002, and recommended a decreased assessment rate of $0.11, with no change to the previously approved budget of $1,226,022. Thirteen of the 14 Committee members and alternates acting as members voted in support of the decrease. One Committee member voted against the decrease. In comparison, last year's budgeted expenditures were $1,236,777. The assessment rate of $0.11 is $0.01 lower than the rate previously in effect. The Committee voted to reduce the assessment rate after determining that its reserve fund was higher than necessary, and to lower handler assessment costs for 2002-03 by $100,000.

The major expenditures recommended by the Committee for the 2002-03 fiscal period include $810,500 for advertising, $179,000 for the Mexican Fruit Fly program, $107,845 for management and administration of the program, and $74,777 for compliance. Budgeted expenses for these items in 2001-02 were $810,500, $197,000, $104,500, and $74,777, respectively.

The assessment rate recommended by the Committee was derived by dividing anticipated expenses by expected shipments of Texas oranges and grapefruit. Texas orange and grapefruit shipments for the year are estimated at 10 million 7/10-bushel cartons, which should provide $1,100,000 in assessment income. Income derived from handler assessments, along with interest income and funds from the Committee's authorized reserve, will be adequate to cover budgeted expenses. Funds in the reserve (currently $274,041) will be kept within the maximum of one fiscal period's expenses permitted by the order (§ 906.35).

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

Although this assessment rate is effective for an indefinite period, the Committee will continue to meet prior to or during each fiscal period to recommend a budget of expenses and consider recommendations for modification of the assessment rate. The dates and times of Committee meetings are available from the Committee or USDA. Committee meetings are open to the public and interested persons may express their views at these meetings. USDA 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 2002-03 budget and those for subsequent fiscal periods will be reviewed and, as appropriate, approved by USDA.

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

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

There are approximately 410 producers of oranges and grapefruit in the production area and approximately 15 handlers subject to regulation under the marketing order. Small agricultural producers are defined by the Small Business Administration (SBA) (13 CFR 121.201) as those having annual receipts less than $750,000, and small agricultural service firms are defined as those whose annual receipts are less than $5,000,000.

An updated Texas citrus industry profile shows that 6 of the 15 handlers (40 percent) shipped over 651,042 7/10-bushel cartons of oranges and grapefruit. Using an average f.o.b. price of $7.68 per 7/10-bushel carton, these handlers could be considered large businesses under SBA's definition, and the remaining 9 handlers (60 percent) could be considered small businesses. Of the approximately 410 producers within the production area, few have sufficient acreage to generate sales in excess of $750,000. Thus, the majority of handlers and producers of Texas oranges and grapefruit may be classified as small entities.

This action continues to decrease the assessment rate established for the Committee and collected from handlers for the 2002-03 and subsequent fiscal periods from $0.12 to $0.11 per 7/10-bushel carton of oranges and grapefruit. The Committee recommended 2002-03 expenditures of $1,226,022 and an assessment rate of $0.11 per 7/10-bushel carton of oranges and grapefruit. The assessment rate of $0.11 is $0.01 lower than the previous rate. The quantity of assessable oranges and grapefruit for the 2002-03 fiscal year is estimated at 10 million cartons. Income derived from handler assessments, along with interest income and funds from the Committee's authorized reserve, will be adequate to cover budgeted expenses.

The major expenditures recommended by the Committee for the 2002-03 fiscal period include $810,500 for advertising, $179,000 for the Mexican Fruit Fly program, $107,845 for management and administration of the program, and $74,777 for compliance. Budgeted expenses for these items in 2001-02 were $810,500, $197,000, $104,500, and $74,777, respectively.

The Committee recommended the $0.11 assessment rate to lower its operating reserve to $171,249. With a $0.12 assessment rate, the Committee projected its reserve on July 31, 2003, to be $271,249, and it thought that was higher than needed to administer the program. It also recommended the reduced rate to lower handler assessments by $100,000 during 2002-03.

The Committee reviewed and unanimously recommended 2002-03 expenditures of $1,226,022, which included a decrease in the Mexican Fruit Fly program and an increase in the management and administration of the program. Budgeted expenses for the advertising program and the compliance program remained the same as last year. In arriving at the budget, the Committee considered information from various sources, including the Executive Committee. The Committee considered leaving the established higher assessment rate unchanged. However, it concluded that the reserves currently held by the Committee are higher than the Committee needs to administer the program.

The assessment rate of $0.11 per 7/10-bushel carton of assessable oranges and grapefruit was determined by dividing the total budget by the 10 million 7/10-bushel cartons of oranges and grapefruit estimated to be handled during the 2002-03 fiscal period. The $0.11 rate will provide $1,100,000 in assessment income. The additional $126,022 to fund the Committees estimated expenses will come from the Committee's reserve, a refund of an overpayment from the Mexican Fruit Fly program, and interest income.

A review of historical information (October 1998 through May 2002) and preliminary information pertaining to the upcoming fiscal period indicates that the packinghouse door price for the 2002-03 fiscal period could range, monthly, from $1.65 to $10.36 per 7/10-bushel carton of Texas oranges and grapefruit, depending upon the fruit variety, size, and quality. Therefore, the estimated assessment revenue for the 2002-03 fiscal period as a percentage of total grower (packinghouse door) revenue could range between 6.67 percent and 1.06 percent.

This action continues to decrease the assessment obligation 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 Committee's meeting was widely publicized throughout the Texas orange and grapefruit industry and all interested persons were invited to attend the meeting and participate in Committee deliberations on all issues. Like all Committee meetings, the August 28, 2002, meeting was a public meeting and all entities, both large and small, were able to express views on this issue. Finally, interested persons are invited to submit information on the regulatory and informational impacts of this action on small businesses.

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

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

An interim final rule concerning this action was published in the Federal Register on October 7, 2002 (67 FR 62318). Copies of that rule were also mailed or sent via facsimile to all orange and grapefruit handlers. Finally, the interim final rule was made available through the Internet by the Office of the Federal Register and USDA. A 60-day comment period was provided for interested persons to respond to the interim final rule. The comment period ended on December 6, 2002, and no comments were received.

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

This final rule is issued under the Fresh Cut Flowers and Fresh Cut Greens Promotion and Information Act of 1993 [7 U.S.C. 6801-6814] (Act).

The U.S. Department of Agriculture (USDA or the Department) is issuing this rule in conformance with Executive Order 12866.

This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This final rule is not intended to have retroactive effect. This final rule will not preempt any state or local laws, regulations, or policies, unless they present an irreconcilable conflict with this termination order. The Act provides that administrative proceedings must be exhausted before parties may file suit in court.

This final rule terminates the Order and its rules and regulations.

The Act authorizes the creation of a generic program of promotion and information for fresh cut flowers and greens and became effective on December 14, 1993. The Order was issued on December 29, 1994, and the National PromoFlor Council (Council) was appointed to administer the Order under USDA supervision. The Order covered approximately 650 wholesale handlers (qualified first handlers) of fresh cut flowers and greens with sales of $750,000 or more annually. In accordance with paragraph (h)(4) of § 6804 of the Act and paragraph (e) of § 1208.41 of the Order, the Council retained 10 percent of the assessment funds collected in an interest-bearing escrow account.

Paragraph (a)(1) of § 6806 of the Act requires USDA to conduct a referendum not later than three years after the issuance of the Order to ascertain whether the Order should be continued. Paragraph (a)(2) of that section requires that the Order be approved by a simple majority of all votes cast in the referendum in order to continue. The referendum was conducted from June 2 through 20, 1997.

In the referendum, only 42 percent of the voters voted to continue the program. Paragraph (d) of § 6806 of the Act and § 1208.60 of the Order, provide that, if the Department determines that termination of the Order is favored by a majority of all votes cast in the referendum, the Department shall terminate the collection of assessments under the Order not later than 180 days after the referendum results are announced. Therefore, the Department published a termination order in the Federal Register on July 28, 1997 [62 FR 40255], stating that termination of the Order was favored by a majority of the qualified handlers voting in the referendum and that the Order should therefore be terminated. The termination order eliminated the requirement for handlers to pay assessments as of July 29, 1997. The Act requires the Department to terminate activities under the Order as soon as practicable and in an orderly manner. The other provisions of the Order remained in effect in order to facilitate the collection of past-due assessments from 14 handlers.

In addition, in accordance with § 1208.61 of the Order, the Department appointed five members of the Council to serve as trustees for the purpose of liquidating the assets of the Council.

Paragraph (h)(4) of § 6804 of the Act provides that refunds of assessments shall be made out of the escrow account to those qualified handlers who apply for refunds prior to the conduct of the referendum and submitted satisfactory proof that they paid the assessment for which a refund is requested. If the amount in the escrow account is not sufficient to refund the total amount of assessments demanded, the amount of all such refunds shall be prorated among all eligible qualified handlers that demand the refunds. Section 1208.61 of the Order provides that refunds are to be made within 30 days of the date the results of the referendum are released by the Department. Due to the number of refund requests, handlers received refunds of about 12 cents for each dollar in assessments paid to the Council. After the refunds were made and the Council's assets were liquidated, a final audit of the Council's books was conducted.

As of July 29, 1997, 14 handlers owed a total of $433,483.50 in past-due assessments. To date, USDA has collected $283,130.00 in past-due assessments, $38,932.98 in late fees, and $4,500.00 in civil penalties from these handlers pursuant to final decisions by the Secretary of Agriculture in 14 administrative proceedings brought by the Agricultural Marketing Service (AMS). In accordance with instructions from the trustees, the past-due assessments and late fees were distributed to three floral industry groups. In accordance with the Act, the civil penalties were forwarded to the U.S. Department of the Treasury.

Collection efforts have been exhausted. Therefore, this action terminates all provisions of the Order and its rules and regulations.

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

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

The Order covered approximately 650 wholesale handlers (qualified handlers). Small agricultural service firms have been defined by the Small Business Administration [13 CFR 121.601] as those having annual receipts of less than $5 million dollars. A majority of the qualified handlers may be classified as small entities.

This final rule terminates the Order covering fresh cut flowers and greens. Assessment obligations were terminated on July 29, 1997. The program has been inoperative since that time.

The floral industry has been operating without a promotion program since assessments were terminated. Reestablishing the Order would mean additional cost to the industry stemming from assessments to operate the Order (the last assessment was 0.5 percent of the gross sales price of the cut flowers and greens sold), reports to the Council, and recordkeeping. By not reinstating the Order, the industry benefits from avoiding these costs. Because the industry has been operating without the Order for five years, termination of the Order will have no noticeable effect on either small or large operations.

In accordance with the Paperwork Reduction Act of 1995 [44 U.S.C. Chapter 35], the information collection requirements under the Order were approved by the Office of Management and Budget (OMB) and assigned OMB Nos. 0581-0096 and 0505-0001. When assessment collections were terminated on July 29, 1997, these information collection requirements were also suspended. Now that the Order is being terminated, these requirements are eliminated.

USDA has not identified any relevant federal rules that duplicate, overlap, or conflict with this final rule.

Termination of the Order was favored by a majority of the qualified handlers voting in a referendum conducted in 1997. The Act requires that, upon such a determination by referendum, the Department shall terminate the Order. The Order has been inoperative for five years, and assessment collection efforts have been exhausted. In addition, the assets of the Council have been liquidated, and a final audit of the Council's books has been conducted.

It is therefore ordered, that pursuant to section 6806 of the Act, the Order, and its rules and regulations [7 CFR Part 1208] are hereby terminated.

It is also found and determined upon good cause that it is impracticable, unnecessary, and contrary to the public interest to give preliminary notice or to engage in further public procedure prior to putting this action into effect, and that good cause exists for not postponing the effective date of this action until 30 days after publication in the Federal Register because (1) termination of the Order was favored by a majority of qualified handlers voting in a referendum in 1997; (2) the Order has been inoperative for five years and assessment collection efforts have been exhausted; and (3) the assets of the Council have been liquidated and a final audit of the Council's books has been conducted.

The vertical clearance under the Conrail Railroad Bridge in the open position is 135 feet at mean high water and 139 feet at mean low water. The draw is normally in the fully open position except for the passage of rail traffic. The existing regulations are listed at 33 CFR 117.589.

The owner of the bridge, the Army Corps of Engineers (ACOE), requested a temporary deviation from the Drawbridge Operation Regulations to facilitate vital unscheduled maintenance, the replacement of the counterweight guide rails, at the bridge. This work must be performed without delay to ensure continued safe reliable operation of the bridge.

The bridge owner advised the mariners who normally use this waterway about the necessary emergency repairs at the bridge and the temporary closures that will be required in order to facilitate the necessary repairs. No objections were received.

Under this temporary deviation the Conrail Railroad Bridge, mile 0.7, across the Cape Cod Canal, may remain closed at 60 feet above mean high water from 8 a.m. through 5 p.m. on January 2, 3, 8, 9, 10, 15, 16, 17, 22, 23, 24, 28, 29, and 30, 2003. From 8 a.m. through 5 p.m. on February 3 and 6, 2003, the bridge may remain fully closed.

Under the deviation schedule listed above, the bridge will be closed three days each week; however, the third day each week and the last week of the closure schedule were added as extra days in case the repair work is delayed by inclement weather.

Mariners may contact the U.S. Army Corps of Engineers Marine Traffic Controller 24-hour telephone line at (508) 759-4431 for the operational status of the bridge.

Thirty days notice to the Coast Guard for approval of this bridge maintenance was not given by the bridge owner and was not required because this work involves vital, unscheduled maintenance that must be performed without undue delay.

This deviation from the operating regulations is authorized under 33 CFR 117.35, and will be performed with all due speed in order to return the bridge to normal operation as soon as possible.

This supplementary information section is organized as follows:

This document is our approval of Ohio's nonattainment NSR SIP revision requests dated from July 23, 1980, to August 19, 1999. On April 22, 1996, we proposed to conditionally approve the revision requests dated up to March 1, 1996 (61 FR 17669). Subsequently, OEPA submitted several rule changes which met our condition for full approval. On February 21, 2002, we issued a proposed approval (67 FR 7996) and a direct final approval (61 FR 7954) of the revision requests dated up to August 19, 1999. On April 16, 2002, we withdrew the direct final rule because we received adverse comments on it (67 FR 18497). The proposed approval remained in effect. Today, we follow up the proposed approval with full, final approval of the revision requests dated up to August 19, 1999.

OEPA submitted its first NSR SIP revision request on January 31, 1972, and submitted replacement regulations on June 6, 1973. The regulations submitted by the State provided requirements, such as best available technology, that were meant to be uniformly applied throughout the State.

The Clean Air Act Amendments (CAAA) of 1977 required States to go further than uniformly applied regulations. The CAAA of 1977 provided for the designation of areas within a State as “attainment” or “nonattainment.” An “attainment” area meets NAAQS for one of six criteria pollutants: total suspended particulates, sulfur dioxide, ozone, carbon monoxide, nitrogen dioxide and lead. A “nonattainment” area does not meet the NAAQS for one or more of these pollutants. The CAAA of 1977 also required states to adopt more stringent regulations, such as offsets and lowest achievable emission rate (LAER), for new pollution sources in nonattainment areas.

