The Office of Government Ethics occasionally receives subpoenas and requests for OGE employees to provide evidence in litigation or other legal proceedings in which OGE is not a party. Typically, these subpoenas and requests are for OGE records that are not available to the public under the Freedom of Information Act (FOIA). Also, OGE sometimes receives subpoenas and requests for OGE employees to appear as witnesses in litigation in conjunction with a request for nonpublic records. Requesters have sought information, for example, on a particular filer of a financial disclosure report, a particular nominee or incumbent or former employee and for any ethics advice that OGE may have given to that individual, or concerning the nature of ethical advice that OGE gave to another agency and how OGE arrived at that advice.

Responding to such demands and requests sometimes results in a significant disruption in an OGE employee's work schedule. The result is that employees may be diverted from performing their official duties in order to respond to requests from parties in litigation. In order to address this problem, many agencies over the years have issued “ Touhy ” regulations that are similar to this final regulation, governing the circumstances and manner in which an employee may respond to demands for testimony or for the production of documents. Such a regulation was upheld by the United States Supreme Court in United States ex rel. Touhy v. Ragen , 340 U.S. 462 (1951).

In Touhy , the Supreme Court held that a Department of Justice (DOJ) official, acting on order of the Attorney General, could not be held in contempt for declining to produce records in response to a subpoena. The employee's refusal was based upon a DOJ regulation that prohibited disclosure of agency files, documents, records, or information without the express approval of the Attorney General. The Court upheld the validity of the DOJ regulation, reasoning that it was appropriate for the Attorney General to prescribe regulations not inconsistent with law for the custody, use, and preservation of records, papers, and property pertaining to DOJ.

On September 24, 2001, OGE published in the Federal Register its own proposed Touhy regulation, for codification in a new part 2608 of 5 CFR. See 66 FR 48824-48828, which provided for a 60-day public comment period. The Office of Government Ethics received suggestions on the rule as proposed from two commenters. As noted below in the summary of this final rule, we are adopting several minor changes in this final rule from the rule as proposed, based primarily on those comments. Moreover, in order to clarify the application of this rule, OGE has decided to revise the proposed part heading to make express that it applies to testimony by OGE employees “relating to official information” (as opposed to private matters), as well as to the production of official records in legal proceedings. In addition, OGE has determined to add a reference to 31 U.S.C. 9701 to the new part 2608 authority citation. This statute authorizes agencies to issue regulations providing for fair and cost-based fees and charges.

Briefly summarized, this final rule prohibits disclosure of nonpublic official records or testimony by OGE employees unless there is compliance with the rule (§§ 2608.201 and 2608.203). Based on a suggestion of one of the commenters, OGE is dropping the word “recorded” before the term “interviews” in the list of types of testimony covered by this regulation. The rule identifies the factors that OGE will consider in making determinations in response to such requests and what information requesters must provide (§§ 2608.202 and 2608.203). In response to a comment, OGE has added “otherwise protected information” to the types of sensitive information enumerated in paragraph (i) of § 2608.202; on its own initiative, OGE is adding the term “demand,” in addition to request, to the text of paragraph (d) of that section. The rule also specifies when the request should be submitted (§ 2608.203), the time period for review (§ 2608.205), potential fees (§ 2608.301), and, if a request is granted, any restrictions that may be placed on the disclosure of records or the appearance of an OGE employee as a witness (§§ 2608.207 and 2608.208). As suggested by one of the commenters, OGE is deleting proposed subparagraph (c)(2) of § 2608.207, which concerned denial of authorization by the General Counsel for fact testimony if contrary to the best interest of OGE or the United States, as unnecessary given the overall requirement for authorization for such testimony in paragraph (c). The Office of Government Ethics is adopting in this final rule two other changes suggested by the commenters. First, OGE is adding the phrase “when necessary” to the procedure provided in § 2608.209 for informing the court or other competent authority and seeking a stay when a decision is not made prior to the time a response is required. This modification from the section as proposed recognizes that at times there can be informal resolution of such matters short of seeking a stay. The second change is that OGE is adding the phrase “unless otherwise advised by the General Counsel” to the procedure provided in § 2608.210 for personal appearance of an OGE employee when a stay of a demand (or, as now added by OGE, a request) is denied. This change likewise recognizes that such denials can sometimes be resolved instead by written response (see the section's last sentence) or otherwise.

The charges for witnesses are the same as those provided by the Federal courts; and the fees related to production of records are the same as those charged under FOIA. The charges for time spent by an employee to prepare for testimony and for certification of records by OGE are authorized under 31 U.S.C. 9701, which permits an agency to charge for services or things of value that are provided by the agency.

This final rule applies to a broad range of matters in any legal proceeding in which OGE is not a named party. It also applies to former and current OGE employees (as well as OGE consultants and advisers). Former OGE employees are prohibited from testifying about specific matters for which they had responsibility during their active employment unless permitted to testify as provided in the rule. They would not be barred from appearing to testify about general matters unconnected with the specific matters for which they had responsibility.

This final regulation will ensure a more efficient use of OGE resources, minimize the possibility of involving OGE in issues unrelated to its responsibilities, promote uniformity in responding to such requests and subpoenas, and maintain the impartiality of OGE in matters that are in dispute between other parties. It will also serve OGE's interest in protecting sensitive, confidential, and privileged information and records that are generated in response to the requirements in the ethics laws and regulations.

This final OGE rule is internal (not branchwide), and is essentially procedural, not substantive. It does not create a right to obtain official records or the official testimony of an OGE employee nor would it create any additional right or privilege not already available to OGE to deny any demand or request therefor. However, any failure to comply with the procedures in this rule would be a basis for denying a demand or request submitted to OGE.

For purposes of the Regulatory Flexibility Act (5 U.S.C. chapter 6), this final rule will not have a significant economic impact on a substantial number of small entities. The rule addresses only the procedures to be followed in the production or disclosure of official OGE materials and information in litigation where OGE is not a party. Accordingly, OGE has determined that a Regulatory Flexibility Analysis is not required.

For purposes of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. chapter 25, subchapter II), this rule will not significantly or uniquely affect small governments and will not result in increased expenditures by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (as adjusted for inflation) in any one year.

In issuing this regulation, the Office of Government Ethics has adhered to the regulatory philosophy and the applicable principles of regulation as set forth in section 1 of Executive Order 12866, Regulatory Planning and Review. This final rule has not been reviewed by the Office of Management and Budget under that Executive order since it is not a significant regulatory action within the meaning of the Executive order.

As Director of the Office of Government Ethics, I have reviewed this final regulation in light of section 3 of Executive Order 12988, Civil Justice Reform, and certify that it meets the applicable standards provided therein.

The Paperwork Reduction Act (44 U.S.C. chapter 35) does not apply because this final regulation does not contain information collection requirements that require approval by the Office of Management and Budget. The Office of Government Ethics expects the collection of information that is called for by the regulation would involve fewer than ten persons each year.

The Office of Government Ethics has determined that this rulemaking involves a nonmajor rule under the Congressional Review Act (5 U.S.C. chapter 8) and has submitted a report thereon to the U.S. Senate, House of Representatives and General Accounting Office in accordance with that law.

On March 7, 2002, the Finance Board published for notice and comment a proposed rule to amend § 966.3(a) of the Finance Board's regulations, which sets forth the assets-to-capital leverage limit that will apply to each Bank until: (1) That Bank's capital structure plan required under part 933 of the regulations becomes effective; and (2) the Bank is in compliance with the new leverage limit set forth in § 932.2 of the regulations. 1 Under § 966.3(a)(1), each Bank generally is required to maintain a leverage ratio not in excess of 21-to-1. However, § 966.3(a)(2) provides that a Bank may maintain a leverage ratio of up to 25-to-1 if the amount of its “non-mortgage assets” (after deducting deposits and capital held by the Bank) does not exceed 11 percent of the Bank's total assets. Thus, this rule is in a transitory stage because as the Banks' capital plans are approved and implemented, this leverage requirement will yield to the new leverage limit in § 932.2 of the Finance Board regulations.

Under § 966.3(a)(2), “non-mortgage assets” are defined to include a Bank's total assets after deduction of core mission activity (CMA) assets described in § 940.3 of the regulations and assets described in sections II.B.8 through II.B.11 of the Federal Home Loan Bank System Financial Management Policy (FMP), 2 which include: mortgage-backed securities (MBS) or collateralized mortgage obligations (CMOs) issued by U.S. government-sponsored enterprises; AAA-rated MBS or CMOs issued by private entities; AAA-rated asset-backed securities backed by manufactured housing loans or home equity loans; and certain obligations of state and local housing finance agencies rated AA or higher.

While serving as a vehicle to transition the Banks from this leverage requirement to their new capital structures and the new leverage limit set forth in § 932.2 of the Finance Board regulations, the final rule amends § 966.3(a)(2) to: (1) Exclude from the scope of the definition of “non-mortgage assets” United States government-insured single family and multifamily mortgages acquired by Banks as part of their acquired member asset (AMA) programs established under part 955 of the regulations; and (2) clarify the definition by eliminating the CMA and FMP cross-references and replacing them with direct descriptions of the assets in question. This clarification will provide the Banks with an unambiguous standard for assets that are to be excluded from the definition of non-mortgage assets in leverage limit calculations.

The Finance Board received four comment letters, all of which were favorable comments, on the proposed rule. The comments are discussed below. Accordingly, the final rule adopts the proposed rule with only one clarification as discussed below.

The Finance Board received four comment letters from Banks. All of the commenters supported the rule change. Two commenters suggested that the list of excluded assets contain certain additional items. Additionally, one commenter recommended that the Finance Board add a provision to codify a Finance Board regulatory interpretation (2001-RI-02) that the Banks may, at their option, calculate the non-mortgage asset ratio on a monthly average. Upon consideration of the comments, the Finance Board has determined that, with one exception, the recommendations would not substantively improve the rule, especially in light of the transitional nature of the rule. Ultimately, of course, the issue is best served by the Banks' new capital structures. In the unlikely event that a question arises in the interim concerning whether an asset may be excluded from the definition of non-mortgage assets, the Finance Board believes that the analysis may best be undertaken on a case-by-case basis.

One Bank requested that the definition of the government-insured or -guaranteed loans be broadened to include government insured or guaranteed multi-family residential mortgage loans in the list of excluded assets. The Finance Board agrees with the comment that all government-insured (or guaranteed) residential mortgage loans—single family and multi-family—should be excluded from non-mortgage assets, and has amended the final rule to reflect that change. As proposed, the final rule also amends

§ 966.3(a)(2) to eliminate any cross-reference to CMA assets and in its place adds “acquired member assets, including all United States government-insured or guaranteed whole single-family and multi-family residential mortgage loans” to the list of assets to be subtracted from a Bank's total assets to obtain the amount of “non-mortgage assets” on a Bank's balance sheet for purposes of the leverage limit calculation under this rule.

In addition to the above-described revision, as proposed, the final rule also eliminates the reference in § 966.3(a)(2) to “assets described in sections II.B.8 through II.B.11 of the FMP” and replaces that reference with an explicit enumeration of the assets to be subtracted from a Bank's total assets in calculating the percentage of non-mortgage assets. By including all relevant information in the published regulatory text, the definition of non-mortgage assets is made clearer and more transparent, without any substantive change.

The Finance Board received several recommendations for additions to the enumerated list of excluded assets. One Bank requested that standby bond purchase agreements for state housing finance agency bonds be excluded from non-mortgage assets, stating that to do so would be consistent with the exclusion of standby letters of credit. The Finance Board has considered the suggestion and determined that the rule should not be amended to include such contracts. Such bonds may be counted as mortgage assets for purposes of this rule only at such time as the purchase is executed.

Another Bank requested that the accrued interest carried on a Bank's books with respect to assets enumerated in § 966.3(a)(2) be added to that list as a stand-alone category of excluded assets. Upon consideration, the Finance Board rejects this suggestion. While accrued interest may be related to an asset, it is shown as a separate line item on a balance sheet. Once an interest payment is made it is removed from the balance sheet and flows through the income statement. An outstanding interest payment due is not the equivalent of a Bank advancing funds to a member. Thus, the Finance Board has determined that the interest due is not a “mortgage asset” for purposes of the final rule. Additionally, the Finance Board is not persuaded that principal amounts carried as receivables on a balance sheet should be granted separate asset status for purposes of this rule.

The Bank also suggested that the list of excluded assets should be broadened to include any adjustments made to the book value of the asset categories stated in § 966.3(a)(2) resulting from the application of SFAS No. 133 under Generally Accepted Accounting Principles (GAAP), and the book value of derivative assets that hedge similar provisions embedded in advances, such as a cap on the floating rate of an advance. The commenter correctly noted that under SFAS No. 133 the Bank includes in the book value of assets hedged with derivatives any fair value gains or losses on those assets. The Finance Board does not believe that the rule should be amended to take such values into account. Nevertheless, the Finance Board has determined that a Bank may value an asset under GAAP, as appropriate, for purposes of this final rule.

Finally, one Bank suggested it would be beneficial to codify in the final rule the Finance Board's regulatory interpretation (2001-RI-02) that the Banks may, at their option, calculate the non-mortgage asset ratio on a monthly average basis. Again, the rule is a transitional provision with a limited shelf life. The Finance Board does not believe that amending the rule is necessary at this late stage in the transition process. Accordingly, the final rule does not incorporate the requested amendment.

As stated, the final rule is a transitional mechanism. In the interim, in the unlikely event that any of these issues arise, the Finance Board is prepared to address such matters on a case-by-case basis in a regulatory interpretation or other appropriate regulatory adjudication.

