The Office of Management and Budget has determined that this final rule does not meet the criteria for a significant regulatory action as specified in Executive Order 12866.

It has been determined that the Regulatory Flexibility Act is not applicable to this final rule because the Natural Resources Conservation Service is not required by 5 U.S.C. 553, or any other provision of law, to publish a notice of proposed rule making with respect to the subject matter of this rule.

No recordkeeping or reporting burden is associated with this rule.

This final rule has been reviewed in accordance with Executive Order 12988. The provisions of this final rule are not retroactive. Furthermore, the provisions of this final rule preempt State and local laws to the extent such laws are inconsistent with this final rule. Before an action may be brought in a Federal court of competent jurisdiction, the administrative appeal rights afforded persons at 7 CFR part 614 must be exhausted.

Pursuant to Title II of the Unfunded Mandates Reform Act of 1995, Public Law 104-4, NRCS assessed the affects of this rulemaking action on State, local, and Tribal governments, and the public. This action does not compel the expenditure of $100 million or more by any State, local, or Tribal governments, or anyone in the private sector, and therefore, a statement under section 202 of the Unfunded Mandates Reform Act of 1995 is not required.

The Wildlife Habitat Incentives Program (WHIP) was originally authorized under section 387 of the Federal Agriculture Improvement and Reform Act of 1996 (the 1996 Act), 16 U.S.C. 3836a. WHIP provides cost-share assistance to landowners to develop wildlife habitat on upland, wetland, riparian, aquatic, and other areas. Section 387 did not specify the cost-share rate or the agreement length.

NRCS published its final rule to implement WHIP, 7 CFR part 636, on September 19, 1997 (62 FR 49358). Section 636.6 of the WHIP final rule specified that NRCS would offer to pay no more than 75 percent of the cost of establishing wildlife habitat development practices. Section 636.8 of the WHIP final rule specified that a WHIP cost-share agreement would be for a period of 5 to 10 years, unless a shorter period was recommended to address situations where wildlife habitat was threatened as a result of a disaster.

Section 2502 of the Farm Security and Rural Investment Act of 2002 (the 2002 Act), Public Law 107-171, repealed the original WHIP statute and amended Title XII of the Food Security Act of 1985 to add a new section 1240N as the authority for WHIP. As amended, the Food Security Act authorizes NRCS to provide additional cost-share payments to protect and restore plant and animal habitat under an agreement or contract that has a term of at least 15 years.

This final rule reflects the new authority to provide additional cost-share assistance under agreements or contracts that have a term of at least 15 years. This change will conform the WHIP regulation with statutory authorization. No public comments are being solicited.

Accordingly, 7 CFR part 636 is amended as follows:

Section 372 of the Illegal Immigration Reform and Immigrant Responsibility Act of 1996 (IIRIRA), Pub. L. No. 104-208, Div. C., 110 Stat. 3009-646, amended section 103(a) of the Act, 8 U.S.C. 1103(a), to permit the Attorney General to authorize any State or local law enforcement officer, with the consent of the head of the department, agency, or establishment under whose jurisdiction the individual is serving, to perform or exercise any of the powers, privileges, or duties conferred or imposed by the Act or implementing regulations upon officers or employees of the Service during a period of a mass influx of aliens.

Under section 103(a)(8) of the Act, the Attorney General may authorize State or local law enforcement officers to perform such powers, privileges, or duties only if the Attorney General determines that “an actual or imminent mass influx of aliens arriving off the coast of the United States, or near a land border, presents urgent circumstances requiring an immediate Federal response.” Under these regulations, the Attorney General will be authorized to consider factors described in the definitions of “immigration emergency” and “other circumstances” contained in 28 CFR 65.81 when determining whether a mass influx of aliens is imminent or occurring. As described in 28 CFR 65.81, the phrase “immigration emergency” means

In declaring that a mass influx of aliens is imminent or occurring, the Attorney General will define the boundaries of the geographic area where the declared mass influx of aliens is imminent or occurring. The Commissioner of the INS is authorized to amend and redefine these boundaries to expand or decrease them, as necessary, based on evolving developments. This authority shall not be further delegated. The Attorney General will also define the time periods that denote the beginning and the end of the declared mass influx of aliens. The authority of State or local law enforcement officers to enforce immigration laws under section 103(a)(8) of the Act can be exercised only during a mass influx of aliens, as determined and declared by the Attorney General. State or local law enforcement officers authorized to exercise immigration law enforcement authorities for transporting or guarding aliens in custody may exercise such authorities as necessary beyond the defined geographic boundaries where the declared mass influx of aliens is imminent or occurring. Apart from this exception, State or local law enforcement officers authorized to enforce immigration laws pursuant to section 103(a)(8) of the Act can exercise that authority only within the defined geographic boundaries where the mass influx of aliens has been declared. In all circumstances, State or local officers may exercise authority pursuant to section 103(a)(8) of the Act only during the time period prescribed by the Attorney General.

The implementation of this final rule will facilitate an expeditious and coordinated response during a mass influx of aliens by enabling the Attorney General to draw upon the voluntary assistance of State or local law enforcement resources to meet urgent and quickly developing demands.

A proposed rule with request for comments was published by the Department of Justice in the Federal Register on April 8, 1999. 64 FR 17128. The Service received a total of eighteen comments, all of which were considered in the formulation of this final rule. Comments were received from the Office of the Governor of the State of Florida, the Florida Department of Law Enforcement, law enforcement organizations in the State of Florida representing Florida sheriffs and chiefs of police, and from non-governmental organizations. Of the total, four commenters expressed support for the regulation and fourteen commenters opposed the rule.

Of the fourteen commenters opposing the regulation, nine commenters opposed State or local law enforcement officers exercising Federal immigration enforcement authority under any circumstances. All the opposing comments expressed concern that authorizing State or local law enforcement officers to exercise Federal immigration enforcement authority would result in civil rights violations and racial profiling by State or local police. The majority of opposing comments also expressed concern that the authorization of State or local law enforcement officers to exercise Federal immigration enforcement authority would undermine public safety by interfering with the normal duties of police in serving and protecting the community at large.

The commenters opposing the regulation generally based their concerns on the premise that the Attorney General would authorize state or local law enforcement officers to exercise Federal immigration enforcement authority during a declared mass influx of aliens in a large geographic area, thereby creating a greater likelihood for racial profiling. Moreover, commenters were concerned that a conflict in police functions would be created that would be counter to the purpose and intent of neighborhood and community policing. Commenters also were concerned that State and local law enforcement officers would use their authority under section 103(a)(8) of the Act to further particular State and local interests, such as gathering information or evidence relating to a State offense.

The Service recognizes and appreciates these concerns, but notes that pursuant to the provisions of section 103(a)(8) of the Act, the Attorney General will authorize State or local law enforcement officers to exercise Federal immigration enforcement authority only during a declared mass influx of aliens, the determination of which will be based on the factors set forth in the definitions of the terms “assistance,” “immigration emergency,” and “other circumstances” as defined in 28 CFR 65.81. The Attorney General will authorize the exercise of only those immigration law enforcement authorities that are essential to meeting the demands imposed by the situation.

In an “immigration emergency,” local Service resources are inadequate to meet the immediate threat to public safety, public health, and national security. Immediate response and immigration law enforcement under such circumstances would be essential. It must be presumed that many of the first officials responding to events in such an urgent and quickly developing situation would be State or local law enforcement officers. They must be provided with the necessary authority to provide effective assistance to Federal authorities to contain and control the situation. In these circumstances, the assistance of State or local law enforcement officers would be essential to protect public safety, public health, and national security.

The regulation does not abridge or abrogate constitutional or civil rights protections. The Service believes that sufficient additional safeguards to protect civil rights have been incorporated in the regulation, and that these safeguards will be further strengthened through supplemental policy and procedures. These safeguards include defining the boundaries and duration of the event, thus limiting the geographic area and time period when State and local law enforcement officers would exercise Federal immigration law enforcement authority. The regulation requires Service training and certification for State or local officers who would exercise immigration law enforcement authorities. The Attorney General will authorize the exercise of only those authorities that are essential to meet the demands imposed by the emergent event. The regulation also requires that State or local law enforcement officers exercising Federal immigration law enforcement authorities adhere to applicable Service policies and standards. The regulation also requires that a contingency agreement between the Service and State or local law enforcement agencies include a statement that the exercise of Federal immigration law enforcement authority will not abrogate or abridge constitutional or civil rights protections. Further, the rule requires a complaint reporting and resolution procedure to be in place and a mechanism to record and monitor complaints of misconduct or wrongdoing by State or local officers in the exercise of Federal immigration law enforcement authority.

Contingency agreements with State or local police agencies that voluntarily agree to assist during a declared mass influx of aliens will detail any authority to enforce immigration laws that State or local law enforcement officers will exercise pursuant to section 103(a)(8) of the Act. State or local law enforcement officers will not be authorized to enforce immigration laws pursuant to section 103(a)(8) of the Act during a declared mass influx of aliens without completing a required training program as required by the regulation.

Preliminary contingency agreements between the Service and several State or local law enforcement agencies in the State of Florida have been developed in order to be in place prior to the authorization of immigration law enforcement in the event a mass influx of aliens is declared. Plans call for the Service to develop and provide training to State or local law enforcement officers who would exercise Federal immigration law enforcement authority during such an event. The Service will oversee and coordinate all immigration law enforcement activities during a declared mass influx of aliens.

The regulation has been modified to provide the Attorney General with the sole authority and responsibility, when declaring a mass influx of aliens, to define the initial geographic boundaries where the mass influx of aliens is imminent or occurring. The regulation will authorize the INS Commissioner subsequently to amend and redefine the boundaries to expand or decrease them as necessary based on evolving developments in the event. The authority to determine and define the boundaries of a mass influx of aliens may not be further delegated. This regulatory scheme will limit the geographic area in which designated State or local law enforcement officers would be authorized to perform the functions of immigration officers.

The regulation has been modified to require the Attorney General to determine when a mass influx of aliens event has concluded, at which point the authorization of State and local law enforcement officers to enforce immigration law under the provisions of section 103(a)(8) of the Act would cease.

The majority of the commenters opposing the implementation of the regulation expressed serious concern that the proposed rule would exacerbate racial profiling. To support these reservations, the commenters cited and quoted several reports and news media articles. A number of the commenters pointed out that the proposed rule indicated bias by indicating that the authority to exercise Federal immigration law enforcement authority would be limited to State or local law enforcement agencies whose jurisdiction is along the southern land border or the coastline of South Florida, thus implying that a mass influx of aliens would be made up of Latino or Caribbean migrants.

Several aspects of the final rule address these concerns. The final rule has been modified to remove reference to the southern land border and the coastline of South Florida and to insert in place of those references the phrase, “aliens arriving off the coast or near a land border of the United States.” During a declared mass influx of aliens, the Service would exercise oversight and control to focus the assisting State or local law enforcement resources on the essential immigration law enforcement activities necessary to contain and control the situation in the defined areas of such an event. Moreover, the potential for unwarranted stops based solely on ethnic appearance would be significantly reduced by the presence of other distinguishing factors consistent with the characteristics of the event.

Several comments dealt with training. Several commenters expressed concern that Service training of State or local law enforcement officers would be insufficient to erase biases or to address the likelihood that police would end up stopping those people who look like members of the group entering or about to enter the United States during a declared mass influx of aliens. Also, given the complex and changing nature of immigration law, concern was expressed that adequate training could not be provided to State or local law enforcement officers to enable them properly to exercise Federal immigration enforcement authority. Concern also was expressed that a significant amount of time could pass between the initial training the Service would provide to State or local law enforcement officers and the time the authorization to exercise Federal immigration authority would occur. Therefore, at the time when they would be expected to apply their knowledge of immigration law, State or local law enforcement officers might not be able to recall crucial elements required for effective enforcement. One commenter recommended that the State or local law enforcement officers who may be called upon to exercise Federal immigration enforcement authority during a mass influx of aliens be required to undergo thorough retraining on a regular basis. One of the comments noted:

The training concerns and recommendations presented in these comments are noted. The Service agrees that training for State or local law enforcement officers who may be called upon to exercise Federal immigration enforcement authority during a mass influx of aliens is a critically important matter. State or local law enforcement officers cannot perform any functions of a Service officer or employee pursuant to section 103(a)(8) of the Act and under the provisions of this rule until they successfully complete training prescribed by the Service and become certified in basic immigration law, immigration law enforcement fundamentals and procedures, civil rights law, and sensitivity and cultural awareness issues. Recognizing that a significant amount of time could pass between initial training and certification and the time when authorization to enforce immigration laws occurs, the Service also will develop a means to provide appropriate refresher training. The Service believes that it is important to mandate the general requirement for training in the regulation, but that the details of how the training will be developed and provided should be addressed through internal policy. The Service will do its utmost to ensure that the training developed and provided meets the essential and critical requirements for sufficiency and timeliness.

One commenter suggested that in addition to training to prevent constitutional and civil rights violations, the regulation should also require that an entity be established to monitor the exercise of Federal immigration enforcement authority by State or local law enforcement officials. The commenter expressed concern that the proposed regulation did not seem to contemplate the possibility that State or local law enforcement officers authorized pursuant to section 103(a)(8) of the Act to enforce immigration laws would engage in improper activity that might warrant discipline.

The Service agrees that a mechanism is needed to monitor the immigration law enforcement activities of State or local law enforcement officers conducted pursuant to section 103(a)(8) of the Act, but does not agree that an independent entity needs to be established to do so. The regulation has been modified to direct that a mechanism to monitor complaints and allegations regarding the immigration enforcement activities of State or local law enforcement officers pursuant to section 103(a)(8) of the Act be included in the contingency agreements implemented between participating State or local law enforcement agencies and the Service. There are existing publicized means for reporting complaints of wrongdoing or misconduct against State or local law enforcement officers. The Service believes that creating a separate entity to handle complaints and violations with respect to the exercise of authorized immigration law enforcement powers would be less effective and efficient than the procedures already established. However, because of the importance of this issue, this rule has been modified to require that a complaint reporting and resolution procedure for such allegations be included in the contingency agreement between the cooperating State or local department and the Service.

Several commenters opposing the rule expressed concern that the proposed rule was inherently vague in that it allowed the Attorney General to make the determination that a mass influx of aliens is imminent or occurring without precisely defining what constitutes a mass influx of aliens. Some of these commenters expressed the view that the vague nature of these provisions was problematic in that the discretionary power to determine whether the power should be exercised is in the hands of the same person who would exercise the power. They expressed concern that such discretionary power can become arbitrary when there are no limiting factors or guidelines that must be met before the authority can be legitimately triggered. The commenters noted that the notice of proposed rulemaking did not offer historical precedent as to whether a mass influx of aliens has occurred at any time in the past. The commenters also noted that there is no guidance to quantify how many incoming noncitizens need to be at the border or off the coast of the United States before the Attorney General of the United States can determine that a mass influx of aliens is imminent or occurring.

The Service notes that there have been a number of events during the past two decades that required the Federal Government to adopt extraordinary measures beyond the capacity of the Service to meet the challenges posed by large groups of undocumented migrants either arriving or en route to the United States. Some of these past events originated in the Caribbean. More recently, significant numbers of undocumented migrants have been discovered bound for this country from China in the holds of cargo vessels. The intent of those directing some of these seagoing cargo vessels has been to run the vessel aground and force their human cargo to abandon ship. In at least one instance, such an event resulted in loss of life. There have been periods when a significant number of such cargo vessels carrying substantial numbers of undocumented migrants in their holds were identified. Again, extraordinary actions by the Federal Government beyond the capacity of the Service were required to deal with these events.

In all of these situations, the undocumented migrants were exposed to extreme hazards and life-threatening conditions. The belief that the Federal Government will not be able to respond and prevent such actions may bolster and encourage such brazen attempts by migrants to enter the United States illegally, with reckless and criminal disregard for human life and safety. The Federal Government must have the capability and the regulatory basis upon which to mobilize and coordinate with State or local law enforcement resources to respond to such events. In so doing, the coordinated efforts of Federal, State, and local governments can be combined to confront, manage, and possibly deter such reckless and illegal behavior by undocumented migrants and those criminal enterprises that seek to prosper unlawfully from them. Such illegal entries into the United States not only greatly endanger the lives of the undocumented migrants, but also endanger the safety, security, and well-being of the United States, affected communities, and the public at large. They cannot go unchecked.

The Service does not believe that it is necessary or appropriate to quantify the basis for the declaring of a mass influx of aliens by the Attorney General. There are several factors articulated in 28 CFR 65.81, specifically those noted in the definitions of “immigration emergency” and “other circumstances,” that the Attorney General will consider in determining whether to declare a mass influx of aliens.

Some of the commenters opposed any rule that would authorize State and local law enforcement officers to exercise Federal immigration enforcement authority. The Service strongly disagrees with this viewpoint. The exercise of Federal law enforcement authority by State and local law enforcement officers is not unique to this rule. For example, the Department has deputized State and local law enforcement officers to assist them in enforcing federal law. Moreover, this final rule sets forth the guidelines under which the Attorney General can authorize State and local officers to exercise Federal immigration law enforcement authority during a mass influx of aliens and establishes appropriate limits on the exercise of such authority.

Four sets of comments strongly supported the regulation. These comments came from the Office of the Governor of the State of Florida, the Florida Department of Law Enforcement, and from two law enforcement organizations in the State of Florida representing Florida sheriffs and chiefs of police, respectively. All of these commenters pointed out that the State of Florida has experienced a number of immigration-related crises over the years. They unanimously expressed the belief that the implementation of this rule would facilitate coordination between agencies to more effectively meet the challenges and demands that arise during such a mass influx event. These comments strongly advocated the position that safety and security of all parties are the paramount government interests during such an event. The commenters also recognized and supported the establishment of contingency agreements between the Service and State or local law enforcement agencies as an effective means to formalize the working relationships and expectations between the Service and State or local law enforcement agencies during a mass influx event.

The Service believes that these commenters reflected the essence of the statutory intent of section 103(a)(8) of the Act and the purpose of this regulatory action. The declaration of a “mass influx” of aliens by the Attorney General would signal an urgent and quickly developing event that requires a coordinated and effective response by the combined resources of the Federal Government and the State or local governments representing the communities that would be directly affected. During such an event, Service resources by themselves would be inadequate to meet the demands imposed by such a crisis. During such an occurrence, the Service would require the use of State or local law enforcement resources to augment available Service resources. Prior planning, appropriate authorizations, adequate training, organized mobilization, and sufficient coordination between the Service and State or local law enforcement agencies would be essential to ensure that public safety, public health, and national security are protected. This regulation provides the foundation and framework to accomplish these essential requirements in the event that an Attorney General declares that a mass influx of aliens is imminent or occurring becomes necessary.

This rule implements the intent of section 103(a)(8) of the Act by providing a mechanism by which a trained cadre of State or local law enforcement officers will be available to enhance the Federal Government's ability to provide an immediate and effective response to a declared mass influx of aliens.