On July 23, 1980, and September 25, 1980, OEPA submitted its NSR plan designed to meet the nonattainment area requirements of title I, part D of the CAA. We conditionally approved this plan on October 31, 1980, 45 FR 72119 (codification corrected on December 17, 1980, at 45 FR 82927). The conditional approval required OEPA to submit a part D NSR plan which refined the criteria for permit issuance and assured that the requirements of CAA sections 172 and 173 were met.

To satisfy the conditional approval, OEPA submitted a request to incorporate revised regulations in the SIP on October 4, 1982, and January 24, 1993. These revised regulations sought to incorporate title 40, part 51, Appendix S of the Code of Federal Regulations (CFR) as the Ohio NSR plan. We granted only limited approval of the revised regulations on September 8, 1993 (58 FR 47214), stating that the regulations did not satisfy the nonattainment area planning requirements of part D.

The CAAA of 1990 imposed further NSR requirements for nonattainment areas. Pursuant to these latter amendments, OEPA submitted a request to revise the entire SIP package on August 20, 1993. We proposed to disapprove the SIP revision request on March 4, 1994, because it did not satisfy the part D requirements of the CAA (59 FR 10349). The final disapproval of the State request was published on September 21, 1994 (59 FR 48392).

OEPA submitted another SIP revision request on March 1, 1996. On April 22, 1996 (61 FR 17669), we proposed to conditionally approve the general and nonattainment provisions for the SIP. We stated that the proposed provisions were deficient for not providing a definition for “pollution control project,” and that this deficiency had to be corrected for the nonattainment provisions to be fully approved. OEPA subsequently submitted a number of revisions to its request dated March 1, 1996, April 16, 1997, September 5, 1997, December 4, 1997, and April 21, 1998. These revisions provide general provisions (OAC 3745-31-01 to 3745-31-10) and nonattainment area provisions (OAC 3745-31-21 to 3745-31-27).

The CAA further requires that the public be given sufficient time to comment on a permit before the permit is issued. To meet this requirement, OEPA submitted an August 19, 1999, request for approval of the incorporation of Ohio Administrative Code (OAC) 3745-47-01, 3745-47-02, 3745-47-03, 3745-05, 3745-47-07, and 3745-47-08 (D) into the SIP. These rules provide public notice procedures for both attainment and nonattainment construction permits.

On February 21, 2002, EPA simultaneously published a proposed approval (61 FR 7996) and a direct final approval (61 FR 7954) of Ohio's submitted NSR SIP revisions. In the direct final rulemaking, we stated that if we received adverse comments by March 25, 2002, the direct final approval would be withdrawn. We did receive adverse comments, and therefore withdrew the rule on April 16, 2002 (67 FR 18497). The proposed approval remained in effect. Today we are following up on our proposed approval by addressing the adverse comments that we received and setting forth our final approval of Ohio's NSR rules under the Clean Air Act.

OEPA's nonattainment NSR rules are now approvable because they fulfill the requirement set by the April 22, 1996, conditional approval: they provide a definition for “pollution control project” as required by 40 CFR 51.165(a)(1)(xxv). The submitted rules also satisfy the minimum Federal requirements for a nonattainment NSR program.

Below we summarize the substantive comments pertaining to the submitted rules, and our responses to them:

(1) Before granting final approval of any Ohio rules, EPA should complete its review of Ohio's programs in response to the petitions for withdrawal or revocation of OEPA's authority. That EPA's August 30, 2001, draft report of its review cited problems with OEPA's implementation of PSD rules indicates that problems could develop in an NSR program that takes a larger role at OEPA.

Response: USEPA is currently reviewing OEPA's implementation of the delegated PSD program in response to a petition submitted by D. David Altman on behalf of Ohio Citizen Action, the Ohio Environmental Council, Rivers Unlimited, and the Ohio Sierra Club. EPA intends to address any potential need on OEPA's part to improve implementation of its PSD rules through EPA's ongoing review of OEPA's program. See Draft Report on U.S. EPA Review of Ohio Environmental Programs, August 30, 2001, United States Environmental Protection Agency. Any concerns that USEPA finds as a result of this review will be addressed through the process of the aforementioned review.

Today's approval only addresses whether or not specific provisions of Ohio's administrative code meet the Federal CAA criteria for an NSR program, and does not address any issues regarding how the code is, or will be, applied or enforced by Ohio. We believe that the submitted rules meet the criteria for approval under the CAA and no particular findings or conclusions pertaining to the EPA petition review should be inferred from today's approval.

(2) The public participation process in Ohio is flawed, and should be corrected before approval of Ohio's rules.

Response: The submitted rules comply with Federal NSR requirements for public participation under the CAA. Any concerns, if any, that U.S. EPA may have with Ohio's public participation process under Ohio's PSD program will be addressed through the ongoing review of Ohio's program. See response to comment #1.

(3) The approval should be withheld because OEPA does not have a training program that ensures a minimum level of training and consistency across the state, and because it currently has a very high level of vacancies with no system in place to expeditiously fill those vacancies.

Response: The submitted rules comply with Federal NSR requirements under the CAA. Any concerns, if any, that U.S. EPA may have with the level of vacancies under Ohio's PSD program will be addressed through the ongoing review of Ohio's program. See response to comment #1.

(4) The approval would take OEPA's NSR permitting activities from Federal scrutiny and move appeal jurisdiction from EPA to OEPA. Such transitions remove Federal safety measures.

Response: Under the Clean Air Act, this approval will not change our level of scrutiny of OEPA's permitting activities. We will retain oversight over OEPA's NSR program, and will continue to require public involvement in the program. The approval will also have no effect on appeal jurisdiction because nonattainment-area permits can only be appealed through the State.

(5) The approval should incorporate by reference all currently outstanding SIP changes, rather than merely on the March 1, 1996, revision request and several subsequent revisions.

Response: This final approval does not address SIP changes dated after August 19, 1999, because those changes have not been subjected to public notice. This approval only addresses the following: (1) All nonattainment NSR SIP changes dated on or before April 21, 1998, which were made available for public comment in the April 22, 1996, proposal for conditional approval and the February 21, 2002, proposed approval; (2) The August 19, 1999, SIP changes for public notice procedures pertaining to both attainment and nonattainment-area permits, which were made available for public comment in the February 21, 2002, proposed approval. For SIP changes dated after August 19, 1999, we will take a separate action to ensure that the public is given proper opportunity to comment on those changes.

(6) In the definition for “major stationary source,” the submitted rules exclude pollutants regulated under CAA section 112 for attainment-area sources subject to 100-ton-per-year thresholds, while Federal regulations do not provide for such an exclusion.

Response: CAA section 112 is a separate program and is not regulated through NSR. NSR does not require the application of 100-ton-per-year thresholds to section 112 pollutants. In fact, CAA section 112(b)(6) prohibits the application of Prevention of Significant Deterioration (PSD) rules to the section 112 pollutants. Therefore, the rule that is the subject of this comment, OAC 3745-31-01 (SS), is consistent with the Federal definition.

(7) OEPA's definition for “major stationary source” is provided for attainment and nonattainment areas, but not for unclassified areas.

Response: As is inferred from the equal treatment of attainment and unclassified areas in 40 CFR 52.21(b)(14)(iii)(a), 52.21(b)(15)(i), and 52.21(i)(3), the Federal definition for “major stationary source” applies to unclassified areas and attainment areas equally. We interpret the submitted OEPA rule, OAC 3745-31-01 (SS), to carry the same inference. Therefore, “major stationary source” need not be defined separately for unclassified areas.

(8) In determining whether there has been a net emissions increase, the submitted rules limit the consideration of fugitive emissions to those source categories having 100-ton-per-year thresholds. The Federal regulations have no such limitation.

Response: We disagree that the Federal regulations have no such limitation. Under 40 CFR 51.165(a)(1)(iv)(C) and 51.165(a)(4), State rules may exempt fugitive emissions from consideration for a major source or major modification unless the source belongs to one of the source categories having 100-ton-per-year thresholds or the source is subject to section 111 (New Source Performance Standards) and section 112 (National Emissions Standards for Hazardous Air Pollutants) of the Clean Air Act. The Ohio rule, OAC 3745-31-01 (RR) is consistent with the Federal rules.

(9) In the submitted rules, the use of alternative fuel or raw material is exempted from the definition of “major modification” if the source was capable of accommodating it before December 21, 1976. It also exempts emission increases caused by increases in hours of operation or production rate if those increases were not prohibited by a Federally enforceable permit condition established after December 21, 1976. However, the Federal regulations set the critical date for both of these exemptions at January 6, 1975, not December 21, 1976.

Response: This comment refers to the Federal PSD rules at 40 CFR 51.166(a)(2)(iii)(e)-(f), which apply the January 6, 1975 date. The PSD rules are not relevant to today's approval, which addresses general and nonattainment NSR provisions. The submitted rule, OAC 3745-31-01(RR)(5)(a), applies the December 21, 1976, date required by the nonattainment NSR rules at 51.165(a)(1)(v)(C)(5)-(6). Therefore, the Ohio rule is consistent with the Federal rule.

(10) In the definition for “major modification,” the submitted rules state that alternative fuel or raw material can be used as long as “the stationary source is approved to use under any permit issued under this ruling.” The “ruling” to which this sentence refers to is unclear.

Response: We disagree that the word “ruling” is unclear in OAC 3745-31-01(RR)(5)(b). In the context of the definition, “ruling” refers to a permit issued under Ohio's SIP.

(11) The Federal definition for “net emissions increase” provides that an increase or decrease in actual emissions of sulfur dioxide, particulate matter, or nitrogen oxides which occurs before the applicable baseline date is creditable only if it is required to be considered in calculating the amount of maximum allowable increases remaining available. OEPA's version of this definition, however, restricts only the consideration of sulfur dioxide and particulate matter (leaving out nitrogen oxides).

Response: This comment relates to maximum allowable increases and baseline dates, which do not apply to the nonattainment rules we are approving. They apply, instead, to the Ohio attainment rules which were conditionally approved on October 10, 2001 (66 FR 51570). Offsets, not maximum allowable increases, govern nonattainment areas.

(12) OEPA's definition for “net emissions increase” fails to specify that only PM-10 emissions can be used to evaluate the net increases for PM-10.

Response: We believe that it is inherent in this rule, OAC 3745-31-01(YY), that only PM-10 emissions can be used to evaluate net PM-10 increases. Ohio's rules distinctly set out the definitions and measuring procedures of particulate matter and PM-10 at OAC 3745-17. (The rules use the term “total suspended particulates” for PM-10.) The distinctions drawn in those rules apply to the definition of “net emissions increase.” Therefore, we do not believe that the definition needs further clarification.

(13) OEPA's definition for “emissions unit” is made unclear by the sentence “This term does not include operations or activities that emit air pollutants regulated under State law but are not regulated under the Clean Air Act.”

Response: We disagree that the definition for “emissions unit” is unclear at OAC 3745-31-01(AA). Under the submitted rule, any operation or activity that emits air pollutants regulated under the CAA is an “emissions unit.” The clarifying sentence serves to distinguish CAA-regulated emissions units from those regulated only under State laws.

(14) The Federal definition of Best Available Control Technology specifically includes “fuel cleaning or treatment or innovative fuel combustion techniques,” but OEPA's definition lists only “fuel combustion techniques.”

Response: We interpret Best Available Control Technology (BACT) requirements to apply to any aspect of fuel combustion, cleaning, or treatment that affects emissions, and do not feel that the clause “including fuel combustion techniques” at OAC 3745-31-01(M) excludes any aspect of BACT. The clause does not preclude technologies beyond fuel combustion techniques because it is not all-inclusive. Therefore, the submitted rule is not limiting.

(15) The Federal definition of “clean coal technology” restricts it to the generation of electricity or process steam. Ohio's definition includes, in addition, “industrial products,” which is an expansion beyond the Federal standard.

Response: We do not anticipate that Ohio's definition at OAC 3745-31-01(O) will be applied to any product or process that the Federal definition was not intended to cover. Nevertheless, we will advise OEPA to change its definition to match the Federal definition. We do not feel that the minor difference between the definitions warrants disapproval.

In this rule, EPA approves OEPA's requests for additions and revisions to OAC 3745-31-21 to 3745-31-27 submitted on March 1, 1996, April 16, 1997, September 5, 1997, December 4, 1997, and April 21, 1998. EPA also approves OEPA's August 19, 1999, request for additions to OAC 3745-47-01, 3745-47-02, 3745-47-03, 3745-05, 3745-47-07, and 3745-47-08 (D). EPA will take action on any subsequently submitted revision requests at a later time.

Today's action will take effect immediately upon publication as provided for by the good cause exemption of section 553 (d)(1) of the Administrative Procedure Act. This approval is a substantive rule that relieves a restriction on Ohio: sanctions would be imposed on Ohio if the SIP continued to lack nonattainment NSR provisions.

Recently, EPA announced new regulations regarding changes to the New Source Review Program through efforts under “New Source Review Reform”. See http://www.epa.gov/nsr/. Today's approval of Ohio's NSR SIP submission does not address EPA's new rules but is limited to portions of Ohio's program under prior existing rules. EPA is taking no position today on whether Ohio will need to make changes to its SIP to meet any new requirements that EPA may promulgate as part of New Source Review Reform.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).

This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. 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 . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by March 11, 2003. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. ( See section 307(b)(2).)

This supplementary information section is organized as follows:

On November 6, 1991, EPA published a nonattainment designation for northern Lake County for the PM 10 standards as given in Title 40 of the Code of Federal Regulations § 50.6 (40 CFR 50.6). 1 (See designations in 40 CFR 81.315.) These standards include a standard for annual average concentrations and a standard for 24-hour average concentrations. The area designated nonattainment included the cities of Gary, East Chicago, Hammond, and Whiting. On September 25, 2002, Indiana requested that the PM 10 designation in 40 CFR 81.315 for this area in Lake County be changed from nonattainment to attainment. Included with this request were a summary of relevant air quality data, evidence of the opportunity for public review of this request (including a public hearing held July 18, 2002), and a discussion of how the various criteria for redesignation have been met.

Statutory criteria for redesignations from nonattainment to attainment are given in section 107(d)(3)(E) of the Clean Air Act. EPA may not promulgate such a redesignation unless: (i) The area has attained the applicable air quality standards, (ii) the area has a fully approved State Implementation Plan (SIP) under section 110(k) of the Act, (iii) EPA has determined that the improvement in air quality in the area is due to permanent and enforceable emission reductions, (iv) EPA has determined that the maintenance plan for the area has met all of the requirements of section 175A of the Act, and (v) the state has met all requirements applicable to the area under section 110 and part D of the Act.

EPA has issued a variety of relevant guidance memoranda interpreting the statutory criteria for redesignations and maintenance plans, most notably including a memorandum dated September 4, 1992, signed by the Director of EPA's Office of Air Quality Planning and Standards. In addition, regulations governing the evaluation of PM 10 monitoring data are in appendix K to 40 CFR part 50.