The final rule applies only to the Banks, which do not come within the meaning of “small entities,” as defined in the Regulatory Flexibility Act (RFA). See 5 U.S.C. 601(6). Therefore, in accordance with section 605(b) of the RFA, see id. at 605(b), the Finance Board hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities.

The final rule does not contain any collections of information pursuant to the Paperwork Reduction Act of 1995. See 44 U.S.C. 3501 et seq. Consequently, the Finance Board has not submitted any information to the Office of Management and Budget for review.

On November 14, 1996, Airbus Industrie applied for an amendment to U.S. type certificate (TC) A43NM to include the new models A340-500 and -600. These models are derivatives of the A340-300, which is approved under the same TC.

The Model A340-500 fuselage is a 6-frame stretch of the Model A340-300 and is powered by 4 Rolls Royce Trent 553 engines, each rated at 53,000 pounds of thrust. The airplane has interior seating arrangements for up to 375 passengers, with a maximum takeoff weight (MTOW) of 820,000 pounds. The Model 340-500 is intended for long-range operations and has additional fuel capacity over that of the Model A340-600.

The Model A340-600 fuselage is a 20-frame stretch of the Model A340-300 and is powered by 4 Rolls Royce Trent 556 engines, each rated at 56,000 pounds of thrust. The airplane has interior seating arrangements for up to 440 passengers, with a MTOW of 804,500 pounds.

Under the provisions of 14 CFR 21.101, Airbus Industrie must show that the Model A340-500 and -600 airplanes meet the applicable provisions of the regulations incorporated by reference in TC A43NM or the applicable regulations in effect on the date of application for the change to the type certificate. The regulations incorporated by reference in the type certificate are commonly referred to as the “original type certification basis.” The regulations incorporated by reference in TC A43NM are 14 CFR part 25 effective February 1, 1965, including Amendments 25-1 through 25-63 and Amendments 25-64, 25-65, 25-66, and 25-77, with certain exceptions that are not relevant to these proposed special conditions.

In addition, if the regulations incorporated by reference do not provide adequate standards with respect to the change, the applicant must comply with certain regulations in effect on the date of application for the change. The FAA has determined that the Model A340-500 and -600 airplanes must be shown to comply with Amendments 25-1 through 25-91,with certain FAA-allowed reversions for specific part 25 regulations to the part 25 amendment levels of the original type certification basis.

Airbus has also chosen to comply with part 25 as amended by Amendments 25-92, -93, -94, -95, -97, -98, and -104.

If the Administrator finds that the applicable airworthiness regulations (i.e., 14 CFR part 25) do not contain adequate or appropriate safety standards for the Airbus Industrie Model A340-500 and -600 airplanes because of a novel or unusual design feature, special conditions are prescribed under the provisions of 14 CFR 21.16.

In addition to the applicable airworthiness regulations and special conditions, the Airbus Industrie Model A340-500 and -600 airplanes must comply with the fuel vent and exhaust emission requirements of 14 CFR part 34 and the noise certification requirements of 14 CFR part 36.

Special conditions, as defined in 14 CFR 11.19, are issued in accordance with § 11.38 and become part of the type certification basis in accordance with 14 CFR 21.101(b)(2).

Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same novel or unusual design feature, or should any other model already included on the same type certificate be modified to incorporate the same novel or unusual design feature, the special conditions would also apply to the other model under the provisions of 14 CFR 21.101(a)(1).

The Airbus Model A340-500 and -600 airplanes will incorporate the following novel or unusual design feature: a four-wheel center landing gear with braking ability.

The basic A340 included a two-wheel center landing gear which did not have brakes. The purpose of the center landing gear was to assist the main landing gear during ground handling conditions for heavy airplane weights. This center landing gear was not intended for energy absorption during landing, even if it could participate in the impact under certain conditions. Therefore, to provide additional taxi, takeoff, and landing criteria for this arrangement, Special Conditions 25-ANM-69 were issued.

The Model A340-500 and -600 airplanes have a four-wheel center landing gear which functions in all respects like a main landing gear, including braking capabilities. Because the speeds and weights of the Model A340-500 and -600 airplanes are greater than that of the basic A340, redesign of the center landing gear was necessary. As a result, the current rules, applying to the original two-wheel center landing gear, are inadequate.

Notice of proposed special conditions No. 25-02-03-SC for the Airbus Industrie Model A340-500 and -600 airplanes was published in the Federal Register on March 20, 2002 (67 FR 12903). No comments were received, and the special conditions are adopted as proposed.

As discussed above, these special conditions are applicable to the Airbus Model A340-500 and -600 airplanes. Should Airbus Industries apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, the special conditions would apply to that model as well under the provisions of § 21.101(a)(1).

Under standard practice, the effective date of final special conditions would be 30 days after the date of publication in the Federal Register ; however, as the certification date for the Airbus Model A340-500 and A340-600 airplanes is imminent, the FAA finds that good cause exists to make these special conditions effective upon issuance.

This action affects only certain novel or unusual design features of the center landing gear on the Model A340-500 and A340-600 airplanes. It is not a rule of general applicability, and it affects only the applicant who applied to the FAA for approval of these features on the airplane.

Part 122, Customs Regulations (19 CFR part 122), sets forth regulations that are applicable to all international air commerce relating to the entry and clearance of aircraft and the transportation of persons and cargo by aircraft.

Under § 1644a, Title 19, United States Code (19 U.S.C. 1644a), the Secretary of the Treasury is authorized to designate places in the United States as ports of entry for civil aircraft arriving from any place outside of the United States, and for merchandise carried on the aircraft. These airports are referred to as international airports, and the location and name of each are listed in § 122.13, Customs Regulations (19 CFR 122.13). In accordance with § 122.33, Customs Regulations (19 CFR 122.33), the first landing of every civil aircraft entering the United States from a foreign area must be at one of these international airports, unless the aircraft has been specifically exempted from this requirement or permission to land elsewhere has been granted. Customs officers are assigned to all international airports to accept entries of merchandise, collect duties and enforce the customs laws and regulations.

Other than making an emergency or forced landing, if a civil aircraft desires to land at an airport not designated by Customs as an international airport, the pilot may request permission to land at a specific airport. If permission is granted, Customs will assign personnel to that airport for the aircraft. The airport where the aircraft is permitted to land is called a landing rights airport (19 CFR 122.14).

Section 236 of Pub. L. 98-573 (the Trade and Tariff Act of 1984), codified at 19 U.S.C. 58b, created an option for civil aircraft desiring to land at an airport other than an international or landing rights airport. A civil aircraft arriving from a place outside of the United States may ask Customs for permission to land at an airport designated by the Secretary of the Treasury as a user fee airport.

Pursuant to 19 U.S.C. 58b, an airport may be designated as a user fee airport if the Secretary of the Treasury determines that the volume of Customs business at the airport is insufficient to justify the availability of Customs services at the airport and the governor of the state in which the airport is located approves the designation. Generally, the type of airport that would seek designation as a user fee airport would be one at which a company, such as an air courier service, has a specialized interest in regularly landing.

As the volume of business anticipated at this type of airport is insufficient to justify its designation as an international or landing rights airport, the availability of Customs services is not paid for out of the Customs appropriations from the general treasury of the United States. Instead, the services of Customs officers are provided on a fully reimbursable basis to be paid for by the user fee airport on behalf of the recipients of the services.

The fees which are to be charged at user fee airports, according to the statute, shall be paid by each person using the Customs services at the airport and shall be in the amount equal to the expenses incurred by the Secretary of the Treasury in providing Customs services which are rendered to such person at such airport, including the salary and expenses of those employed by the Secretary of the Treasury to provide the Customs services. To implement this provision, generally, the airport seeking the designation as a user fee airport of that airport's authority agrees to pay Customs a flat fee annually and the users of the airport are to reimburse that airport/airport authority. The airport/airport authority agrees to set and periodically to review its charges to ensure that they are in accord with the airport's expenses.

Pursuant to Treasury Department Order No. 165, Revised (Treasury Decision 53564), all the rights, privileges, powers and duties vested in the Secretary of the Treasury by the Tariff Act of 1930, as amended, by the navigation laws, or by any other laws administered by Customs, are transferred to the Commissioner of Customs. Accordingly, the authority granted to the Secretary of the Treasury to designate user fee airports and to determine appropriate fees is delegated to the Commissioner of Customs.

Under this authority, Customs has determined that certain conditions must be met before an airport can be designated as a user fee airport. At least one full-time Customs officer must be requested, and the airport must be responsible for providing Customs with satisfactory office space, equipment and supplies, at no cost to the Federal Government.

Thirty-six airports are currently listed in § 122.15, Customs Regulations, as user fee airports. This document revises the list of user fee airports. It adds McKinney Municipal Airport, in Dallas, Texas, to this listing of designated user fee airports.

Because this amendment merely updates the list of user fee airports designated by the Commissioner of Customs in accordance with 19 U.S.C. 58b and neither imposes any additional burdens on, nor takes away any existing rights or privileges from, the public, pursuant to 5 U.S.C. 553 (b)(B), notice and public procedure are unnecessary, and for the same reasons, pursuant to 5 U.S.C. 553(d)(3) a delayed effective date is not required.

Because no notice of proposed rulemaking is required for this final rule, the provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) do not apply. Agency organization matters such as this amendment are exempt from consideration under Executive Order 12866.

The principal author of this document was Janet L. Johnson, Regulations Branch, Office of Regulations and Rulings, U.S. Customs Service. However, personnel from other offices participated in its development.

The final regulations that are the subject of these corrections affect disability determinations and decisions we make for individuals under title II and title XVI of the Social Security Act. In addition, to the extent that Medicare and Medicaid eligibility are based on entitlement to benefits under title II and eligibility for benefits under title XVI, these corrections would also affect the Medicare and Medicaid programs.

As published, the final regulations inadvertently did not update the cross-references in listings 111.07A and 111.08A of part B of the listings to reflect the new musculoskeletal listings criteria. The cross-references in current listings 111.07A and 111.08A are to listings 101.03 or 111.06. To reflect the revised musculoskeletal listings, the correct cross-references should be to listings 101.02 or 111.06.

In 1997, FDAMA amended section 409 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C 348) to establish a premarket notification process as the primary method for authorizing new uses of food additives that are FCSs. In the proposed rule, published in the Federal Register of July 13, 2000 (65 FR 43269) (hereinafter referred to as the July 2000 proposal), FDA referred to a premarket notification for a food contact substance as a “PMN” and the process of premarket notification for such substances as the “PMN process.” This document refers to a premarket notification for a food contact substance as an “FCN” and to the process as the food contact notification (FCN) process. This change responds to a request from the comments (see section II.H of this document). A “food contact substance” is defined in section 409(h)(6) of the act as “any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have any technical effect in such food.” The FDAMA amendments and their legislative history make clear that the FCN process is to be the preferred process for authorizing new uses of food additives that are FCSs. Specifically, section 409(h)(3)(A) of the act states that the FCN process shall be utilized for authorizing the marketing of food additives that are FCSs except where the Secretary of Health and Human Services determines that the submission and review of a FAP is necessary to provide adequate assurance of safety, or where FDA and any manufacturer or supplier agree that a petition may be submitted. (See S. Rept. No. 105-43, 105th Cong., 1st sess. 46 (1997); H. Rept. 105-306, 105th Cong., 1st sess. 19 (1997).) FDA expects most new uses of FCSs that previously would have been regulated by issuance of a listing regulation in response to an FAP or would have been exempted from the requirement of a regulation under the threshold of regulation (TOR) process (21 CFR 170.39) will be the subject of FCNs.

The FCN program began operating on October 22, 1999, with the signing of FDA’s Fiscal Year 2000 budget. This budget met the requirements under section 409(h)(5) of the act for funding the FCN program. On October 25, 1999, FDA sent letters to trade associations and persons with pending submissions (i.e., a food additive petition or a TOR exemption request) under active review by the agency to authorize use of an FCS. The letter stated that FDA expected to be ready to accept new FCNs on January 18, 2000, and requested that those persons with a pending submission for approval of an FCS under active review contact FDA prior to withdrawing such submission and converting it to an FCN. After October 25, 1999, FDA began working with the food packaging industry to convert these pending submissions under FDA review to FCNs. 1

In the Federal Register of November 12, 1999 (64 FR 61648), FDA published a notice announcing the availability of a draft guidance on the chemistry and toxicology information that should be included in an FCN. In the November 12, 1999, notice FDA requested comments on the guidance documents and on the information collection burden associated with the FCN program.

In addition, FDA published a direct final rule in the Federal Register of May 11, 2000 (65 FR 30352), that amended the agency’s regulations on environmental impact considerations to permit manufacturers or suppliers to claim in FCNs the categorical exclusions currently applicable to FAPs and TOR exemption requests. The regulations in the May 11, 2000, direct final rule became effective on August 24, 2000.

Finally, in the July 2000 proposal (65 FR 43377), the agency proposed regulations to implement the FCN process and announced the availability of an administrative guidance document concerning the FCN process.