To enable implementation of the Attorney General's authority, the rule provides that the Commissioner of the INS may execute written contingency agreements with State or local law enforcement agencies regarding assistance under section 103(a)(8) of the Act, which may be activated in the event that the Attorney General determines that such assistance is required during a period of a declared mass influx of aliens. Such contingency agreements shall not authorize State or local law enforcement officers to perform any functions of Service officers or employees pursuant to the provisions of section 103(a)(8) of the Act until the Attorney General declares that a mass influx of aliens is imminent or occurring, and specifically authorizes such performance.

Written agreements regarding assistance under 28 CFR 65.83(d), including contingency agreements, shall include the following:

(1) A statement of the powers, privileges, or duties that State or local law enforcement officers will be authorized to perform or exercise and the conditions under which they may be performed or exercised;

(2) a statement of the types of assistance by State or local law enforcement officers for which the Attorney General shall be responsible for reimbursing the relevant parties in accordance with the procedures set forth;

(3) a statement that the relevant State or local law enforcement officers are not authorized to perform any functions of Service officers or employees pursuant to section 103(a)(8) of the Act until the Attorney General has made a determination pursuant to that section and authorizes such performance;

(4) a requirement that State or local law enforcement officers cannot perform any authorized functions of Service officers or employees pursuant to section 103(a)(8) of the Act until they have successfully completed and been certified in a Service prescribed course of instruction in basic immigration law, immigration law enforcement fundamentals and procedures, civil rights law, and sensitivity and cultural awareness issues;

(5) a description of the duration of both the written agreement and the authority the Attorney General will confer upon State or local law enforcement officers pursuant to section 103(a)(8) of the Act, along with a mechanism for amending, terminating, or extending the duration of authority and/or the written agreement;

(6) a requirement that the performance of any Service officer functions by State or local law enforcement officers pursuant to section 103(a)(8) of the Act be at the direction of the Service;

(7) a requirement that any State or local law enforcement officer performing Service officer or employee functions pursuant to section 103(a)(8) of the Act must adhere to the policies and standards set forth during the training, including applicable immigration law, immigration law enforcement standards and procedures, civil rights law, and sensitivity and cultural awareness issues;

(8) a statement that the authority to perform Service officer or employee functions pursuant to section 103(a)(8) does not abrogate or abridge constitutional or civil rights protections;

(9) a requirement that a complaint reporting and resolution procedure for allegations of misconduct or wrongdoing by State or local officers designated, or activities undertaken, pursuant to section 103(a)(8) of the Act be in place;

(10) a requirement that a mechanism to record and monitor complaints regarding the immigration enforcement activities of State or local law enforcement officers exercising the authority to enforce immigration laws be in place;

(11) a listing by position (title and name, when available) of the Service officers authorized to provide operational direction to State or local law enforcement officers assisting in a Federal response pursuant to section 103(a)(8) of the Act;

(12) a requirement that a State or local law enforcement agency maintain records of operational expenditures incurred as a result of supporting the Federal response to a mass influx of aliens;

(13) provisions concerning State or local law enforcement officer use of Federal property or facilities, if any;

(14) a requirement that any department, agency, or establishment whose State or local law enforcement officer is performing Service officer or employee functions shall cooperate fully in any Federal investigation related to allegations of misconduct or wrongdoing in conjunction with such functions, or to the written agreement; and

(15) a procedure by which the appropriate law enforcement department, agency, or establishment will be notified that the Attorney General has made a determination under section 103(a)(8) of the Act to authorize State or local law enforcement officers to exercise Federal immigration enforcement authority under the provisions of the respective agreements.

The boundaries of the geographic area where the declared mass influx of aliens is imminent or occurring would be defined by the Attorney General, who would also determine the time period of the mass influx of aliens. The Commissioner is authorized to amend and redefine the geographic boundaries of the area of the mass influx of aliens, including expanding or decreasing the boundaries, as necessary, based on evolving developments in the scope of the event. This authority shall not be further delegated.

State or local law enforcement officers cannot perform any functions of a Service officer or employee pursuant to section 103(a)(8) of the Act and under the provisions of this rule until they successfully complete training prescribed by the Service and become certified in basic immigration law, immigration law enforcement fundamentals and procedures, civil rights law, and sensitivity and cultural awareness issues.

The Service will provide all necessary training materials and will conduct training sessions to designated officers at sites within their jurisdictional or commuting areas when possible. Any employing State or local law enforcement agency, department, or establishment will be required to fund its officers' transportation, lodging, and subsistence costs as may be required.

This rule amends the existing regulations of the Department of Justice relating to the Immigration Emergency Fund. Under the amended rule, the Department of Justice has the authority to reimburse State or local law enforcement agencies that assist in the Federal response to a mass influx of aliens from any authorizing statutory source or other available funding source, provided such funding exists and has been made available to the Department for this purpose. Therefore, the final rule allows for the reimbursement of these entities up to the amount available to the Department of Justice for such purposes. This rule provides no guarantee of reimbursement for actual expenses incurred but seeks to assure State or local law enforcement agencies that they will not bear undue increased operational expenditures incurred in direct support of a Federal response to declaration of a mass influx of aliens.

Execution of advance contingency agreements will expedite subsequent action by the Attorney General to authorize State or local law enforcement officers to exercise Federal immigration enforcement authority. The execution of advance contingency agreements will also facilitate reimbursement of actual expenditures in support of a Federal response to a mass influx of aliens, pursuant to existing financial requirements.

Within the regulation, the phrase “State or local law enforcement officers” means State law enforcement officers, local law enforcement officers, or both. The phrase “State or local law enforcement agencies” refers to State law enforcement agencies, local law enforcement agencies, or both.

The Attorney General, in accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), has reviewed this regulation and, by approving it, certifies that this rule will not have a significant impact on a substantial number of small entities because of the following factors:

(1) The Service anticipates that participation in written agreements executed with State or local law enforcement agencies under section 103(a)(8) of the Act and this rule will be limited to those State or local law enforcement agencies whose jurisdiction is along the coast of the United States, or near a land border;

(2) Participation by State or local law enforcement agencies is voluntary, and no State or local law enforcement agency outside the contiguous area of a mass influx of aliens would be affected by implementation of this rule;

(3) This rule provides a means to relieve undue financial burdens on participating law enforcement agencies by allowing for reimbursement of actual expenses incurred in direct support of a Federal response to declaration of a mass influx of aliens; and

(4) It is anticipated that the authorization of State or local law enforcement officers to enforce immigration law under the provisions of this rule will be infrequent, as such authorization can occur only during times of an actual or imminent mass influx of aliens into the United States pursuant to such declaration by the Attorney General.

This rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

This rule is not a major rule as defined in the Small Business Regulatory Enforcement Fairness Act of 1996, 5 U.S.C. 804. This rule will not result in an annual effect on the economy of $100 million or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.

This rule is considered by the Department of Justice to be a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review. Accordingly, this regulation has been submitted to the Office of Management and Budget for review.

This regulation will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among various levels of government. This rule allows for reimbursement by the Department of Justice (contingent upon availability of such funds) as determined by the Attorney General, of actual expenditures incurred by State or local law enforcement agencies whose law enforcement officers are supporting a Federal response to an actual or imminent mass influx of aliens. Moreover, participation by State or local law enforcement agencies is voluntary. Therefore, in accordance with section six of Executive Order 13132, it is determined that this rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.

This rule meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform.

As contained in this rule under 28 CFR 65.85(e), the Attorney General will consider all applications from State or local governments for reimbursement of actual expenses incurred in direct support of a Federal response to a mass influx of aliens, until the Attorney General has obligated funding available for such purposes as determined by the Attorney General. The information that must be included in the application for reimbursement is described in 28 CFR 65.85(c). The information required in 28 CFR 65.85(c) is considered an information collection covered under the Paperwork Reduction Act (PRA). This information collection has previously been approved by the Office of Management and Budget (OMB) under the PRA. The OMB control number for this approved information collection is 1115-0184.

The FAA has determined that notice and opportunity for prior public comment hereon are impracticable because these procedures would significantly delay certification of the airplane and thus delivery of the affected airplanes. The FAA therefore finds that good cause exists for making these special conditions effective upon issuance.

The FAA invites interested persons to participate in this rulemaking by submitting written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data. We ask that you send us two copies of written comments.

We will file in the docket all comments we receive, as well as a report summarizing each substantive public contact with FAA personnel concerning these special conditions. The docket is available for public inspection before and after the comment closing date. If you wish to review the docket in person, go to the address in the ADDRESSES section of this preamble between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

We will consider all comments we receive on or before the closing date for comments. We will consider comments filed late if it is possible to do so without incurring expense or delay. We may change these special conditions in light of the comments we receive.

If you want the FAA to acknowledge receipt of your comments on these special conditions, include with your comments a pre-addressed, stamped postcard on which the docket number appears. We will stamp the date on the postcard and mail it to you.

On May 22, 2002, Embraer applied for an amendment to Type Certificate No. T00011AT to include a corporate jet version of the Model EMB-135 airplane. The Model EMB-135BJ, which is a derivative of the EMB-135LR aircraft currently approved under Type Certificate No. T00011AT, is a pressurized, low-wing, “T” tail, transport category airplane with tricycle landing gear. It is powered by two Rolls-Royce model AE3007A1P engines, and will carry a maximum of 19 passengers. The primary differences between the existing EMB-135LR and the new EMB- 135BJ are the addition of winglets, increased maximum takeoff weight (to 21,990 kg), increased maximum operational ceiling (to 39,000 feet), additional exposed underbelly fuel tank installed ahead of the air conditioning area, extra internal fuel tanks installed in the back of the baggage compartment, and a modified fuel system due to the extra tanks. The new fuel system can serve to alleviate loads in the airframe and, when in a failure state, can create loads in the airframe. The current regulations do not adequately account for the effects of these systems and their failures on structural performance. These special conditions will require Embraer to substantiate the strength capability and freedom from aeroelastic instabilities after failures in the fuel transfer system.

Under the provisions of § 21.101, Embraer must show that the Model EMB-135BJ meets the applicable provisions of the regulations incorporated by reference in Type Certificate T00011AT, or the applicable regulations in effect on the date of application for the change. 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 Type Certificate No.T00011AT are 14 CFR part 25, effective February 1, 1965, including Amendments 25-1 through 25-84; Amendment 25-85; § 25.1517, as amended by Amendment 25-86; Amendment 25-88; Amendment 25-90; §§ 25.331, 25.335(b)(2), 25.345, 25.351, 25.363, 25.371, 25.415, 25.491, 25.499 and 25.561, as amended by Amendment 25-91; Amendment 25-93; § 25.807, as amended by Amendment 25-94; and Amendment 25-97. In addition, the certification basis includes certain special conditions, exemptions, and equivalent safety findings that are not relevant to these special conditions.

If the Administrator finds that the applicable airworthiness regulations ( i.e., part 25, as amended) do not contain adequate or appropriate safety standards for the Model EMB-135BJ because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

In addition to the applicable airworthiness regulations and special conditions, the Model EMB-135BJ 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 § 11.19, are issued in accordance with § 11.38, and become part of the type certification basis in accordance with § 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 § 21.101(a)(1).

The Model EMB-135BJ will have systems that affect the structural performance of the airplane, either directly or as a result of a failure or malfunction. These novel or unusual design features are systems that can serve to alleviate loads in the airframe and, when in a failure state, can create loads in the airframe. The current regulations do not adequately account for the effects of these systems and their failures on structural performance. These special conditions provide the criteria to be used in assessing the effects of these systems on structures.

This action affects only certain novel or unusual design features on one model airplane. It is not a rule of general applicability and affects only the applicant who applied to the FAA for approval of these features on the airplane.

The substance of these special conditions has been subjected to the notice and comment period in several prior instances and has been derived without substantive change from those previously issued. It is unlikely that prior public comment would result in a significant change from the substance contained herein. For this reason, and because a delay would significantly affect certification of the Embraer Model EMB-135BJ, which is imminent, the FAA has determined that prior public notice and comment are unnecessary and impracticable, and good cause exists for adopting these special conditions upon issuance. The FAA is requesting comments to allow interested persons to submit views that may not have been submitted in response to the prior opportunities for comment described above.

The authority citation for these special conditions is as follows:

For airplanes equipped with systems that affect structural performance, either directly or as a result of a failure or malfunction, the influence of these systems and their failure conditions must be taken into account when showing compliance with the requirements of subparts C and D of part 25. The following criteria must be used for showing compliance with these special conditions for airplanes equipped with flight control systems, autopilots, stability augmentation systems, load alleviation systems, flutter control systems, and fuel management systems. If these special conditions are used for other systems, it may be necessary to adapt the criteria to the specific system.

(a) The criteria defined herein only address the direct structural consequences of the system responses and performances and cannot be considered in isolation but should be included in the overall safety evaluation of the airplane. These criteria may in some instances duplicate standards already established for this evaluation. These criteria are only applicable to structures whose failure could prevent continued safe flight and landing. Specific criteria that define acceptable limits on handling characteristics or stability requirements when operating in the system degraded or inoperative modes are not provided in these special conditions.

(b) Depending upon the specific characteristics of the airplane, additional studies that go beyond the criteria provided in these special conditions may be required in order to demonstrate the capability of the airplane to meet other realistic conditions, such as alternative gust or maneuver descriptions, for an airplane equipped with a load alleviation system.

(c) The following definitions are applicable to these special conditions.

Structural performance: Capability of the airplane to meet the structural requirements of part 25.

Flight limitations: Limitations that can be applied to the airplane flight conditions following an in-flight occurrence and that are included in the flight manual ( e.g., speed limitations, avoidance of severe weather conditions, etc. ).

Operational limitations: Limitations, including flight limitations that can be applied to the airplane operating conditions before dispatch ( e.g., fuel, payload, and Master Minimum Equipment List limitations).

Probabilistic terms: The probabilistic terms (probable, improbable, extremely improbable) used in these special conditions are the same as those used in § 25.1309.

Failure condition: The term failure condition is the same as that used in § 25.1309; however, these special conditions apply only to system failure conditions that affect the structural performance of the airplane ( e.g., system failure conditions that induce loads, lower flutter margins, or change the response of the airplane to inputs such as gusts or pilot actions).

The following criteria will be used in determining the influence of a system and its failure conditions on the airplane structure.

(a) System fully operative. With the system fully operative, the following apply:

(1) Limit loads must be derived in all normal operating configurations of the system from all the limit conditions specified in subpart C, taking into account any special behavior of such a system or associated functions, or any effect on the structural performance of the airplane that may occur up to the limit loads. In particular, any significant nonlinearity (rate of displacement of control surface, thresholds, or any other system nonlinearities) must be accounted for in a realistic or conservative way when deriving limit loads from limit conditions.

(2) The airplane must meet the strength requirements of part 25 (static strength, residual strength), using the specified factors to derive ultimate loads from the limit loads defined above. The effect of nonlinearities must be investigated beyond limit conditions to ensure the behavior of the system presents no anomaly compared to the behavior below limit conditions. However, conditions beyond limit conditions need not be considered when it can be shown that the airplane has design features that will not allow it to exceed those limit conditions.

(3) The airplane must meet the aeroelastic stability requirements of § 25.629.

(b) System in the failure condition. For any system failure condition not shown to be extremely improbable, the following apply:

(1) At the time of occurrence. Starting from 1-g level flight conditions, a realistic scenario, including pilot corrective actions, must be established to determine the loads occurring at the time of failure and immediately after failure.

(i) For static strength substantiation, these loads multiplied by an appropriate factor of safety that is related to the probability of occurrence of the failure are ultimate loads to be considered for design. The factor of safety (FS) is defined in Figure 1.

(ii) For residual strength substantiation, the airplane must be able to withstand two thirds of the ultimate loads defined in paragraph (b)(1)(i) above.

(iii) Freedom from aeroelastic instability must be shown up to the speeds defined in § 25.629(b)(2). For failure conditions that result in speed increases beyond Vc/Mc, freedom from aeroelastic instability must be shown to increased speeds, so that the margins intended by § 25.629(b)(2) are maintained.

(iv) Failures of the system that result in forced structural vibrations (oscillatory failures) must not produce loads that could result in detrimental deformation of primary structure.

(2) For the continuation of the flight. For the airplane in the system failed state and considering any appropriate reconfiguration and flight limitations, the following apply:

(i) The loads derived from the following conditions at speeds up to Vc, or the speed limitation prescribed for the remainder of the flight, must be determined:

(A) The limit symmetrical maneuvering conditions specified in §§ 25.331 and 25.345.

(B) The limit gust and turbulence conditions specified in §§ 25.341 and 25.345.

(C) The limit rolling conditions specified in § 25.349, and the limit unsymmetrical conditions specified in § 25.367 and § 25.427(b) and (c).

(D) The limit yaw maneuvering conditions specified in § 25.351.

(E) The limit ground loading conditions specified in §§ 25.473 and 25.491.

(ii) For static strength substantiation, each part of the structure must be able to withstand the loads defined in paragraph (2)(i) above, multiplied by a factor of safety depending on the probability of being in this failure state. The factor of safety is defined in Figure 2.

Q j = (T j )(P j ) where:

T j = Average time spent in failure condition j (in hours).

P j = Probability of occurrence of failure mode j (per hour).

(iii) For residual strength substantiation, the airplane must be able to withstand two thirds of the ultimate loads defined in paragraph (2)(ii) above.

(iv) If the loads induced by the failure condition have a significant effect on fatigue or damage tolerance, then their effects must be taken into account.

(v) Freedom from aeroelastic instability must be shown up to a speed determined from Figure 3. Flutter clearance speeds V I and V II may be based on the speed limitation specified for the remainder of the flight using the margins defined by § 25.629(b).

V I = Clearance speed as defined by § 25.629(b)(2).

V II = Clearance speed as defined by § 25.629(b)(1).

Q  j = (T j )(P j ) where:

T j = Average time spent in failure condition j (in hours).

P j = Probability of occurrence of failure mode j (per hour).

(vi) Freedom from aeroelastic instability must also be shown up to V I in Figure 3 above for any probable system failure condition combined with any damage required or selected for investigation by § 25.571(b).

(3) Consideration of certain failure conditions may be required by other sections of part 25, regardless of calculated system reliability. Where analysis shows the probability of these failure conditions to be less than 10 −9 , criteria other than those specified in this paragraph may be used for structural substantiation to show continued safe flight and landing.

(c) Warning considerations. For system failure detection and warning, the following apply:

(1) The system must be checked for failure conditions, not extremely improbable, that degrade the structural capability below the level required by part 25, or significantly reduce the reliability of the remaining system. The flightcrew must be made aware of these failures before flight. Certain elements of the control system, such as mechanical and hydraulic components, may use special periodic inspections, and electronic components may use daily checks, in lieu of warning systems, to achieve the objective of this requirement. These certification maintenance requirements must be limited to components that are not readily detectable by normal warning systems and where service history shows that inspections will provide an adequate level of safety.

(2) The existence of any failure condition, not extremely improbable, during flight that could significantly affect the structural capability of the airplane, and for which the associated reduction in airworthiness can be minimized by suitable flight limitations, must be signaled to the flightcrew. For example, failure conditions that result in a factor of safety between the airplane strength and the loads of subpart C below 1.25, or flutter margins below V II , must be signaled to the crew during flight.