Title 40 CFR part 50, appendix K provides for evaluating three years of representative monitoring data. Indiana monitors PM 10 concentrations at numerous locations in Lake County. Detailed results of this monitoring are available in EPA's Air Quality System (AQS) and on the Internet at http://www.epa.gov/air/data/. Indiana's submittal summarizes these air quality data.

For the most recent three calendar years, i.e. , 1999 to 2001, Indiana collected PM 10 air quality data at five monitoring locations, including locations in Gary, Hammond, and East Chicago, where emissions are highest and the highest concentrations are expected. All sites recorded annual average concentrations below the annual average standard in all three years. Four of the five sites also recorded no exceedances of the 24-hour standard and thus clearly meet this standard. However, the fifth site, located in Gary at 201 Mississippi Street near the USX steel mill, recorded three exceedances in the 1999 to 2001 period. Thus, further analysis is necessary to determine whether this site meets the 24-hour standard.

The procedures in appendix K to 40 CFR part 50 for assessing compliance with the 24-hour standard estimate the number of days per year that the site is expected to exceed the level of the standard (150 micrograms per cubic meter). If a monitoring site collects complete information, the number of expected exceedances is simply equal to the number of measured exceedances. However, if data from a monitor are missing or inadequate for one or more days, these procedures provide for the assessment of the additional number (potentially fractional) of additional exceedances estimated to have occurred on unmonitored or inadequately monitored days. The number of expected exceedances is then the sum of the number of measured exceedances plus the additional inferred number of exceedances expected for unmonitored or inadequately monitored days. The number of expected exceedances is thus the likely total number of exceedances that a monitor would have recorded had it obtained complete data.

Since PM 10 concentrations often vary by season, appendix K provides for estimation of expected exceedances separately for each quarter year. A location is attaining the standard if the monitor has a three-year average number of expected exceedances (rounded to the nearest tenth) of 1.0 or less.

The above Gary monitor recorded two exceedances in 1999, no exceedances in 2000, and one exceedance in 2001. The exceedances in 1999 both occurred in the last quarter. The monitor at this site is a continuous instrument that records hourly average values. The data obtained were adequate (at least 18 hours per day) to be considered complete for every day during the quarter. Therefore, the number of expected exceedances for 1999 at this site is equal to the 2.0 measured exceedances. The year 2000 had 0.0 expected exceedances. For 2001, the monitor recorded one exceedance in the first quarter out of 87 days with adequate data; three days in the first quarter had either no data or insufficient data. This leads to an estimated exceedances of 1.03, which rounds to a 2001 expected exceedances value of 1.0. Average expected exceedances for 1999 to 2001 then is 1.0. Consequently, this site is attaining the standard. More generally, since the monitoring includes representation of the worst-case locations in Lake County, EPA concludes that all of Lake County is attaining the PM 10 standards.

The principal relevant element of the SIP required under Part D of Title I of the Clean Air Act for Lake County is a plan for attaining the particulate matter standards. Indiana submitted this attainment plan on June 16, 1993, with subsequent supplemental submittals. EPA approved this attainment plan on June 15, 1995, at 60 FR 31412. Indiana submitted separate rules addressing requirements for nonattainment area new source review; EPA approved these rules as satisfying applicable requirements on October 7, 1994, at 59 FR 51108. While Clean Air Act section 172(c)(9) identifies a requirement for contingency plans, EPA has concluded that areas that are attaining the standards need not submit such contingency plans. (See 57 FR 13564, published April 16, 1992.) This reflects EPA's view that contingency plans under section 172(c)(9) are designed to address the possibility of an area failing to achieve the expected air quality improvement, that the need for such plans no longer exists after an area attains the standard, and that an area that has attained the standard and has a maintenance plan can rely on the contingency plans in the maintenance plan to address any recurrence of violations. Thus, EPA concludes that it has approved all required SIP elements for the Lake County particulate matter nonattainment area.

Indiana's SIP requires permanent emission reductions at a wide range of facilities including those facilities that Indiana's modeling has demonstrated to be the key contributors to prior air quality problems. The emission reductions result from installation of air pollution control equipment to capture and control particulate matter that was previously emitted. The reductions also result from ongoing measures to reduce emissions from plant roadways and storage piles. Enforceable emission limits adopted in Title 326 Indiana Administrative Code Article 6 and approved by EPA (as compiled at http://www.epa.gov/region5/air/sips/sips.htm ) assure the permanence of these emission reductions. EPA thus concludes that permanent and enforceable emission reductions have enabled this county to attain the standards.

Under section 175A of the Clean Air Act, maintenance plans must demonstrate continued attainment of the standards for 10 years after the redesignation. Thus, Indiana demonstrated maintenance through 2012. This demonstration focused on industrial sources, especially steel mills, which were the predominant cause of prior nonattainment in Lake County. Indiana compiled estimates of industrial source emissions for 1999 and anticipated emissions for 2012, projecting a 21 percent decline in emissions during that period. This indicates, in turn, that the area can be expected to continue to attain the standards over the next 10 years.

In addition, the attainment plan that EPA approved in 1995 constitutes further evidence that Lake County can be expected to maintain the standards. This plan reflected maximum allowable emissions. By relying on an inventory of maximum allowable emissions from the most significant sources of particulate matter emissions in the area, the attainment plan demonstrated that the area would achieve and maintain attainment even if the sources operated at maximum capacity. This suggests that Lake County can be expected to maintain the standards permanently unless background impacts, particularly from area sources such as home heating and motor vehicles, increase significantly. Trends in home heating emissions can be deduced from trends in population, which in Lake County has essentially remained unchanged in the last five years and can be expected to remain essentially unchanged in the next 10 years as well. Motor vehicle emissions can be expected to decline, particularly as a result of new regulations reducing sulfur content of motor fuels and requiring lower emissions from both gasoline and diesel vehicles. Background concentrations of PM 10 transported into the area can also be expected to decline as a result of sulfur dioxide emission reductions from the acid rain program. These factors suggest that Lake County can be expected to maintain the standards through 2012 and beyond.

Maintenance plans must include contingency measures in case violations of the air quality standards unexpectedly arise. Indiana has adopted a rule for contingency planning in 326 Indiana Administrative Code 6-1-11.2, which EPA approved on October 11, 2002, at 67 FR 63268. This rule provides two levels of response, depending on the severity of the air quality problem. A “Level II” response occurs when a year's second high concentration in the area exceeds 140 micrograms per cubic meter. In this case, the State would assess what controls need to be implemented to avoid violations of the standard. A “Level I” response occurs when a violation occurs (excluding circumstances where the violation is attributable to an exceptional event, malfunction, or noncompliance). In this case, the State assesses the origins of the violation and adopts any necessary control measures within 18 months. EPA believes that these provisions satisfy the requirements for contingency measures as part of Indiana's maintenance plan for particulate matter for Lake County.

Maintenance plans must also include commitments to continued air quality monitoring and to submittal of a reassessment of maintenance in 8 years. Indiana commits in its submittal to continue monitoring PM 10 concentrations in accordance with its current monitoring plan. The core elements of Indiana's maintenance plan are permanent and will likely assure permanent maintenance, but the State nevertheless explicitly committed to submit the necessary additional maintenance plan in 8 years.

EPA's guidance memorandum of September 4, 1992, identifies various additional recommended features of maintenance plans. Many of these recommended features are not germane to pollutants like PM 10 in areas like Lake County that have plans showing attainment even with key sources emitting their maximum allowable emissions. Indiana nevertheless included these features in its maintenance plan.

EPA's guidance states that “The State should develop an attainment emission inventory to identify the level of emissions in the area which is sufficient to attain the NAAQS.” (Section 5a) Attainment for PM 10 in Lake County is assured not by limiting total emissions for the area to one specific level, but rather by defining allowable emissions for each location in the area and assuring that emissions for each location are at or below the allowable levels. Thus, the best “attainment emission inventory” for Lake County is the inventory of allowable emissions that Indiana used in its modeled attainment demonstration. Nevertheless, Indiana also provided estimates of more recent actual emissions.

Indiana has complied with the “Maintenance Demonstration and Monitoring Network” requirements of EPA's guidance of September 4, 1992 (sections 5b and c), as addressed above. Indiana satisfied the “Verification of Continued Attainment” requirement (section 5d) by periodically examining the air quality data that it will continue to collect. Finally, Indiana has satisfied the “Contingency Plan” requirements (section 5e), as addressed above. Thus, Indiana has satisfied all requirements for this maintenance plan.

As noted in the rulemaking on Indiana's particulate matter plan cited above, published on June 15, 1995, at 60 FR 31412, Indiana has met the requirements of section 110 and Part D with respect to particulate matter planning in Lake County. That rulemaking focused on Indiana's plan for attaining the particulate matter standards in Lake County, which is the most significant relevant requirement under section 110 and Part D. That rulemaking also addressed related requirements for reasonably available control measures and for reasonable further progress. Indiana was not required to address transportation conformity for particulate matter because transportation sources are not significant contributors to PM 10 concentrations in Lake County.

EPA is redesignating Lake County, Indiana, to attainment for PM 10 . In addition, EPA is approving Indiana's maintenance plan for this area.

Clean Air Act section 107(d)(3)(E) identifies five prerequisites for redesignation of areas from nonattainment to attainment. EPA concludes that these criteria are met with respect to PM 10 in Lake County.

EPA is publishing these actions without a prior proposal because we view these as noncontroversial actions and anticipate no adverse comments. However, in the “Proposed Rules” section of today's Federal Register , EPA is publishing a separate document that will serve as the proposal to approve the redesignation and maintenance plan if adverse comments are filed. This rule will be effective on March 11, 2003 without further notice unless we receive relevant adverse written comment by February 10, 2003. If the EPA receives adverse comment, we will publish a final rule informing the public that this rule will not take effect. We will address all public comments in a subsequent final rule based on the proposed rule. We will not institute a second comment period on this action. Any parties interested in commenting on these actions must do so at this time.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely changes the attainment status of a portion of a county and imposes no additional requirements. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule does not impose any additional enforceable duty, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).

This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state request to change the attainment status of an area, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.

Indiana's request for redesignation did not include any additional limitations on sources, and thus provided no opportunity to use voluntary consensus standards (VCS). Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. 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 . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by March 11, 2003. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

The Life Safety Code (LSC) is a compilation of fire safety requirements for new and existing buildings and is updated and published every 3 years by the National Fire Protection Association (NFPA), a private, nonprofit organization dedicated to reducing loss of life due to fire. The Medicare and Medicaid regulations have historically incorporated by reference these requirements along with Secretarial waiver authority. The statutory basis for incorporating NFPA's LSC for our providers is under the Secretary's general rulemaking authority at sections 1102 and 1871 of the Social Security Act.

We have not updated the LSC regulations for several years. We published a proposed rule in the Federal Register on August 1, 1990 (55 FR 31196) proposing to eliminate the use of the 1967 and 1973 editions of the LSC. In the August 1990 proposed rule, hospitals, nursing homes, and intermediate care facilities for the mentally retarded (ICFs/MR) would be required to comply with either the 1981 or 1985 editions of the LSC, depending on the date the provider entered the program. The proposed rule did not include ambulatory surgery centers (ASCs), hospices, or end-stage renal disease (ESRD) facilities. The August 1990 proposed rule also made no reference to the Program of the All-Inclusive Care for the Elderly (PACE) facilities, Critical Access Hospitals, and religious nonmedical health care institutions (RNHCIs) because these provider and supplier types did not exist when we published the August 1990 proposed rule.

On October 26, 2001, we published a proposed rule proposing to withdraw the August 1, 1990 proposed rule because the NFPA published four new editions of the LSC since the publication of our August 1990 proposed rule. Some accrediting organizations had adopted the 1997 edition of the LSC. The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) which accredits over 4,000 hospitals, as well as ASCs, long-term care (LTC) facilities, and hospices that provide inpatient services has adopted the 1997 edition of the LSC. We had to update our requirements to a more recent edition of the LSC because the 1985 edition of the LSC had been superseded by later editions which incorporated the latest technology in fire protection.

The 2000 edition of the LSC includes new provisions that we believe are vital to the health and safety of all patients and staff. The term “patient” represents the population in each of the provider-types discussed in this rule. We proposed not to grandfather any facility under these new provisions because the provisions would not impose an undue burden. Our intention is to ensure that patients and staff continue to experience the highest degree of fire safety possible.

In the past, our authority to grant waivers was critical to our ability to continuously improve fire safety in the Medicare and Medicaid programs and not impose an undue burden on providers. The Secretary has broad authority to grant waivers to hospitals under section 1861(e)(9)(C) of the Act, and to LTC facilities under sections 1819(d)(2)(B) and 1919(d)(2)(B) of the Act. For all other providers we have authority under the Secretary's general rulemaking authority to establish specific health and safety standards as well as under section 1871 of the Act. The proposed rule allows the Secretary to grant waivers on a case-by-case basis if specific provisions of the LSC would result in unreasonable hardship on the provider, and if the safety of patients would not be compromised. The Secretary may also accept a State's fire and safety code instead of the LSC if the State's fire and safety code adequately protects patients. Further, the NFPA's Fire Safety Evaluation System (FSES), an equivalency system, provides alternatives to meeting various provisions of the LSC, thereby achieving the same level of fire protection as the LSC.

In addition to the development of a proposed rule to adopt the 2000 edition of the LSC, we planned to propose a more efficient process that allows us to adopt future editions of the LSC in a more timely manner. We explored incorporating, by reference, the NFPA LSC without specific dates in the regulations text and publishing a Federal Register notice, instead of a proposed rule. We worked closely with the Office of the Federal Register (OFR) staff on our draft proposed approach; however, it has become clear that adoption of multiple successive editions of the LSC via reference is not possible. Changes in future editions of the LSC may be substantial, necessitating that we go through a proposed rule and public comment period. Moreover, we cannot automatically incorporate successive versions of the LSC because of the statutory restrictions of 5 U.S.C. section 552(a) and accompanying regulations at 1 CFR part 51. All LSC editions we adopt must include a specific edition and a copy of the edition cited must be on file at the OFR.

In the October 26, 2001 proposed rule, we proposed to (1) require that all providers and suppliers meet the provisions of the 2000 edition of the LSC with certain exceptions; and (2) remove references to all previous editions of the LSC.

Some requirements in the 2000 edition of the LSC are substantially different than earlier LSC editions. We solicited public comments regarding whether to adopt Chapter 5, “Performance Based Option,” of the LSC. Specifically, we wanted to know (1) whether health care facilities are using performance based design; and (2) what benefits the facility receives by using performance based design.

The LSC fire safety goals establish outcomes to be achieved with regard to fire safety. These overall outcomes are communicated through specific requirements in the LSC. The performance based design option translates fire safety goals into performance objectives and performance criteria. Performance based design establishes broad goals and objectives with a team effort. The performance based design is applied to make the building safe as well as functional. The design is specific to the building. Computer fire models and other calculation methods are used in combination with the building design specifications, specified fire scenarios and assumptions to calculate the overall performance criteria and whether it meets the fire life safety goals and is in compliance with the intent of the LSC.