The agency provided 75 days for comment on the proposed rule. FDA received comments from three trade associations representing the food packaging industry. In general, the comments supported the proposal. They also raised issues specific to the draft administrative guidance document announced with the proposed rule in the July 13, 2000, issue of the Federal Register (65 FR 43377) and the draft chemistry and toxicology guidance documents announced in the Federal Register of November 12, 1999 (64 FR 61648 ). In accordance with FDA's good guidance practice (GGP) regulations (21 CFR 10.115), such comments have been addressed by modification of the final toxicology and chemistry guidance documents announced in the Federal Register of April 11, 2002 (67 FR 17703), and in FDA's revised administrative guidance document, the availability of which is published elsewhere in this issue of the Federal Register . Comments also requested that FDA clarify several specific issues in the proposal. These issues and FDA's responses follow.

(Comment 1) Two of the comments were concerned with the language in proposed § 170.104(b) describing FDA’s initial review of an FCN submission. Proposed § 170.104(b) reads: “In order for the 120-day review period to begin FDA must accept that notification.” The comments expressed the opinion that the language in proposed § 170.104(b) could be read to mean that the 120-day review period for the FCN does not begin until after FDA “accepts” the submission as an FCN. These comments referenced the language in section 409(h)(2)(A) of the act that states that a “* * * notification submitted under paragraph (1) shall become effective 120 days after the date of receipt by the Secretary * * *.”

FDA agrees with these comments that the 120-day review period for the FCN runs from the date of receipt of a complete notification. The purpose of § 170.104(b) is to provide FDA with an opportunity to determine whether the submission is a complete notification and to ensure that FDA would not be required to review or object to an incomplete FCN. The following are examples of how FDA’s initial review of FCN submissions has operated thus far and how FDA expects its initial review of FCNs to proceed in the future. FDA expects to determine whether an FCN is complete and reviewable within 30 days after receipt of a submission. If FDA finds that an FCN is complete and reviewable as received, then FDA will accept the FCN and the 120-day review period will continue to run from the date of receipt of the FCN. However, if FDA determines that, as submitted, an FCN is incomplete, the agency will request additional information from the manufacturer or supplier. If the information is submitted before FDA issues a nonacceptance letter, FDA will accept the now complete FCN, and the 120-day review period begins on the date of receipt of the additional information. If the required additional information is not submitted, and the FCN is not withdrawn, FDA will issue a nonacceptance letter. Issuance of the nonacceptance letter will complete the review of the FCN submission.

In any case, the date of receipt of the complete FCN is the date of receipt for the purposes of section 409(h)(2) of the act. FDA is revising the language in § 170.104(b) to clarify that the 120-day review period begins on the date of receipt of a complete FCN and not on the date the FCN is accepted.

(Comment 2) All three comments requested that FDA clarify that the requirements in proposed § 170.101(c) regarding compliance with FDA’s good laboratory practice regulations in part 58 (21 CFR part 58) do not apply to analytical testing (e.g., migration testing). The comments noted that analytical testing had not been previously required to comply with part 58. One comment requested that FDA make this clarification by explicitly referencing the definition of nonclinical laboratory studies in § 58.3.

FDA agrees that, historically, it has not applied its good laboratory practice regulations to analytical testing such as migration testing. Therefore, FDA is revising § 170.101(c) to explicitly reference the definition of nonclinical laboratory studies in § 58.3(d).

(Comment 3) All three comments requested that FDA make it clear that FCNs are required only for FCSs that are food additives. The comments referenced a statement in the preamble of the July 2000 proposal (65 FR 43269 at 43274) that reads as follows “* * * Under section 409(a) of the act, in the absence of an effective notification an FCS cannot be legally marketed.” One of the comments requested that FDA revise the referenced language to read as follows: “Under section 409(a) of the act, in the absence of an effective notification, an FCS that is a food additive cannot be legally marketed.”

FDA agrees with the comments that FCNs are required only for those FCSs that are food additives as defined by section 201(s) of the act (21 U.S.C. 321(s)). FDA intended the referenced statement to clarify that in cases where FDA objects to an FCN, the FCN cannot become effective. Because the language referred to was not in the codified portion of the proposed regulation, the agency is taking no further action in response to these comments.

FDA also believes, however, that the language suggested by one comment is misleading because it implies that FCSs are authorized only through the FCN process. Although the FCN process is the primary means for authorizing new uses of FCSs, some new uses of FCSs still will be authorized through the petition process in section 409(b) of the act.

(Comment 4) All three comments requested that FDA clarify the relationship of FDA Form 3480 to the recommendations in the agency’s draft guidance documents for FCNs. The comment noted that adopting § 170.101(e), as proposed, would require that a completed and signed FDA Form 3480 be included in an FCN. FDA Form 3480 requires that manufacturers or suppliers list summary toxicology information on the FCS and its constituents. In addition, the comments noted, the draft guidance on toxicology information in an FCN advises that notifiers (i.e., manufacturers and suppliers) should provide a comprehensive toxicological profile for the FCS and its constituents. The comments expressed uncertainty about the level of detail required in FDA Form 3480. The comments noted that the draft toxicology guidance document appeared to request that some of the same information be included in both the comprehensive toxicology profile and the safety narrative, as is required in FDA Form 3480. Thus, a notifier might have to list the same information in two sections of a notification.

FDA has revised FDA Form 3480 (Ref. 1) to minimize duplication of effort in developing the toxicology package for FCNs. FDA also has revised its guidance documents to assist manufacturers and suppliers in completing FDA Form 3480. Published elsewhere in this issue of the Federal Register , FDA is announcing the availability of administrative, chemistry, and toxicology guidance documents.

(Comment 5) One comment requested that FDA make mandatory the issuance by the agency of a final letter for FCNs that become effective. The comment argued that the listing of notifications in FDA’s inventory of effective notifications on the agency’s Internet site may not be adequate to inform interested persons regarding the status of an FCN. In addition, the comment contended that listing of notifications on FDA’s Internet site may not be completed in a timely manner.

FDA disagrees with this comment. The statute does not require FDA to issue a letter at the conclusion of the review of an FCN. Indeed, no action is required by FDA for an FCN to become effective. FDA believes that issuance of final letters for effective FCNs has some value, but FDA is concerned that the issuance of such letters may consume limited resources that are necessary to complete a timely review of FCNs. Therefore, FDA is denying the request to require the agency to issue a final letter for effective notifications. However, as noted above, FDA has been reviewing FCNs since the program began operating and, since that time, FDA has consistently issued final letters and listed effective notifications on its Internet site in a timely manner. Accordingly, FDA expects to continue to issue final letters as long as the resources necessary to do so do not prevent timely review of FCNs.

(Comment 6) One comment requested that FDA provide an opportunity for a company to notify the agency of any change in name or corporate structure subsequent to its filing of an FCN. The comment also requested that FDA establish a procedure whereby FDA would change the name of the manufacturer in the listing of the FCN on FDA’s Internet site and reissue the final letter for the FCN with the new company’s name.

The agency agrees in part with this comment. Under § 170.100(d), manufacturers or suppliers are required to keep on file with FDA an address at which FDA may contact the manufacturer or supplier regarding the notification. FDA already had one experience with the sale of the manufacturing unit of a notified FCS from one company to another. In that case, the original manufacturer verified the sale and FDA changed the name of the manufacturer in the listing for the FCN on the agency’s Internet site. FDA did not, however, reissue the final letter. FDA believes that reissuing final letters would be an ineffective use of its limited resources. Therefore, FDA will not reissue an updated final letter when the manufacturer or supplier of the FCN changes. FDA has included guidance on the above procedure in “Preparation of Premarket Notifications for Food Contact Substances: Administrative Recommendations,” the availability of which is announced elsewhere in this issue of the Federal Register .

FDA also is revising the language in all the regulations to replace the word “notifier” with the words “manufacturer or supplier.” FDA believes “manufacturer or supplier” is more appropriate because it is the term used in section 409(h) of the act.

(Comment 7) One comment requested that FDA clarify its position on the issue of transferability of FCNs. Specifically, the comment requests that FDA establish regulations to permit a manufacturer identified in an effective FCN to transfer the rights granted under an effective notification. The comment contended that licensing the manufacture of an FCS would maintain the safety of the FCS because it would continue to be manufactured in the manner reviewed by the agency.

At the time of the proposal, FDA did not contemplate regulations to permit a subsequent manufacturer other than the manufacturer identified in the FCN to produce and market the FCS under that FCN and did not discuss such regulations in the proposed rule. Thus, FDA believes that the issues raised in this comment are outside the scope of the proposal. Currently, FDA requires any subsequent manufacturer who wishes to market an FCS for a use that is the subject of an already effective FCN to submit a notification to FDA. In addition, the manufacturer identified in an effective FCN may authorize other manufacturers to reference information contained in the effective FCN. Thus, other manufacturers may have to provide only limited additional information in subsequent FCNs but they must notify FDA separately and wait 120 days for their FCN to become effective. However, FDA is interested in hearing the views of other interested parties on this issue. Therefore, elsewhere in this issue of the Federal Register , FDA is publishing an advanced notice of proposed rulemaking requesting comments on the issue of transferability of FCNs.

(Comment 8) All three comments requested FDA to replace the abbreviation “PMN” with “FCN” to represent a premarket notification for a food contact substance (also called a Food Contact Notification). The comments argued that this change will avoid confusing a premarket notification for a food contact substance with a “PMN” submitted to the U.S. Environmental Protection Agency (EPA).

FDA already made this change in the operation of the FCN program, throughout this document, and where appropriate in the codified regulations. FDA also made other nonsubstantive editorial changes in the regulations.

(Comment 9) In § 170.100(a)(2), FDA is replacing the word “should” with “must.” FDA is making this change to be consistent with the description of the provision in the proposed rule. In the preamble of the proposed rule, the agency stated that it would permit a manufacturer or supplier to incorporate by reference information in FDA’s files where the submitter of the information has given the notifier permission to reference the information (65 FR 43269 at 43271). Requiring the manufacturer or supplier to establish that it has permission to incorporate certain information by reference also is consistent with standard FDA practice on incorporation by reference. (See 21 CFR 171.1(f); 21 CFR 314.420(d); 21 CFR 571.1(f); 21 CFR 814.20(c).)

The comments received in response to the July 2000 proposal requested changes to the proposed language in §§ 170.101(c) and 170.104(b). In addition, FDA is revising certain language throughout the proposed regulations. Because no comments were received relating to the remaining regulations included in the July 2000 proposal, FDA is finalizing those regulations as proposed with only minor editorial changes. Listed below are the revisions that are being incorporated into this final rule, based on the comments received in response to the proposal:

1. FDA is replacing the term “notifier” with the term “manufacturer or supplier” throughout the regulations to correspond with the language in section 409(h) of the act.

2. FDA is revising the language in § 170.101(c) to reference the definition of nonclinical laboratory studies in § 58.3(d) to clarify that 170.101(c) does not apply to analytical testing to determine the functionality or to determine physical or chemical characteristics of the test article.

3. FDA is revising the language in § 170.104(b) to clarify that the 120-day review period for an FCN begins on the date FDA receives the complete FCN. Thus, where FDA receives an incomplete FCN, the 120-day review period begins when FDA receives the missing information.

4. FDA is replacing the acronym “PMN” with “FCN” to refer to a premarket notification for a food contact substance (also known as a Food Contact Notification). FDA is using the acronym FCN throughout this document and in the codified regulations.

5. In § 170.100(a)(2) FDA is replacing the word “should” with “must.”

This final rule contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The title, description, and respondent description of the information collection provisions are shown below with an estimate of the annual reporting burden. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information.

Title : Food Contact Substances Notification System.

Description : Section 409(h) of the act establishes a premarket notification process for FCSs. Section 409(h)(6) of the act defines a “food contact substance” as “any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have any technical effect in such food.” Section 409(h)(3) of the act requires that the notification process be used for authorizing the marketing of FCSs except where FDA determines that the submission and premarket review of an FAP under section 409(b) of the act is necessary to provide adequate assurance of safety or where FDA and the manufacturer or supplier agree that a petition should be submitted. Section 409(h)(1) of the act requires that a notification include information on the identity and the intended use of the FCS and the basis for the manufacturer’s or supplier’s determination that the FCS is safe under the intended conditions of use. Because section 409(h)(1) of the act references the general safety standard for food additives, the data in an FCN should be comparable to the data in an FAP. FDA is issuing regulations necessary to implement the FCN program that will largely replace the FAP process for those food additives that are FCSs.

Also, FDA is requiring that an FCN include FDA Form 3480 entitled “Notification for New Use of a Food Contact Substance” (Ref. 1) and is requiring that a notification for a food contact substance formulation (NFCSF) include FDA Form 3479 entitled “Notification for a Food Contact Substance Formulation” (Ref. 2). These forms will serve to summarize pertinent information in the notification. FDA made Form 3480 available for public comment in the November 12, 1999 (64 FR 61648 at 61649), notice and Form 3479 available for public comment in the July 2000 proposal (65 FR 43269 at 43277). FDA believes that these forms will facilitate both preparation and review of notifications because the forms will serve to organize information necessary to support the safety of the use of the FCS. The burden of filling out the appropriate form has been included in the burden estimate for the notification.

Description of Respondents : Manufacturers of food contact substances.

FDA estimates the burden of this collection of information as follows:

The above estimate is based on the types of submissions that FDA currently receives for food contact substances in the TOR and the FAP processes and the following assumptions and information:

• FDA estimates that the likely increase in FCNs over the number of FAPs and TOR requests will be approximately four times the highest recent annual influx of these submissions (50 and 54, respectively). This factor is based on an analysis of the number of companies producing various types of FCSs and the types of FCSs for which FAPs and TORs most commonly are submitted to FDA.

• Based on input from industry sources, FDA estimates that the agency will receive approximately 800 notifications annually for food contact substance formulations.