(d) Dispatch with known failure conditions. If the airplane is to be dispatched in a known system failure condition that affects structural performance, or affects the reliability of the remaining system to maintain structural performance, then the provisions of these special conditions must be met for the dispatched condition and for subsequent failures. Flight limitations and expected operational limitations may be taken into account in establishing Q  j as the combined probability of being in the dispatched failure condition and the subsequent failure condition for the safety margins in Figures 2 and 3. These limitations must be such that the probability of being in this combined failure state and then subsequently encountering limit load conditions is extremely improbable. No reduction in these safety margins is allowed if the subsequent system failure rate is greater than 10 −3 per hour.

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an AD that is applicable to Hamilton Sundstrand Power Systems (formerly Sundstrand Power Systems, Turbomach, and Solar) T-62T series APU's with compressor wheel P/N 100636-1 was published in the Federal Register on March 28, 2002 (67 FR 14889). That action proposed to mandate the replacement of the affected compressor wheels, which if not replaced, could result in uncontained compressor wheel failure and damage to the airplane.

Interested persons have been afforded an opportunity to participate in the making of this amendment. No comments were received on the proposal or the FAA's determination of the cost to the public. The FAA has determined that air safety and the public interest require the adoption of the rule as proposed.

There are approximately 492 Hamilton Sundstrand Power Systems (formerly Sundstrand Power systems, Turbomach, and Solar) models T-62T-2C, T-62T-25, T-62T-29, and T-62T-39 APU's of the affected design in the worldwide fleet. The FAA estimates that 337 APU's installed on aircraft of U.S. registry will be affected by this AD, that it will take approximately 40 work hours per APU to perform the required actions, and that the average labor rate is $60 per work hour. Required parts will cost approximately $16,799 per engine. Based on these figures, the total cost of the AD to U.S. operators is estimated to be $ 6,470,063.

This final rule does not have federalism implications, as defined in Executive Order 13132, because it would not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the FAA has not consulted with state authorities prior to publication of this final rule.

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

On April 19, 2002, the FAA issued AD 2002-08-18, amendment 39-12730 (65 FR 21567, May 1, 2002), applicable to certain EMBRAER Model EMB-135 and -145 series airplanes, to require repetitive inspections (tests) of the actuator clutches of the primary and backup pitch trim systems of the horizontal stabilizer for proper pitch trim indications, and replacement of the actuator, if necessary. The actions required by that AD are intended to prevent loss of pitch trim command during the takeoff and climb phase of flight due to improper set point of the actuator clutches, which could result in high pitch control forces and consequent reduced controllability of the airplane.

Since the issuance of that AD, the Departmento de Aviacao Civil (DAC), which is the airworthiness authority for Brazil, has revised the Brazilian airworthiness directive referenced in the existing AD to expand the applicability to include all airplanes equipped with certain actuators of the horizontal stabilizer. The DAC issued Brazilian airworthiness directive 2001-10-02R2, dated May 6, 2002, in order to assure the continued airworthiness of these airplanes in Brazil.

In addition, the manufacturer has issued EMBRAER Service Bulletin 145-27-0082, Change No. 01, dated December 13, 2001. Change No. 01 clarifies certain accomplishment instruments and adds certain airplanes to the effectivity of the original version of the service bulletin. AD 2002-08-18 cites the original version of EMBRAER Service Bulletin 145-27-0082, dated September 18, 2001, as the appropriate source of service information for accomplishment of the requirements.

Since an unsafe condition has been identified that is likely to exist or develop on other airplanes of the same type design registered in the United States, this AD supersedes AD 2002-08-18 to continue to require repetitive inspections (tests) of the actuator clutches of the primary and backup pitch trim systems of the horizontal stabilizer for proper pitch trim indications, and replacement of the actuator, if necessary. This AD expands the applicability in the existing AD.

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

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

Submit comments using the following format:

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

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

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

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

Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this rule must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket Number 2002-NM-131-AD.” The postcard will be date stamped and returned to the commenter.

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

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

Section 313 of the Tariff Act of 1930, as amended, (19 U.S.C. 1313), concerns drawback and refunds. Drawback is a refund of certain duties, taxes and fees paid by the importer of record and granted to a drawback claimant upon the exportation, or destruction under Customs supervision, of eligible articles. The purpose of drawback is to place U.S. exporters on equal footing with foreign competitors by refunding most of the duties paid on imports used in domestic manufactures intended for export.

There are several types of drawback. Under section 1313(b), a manufacturer can recoup duties paid for imported merchandise if it uses merchandise of the same kind and quality to produce exported articles pursuant to the terms of the statute. Section 1313(b) reads, in pertinent part, as follows:

Manufacturing substitution drawback is intended to alleviate some of the difficulties in accounting for whether imported merchandise has, in fact, been used in a domestic manufacture. Section 1313(b) permits domestic or other imported merchandise to be used as the basis for drawback, instead of the actual imported merchandise, so long as the domestic merchandise is of the “same kind and quality” as the actual imported merchandise.

Several recent court cases have examined the scope of the term “same kind and quality” as used in 19 U.S.C. 1313(b). See E.I. DuPont De Nemours and Co. v. United States, 116 F. Supp. 2d 1343 (Ct. Int'l Trade 2000). See also International Light Metals v. United States, 194 F.3d 1355 (Fed. Cir. 1999). In these cases, the courts held that a chemical element that is contained in an imported material that is dutiable on its value may be designated as same kind and quality merchandise for purposes of manufacturing substitution drawback pursuant to 19 U.S.C. 1313(b).

In DuPont, the court held that apportionment is a feasible method of claiming a drawback entitlement. DuPont, 116 F. Supp. 2d at 1348-49. Under these regulations, therefore, a substitution drawback claimant must apportion the duty attributable to a chemical element contained in an ad valorem duty-paid imported material if it is claimed that a chemical element was used in the domestic production of articles that were exported or destroyed under Customs supervision within the prescribed time period. The drawback claim on the chemical element that is the designated merchandise must be limited to the duty apportioned to that chemical element on a unit-for-unit attribution using the unit of measure set forth in the Harmonized Tariff Schedule of the United States that is applicable to the imported material. The apportionment is necessary to avoid overpayment of drawback.

Section 191.26 of the Customs Regulations (19 CFR 191.26) sets forth the recordkeeping requirements for manufacturing drawback. Paragraph (b) of this section describes the recordkeeping requirements for substitution drawback.

To implement the courts' interpretation of 19 U.S.C. 1313(b), this document amends § 191.26(b) by adding language that explains how to apportion the duty attributable to same kind and quality chemical elements contained in ad valorem duty-paid imported materials for purposes of manufacturing substitution drawback. This document also amends § 191.26(b) to provide an example of apportionment calculations.

In order for a drawback claimant to be able to ascertain what portion of the ad valorem duty paid on imported merchandise is attributable to a chemical element contained in the merchandise, an apportionment calculation is necessary. First, if the imported duty-paid material is a compound with other constituents, including impurities, and the purity of the compound in the imported material is shown by satisfactory analysis, that purity, converted to a decimal equivalent of the percentage, is multiplied against the entered amount of the material to establish the amount of pure compound. The amount of the element in the pure compound is to be determined by use of the atomic weights of the constituent elements, converting to the decimal equivalent of their respective percentages, and multiplying that decimal equivalent against the above-determined amount of pure compound. Second, the amount claimed as drawback based on a contained element must be taken into account and deducted from the duty paid on the imported material that may be claimed on any other drawback claim.

Before adopting this interim regulation as a final rule, consideration will be given to any written comments timely submitted to Customs, including comments on the clarity of this interim rule and how it may be made easier to understand. Comments submitted will be available for public inspection in accordance with the Freedom of Information Act (5 U.S.C. 552), § 1.4 of the Treasury Department Regulations (31 CFR 1.4), and § 103.11(b) of the Customs Regulations (19 CFR 103.11(b)), on regular business days between the hours of 9 a.m. and 4:30 p.m. at the Regulations Branch, Office of Regulations and Rulings, U.S. Customs Service, 799 9th Street, NW., Washington, DC.

Pursuant to the provisions of 5 U.S.C. 553(b)(B), Customs has determined that prior public notice and comment procedures on this regulation are unnecessary and contrary to public interest. The regulatory changes to the Customs Regulations add language necessitated by recent decisions of the Court of International Trade and the Court of Appeals for the Federal Circuit. The regulatory changes benefit the public by providing specific information as to how a drawback claimant is to correctly make the requisite duty apportionment calculations when claiming manufacturing substitution drawback for a chemical element contained in ad valorem duty-paid imported merchandise. For these reasons, pursuant to the provisions of 5 U.S.C. 553(d)(1) and (3), Customs finds that there is good cause for dispensing with a delayed effective date.

This document does not meet the criteria for a “significant regulatory action” as specified in Executive Order 12866.

Because no notice of proposed rulemaking is required for this rule, the provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) do not apply.

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

A. Removal of the Term “Propellant”

B. Change to Essentiality Determinations

C. Metered-Dose Steroid Human Drugs for Nasal Inhalation

D. Products No Longer Marketed

E. Petitions to Add New Essential Uses

F. Determinations of Continued Essentiality

A. General Comments About the Proposed Rule

B. Number of Alternatives Proposed

C. Specific Comments on the Proposed Criteria for Phaseout

D. Patient Subpopulations

E. Postmarketing Data and Suggested Duration

F. Timing of Phaseout

G. Nasal Steroids

H. Incentives for Development of Alternatives

I. Cost of New Products

J. Environmental Impact of CFC-MDI Use

K. Generics

L. New Essential Uses

M. Additional Comments

A. Regulatory Benefits

B. Regulatory Costs

C. Distribution Impacts

D. Small Business Impact

FDA, in consultation with EPA, determines whether a medical product is essential for purposes of Title VI of the Clean Air Act (42 U.S.C. 7671, et seq .) (Title VI). If a medical product is determined to be essential, and meets the other elements of the definition found in section 601 of the Clean Air Act, it will be considered a “medical device.” “Medical devices” are exempt from the general prohibition on nonessential uses of CFCs found in section 610 of the Clean Air Act. If certain conditions are met, EPA may authorize production of ODS for use in “medical devices” under an exemption from the general prohibitions on production and consumption of ODS found in sections 604 and 605 of the Clean Air Act. FDA lists essential medical products in § 2.125 (21 CFR 2.125). Most of the medical products listed as essential are metered-dose inhalers (MDIs). FDA will maintain the designation of ODS medical products such as MDIs as essential until non-ODS medical products adequately meet the needs of patients.

In the Federal Register of September 1, 1999 (64 FR 47719), FDA published a proposed rule that sought public comment on the process FDA would use to make essential-use determinations. 1 FDA received 22 comments on the proposed rule and addresses those comments in section IV of this document.

The United States, as a party to the international agreement called the Montreal Protocol on Substances that Deplete the Ozone Layer (Montreal Protocol) (September 16, 1987, S. Treaty Doc. No. 10, 100th Cong., 1st sess., 26 I. L. M. 1541 (1987)), has agreed to phase out production and importation of ODSs, including CFCs. The United States has generally banned the use of CFCs in consumer aerosols for decades and eliminated almost all manufacture and importation of CFCs as of January 1, 1996. However, the Montreal Protocol permits parties to the Protocol to continue to produce or import CFCs for use in essential medical products if such production or importation is approved by the parties, and the United States continues to do so at this time.

The twelfth meeting of the parties to the Montreal Protocol took place in Ouagadougou, Burkina Faso. The parties issued Decision XII/2—“Measures to facilitate the transition to chlorofluorocarbon-free metered-dose inhalers.” Decision XII/2 is contained in the Report of the Twelfth Meeting of the Parties to the Montreal Protocol on Substances that Deplete the Ozone Layer. The report can be found on the United Nations Environment Programme Web site at http://www.unep.org/ozone/mop/12mop/12mop-9.e.shtml. Decision XII/2 states the following:

FDA believes that this rule is consistent with Decision XII/2. This rule is also a key step in fulfilling the United States' obligation under paragraph 5 of Decision XII/2 to develop a national transition strategy that “includes effective criteria and measures for determining when chlorofluorocarbon metered-dose inhaler product(s) is/are no longer essential.”

Title VI and the Montreal Protocol work in independent but complementary ways. The Montreal Protocol deals primarily with restrictions on the production and importation of new ODSs. Title VI deals with the use of ODSs, as well as their production and importation. The following hypothetical example may be helpful in illustrating the interaction of Title VI and the Montreal Protocol. A United States company makes CFC-propelled plastic party streamers using recycled and stockpiled CFCs. This use of ODSs would not be impacted by the Montreal Protocol because no newly manufactured or imported ODSs were used. However, this use of ODSs would be prohibited by Title VI, because CFC-propelled plastic party streamers are specifically banned by section 610(b)(1) of the Clean Air Act.

Through this rule, the Bureau of Prisons (Bureau) will add a subpart D to its regulations in 28 CFR part 523, on Computation of Sentence. The new subpart D will establish procedures for awarding educational good time credit consistent with D.C. Code § 24-221.01. (We refer to educational good time credit consistent with the D.C. Code as “DCEGT.”)

This rule will apply to D.C. Code offenders who committed their offense before August 5, 2000 and are in Bureau institutions or Bureau contract facilities under the D.C. Revitalization Act.

We are making this rule to comply with the D.C. Revitalization Act, enacted August 5, 1997. This Act makes the Bureau responsible for the “custody, care, subsistence, education, treatment and training” of “the felony population sentenced pursuant to the District of Columbia Code” (D.C. Code offenders). (D.C. Code § 24-101(b)) D.C. Code offenders in Bureau custody are subject to Federal laws and Bureau regulations as long as they are “consistent with the sentence imposed.”

In August of 1997, when the D.C. Revitalization Act was enacted, the Bureau began absorbing approximately 8000 D.C. Code offenders. It was unclear at that time to what extent, if any, the Bureau would be bound by D.C. Code legislation which purported to direct Bureau functions.

As numerous D.C. Code provisions were analyzed for applicability to Bureau functions, it was generally concluded that the Bureau would have to follow D.C. Code sentence calculation provisions (e.g., good time, jail credit, etc.) to the extent non-compliance would result in an ex post facto violation of the offender's sentence. The Bureau based this approach on the provision in D.C. Revitalization Act requiring the Bureau to apply Federal laws to D.C. Code offenders “consistent with the sentence imposed.”

The Bureau concluded that D.C. Code offenders who committed their offenses before August 5, 2000 are entitled to educational good time sentence credit. As a result, we developed these rules to give effect to the D.C. Code educational good time sentence credit (DCEGT) provisions in the Bureau's education and sentence calculation systems.

Section 24-221.01 of the D.C. Code provides for “educational good time credits of no less than 3 days a month and not more than 5 days a month” when a D.C. Code offender completes an educational program and obeys institution rules. This provision applies when a D.C. Code offender completes an educational program on or after April 11, 1987, when section 24-221.01 was enacted.

Section 24-403.01(d) of the D.C. Code, enacted April 23, 1998, however, requires that D.C. Code offenders who committed their offense on or after August 5, 2000, receive good time credit “only as provided in 18 U.S.C. 3624(b).” This statute in the Federal Criminal Code directs the Bureau how to award good time credit to U.S. Code offenders. Bureau regulations implementing this provision are in 28 CFR 523.20.

D.C. Code offenders who successfully complete an educational program on or after April 11, 1987, and who committed their offense before August 5, 2000, may receive educational good time credit consistent with D.C. Code § 24-221.01 (DCEGT). By contrast, D.C. Code offenders who commit their offense on or after August 5, 2000, are eligible for good time credit only under the Federal law, 18 U.S.C. 3624(b).

To be “consistent with the sentence imposed,” as required by the D.C. Revitalization Act (D.C. Code § 24-101(b)), the Bureau developed these rules on DCEGT to conform with D.C. law on DCEGT in D.C. Code § 24-221.01.

The rules describe eligibility for DCEGT, how we award it, how we limit it, and how to appeal our decisions on DCEGT. We will allow 5 days of DCEGT for each calendar month that a D.C. offender is enrolled in a Bureau-designated education program. Eligible D.C. offenders can earn DCEGT up to a Bureau-determined maximum amount, which varies for different types of educational programs.

We are making this an interim final rule for the following reasons:

As a result of National Capital Revitalization and Self-Government Improvement Act of 1997 (D.C. Revitalization Act), D.C. Code § 24-101(b), passed August 5, 1997, we are responsible for administering the sentences of D.C. Code offenders in our custody, including DCEGT awards.

Since the D.C. Revitalization Act's enactment on August 5, 1997, D.C. Code offenders in Bureau custody may have completed educational programs designated by these rules as eligible for DCEGT.

If we do not implement this rule as soon as possible, inmates eligible for DCEGT risk being considered parole eligible at a later date than if the credit were awarded. Also, for D.C. Code offenders projected for mandatory release, an award of DCEGT may affect their release date.

Therefore, to insure that D.C. Code offenders in our custody receive the benefit of DCEGT, these rules must take effect as soon as possible. Having a DCEGT system in place also provides eligible offenders incentive to pursue educational programming, which may ultimately help them re-adjust to the community.

You can send written comments on this rule to the Rules Unit, Office of General Counsel, Bureau of Prisons, 320 First Street, NW., HOLC Room 754, Washington, DC 20534.

We will consider comments we receive during the comment period before we take final action. We will try to consider comments we receive after the end of the comment period. In light of comments we receive, we may change the rule.

We do not plan to have oral hearings on this rule. All the comments we receive remain on file for public inspection at the above address.

The Office of Management and Budget (OMB) determined that certain rules are part of a category of actions which are not “significant regulatory actions” under section 3(f) of Executive Order 12866. Because this rule falls within that category, OMB did not review it.

This regulation will not have substantial direct effects on the States, on the relationship between the national government and the States, or on distribution of power and responsibilities among the various levels of government. Under Executive Order 13132, this rule does not have sufficient federalism implications for which we would prepare a Federalism Assessment.

The Director of the Bureau of Prisons, under the Regulatory Flexibility Act (5 U.S.C. 605(b)), reviewed this regulation. By approving it, the Director certifies that it will not have a significant economic impact upon a substantial number of small entities because: This rule is about the correctional management of offenders committed to the custody of the Attorney General or the Director of the Bureau of Prisons, and its economic impact is limited to the Bureau's appropriated funds.

This rule will not cause State, local and tribal governments, or the private sector, to spend $100,000,000 or more in any one year, and it will not significantly or uniquely affect small governments. We do not need to take action under the Unfunded Mandates Reform Act of 1995.

This rule is not a major rule as defined by § 804 of the Small Business Regulatory Enforcement Fairness Act of 1996. This rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.

We want to make Bureau documents easier to read and understand. If you can suggest how to improve the clarity of these regulations, call or write to Sarah Qureshi at the address or telephone number listed above.