In the October 2001 proposed rule, we proposed not to adopt the roller latch provision in chapter 19, “Existing Health Care Occupancies,” section 19.3.6.3.2 (exception No. 2), of the LSC for any facility. A roller latch is a type of door latching mechanism to keep a door closed. The 2000 edition of the LSC prohibits the use of roller latches on corridor doors in buildings not fully protected by an approved sprinkler system. Exception No. 2, however, allows for the use of roller latches under this prohibition, if the latch can withstand a specific level of force applied to it. We proposed not to adopt exception No. 2 regarding existing roller latches.

Through fire investigations, roller latches have proven to be an unreliable door latching mechanism requiring extensive on-going maintenance to operate properly. Many roller latches in fire situations failed to provide adequate protection to residents in their rooms during an emergency. Roller latches that are not properly maintained may be a danger to the health and safety of patients and staff. In addition, we have found through our online survey, certification, and reporting (OSCAR) system data report that doors that include roller latches are consistently one of our most cited deficiencies. In fact, in skilled nursing facilities roller latches in corridor doors are consistently the number one cited deficiency under the life safety requirements.

The estimated cost to remove roller latches on existing doors is $30,754,540 ($190 per door for 161,866 doors). We derived the cost estimate from information the American Health Care Association (AHCA) gave to us.

In the October 2001 proposed rule, we provided the LSC citation, a description of the requirement, an explanation of why we believe the requirement is critical to the safety of beneficiaries and a brief discussion of our analysis of the burden imposed by the requirement. We derived the cost estimates from information the AHCA gave to us. The following are new provisions in the 2000 edition of the LSC from chapter 19, “Existing Health Care Occupancies.”

(1) 19.1.1.4.5—Renovations, Alterations, and Modernization—This provision requires that renovations, alterations, and modernizations comply with standards applicable to new construction when possible. Existing facilities that are extensively renovated must meet the requirements of a newly constructed facility, including the installation of sprinkler systems in nonsprinklered buildings. The Fire Analysis & Research Division of the NFPA has shown that sprinklers have been the most important life safety system installed in health care facilities. The LSC generally requires sprinkler systems in renovations, regardless of construction. The estimated cost of installing sprinkler systems in buildings that presently do not have them is $2.50 per square foot, or approximately $125,000 for a 50,000 square foot building. This requirement is not imposed on facilities not undergoing renovations. Approximately 2,550 facilities currently do not have sprinkler systems. Because a facility does not have to comply with this provision unless the facility chooses to renovate an existing building, we estimate approximately 128 facilities may be renovated in a year. The total amount to implement this provision would be $16,000,000 annually.

(2) 19.2.9—Emergency Lighting—This provision requires emergency lighting for a period of 1 1/2 hours in health care facilities, enabling those inside to move about safely in an emergency. We proposed to phase in this requirement over a 3-year period, to allow for the normal replacement cycle of batteries used in emergency lighting systems. We believe this phase-in period would not adversely impact the health and safety of the beneficiaries. We estimate the cost to install this equipment will be $600 per light. Approximately 790 existing facilities do not have emergency lighting for 1 1/2 hours. To be in compliance, we estimated that each building would need 12 emergency light units for a total of 9,482 units. The total amount to implement this provision over a 3-year period would be $5,452,150 or $1,817,383 annually.

(3) 19.3.1—Protection of Vertical Openings—Unprotected vertical openings (for example, open stairwells) permit fire and toxic gases to spread from one level to another in a building, making evacuation difficult, if not impossible. The estimated cost of compliance with this requirement is $2,938 per vertical opening. Approximately 9,877 vertical openings in 1,976 facilities would need to be upgraded for compliance. Total cost of compliance with this provision is $29,018,626.

(4) 19.3.4.3.2—Emergency Forces Notification—This provision requires the fire alarm system to provide automatic notification of a fire to emergency forces. This is of great importance to the protection of all patients. Any delay in the notification of fire or rescue personnel could adversely impact the health and safety of patients and expose them to a fire, smoke or toxic gases created by the fire. Approximately 2,750 buildings at $900 per facility would need to be connected to a fire alarm retransmission system. The cost is estimated to be a total of $2,475,000.

(5) 19.3.6.1—Corridors—This provision requires that all areas in nonsprinklered buildings be separated from the corridor by corridor walls that are fire-rated. This requirement, which provides a protected passageway for movement during an emergency, is necessary to increase the safety of the patients. The cost to upgrade a facility to meet this requirement is estimated to be approximately $7,124 for 1,976 buildings that currently meet the 1967 LSC and approximately $5,735 for 46 buildings meeting the 1973 LSC. The total estimated cost for compliance is $14,341,000.

(6) 19.7.5.2 & 19.7.5.3—Upholstered Furniture—These provisions allow patient-owned furniture to be brought into the facility without meeting the requirements of 10.3.2(2) and 10.3.3 (regarding fire resistant furniture) if a single station smoke detector is placed in the sleeping room where the furniture is located. The cost to the facility is estimated at $100 per sleeping room where patient-owned furniture is located. We estimate approximately 18,498 smoke detectors would need to be installed at a total cost of $1,849,800.

In the October 2001 proposed rule, we proposed to retain our existing authority to waive provisions of the 2000 edition of the LSC, on a case-by-case basis, and thereby reduce the exposure to additional cost and burden for those facilities with unique situations that may justify the application of waivers. We may grant a waiver for a specific LSC requirement if (1) We determine that the waiver would not adversely affect patient and staff health and safety; and (2) we determine that it would impose an unreasonable hardship on the facility to meet a specific LSC requirement. Generally, a provider may request a waiver from its State agency. The State agency will review the request and make a recommendation to our appropriate regional office. Our regional office will review the waiver request and the State agency's recommendation and make a final decision. We cannot grant a waiver if patient safety is compromised in any way. A State may also request that the State fire and safety code be applied to all its facilities rather than the 2000 edition of the LSC we proposed in the October 2001 proposed rule. State law must impose the State fire and safety code. The State must submit the request to our appropriate regional office. The regional office will forward the request to our central office for a final determination.

We proposed to retain our authority to apply the Fire Safety Evaluation System (FSES) as an alternative approach to meeting the requirements of the LSC, as well as accept alternative State fire and safety codes as we discussed in section I.B in the October 2001 proposed rule.

In the October 2001 proposed rule, we proposed changes to the requirements that affect all provider types, as described in sections II.A and II.B of this preamble. We proposed changes for distinct types of providers that include the following:

1. Religious Nonmedical Health Care Institutions—Benefits, Conditions of Participation, and Payment: 42 CFR 403.744 Condition of participation: Life safety from fire.

We proposed to retain the provisions of the existing interim final regulation for RNHCIs published in the Federal Register on November 30, 1999 (64 FR 67028), except as they conflict with the 2000 edition of the LSC and are not within the exceptions detailed in section II.B of this preamble (regarding our exceptions to the LSC).

2. Ambulatory Surgery Centers: 42 CFR 416.44 Condition for coverage: Environment.

We proposed to change the terminology in § 416.44 (b)(1) to reflect that the LSC refers to ASCs as Ambulatory Health Care Centers. We proposed that all ASCs meet the provisions applicable to Ambulatory Health Care Centers in the 2000 edition of the LSC, except as detailed in section II.B of this preamble, regardless of the number of patients the facility serves.

We believe the protection provided in the Ambulatory Health Care Centers chapter is necessary to protect the health and safety of patients who are incapable of taking action of self-preservation. We do not believe that the Business Occupancy chapter of the LSC (applied by some authorities having jurisdiction to ASCs treating fewer than four patients at a time) affords an adequate level of protection to patients in an ASC.

We also proposed to retain the discretion to accept compliance with fire and safety codes imposed by a State, if we determine that the State's fire and safety code will adequately protect patients in ASCs. We have included this provision in § 416.44 (b)(3).

3. Hospice Care: 42 CFR 418.100(d) Condition of participation: Hospices that provide inpatient care directly.

In the October 2001 proposed rule, we proposed that all inpatient hospices meet the provisions applicable to nursing homes in the 2000 edition of the LSC, with the exceptions discussed in section II.B of this preamble, regardless of the number of patients they serve. This is not a change in requirements, but merely a clarification that, for LSC purposes, an inpatient hospice is considered a nursing home, and not another type of occupancy.

We also proposed not to adopt for hospices chapter 18—section 3.4.5.3 of the 2000 edition of the LSC. This section requires new nursing homes to be equipped with corridor smoke detection systems. We believe there is no technical justification for this requirement because the 2000 edition of the LSC requires that newly constructed patient sleeping zones be provided with quick-response sprinklers. Quick-response sprinklers activate quickly enough to serve a detection function, thus making corridor smoke detection unnecessary. The 1991 and 1994 editions of the LSC required quick-response sprinklers in new nursing homes but did not require smoke detection. Therefore, we see no technical reason to require corridor smoke detection in new facilities and thus increase the cost of new construction without a parallel increase in safety.

We also proposed, in § 418.100(d)(3), to permit a hospice to meet a fire and safety code imposed by the State in lieu of the 2000 edition of the LSC if we determine that the State code adequately protects patients. We proposed to do this for two reasons: (1) To afford hospices the benefit of meeting a State code in lieu of the Federal requirements where the State code offers adequate protection; and (2) because we recognize that hospices are often located within buildings containing other providers already subject to this provision. For example, a hospice may be located entirely within a skilled nursing facility (SNF). If the SNF is exempt from the LSC by virtue of meeting a State code, other participating providers within the same building should also be afforded this exception.

We also proposed to remove § 418.100(d)(4), the requirement that blind and nonambulatory patients may not be housed above the street level floor unless the building is fully sprinklered or has achieved a passing score on the FSES comparison, which is less stringent than the LSC. The provision is redundant since any facility that meets the requirements of the 2000 edition of the LSC would, by definition, achieve a passing score on the FSES comparison. In addition, this requirement was removed from the SNF regulations in 1989; however, we did not remove it from the parallel hospice regulations.

4. Programs of All-Inclusive Care for the Elderly (PACE): 42 CFR 460.72 Physical environment.

In the October 2001 proposed rule, we proposed to retain most of the provisions of the existing interim final regulation for PACE that we published in the Federal Register on November 24, 1999 (64 FR 66234). PACE centers will continue to be required to meet the LSC specifications for the type of facilities in which the programs are located (that is, hospitals, office buildings, etc.).

We also proposed to require that a PACE center meet the requirements for use of fire alarm systems in accordance with the occupancy section of the LSC that applies to its building. Each occupancy section of the LSC also requires evacuation plans, fire exit drills, and fire procedures, and these will be applicable to the PACE program.

We also proposed to retain § 460.72(b)(2)(i), which permits a PACE center to meet fire and safety requirements imposed by the State in lieu of the 2000 edition of the LSC if we determine that the State code adequately protects patients. We have done this for two reasons: (1) To afford a PACE center the benefit of meeting a State code in lieu of the Federal requirements where the State code offers adequate protection; and (2) because we recognize that PACE centers are often located within buildings containing other providers already subject to this provision. For example, a PACE center may be located within a hospital. If the hospital is exempt from the LSC by virtue of meeting a State code, other participating providers within the same building should also be afforded this exemption.

Further, in some buildings it may be impractical or impossible to provide a specific feature due to the construction of the building. Therefore, we proposed to retain § 460.72(b)(2)(ii), which allows for the waiver of specific provisions of the 2000 edition of the LSC that, if rigidly applied, would result in unreasonable hardship on the organization. We may waive specific provisions only if the waiver does not adversely affect the health and safety of the patients and staff.

5. Conditions of Participation For Hospitals: 42 CFR 482.41 Condition of participation: Physical environment.

In the October 2001 proposed rule, we proposed only the changes to this section described in sections II.A and II.B of this preamble, for the reasons described therein.

6. Long-Term Care Facilities: 42 CFR 483.70 Condition of participation: Physical environment.

As with hospices, we proposed not to adopt chapter 18-section 3.4.5.3 of the 2000 edition of the LSC for LTC facilities such as SNFs. This section requires new nursing homes to have corridor smoke detection systems. We believe there is no technical justification for this new requirement because the 2000 edition of the LSC requires that new construction patient sleeping zones be provided with quick-response sprinklers. We believe that quick-response sprinklers activate quickly enough to serve a detection function, thus making corridor smoke detection unnecessary. The 1991, 1994, and 1997 editions of the LSC required quick-response sprinklers in new nursing homes, but did not require smoke detection. Therefore, we do not see any technical reason to require smoke detection in new facilities and thus increase the cost of new construction without a parallel increase in safety.

7. Intermediate Care Facilities for the Mentally Retarded: 42 CFR 483.470 Condition of participation: Physical environment.

In the October 2001 proposed rule, we proposed to retain most of the provisions of the existing regulation for ICFs/MR. ICFs/MR will continue to be permitted to meet either the Residential Board and Care Occupancies chapter or the Health Care Occupancy chapter of the 2000 edition of the LSC, as appropriate.

We also proposed to retain the provision in § 483.470(j)(1)(ii) that allows the State survey agency to apply different chapters of the LSC to different buildings or parts of buildings so as not to place an undue burden on providers to have an entire building comply with the more stringent provisions of the Health Care chapter when they could instead meet the Board and Care for part of their facility, when appropriate.

We also proposed that, for ICFs/MR under Board and Care, the Evacuation Difficulty Index (EDI) must be determined by use of the Fire Safety Evaluation System for Board and Care Facilities (FSES/BC). In referring to the EDI, we proposed to remove the reference to Appendix F in § 483.470(j)(1)(iii). The FSES/BC is no longer an appendix of the LSC, but appears as its own NFPA document in the NFPA 101A Guide on Alternative Approaches to Life Safety. Additionally, we proposed to remove the reference to facilities of 16 beds or less from § 483.470(j)(1)(iii) to clarify that a larger facility could be subject to the Board and Care Chapter, and that its EDI would have to be calculated based on the FSES/BC. Again, this provision would allow certain ICFs/MR to meet the less restrictive Board and Care Chapter rather than the health care chapter.

In § 483.470(j)(2)(ii), we proposed to change “the Secretary” to “CMS” to more accurately reflect the statutory authority (this provision currently appears in § 483.470(j)(2)(i)(B)).

We also proposed in § 483.470(j)(3) that waivers of specific provisions of the 2000 edition of the LSC apply only to facilities that meet the LSC definition of a Health Care occupancy. There are no waivers for facilities under Board and Care, since the FSES/BC affords the flexibility of alternative arrangements for compliance.

We received approximately 160 timely public comments in response to the October 26, 2001 proposed rule. We received letters from State government officials, county government organizations, health care providers and provider organizations, and private citizens. We reviewed each comment and grouped like or related comments. The comments and our responses are summarized below.