• FDA also has included 200 expected duplicate submissions in the second lowest tier. FDA expects that the burden for preparing these notifications primarily will consist of the manufacturer or supplier filling out FDA Form 3480, verifying that a previous notification is effective, and preparing necessary documentation.

• Based on the amount of data typically submitted in FAPs and TOR requests, FDA identified three other tiers of FCNs that represent escalating levels of burden required to collect information.

• FDA estimated the median number of hours necessary for collecting information for each type of notification within each of the three tiers based on input from industry sources.

In the July 2000 proposal (65 FR 43269 at 43276), the agency requested comments on the proposed collection of information. On October 3, 2000, OMB filed comment on the information collection provisions, assigning OMB control number 0910-0447. OMB’s comments stated that, “FDA shall evaluate the contents of this collection in light of any comments received regarding the information collection requirements contained in the rule. In addition, FDA shall address any issues related to reducing duplication between FDA and EPA related to this collection.”

FDA received no comments on the information collection requirements in the proposed rule. FDA continues to work with EPA and the U.S. Department of Agriculture (USDA) to eliminate areas of duplicative data collection and evaluation. Within the past 2 years USDA has eliminated its separate approval process for components of food contact materials that duplicated FDA’s process. In addition, the Food Quality Protection Act of 1996 gave sole jurisdiction to EPA for certain substances formerly regulated by FDA as food additives and by EPA as pesticide chemicals. Currently, there is no significant duplication of data collection and evaluation for food contact substances among Federal agencies with jurisdiction. In addition, to avoid unnecessary duplication for individual submissions, existing data will be used whenever possible by FDA in evaluating notifications for food contact substances.

FDA submitted the information collection provisions of this final rule to OMB for review. Prior to the effective date of this final rule, FDA will publish a notice in the Federal Register announcing OMB’s decision to approve, modify, or disapprove the information collection provisions in this final rule. 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.

FDA has examined the economic implications of this final rule as required by Executive Order 12866. Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). Executive Order 12866 classifies a rule as significant if it meets any one of a number of specified conditions, including having an annual effect on the economy of $100 million, adversely affecting a sector of the economy in a material way, adversely affecting competition, or adversely affecting jobs. A regulation also is considered a significant regulatory action if it raises novel legal or policy issues. OMB determined that this final rule is a significant regulatory action as defined by Executive Order 12866. Accordingly, OMB has reviewed this final rule and has approved its publication in the Federal Register .

There were no comments that pertained directly or indirectly to the preliminary regulatory impact analysis (PRIA) so FDA has made no change in the evaluation of the regulation for the final regulatory impact analysis. The rulemaking was necessary to implement the FCN process established by FDAMA. The notification process largely will replace the FAP process for FCSs. The FCN process requires FDA to object within 120 days to the notification of an FCS manufacturer or supplier that it intends to market a particular food contact substance for a specific use, or the substance may be marketed legally on the 121st day without issuance of a regulation.

FDA estimates that the social benefits of the change in regime will be from new product innovation. The agency estimates that four times the current annual number of petitions and threshold of regulation exemptions will be introduced into the market, for a total of 416. The social costs from the change in regimes are the costs to submit duplicate notifications. The agency estimates that 50 percent of the total will be duplicates for a total social cost of $26,387,500. For a full explanation of the estimated costs and benefits of this final rule, see the preliminary regulatory impact assessment published in the July 2000 proposal (65 FR 43269 at 43277), which is incorporated by reference.

FDA has examined the economic implications of this final rule as required by the Regulatory Flexibility Act (5 U.S.C. 601-612.) If a rule has a significant economic impact on a substantial number of small entities, the Regulatory Flexibility Act requires agencies to analyze regulatory options that would lessen the economic effect of the rule on small entities.

There were no comments that pertained directly or indirectly to the initial regulatory flexibility analysis so FDA made no change in the evaluation of the regulation for the final regulatory flexibility analysis. The final rule could affect small businesses because new costs will be imposed that did not exist before the change in regimes. A small firm that wants to introduce a new FCS will have to produce more documentation after the final rule than before. However, because the final rule reduces the uncertainty about the period of evaluation of new uses of substances, firms that rely heavily on the authorization of a unique use of a substance stand to benefit the most. Because new small businesses may rely on innovation that requires new use authorization, they are more likely to benefit the most from the final rule. However, they also may incur proportionately greater costs than if they would have relied on rival firms to incur the authorization costs.

Because some small firms are expected to be adversely affected by the final rule, options for regulatory relief, such as a small business exemption, were addressed in the proposed rule. The benefit of this option is that small businesses would not incur an additional cost. The drawback is that small firms could copy and distribute themselves the substances being reviewed in response to the marketing submission of a competitor, thus, creating disincentives for new substance development by rival firms.

There are no additional recordkeeping requirements for the final rule.

FDA estimates that there will be no net costs to small businesses because of this final rule. If small business entities determine that the costs of notification outweigh the benefits, the small business entities could rely on existing authorized FCSs.

Section 1531(a) of the Unfunded Mandates Reform Act of 1995 (Public Law 104-4), defines a significant rule as a Federal mandate that may result in the expenditure by State, local, and tribal governments in the aggregate, or by the private sector, of $100 million (adjusted annually for inflation) in any one year. FDA has determined that this rule does not constitute a significant rule under the Unfunded Mandates Reform Act of 1995.

The agency previously reviewed the potential environmental effects of this final rule as announced in the July 2000 proposal (65 FR 43269). The agency concluded under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

The following references have been placed on display in the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.

1. The authority citation for 21 CFR part 20 continues to read as follows:

The final and temporary regulations that are the subject of these corrections are under sections 401, 403, 408, 457, and 4974 of the Internal Revenue Code.

As published, the final and temporary regulations contain errors that may prove to be misleading and are in need of clarification.

Accordingly, the publication of the final and temporary regulations (TD 8987), that were the subject of FR Doc. 02-8963, are corrected as follows:

1. On page 18991, column 2, in the preamble under the paragraph heading “ Temporary Rules for Defined Benefit Plans and Annuity Contracts ”, first paragraph, line 2 from the bottom, the language “assets has been replaced with this more” is corrected to read “assets have been replaced with this more”.

Increasing the employment of individuals with disabilities is one of the goals of section 501 of the Rehabilitation Act of 1973, as amended (section 501), 1 and Title I and selected sections of Title V of the Americans with Disabilities Act (ADA). 2 Section 501 has prohibited the federal government, as an employer, from discriminating on the basis of disability since the late 1970's. Title I of the ADA applied similar prohibitions to private sector and state and local government employers in 1990. To promote consistent and full enforcement of these two laws, Congress amended section 501 in 1992  3 to adopt the employment nondiscrimination standards of the Americans with Disabilities Act (ADA). 4 In a Notice of Proposed Rulemaking (NPRM), the U.S. Equal Employment Opportunity Commission (EEOC or Commission) proposed to implement the 1992 Amendments by deleting the text of its old section 501 regulation, at 29 CFR 1614.203, and inserting new language to cross-reference the Commission's existing ADA regulation at 29 CFR part 1630. 5 The Commission now responds to public comments submitted in response to this NPRM and issues a final rule. Consistent with President George W. Bush's New Freedom Initiative, this final rule continues “the movement towards full integration of individuals with disabilities” into the workforce and promotes full compliance with section 501. 6

The Commission received fifteen comments in response to this NPRM. Of these comments, four were from federal agencies, two were from federal unions, two from advocacy groups representing persons with disabilities, one from a group representing employment attorneys, and one from a state agency. The remaining submissions were from four individuals and one group not specifically involved with federal employees or disability rights. The Commission has carefully considered all of the comments and, as a result, has made some changes to the proposed regulation. The public comments and the text of the final regulation are discussed below.

An advocacy group for individuals with disabilities expressed concern that paragraph (a) of the proposed rule specifically referenced hiring, placement, and advancement of qualified individuals with disabilities, but did not enumerate all the types of employment discrimination prohibited by the ADA. To clarify that the ADA's broad nondiscrimination standards apply in the federal sector, this commenter suggested cross-referencing the ADA's list of prohibited activities in paragraph (a) and also deleting the specific references to hiring, placement, and advancement.

The Commission concludes that these changes are not necessary because paragraph (b) of the rule already cross references the ADA statute and regulation. Specifically, paragraph (b) states that the ADA's nondiscrimination standards apply to section 501 complaints, and cross references the ADA rule at 29 CFR part 1630. Title I of the ADA, and the ADA rule at 29 CFR part 1630, both enumerate many types of prohibited employment discrimination. In light of this cross-reference, it is unnecessary to supplement paragraph (a) to establish that the ADA's broad discrimination prohibitions apply under section 501. Furthermore, for purposes of simplicity and clarity, the Commission makes paragraph (b) the sole reference to nondiscrimination in the final rule, deleting the general nondiscrimination language from paragraph (a).

One commenter questioned the Commission's proposal to implement the 1992 Amendments by cross-referencing its ADA regulation at 29 CFR part 1630. The Commission remains convinced that this is the most efficient way to implement the 1992 Amendments. The Commission's ADA regulation at 29 CFR part 1630 implements the ADA employment provisions that are cited in the 1992 Amendments. 7

This commenter also correctly noted that the ADA's statutory definition of “employer” excludes the United States. On this basis, the commenter contended that the ADA cannot cover federal employers. This commenter misapprehended both the purpose and effect of the 1992 Amendments and this regulation. Neither the 1992 Amendments nor this regulation result in the ADA directly covering federal employers. Rather, section 501 of the Rehabilitation Act continues to cover federal employers. Due to the text of the 1992 Amendments, however, section 501 now incorporates by reference the ADA's nondiscrimination standards. The ADA's statutory definition of “employer” does not impact the coverage of section 501.

One advocacy group for individuals with disabilities asserted that old subparagraph 1614.203(e)(3), which permitted self-identification for affirmative action purposes, should be retained so that federal agencies can comply with their affirmative action responsibilities under section 501. 8 The Commission has considered the comment but concludes that old subparagraph 1614.203(e)(3) should be deleted in its entirety. Contrary to the commenter's assertions, the ADA standard does not prevent federal employers from satisfying their section 501 affirmative action obligations. The ADA permits affirmative action disability-related inquiries of job applicants if certain requirements are met. Specifically, employers may ask applicants to voluntarily self-identify as individuals with disabilities if the employer is undertaking affirmative action because of a federal, state, or local law (including a veterans' preference law) that requires affirmative action for individuals with disabilities. 9 This would include the government's affirmative action efforts under section 501. See 29 U.S.C. 791(b).

An advocacy group for individuals with disabilities contended that the U.S. Supreme Court's decision in Sutton v. United Airlines, Inc., 527 U.S. 471 (1999), should not apply to section 501. The Commission has considered this comment but does not adopt it. The ADA definition of “disability” as construed by the Supreme Court must apply to section 501. 10

A federal agency commented that the NPRM imposes a burden on federal employers because they may need to determine whether an applicant or employee poses a “direct threat” to health or safety. The Commission has considered this comment but has decided that, pursuant to the 1992 Amendments, the same “direct threat” standard must apply to federal employers as to private employers. The NPRM correctly stated the ADA standard for “direct threat,” which requires employers to assess each individual's ability to safely perform a particular job, based on the most current medical assessment or other objective evidence. 11

Section 501 requires federal employers to provide reasonable accommodation for qualified applicants and employees with disabilities, barring undue hardship. Reasonable accommodation is central to integrating individuals with disabilities into the workforce. 12 The NPRM preamble addressed the ADA's treatment of the interactive process, reassignment, and undue hardship. The Commission reiterates that the ADA standards that apply in private sector employment apply to federal employment as well. 13 The following discussion addresses some of the public comments regarding reasonable accommodation.

The Commission agrees with the public comment that, under ADA standards, a request for reasonable accommodation and the informal interactive process are two distinct steps. First, the individual must request reasonable accommodation, in all but the most limited circumstances. 14 Second, the employer engages in the interactive process if the disability or the type of accommodation needed are not obvious. 15 Under ADA standards, employers must make a reasonable effort to identify an effective accommodation that does not pose an undue hardship. See 29 CFR part 1630 app. 1630.9.

Several agencies expressed concern that section 501 reassignment actions could violate the federal merit promotion system. Under ADA standards, however, reassignment of a qualified individual with a disability is distinct from the competitive selection process. The ADA defines reassignment to be part of the duty of reasonable accommodation, which is a nondiscrimination obligation separate and apart from the competitive selection process. 16 Indeed, the Office of Personnel Management (OPM) has characterized the reasonable accommodation of reassignment as “a non-competitive process.”  17

Agencies also expressed concern that the ADA approach to reassignment permits reassignment of probationary employees, contrary to the categorical prohibition against such reassignment in the old regulation at 29 CFR 1614.203(g). The Commission considered these comments and again concludes that reassignment is available as a reasonable accommodation for probationary employees.