You can use the Administrative Remedy Program, 28 CFR 542.10 through 542.19, to challenge Bureau of Prisons decisions regarding DCEGT.

The Department of the Treasury published a notice of a proposed rule exempting a system of records from certain provisions of the Privacy Act of 1974, as amended. The Internal Revenue Service (IRS) published the system notice in its entirety at 66 FR 59839-59841 (November 30, 2001), and the proposed rule in the same Federal Register on pages 59754-59755.

Under 5 U.S.C. 552a(k)(2), the head of an agency may promulgate rules to exempt any system of records within the agency from certain provisions of the Privacy Act of 1974, as amended, if the system is investigatory material compiled for law enforcement purposes. The Employee Protection System Records-Treasury/IRS 60.000, contains investigatory material compiled for law enforcement purposes.

The proposed rule requested that public comments be sent to the Office of Governmental Liaison and Disclosure, Internal Revenue Service, 1111 Constitution Ave., NW, Washington, DC 20224, CL:GLD:D, no later than December 31, 2001.

The IRS did not receive comments on the proposed rule. Accordingly, the Department of the Treasury is hereby giving notice that the system of records entitled “Employee Protection System Records-Treasury/IRS 60.000,” is exempt from certain provisions of the Privacy Act. The provisions of the Privacy Act from which exemption is claimed pursuant to 5 U.S.C. 552a(k)(2) are as follows: 5 U.S.C. 552a (c)(3), (d)(1), (d)(2), (d)(3), (d)(4), (e)(1), (e)(4)(G), (H) and (I), and (f).

As required by Executive Order 12866, it has been determined that this proposed rule is not a significant regulatory action, and therefore, does not require a regulatory impact analysis.

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

Pursuant to the requirements of the Regulatory Flexibility Act, 5 U.S.C. 601-612, it is hereby certified that these regulations will not significantly affect a substantial number of small entities. The final rule imposes no duties or obligations on small entities.

In accordance with the provisions of the Paperwork Reduction Act of 1995, the Department of the Treasury has determined that this final rule would not impose new record keeping, application, reporting, or other types of information collection requirements.

The Bank Secrecy Act, Public Law 91-508, as amended, codified at 12 U.S.C. 1829b, 12 U.S.C. 1951-1959, and 31 U.S.C. 5311-5332 (the “BSA”), authorizes the Secretary of the Treasury, inter alia, to issue regulations requiring financial institutions to keep records and file reports that are determined to have a high degree of usefulness in criminal, tax, and regulatory matters, or in the conduct of intelligence or counter-intelligence activities to protect against international terrorism, and to implement counter-money laundering programs and compliance procedures. 1 Regulations implementing Title II of the BSA (codified at 31 U.S.C. 5311 et seq. ) appear at 31 CFR part 103. The authority of the Secretary to administer the BSA has been delegated to the Director of FinCEN.

This document, FinCEN Issuance 2002-1, rescinds an exemption from the provisions of 31 CFR part 103 granted to persons registered with the Securities and Exchange Commission as broker-dealers solely in order to offer and sell variable annuity contracts issued by life insurance companies. The background and purpose of the rescission are explained below.

The definition of “financial institution” for BSA purposes, found at 31 CFR 103.11(n), includes “a broker or dealer in securities.”  2 BSA regulations further define the term “broker or dealer in securities” to include a “broker or dealer in securities, registered or required to be registered with the Securities and Exchange Commission under the Securities Exchange Act of 1934. 3 Because variable annuity contracts fall within the definition of “security” under the federal securities laws, life insurance companies wishing to sell variable annuity contracts must register as broker-dealers under the Securities Exchange Act of 1934, and thus fall under the definition of “broker or dealer in securities” found in 31 CFR part 103.

In response to a request from the American Life Convention—Life Insurance Association of America, Treasury in 1972 granted an exemption from the provisions of 31 CFR part 103 to persons registered with the Securities and Exchange Commission as broker-dealers solely in order to offer and sell variable annuity contracts issued by life insurance companies. 4 However, given the Congressional mandate found in the USA PATRIOT ACT to extend to all entities defined as financial institutions under the BSA the requirement to establish an anti-money laundering program ( See Section 352(a) of the USA PATRIOT ACT), and to extend suspicious activity reporting to broker-dealers ( See Section 356 of the USA PATRIOT ACT), FinCEN believes that it is now appropriate to rescind this exemption pursuant to 31 CFR 103.86.

On December 31, 2001, FinCEN published a notice of proposed rulemaking (the “Notice”), 66 FR 67670, that would extend to broker-dealers the requirement to report suspicious transactions to the Department of the Treasury. In the Notice, FinCEN indicated that it anticipated that the exemption relating to variable annuity contracts issued by life insurance companies would be rescinded on the effective date of the final rule based on the Notice. 5 A final rule based on the Notice was published in the Federal Register on July 1, 2002. 6 FinCEN did not receive any adverse comments on the issue of rescinding the exemption. However, in response to a comment, FinCEN wishes to clarify that rescission of the exemption extends BSA coverage only to the activity of a life insurance company requiring the company to register with the SEC as a broker-dealer, and not to all activity of the life insurance company.

Thus, a person registered with the SEC as a broker-dealer solely to offer and sell variable annuity contracts issued by life insurance companies is subject to all applicable BSA requirements, including the requirement to file reports of suspicious activity, to the extent they offer and sell such contracts.

Throughout this document, wherever “we,” “us,” or “our” is used, we mean the EPA. Information is organized as follows:

Section 110 of the Clean Air Act as amended in 1990 (the Act) requires States to develop air pollution regulations and control strategies to ensure that State air quality meets the National Ambient Air Quality Standards (NAAQS) established by the EPA. These ambient standards are established under section 109 of the Act and they address six criteria pollutants: CO, nitrogen dioxide, ozone, lead, particulate matter and sulfur dioxide.

Each State must submit these regulations and control strategies to us for approval and incorporation into the Federally enforceable SIP. Each State has a SIP designed to protect its air quality. These SIPs can be extensive, containing regulations, enforceable emission limits, emission inventories, monitoring networks, and modeling demonstrations.

Oregon submitted their original section 110 SIP on January 25, 1972, and it was approved by EPA soon thereafter. Other SIP revisions have been submitted over the intervening years and likewise have been approved. The Medford CO SIP revisions and redesignation request submitted on May 31, 2001, are the subject of today's action.

Oregon believes that the Medford, Oregon CO nonattainment area is eligible for redesignation to attainment because air quality data shows that it has not recorded a violation of the primary or secondary CO air quality standards since 1991. The Medford nonattainment area has shown attainment of the CO NAAQS since 1993 and the maintenance plan demonstrates that Medford will be able to remain in attainment for the next 10 years.

Today's rulemaking announces three actions being taken by EPA related to air quality in the State of Oregon. These actions are taken at the request of the Governor of Oregon in response to requirements of the Act and EPA regulations.

First, EPA approves the 1993 base/attainment year CO emissions inventory for Medford. The 1993 inventory establishes a baseline of emissions that EPA considers comprehensive and accurate and provides the foundation for air quality planning in the Medford, Oregon CO nonattainment area.

Second, EPA approves the CO maintenance plan for the Medford nonattainment area into the Oregon SIP.

Third, EPA redesignates Medford from nonattainment to attainment for CO. This redesignation is based on validated monitoring data and projections made in the maintenance plan's demonstration. EPA believes the area will continue to meet the NAAQS for CO for at least ten years beyond this redesignation, as required by the Act.

Section 107(d)(3)(E) of the Act states that EPA can redesignate an area to attainment if the following conditions are met:

1. The State must attain the applicable NAAQS.

2. The area must have a fully approved SIP under section 110(k) of the Act and the area must meet all the relevant requirements under section 110 and part D of the Act.

3. The air quality improvement must be permanent and enforceable.

4. The area must have a fully approved maintenance plan pursuant to section 175A of the Act.

EPA has found that the Oregon redesignation request for the Medford, Oregon CO nonattainment area meets the above requirements. A Technical Support Document on file at the EPA Region 10 office contains a detailed analysis and rationale in support of the redesignation of Medford's CO nonattainment area to attainment.

To attain the CO NAAQS, an area must have complete quality-assured data showing no more than one exceedance of the standard per year at any monitoring site in the nonattainment area for at least two consecutive years. The redesignation of Medford is based on air quality data that shows that the CO standard was not violated from 1992 through 1995, or since. These data were collected by the Oregon Department of Environmental Quality (ODEQ) in accordance with 40 CFR 50.8, following EPA guidance on quality assurance and quality control, and are entered in the EPA Aerometric Information and Retrieval System, or AIRS. Since the Medford, Oregon area has complete quality-assured monitoring data showing attainment with no violations, the area has met the statutory criterion for attainment of the CO NAAQS. ODEQ has committed to continue monitoring in this area in accordance with 40 CFR part 58.

Yes. Medford was classified as a nonattainment area with a design value less than 12.7 parts per million (ppm). Therefore, the 1990 requirements applicable to the Medford nonattainment area for inclusion in the Oregon SIP include a 1990 emission inventory with periodic updates, an oxygenated fuels program, basic motor vehicle inspection/maintenance (I/M) program, contingency measures, conformity procedures, and a permit program for new or modified major stationary sources.

For the purposes of evaluating the request for redesignation to attainment, EPA has previously approved all but one element of the Oregon SIP. Section 187(a) of the Act requires moderate CO areas to submit a comprehensive, accurate, and current inventory of actual emissions from all sources as described in section 172(c)(3). Specifically, the 1990 emissions inventory was reviewed but not acted upon to allow for additional correction and revision. We later determined that a 1993 inventory that incorporated these changes would satisfy the requirement for a base/attainment year inventory and would also serve as the attainment year emissions inventory submitted with the maintenance plan. Today's action concurrently approves this required element of the 110 SIP as part of the Oregon SIP with the redesignation to attainment.

Yes. Emissions reductions achieved through the implementation of control measures are enforceable. These measures are: (1) The Federal Motor Vehicle Control Program, establishing emission standards for new motor vehicles; (2) a basic I/M program, and (3) an oxygenated fuels program.

ODEQ has demonstrated that actual enforceable emission reductions are responsible for the air quality improvement and that the CO emissions in the base year are not artificially low due to a local economic downturn or unusual or extreme weather patterns. We believe the combination of certain existing EPA-approved SIP and Federal measures contribute to permanent and enforceable reductions in ambient CO levels that have allowed the area to attain the NAAQS.

Today's action by EPA approves the Medford CO maintenance plan. Section 175A sets forth the elements of a maintenance plan for areas seeking redesignation from nonattainment to attainment. The plan must demonstrate continued attainment of the applicable NAAQS for at least ten years after the Administrator approves a redesignation to attainment. Eight years after the redesignation, the State must submit a revised maintenance plan which demonstrates attainment for the ten years following the initial ten-year period. To provide for the possibility of future NAAQS violations, the maintenance plan must contain contingency measures, with a schedule for implementation adequate to assure prompt correction of any air quality problems. The Medford CO maintenance plan meets all of these requirements.

Yes. ODEQ submitted comprehensive inventories of CO emissions from point, area and mobile sources using 1993 as the attainment year. Since air monitoring recorded attainment of CO in 1993, this is an acceptable year for the attainment year inventory. This data was then used in calculations to demonstrate that the CO standard will be maintained in future years. ODEQ calculated inventories for the required maintenance year (2012) and three years beyond (2015). Future emission estimates are based on forecast assumptions about growth of the regional economy and vehicle miles traveled.

Mobile sources are the greatest source of CO. Although vehicle use is expected to increase in the future, more stringent Federal automobile standards and removal of older, less efficient cars over time will still result in an overall decline in CO emissions. The projections in the maintenance plan demonstrate that future emissions are not expected to exceed attainment year levels.

Total CO emissions were projected from the 1993 attainment year out to 2015. These projected inventories were prepared according to EPA guidance. Because compliance with the 8-hour CO standard is linked to average daily emissions, emission estimates reflecting a typical winter season day (pounds of CO per day) were used for the maintenance demonstration. Oregon calculated these emissions without the implementation of the oxygenated fuels program. Oregon is requesting that the SIP requirement for an oxygenated fuels program be discontinued upon EPA's approval of the maintenance plan and redesignation. The projections show that CO emissions calculated without the implementation of the oxygenated fuels program are not expected to exceed 1993 attainment year levels. The following table summarizes the 1993 attainment year emissions, the 2015 maintenance year emissions, and 2015 emissions. The on-road mobile emissions are modeled for 1993 and 2015. Emissions for 2012 were calculated on the basis of a straight line interpolation between these two analysis years.

Entities potentially regulated by this action are expected to include manufacturers of zinc fertilizers, and the generators of hazardous secondary materials who will supply zinc-bearing feedstocks to those manufacturers. Some intermediate handlers, such as brokers, who manage hazardous secondary materials may also be affected by this rule.

EPA has established an official public docket for this action under Docket ID No. RCRA-2000-0054. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the OSWER Docket, 1235 Jefferson Davis Hwy, 1st Floor, Arlington, VA 22201. You may copy up to 100 pages from any docket at no charge. Additional copies cost $0.15 each.

You may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/edocket/ to access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified above. Once in the system, select “search,” then key in the appropriate docket identification number.

The index of comments received and supporting materials for this rulemaking are available from the RCRA Information Center. The official record for this action is in paper form. EPA has transferred all comments received electronically into paper form and has placed them in the official record, which also includes all comments submitted directly in writing. The official record is the paper record maintained at the address in ADDRESSES at the beginning of this document.

EPA's responses to the major comments received on this rulemaking are presented in the preamble to this final rule; other comments are addressed in a separate “Response to Comments” document which is also part of the official record for this rulemaking.

The contents of today's action are listed in the following outline:

These regulations are promulgated under the authority of sections 3001, 3002, 3003, and 3004 of the Solid Waste Disposal Act of 1970, as amended by the Resource Conservation and Recovery Act of 1976 (RCRA), as amended by the Hazardous and Solid Waste Amendments of 1984 (HSWA), 42 U.S.C 6921, 6922, 6923 and 6924.

Today's final rule puts in place a new, more coherent system for regulating the practice of manufacturing zinc fertilizers from hazardous secondary materials, and establishes conditions under which such materials can be recycled to produce fertilizers without the materials or the fertilizers being regulated as hazardous wastes. The rule, which was proposed on November 28, 2000 (65 FR 70954), is the Agency's response to concerns expressed by public interest groups, citizens, industry and state environmental agencies with regard to the RCRA regulations that have previously applied to this practice. We believe that these new regulations will create a more consistent and comprehensive regulatory framework for such recycling activities, will make industry more accountable for those activities, will establish more appropriate limits on contaminants in zinc fertilizers made from hazardous secondary materials, and in general will promote safe, beneficial recycling in the zinc fertilizer industry.

EPA wishes to emphasize that today's regulatory action addresses only one aspect of the larger issue of contaminants in fertilizers. Fertilizers made from recycled hazardous wastes (which are the only types of fertilizers subject to regulation under EPA's RCRA authorities) represent a very small segment-less than one half of one percent—of the total fertilizer market. To our knowledge, virtually all of these are zinc micronutrient fertilizers. Currently, less than half of all zinc fertilizers on the market are made from such recycled materials. In any case, EPA's studies of contaminants in fertilizers have indicated that the great majority of fertilizers are safe when used properly. This general finding is consistent with similar studies done by states such as Washington and California.

Because fertilizers are generally safe, EPA sees no compelling reason to launch a broad new federal regulatory program to address fertilizer contaminants generally (such regulatory authority is potentially available under the Toxic Substances Control Act). This is not to say, however, that there is no need at all to regulate fertilizer contaminants. A wide range of fertilizers and soil amendments, including many products that are not made from recycled wastes, contain appreciable levels of heavy metal contaminants. In addition, EPA's fertilizer studies concluded that a few of these products may contain contaminants at levels approaching those which could pose unacceptable risks to human health and the environment. There is also the potential for tainted feedstocks to be introduced into the market unknowingly, particularly when such materials are imported into the country from unknown sources. A recent incident in the Pacific Northwest involving imported shipments of zinc sulfate material with extremely high cadmium levels is evidence that such problems can occur ( see Washington Department of Ecology fact sheet at http://www.ecy.wa..gov/pubs/004025.pdf ).

Traditionally, state agriculture agencies have had responsibility for regulating the content of fertilizers, and in recent years several states (so far, Washington, Texas and California) have developed comprehensive programs to control contaminants in fertilizers and soil amendments. We believe that these state programs have been largely successful, and the Agency supports further state efforts in this area. Additional discussion of state fertilizer regulations and how they relate to this RCRA rulemaking is presented in section V. of this preamble.

We expect that the primary impact of this rule will be on manufacturers of zinc fertilizer products who have an interest in using hazardous secondary materials as feedstocks, and the generators who supply them. We expect that a number of manufacturers who have heretofore been avoiding the use of hazardous wastes will use the exclusion in today's rule to begin using materials such as zinc-rich dusts from brass foundries and fabricators as substitutes for other feedstocks. The generators of those materials are thus expected to benefit from this rule. The Agency is aware that the last manufacturer of K061 derived fertilizer (Frit Industries of Ozark, Alabama) has already begun the transition to use of alternative feedstock materials. Nucor Steel, the K061 generator that has been Frit Industries' supplier, is likewise switching to other recycling or disposal options. More detailed discussion of the impacts of this rule is presented in section VII.A of this preamble, and in the economic impact analysis document that has been prepared for this rulemaking.

EPA received more than 600 comments on the proposal during the formal comment period, which closed on February 26, 2001. The Agency also received a number of letters, cards and emails commenting on the proposal after the comment period, and these comments have been entered into the docket for this rulemaking. In addition, more than seventy individuals made oral statements at the public hearing on the proposal, which was held in Seattle, WA on November 29, 2001. Those statements have been recorded in the transcript of that hearing, which is also in the docket. At the hearing a substantial number of written comments were also submitted to the Agency, and have been included in the docket as well. In total, nearly 1000 comments were received on the proposed rule.

EPA has reviewed each comment on the proposal that was submitted. The major substantive comments that were received, and the Agency's response to them, are discussed in following sections of today's preamble. Other comments (with EPA's responses) are set out in a separate Response to Comments document. Where many commenters expressed similar or identical views on certain issues, these have been consolidated in the document, and the Agency has prepared a collective response to them. The Response to Comments document has been placed in the docket for this rulemaking.

In today's final rule EPA is promulgating the same basic regulatory approach that was outlined in the November 28, 2000 proposal. To summarize, today's rule:

• Removes the exemption from land disposal restrictions (LDR) treatment standards for zinc fertilizers made from electric arc furnace dust, or K061; and

• Establishes a conditional exclusion from the RCRA regulatory definition of solid waste for hazardous secondary materials that are legitimately recycled to make zinc micronutrient fertilizers; and

• Establishes conditions (chiefly concentration limits for certain heavy metals and dioxins) under which zinc fertilizers produced from hazardous secondary materials are not classified as solid wastes, and hence are not subject to RCRA subtitle C regulation.