Comment: The majority of commenters expressed support of our adoption of the 2000 edition of the National Fire Protection Association (NFPA) Life Safety Code (LSC).

Response: We appreciate the support. Our current regulations allow health care providers to meet different editions of the LSC (that is, providers may meet the 1967, 1973 and 1985 editions of the LSC). These earlier editions are outdated and create confusion in the industry. The updated LSC includes new provisions vital to the health and safety of all our beneficiaries. This rule is intended to ensure that beneficiaries continue to experience the highest degree of fire safety possible.

Comment: Several commenters, while supporting the adoption of the LSC, urged us to adopt the LSC as written, with no exceptions. The commenters argued that by allowing exceptions to the NFPA LSC, we are violating the National Technology Transfer and Advancement Act (Pub. L. 104-113).

Response: Section 12 of the National Technology Transfer and Advancement Act of 1995 (Pub. L. 104-113) codified an existing Office of Management and Budget (OMB) circular (OMB Circular A-119). Section 12 directs Federal agencies to use, to the extent not inconsistent with applicable law or otherwise impractical, technical standards that are developed or adopted by voluntary consensus standards organizations.

The National Technology Transfer and Advancement Act does not mandate that we use an entire code without exceptions if we determine it is impractical. We did not adopt the entire LSC as written because through our surveys, comments, and experience, we have determined that for the health and safety of patients and staff we could not adopt the LSC in its entirety.

We have “carved-out” two provisions from the LSC. These provisions are: (1) Roller latches; and (2) ambulatory facilities serving under four patients.

We are not allowing any exceptions for roller latches because roller latches are one of our top three deficiencies for life safety. Roller latches that are not properly maintained may be a danger to the health and safety of patients and staff. We have found through our OSCAR data report that doors that include roller latches are consistently one of our most cited deficiencies. In fact, in skilled nursing facilities, roller latches in corridor doors are consistently the number one cited deficiency under our life safety requirements.

We also define all ambulatory facilities as surgery centers regardless of the number of patients they serve. Under § 416.44, ASCs are required to maintain a fully equipped operating room for the types of surgery the ASC conducts for the surgery to be performed in a manner that protects the lives and ensures the physical safety of all individuals in the area. It is imperative that these facilities provide the protection of the Ambulatory Health Care chapter (chapters 20 and 21) rather than the Business Occupancy chapter of the 2000 edition of the LSC that pertains to physician offices or clinics because surgery is being performed in these facilities.

Comment: Several commenters opposed the October 2001 proposed rule's carve-out of the roller latch exception provision in the LSC (chapter 19-3.6.3.2 (exception No. 2)). The commenters claimed there is no evidence supporting our carve-out of the roller latch exception.

Response: As described above, roller latches that are not properly maintained may be a danger to the health and safety of patients and staff and are consistently one of our most cited deficiencies.

One of the most tragic examples of roller latch failure occurred in the fall of 1989 where a fire claimed 12 lives in a nursing home. In all the rooms where the door was closed and remained closed through out the fire, the patients lived. In the rooms where the door was open or originally closed but bounced open, the patients died. During our investigation, we tested the doors on the floor above the fire origin. We discovered the majority of the doors tested failed to stay closed because of the roller latches. In fact, as a result of the failure of the roller latches in this facility, the 1991 edition of the NFPA LSC prohibited the use of roller latches in new buildings.

Therefore, in this final rule, we are prohibiting the use of roller latches in existing and new buildings except for ASCs under Chapter 20 and Chapter 21. We understand the burden that may be caused to replace all existing roller latches and will phase-in this requirement over a 3-year period beginning March 11, 2003.

Comment: Many commenters supported the proposed rule's carve-out of the roller latch exception in the LSC (chapter 19-3.6.3.2).

Response: We appreciate the support. We believe, as discussed in our response to the previous comment, that prohibiting use of roller latches will allow patients and staff to experience the highest degree of fire safety possible.

Comment: Several commenters opposed the proposed exception to delete the smoke detector requirement for hospices and nursing facilities. Many believed smoke detectors are an inexpensive requirement for new facilities that provides an extra layer of protection.

Response: We agree with these comments and have changed the regulations text to no longer exempt new nursing homes or inpatient hospices from Chapter 18-3.4.5.3 of the LSC. Please note that this requirement does not apply to existing facilities, but only to new nursing homes or inpatient hospices.

Comment: In the October 2001 proposed rule, we solicited comments on whether to adopt chapter 5, the performance based option of the LSC. Most of the comments we received specifically on chapter 5, the performance based option, stated that they had little experience with this option.

The performance based design option in chapter 5 of the LSC translates fire safety goals into performance objectives and performance criteria. Performance based design establishes broad goals and objectives with a team effort. The performance based design is applied to make the building safe as well as functional. The design is specific to the building. Computer fire models and other calculation methods are used in combination with the building design specifications, specified fire scenarios and assumptions to calculate the overall performance criteria and whether it meets the fire life safety goals and is in compliance with the intent of the code.

Response: We have decided to include chapter 5, the performance based option provision. We do not expect many providers to choose this option. However, we would like all providers to have the alternative to use the performance based option if the provider believes it would be beneficial for it to comply with the LSC.

Please note that the final rule will also continue to allow two other options besides the prescriptive requirements of the LSC. Health care facilities may choose the FSES, and a facility may apply for a waiver of specific provision of the LSC if it is unable to meet a specific requirement. We may grant a waiver for a specific LSC requirement if (1) we determine that the waiver would not adversely affect patient and staff health and safety; and (2) we determine that it would impose an unreasonable hardship on the facility to meet a specific LSC requirement. A provider may request a waiver from its State agency. The State agency will review the request and make a recommendation to our appropriate regional office. Our regional office will review the waiver request and the State agency's recommendation and make a final decision on the waiver request. We cannot grant a waiver if patient safety is compromised in any way.

Comment: One commenter opposes the LSC because it would preempt State or local decision-making authority and create an unfunded mandate.

Response: If a State or local authority would rather use its State fire and safety code, this is an allowable option as long as the State fire and safety code is imposed by State law and adequately protects the life and safety of the patients. To request this option, the State must forward the request to its CMS regional office. The CMS regional office will forward the request to the CMS central office where a final determination will be made as to whether the State fire and safety code may be used in place of the NFPA LSC.

We also have retained our authority to waive provisions of the LSC, on a case-by-case basis. We may grant a waiver for a specific LSC requirement if we determine that the waiver would not adversely affect the patient or staff health and safety and it would impose an unreasonable hardship on the facility to meet a specific LSC requirement. If a health care facility would like a waiver for a specific provision in the LSC, the facility must forward the request to their State survey agency. The State agency will review the request, make a recommendation and forward the request to the appropriate CMS regional office. The CMS regional office will review the State agency's recommendation and make a final decision.

Comment: Several commenters requested that the October 2001 proposed rule be revised to allow health care facilities to choose other codes that are nationally recognized, such as the International Building Code and International Fire Code. Referencing only the NFPA's LSC in the final rule creates conflict for many jurisdictions that enforce other equivalent or more stringent fire and life safety requirements. By not referencing other applicable codes, CMS favors one code to the detriment of other codes.

Response: We continue to specifically cite the LSC because under sections 1819(d)(2)(B) and 1919(d)(2)(B) of the Act, nursing homes must meet the provisions of “such edition (as specified by the Secretary in regulation) of the Life Safety Code of the National Fire Protection Association * * *.” To avoid confusion and to be consistent for all provider types we require the LSC for all inpatient facilities. This is especially applicable for facilities with mixed occupancies. For example, a health care facility's west wing could be a nursing home while the rest of the facility is a hospital. It would be impractical as well as burdensome for the facility to follow the LSC for the nursing home and another health and safety code for the hospital. The regulation reflects this by requiring a single code for all inpatient health care facilities.

However, if a State's own fire and safety code would “adequately protect patients” and the State code is imposed by State law, the State may submit a request in writing to its CMS regional office. The CMS regional office will forward the request to the CMS central office. The CMS central office will make a final decision on whether the State code may be used in place of the NFPA LSC.

Comment: Several commenters support CMS's authority to “accept a State's fire and safety code instead of the LSC if the State's fire and safety code adequately protects patients.” However, these same commenters stated that the CMS must have a system in place to evaluate any State code to determine that the requirement provides adequate protection for patients and staff.

Response: We appreciate the support for accepting State fire and safety codes in addition to the LSC. If a State chooses to use its fire and safety code rather than the LSC, it must be imposed by State law and adequately protect patients and staff. Any State that chooses this option should send the request to its CMS regional office. The regional office will forward the request to the CMS central office. The central office will make the final determination and respond in writing as to whether the State fire and safety code adequately protects patients and staff.

Comment: Some commenters believe that we should allow grandfathering for Ambulatory Surgical Centers (ASCs) that meet previous editions of the LSC. Some commenters stated that, at the very least, we should permit ASCs to postpone compliance with the 2000 edition of the LSC until the ASC undertakes a major renovation. The commenters stated that compliance with the 2000 edition of the LSC, especially for smaller ASCs would impose a financial burden. One commenter asked us to phase-in the requirements because it would be a financial hardship for most ASCs to comply with the 2000 edition of the LSC. The commenter suggested that we consider a couple of approaches for phasing in the 2000 edition of the LSC. For ASCs already Medicare-certified, the 2000 edition of the LSC would only need to be met if the ASC underwent a major renovation, or we could implement a timeline for full compliance to the 2000 edition of the LSC (for example, 5 years).

Response: It is not our intent to impose a retroactive requirement for ASCs. For existing ASCs, most provisions in the 2000 edition of the LSC are similar to past editions. Furthermore, existing facilities in compliance with early editions of the LSC are not required to upgrade to a later edition of the LSC for certain provisions. For example, an existing ASC is not required to upgrade its Type I Essential Electrical System (EES). Chapter 21-2.9.2 references NFPA 99, Standard for Health Care Facilities. This provision states that ASCs “shall be provided with an EES in accordance with NFPA 99, Standard for Health Care Facilities.” Under NFPA 99 existing ASCs are able to continue to use existing electrical and medical gas systems that are in compliance with the earlier editions of the LSC provided the ASC continues to meet the edition of the LSC requirements when it was constructed. The referencing to the NFPA 99 for certain provisions (that is, EES, and medical gas) should relieve some burden for ASCs.

In addition, an ASC may also request a waiver for a specific provision of the LSC further reducing the exposure to additional cost and burden for ASCs with unique situations that can justify the application of waivers and will not endanger the health and safety of patients. A waiver may be granted for a specific LSC requirement if (1) we determine that the waiver would not adversely affect patient and staff health and safety; and (2) we determine that it would impose an unreasonable hardship on the facility to meet a specific LSC requirement. All waivers are determined on a case-by-case basis. An ASC may request a waiver from its State Agency. The State Agency will review the request and make a recommendation to the appropriate CMS regional office. The CMS regional office will review the waiver request and the State agency's recommendation and make a final decision on the waiver request. A waiver cannot be granted if patient safety is compromised in any way.

Comment: A few commenters objected to the requirements in the 2000 edition of the LSC that ASCs must have a Type I Essential System (EES) and upgrade their medical gas capabilities. Most of the ASCs, especially smaller ASCs, do not have a Type I EES or meet the medical gas requirement in the 2000 edition of the LSC. The commenters stated that the change to a Type I EES and to upgrade their medical gas capabilities will be a financial hardship on the ASCs.

Response: Only new facilities will be required to have a Type I EES or upgrade its medical gas capabilities. Existing ASC facilities in compliance with early editions of the LSC for EES and medical gas requirements are not required to upgrade to the 2000 edition of the LSC. Per chapter 21-2.9.2 and chapter 21-3.2.2, an ASC facility shall be in compliance with “NFPA 99, Standard for Health Care Facilities.” Under NFPA 99 existing ASCs may continue to use existing electrical and medical gas systems that are in compliance with earlier editions of the LSC provided the ASC continues to meet the earlier edition of the LSC requirements when it was constructed. If the ASC fails to meet the earlier LSC requirements, the ASC must upgrade to the 2000 edition of the LSC. An ASC must also meet the 2000 edition of the LSC if its EES or medical gas system undergo alteration, modernization, or renovation.

Comment: Three commenters requested that ASCs be exempt from the fire-rated wall standards in Chapter 19-3.6.1 and the vertical opening standard in Chapter 19-3.1 of the 2000 edition of the LSC. The commenters explained that ASCs would be unable to comply with these requirements because most ASCs do not control spaces outside of their leased area.

Response: The commenters may have misunderstood which chapters apply to ASCs. Chapters 20 and 21 apply to ASCs, not chapter 19. This confusion may have been caused because we improperly cited chapter 19 in the ASC regulatory text. We deleted all chapter 19 provisions in the ASC regulatory text. Chapter 19 only applies to existing Health Care Facilities (for example, hospitals, nursing homes, etc.). Chapter 21 applies to existing ASCs. The related sections of chapter 21 are not significantly different than what existing ASCs are required to meet currently. For example, building construction type, vertical opening requirements and, fire alarm requirements have not changed from earlier editions of the life safety code.

Comment: Several commenters believed that ASCs should only be classified as Ambulatory Health Care Centers if they serve four or more patients who are rendered incapable of self-preservation. If there are less than four patients, we should not subject the ASC to more stringent requirements when the risk is not severe enough to warrant those restrictions and should be classified under the less stringent Business Occupancy chapter of the 2000 edition of the LSC.

Response: Ambulatory facilities are surgery centers regardless of the number of patients they serve. Under § 416.44, ASCs are required to maintain a fully equipped operating room for the types of surgery the ASC conducts in order for the surgery to be performed in a manner that protects the lives and ensures the physical safety of all individuals in the area. It is imperative that these facilities provide the protection of the Ambulatory Health Care Chapters (chapters 20 and 21) rather than the Business Occupancy chapter of the 2000 edition of the LSC that generally pertains to physician offices or clinics because surgery is being performed.

Comment: Several commenters asked why Critical Access Hospitals (CAHs) were not included in the October 2001 proposed rule.

Response: We should have included CAHs in the October 2001 proposed rule. We corrected this mistake and added CAHs to the final rule at § 485.623(d). Similar to the other facilities, roller latches under chapter 19-3.6.3.2 (exception No. 2) will not be adopted. Thus, all existing CAHs will no longer be permitted to use roller latches. Through fire investigations, roller latches have proven to be an unreliable door latching mechanism requiring extensive maintenance to operate properly. We realize there is some burden with replacing existing roller latches and will phase in this requirement over a 3-year period beginning March 11, 2003. If a CAH believes that this rule (including the 3-year phase in period for the roller latches) imposes an unreasonable burden, the facility should contact its State Office to request a waiver. The State Agency will review the request for the waiver and make a recommendation to the appropriate CMS regional office. The CMS regional office will review the waiver and the State Agency's recommendation and make a final decision on the waiver request.

Comment: Two commenters asked us to define major and minor renovations to a facility.