Under the ADA, qualified individuals with disabilities are entitled to reasonable accommodation, barring undue hardship. Reassignment is a form of reasonable accommodation. An individual with a disability is qualified for reassignment if s/he has adequately performed the essential functions of the original position, with or without reasonable accommodation, before the need for reassignment arose. 18 The longer the period of time in which a probationary employee has adequately performed the essential job functions, with or without reasonable accommodation, the more likely it is that reassignment is appropriate if s/he becomes unable to continue performing the essential functions of the position due to a disability. If, however, the probationary employee has never adequately performed the essential functions, with or without reasonable accommodation, then s/he is not entitled to reassignment because s/he was never “qualified” for the original position. 19

Two federal agencies responded to the Commission's request for comment on when a position becomes vacant in the federal government. One agency commented that a position must not only be funded and unencumbered but must also be one that the agency intends to fill rather than eliminate for budgetary or mission reasons. The other agency commented that positions subject to hiring or other employment freezes are not presently funded and so cannot be considered vacant positions even though they may be authorized and not filled. It further contended that if an employee leaves a position, the employer must continue to have the opportunity to decide whether to fund the position, abolish it, or modify it in accordance with changed work or business requirements. Both agencies contended that a position cannot be considered vacant if it has been unconditionally offered to another individual. Finally, one of the agencies argued that a position cannot be considered vacant if another employee has a vested priority to it by seniority or some other superior right based on the employer's non-discriminatory policies.

The Commission agrees that an agency must have an opportunity to decide whether to abolish, modify, or simply continue funding a position after an employee departs. The Commission also agrees that the duty to provide reassignment does not include reassignment to a position for which there has already been an offer to another individual. 20 Finally, a position is not vacant if it is subject to a hiring freeze. Any decision not to continue a position, whether for funding or mission reasons, must not be discriminatorily based.

Several agencies commented on an employer's duty to search for vacancies throughout its organization and on issues involving reassignments denied on the basis of undue hardship. These agencies expressed concern that an obligation to search for vacant positions beyond a commuting area and throughout an entire organization would result in administrative difficulty and expense. One commenter asserted that federal employers should not always be required to search for vacancies in different subagencies or components of the larger agency, because subagencies may be legally separate and may operate under separate appropriations, appointing authorities, and personnel offices. Another commenter urged the Commission to redefine the ADA “undue hardship” standard for the federal sector, so that reassignment decisions could be based on the budget of a particular facility. In the federal sector, the agency commented, a facility may have a limited budget with which to respond to growing public needs.

Under the 1992 Amendments, the Commission is bound by ADA standards, including the undue hardship standard. 21 The Commission concludes, however, that the ADA's “undue hardship” analysis takes into account the operational, financial, and legal relationships between components of large organizations, whether the organizations are private or federal. 22 An employer seeking to demonstrate “undue hardship” under the ADA standard would have to demonstrate why, in light of the resources, operations, and constraints of its particular organization, a reasonable accommodation would result in significant difficulty or expense. If a federal employer seeks to demonstrate that a specific reasonable accommodation poses an undue hardship because it would compromise the agency's mission, the agency needs to factually assess the “impact of the accommodation” on operations. 23

An advocacy group for individuals with disabilities objected that the proposed rule appeared to limit reassignment to situations in which there was no other effective accommodation, or in which all other accommodations would impose an undue hardship. The Commission has consistently interpreted the ADA to mean that reassignment is only required in these circumstances. 24 Reassignment may be an option in other circumstances if the employer and the employee agree to it. 25 To avoid any ambiguity concerning when reassignment is appropriate, we eliminated paragraph (b)(2) which defined the employer's duty to provide reasonable accommodation and reassignment. The remaining cross-reference to the ADA standards in paragraph (b) provides the appropriate standard.

Some federal unions and employers questioned whether reassignment should be required as a reasonable accommodation when it would create a conflict with another employee's seniority rights under a collective bargaining agreement (CBA). These commenters cited developing ADA case law on this issue and urged the view that CBA seniority rights should prevail. Following the submission of these public comments to the Commission, the U.S. Supreme Court decided US Airways, Inc. v. Barnett, No. 00-1250, (U.S. April 29, 2002). In Barnett, the Court considered whether the ADA requires an employer to reassign an individual with a disability as a reasonable accommodation when another employee is entitled to hold the position under an established seniority system.

The Court held that a conflict between a seniority system and a proposed accommodation should be analyzed to determine whether the requested accommodation is reasonable. The Court ruled that “ordinarily” a proposed accommodation will not be reasonable if it conflicts with a seniority system. Barnett, slip op. at 14. However, the Court also stated that, even if an employer shows that the proposed accommodation will violate a seniority system, a plaintiff/employee may nevertheless show that “special circumstances” warrant a finding that the accommodation is “reasonable” on the facts of the particular case. The plaintiff/employee has the burden of proof to show that such “special circumstances” exist. The Court remanded Barnett for consideration under this standard.

In Barnett, a seniority system was linked to longstanding employer practice but was not part of a negotiated CBA. In its analysis, the Court relied primarily on Rehabilitation Act and ADA case law involving collectively bargained seniority systems to conclude that accommodations conflicting with seniority systems are unreasonable absent special circumstances. The Court's language broadly and consistently referred to “seniority systems.” Accordingly, the Commission construes Barnett as applying to CBA seniority provisions as well as to seniority systems based on employer practices.

This regulation will be effective 30 days after publication of the final rule in the Federal Register , and will apply to conduct occurring on or after that date.

The Commission did not receive public comment on its proposal to delete the provision in § 1614.102(a)(9) which refers to reassignment pursuant to § 1614.203(g). That paragraph is now deleted.

Pursuant to Executive Order 12866, EEOC has coordinated this final rule with the Office of Management and Budget. Under section 3(f)(1) of Executive Order 12866, EEOC has determined that the regulation will not have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State or local tribal governments or communities. Therefore, a detailed cost-benefit assessment of the regulation is not required.

This regulation contains no information collection requirements subject to review by the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).

In addition, the Commission certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities, because it applies exclusively to employees and agencies and departments of the federal government. For this reason, a regulatory flexibility analysis is not required.

The proposed rule was published in the Federal Register on July 26, 2001 (66 FR 38967). A 90-day comment period followed (ending October 26, 2001), during which time, EPA Region 4 received 1,050 comments via letter, fax, or E-Mail. The comment tally was 1,016 in favor and 34 opposed. This Federal Register document will address comments submitted in response to the July 26, 2001 (66 FR 38967), Federal Register document. Comments in opposition to the NDZ designation are addressed in section II below in general subject categories. Comments in favor of the NDZ designation focused on the fact that the FKNMS contains unique marine ecosystems(seagrass meadows, third largest coral barrier reef in the world, and mangrove islands) that are a State and national treasure and of high ecological, educational, aesthetic, recreational, and commercial value. Commentors supporting the NDZ pointed out that these ecosystems support tremendous biological diversity, containing more than 6,000 species of plants, fish and invertebrates that depend upon pristine water quality. Further, they stated that all boaters who use the FKNMS share the responsibility to protect this resource for future generations and that establishment and compliance with the NDZ is important and necessary to protect water quality.

A map which delineates the area to be designated can be obtained or viewed by accessing the FKNMS's Web site at http://www.fknms.nos.noaa.gov/ , by calling the Sanctuary office at (305) 743-2437, or by writing to the Sanctuary Superintendent at P.O. Box 500368, Marathon, Florida 33050. Basically, State waters extend from land out to a distance of three statute miles on the Atlantic side of the Florida Keys and nine nautical miles on the Gulf side. It should be noted that the National Oceanic and Atmospheric Administration (NOAA) is pursuing NDZ status for Federal waters within the FKNMS. It is estimated that NOAA will complete its rule-making process in late 2002 or early 2003.

Currently, there are about 30 pump out facilities located throughout the Florida Keys. To obtain a list of these facilities you may contact George Garrett, Director of Marine Resources for Monroe County, at (305) 289-2507, E-mail at garrettg@mail.state.fl.us, or by writing to Monroe County Service Center, 2798 Overseas Highway, Suite 420, Marathon, Florida 33050-2227.

The Florida Keys are a national treasure of international acclaim that contain unique environments and possess high value to humans when properly conserved. Adjacent to the Florida Keys land mass are located spectacular, unique nationally significant marine environments, including seagrass meadows, mangrove islands, and extensive living coral reefs. These marine environments support rich biological communities possessing extensive conservation, recreational, commercial, ecological, historical, research, educational, and aesthetic values. These marine environments are the maritime equivalent of tropical rain forests in that they support high levels of biological diversity, are fragile and easily susceptible to damage from human activities, including nutrient enrichment. The economy of the Florida Keys is based in large part on tourism and fisheries that are directly tied to the ecological resources and quality of the waters surrounding the Florida Keys. In recognition of this, Congress created the FKNMS with the signing of H.R. 5905 (Public Law 101-605, the FKNMS and Protection Act) on November 16, 1990. The purpose of a marine sanctuary is to protect resources and their conservation, recreational, ecological, historical, research, educational, or aesthetic values through comprehensive long-term management. The mission of the National Marine Sanctuary Program is to identify, designate, and comprehensively manage marine areas of national significance. National Marine Sanctuaries are established for the public's long-term benefit, use, and enjoyment. Congress also recognized the critical role of water quality in maintaining the ecological resources of the Florida Keys, and directed the U.S. EPA and the State of Florida to develop a Water Quality Protection Program (WQPP) for the Sanctuary. The WQPP was finalized in September 1996 and implementation of the numerous recommended actions within the WQPP is ongoing.

The State of Florida recognized the importance of water quality to ecosystem structure and function and declared the State waters surrounding the Florida Keys as “Outstanding Florida Waters” (OFW) in 1985. Florida Statute grants the Florida Department of Environmental Protection the power to establish rules that provide for the category of water bodies called OFW, which are worthy of special protection because of their natural attributes. No degradation of water quality is allowed in OFW, except as allowed in Florida Administrative Code (F.A.C.) 62-4.242(2). In addition, the Florida Keys have been designated as an “Area of Critical State Concern.” The objective of this program is to provide another level of legislative review for development plans within areas where unique and fragile natural resources exist and local protection may be lacking. “Areas of Critical State Concern” are declared where there is a perceived need to protect public resources from risk by unregulated or inadequately regulated development. Further, the pristine and unique habitats of the Florida Keys have led to the establishment of special protection areas by the Federal government, including the Key West Wildlife Refuge and the Great White Heron Wildlife Refuge. These actions are further evidence of the importance of the Florida Keys and their unique natural resources.

The purpose of the WQPP is to recommend priority corrective actions and compliance schedules addressing point and nonpoint sources of pollution to restore and maintain the chemical, physical, and biological integrity of the FKNMS. This includes restoration and maintenance of a balanced, indigenous population of corals, shellfish, fish and wildlife, and recreational activities in and on the water. NOAA's Final Management Plan/Environmental Impact Statement for the FKNMS became effective on July 1, 1997 and includes the WQPP. The Monroe County Board of County Commissioners and the State of Florida recognize and support this document.

There is a large community in the Florida Keys that live on boats and many live-aboard vessels are permanently anchored in harbors and are not capable of movement. Transient vessels also anchor in harbors and other protected sites and are very numerous in winter months. The number of live-aboard vessels has increased dramatically in recent years. While the Clean Vessel Act prohibits the dumping of raw sewage, treated wastewater from vessels may be discharged into State waters. Wastewater treatment (disinfection) by Type I and II MSDs does not remove nutrients from wastewater. Many live-aboard and transient vessels discharge wastewater into surface waters. It is estimated that nutrients from vessel wastewater account for about 2.8% of nitrogen and 3.0% of phosphorus loadings into nearshore waters of the Florida Keys (U.S. EPA, 1993, Phase II Report). Nutrient loadings from vessels may be relatively small contributions to total Keys-wide loadings. However, loadings from vessels are a significant source of nutrients to harbors and result in eutrophication of waters that typically exhibit poor circulation/flushing. Violations of fecal coliform standards are common in marinas and harbors throughout the Florida Keys (Florida Department of Environmental Regulation 1987, 1990). The WQPP Phase II Report (1993) and other studies have determined that discharges of wastewater from vessels are degrading water quality in nearshore and confined waters. The final WQPP document (1996) identified the need to eliminate sewage discharges from live-aboard vessels and other vessels as a high priority action item. The State of Florida, as requested by the City of Key West, recently determined that the protection and enhancement of the quality of waters surrounding the City of Key West require greater environmental protection. This action prohibits the discharge from all vessels of any sewage, whether treated or not, into such waters out to a distance of 600 feet from shore. The U.S. EPA, pursuant to section 312(f)(3) of the Clean Water Act (Public Law 92-500), recently (August 25, 1999) concurred with the State's determination that adequate pumpout facilities for safe and sanitary removal and treatment of sewage from all vessels are reasonably available for the waters surrounding the City of Key West.

The Board of County Commissioners of Monroe County, Florida has for some time been concerned about water quality in the Florida Keys. Monroe County's Comprehensive Plan is very strongly predicated upon environmental protection and the associated Executive Order and Work Program adopted by the Florida Governor and Cabinet are geared toward assisting Monroe County with improving and protecting water quality. The Board of County Commissioners of Monroe County has adopted a resolution requesting that the Governor of the State of Florida petition the EPA to declare all waters of the State within the boundaries of the FKNMS to be a NDZ for sewage, whether treated or not, from all vessels. Monroe County believes that this action would be a major step in protecting water quality around the Keys and especially in those areas where there are high concentrations of vessels. The NDZ designation is fully supported by the WQPP Steering Committee and is consistent with the overall goals of the WQPP for the FKNMS. This designation is also consistent with Florida's Area of Critical State Concern Program and the Principles for Guiding Development for the Florida Keys. The Governor of the State of Florida supports Monroe County's decision and submitted the County's request to EPA Region 4, asking EPA to designate all State waters within the boundary of the FKNMS as a NDZ under the authority of section 312(f)(4)(a) of the CWA.