Although EPA has finalized the same basic regulatory approach that was outlined in the November 28, 2000 proposed rule, several substantive revisions have been made in response to comments received. The following is a summary of these changes, which are discussed in more detail in following sections of this preamble:

Applicability. The final rule clarifies how the new product specification contaminant limits will apply to zinc fertilizers made from regulated ( i.e., non-excluded) hazardous wastes. In short, such fertilizers will need to comply with the existing, applicable land disposal restrictions (LDR) treatment standards for the hazardous wastes the fertilizers contain. Manufacturers of such fertilizers may, however, choose to meet the new, more stringent contaminant limits, if they wish.

Intermediate handlers. Under today's final rule, intermediate handlers ( e.g., brokers) of excluded materials will be eligible for the same exclusion as generators, provided they choose to meet the same conditions for reporting, record keeping and storage of excluded materials that apply to generators of such materials. The proposed rule did not contain any provisions specifically addressing intermediate handlers.

Additional testing. Today's final rule provides for additional sampling and analysis of fertilizer products in cases where processes or feedstock materials are changed in ways that could significantly affect contaminant levels in the fertilizers.

One-time notice. Two changes have been made to the condition for one-time notices that generators will need to submit to EPA or to authorized state agencies. One change eliminates the need to provide certain potentially proprietary information in the notices ( e.g., estimated quantities of material to be shipped to specific manufacturers). The other change will require that facilities identify in the one-time notice when they intend to begin managing materials under the terms of the conditional exclusion.

Certifications. The final rule eliminates the proposed condition that each shipment of excluded material to another state be accompanied by a certification that the receiving state is authorized to administer the conditional exclusion in this regulation.

Unit Closure. The final rule includes a provision clarifying that storage units which have previously stored hazardous wastes, and that subsequently will only store excluded materials according to these regulations, will not be subject to RCRA closure requirements.

Limits for nickel and arsenic. The proposed level for arsenic has been lowered in this final rule, and the proposed level for nickel has been eliminated.

Storage in supersacks. The proposed condition that would have prohibited outside storage of excluded secondary materials in non-rigid “supersack” containers has been revised to allow the use of these types of containers outdoors, provided they are managed within units ( e.g., on concrete pads) that have containment systems to prevent releases from leaks, spills or precipitation events.

EPA's main objectives for this rulemaking are to:

• Establish a more consistent, more comprehensive, and more protective regulatory framework for this recycling practice; and

• Establish more appropriate limits on contaminants in recycled zinc fertilizers that effectively distinguish fertilizer products from wastes by adopting limits that are already found in commercial fertilizers, which can be achieved with well-demonstrated manufacturing techniques, and that are protective; and

• Encourage legitimate recycling by streamlining regulatory restrictions on the management of hazardous secondary materials used to make zinc fertilizers, while making industry more accountable for its recycling activities.

EPA believes that the regulatory approach in today's final rule is the best means of achieving these objectives, for several reasons. We expect it to be environmentally beneficial by removing regulatory anomalies and making zinc fertilizers cleaner—for example, by halting production of K061-derived zinc fertilizers with relatively high contaminant levels ( see section III.B. of this preamble). A further environmental benefit will be recovery of large volumes of valuable zinc, rather than landfilling this resource. The rule will also enhance the ability of regulatory agencies to effectively monitor this recycling practice, while removing unnecessary regulatory disincentives on legitimate recycling. We also believe that the new contaminant limits in this rule are reasonable and are consistent with the environmental objectives stated above, and can be (and are being) easily achieved by industry using relatively simple, economically viable, existing manufacturing practices. These levels thus reasonably demarcate products from wastes.

While EPA believes that this final rule provides an appropriate balance of conditions and incentives, a large proportion of the more than 1000 total comments we received expressed a clear preference for a more stringent regulatory approach. Most of these comments were received in the form of emails, post cards, form letters and oral statements made at the public hearing. In general, these commenters expressed support for a regulatory approach similar to the option in the preamble identified as “Maintain current UCD requirements, with additional reporting, record keeping and testing requirements for all hazardous waste derived fertilizers” ( see 65 FR 70964-5, November 28, 2000). Under this type of approach, the current hazardous waste regulatory structure would be maintained and made more stringent by requiring lower limits on a wider range of potential fertilizer contaminants, greatly expanded testing requirements, labeling of hazardous waste derived fertilizer products, and much more in-depth reporting of environmental and manufacturing data. Many commenters suggested in addition that there should be a complete prohibition on the use of any dioxin-containing hazardous wastes to make fertilizers.

Such a regulatory approach would likely result in a complete elimination of hazardous secondary materials as a source of zinc to make fertilizers, since it would perpetuate existing regulatory disincentives ( e.g., RCRA permit requirements, as explained further in this preamble) and substantially increase compliance costs. To avoid these regulatory disincentives, manufacturers would almost certainly use alternative feedstock materials (which would likely contain the same or similar contaminants as are found in hazardous wastes) to make fertilizers. The resulting fertilizers would be largely unregulated, since they would not be subject to EPA's RCRA regulatory system, and only a few states presently regulate fertilizer contaminants under other legal authorities. Therefore, by eliminating the use of hazardous wastes in fertilizer manufacture, contaminant levels in some fertilizers could actually increase, which we do not believe is a desirable environmental result (not to mention the energy and other resources conserved by avoiding treatment and disposal of zinc-bearing secondary materials).

As explained in the preamble to the proposed rule, EPA has found that a wide variety of zinc-bearing materials—including hazardous wastes—can be safely and legitimately processed and recycled into high-quality zinc fertilizer products by using relatively simple, existing manufacturing techniques. In other words, the quality of the end fertilizer product depends almost entirely on the manufacturing process, rather than on the type of feedstock material that is used. EPA did not receive any comments on the proposal that presented technical or scientific information to challenge these findings, and we therefore have no reason to believe that high-purity zinc fertilizers made from recycled hazardous wastes are any different in composition or risk potential from those made from other types of materials. ( See proposed rule at 65 FR at 70959 n. 2 discussing the similarity of hazardous constituent levels in zinc fertilizers made from hazardous wastes and from other materials). Given that high purity zinc fertilizers made from hazardous secondary materials are essentially identical to those made from other types of feedstock materials, we see no environmental reason for increasing regulatory restrictions over such products. We believe that today's rule provides the proper balance of protections and incentives for this recycling practice without the need for additional, more prescriptive regulatory controls. The Agency therefore chose not to adopt the more stringent regulatory approach (described above) that was advocated by many commenters.

We also received a number of comments that simply decried the practice of using hazardous waste to make fertilizers, claiming that it creates serious threats to human health, the food supply, and the environment. None of these commenters, however, offered any specific evidence of such threats, or any concrete information indicating that hazardous wastes are being indiscriminately added to fertilizers as a way of disposing of them. It is important to note that any such acts would be considered “sham” recycling of hazardous waste, which is illegal. 1 Further, EPA's studies of contaminants in fertilizers have not found evidence to support such serious concerns. We do not wish to minimize the potential for adverse health effects from exposure generally to toxic chemicals such as heavy metals. We believe, however, that with regard to fertilizers, much of this concern is apparently misplaced, and may have resulted from unsubstantiated speculations and exaggerated claims of risk that have appeared in the media and elsewhere. We hope that this final rule, and the record of evidence that supports it, will help to allay unnecessary public fears with regard to fertilizers made from recycled hazardous wastes.

Today's rule establishes a new regulatory framework for legitimate recycling of “hazardous secondary materials” in the manufacture of zinc micronutrient fertilizers. A secondary material is a sludge, by-product, or spent material. See 50 FR at 616 n. 4 (Jan. 4, 1985). A hazardous secondary material is a secondary material that would be a hazardous waste ( i.e., is listed or exhibits a characteristic of hazardous waste) if it is first a solid waste. Hazardous secondary materials are presently classified as hazardous wastes when recycled to produce fertilizers. See 65 FR at 70958-59, explaining the “use constituting disposal” provisions in EPA's hazardous waste recycling rules. However, EPA is referring to these materials in this preamble as “secondary materials” or “hazardous secondary materials,” rather than as “hazardous wastes,” since today's rule excludes them from being defined as wastes provided that certain conditions are followed.

The rule will potentially apply to manufacturers of zinc fertilizers who use (or wish to use) hazardous secondary materials as ingredients in their production processes, and to the generators and any intermediate handlers who supply those materials to the manufacturers. The rule will not directly affect any zinc fertilizers that are made from non-hazardous materials (“secondary” or otherwise), nor will it change the current regulatory requirements for non-zinc fertilizers made from hazardous wastes. A full explanation of the regulatory requirements for hazardous waste fertilizer recycling that have been in effect prior to today's action is presented in the preamble to the proposed rule ( see November 28, 2000, 65 FR at 70956).

It should be noted that today's final rule creates two separate conditional exclusions-an exclusion from regulation for the hazardous secondary materials used in zinc fertilizer manufacture, and an exclusion for the fertilizer products that are made from these materials. The exclusion for hazardous secondary materials will potentially be available to those parties who handle such materials prior to recycling ( i.e., the secondary material generators, any intermediate handlers, and the fertilizer manufacturers). The exclusion provided for the finished zinc fertilizer products will only apply to fertilizer manufacturers, since they are solely responsible for ensuring that their products meet the specifications in today's rule.

To reiterate, today's final rule will not apply to any fertilizers other than zinc fertilizers that are made from recycled hazardous secondary materials. Thus, if a manufacturer were to use hazardous waste as an ingredient in a non-zinc fertilizer, the manufacturer would not be eligible for the conditional exclusion in today's rule, and will need to comply with applicable hazardous waste management requirements [ see existing § 266.20(b)].

Effective Dates. Except for one provision, today's rule will become effective immediately upon publication in the Federal Register . The exception is the provision in the rule that amends § 266.20(b), removing the exemption from treatment standards for fertilizers made from recycled K061. The effective date for that provision will be January 23, 2002.

The RCRA statute establishes six months as the usual effective date for Subtitle C rules ( see RCRA section 3010 (b)), though the Agency may provide for a shorter or immediate effective date in the case of regulations with which the regulated community does not need six months to come into compliance, as determined by the Admininstrator. Since today's final rule is essentially deregulatory in nature (with the exception noted above), we see no reason to delay its effective date. Thus, except for the provision that removes the exemption for K061 derived fertilizers, today's rule will be effective immediately upon publication in the Federal Register .

One commenter (Frit Industries) requested an extended (nine month) effective date for removing the exemption from treatment standards for K061 fertilizers. We note that there is no provision in the RCRA statute for such extended effective dates. In addition, the commenter has had ample notice of the Agency's intent to finalize this provision, and has been aware of the Agency's schedule for completing this regulatory action. Thus, we believe the commenter has had sufficient notice of this action.

Once this provision of the rule becomes effective, sales of K061 derived fertilizers by manufacturers to other parties will not be permitted, unless those fertilizers can meet the specifications for exclusion in today's rule. Assuming they cannot meet the exclusion specifications, remaining manufacturer inventories of K061 fertilizers after the effective date will need to be managed in accordance with applicable hazardous waste regulations. As a practical matter, however, inventories of K061 (or other) fertilizers that have already entered commerce ( i.e., have been sold and shipped to other parties) before the effective date will not be affected. Thus, fertilizer dealers and others who may have unsold stocks of K061 fertilizers after this rule's effective date will not be affected, provided the fertilizers were sold and shipped by the manufacturer prior to the effective date. It is our intent to hold manufacturers of K061 fertilizers (and any other affected fertilizers) responsible for ensuring that non-compliant products do not enter commerce after the effective date of this rule.

Today's rule eliminates the provision in § 266.20 that has exempted zinc fertilizers made specifically from electric arc furnace dust (K061) from having to meet applicable land disposal restrictions (LDR) treatment standards ( i.e., the treatment standards for K061). This exemption was originally promulgated in the “First Third” LDR rulemaking (August 17, 1988, 52 FR 31138), based on a determination by EPA that fertilizers made from K061 had metal contaminant levels comparable to those of substitute zinc fertilizers (including those made from non-hazardous waste feedstocks), and that the use of K061 fertilizers did not appear to pose significant risks ( see 53 FR 31164, August 17, 1998). However, in recent years zinc fertilizers of much higher purity ( e.g., zinc sulfate monohydrate, or ZSM fertilizers) have become widely available, and K061 derived zinc fertilizers now have among the highest contaminant ( i.e., hazardous constituent) levels of any zinc fertilizers. Thus, EPA believes that the original basis for the K061 exemption is no longer valid, and sees no reason why these fertilizer products should not have to meet the same contaminant limits as other fertilizers made from recycled hazardous wastes (or be excluded from regulation in the same way as other such fertilizers).

Response to Comments. Numerous commenters expressed support for a complete ban on the use of K061 in fertilizer manufacture, often citing the relatively high levels of dioxins in K061 fertilizers compared to other fertilizer products. Others urged a ban on the use of all “dioxin laden wastes” to make fertilizer. A few commenters opposed removing the current LDR exemption for K061 derived fertilizers.

EPA chose not to ban the use of K061 to make zinc fertilizers, for several reasons. Most importantly, we believe that with the promulgation of today's rule the issue of dioxins in K061 derived fertilizers will effectively become moot, largely because the new rules will in all likelihood eliminate the use of K061 to make zinc oxysulfate fertilizers. Oxysulfate is a type of zinc fertilizer that is typically made by simply mixing zinc-bearing material ( e.g., K061) with sulfuric acid. There is typically no processing step to remove contaminants—whatever impurities are in the feedstock material will usually remain in the finished product. Such products will be unable to meet the new exclusion levels in today's rule, or the applicable LDR standards. Thus, we do not expect this type of fertilizer to be produced after the effective date of today's regulations.

At the same time, it is possible to remove the contaminants in K061 to make a different type of fertilizer, such as high-purity ZSM fertilizer, which can satisfy the conditional exclusion levels. Most of the zinc in K061 is bound with iron in a zinc ferrite compound that is relatively insoluble and, at normal temperatures, cannot be effectively digested with acids to precipitate and filter out contaminants such as lead and other metals. However, it has been demonstrated that raw K061 can be first processed in high-temperature furnaces to form a zinc oxide material that can then easily be made into ZSM. Such thermal treatment, combined with subsequent manufacturing processes, is likely to destroy most or nearly all dioxins present in K061. The agency thus sees no dioxin-related reason to prohibit this use of K061. Further discussion of dioxins in hazardous waste derived fertilizers is presented in section III.D.3 of this preamble.

A few comments were received that opposed removing the current exemption from LDR treatment standards for K061 derived zinc fertilizers. These commenters did not, however, challenge the Agency's logic for eliminating the exemption, but rather argued that EPA has no legal jurisdiction to regulate these fertilizers at all, based on recent court decisions. EPA rejects these arguments, for the reasons discussed later in this preamble.

In this final rule, EPA has created a “conditional exclusion” from the RCRA definition of solid waste for hazardous secondary materials (which would otherwise be classified as hazardous wastes, as explained above) that are used as ingredients to make zinc micronutrient fertilizers. As mentioned previously, this feature of the final rule is consistent with the proposal, though a few specific changes have been made, as explained below.

The conditional exclusion provided in today's rule is an exclusion only from the RCRA subtitle C regulations, and not from the emergency, remediation and information-gathering sections of the RCRA statute [sections 3004(u), 3007, 3013, and 7003]. This is consistent with the principle already codified for other excluded secondary materials—that the exclusion is only from RCRA regulatory provisions, and not from these statutory authorities. See § 261.1(b). EPA is restating this principle here in the interests of clarity, not to reopen the issue. The legal basis for the distinction of the Agency's authority under these provisions is that they use the broader statutory definition of solid waste (and hazardous waste as well) and so need not (and should not) be read as being limited by the regulatory definition. See, for example, 50 FR at 627. See also Connecticut Coastal Fishermen's Assn. v. Remington Arms, 989 F. 2d 1305, 1313-15 (2d Cir. 1993) (EPA may permissibly ascribe different definitions to the term “solid waste” for regulatory and statutory purposes).

Today's conditional exclusion is intended to remove many of the regulatory disincentives that to date have discouraged legitimate recycling in the zinc fertilizer industry. Previously, hazardous wastes that were recycled to make fertilizers were subject to the full suite of hazardous waste regulatory requirements, including the requirement to obtain a RCRA permit for storage of wastes prior to fertilizer production. This permitting requirement in particular has dissuaded a number of fertilizer manufacturers from using valuable secondary materials as feedstocks, since RCRA permits can be time and resource-intensive to obtain and maintain, and a number of alternative materials are readily available that are not subject to subtitle C regulation, either because they are not hazardous ( i.e., are not listed and do not exhibit a characteristic), or are raw materials. By allowing companies to manage these hazardous secondary materials in accord with the conditions which are established in today's final rule, EPA expects that the rate of legitimate recovery of zinc values in these materials will increase considerably, which should be environmentally beneficial and result in lower costs to farmers for zinc fertilizers.

Once this rule becomes effective, those who wish to begin managing hazardous secondary materials according to the conditional exclusion will first need to notify EPA or the authorized state of their intent to do so. This will provide overseeing agencies information as to who will be operating under this alternative regulatory system, when they will start, and the type of materials involved. In EPA's view, for this particular recycling practice, this is the minimum information needed to ascertain that legitimate recycling of the zinc-bearing materials will occur, and by whom. The other conditions that must be met to use and maintain the conditional exclusion address the proper storage of materials prior to recycling, and documentation of all off-site shipments of excluded materials. In addition, fertilizer manufacturers will need to submit an annual report to the overseeing agency that identifies the type, quantity and origin of all excluded materials that were used in the previous year. Again, EPA believes that for this recycling practice, these conditions are needed to assure that the materials will be recycled legitimately.

Several changes have been made to the final rule with regard to its applicability. For one, the final rule has been modified with regard to how it applies to intermediate handlers who act as brokers or middlemen between generators and fertilizer manufacturers. The proposed regulatory language did not specify any requirements or conditions specifically for intermediate handlers, though EPA discussed the issue and solicited comments on it in the preamble (65 FR at 70962-3). Several commenters observed that the use of intermediate handlers in this industry is not uncommon, with one commenter suggesting that in the final rule an intermediate handler should have the same responsibilities as a manufacturer who uses the conditional exclusion.

The conditions in the final rule for excluding hazardous secondary materials are intended to reflect normal, responsible practices for management of valuable material commodities, rather than waste management. Since intermediate handlers may be an integral part of the management chain for these materials prior to recycling, we believe it is reasonable to also establish conditions for them. If intermediate handlers had no responsibilities for maintaining the excluded status of materials they receive, the materials could potentially be mixed or consolidated with other materials, or could in some other way lose their regulatory identity and escape the chain of custody that provides accountability to the government and the public to ensure that these materials are being handled in way that is consistent with the handling of a valuable commodity. They also could simply be stored haphazardly and create the types of damage associated with improper management of discarded materials, as has occurred in past damage incidents within the zinc fertilizer recycling industry (records of these damage cases are in the docket for this rulemaking).