Response: The difference between major and minor renovations has to do with the size and cost of the upgrade. Obviously, replacing a door would be a minor renovation, but adding a wing to a hospital would be a major renovation. We understand there may be times when it is difficult to determine if the renovation would qualify as a major renovation. These decisions are made on a case-by-case basis rather than a “one size fits all” requirement. If a facility is unsure if the renovation would be considered major or minor, the facility may call the State survey agency for an evaluation and final decision.

Comment: Some commenters requested that we adopt updated versions of the LSC more quickly in the future. One commenter requested that we adopt any updated version of the LSC within 90 days of the LSC publication.

Response: We agree and would like to revise our regulations to update the LSC in a more timely manner. However, we cannot adopt the LSC within 90 days of the LSC publication because under the Administrative Procedure Act (APA), we must give notice to the public that we are proposing to revise a regulation. Once we notify the public of the proposal, the public must have the opportunity to comment on the revisions, and we must answer the comments before the update becomes final and binding.

Comment: Some commenters asked when all health care facilities must be in compliance with this final rule.

Response: The final rule is effective 60 days after publication. However, to relieve some burden for providers, we are delaying enforcement of the 2000 edition of the LSC for six months until September 11, 2003. In addition, as stated earlier, because of the burden that may be imposed by the requirement to replace all existing roller latches we will phase in this requirement over a 3-year period beginning on March 11, 2003. We will also phase in the emergency lighting requirement (19.2.9) over a 3-year period beginning on March 11, 2003. We have revised the regulations text to reflect the phase-in period.

Comment: Several commenters stated that our “carve-out” of the roller latch exception would be a cost burden.

Response: Roller latches are one of our top three deficiencies and, based on prior incidents, we are concerned about the possible threats to patient safety. We believe that, in the interest of patient and staff safety, all roller latches must be removed. To help alleviate some of the burden to health care facilities, we will phase in this requirement over 3 years.

Comment: A couple of commenters questioned our cost estimates. The commenters stated that our reliance on the AHCA report only applied to nursing homes and the estimates were outdated.

Response: We agree and we reviewed our cost estimates and revised the cost impact for the final rule. All of the revised cost estimates were gathered using OSCAR data as well as figures sent as comments to the October 2001 proposed rule. The revision of our estimates reflects a significant decrease in the number of facilities using the 1985 edition of the LSC. Many of the older facilities that were originally included in our estimate have upgraded their facility using a more recent edition of the LSC rather than the 1985 edition. The total cost impact we originally estimated has changed because many of the items that need to be updated have already been done because older facilities have been phased out or upgraded. Therefore, the number of facilities we originally determined had to make upgrades has decreased.

We phased in two requirements of the LSC over a 3-year period. The requirements are: Emergency lighting (that is, 19.2.9) and replacing all roller latches (that is, 19.3.6.3.2). We phased in the emergency lighting requirement because it is standard practice to routinely replace emergency lighting system batteries every 3 years. Therefore, our decision to phase in the emergency lighting requirement over 3 years is to match providers' current cycle of replacing the batteries in their emergency lighting systems. We believe by phasing in this requirement, we will not adversely affect the health and safety of the patients or staff.

We also phased in over 3 years our requirement that all providers must replace roller latches. In the October 2001 proposed rule, we did not propose to phase in roller latches because we believed that it was an important issue of ensuring fire safety for patients and staff. However, we received a large number of comments regarding the amount of time and the cost required to replace the roller latches. While we still believe that replacing roller latches is an important fire safety issue, we realize we have to balance the burden to providers with the impact this change will have. To alleviate some of the burden of the roller latch requirement, we are phasing in the requirement over 3 years. During this 3-year phase in period, we will continue to monitor, through our existing survey process, a facility's maintenance of its existing roller latches to ensure that they are maintained and operating properly. We believe that this will help ensure fire safety for patients and staff.

We did not phase in any other of the LSC requirements because we believe updating the other requirements is an important safeguard for ensuring fire safety to all patients and staff of each facility.

Below we outlined all the major changes a health care facility would have to undergo if the health care facility has not upgraded its facility since meeting earlier editions of the LSC. As in the October 26, 2001 proposed rule, below we have provided the LSC citation, a description of the requirement, an explanation of why we believe it is critical to the safety of patients to require it, and a brief discussion of our analysis of the burden imposed by the requirement. The following are new provisions in the 2000 edition of the LSC from chapter 19, “Existing Health Care Occupancies.”

Please note that we did not include chapter 19, section 1.1.4.5 (Renovations, Alterations, and Modernization) in our total estimate. This provision is not a requirement of the final rule. This provision only applies if a health care facility chooses to extensively renovate its facility or build a new facility. Existing facilities that are extensively renovated must meet the requirements of a newly constructed facility, including the installation of sprinkler systems in nonsprinklered buildings. The Fire Analysis & Research Division of the NFPA has shown that sprinklers have been the most important life safety system installed in health care facilities. The LSC generally requires sprinkler systems in renovations, regardless of construction techniques or materials used in constructing the facility. The estimated cost of installing sprinkler systems in buildings that presently do not have them is $2.50 per square foot, or approximately $125,000 for a 50,000 square foot building. This requirement is not imposed on existing facilities. In the proposed rule we stated there were 255 facilities that do not have sprinkler systems. This was a typographical error. There are approximately 2,550 facilities that do not currently have sprinkler systems. Again, none of these facilities are required to install sprinkler systems under this final rule.

(1) 19.2.9—Emergency Lighting—This provision requires emergency lighting for a period of 1 1/2 hours in health care facilities, enabling those inside to move about safely in an emergency. We proposed to phase-in this requirement over a 3-year period, to allow for the normal replacement cycle of batteries used in emergency lighting systems. We believe this phase in period would not adversely impact the health and safety of the patient. In the October 2001 proposed rule, we estimated that 790 existing facilities do not have emergency lighting for 1 1/2 hours. Approximately 12 emergency light units would be needed for each facility. We estimated that the cost to be in compliance with this provision was $7,200 per facility. In the proposed rule we estimated that the total cost for all facilities to be upgraded under this provision would be $5,452,150.

Approximately 642 existing facilities do not have emergency lighting for 1 1/2 hours. We estimate each facility would need approximately 12 emergency light units at a cost of $750 per light. We estimate it will cost each facility $9,000 to upgrade its emergency lighting. The total amount to implement this requirement for all facilities will be $1,926,000 for the first year. Because we are phasing in this requirement over 3 years, we estimate that it will be approximately $1,926,000 for each of the next 2 years.

(2) 19.3.1—Protection of Vertical Openings—Unprotected vertical openings (for example, open stairwells) permit fire, smoke, and toxic gases to spread from one level to another in a building, making evacuation difficult, if not impossible. In the October 2001 proposed rule, we estimated that to upgrade the vertical openings would be $2,938 per vertical opening. We estimated that 9,877 vertical openings in 1,976 facilities needed to be upgraded for a total cost of $29,018,626 or an average of $14,690 per facility.

We revised this figure estimating that 5,573 vertical openings in 1,115 facilities would be affected because many facilities have already upgraded their buildings to meet this requirement. Each vertical opening costs approximately $3,819. We estimate the facilities that need to be upgraded will need to install an average of five vertical openings. The total estimated cost is $21,283,687 for all facilities to be upgraded or an average of $19,095 per facility.

(3) 19.3.4.3.2—Emergency Forces Notification—This provision requires the fire alarm system to provide automatic notification of a fire to emergency forces. This is of great importance to the protection of all patients. Any delay in the notification of fire or rescue personnel could adversely impact the health and safety of patients and expose them to a fire, smoke, or toxic gases created by the fire. In the October 2001 proposed rule, we estimated that approximately 2,750 buildings at $900 per facility would need to be connected to a fire alarm retransmission system for a total estimated cost of $2,475,000.

We revised our cost estimates because the October 2001 proposed rule was incorrect. The proposed rule estimate did not account for installation. The one time cost to install a fire department or central monitoring station connection is $1,707 per facility. In addition, we estimate that there is a $97.50 monthly fee for the monitoring stations and telephone costs.

We determined that 2,358 buildings at $2,877 (installation fee + monthly fee for one year) per facility would need to be connected to a fire alarm retransmission system. We estimate that to be in compliance with this provision the total cost is approximately $6,783,966.

(4) 19.3.6.1—Corridors—This provision requires that all areas in nonsprinklered buildings must be separated from the corridor by corridor walls that are fire-rated. This requirement, which provides a protected passageway for movement during an emergency, is necessary to increase the safety of the patients. In the October 2001 proposed rule, we estimated that the cost to upgrade a facility to meet this requirement was $7,124 for 1,976 buildings that currently meet the 1967 LSC and approximately $5,735 for 46 buildings meeting the 1973 LSC.

We revised the proposed rule estimates and approximately 1,606 buildings currently meet the 1967 LSC and will need to be upgraded. We estimate that to upgrade facilities that currently meet the 1967 LSC is $14,871,560 or approximately $9,260 per facility.

We also calculated that 39 buildings currently meet the 1973 LSC. The estimated cost to upgrade the 39 buildings is $290,745, approximately $7,455 per facility.

The revised total cost estimate for all facilities to meet this requirement is $15,162,305.

(5) 19.7.5.2 & 19.7.5.3—Upholstered Furniture—These provisions allow patient-owned furniture to be brought into the facility without meeting the requirements of 10.3.2(2) and 10.3.3 (regarding fire resistant furniture) if a single station smoke detector is placed in the sleeping room where the furniture is located. This gives the facility a more home-like atmosphere. In the October 2001 proposed rule, we estimated that 18,498 smoke detectors would need to be installed at approximately $100 per smoke detector. We estimated in the proposed rule that the total cost to be in compliance with this provision was $1,849,800.

We revised this cost estimate because we believe 19,262 smoke detectors need to be installed rather than the 18,498 we estimated in the October 2001 proposed rule. We did not change our estimate of the cost of the smoke detector (that is, $100 per smoke detector). The total amount to be in compliance with this provision is $1,926,200.

(6) 19.3.6.3.2—Roller Latches—We “carved out” the exception the LSC allowed for roller latches in existing buildings. In the October 2001 proposed rule we estimated the total cost for all facilities to remove exiting roller latches was $30,754,540 ($190 per door for 161,866).

We revised the estimate and 190,303 roller latches must be replaced at a cost of $250 per roller latch, for a total cost estimate of $47,575,750. We are phasing in this requirement over 3 years. Thus, we estimate that it will cost $15,858,583 for the first year and $15,858,583 for each of the next 2 years.

In the October 2001 proposed rule, we proposed to retain our existing authority to waive provisions of the 2000 edition of the LSC, on a case-by-case basis, further reducing the exposure to additional cost and burden for facilities with unique situations that can justify the application of waivers, which we determine will not endanger the health and safety of patients.

We proposed to retain our authority to apply the FSES as an alternative approach to meeting the requirements of the LSC, as well as accept alternative State fire and safety codes discussed in section I.B in the October 2001 proposed rule.

For the most part, this final rule adopts the provisions of the October 26, 2001 proposed rule. Those provisions of this final rule that differ from the October 2001 proposed rule follow. In response to comments, we are revising § 485.623(d) to require all critical access hospitals (CAHs) to meet the applicable provisions of the 2000 edition of the LSC. The provision of the adopted 2000 edition of the LSC that does not apply to a CAH is chapter 19, “Existing Health Care Occupancies,” section 19.3.6.3.2 (exception No. 2), roller latches.

We deleted the reference to chapter 19 (that is, 19.3.6.3.2) under the ASC regulatory text because it was improperly cited for ASCs. We cited chapter 19.3.6.3.2 because all roller latches must be replaced in existing health care occupancies. However, Chapter 19 does not apply to ASCs. ASCs are under chapter 20 (that is, new ASCs) and chapter 21 (that is, existing ASCs).

We also decided to include chapter 5, the performance based option provision. We do not expect many providers to choose this option. However, we would like all providers to have the alternative to use the performance based option if the provider believes it would be useful for it to comply with the LSC. In addition, we have provided for a 3-year phase in period for the requirements regarding roller latches and emergency lighting.

The final rule will continue to allow other options besides the prescriptive requirements of the LSC. Health care facilities may choose the FSES, and a facility may apply for a waiver of a specific provision of the LSC if it is unable to meet a specific requirement. We may grant a waiver for a specific LSC requirement if (1) we determine that the waiver would not adversely affect patient and staff health and safety; and (2) we determine that it would impose an unreasonable hardship on the facility to meet a specific LSC requirement. A provider may request a waiver from its State agency. The State agency will review the request and make a recommendation to the appropriate CMS regional office. The CMS regional office will review the waiver request and the State agency's recommendation and make a final decision on the waiver request. We cannot grant a waiver if patient safety is compromised in any way.

A State may also choose to use its fire and safety code rather than the LSC if the State fire and safety code is imposed by State law and adequately protect patients. Any State that chooses this option must send the request to its CMS regional office. The regional office will forward the request to the CMS central office. The central office will make the final determination and respond in writing as to whether the State fire and safety code adequately protects patients and staff. Lastly, we no longer exempt new nursing homes or new hospices providing inpatient care from chapter 18.3.4.5.3 of the LSC. Several commenters opposed the proposed exception to remove the smoke detector requirement for hospices and nursing facilities. Many commenters believe smoke detectors are an inexpensive requirement for new facilities and they provide an extra layer of protection. We agree and removed the exception from the regulations text in hospices at § 418.100(d) and nursing facilities at § 483.70(a).

This rule does not impose any information collection and record keeping requirements that are subject to review by the Office of Management and Budget under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

This final rule adopts the 2000 edition of the LSC. The objective is to provide safety to life during fires and other emergencies. Adoption and use of the 2000 edition of the LSC will bring us up-to-date in requiring the latest and best technology in fire protection for our beneficiaries. These requirements are designed to protect all patients and staff. The 2000 edition of the LSC also protects property and can reduce the dollar loss associated with a fire. For example, the 2000 edition of the LSC requires that any new construction install quick-response sprinkler systems increasing the level of protection to our beneficiaries. Adopting the 2000 edition of the LSC and removing references to all older editions of the LSC will eliminate confusion as to which edition a health care facility must follow. This is particularly important when a facility has multiple buildings constructed at differing times or a single building with multiple wings or additions constructed at different times. Instead of each building complying with different editions of the LSC, this final rule requires all the buildings to comply with the same edition of the LSC. The use of a single edition of the code should also contribute to lowering the cost of complying with the requirements for testing and maintenance of fire protection systems.

We have examined the impacts of this final rule as required by Executive Order 12866 (September 1993, Regulatory Planning and Review) and the Regulatory Flexibility Act (RFA) (September 16, 1980 Pub. L. 96-354), section 1102(b) of the Social Security Act, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) and Executive Order 13132. Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year).

We have examined the impact of this final rule and we have determined that this rule is neither expected to meet the criteria to be considered economically significant, nor do we believe it will meet the criteria for a major rule. All entities affected by this rule are considered small entities. Therefore, a final regulatory impact analysis is not required for the same reasons explained in section VI.C of this rule.