Section 312(f)(4)(a) states: “If the EPA Administrator determines upon application by a State that the protection and enhancement of the quality of specified waters within such State requires such a prohibition, he shall, by regulation completely prohibit the discharge from a vessel of any sewage (whether treated or not) into such waters.” This authority has now been delegated to EPA Regional Administrators. On December 7, 2000, the Governor of Florida, Jeb Bush, requested that EPA Region 4 establish the NDZ status for State waters within the FKNMS. The EPA Region 4 Administrator concurs with this request.

Several commentors appeared to misinterpret the different requirements of Clean Water Act (CWA) section 312(f)(4)(A) and CWA section 312(f)(3) and which regulatory process was being used to propose this NDZ. To propose a NDZ in this situation, there are two primary but distinct regulatory approaches that may be followed. Under CWA section 312(f)(3), the State may designate a NDZ based on a State determination that protection and enhancement of the quality of the waters within the area requires additional protection and a determination by EPA that adequate pump out facilities for safe and sanitary removal and treatment of sewage from vessels are reasonably available. This is contrasted with CWA section 312(f)(4)(A), which focuses solely on the water quality issues and does not require EPA to make the determination that adequate pump out facilities are reasonably available for State waters within the boundary of the NDZ. Under section 312(f)(4)(A), “if EPA determines upon application by a State that the protection and enhancement of the quality of specified waters within the state requires a prohibition, EPA shall, by regulation completely prohibit the discharge from a vessel of any sewage, whether treated or not, into such waters.” In this particular matter, the Board of County Commissioners of Monroe County, by resolution, requested that Florida Governor Jeb Bush submit an application to EPA for a NDZ designation pursuant to section 312(f)(4)(A). The Governor honored this request and applied to EPA under the authority of section 312(f)(4)(a) based on the State's finding that its waters within the boundary of the FKNMS have particular environmental importance considering the unique, fragile, and ecologically important natural resources of the Florida Keys ecosystem. However, although section 312(f)(4)(A) does not require an analysis of whether adequate pump out facilities are reasonably available, due to the number of comments received related to this issue, EPA, working with the County and the State has provided information concerning this issue below.

Many commentors' letters expressed concern about the adequacy of existing pump out facilities in the Florida Keys, including the total number of facilities and the availability of the pump outs. In addition, a few commentors stated that EPA did not investigate the availability of pump out facilities. Although it was not required for this determination under section 312(f)(4)(a), staff from EPA, the Florida Department of Environmental Protection (FDEP), and Monroe County did conduct a survey and collect information on the existing and planned pump out facilities throughout the Florida Keys. This effort identified 29 locations with active pump-out stations and several more in the planning stages (see the summary section of this final notice for instructions on how to obtain this information). The types of pump outs varied from stationary facilities located on docks, to carts that boaters can roll to their vessels, to pump out boats/barges that navigate to vessels in need of pump out services. The hours of operation usually coincided with the normal business hours of marinas and many facilities were open seven days a week. Several pump out stations in Key West are capable of servicing large vessels. During the survey, a review of GIS maps identified several areas throughout the Florida Keys where gaps exist and where additional pump out facilities may be needed. The survey effort resulted in the development of a detailed spreadsheet and maps with specific information concerning all pump out facilities in the Florida Keys. Ideally, about 26 additional pump out facilities are recommended (by the interagency planning group mentioned above) throughout the Florida Keys for total coverage along the entire length of the islands which would eliminate the identified gaps. It should be noted that most of those areas in the Florida Keys with large populations and density of vessels have available pump out stations.

Currently, the majority of existing marinas in the Florida Keys are not required to provide pump out services. State regulations only require installation of pump out systems for new and expanded docking facilities where the development project involves construction of ten or more slips in Outstanding Florida Waters, pursuant to Rule 62-312.430 of the Florida Administrative Code (F.A.C.), or in sovereign submerged lands owned by the State, in accordance with Rule 18-21.0041(1)(b)6, F.A.C.

The FDEP Division of Law Enforcement administers the Clean Vessel Act (CVA) grant program. Under this program, grants are available to fund installation of vessel sewage pump out facilities and portable toilet dump stations at marinas. These grants can be used to fund mobile pump out systems and are available to local governments and commercial and non-profit entities operating marinas, boat ramps, mooring fields, etc.

Projects under this program receive federal/state funds for up to 75% of the project cost. Grantees are required to provide pump out services to the recreational boating public and fees shall not exceed $5.00 per service, unless justified and approved by FDEP and the U.S. Fish and Wildlife Service. FDEP staff is currently working with local governments and marina owners to increase the number of pump out facilities. Since 1996, eighteen pump out facilities have been funded with CVA grants totaling approximately $520,000 in the Florida Keys. In addition, National Fish and Wildlife Foundation and Coastal Improvement Assistance Program (CIAP) grants obtained by Monroe County will be used to establish mooring fields. CIAP grants will also be used to develop additional pump out systems.

FDEP in consultation with EPA and many other state, regional, local, and federal government agencies and concerned citizens have initiated an effort to develop an implementation plan for the NDZ. This implementation plan will consist of many components, including a public education/outreach program, a strategy to develop additional infrastructure (pump outs, mooring fields, etc.) and an enforcement strategy. Initial efforts will be focused on public education and outreach and the construction of additional pump out facilities in areas where gaps have been identified. Initially, enforcement of the NDZ will be focused in the marinas, harborages, and other protected areas where vessels congregate and where pump out facilities are available. Later, after pump out stations are added in the areas with gaps, enforcement will be expanded to all areas of the Florida Keys.

One group of commentors representing the tugboat, barge, and towboat industry commented that there are no existing facilities in the Florida Keys that can accommodate large tug/towboat units. In 1999, pursuant to section 312(f)(3) of the CWA, the State of Florida designated the waters around the City of Key West out to a distance of 600 feet from shore as a NDZ and EPA determined that adequate pump out facilities for safe and sanitary removal and treatment of sewage from vessels are reasonably available. In addition, according to the Assistant City Manager of Key West, there are existing facilities in the City of Key West that can accommodate large ocean-going vessels and can provide pump out services. The dock at Mallory Square can accommodate large tugs and towboats and presently, the City pumps the holding tanks of large vessels by running a hose from the dock to a sewage collection line that is directly connected to the City's state-of-the-art sewage treatment and disposal facility. The City has plans to install a large capacity pump station capable of servicing large vessels at Mallory Square by April 2002. The U.S. Naval Base at Truman Annex in Key West can also accommodate large vessels and is equipped with a pump out station that is directly connected to the collection system of the City's wastewater treatment facility. This U.S. Naval facility may be transferred to the City of Key West in the near future and can now be used by the City in emergency situations for pump out services. The U.S. Coast Guard Base at Trumbo Point does receive fuel shipments via tankers and this facility has a pump out station that is connected to the Key West wastewater management system. In addition, the City of Key West operates a pump out vessel with a capacity of 300 gallons and is scheduled to acquire another pump out vessel with a capacity of 1,000 gallons by summer 2002. Accordingly, consistent with our 1999 determination, EPA still believes that there are sufficient pump out facilities in the Key West area to service the limited number of ocean-going tugs, towboats, and other large vessels with destinations in the Key West area. Further, we believe that ocean-going barge traffic navigating through Sanctuary waters should be able to retain the minimum volume of sewage generated while in Sanctuary waters and then discharge that sewage when outside the established NDZ in an environmentally safe manner.

Some commentors questioned whether land-based wastewater treatment systems were more effective at treating and disposing of sewage from vessels than Type 1 and 2 MSDs. EPA believes that the land based facilities which are available to treat the pumped sewage are more effective in removing a greater range of pollutants than the Type 1 and Type 2 MSDs. Type 1 and 2 MSDs are flow-through devices for treating and discharging sewage on commercial and recreational vessels that are equipped with installed toilets. When operated properly, these devices macerate fecal material and add chemicals, or otherwise treat/disinfect the sewage to meet specified requirements for fecal coliform bacteria. However, Type 1 and 2 MSDs do not remove nutrients and other pollutants (e.g.; oxygen demanding materials) that contribute to water quality degradation. The City of Key West and the City of Key Colony Beach have recently completed significant and costly upgrades to their wastewater management systems, including construction of advanced wastewater treatment plants, subsurface well injection of effluent, and replacement of inadequate sewage collection lines. In addition, there are waste water treatment facilities in the Miami area that properly treat and dispose of sewage pumped from vessel holding tanks. Further, Monroe County's Sanitary Wastewater Master Plan has been completed and the County is pursuing wastewater system upgrades to state-of-the-art wastewater management systems that remove the vast majority of nutrients from sewage prior to disposal. Pursuant to recent State legislation, all new and expanded land-based wastewater discharges permitted in the Florida Keys after June 1999 are required to meet best available technology standards for treatment and disposal, including nutrient removal. In addition, the legislation requires all existing sewage treatment plants and on-site sewage treatment and disposal systems to meet these standards by year 2010.

Several commentors stated that they had already installed an approved Type 1 MSD and that this type device is adequate to protect the environment. Boaters who have taken the initiative to install approved Type 1 MSD devices are to be commended. However, as mentioned above, Type 1 MSDs do not remove nutrients or the biochemical oxygen demand loading from vessel sewage. The population of the Florida Keys includes a large number of individuals that live on their boats and many of these vessels are permanently anchored in various harbors throughout the chain of islands. Thousands of transient vessels also anchor in harbors and other protected sites and are especially numerous in the winter months. Nutrient loadings from vessels may be a relatively minor contribution to total Keys-wide loadings. However, loadings from vessels are a significant source of nutrients to harbors and other protected areas that experience poor circulation and flushing contributing to eutrophication. Several scientific studies have determined that discharges from vessels have caused degraded water quality in nearshore areas of confined and semi-confined waters. The discharge of minimally treated sewage from vessels is not consistent with the numerous actions that the State of Florida and Monroe County have taken to restore and protect the water quality of the Florida Keys, and which formed the basis for the State's application for a NDZ.

Some respondents to the NDZ Federal Register Notice pointed out that land-based sources of pollution are the primary cause of water quality problems in the Florida Keys and that the relative contribution of vessel sewage versus other sources is minuscule. It is true that comparatively, most sewage nutrients entering the nearshore waters of the Florida Keys are from land-based sources such as inadequate cesspits, malfunctioning septic systems, and leaky collection lines associated with aging wastewater treatment plants. It is also true that the relative contribution of vessel sewage versus other sources represents a small percentage of the overall sewage load entering the system. Several scientific studies conducted in the Florida Keys have documented that sewage and the associated nutrients from onsite wastewater treatment systems migrate from land to semi-confined waters (canal systems) and other nearshore coastal waters and cause water quality degradation and eutrophication of the environment. It is estimated that nutrients from vessel wastewater account for only about 2.8% of the total nitrogen and 3.0% of the total phosphorus loadings into nearshore waters of the Florida Keys (EPA, 1999). However, loadings from vessels are a significant source of nutrients to harbors, marinas, and other protected areas where vessels congregate and result in eutrophication of waters that typically exhibit poor circulation and flushing. The WQPP document and action plan (EPA, 1996) concluded that sewage discharges from vessels were degrading water quality in nearshore and confined waters. However small the contribution from vessels may be, the fact remains that nutrients from vessel sewage does negatively impact the fragile environment of the Florida Keys (additional information is provided in section G below).

Several commentors expressed concern over the relatively large size of the proposed NDZ and felt that enforcement would be difficult. These respondents also commented that previous NDZ designations in other areas (i.e., Rhode Island) have been ineffective. As mentioned above, FDEP in consultation with EPA and many other state, regional, local, and federal government agencies and concerned citizens have initiated an effort to develop an implementation plan for the NDZ. This implementation plan will consist of many components, including a public education/outreach program, a strategy to develop additional infrastructure (pump outs, mooring fields, etc.), and an enforcement strategy. Initial efforts will be focused on public education and outreach and the construction of additional pump out facilities in areas where gaps have been identified. The NDZ implementation plan recommends that enforcement activities be phased in after the public education/outreach initiative. The recommended approach is to conduct a comprehensive public education/outreach program, after the NDZ designation becomes effective, before taking formal enforcement action, issuing citations, and imposing penalties. This phased approach will not apply to the previously established NDZ for the jurisdictional waters surrounding the City of Key West. Marine law enforcement agencies including federal, State, and local governments will actively participate in the implementation of the public education/outreach program by distributing information on the NDZ regulations to boaters.

Initially, enforcement of the NDZ will be focused in the marinas, harborages, and other protected areas where vessels congregate and where pump out facilities are available. Later, after pump out stations are added in the areas that have been identified as requiring pump outs, enforcement activities can be expanded to all areas of the Florida Keys. Achieving 100% compliance with the NDZ designation in all the State waters of the FKNMS is probably not realistic. However, EPA does believe that the vast majority of the boating public will voluntarily comply with the requirements of the NDZ and utilize the available pump out stations. This will lead to a decrease in the amount of nutrients and other pollutants entering the waters of the FKNMS and an increase in the level of protection for the waters and unique marine resources of the Florida Keys ecosystem. EPA staff reviewed the magazine articles provided by respondents concerning the Rhode Island NDZ and have discussed the status of this NDZ with staff from EPA Region 1 in Boston, Massachusetts. Problems do appear to exist with the availability of pump out facilities during certain times of the day and in some specific areas throughout the designated NDZ area. However, this information does not lead to a conclusion that the NDZ for the State of Rhode Island is ineffective. Based on the existing level of public concern for and demonstrated desire to protect the environment of the Florida Keys and the level of commitment and willingness to cooperate and coordinate on the part of all levels of government, we are confident that the NDZ designation for State waters within the boundary of the FKNMS will be successful.