EPA sees no reason to prohibit excluded materials from being shipped through intermediate handlers, since they may provide a useful service to both generators and manufacturers in this industry. Moreover, use of such middle-men is relatively common in the industry, and so is consistent with the idea of an exclusion conditioned to conform to industry commercial practice. However, their use must not compromise the protections that have been built into this conditional exclusion.

We believe that intermediate handlers have incentives for managing conditionally excluded materials that are very similar to the generators’, and thus should have similar responsibilities ( i.e., any exclusion for intermediate handlers should be conditioned in the same manner as for generators). The final rule therefore specifies that intermediate handlers who wish to use the conditional exclusion must meet the same set of conditions that apply to the generators of the materials [ see § 261.4(a)(20)(ii)]. In effect, any intermediate handler who elects to receive conditionally excluded materials and wishes to maintain their excluded status under the terms of today's rule would need to provide prior notice to the appropriate regulatory agency, store the materials in accordance with the conditions in the rule, and meet all other conditions that would otherwise apply to the generator of the material. Alternatively, it is possible that an intermediate handler might choose not to use the conditional exclusion, in which case any excluded materials received by the handler would lose their excluded regulatory status.

In general, the conditions established in today's final rule for storage and documentation of excluded material are designed to reflect normal fertilizer industry handling practices for zinc-bearing feedstock materials. They are the same basic conditions that were proposed for establishing and maintaining a regulatory exclusion for hazardous secondary materials used to make zinc fertilizers, with several relatively minor changes.

Under this rule, in order to begin managing hazardous secondary materials that will be used to make zinc fertilizers without being subject to the current hazardous waste regulatory system, the responsible party ( i.e., the secondary material generator, the fertilizer manufacturer or an intermediate handler) must initially notify the appropriate regulatory agency that he or she intends to begin doing so, and must then meet the conditions set out in this regulation. These conditions address proper storage of the excluded secondary material, notification of regulatory agencies, and documenting and maintaining records of any off-site shipments of such material. Fertilizer manufacturers who wish to use the conditional exclusion will also need to submit an annual report to EPA or the authorized state agency on the types, origins and quantities of excluded materials used in the previous year.

The storage conditions in today's rule are based on normal industry practices for storing zinc-bearing feedstock materials used to make fertilizers, and thus are analogues to the hazardous constituent specification levels for the fertilizers, which likewise are drawn from existing industry practice. The conditions generally serve to prevent these materials from being discarded via wholesale release into the environment. The conditions also reflect the fact that zinc fertilizer feedstock materials are typically valued commodities, and are thus stored so as to prevent releases or other losses of the material. EPA's review of feedstock storage practices by zinc fertilizer manufacturers indicated, for example, that bulk feedstock materials are usually stored outdoors in hoppers or other types of tanks, while indoor storage is typically in supersack containers or in piles. We are not aware of any zinc fertilizer manufacturer currently storing feedstock materials in ways that readily allow dispersal via wind or precipitation runoff (e.g., open, outdoor piles). See the memorandum “Industry Storage Practices,” in the docket for this rulemaking. Thus, we believe that the conditions in today's rule reflect this industry's feedstock storage practices, and thus reasonably serve to demarcate valuable feedstocks from wastes.

EPA has made several changes from the proposed rule to the specific conditions that must be met in order to be eligible for the exclusion. These changes address outside storage of material in supersack containers, initial notifications to regulatory agencies, certifications for off-site shipments of excluded material, and enforcement of the conditions, as discussed in more detail below.

Outdoor storage in supersack containers. Supersacks are flexible, woven resin containers designed to hold approximately one ton of dry material, and are commonly used by generators, manufacturers and others to store various types of solid zinc fertilizer feedstock materials. Several commenters objected to the proposed condition that would have allowed only indoor storage of excluded materials in this type of container, asserting that such a restriction could be a hardship for smaller facilities that may not have sufficient indoor storage capacity, and that with a few simple safeguards supersacks can be safely and reliably used to store this type of material out of doors.

EPA agrees with the commenters' assertions that outdoor storage of excluded material in supersack containers can be safe and does not automatically indicate the material is being discarded, and therefore should be allowed under certain conditions. We are unaware of any environmental damage cases associated with storage of zinc fertilizer feedstock materials in supersack containers. The final rule therefore specifies that storage of excluded material in non-rigid containers ( e.g., supersacks) will be allowed outdoors, as long as they are kept closed and are in sound condition, and are managed within storage units ( e.g., on concrete pads) that can contain, drain and allow removal of leaks, spills, and accumulated precipitation, and can prevent run-on into the unit. These conditions are intended to assure management commensurate with the secondary material's classification as a valuable feedstock, rather than as a waste. Put another way, the conditions assure both that the material is being managed comparably to other material inputs used in fertilizer manufacture, and that the secondary materials will not be discarded via haphazard management that allows wholesale environmental release of the material, so becoming “part of the waste disposal problem”. American Mining Congress v. EPA, 824 F. 2d 1177, 1193 (D.C. Cir. 1987); Association of Battery Recyclers v. EPA, 298 F. 3d 1047, 1056 n. 6 (D.C. Cir. 2000).

One-time notice. Under the proposed rule, generators would have had to identify in their one-time notices to regulatory agencies the estimated annual quantities of excluded materials that they expected to ship to each fertilizer manufacturer. Some commenters objected to this condition on the grounds that such information would be speculative, commercially sensitive, and of questionable use to regulatory agencies. EPA agrees, largely for the reasons offered by the commenters, and has removed this element of the one-time notice condition from the final rule.

Certification. The proposed rule specified that generators using the conditional exclusion in today's rule would need to ensure that each shipment of excluded material off-site to another state was accompanied by a certification stating that the receiving state is authorized to administer the provisions of this rule. The implication of this proposed provision was that out-of-state shipments of excluded material would only have been allowed if the receiving state had adopted and obtained authorization from EPA to implement these rules. Several commenters objected to this provision, arguing that shipments to states not authorized for this rule should be allowed, provided the materials are managed as hazardous wastes once they enter the receiving state. EPA agrees with these commenters, and has removed this certification provision from the final rule language.

Burden of Proof. The proposed rule contained a provision stating that in an enforcement action, the burden of proof in establishing conformance with the conditions in § 261.4(a)(20) shall be on the generator, intermediate handler or manufacturer claiming the exclusion. One commenter correctly noted that this provision is redundant with the provision in § 261.2(f), which also addresses assigning burdens of proof (both the burden of going forward and the ultimate burden of persuasion, see 50 FR at 642) when conditional exclusions are involved. The proposed provision has therefore been deleted from the final rule.

Unit Closure. Today's final rule specifies that storage units ( e.g., tanks and containers) used only to store zinc-bearing hazardous wastes before a conditional exclusion takes effect ( i.e., before the facility owner/operator submits the one-time notice provided under § 261.4(a)(20)(ii)(B)), and that will be used thereafter only to store secondary material excluded under today's rule, will not be subject to the closure requirements of 40 CFR part 264 (for units at permitted facilities) or Part 265 (for units at interim status facilities). This provision is intended to address situations where units such as tanks that have been used to store hazardous wastes would be required under the existing regulations to go through RCRA closure before storage of the excluded material could commence. As explained in the preamble to the proposed rule, the existing regulations require closure of units within 90 days of receiving the final volume of hazardous waste ( see § 264.113(a) and § 265.113(a)). In the case of facilities affected by today's rule, this would mean that for units such as tanks that have been storing zinc-bearing hazardous wastes, the owner/operator would need to remove all waste residues and other contamination from the unit, in order for the unit to then commence storing the identical material under the terms of the conditional exclusion. We believe that requiring closure under these circumstances would serve little, if any environmental purpose, and today's rule explicitly provides that in these situations storage units will not be subject to RCRA closure requirements.

Although these storage units will not be required to undergo closure according to the RCRA hazardous waste regulations, when the use of such a unit for this purpose is ultimately discontinued for some reason, the Agency expects that owner/operators will take common-sense steps to decontaminate and decommission the unit. We encourage owner/operators in these situations to consult with regulatory agencies as to the best way to ensure that such units and their surroundings are cleaned up properly.

EPA wishes to emphasize that relieving storage units from closure requirements in these situations will not relieve facility owner/operators of their responsibility to respond to any releases from such units during their operational life. As explained elsewhere in this preamble, not responding to such releases could be considered an act of illegal disposal under RCRA, and could thus be subject to enforcement action under RCRA section 3008(a), which could impose penalties, as well as require any necessary cleanup actions. The conditional exclusion also will not affect a facility owner/operator's corrective action obligations under RCRA section 3004(u) or section 3008(h). If necessary, other federal or state remedial authorities may also be used to address such releases. We also note that the facilities operating under the terms of today's conditional exclusion will remain subject to regulatory oversight by authorized states and EPA, and as such we expect that environmental conditions at these facilities will continue to be scrutinized by regulatory personnel. Another consideration for not requiring RCRA closure in today's rule is that storage in land-based units (e.g., outdoor piles) will not be allowed under the conditional exclusion. Generally, land-based units are more likely to have releases and are often more difficult to remediate. We thus believe, for the reasons cited above, that eliminating the closure requirement for storage units at facilities affected by today's rule will not compromise environmental protections at these facilities.

Implementation. The preamble to the proposed rule discussed and requested comments on several issues relating to implementation of this rule once it takes effect (65 FR at 70966-70967). These issues addressed the potential regulatory consequences of the rule on permitted and interim status RCRA facilities, and how the rule would be enforced. EPA has not made any specific regulatory changes in the final rule to address these issues, since we believe they can be satisfactorily resolved by the following explanation.

One key issue has to do with the effects of the rule on facilities that currently have RCRA permits or interim status, and are managing hazardous wastes that will become conditionally excluded under this rule. Under one scenario, a facility that manages a variety of hazardous waste materials, including some that become excluded under this rule, would be affected only to the extent that certain units or procedures at the facility would no longer be subject to hazardous waste regulations. A somewhat different scenario could involve a facility whose hazardous wastes all become conditionally excluded from regulation when this rule takes effect ( i.e., the facility no longer operates any hazardous waste management units).

One idea discussed in the proposal was to amend the current regulations to automatically terminate permit conditions, permits and/or interim status at facilities where hazardous waste management units or activities become de-regulated under today's rule. This could eliminate the need for regulatory agencies to process permit modifications or administratively terminate permits or interim status for those facilities. One state agency commenting on the proposal argued, however, for maintaining a government role in managing these facility transitions, asserting that automatically terminating permit conditions would not provide adequate oversight over facilities in these situations. Although cases like this are expected to be relatively few in number (perhaps only one facility in the nation will potentially be able to have its RCRA permit terminated because of this rule), we agree with the state agency commenter that making the transition to non-permitted status may not be entirely straightforward, especially when such facilities are undergoing cleanup actions under RCRA authorities. Thus, we concur that there should be some regulatory agency oversight in changing a facility's permit or interim status obligations under these regulations, and today's rule does not contain any regulatory provision for automatically terminating permits, permit conditions or interim status at facilities affected by this final rule. We believe that making these changes at affected facilities can be done efficiently under current authorized state administrative procedures for modifying or terminating a facility's RCRA permit or interim status.

Another potential implementation issue that could arise has to do with ensuring cleanup of historic contamination problems at facilities that may no longer need permits or interim status once the conditional exclusion takes effect. An example might be a facility with a RCRA operating permit that is working to remediate ground water contamination under the conditions of the permit. While the facility's operating permit may no longer be needed (since it is no longer actively managing hazardous waste), the owner/operator's obligations to remediate the contamination problems at the facility would not be affected by a change in the facility's operating status. In these situations, the authorized states would have the flexibility to address the facility's cleanup obligations by either maintaining in effect the corrective action-related provisions of the permit, or by using alternative federal or state enforcement mechanisms that may be available.

Enforcement. The exclusion in today's rule for hazardous secondary materials (§ 261.4(a)(20)) will take effect once a generator, intermediate handler or manufacturer provides notice to the appropriate regulatory agency of his/her intent to begin using the exclusion. There is no requirement for the regulatory agency to formally approve or otherwise act on such notices, though some state agencies may wish to do so.

The party claiming the conditional exclusion will be responsible for maintaining the exclusion by ensuring that all of the conditions are met. In the event that a condition is not met, the facility owner/operator will need to remedy the situation as soon as possible in order not to jeopardize the exclusion. Should there be any questions as to whether the facility has properly maintained its exclusion, it will be the responsibility of the owner/operator to demonstrate that the conditions have been and are being met. See section 261.2(f), discussed earlier. If necessary, the overseeing regulatory agency may use RCRA inspection and information collection authorities to assist in establishing whether or not a facility is meeting the exclusion conditions.

Facilities that claim the exclusion but fail to meet one or more of its conditions may be subject to enforcement action. For example, if a facility claiming the conditional exclusion failed to store secondary material in accordance with one or more of the conditions, the facility would in effect automatically lose its exclusion, and EPA or an authorized state agency could take enforcement action (under RCRA section 3008(a)), since the facility would likely then be violating hazardous waste regulatory requirements. In these situations a range of specific enforcement actions might be taken. In less serious cases the facility might simply be required to promptly remedy the situation, though fines or other penalties could also be assessed if appropriate. In especially serious cases the facility could be ordered to obtain a RCRA permit and comply with all applicable hazardous waste regulations.

As a general matter, if a facility fails to meet a condition of the exclusion it will not necessarily affect the regulatory status of the secondary material at other facilities. For example, if a fertilizer manufacturer's facility were to lose its exclusion, the facility generating the secondary material would typically be allowed to retain its exclusion, provided that he or she continues to meet the applicable conditions. In such a case, the manufacturer would need to be in compliance with applicable hazardous waste regulations in order to accept any further shipments of excluded (or non-excluded) material from a generator.

With regard to enforcement, it should also be noted that the conditional exclusion in today's rule will not affect a facility owner/operator's obligation to promptly respond to and remediate any releases of excluded secondary material that may occur at the facility. An accident, for example, could rupture or otherwise damage a tank or container, causing spillage of material onto soils. If such released material were not cleaned up promptly, the owner/operator would be subject to enforcement action for illegal disposal of waste. See § 264.1(g)(8)(iii).

Today's conditional exclusion will not affect the rights of concerned citizens to bring to regulators' attention any circumstance that might aid authorities in their monitoring and enforcement efforts. A concerned citizen also may file a suit under RCRA section 7002 against a party for violations that may result from failure to meet any of the conditions in this rule. Moreover, imminent and substantial endangerment provisions under Section 7003 of RCRA will continue to apply to conditionally excluded secondary materials as a safeguard, since those materials remain a statutory solid waste. Thus, EPA or an authorized State can act in the unlikely event of circumstances which may endanger human health or environment.

EPA received a number of comments addressing the general issue of whether or not a conditional exclusion from hazardous waste regulations is appropriate in the context of this rulemaking. One set of commenters presented arguments contending that EPA has no legal jurisdiction at all under RCRA to establish conditions or otherwise regulate hazardous secondary materials that are recycled to make zinc fertilizers. On the other hand, a substantial number of commenters expressed support for EPA continuing to regulate these materials as hazardous wastes, and called for adding a number of new, more stringent regulatory controls and restrictions over these waste materials.

With respect to comments challenging EPA's authority to classify hazardous secondary materials used as ingredients in fertilizer as solid wastes at all, EPA notes first that this issue has been long-settled, and was not reopened in this rule. EPA's rules classifying hazardous secondary materials used in a manner constituting disposal—which includes use as fertilizers, or as ingredients in fertilizers—were promulgated in 1985. 50 FR at 664, 666-67. These use constituting disposal rules were never challenged. 2 EPA did not reopen the issue of jurisdiction for comment in this proceeding. 65 FR at 70959 n. 2. Thus, EPA believes that these comments are untimely.

In the event that response is considered necessary, however, EPA believes that it has ample jurisdiction to classify hazardous secondary materials used to produce zinc fertilizers as solid wastes. We also note that the following discussion applies to authority over uses constituting disposal as defined in section 261.2(c)(1), and does not deal with, or apply to, any other type of recycling. First, the generator of the hazardous secondary material is an unrelated entity getting rid of its secondary materials to a different industry sector. Thus, when one entity takes a secondary material for which it has no continuing use and transfers it to an unrelated entity, the materials can be viewed as discarded by that first entity. See Owen Electric Steel Co., v. EPA, 37 F. 3d 146, 150 (4th Cir. 1994) EPA properly classified secondary material as a solid waste “because the slag is sold to others for use in roadbed construction, it is not ‘destined for beneficial reuse or recycling in a continuous process by the generating industry itself  ’, quoting AMC I , 824 F. 2d at 1186 (emphasis in original). See generally American Petroleum Institute v. EPA (“API II”), 216 F. 3d 50_, 58 (D.C. Cir. 2000); Association of Battery Recyclers v. EPA, 208 F. 3d 1047, 1059-60 (D.C. Cir. 2000); American Petroleum Institute v. EPA, 906 F. 2d 729, 741 (D.C. Cir. 1990) 3 ; Specialty Steel Mfrs. Assn v. EPA, 27 F. 3d 642, 646 (D.C. Cir. 1994).

Recycling via land application is a further indication of discarding. As EPA has stated years ago, “Use constituting disposal involves as a practical matter the disposal of wastes. The wastes are being gotten rid of by placing them directly on the land.” 53 FR at 31198; see also 48 FR at 14484 (April 4, 1983) (“these practices are virtually the equivalent of unsupervised land disposal”). When placed on the land, hazardous secondary materials and the hazardous constituents they contain (few, if any, of which contribute to the recycling activity) could escape via all conceivable exposure pathways—air, runoff, leaching, even (as here) foodchain uptake. Such activities can certainly be viewed as discarding that is “part of the waste disposal problem.”

The statute supports this position. See RCRA section 3004 (l) (use of “waste or used oil or other material, which is contaminated with dioxin or any hazardous waste * * * for dust suppression or road treatment is prohibited”) 4 ; H.R. Rep. No. 198, 98th Cong., 1st Sess. at 46, 67-68 (hazardous waste-derived products that are placed on the land are to be the special object of EPA scrutiny in implementing subtitle C); see also Association of Battery Recyclers v. EPA, 208 F. 3d 1047, 1059-60 (recycling via uses constituting disposal pose even greater potential risks than conventional land disposal, and thus justify stricter regulation). As the Agency concluded in 1988 (in another determination that was never challenged), “To say that Congress did not intend to control these use constituting disposal situations under RCRA is to say that Congress had no intention of controlling such damage incidents as the Times Beach dioxin spreading incident where a group of communities were rendered uninhabitable as a result of use of a distillation botto[m] mixed with used oil as a dust suppressant. No credible reading of the statute would authorize this type of conduct.” 53 FR at 31198. Indeed, some of the fertilizers addressed by today's rule contain dioxin, which comes from the hazardous secondary materials used as a source of zinc. EPA does not consider it plausible that Congress prohibited the use of dioxin-containing secondary materials as dust suppressants, but denied EPA the authority to even consider the question of dioxin-containing hazardous secondary materials used as fertilizers—the more potentially harmful practice given the possibility of food chain contamination.