We revised our estimate of the regulatory impact of this final rule from $96,356,599 to $63 million for the first year and $17.5 million for each of the next 2 years. The estimate appears lower than the estimate in the October 2001 proposed rule because unlike the October 2001 proposed rule, we are phasing in the requirement to replace all existing roller latches over 3 years. Thus, the cost estimate to replace the roller latches is reduced from approximately $48 million for the first year to approximately $16 million per year for 3 years. For a detailed description of our estimates for each provider, section II.C of this final rule outlines our cost estimates in the 2001 proposed rule, and section III.H of this final rule outlines our revised cost estimates for this rule as well as why we revised the estimates.

The RFA requires agencies to analyze options for regulatory relief of small businesses. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and government agencies. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of $6 to $29 million in any one year (for details, see the Small Business Administration's regulation that sets forth size standards for health care industries at 65 FR 69432). For purposes of the RFA, all health care facilities affected by this regulation are considered to be small entities. Individuals and States are not included in the definition of a small entity.

In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside a Metropolitan Statistical Area and has fewer than 100 beds.

Based on the Small Business Administration (SBA) and CMS data (these data can be found in the April 2002 CMS Statistics Publication No. 03437 or www.cms.hhs.gov ), approximately 4,593 out of 6,650 hospitals are considered to be small businesses or nonprofit hospitals. We do not consider this rule to significantly impact these hospitals because the cost of this rule is less than 1 percent of the total costs for hospitals. According to the CMS 2002 national expenditure data, the total national costs for hospitals in 2002 was $412.1 billion. We estimate this rule will cost hospitals, including CAHs, approximately $8,263,848 for the first year and $4,131,924 for each of the next 2 years due to the phase in of emergency lighting and the replacement of all roller latches.

Based on the SBA and CMS data, approximately 3,064 out of 3,474 ASCs are considered to be small businesses or nonprofit providers. However, we do not consider this rule to significantly impact the ASCs because the cost of this rule is less than 1 percent of the total costs for ASCs. According to the CMS 2002 national expenditure data, the total national cost for ASCs in 2002 was $286.4 billion. We estimate that it will cost ASCs approximately $2,511,667 for the first year and $1,255,833 for each of the next 2 years due to the phase in of emergency lighting and the replacement of all roller latches.

Based on the SBA and CMS data, approximately 17,901 out of 23,500 LTC providers, inpatient hospices, and ICF/MR facilities are considered to be small businesses or nonprofit providers. We do not consider this rule to significantly impact the LTC providers, inpatient hospices, or ICF/MR facilities because the cost of this rule is less than 1 percent of the total costs for these providers. According to the CMS 2002 national expenditure data, the total national costs for LTC providers, inpatient hospices, and ICF/MR facilities in 2002 were $89.3 billion. Our cost estimate for compliance with this rule for LTC providers, inpatient hospices, and ICF/MR facilities is approximately $59,195,736 for the first year and $5,788,375 for each of the next 2 years due to the phase in of emergency lighting and the replacement of all roller latches. We combined the estimates of LTC facilities, inpatient hospices, and ICF/MR facilities because of the similarities in how the provider types are surveyed for compliance with the LSC and the items that must be upgraded to meet the 2000 edition of the LSC. In addition, most ICF/MR facilities will not be impacted by this rule because the majority of these facilities are fairly new and are considered a residential occupancy rather than the more stringent health care occupancy type. However, there are ICF/MR facilities that care for the more severely impaired. These ICF/MR facilities are similar to an LTC facility and will be impacted by the 2000 edition of the LSC.

Lastly, we do not believe this rule will affect PACE centers or RNHCI facilities because PACE and RNHCI are new programs and they already meet the 1997 edition of the LSC. The changes from the 1997 edition of the LSC to the 2000 edition of the LSC are negligible. For example, PACE centers and RNHCI facilities have 1.5-hour emergency lighting, no vertical opening problems, and do not have any roller latches. Moreover, because both of these providers are new programs, the SBA does not have an estimate as to how many are considered small businesses. We consider all RNHCIs to be nonprofit entities.

Please note we also provided a cost estimate for each of the provisions with respect to which we believe that each facility will need to upgrade to be in compliance with this final rule in section III.H.

The cost estimate does not take into account any waivers that may be granted. We will retain the existing authority to waive specific provisions of the 2000 edition of the LSC, further reducing the exposure to additional cost and burden for facilities with unique situations that can justify the application of waivers, and that we determine will not endanger the health and safety of patients.

The cost estimate does not factor in any cost reduction if we accept a State's fire and safety code instead of the NFPA's 2000 edition of the LSC. We have the authority to accept a State fire and safety code in lieu of the NFPA LSC if the State code is imposed by State law, and adequately protects patients.

We also note that the 2000 LSC permits the use of the FSES as an alternative approach that may also reduce the cost of compliance significantly. The FSES is an equivalency system. The FSES may allow a facility to comply with the LSC without having to make changes to the facility due to other offsetting or compensating fire protection features that exist in the facility.

We do not know the amount that any of the above waivers or alternatives may save a health care facility because each facility must be reviewed on a case-by-case basis to determine whether the facility will be granted a waiver for a specific provision of the LSC or use its State fire and safety code or if the facility chooses to use the FSES.

While we expect a revised edition of the LSC to be published in 2003, we believe it is imperative to publish this final rule, which incorporates the 2000 edition of the LSC in response to the needs of the providers, States, accrediting organizations, and the public for clarity and consistency with the current regulatory and accreditation setting. The 2000 edition of the LSC includes new provisions that we believe are vital to the health and safety of all patients and staff. This final rule is intended to ensure that beneficiaries continue to experience the highest degree of fire safety possible. We believe by adopting the 2000 edition of the LSC now instead of waiting for the release of the 2003 edition will (1) minimize the burden on health care providers because the standards we currently require most of the providers to follow are at least 15-years old and (2) increase the level of safety for patients and staff. Once the NFPA adopts the 2003 edition of the LSC, we will quickly begin the process of reviewing the revised edition with the intent to publish a proposed rule to set forth requirements we think would be beneficial to the providers, States, accrediting organizations, and the public. Providers, States, accrediting organizations, and the public are requesting that we publish this rule now rather than wait because many of the providers can only comply with our regulations by using older fire safety techniques.

Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule that may result in expenditure in any 1 year by State, local, or tribal governments, in the aggregate, or by the private sector, of $110 million. This rule will not have an effect on the governments mentioned, and the private sector costs will not be greater than the $110 million threshold. We discuss specific private sector costs in section VI.C of this rule.

Executive Order 13132 establishes requirements that an agency must meet when it publishes a final rule that imposes substantial direct requirement costs on State, local, or tribal governments, preempts State law, or otherwise has Federalism implications.

We have examined this final rule and have determined that this rule will not have a substantial effect on State, local, or tribal governments.

While all health care facilities are affected by this regulation, most health care facilities will be affected minimally. Most changes that would occur would be minor and should not adversely impact patients. Each new edition of the LSC builds on prior editions; changes from one edition to the next have been relatively minor since 1985. Many health care providers have updated their facilities since 1985 and already meet most of the provisions in the 2000 edition of the LSC. In fact, most health care providers stated that they are exposed to additional work and expense without any gain in fire safety by continuing to abide by the 1985 edition of the Life Safety Code. For example, the JCAHO requires all its accredited facilities to meet the 1997 edition of the LSC, while Medicare requires all facilities to meet an earlier edition of the LSC. This has caused confusion, as well as additional burden to the health care facility in requesting waivers or changing some of the renovations to meet both editions of the LSC. Updating the LSC will not only relieve burden for health care providers but also assist in ensuring the health and safety of patients and staff.

By adopting the 2000 edition of the LSC, we will eliminate confusion as to which edition a health care facility must follow. The use of a single edition of the code should also contribute to lowering the cost of complying with the requirements for testing and maintenance of fire protection systems under multiple editions of the LSC.

This rule will affect hospitals, LTC facilities, ICFs/MR, ASCs, hospices that provide inpatient services, RNHCIs, CAHs, and PACE Centers.

We do not expect this regulation to affect any other providers.

If facilities decide to use the performance-based option to meet the requirements of the LSC, we estimate that it could cost approximately $3.5 million in the aggregate for States to survey facility plans using the performance-based option. We estimate that 25 states will be affected by the use of the performance-based option. Our estimate is based on the hiring of one fire protection engineer at an average of $60,000 annual salary and one engineer technician at an average $40,000 annual salary plus minimal travel and training expenses. We expect that we would have to additionally fund the States in order for them to be able to have the expertise to survey any facility using the performance-based option.

The statutory basis for incorporating the NFPA's code for nursing homes is specific authority in the Act at sections 1819(d)(2) and 1919(d)(2). For hospitals, the statutory authority to adopt fire safety provisions is section 1861(e)(9) of the Act. To be consistent and to avoid confusion among health care providers, we incorporated the NFPA's 2000 edition of the LSC for all Medicare inpatient facilities under the Secretary's general rulemaking authority.

Alternatively, we could have chosen not to update the fire safety code. This is not an acceptable alternative because many health care facilities are exposed to additional work and expense without any gain in fire safety by continuing to abide by the 1985 edition of the Life Safety Code. For example, the JCAHO requires all its accredited facilities to meet the 1997 edition of the LSC, while Medicare requires all facilities to meet an earlier edition of the LSC. This has caused confusion, as well as additional burden to the health care facility in requesting waivers or changing some of the renovations to meet both editions of the LSC. Updating the LSC will not only relieve burden for health care providers but also assist in ensuring the health and safety of patients and staff.

Please note that while we incorporate the NFPA's 2000 edition of the LSC, all health care providers have other options besides the prescriptive requirements of the LSC. Health care facilities may choose the Fire Safety Evaluation System (FSES) and a facility may apply for a waiver of a specific provision of the LSC if it is unable to meet a specific requirement. A waiver may be granted for a specific LSC requirement if (1) we determine that the waiver would not adversely affect patient and staff health and safety; and (2) we determine that it would impose an unreasonable hardship on the facility to meet a specific LSC requirement. A provider may request a waiver from its State Agency. The State Agency will review the request and make a recommendation to the appropriate CMS regional office. The CMS regional office will review the waiver request and the State agency's recommendation and make a final decision on the waiver request. A waiver cannot be granted if patient safety is compromised in any way.

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

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

The Migratory Bird Treaty Act of 1918 (Act) (16 U.S.C. 703B-712 and 16 U.S.C. 742 a-j) implements migratory bird treaties between the United States and Great Britain for Canada (1916 and 1996 as amended), Mexico (1936 and 1972 as amended), Japan (1972 and 1974 as amended), and Russia (then the Soviet Union, 1978). These treaties protect certain migratory birds from take, except as permitted under the Act. The Act authorizes the Secretary of the Interior to regulate take of migratory birds in the United States. Under this authority, the Fish and Wildlife Service controls the hunting of migratory game birds through regulations in 50 CFR part 20.

Since the mid-1970s, we have sought to identify shot that is not significantly toxic to migratory birds or other wildlife. Compliance with the use of nontoxic shot has increased over the last few years (Anderson et al. 2000), and we believe that it will continue to increase with the approval and availability of other nontoxic shot types. Currently, steel, bismuth-tin, tungsten-iron, tungsten-polymer, tungsten-matrix, and tungsten-nickel-iron shot are approved as nontoxic.

The purpose of this rule is to approve the use of TINT shot in the tested formulation (65% tungsten, 10.4% iron, 2.8% nickel, and 21.8% tin by weight) for waterfowl and coot hunting. This rule amends 50 CFR 20.21(j), which describes prohibited types of shot for waterfowl and coot hunting, to allow the use of this shot.

On October 12, 2001, we received an application (Tier 1) under 50 CFR 20.134 from ENVIRON-Metal, Inc. for approval of HEVI-SHOT TM brand of Soft Shot in a 65% tungsten, 10.4% iron, 2.8% nickel, and 21.8% tin formulation. The application included information on chemical characterization, production variability, use volume, toxicological effects, environmental fate and transport, and evaluation. In accordance with our regulation, on May 10, 2002, we published in the Federal Register a proposed rule indicating our intention to approve TINT shot. We have reviewed the Tier 1 application, the supporting data, and the public comment, and the Director, U.S. Fish and Wildlife Service, has concluded that this shot does not impose a significant danger to migratory birds and other wildlife or their habitats.

In addition, since the 2000-2001 hunting season is completed, tin (99.9 percent tin with 1 percent residual lead) shot is no longer authorized for use and therefore the reference to it in 50 CFR 20.21(j) is deleted.

Tungsten may be substituted for molybdenum in enzymes in mammals. Ingested tungsten salts reduce growth and can cause diarrhea, coma, and death in mammals (Bursian et al. 1996, Cohen et al. 1973, Karantassis 1924, Kinard and Van de Erve 1941, National Research Council 1980, Pham-Huu-Chanh 1965), but elemental tungsten is virtually insoluble and therefore essentially nontoxic. A dietary concentration of 94 parts-per-million (ppm) did not reduce weight gain in growing rats (Wei et al. 1987). Lifetime exposure to 5 ppm tungsten as sodium tungstate in drinking water produced no discernible adverse effects in rats (Schroeder and Mitchener 1975). At 100 ppm tungsten as sodium tungstate in drinking water, rats had decreased enzyme activity after 21 days (Cohen et al. 1973).

Chickens given a complete diet showed no adverse effects of 250 ppm sodium tungstate administered for 10 days in the diet. However, 500 ppm in the diet had detrimental effects on day-old chicks (Teekell and Watts 1959). Adult hens had reduced egg production and egg weight on a diet containing 1,000 ppm tungsten (Nell et al. 1981a). EPT (1999) concluded that 250 ppm in the diet would produce no observable adverse effects. Kelly et al. (1998) demonstrated no adverse effects on mallards dosed with tungsten-iron or tungsten-polymer shot according to nontoxic shot test protocols.

Most toxicity tests reviewed were based on soluble tungsten compounds rather than elemental tungsten. As we found in our reviews of other tungsten shot types, we have no basis for concern about the toxicity of the tungsten in TINT shot to fish, mammals, or birds.

Nickel is a dietary requirement of mammals, with necessary consumption set at 50 to 80 parts per billion for the rat and chick (Nielsen and Sandstead 1974). Though it is necessary for some enzymes, nickel can compete with calcium, magnesium, and zinc for binding sites on many enzymes. Water-soluble nickel salts are poorly absorbed if ingested by rats (Nieboer et al. 1988). Nickel carbonate caused no treatment effects in rats fed 1,000 ppm for 3 to 4 months (Phatak and Patwardhan 1950). Rats fed 1,000 ppm nickel sulfate for 2 years showed reduced body and liver weights, an increase in the number of stillborn pups, and decrease in weanling weights through three generations (Ambrose et al. 1976). Nickel chloride was even more toxic; 1,000 ppm fed to young rats caused weight loss in 13 days (Schnegg and Kirchgessner 1976).