The Florida Keys have been, and continue to be an international tourist/boating destination. According to a study sponsored by NOAA, the Florida Keys Tourist Development Council, and The Nature Conservancy, visitors in the Florida Keys spent $1.38 billion during the 12-month period from June 1997 through May 1998. The primary attractions for people who visit this area are warm weather, historic areas, fishing, and diving/snorkeling activities that are available in the nearby coral reef communities. Currently, the coral reef ecosystem is degrading. Coral reefs require waters low in nutrients to thrive. Therefore, actions that reduce the input of nutrients into this system are likely to benefit coral reefs. If the coral reefs and associated biological resources are allowed to decline, then a significant portion of the attraction for visiting this area will no longer exist.

One commentor thought that a NDZ would make it illegal to discharge grey water associated with bathing and washing dishes. Designation of an area as a NDZ does not make it illegal to discharge grey water. Another commentor believed that the NDZ would outlaw existing Type 1 and 2 MSDs currently installed onboard vessels. The NDZ designation would not cause existing Type 1 and 2 MSDs to be in violation by their mere presence onboard the vessel. However, it would be illegal for vessel operators to discharge from these devices while inside the NDZ. Type 1 and 2 MSDs should be secured to prohibit discharge while navigating or otherwise situated within the NDZ.

Some commentors stated that holding tanks were personally unacceptable and installation of Type 3 MSDs could cause various problems, including unpleasant odors, decrease in boat stability, and substantially reduce the limited usable space on the average vessel. Cost to retrofit was also cited as a negative impact on boat owners. It is indisputable that boating safety is an important consideration. Neither EPA or the State of Florida would promulgate any rule which compromises the safety of the boating public. Installation of a holding tank should be approached no differently than any other marine retrofit, and if done properly by a well-trained and certified marine mechanic, safety, odor, and cost issues can be dealt with effectively. According to the Monroe County Department of Marine Resources and the FDEP Division of Law Enforcement, the average cost of installing a typical Type 3 MSD in most vessels should be about $600. As an alternative, portable toilets (i.e.; porto-potties) can be purchased ($50 to $100) and used onboard most vessels, or boaters can tie-up at a marina with shoreside facilities.

The vast majority of vessels that operate within the FKNMS are recreational (approximately 22,000 registered recreational vessels). However, there are a significant number of commercial fishing, charter/dive/party boats, and some tugboats/towboats that operate within the boundary of the FKNMS. According to the U.S. Coast Guard, most charter/dive/party boats in the Florida Keys are already equipped with Type 3 MSDs and these commercial vessels will be able to use the available pump out facilities (most already do this) and comply with the NDZ rule. Other commercial vessels without Type 3 MSDs should be able to retrofit for less than $1,000 in most cases. A commercial vessel (e.g., tugboat/towboat, etc.) operator with an existing Type 2 MSD that chooses not to retrofit (prohibitive cost or other considerations) may install an appropriate portable toilet in addition to the existing Type 2 MSD for use while navigating through waters of the FKNMS designated as a NDZ.

Several commentors were concerned about the cost to pump out vessel holding tanks. EPA, FDEP, and Monroe County conducted a survey and collected information on the existing pump outs in the Florida Keys and determined that the range of costs to pump out was from $5.00 to $25.00, with the majority of pump out facilities charging $5.00. The number of times a tank will need to be pumped out will depend on usage. Live-aboards will have to pump out fairly often while less frequent boat users will need to empty the tank much less often. Using $10.00 as the pump out charge, ($10 is on the high end, most pump outs cost $5) and one pump out per week, results in an estimated annual cost of $520 per vessel per year. Annual costs in this range are considered reasonable. It should also be noted that pump out fees may qualify as a business expense and may be tax deductible for some vessel owners.

One commentor suggested that it would be a better use of funds from FDEP to provide money for research into more effective MSD technology. The State of Florida, in accordance with section 312 (f)(4)(A) filed an application for the designation of the NDZ and EPA has the responsibility of processing that application. EPA would always encourage research into more effective means to reduce pollution that is being discharged into the nation's waters. However, whether FDEP should fund research into more effective MSDs is an issue that EPA would defer to the State.

Several commentors claimed that there is no scientific evidence to demonstrate that the proposed NDZ will improve water quality in the Florida Keys aquatic environment. It is their opinion that Type I or Type II MSDs are effective and that their use does not contribute to water quality problems.

As part of the Florida Keys National Marine Sanctuary and Protection Act of 1990, specific programs were established to address water quality issues. Water quality matters in the Florida Keys are reviewed and evaluated by the Steering Committee for the Water Quality Protection Program. The Steering Committee consists of federal and State resource agency managers, local elected officials and knowledgeable citizens. The Steering Committee receives technical guidance from the Water Quality Protection Program Technical Advisory Committee which consists of scientists from the Florida Keys and South Florida. Both committees concurred that water quality concerns in the Florida Keys must be addressed comprehensively. The committees concluded that elimination of discharges from vessels, including discharge from Type I or Type II MSDs, will eliminate a known source of water quality degradation.

A major challenge to scientists and managers working in the Florida Keys, and elsewhere, is being able to differentiate the natural variability of ecosystems from human-caused disturbances. Signs of ecosystem stress in the Florida Keys include loss of coral cover and diversity, particularly at offshore bank reefs, increasing nitrogen and phosphorus concentrations in the near shore waters, decreased water clarity, and changes in the natural benthic community composition. Comprehensive monitoring has documented a 37% reduction in stony coral coverage between 1996 and 2000. Also, the reason that monitoring was initiated was the observed, but poorly quantified loss of coral cover at many sites prior to 1996. Habitat and water quality degradation in canals and other semi-confined waters within the Florida Keys has been measured and is related to population density. The distance from shore at which ecological changes are attributable to sources of pollution continues to be a subject of scientific debate.

Scientists have postulated that the observed degradation of the Florida Keys marine ecosystem is due to multiple stressors operating on different scales. The increase in atmospheric carbon dioxide and warming of ocean waters is occurring on a global scale and may be responsible for weakening corals through bleaching or other heat-related stresses. Nutrient addition to coastal waters is a local stressor that may be more easily managed than others by implementing wastewater and storm water treatment technologies to eliminate or significantly reduce nutrient addition.

Just like lawn fertilizer, human wastes contain nutrients that if discharged to water can stimulate algal growth and deplete the amount of oxygen in the water. Algal growth and changes in water chemistry are two of the identified factors in ecosystem decline. The most readily observed impacts of nutrient addition occur in confined waters (canals, marina basins) because of reduced circulation and/or reduced dilution. However, it is feared that if nutrient additions continue or increase, those perturbations will result in changes in community structure further and further from shore.

Manipulative experiments in seagrass beds in south Florida have demonstrated that the time course of response of seagrass beds to nutrient enrichment is on the order of decades. Since the bank reefs are already stressed and are a major component of the economy of the Keys, it is prudent to reduce all manageable sources of pollution before additional environmental degradation occurs.

The Florida Keys ecosystem is, hydrologically, very “open.” Water current directions and speeds are very complex and are just beginning to be understood. Nutrients and other pollutants derived from other geographical areas undoubtedly reach waters surrounding the Florida Keys. The mass balance loadings from these various sources have not been quantified because of the hydrological complexity. However, nutrient loadings from land-based sources and vessels in the Keys have been estimated (EPA, 1993; Monroe County Sanitary Wastewater Master Plan, 2000; Monroe County Storm Water Master Plan, 2001). Nutrient loading to a water body can come from various land-based sources including residential, commercial, and municipal sewage treatment systems, poor storm water practices, and other discharges from shoreline facilities and boats.

It is estimated that nutrients from vessel wastewater account for only about 2.8% of the total nitrogen and 3.0% of the total phosphorus loadings into nearshore waters of the Florida Keys (EPA, 1999). While these percentages may not seem significant Keys-wide, it is thought that vessel discharge is a major contributor of nutrients in harbors and other anchorages where vessels congregate.

Type I MSDs treat sewage with disinfectant chemicals before discharge and the discharges must not show any visible floating solids. Type II MSDs provide a higher level of maceration and disinfection, and the discharge contains a greater level of chemicals. Neither Type I or Type II MSDs remove nutrients from the discharge. Raw sewage or improperly treated sewage from vessels or other sources is not only visually repulsive, but also has the potential to expose swimmers and shellfish to pathogens.

Waterborne illnesses directly attributable to sewage pollution include hepatitis, typhoid, cholera, and gastroenteritis. The indicators used to detect the presence of sewage pollution are usually not the pathogens themselves, but rather a type of bacteria called fecal coliform bacteria. Fecal coliform bacteria detected in water can be an indicator of the presence of human waste and the potential exposure to diseases. Enterococci bacteria are another indicator of fecal contamination that is more specific to human wastes than fecal coliform bacteria. When bacteria levels exceed designated public health standards, swimming beaches and shellfish beds may be closed, which can harm tourism and deteriorate the quality of life.

Several studies conducted by the FDEP, or its predecessor agency, have documented water quality standard violations or other signs of eutrophication (nutrient enrichment) in areas where vessels congregate in the Florida Keys. In 1985, State scientists studied the water quality of waters surrounding the Keys in preparation for their proposed designation as Outstanding Florida Waters (OFW). That study concluded that the majority of waters met the criteria for designation as OFW, but that certain areas, including canals and other confined waters exhibited low values in dissolved oxygen, high nutrient concentrations, and violations of the fecal coliform standard. These areas were listed as “hot spots” by EPA (Phase 1 Report, 1992). Included in that list are several marinas or boat basins (e.g., Plantation Yacht Harbor, Faro Blanco Marina, Boot Key Harbor, Oceanside Marina, and Garrison Bight Marina).

In 1984, FDEP (1987) measured water quality parameters in the vicinity of the City of Marathon (Middle Keys). High levels of nutrients and fecal coliform bacteria were found at Faro Blanco Marina during the tourist season due to discharge of sewage from vessels. In 1990, the Florida Department of Environmental Regulation conducted an intensive one-year study to assess the water quality in Boot Key Harbor (Marathon). Boot Key Harbor is a basin with limited flushing that has approximately 400 live-aboard vessels during winter months. The canals discharging into the basin and the basin itself had reduced oxygen concentration and high fecal coliform concentrations. Fecal coliform levels in the basin were highest during winter months at stations in close proximity to live-aboard vessels; violations of the State standard for fecal coliform bacteria were common.

In 1994, Lapointe et al. assessed nutrient concentrations along transects from known sources, including House Boat Row (Cow Key Channel), Key West. Nutrients were highest at the sources and decreased seaward. They found elevated nutrients hundreds of meters offshore of the source. Because any degradation from ambient conditions is a violation of OFW standards, these elevated nutrient concentrations were a violation of State water quality standards. They also concluded that nutrient enrichment was resulting in significant degradation to seagrass community structure for a considerable distance from shore.

One commentor stated that the use of MSDs on commercial vessels transiting the Keys would cause no water quality or habitat degradation. There are no site-specific scientific studies available that directly address that matter. There are many variables to consider in assessing the impacts of vessels transiting Keys waters including the volume of discharge, level of treatment, the number of vessels, the depth and distance from shore or other sources of pollution, current patterns, and the habitat type at the discharge point. The dilution of wastewater from a single vessel transiting the Keys may be so great that the discharge may not cause serious ecological problems and may not be detectable within a short distance from the point of discharge. However, the cumulative impact from many transiting vessels could be significant. The potential impacts are increased if the transiting vessels discharge in close proximity to coral reef or seagrass habitats. As a practical matter, allowing some vessels to discharge at some locations within the FKNMS would lead to confusion among boaters and enforcement problems. Thus, it is our determination that the prudent and expedient course of action is to eliminate all discharges of wastewater from all vessels in State waters in the FKNMS.

At least one commentor noted that the jurisdictional waters surrounding the City of Key West have previously been designated as a NDZ and suggested that the proposed Keys-wide NDZ be limited to 600 feet from shore and only in areas with adequate pump outs. EPA, pursuant to section 312 (f)(3) of the CWA, concurred (August 1999) with the State of Florida's determination that adequate pump out facilities for safe and sanitary removal and treatment of sewage from all vessels are reasonably available for waters surrounding the City of Key West. The action cited above prohibits the discharge from all vessels of any sewage, whether treated or not, into such waters around Key West out to a distance of 600 feet from shore.

Based on information provided by the Monroe County Department of Marine Resources, there are many vessel anchorage areas (both nearshore and offshore) throughout the Florida Keys that are outside the zone that would be delineated by a line 600 feet from shore. Many, if not most, of these anchorages are situated in areas with extensive living corals, seagrass meadows, and other unique and ecologically important marine resources. A NDZ limited to 600 feet from shore would not provide an increased level of protection to a vast area within the FKNMS that contains fragile and nationally significant marine resources. In addition, limiting the NDZ area to a line 600 feet from shore would cause confusion among the boating public and would complicate and confound enforcement of the NDZ designation. Therefore, EPA believes that the NDZ should encompass all State waters within the boundary of the FKNMS to provide the highest level of protection afforded by law to the waters and the precious marine ecosystem of the Florida Keys.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), the Agency must determine whether the regulatory action is significant and therefore subject to Office of Management and Budget (OMB) review and the requirements of the Executive Order. This Order defines “significantly regulatory action” as likely to result in a rule that may:

(1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities;

(2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;

(3) Materially alter the budgetary impact or entitlement, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or

(4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.