EPA notes, in addition, that many of the conditions in today's rule serve to demarcate legitimate recycling. The hazardous constitutent levels for fertilizers, for example, are drawn from typical levels in commercial zinc micronutrient fertilizers. To the extent that fertilizers contain non-nutritive hazardous constituents which come from hazardous secondary materials in concentrations significantly in excess of these levels, the recycling practice can be viewed as simply discarding those materials and constituents. American Petroleum Inst. II, 216 F. 3d at 58.

This is not to say that EPA lacks discretion to classify some hazardous secondary materials, and products derived therefrom, which are used in a manner constituting disposal as not being solid wastes. The facts justifying such discretion here (stated broadly) are (a) the usefulness of the materials as a source of zinc for fertilizer; (b) the similarity of hazardous constituent levels in hazardous and non-hazardous feedstock materials, and the fact that zinc fertilizers made from hazardous secondary materials are indistinguishable from those made from non-hazardous materials, and are processed identically ( see, e.g. 46 FR at 44971 (Aug. 8, 1981) (EPA's first announcement of the principle that identity of waste-derived and non-waste derived products justifies cessation of RCRA regulation); and (c) management practices commensurate with the idea that the secondary materials are being managed as a valuable commodity rather than as a waste. The conditions adopted in today's rule are designed to assure that this fact pattern actually occurs, and (as noted above) are further designed to assure that legitimate rather than sham recycling occurs.

As mentioned previously, a number of commenters did not support a regulatory exclusion of any kind for hazardous secondary materials used to make fertilizers, and instead favored maintaining and expanding the current hazardous waste regulatory controls over these materials. Among the suggestions for increased regulatory controls were greatly enhanced reporting by waste generators, middlemen and fertilizer manufacturers with regard to all shipments of hazardous wastes, including reporting on the composition of both the wastes that are used and of the fertilizers that are produced from those wastes. These additional reports would be required as part of the RCRA biennial reporting system ( see § 262.41). More thorough testing for a wider range of hazardous constituents was also suggested, as was labeling of fertilizer packaging to indicate that the fertilizer was made from hazardous waste.

As discussed earlier, we believe that maintaining RCRA regulatory controls over all hazardous secondary materials used to make zinc fertilizer is counter-productive, in that it discourages legitimate, safe recycling of these valuable materials, and can actually encourage production of fertilizers with higher contaminant levels . Adding further regulatory requirements would almost certainly ensure that this recyling practice would be eliminated completely, which we do not believe would be beneficial environmentally. With regard specifically to requiring additional testing of wastes and materials, the commenters did not supply any data to demonstrate why such additional testing is necessary, or any evidence indicating that fertilizers which meet today's exclusion levels are likely to contain meaningful levels of contaminants other than those for which we have established limits. EPA thus sees no reason to impose such additional requirements without a clear rationale for doing so.

With regard to commenters who supported labeling of hazardous waste derived fertilizer products, we note that there is no legal authority under RCRA to impose such a labeling requirement on products that are made from legitimately recycled hazardous wastes or conditionally excluded secondary materials. We also question the appropriateness of requiring such labels, since they would likely unnecessarily stigmatize products that are identical in composition to fertilizers made from other types of materials.

As mentioned previously, today's rule finalizes the same basic approach as was proposed with regard to setting conditional limits on contaminants in zinc fertilizers made from recycled hazardous secondary materials. This rule therefore establishes specific limits on heavy metals and dioxins that may be contained in these zinc fertilizers (the limits serving as the means for distinguishing wastes from fertilizer products under the conditional exclusion), and sets conditions for sampling, analysis and recordkeeping to verify compliance with these limits (i.e., to verify that excluded recycling is occurring). In effect, these conditions must all be met in order for zinc fertilizers made from hazardous secondary materials to be considered products, rather than wastes.

Today's rule establishes a new set of product specification limits for contaminants in zinc fertilizers made from hazardous secondary materials. Zinc fertilizers that meet these specification limits will in effect be considered products, rather than wastes.

The new exclusion limits in today's final rule address five metal contaminants—i.e., metals coming from zinc-containing hazardous secondary materials that are both non-nutritive and toxic (lead, cadmium, arsenic, mercury and chromium)—and dioxins (likewise non-contributing). In absolute terms, the exclusion limits for the five metals are numerically higher than the LDR treatment standards for those metals ( i.e., the “universal treatment standards” specified at § 268.48). However, direct comparisons between the two sets of limits are difficult to make. This is because the LDRs are measured according to a leachate extraction procedure (the toxicity characteristic leaching procedure, or TCLP— see § 261.24), while the new exclusion levels are expressed as total concentrations. Since the leachability of metal constituents varies according to a number of factors, it is difficult to predict the relationship between TCLP-measured levels vs. total concentration levels with any degree of certainty. To illustrate, the new exclusion level for lead in a 20% zinc fertilizer formulation would be 56 ppm, while the universal treatment standard for lead is 0.75 ppm (milligrams per liter). If in this case the tested sample contained 56 ppm total lead, the TCLP result could be either higher than 0.75 ppm, or lower if the lead was in (for example) a relatively insoluble compound form.

The exclusion limit for dioxins in today's rule is more stringent than the LDR standards, since dioxins are typically not “underlying constituents” subject to treatment in the secondary materials that are likely to be excluded under today's rule ( i.e., secondary materials that exhibit a hazardous characteristic— see § 268.40(e)). Because of this, and in light of the uncertainties inherent in comparing LDR standards for metals with the new exclusion levels, EPA considers today's exclusion levels to be generally more stringent than the LDR standards.

The product specifications in today's rule must be met for any zinc fertilizer that is made from excluded secondary materials. In this sense the two exclusions are linked—a manufacturer who uses the exclusion for hazardous secondary materials must meet the new, more stringent exclusion levels for the zinc fertilizers he or she produces. The LDR standards will continue to apply to any non-zinc fertilizer that is made from recycled hazardous waste.

It is possible under some circumstances that a zinc fertilizer manufacturer might choose not to use the conditional exclusion for hazardous secondary materials, and instead use fully regulated hazardous wastes as feedstock materials. This might happen, for instance, if the manufacturer has already obtained a RCRA permit and made the necessary investments to comply with hazardous waste regulations. In such a case the LDR standards would apply to the hazardous waste derived fertilizers. Such a manufacturer would have the option, however, of meeting the generally more stringent product specifications in today's rule if there were some incentive ( e.g., a marketing advantage) to do so.

To reiterate, today's conditional exclusions apply only to zinc fertilizers and the secondary materials used to produce them. Thus, if hazardous wastes are used to make non-zinc fertilizers, both the wastes and the fertilizers will be subject to applicable hazardous waste regulations ( see § 262.20(a)).

Table 1 presents the final limits on five metal contaminants in zinc fertilizers that are made from hazardous secondary materials:

As noted in the table, these limits are expressed as total concentrations of the metal in the fertilizer product. The alternative of establishing limits based on a different type of test procedure, such as the TCLP used in the RCRA program to identify hazardous wastes, was not supported by any of the commenters on the proposal (one obvious reason being that satisfying a leach test would normally mean that the material is unusable as a fertilizer, since the nutritive metal would be bound up along with the hazardous constitutents). It should also be noted that the limits are tied to the percentage of zinc in the fertilizer. This is primarily because the zinc content of fertilizers varies widely. If the limits were not tied to the percentage of zinc in the product, it is possible that manufacturers could comply with the limits simply by lowering the zinc content of the product, in effect diluting the contaminants with other ingredients. 55 FR at 70969.

These limits on metals are based on the levels of contaminants in commercial zinc fertilizers that have been well demonstrated as technically and economically practical, by using sound, relatively simple manufacturing techniques. They thus are reasonable levels for demarcating products from wastes. As explained in the preamble to the proposed rule, a widely-marketed zinc fertilizer formulation known as zinc sulfate monohydrate, or ZSM, was used as the basis for developing these limits. 55 FR at 70969.

EPA has made three substantive changes in finalizing the conditional limits for metal contaminants. One change was made in response to a commenter who suggested that additional sampling and testing for metal contaminants should be required whenever a change in manufacturing processes or ingredients is made that could significantly affect the amounts of contaminants in the fertilizer product. The Agency has added this condition to the final rule, since we believe it to be a reasonable precaution that prudent manufacturers would likely take in the normal course of production, even without such a regulatory provision. As such, we believe it a reasonable condition to demarcate products from wastes and to assure that legitimate recycling occurs.

Another substantive change that has been made to the proposed limits on metal contaminants is that the final rule does not include a limit for nickel. Several commenters expressed the view that the proposed limit on nickel (1.4 ppm per percent of zinc in the fertilizer) was unnecessary from an environmental perspective, in that nickel is generally less toxic than the five other metal contaminants, and EPA's background data did not reveal especially high levels of nickel in any of the fertilizer products that were studied [ see “Background Document on Fertilizer Use, Contaminants and Regulation” (EPA 747-R-98-003, January, 1999)]. Some of these commenters also opined that setting a limit on nickel in the context of this EPA rulemaking could create an unnecessary and unwarranted perception that exposure to nickel generally poses serious human health and/or environmental risks.

EPA agrees that nickel is generally less toxic to humans than metals such as lead, cadmium, arsenic and others, and we acknowledge that our review of fertilizer contaminant data did not identify any fertilizer product with nickel at levels that could pose significant health or ecological risks. Further, the processing and filtering steps that are required to manufacture high-purity zinc fertilizers (such as ZSM fertilizers) remove nickel along with other metal contaminants. It is therefore highly unlikely that fertilizers which meet the RCRA contaminant limits for other metals (lead, cadmium, arsenic, mercury and chromium) would contain elevated levels of nickel.

Given that excessive levels of nickel are unlikely in zinc fertilizers that meet the limits for the other five metals in today's rule, and given the relatively lower toxicity of nickel as compared with those metals, the Agency is persuaded that specifying a limit for nickel in today's final rule would serve no real environmental or regulatory purpose. We have therefore removed the limit for nickel in today's final rule.

The third change that has been made to the proposed limits for metals is that the final conditional limit for arsenic has been lowered, from 0.6 ppm per unit of zinc, to 0.3 ppm. This change was made in response to a commenter who questioned the validity of certain data that were used to derive the numerical limit for arsenic. Specifically, the commenter noted that the proposed limit appeared to be based on test results that represented analytical detection limits, rather than actual measured levels of arsenic in tested fertilizers. Our further review of the data confirmed this to be the case, and we have therefore established an arsenic limit that more accurately reflects what we believe to be the actual levels of arsenic in ZSM fertilizers.

Response to comments. EPA received comments reflecting a wide range of viewpoints (in addition to those described above) regarding the proposed limits on metals in recycled zinc fertilizers. One group of commenters questioned the Agency's legal authority to establish any limits at all on contaminants in these fertilizers, arguing that recent court decisions have narrowed the scope of EPA's regulatory jurisdiction over this type of hazardous waste recycling (an issue addressed earlier in this preamble). Some of these commenters also argued that, legal issues aside, it is unnecessary to set any limits on fertilizer contaminants, since EPA's own studies have concluded that fertilizers are generally safe when used properly. Other commenters expressed the view that the technology-based limits ( i.e. conditional levels reflecting demonstrated fertilizer production process capabilities) as proposed were unnecessarily stringent from a risk perspective, and that any such contaminant limits should be risk-based ( i.e., set at levels that are “safe,” based on an assessment of potential risks to humans and ecosystems). Some of these commenters further suggested that the risk-based guidelines for metal contaminants in fertilizers that were recently adopted by the Association of American Plant Food Control Officials (AAPFCO) ( see http://aapfco.org/SUIP25Aug08.htm ) could be used for this purpose. Other commenters expressed the view that the proposed limits for metals were not stringent enough, and should be set at the lowest levels that can be technically achieved. Some of these commenters further suggested that limits should be set for additional metals ( e.g., selenium, vanadium, beryllium, antimony). One commenter further argued that the limit on chromium should apply only to the more toxic, hexavalent form of chromium, rather than to total chromium as proposed.

EPA chose not to use risk-based limits in this final rule, primarily because we continue to believe that technology-based limits are more appropriate in the context of this rulemaking. Our rationale for using technology-based limits for metals in fertilizers—viz. as explained above, establishing a specification based on contaminant levels found in normal commercial fertilizers in order to reasonably distinguish products from wastes—was explained in detail in the preamble to the proposal, and many commenters supported the approach. Given that today's rule is an exclusion of these materials from being solid wastes, rather than an exclusion from being a hazardous waste (which would more naturally call for a risk-based justification), EPA continues to believe that this approach is reasonable. We did not receive any comments persuading us that the use of technology-based limits in the context of this rulemaking is inappropriate, technically difficult or unduly burdensome for industry.

Moreover, developing risk-based limits for zinc fertilizers would be a highly complex and resource intensive undertaking, and risk-based limits might actually allow contaminant levels in fertilizers to increase substantially, which we do not believe is an environmentally desirable result. To illustrate, Table 2 compares today's exclusion levels with AAPFCO's recommended standards (which were developed from risk assessment studies) for five metals in micronutrient fertilizers, assuming a 35.5% zinc content that is typical for zinc sulfate monohydrate fertilizers:

It should be noted that the AAPFCO recommended standards listed in Table 2 were based primarily on a risk assessment study commissioned by The Fertilizer Institute (an industry trade organization). As with other similar risk assessments, including EPA's (“Estimating Risk from Contaminants Contained in Agricultural Fertilizers,” September 1, 1999; Web site address www.epa.gov/epaoswer/hazwaste/recycle/fertiliz/risk/report.pdf ), a number of simplifying assumptions and models were used to address data gaps and other uncertainties inherent in that analysis. EPA does not necessarily accept or dispute the validity of the AAPFCO recommended levels as accurate indicators of potential risks; any such technical judgment would of necessity have to be based on additional data and more rigorous analysis. We note, however, that the general findings of EPA's risk assessment did not differ dramatically from those of the TFI-sponsored study. In any case, we simply wish to underscore the point that any risk-based standards for fertilizer contaminants, including those adopted by AAPFCO, have a considerable uncertainty factor associated with them.

The comparison in Table 2 indicates that risk-based limits for zinc fertilizers are likely to be far higher than the levels of contaminants that are now found in many commonly marketed products. At best, therefore, risk-based standards would have very little effect in terms of actually limiting the amounts of toxic metals in fertilizer products. In fact, as noted already, such standards could allow contaminant levels in zinc fertilizers to increase substantially over current levels. From an environmental perspective, and in light of the public policy debate that has recently taken place over fertilizer contamination, we believe such a result to be inappropriate from an environmental and public policy perspective. In EPA's view, regulatory efforts to control contaminants in fertilizers should be focused mainly on ensuring that fertilizers remain relatively clean, rather than allowing fertilizers to become increasingly contaminated to the point where they may begin to pose unacceptable human health or ecological risks. More importantly for the purposes of this rulemaking, risk-based levels are inappropriate as a measure of distinguishing zinc fertilizer products from wastes, since they bear no relation to the levels that are found in currently marketed zinc fertilizers, and therefore bear no relation to the question of whether the waste-derived fertilizers should be viewed as being or containing waste.

As for the comment suggesting that it is unnecessary to place any limits on contaminants in fertilizers because EPA's studies indicate fertilizers are generally safe, we disagree. In our view, it would be difficult, if not unconscionable, to assure the public and other stakeholders as to the safety and legitimacy of using hazardous secondary materials— i.e., what otherwise are hazardous wastes—to make fertilizers without having any means of limiting contaminants in the resulting fertilizer products. Moreover, opportunities for sham recycling obviously would become rife under such an approach.

Some commenters expressed support for EPA's proposal to use technology-based limits for metals in recycled zinc fertilizers, but suggested that lower limits can and should be achieved. One industry commenter agreed, noting that his company consistently produces pharmaceutical grade zinc sulfate monohydrate with lower contaminant levels than those proposed, and that other companies could meet similar levels.

EPA does not question the assertion that lower contaminant levels than those proposed are technically achievable through the use of more refined (and more expensive) manufacturing processes. However, it is not the Agency's intent to set these limits at the very lowest levels that can be technically achieved. Cf. 63 FR at 33784-33785 (June 19, 1998) (explaining a similar benchmark approach for establishing levels to distinguish products from waste fuels based on comtaminant levels found in normal fossil fuels, rather than the very “cleanest” or “dirtiest” fossil fuels). The Agency's fertilizer risk assessment indicates that the proposed limits are considerably below levels that we estimate (albeit roughly) to be safe for humans and ecosystems. Thus, the actual environmental benefit to be gained from more stringent limits would likely be negligible. Further, we find highly questionable the notion that there would be any real public benefit in requiring zinc fertilizers to be suitable for pharmaceutical use, or that such exceptional purity (necessary for such a specialized use) is a reasonable means of demarcating fertilizer products from wastes. Finally, setting stricter limits in this rule would almost certainly force most manufacturers to either raise prices for finished zinc fertilizer products, or avoid regulatory requirements altogether by simply switching to alternative feedstock materials that are unregulated by RCRA. We see little if any benefit in either outcome. We have therefore not adjusted the final limits for metals in response to these comments.

Some commenters expressed the view that this rule should set limits for additional metals such as selenium, vanadium, beryllium, antimony and others, citing the possibility that potentially harmful levels of such metals could occur in zinc fertilizers. These commenters did not, however, provide any data to establish that elevated levels of such metals occur in ZSM products (or any other types of fertilizers), or that the purification techniques used in manufacturing ZSM would fail to remove these metals. We note, too, that the data we have reviewed to date on fertilizer contaminants did not indicate the presence of elevated levels of such additional contaminants in zinc fertilizers or any other fertilizer products. We are therefore not persuaded that there is any real need to set limits on additional metals in this rule, and the final rule addresses only the five metal constituents listed above.

A few commenters questioned the proposed limit on chromium (0.6 ppm per unit of zinc), contending that it would be unnecessarily stringent since it does not differentiate between the hexavalent and trivalent forms of chromium, and only the hexavalent form is a potential threat to human health. One commenter also stated that there is no basis or precedent in RCRA to establish controls on the less toxic forms of chromium. That commenter argued further that new fertilizer manufacturing techniques under development may be unable to meet the proposed limit if it applied to total chromium, but could presumably meet that level if it applied only to the hexavalent form.

EPA does not dispute that the potential adverse health effects from exposure to hexavalent chromium are considerably greater than for trivalent chromium, although we do not agree with the commenter's assertion that RCRA controls only apply to hexavalent chromium. As one example, the listing of chromium as a “hazardous constituent” in Appendix VIII of 40 CFR part 261 does not distinguish between the hexavalent and trivalent forms. Similarly, the “land disposal restrictions” treatment standard for chromium (see § 268.48) applies to total chromium. There are a number of other examples, as well. We acknowledge, however, that some regulatory provisions of RCRA do make risk distinctions between hexavalent and trivalent chromium. One example is the exemption from the definition of hazardous waste for certain wastes that, upon specific demonstration, are shown to contain only trivalent chromium (see § 261.4(b)(6)).