Soluble nickel salts are toxic to mammals, with an oral LD 50 (lethal dose) of 136 mg/kg in mice, and 350 mg/kg in rats (Fairchild et al. 1977). Nickel catalyst (finely divided nickel in vegetable oil) fed to young rats at 250 ppm for 16 months, however, produced no detrimental effects (Phatak and Patwardhan 1950).

In chicks from hatching to 4 weeks of age, 300 ppm nickel as nickel carbonate or nickel acetate in the diet produced no observed adverse effects. However, concentrations of 500 ppm or more reduced growth (Weber and Reid 1968). A diet containing 200 ppm nickel as nickel sulfate had no observed effects on mallard ducklings from 1 to 90 days of age. Diets of 800 ppm or more caused significant changes in physical condition of the ducklings (Cain and Pafford 1981). Eastin and O'Shea (1981) observed no apparent significant changes in pairs of breeding mallards fed diets containing up to 800 ppm nickel as nickel sulfate for 90 days. We have no basis for concern about the toxicity of nickel in TINT shot to fish, mammals, or birds.

Iron is an essential nutrient, so reported iron toxicosis in mammals, such as livestock, is primarily a phenomenon of overdosing. Maximum recommended dietary levels of iron range from 500 ppm for sheep to 3,000 ppm for pigs (National Research Council [NRC] 1980). Chickens require at least 55 ppm iron in the diet (Morck and Austic 1981). Chickens fed 1,600 ppm iron in an adequate diet displayed no ill effects (McGhee et al. 1965), and turkey poults fed 440 ppm in the diet also suffered no ill effects. The tests in which eight No. 4 tungsten-iron shot were administered to each mallard in a toxicity study indicated that the 45% iron content of the shot had no adverse effects on the test animals (Kelly et al. 1998). We have no basis for concern about the toxicity of iron in TINT shot to fish, mammals, or birds.

Elemental and inorganic tins have low toxicity, due largely to low absorption rate, low tissue accumulation, and rapid excretion rates. Inorganic tin is only slightly to moderately toxic to mammals. The oral LD 50 values for tin (II) chloride for mice and rats are 250 and 700 mg/kg of body weight, respectively (WHO 1980).

A 150-day chronic toxicity/reproductive study conducted for tin shot revealed no adverse effects in mallards dosed with eight No. 4 sized shot. There were no significant changes in egg production, fertility, or hatchability of birds dosed with tin when compared to steel-dosed birds (Gallagher et al. 2000).

Elemental tungsten and iron are virtually insoluble in water and do not weather or degrade in the environment. Tungsten is stable in acids and does not easily form compounds with other substances. Preferential uptake by plants in acidic soil suggests uptake of tungsten when it has formed compounds with other substances rather than when it is in its elemental form (Kabata-Pendias and Pendias 1984).

Nickel is common in fresh waters, though usually at concentrations of less than 1 part per billion in locations unaffected by human activities. Pure nickel is not soluble in water. Free nickel may be part of chemical reactions, such as sorption, precipitation, and complexation. Reactions of nickel with anions are unlikely. Complexation with organic agents is poorly understood (U.S. Environmental Protection Agency [EPA] 1980). Water hardness is the dominant factor governing nickel effects on living things (Stokes 1988).

Tin occurs naturally in soils at 2 to 200 mg/g with areas of enrichment at much higher concentrations (up to 1,000 mg/g) (WHO 1980). However, in the United States, soil concentrations are between 1 and 5 ppm (Kabata-Pendias and Pendias 2001).

Calculation of the estimated environmental concentration (EEC) of a candidate shot in a terrestrial ecosystem is based on 69,000 shot per hectare (2.47 acre) (Bellrose 1959, 50 CFR 20.134). Assuming complete dissolution of the shot, the EEC for tungsten in soil is 15.09 mg/kg. The EECs for nickel and iron would be 0.65 and 2.41 mg/kg, respectively. The EEC for nickel (the only one of the four elements with an application limit) is substantially below the U.S. Environmental Protection Agency (EPA) biosolid application limit. The 0.65 mg/kg EEC for nickel also is far below the 16 to 35 mg/kg concentrations suggested as minimum sediment concentrations at which effects of the metal are likely to occur (EPA 1997, Ingersoll et al. 1996, Long and Morgan 1991, MacDonald et al. 2000, Smith et al. 1996). The EEC for tungsten from TINT shot is below that for the already-approved TNI shot. The EEC for iron is less than 0.01% of the typical background concentration, and the iron is in an insoluble form. The EEC for tin in soil is 5.06 mg/kg, one order of magnitude smaller than the 50 mg/kg suggested maximum concentration in surface soil tolerated by plants (Kabata-Pendias and Pendias 2001).

Calculation of the EEC in an aquatic ecosystem assumes complete erosion of 69,000 shot in one hectare (2.47 acre) of water 1 foot deep. The EECs for the elements in TINT shot in water are 3,218 μg/L for tungsten, 515 μg/L for iron, 139 μg/L for nickel, and 1,079 μg/L for tin. We concluded that a tungsten concentration of 10,500 μg/L posed no threat to aquatic life (62 FR 4877). The EEC for nickel from TINT shot is below the EPA acute water quality criterion of 1,400 μg/L in fresh water, but would exceed the 75 μg/L criterion for salt water. However, tests showed that corrosion of TINT shot occurs at very low rates. The amount of nickel liberated into seawater by eight No. 4 TINT shot for a 30-day exposure was 23% of the amount liberated by TNI. TINT shot is predicted to release 1.8 μg/L of nickel into 1 ha-ft of seawater over 1 year. This value is 2.4% of the acute criterion and less than 23% of the chronic criterion.

The EEC for iron is below the chronic criterion for protection of aquatic life and for tin; it is four times less than the Minnesota Water Quality Standard. Previous assessments of tungsten demonstrated dissolution at a rate of 10.5 mg/L (equal to 10,500 μg/L) and concluded no risk to aquatic life (62 FR 4877). The EEC of tungsten from TINT shot is 3,218 μg/L. This level is three times less than the 10,500 μg/L level previously mentioned.

Kraabel et al. (1996) surgically embedded tungsten-bismuth-tin shot in the pectoralis muscles of ducks to simulate wounding by gunfire and to test for toxic effects of the shot. The shot neither produced toxic effects nor induced adverse systemic effects in the ducks during the 8-week period of their study.

Nell et al. (1981a) fed laying hens ( Gallus domesticus ) 0.4 or 1.0 g/kg tungsten in a commercial mash for 5 months to assess reproductive performance. Weekly egg production was normal, and hatchability of fertile eggs was not affected. Exposure of chickens to large doses of tungsten either through injection or by feeding resulted in an increased tissue concentration of tungsten and a decreased concentration of molybdenum (Nell et al. 1981b). The loss of tungsten from the liver occurred in an exponential manner, with a half-life of 27 hours. The alterations in molybdenum metabolism seemed to be associated with tungsten intake rather than molybdenum deficiency. Death due to tungsten occurred when tissue concentrations increased to 25 ppm in the liver.

A 150-day chronic toxicity/reproductive study conducted for tin shot revealed no adverse effects in mallards dosed with eight No. 4 sized shot. In this investigation, there were no significant changes in egg production, fertility, or hatchability of birds dosed with tin when compared to steel-dosed birds (Gallagher et al. 2000).

Ringelman et al. (1993) conducted a 32-day acute toxicity study that involved dosing game-farm mallards with tungsten-bismuth-tin shot in a relative composition of 39%, 44.5%, and 16.5% by weight, respectively. No dosed birds died during the trial, and their behavior was normal. Post-euthanization examination of tissues revealed no toxicity or damage related to shot exposure. Blood calcium differences between dosed and undosed birds were judged as unrelated to shot exposure. That study indicated that tungsten presented little hazard to waterfowl.

The Tier 1 application of TINT shot included analyses comparing corrosion data of TNI shot to TINT shot. Samples of both shot types were exposed to seawater for 10.8 days. The two seawater samples were then analyzed for nickel, iron, tungsten, and tin. Samples were then returned to fresh seawater and exposed for an additional 44.5 days, whereupon the seawater solutions were again analyzed for nickel, iron, tungsten, and tin.

The total release of nickel from TINT shot over the 55.3-day exposure was only 13% that of TNI shot. The results indicate that TINT shot shows lower rates of nickel release due to the collection of corrosive materials on surfaces that inhibit additional corrosion.

Assuming that a duck eats 10 No. 4 TINT shot in 1 day and that the shot are completely eroded in the gizzard in 24 hours, the duck would be exposed to .061g of nickel. This amount is slightly more than half of the .102g/day that Eastin and O'Shea (1981) found produced no ill effects on mallards. We believe, therefore, that consumption of nickel from TINT shot is unlikely to have detrimental effects on waterfowl.

Based on the best available information and past reviews of tungsten-based and tin shot, we expect no detrimental effects due to tungsten, iron, or tin on animals that might ingest TINT shot. We know of no studies of ingestion of nickel by reptiles or amphibians. The exposure of nickel to any animal in these taxa that might consume a TINT shot pellet would be lower, because the pellet likely would not be retained in most animals that might consume one. Their exposure to nickel would therefore be much lower than the worst-case scenario for waterfowl.

The first condition for nontoxic shot approval is toxicity testing, Tiers 1, 2, or 3 (50 CFR § 20.134). Based on the results of past toxicity tests, we conclude that TINT shot does not pose a significant danger to migratory birds, other wildlife, or their habitats.

The second condition for approval is testing for residual lead levels. We determined that the maximum environmentally acceptable level of lead in shot is 1% (50 CFR § 20.134(b)(5)). ENVIRON—Metal, Inc. has documented that TINT shot meets this requirement.

The third condition for approval involves enforcement. Approval of any nontoxic shot is contingent upon the development and availability of a noninvasive field testing device (50 CFR § 20.134(b)(6)). TINT shotshells can be drawn to a magnet as a simple field detection method.

We received two comments on the May 10, 2002 proposed rule (67 FR 31754) to approve TINT shot for hunting waterfowl and coots. Both comments supported granting approval for use of the shot.

In compliance with the requirements of section 102(2)(C) of the National Environmental Policy Act of 1969 (42 U.S.C. 4332(C)), and the Council on Environmental Quality's regulation for implementing NEPA (40 CFR 1500-1508), we have prepared an Environmental Assessment (EA) for approval of TINT shot. The EA is available to the public at the location indicated in the ADDRESSES section.

Section 7 of the Endangered Species Act (ESA) of 1972, as amended (16 U.S.C. 1531 et seq. ), provides that Federal agencies shall Ainsure that any action authorized, funded or carried out * * * is not likely to jeopardize the continued existence of any endangered species or threatened species or result in the destruction or adverse modification of (critical) habitat * * *” We have completed a Section 7 consultation under the ESA for this rule. The result of our consultation under Section 7 of the ESA is available to the public at the location indicated in the ADDRESSES section.

This rule is not a significant regulatory action subject to OMB review under Executive Order 12866. OMB makes the final determination under E.O. 12866.

a. This rule will not have an annual economic effect of $100 million or adversely affect an economic sector, productivity, jobs, the environment, or other units of government. A cost-benefit and economic analysis is not required.

b. This rule will not create inconsistencies with other agencies' actions because the Service is the sole agency responsible for regulating activities under the Migratory Bird Treaty Act.

c. This rule will not materially affect entitlements, grants, user fees, loan programs, or the rights and obligations of their recipients because it has no mechanism to affect entitlements, grants, user fees, loan programs or the rights and obligations of their recipients.

d. This rule will not raise novel legal or policy issues because the Service has already approved six other nontoxic shot types.

The Regulatory Flexibility Act of 1980 (5 U.S.C. 601 et seq. ) requires the preparation of flexibility analyses for rules that will have a significant economic impact on a substantial number of small entities, which includes small businesses, organizations, or governmental jurisdictions. This rule approves an additional type of nontoxic shot that may be sold and used to hunt migratory birds; this rule provides one shot type in addition to the existing six that are approved. We have determined, however, that this rule will have no effect on small entities since the approved shot merely will supplement nontoxic shot already in commerce and available throughout the retail and wholesale distribution systems. We anticipate no dislocation or other local effects, with regard to hunters and others.

Similarly, this rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act.

a. This rule does not have an annual effect on the economy of $100 million or more.

b. This rule will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions. This rule does not deal with traded commodities and, therefore, does not have an impact on prices for consumers.

c. This rule does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. We have examined this regulation under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ) and found it to contain no information collection requirements.

We have determined and certify pursuant to the Unfunded Mandates Reform Act, 2 U.S.C. 1502, et seq. , that this rule-making will not impose a cost of $100 million or more in any given year on local or State government or private entities. This rule does not impose an unfunded mandate of more than $100 million per year or have a significant or unique effect on State, local, or tribal governments or the private sector because it is the Service's responsibility to regulate the take of migratory birds in the United States.

We have determined that these regulations meet the applicable standards provided in Sections 3(a) and 3(b)(2) of Executive Order 12988.

In accordance with Executive Order 12630, this rule, authorized by the Migratory Bird Treaty Act, does not have significant takings implications and does not affect any constitutionally protected property rights. This rule will not result in the physical occupancy of property, the physical invasion of property, or the regulatory taking of any property. In fact, this rule will allow hunters to exercise privileges that would be otherwise unavailable and, therefore, reduces restrictions on the use of private and public property.

Due to the migratory nature of certain species of birds, the Federal Government has been given responsibility over these species by the Migratory Bird Treaty Act. This rule does not have a substantial direct effect on fiscal capacity, change the roles or responsibilities of Federal or State governments, or intrude on State policy or administration. Therefore, in accordance with Executive Order 13132, this proposed regulation does not have significant federalism effects and does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.

In accordance with the President's memorandum of April 29, 1994, “Government-to-Government Relations with Native American Tribal Governments'' (59 FR 22951) Executive Order 13175, and 512 DM 2, we have determined that this rule has no effects on Federally recognized Indian tribes.

In accordance with Executive Order 13211, this rule, authorized by the Migratory Bird Treaty Act, does not significantly affect energy supply, distribution, and use. This rule is not a significant energy action and no Statement of Energy Effects is required.

Under the Administrative Procedure Act (5 U.S.C. 551-553), our normal practice is to publish rules with a 30-day delay in effective date. In this case, however, we use the “good cause” exemption under 5 U.S.C. 553(d)(3) to make this rule effective upon publication. This rule relieves a restriction, and it is not in the public interest to delay its effective date.

An incorrect date was was published under the DATES heading of the notification of U.S. quota allocations and an effort allocation, FR Doc 02-30751, in the issue of December 4, 2002 (67 FR 72110). That document is corrected to read as follows:

On page 72110, column 2, line 8 “January 3, 2004” is corrected to read “January 24, 2003”.

An incorrect paragraph designation was published under the DATES heading of the final rule, FR Doc. 02-30694, in the issue of December 6, 2002 (67 FR 72595). It is corrected as follows:

On page 72595, column 2, line 1 “679.79(a)(3)” is corrected to read “679.7(a)(3)”.