The State of Florida is requesting that EPA take action to designate State waters within the FKNMS as a NDZ. Therefore, this order does not apply.

This order pertains to compliance costs of this rule to tribes. There are no tribal lands within the boundaries of the FKNMS. Therefore, this order does not apply.

This order authorizes EPA the discretion to consider health or safety risks (especially for children) when making regulatory determinations. The net result of this action will be to improve environmental conditions within the FKNMS.

Pursuant to the Regulatory Flexibility Act of 1980, 5 U.S.C. 6501 et seq whenever an agency is developing regulations, it must prepare and make available for public comment the impact of the regulations on small entities (i.e., small businesses, small organizations, and small governmental jurisdictions). A regulatory flexibility analysis is not required if the head of the agency certifies that the rule will not have significant economic impact on a substantial number of small entities. EPA policy dictates that an Initial Regulatory Flexibility Analysis (IRFA) be prepared if the proposed action will have any significant effect on any small entities. An abbreviated IRFA can be prepared depending on the severity of the economic impact and relevant statute's allowance of alternatives. After considering the economic impacts of this proposed regulation/rule on small entities, EPA certifies that this action will not have a significant economic impact on a substantial number of small entities.

The Paperwork Reduction Act, 44 U.S.C. 3501 et seq. , is intended to minimize the reporting and recordkeeping burden on the regulated community, as we minimize the cost of Federal information collection and dissemination. In general, the Act requires that information requests and recordkeeping requirements affecting 10 or more non-Federal respondents be approved by OMB. Since today's rule would not establish or modify any information and recordkeeping requirements, it is not subject to the requirements of the Paperwork Reduction Act.

Under section 202 of the Unfunded Mandates Reform Act of 1995 (the Act), Public Law 104-4, which was signed into law on March 22, 1995, EPA generally must prepare a written statement for rules with Federal mandates that may result in estimated costs to State, local, and tribal governments in the aggregate, or to the private sector, of $100 million or more in any one year. When such a statute is required for EPA rules under section 205 of the Act, EPA must identify and consider alternatives, including the least costly, most cost-effective or least burdensome alternative that achieves the objectives of the rule. EPA must consider that alternative, unless the Administrator explains otherwise in the final rule. Before EPA establishes regulatory requirements that may significantly or uniquely affect small governments, including tribal governments, it must develop under section 203 of the Act a small government agency plan. The plan must provide for notifying potentially affected small governments, giving them opportunity for meaningful and timely input during the development of EPA regulatory proposals with significant Federal intergovernmental mandates, and informing, educating, and advising them of compliance with the regulatory requirements.

EPA, in consultation with local and State government officials, has determined that this rule does not include a Federal mandate that will result in estimated annualized costs of $100 million or more to either State, local, and tribal governments in the aggregate, or to the private sector. All vessels that are equipped with MSDs and that navigate throughout the FKNMS are already subject to the EPA MSD Standard at 40 CFR part 140 and the U.S. Coast Guard MSD Standard at 33 CFR part 159. These standards prohibit the overboard discharge of untreated vessel sewage in State waters in the FKNMS and require that vessels with on-board toilets shall have U.S. Coast Guard certified MSDs which either retain sewage or treat sewage to the applicable standards.

There are 3 types of MSDs certified by the U.S. Coast Guard. Only those vessels that have either one of the two types of certified flow-through devices will be affected by this rule. Those vessels affected by this rule will either retain and pump out treated sewage or discharge outside of the designated NDZ. Any costs associated with those activities is minimal and it is therefore estimated that the annualized costs to State or tribal governments in the aggregate, or to the private sector, will not exceed $100 million.

Therefore, this rule is not subject to the requirements of sections 202 and 205 of the Act. Because the rule contains no regulatory requirements that might significantly or uniquely affect small governments, it is also not subject to the requirements of section 203 of the Act. Small governments are subject to the same requirements as other entities whose duties result from this rule and they have the same ability as other entities to retain and pump out treated sewage or discharge outside of the designated zones.

The modified base flood elevations are not listed for each community in this interim rule. However, the address of the Chief Executive Officer of the community where the modified base flood elevation determinations are available for inspection is provided.

Any request for reconsideration must be based upon knowledge of changed conditions, or upon new scientific or technical data.

The modifications are made pursuant to section 201 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq. , and with 44 CFR part 65.

For rating purposes, the currently effective community number is shown and must be used for all new policies and renewals.

The modified base flood elevations are the basis for the floodplain management measures that the community is required to either adopt or to show evidence of being already in effect in order to qualify or to remain qualified for participation in the National Flood Insurance Program (NFIP).

These modified elevations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own, or pursuant to policies established by other Federal, state or regional entities.

The changes in base flood elevations are in accordance with 44 CFR 65.4.

National Environmental Policy Act. This rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Consideration. No environmental impact assessment has been prepared.

Regulatory Flexibility Act. The Acting Executive Associate Director, Mitigation Directorate, certifies that this rule is exempt from the requirements of the Regulatory Flexibility Act because modified base flood elevations are required by the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are required to maintain community eligibility in the National Flood Insurance Program. No regulatory flexibility analysis has been prepared.

Regulatory Classification. This interim rule is not a significant regulatory action under the criteria of Section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

Executive Order 12612, Federalism. This rule involves no policies that have federalism implications under Executive Order 12612, Federalism, dated October 26, 1987.

Executive Order 12778, Civil Justice Reform. This rule meets the applicable standards of Section 2(b)(2) of Executive Order 12778.

The modified BFEs are not listed for each community in this interim rule. However, the address of the Chief Executive Officer of the community where the modified BFE determinations are available for inspection is provided.

Any request for reconsideration must be based on knowledge of changed conditions or new scientific or technical data.

The modifications are made pursuant to section 201 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq. , and with 44 CFR part 65.

For rating purposes, the currently effective community number is shown and must be used for all new policies and renewals.

The modified BFEs are the basis for the floodplain management measures that the community is required to either adopt or to show evidence of being already in effect in order to qualify or to remain qualified for participation in the National Flood Insurance Program (NFIP).

These modified BFEs, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own, or pursuant to policies established by other Federal, State, or regional entities.

The changes in BFEs are in accordance with 44 CFR 65.4.

National Environmental Policy Act . This rule is categorically excluded from the requirements of 44 CFR Part 10, Environmental Consideration. No environmental impact assessment has been prepared.

Regulatory Flexibility Act . The Acting Administrator for Federal Insurance and Mitigation Administration certifies that this rule is exempt from the requirements of the Regulatory Flexibility Act because modified BFEs are required by the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are required to maintain community eligibility in the NFIP. No regulatory flexibility analysis has been prepared.

Regulatory Classification . This interim rule is not a significant regulatory action under the criteria of Section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

Executive Order 12612, Federalism . This rule involves no policies that have federalism implications under Executive Order 12612, Federalism, dated October 26, 1987.

Executive Order 12778, Civil Justice Reform . This rule meets the applicable standards of Section 2(b)(2) of Executive Order 12778.

FEMA makes the final determinations listed below of the final determinations of modified BFEs for each community listed. These modified elevations have been published in newspapers of local circulation and ninety (90) days have elapsed since that publication. The Acting Administrator, Federal Insurance and Mitigation Administration, has resolved any appeals resulting from this notification.

The modified BFEs are not listed for each community in this notice. However, this rule includes the address of the Chief Executive Officer of the community where the modified BFE determinations are available for inspection.

The modifications are made pursuant to section 206 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq. , and with 44 CFR part 65.

For rating purposes, the currently effective community number is shown and must be used for all new policies and renewals.

The modified BFEs are the basis for the floodplain management measures that the community is required to either adopt or to show evidence of being already in effect in order to qualify or to remain qualified for participation in the National Flood Insurance Program (NFIP).

These modified BFEs, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own, or pursuant to policies established by other Federal, State, or regional entities.

These modified BFEs are used to meet the floodplain management requirements of the NFIP and are also used to calculate the appropriate flood insurance premium rates for new buildings built after these elevations are made final, and for the contents in these buildings.

The changes in BFEs are in accordance with 44 CFR 65.4. National Environmental Policy Act. This rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Consideration. No environmental impact assessment has been prepared.

Regulatory Flexibility Act. The Acting Administrator, Federal Insurance and Mitigation Administration, certifies that this rule is exempt from the requirements of the Regulatory Flexibility Act because modified base flood elevations are required by the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are required to maintain community eligibility in the NFIP. No regulatory flexibility analysis has been prepared.

Regulatory Classification. This final rule is not a significant regulatory action under the criteria of Section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

Executive Order 12612, Federalism. This rule involves no policies that have federalism implications under Executive Order 12612, Federalism, dated October 26, 1987.

Executive Order 12778, Civil Justice Reform. This rule meets the applicable standards of Section 2(b)(2) of Executive Order 12778.

The Federal Emergency Management Agency makes the final determinations listed below of modified base flood elevations for each community listed. These modified elevations have been published in newspapers of local circulation and ninety (90) days have elapsed since that publication. The Acting Executive Associate Director has resolved any appeals resulting from this notification.

The modified base flood elevations are not listed for each community in this notice. However, this rule includes the address of the Chief Executive Officer of the community where the modified base flood elevation determinations are available for inspection.

The modifications are made pursuant to section 206 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq. , and with 44 CFR part 65.

For rating purposes, the currently effective community number is shown and must be used for all new policies and renewals.

The modified base flood elevations are the basis for the floodplain management measures that the community is required to either adopt or to show evidence of being already in effect in order to qualify or to remain qualified for participation in the National Flood Insurance Program (NFIP).

These modified elevations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own, or pursuant to policies established by other Federal, state or regional entities.

These modified elevations are used to meet the floodplain management requirements of the NFIP and are also used to calculate the appropriate flood insurance premium rates for new buildings built after these elevations are made final, and for the contents in these buildings.

The changes in base flood elevations are in accordance with 44 CFR 65.4. National Environmental Policy Act. This rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Consideration. No environmental impact assessment has been prepared.

Regulatory Flexibility Act. The Acting Executive Associate Director, Mitigation Directorate, certifies that this rule is exempt from the requirements of the Regulatory Flexibility Act because modified base flood elevations are required by the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are required to maintain community eligibility in the NFIP. No regulatory flexibility analysis has been prepared.

Regulatory Classification. This final rule is not a significant regulatory action under the criteria of Section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

Executive Order 12612, Federalism. This rule involves no policies that have federalism implications under Executive Order 12612, Federalism, dated October 26, 1987.

Executive Order 12778, Civil Justice Reform. This rule meets the applicable standards of Section 2(b)(2) of Executive Order 12778.

The Federal Emergency Management Agency (FEMA or Agency) makes final determinations listed below of base flood elevations and modified base flood elevations for each community listed. The proposed base flood elevations and proposed modified base flood elevations were published in newspapers of local circulation and an opportunity for the community or individuals to appeal the proposed determinations to or through the community was provided for a period of ninety (90) days. The proposed base flood elevations and proposed modified base flood elevations were also published in the Federal Register .

This final rule is issued in accordance with Section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part 67.

The Agency has developed criteria for floodplain management in floodprone areas in accordance with 44 CFR part 60.

Interested lessees and owners of real property are encouraged to review the proof Flood Insurance Study and Flood Insurance Rate Map available at the address cited below for each community.

The base flood elevations and modified base flood elevations are made final in the communities listed below. Elevations at selected locations in each community are shown.

National Environmental Policy Act. This rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Consideration. No environmental impact assessment has been prepared.

Regulatory Flexibility Act. The Acting Executive Associate Director, Mitigation Directorate, certifies that this rule is exempt from the requirements of the Regulatory Flexibility Act because final or modified base flood elevations are required by the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and are required to establish and maintain community eligibility in the NFIP. No regulatory flexibility analysis has been prepared.

Regulatory Classification. This final rule is not a significant regulatory action under the criteria of Section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

Executive Order 12612, Federalism. This rule involves no policies that have federalism implications under Executive Order 12612, Federalism, dated October 26, 1987.

Executive Order 12778, Civil Justice Reform. This rule meets the applicable standards of Section 2(b)(2) of Executive Order 12778.

The Federal Emergency Management Agency (FEMA or Agency) makes final determinations listed below of base flood elevations and modified base flood elevations for each community listed. The proposed base flood elevations and proposed modified base flood elevations were published in newspapers of local circulation and an opportunity for the community or individuals to appeal the proposed determinations to or through the community was provided for a period of ninety (90) days. The proposed base flood elevations and proposed modified base flood elevations were also published in the Federal Register .

This final rule is issued in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part 67.

The Agency has developed criteria for floodplain management in floodprone areas in accordance with 44 CFR part 60.

Interested lessees and owners of real property are encouraged to review the proof Flood Insurance Study and Flood Insurance Rate Map available at the address cited below for each community.

The base flood elevations and modified base flood elevations are made final in the communities listed below. Elevations at selected locations in each community are shown.

This rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Consideration. No environmental impact assessment has been prepared.

The Acting Executive Associate Director, Mitigation Directorate, certifies that this rule is exempt from the requirements of the Regulatory Flexibility Act because final or modified base flood elevations are required by the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and are required to establish and maintain community eligibility in the NFIP. No regulatory flexibility analysis has been prepared.

This final rule is not a significant regulatory action under the criteria of Section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

This rule involves no policies that have federalism implications under Executive Order 12612, Federalism, dated October 26, 1987.

This rule meets the applicable standards of section 2(b)(2) of Executive Order 12778.