The proposed limit for total chromium (0.6 ppm per unit of zinc) represents the level that has been demonstrated as readily achievable in ZSM fertilizers, including a small margin to account for variabilities in the manufacturing process. The commenter who proposed applying the limit only to hexavalent chromium did not question EPA's assertion that this level can be easily achieved in ZSM products, but instead referred to an unspecified “advanced technology” for making zinc fertilizer that is not designed to remove these contaminants. We note that the commenter did not supply any description of this advanced process, or submit any data to substantiate the claim that this technology would be unable to meet the proposed limit for total chromium. In fact, it is unclear from the commenter's discussion that this unspecified technology has been actually used in full-scale manufacture of zinc fertilizers. We also note that there is little, if any, available ZSM analytical data that differentiates between the different forms of chromium, although the basic chemical properties of chromium suggest that the presence of hexavalent chromium in ZSM fertilizers is likely to be relatively rare. In any case, it is certainly not EPA's intent in this rule to stifle development of new technologies for legitimate recycling in the fertilizer industry. However, without additional data and/or considerably more substantiation of the commenter's claims it is difficult for the Agency to conclude that the proposed limit on chromium is inappropriate or will otherwise be a hardship for zinc fertilizer manufacturers. The final limit on (total) chromium is therefore unchanged from the proposal.

Today's rule finalizes the proposed limit of eight (8) parts per trillion of dioxins in zinc fertilizers, as measured according to the “toxicity equivalence” or TEQ method (see “Estimating Exposures to Dioxin-like Compounds” (EPA publication #600/6-88/005 Ca)). The eight part per trillion limit is based on EPA's estimate of average national background levels of dioxins in soils ( see EPA report “Estimating Exposure to Dioxin-Like Compounds, Review Draft” (EPA/600/6-88/000Ca; June 1994)). EPA has included dioxins in its list of priority “persistent, bioaccumulative and toxic” (PBT) chemicals that are of particular concern environmentally and are the focus of new control strategies being developed by EPA. Further information on the Agency's overall strategy for addressing PBTs can be found on our Web site ( see www.epa.gov/pbt.htm ).

Significant levels of dioxins (in the hundreds of parts per trillion range) have been found in zinc oxysulfate fertilizers made from K061 hazardous wastes. EPA's fertilizer risk assessment concluded that exposure to dioxins in fertilizers at these levels is unlikely to pose unacceptable risks, based on currently available dioxin health effects information. However, available data on dioxin levels in fertilizers are admittedly very limited, so it is possible that dioxin levels in some fertilizer products could be higher than the current data suggest. It is also possible that, when finished, the Agency's ongoing reassessment of dioxin health effects could conclude that even more aggressive measures to control this class of PBT compounds are warranted. Because of these uncertainties, and because EPA is committed generally to a multifaceted national strategy aimed at reducing PBTs in the environment, we believe it is appropriate and prudent to limit dioxins in fertilizers in today's final rule. Moreover, given the presence of dioxins in at least some of the hazardous secondary materials used to produce zinc fertilizers, the extreme health risks associated with dioxins, and the fact that they contribute nothing to the efficacy of fertilizer products, some limit on dioxins is necessary for distinguishing product fertilizers from wastes, and to guard against sham recycling.

As explained in the preamble to the proposed rule, EPA chose to use a “background” approach to setting a limit for dioxins in zinc fertilizers primarily because we do not have sufficient data on dioxin levels in zinc fertilizers to establish a technology-based limit, which would be consistent with the approach used in this rulemaking to set limits for metals. The limited data that are available on dioxin concentrations in zinc sulfate monohydrate (the zinc fertilizer formulation used to develop the technology-based limits for metals) indicate dioxin levels of approximately one part per trillion (TEQ) or less. We did not receive any additional data from commenters with regard to dioxin levels in ZSM products, nor did any commenters offer persuasive evidence that the 8 ppt limit would be technically or economically difficult for ZSM producers to achieve in their products. Thus, we believe that the 8 ppt limit can be (and is being) easily achieved by industry, should not impose any significant economic burden on zinc fertilizer manufacturers, and serves as a reasonable level for distinguishing fertilizer products from wastes.

Response to comments. Many of the commenters on the proposal cited the need to limit dioxins in fertilizers as one of their primary concerns with regard to this rulemaking. Most of these commenters argued for either a more stringent limit than was proposed (e.g., a technology-based limit), or a complete ban on the recycling of any dioxin-containing waste material to make fertilizers. Some commenters suggested that a limit based on average national soil background levels would be appropriate only if it were based on “pre-industrial” background levels (which would presumably be lower than eight parts per trillion). In contrast, a number of other commenters opposed setting any limit on dioxins in this rule, arguing that it would increase costs to industry and would have little or no net environmental benefit. Other commenters suggested that if a limit on dioxins in fertilizer is established it should be risk-based, rather than based on national background soil levels. One commenter suggested that a dioxin limit of 100 parts per trillion would be more reasonable and appropriate than the proposed limit, though the basis for that specific limit was not provided.

None of the commenters who argued for more stringent limits on dioxins in this rule offered any scientific evidence establishing an environmental need for such additional controls, or questioning EPA's basic risk findings with regard to dioxins in zinc fertilizers. In addition, it is likely that more stringent limits would raise costs for this rule considerably. We see no reason to impose such additional costs without a convincing environmental rationale for doing so; thus, we chose not to adopt more stringent controls for dioxins in this final rule.

We disagree with the commenters who questioned the need for any limit on dioxins in this rule. As explained above, we believe that a limit on dioxins is appropriate as part of the Agency's broader strategy to control PBT chemicals in the environment, and should moreover have minimal cost impacts on industry. We also believe that a limit on dioxins in this rule is useful in distinguishing products from wastes, and in guarding against sham recycling of dioxin-containing secondary materials (dioxin being a non-contributing hazardous constituent in fertilizers). We do not agree with the commenters who suggested using a risk-based approach to setting limits on dioxins in this rule, for reasons similar to those in the preceding discussion of risk-based levels for metal contaminants. A risk-based limit on dioxins would likely be much higher than the actual levels of dioxins in high-quality zinc fertilizer, or the national soil background level of eight parts per trillion. Thus, a risk-based limit on dioxins would likely allow dioxin levels in these fertilizer products to increase greatly, to the point where they could pose unacceptable risks. EPA does not believe this to be a desirable environmental result, particularly in light of the current scientific uncertainty over the health effects of dioxins.

We also chose not to adopt a limit of 100 parts per trillion, as was suggested by one commenter. That commenter did not offer any scientific, technical or economic basis for this particular limit, nor did the commenter offer any evidence to refute our assumption that the eight ppt limit would be easily achievable by manufacturers of high-quality zinc fertilizers. We thus see no reason to adopt this higher, alternative limit for dioxins in this rule.

In the preamble to the proposed rule, EPA discussed and requested comment as to the regulatory status of certain fertilizers that are made from mining wastes which exhibit a hazardous characteristic ( e.g., are toxic when tested according to the TCLP, cited earlier). One particular iron fertilizer product, which is widely marketed to consumers through retail outlets under the name “Ironite,” has been identified as being made from such material. This product is notable for containing approximately 4400 parts per million of arsenic—to our knowledge, the highest arsenic levels of any fertilizer, by several orders of magnitude. At issue is the fact that the hazardous mining wastes used to make Ironite are presently exempt from regulation as hazardous wastes, under the so-called Bevill exemption in the RCRA statute (section 3001(b)(3)(A)(ii)).

In the proposed rule we invited comment as to whether EPA should undertake a regulatory initiative to remove the current exemption for this type of fertilizer. Most of the commenters on the proposed rule supported the idea of regulating Ironite (and other similar fertilizers, though we are not aware of any) under the same set of regulations that apply to hazardous waste derived fertilizers. Several commenters, in fact, expressed strong concerns as to the potential adverse health effects of Ironite, particularly acute effects that could result from direct ingestion ( e.g., by children) of Ironite products. Some of these commenters also questioned the validity of the studies that have been cited by the Ironite Products Company as demonstrating the safety of their products. One commenter, however (the American Mining Association), disputed the idea that Ironite is unsafe, suggesting that EPA's actual motive in this regard is to “backdoor” its way into narrowing the scope of the Bevill exemption. These commenters also cited the argument made by others that EPA has no legal authority at all to regulate hazardous wastes that are recycled to make fertilizers, let alone mining wastes that are specifically exempt from hazardous waste regulations.

EPA continues to believe that concerns regarding exposure to arsenic in Ironite products are worthy of serious consideration, particularly since it is a widely marketed consumer product intended for use by home gardeners and others. As such, the potential for misuse and/or accidental exposure (especially to children) cannot be discounted. At the same time, however, we recognize that there are technical issues associated with estimating risks from exposure to contaminants in Ironite that merit further study before the Agency can reach any definitive conclusions as to the potential risks of the product. For example, there has been some controversy regarding the bio-availability of the arsenic and lead compounds in Ironite and Ironite-amended soils.

EPA's Office of Solid Waste is partnering with EPA's Office of Research and Development and EPA's Region 8 Office to further evaluate the potential human health and environmental risks that may occur from the use of Ironite fertilizer. We expect that these efforts will provide the Agency with a much clearer sense of the environmental implications of Ironite use, and whether or not there is a need to pursue regulatory action to impose RCRA controls. The Agency will be coordinating this effort with state environmental and public health agencies and others who may have conducted similar studies or may have supporting analyses underway. Preliminary results of EPA's evaluation should be available in calendar year 2003. We hope to announce the Agency's follow-up regulatory strategy with regard to specific mining waste-derived fertilizers, such as Ironite, subsequently.

Virtually all States have regulatory programs for fertilizers, which are usually administered by state agricultural agencies. Traditionally, the primary focus of these regulatory programs has been to ensure that fertilizers are accurately classified and labeled, and meet manufacturers' plant nutrient claims. Until quite recently, state regulatory programs did not explicitly address the issue of controlling contaminants such as heavy metals in fertilizer products. In 1998 the State of Washington enacted legislation to create this country's first comprehensive system for regulating fertilizer contaminants. A key feature of Washington's program is a publicly accessible internet website containing data on all fertilizers registered in the State of Washington, including data on levels of non-nutrient metals in each registered product. This database can be accessed at http//www.wa.gov/agr/pmd/fertilizers.

The States of Texas and California have also recently established regulatory programs for fertilizer contaminants, and a number of other states are likewise considering regulatory initiatives in this area.

EPA supports state efforts to regulate contaminants in fertilizers. EPA regulates only a small fraction of the fertilizers currently on the market (one half of one percent or less) under its RCRA authorities. The potential certainly exists, however, for contaminant problems in other types of fertilizers. For example, cadmium levels in certain phosphate fertilizers (which typically are not waste derived) have been the subject of some concern recently by researchers, state regulators and others. We believe that the State of Washington's fertilizer regulatory program has been highly successful in controlling, and in a number of cases reducing, contaminants in fertilizer products sold in that state, and we thus encourage other states to develop similar programs.

Under section 3006 of RCRA, EPA may authorize qualified states to administer the RCRA hazardous waste program within the state. Following authorization, the state requirements authorized by EPA apply in lieu of equivalent federal requirements and become federally enforceable as requirements of RCRA. EPA maintains independent authority to bring enforcement actions under RCRA sections 3007, 3008, 3013, and 7003. Authorized states also have independent authority to bring enforcement actions under state law.

A state may receive authorization by following the approval process described in 40 CFR part 271. Part 271 of 40 CFR also describes the overall standards and requirements for authorization. After a state receives initial authorization, new Federal regulatory requirements promulgated under the authority in the RCRA statute which existed prior to the 1984 Hazardous and Solid Waste Amendments (HSWA) do not apply in that state until the state adopts and receives authorization for equivalent state requirements (this does not, however, preclude a state from adopting and implementing such new regulations under state law only, prior to being authorized for them). The state must adopt such requirements to maintain authorization. In contrast, under RCRA section 3006(g), (42 U.S.C. 6926(g)), new Federal requirements and prohibitions imposed pursuant to HSWA provisions take effect in authorized states at the same time that they take effect in unauthorized States. Although authorized states are still required to update their hazardous waste programs to remain equivalent to the Federal program, EPA carries out HSWA requirements and prohibitions in authorized states, including the issuance of new permits implementing those requirements, until EPA authorizes the state to do so. Authorized states are required to modify their programs only when EPA promulgates Federal requirements that are more stringent or broader in scope than existing Federal requirements.

RCRA section 3009 allows the states to impose standards more stringent than those in the Federal program. See also 40 CFR 271.1(i). Therefore, authorized states are not required to adopt Federal regulations, either HSWA or non-HSWA, that are considered less stringent.

Today's rule is promulgated pursuant in part to HSWA authority and in part to non-HSWA authority. The conditional exclusion from the definition of solid waste for hazardous secondary materials used in zinc fertilizers is promulgated pursuant to non-HSWA authority, and is also less stringent than the current Federal requirements. Therefore, States will not be required to adopt and seek authorization for the conditional exclusion. EPA will implement the exclusion only in those States which are not authorized for the RCRA program. EPA believes, however, that this final rulemaking has considerable merit, and we thus strongly encourage States to amend their programs and become federally authorized to implement these rules.

The elimination of the exemption from LDR treatment standards for K061 derived fertilizers is promulgated pursuant to RCRA section 3004(g), a HSWA provision. 5 Therefore, the Agency is adding this rule to Table 1 in 40 CFR 271.1(j), which identifies the Federal program requirements that are promulgated pursuant to HSWA and take effect in all States, regardless of their authorization status. Table 2 in 40 CFR 271.1(j) is modified to indicate that these requirements are self-implementing. Until the States receive authorization for these more stringent HSWA provisions, EPA will implement them. Once authorized States adopt an equivalent rule and receive authorization for such rule from EPA, the authorized state rule will apply in that State as the RCRA Subtitle C requirement in lieu of the equivalent federal requirement.

Under Executive Order 12866 (58 FR 51735), the Agency must determine whether this regulatory action is “significant” and therefore subject to formal review by the Office of Management and Budget (OMB) and to the requirements of the Executive Order, which include assessing the costs and benefits anticipated as a result of the proposed regulatory action. The Order defines “significant regulatory action” as one that is 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 of entitlements, 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. Pursuant to the terms of Executive Order 12866, the Agency has determined that today's proposed rule is a significant regulatory action because this proposed rule contains novel policy issues. As such, this action was submitted to OMB for review. Changes made in response to OMB suggestions or recommendations are documented in the docket to today's proposal.

EPA's economic analysis suggests that this rule is not economically significant under Executive Order 12866.

Detailed discussions of the methodology used for estimating the costs, economic impacts and the benefits attributable to today's rule for regulatory modifications to the definition of solid waste for zinc-containing hazardous waste-derived fertilizers, followed by a presentation of the cost, economic impact and benefit results, may be found in the background document: “Economic Analysis for Regulatory Modifications to the Definition of Solid Waste For Zinc-Containing Hazardous Waste-Derived Fertilizers, Notice of Final Rulemaking,” which is in the docket for today's final rule.

Methodology. To estimate the cost, economic impacts to potentially affected firms and benefits to society from this rulemaking, we analyzed data from zinc micronutrient producers, firm financial reports, trade associations and chemical production data. The Agency has used both model facilities and actual facilities in analyzing the effects of this proposed regulation.

To estimate the incremental cost or cost savings of this rule making, we reviewed baseline management practices and costs of potentially affected firms. The Agency has modeled the most likely post-regulatory scenario resulting from this action ( e.g., shifts to non-hazardous fertilizer feedstocks, shifting from zinc oxysulfate to zinc sulfate monohydrate production) and the estimated cost of complying with it. The difference between the baseline management cost and the post-regulatory cost is either the incremental cost or cost savings resulting from the rulemaking.

To estimate the economic impact of today's rule, we compared the incremental cost or cost savings of the rule with model firm sales. The Agency has also considered the ability of potentially affected firms to pass compliance costs on in the form of higher prices.

To characterize the benefits of today's rule, we evaluated available data and presented a qualitative assessment of benefits including ecological benefits and protection of natural resources such as groundwater.

Results. Volume. Data reviewed by the Agency indicates that there are 3 to 4 zinc micronutrient producers, one zinc producer, one steel mill, and 23 brass fume dust generators (ingot makers, mills, and foundries) potentially affected by today's rule. Although the exact amount of hazardous waste used in zinc micronutrient fertilizer production on annual basis varies from year to year, in 1997, data indicate that approximately 46,000 tons of hazardous waste were used in the production of zinc micronutrient fertilizer. The principal hazardous waste feedstocks were tire ash, electric arc furnace dust (K061) and brass fume dust from ingot makers, mills and foundries.

Costs. For the part of today's rule pertaining to zinc micronutrient fertilizers, we estimate the total annual cost savings from today's proposal to be $2.14 million for all facilities. Costs savings for different groups are summarized in Table 1.

Costs and cost savings to zinc oxysulfate producers are estimated from either shifting production to zinc sulfate monohydrate or shifting to nonhazardous sources of oxysulfate feedstocks. Zinc sulfate monohydrate producers and primary zinc producers are estimated to realize cost savings from shifting brass fume dust currently used in animal feed production to fertilizer production. Under current zinc sulfate markets, fertilizers are sold at a higher price than animal feed. One steel mill that has generated baghouse dust used in fertilizer manufacturing is expected to incur additional costs from having to shift their dust from fertilizer production to land disposal. And brass fume dust generators (mills, ingot makers, foundries) are estimated to incur cost savings from shifting their dust from zinc reclamation and animal feed to fertilizer production.

Economic Impact Results. To estimate potential economic impacts resulting from today's rule, we use a first order economic impacts measure: the estimated incremental costs or cost savings of today's rule as a percentage of affected firms sales. Because of data limitations, EPA was unable to obtain profit information for potentially affected firms. For two zinc oxysulfate producers the estimated impact of the rule is 1.42 percent in incremental costs for one firm and 0.64 percent in cost savings for the other. Two zinc sulfate monohydrate producers are estimated to realize cost savings of 0.1 and 15 percent of revenue. For the primary zinc producer, the rule is estimated to result in cost savings equal to 1 percent of firm sales. More detailed information on this estimate can be found in the economic analysis placed into today's docket.

Benefits Assessment. Because EPA did not use any risk assessments of current or projected metals and dioxin concentrations in zinc fertilizers in the development of this rulemaking, the Agency cannot make any quantitative conclusions about the risk reduction from today's final rule. To estimate the benefits resulting from today's rule, EPA looked at available literature and records regarding hazardous waste feedstocks used to make zinc micronutrient fertilizers. The data suggest that today's rule will reduce loading of toxic non-nutritive constituents to the soil. Two zinc oxysulfate samples produced from hazardous waste and analyzed by the State of Washington had dioxin concentrations between 17 and 42 times background level (“Final Report Screening Survey for Metals and Dioxins in Fertilizer Products and Soils in Washington State,” Washington State Department of Ecology, April 1999, Figures 1-1 and 1-2). In addition, the zinc oxysulfate manufacturing process does not remove any of the lead or cadmium from the feedstock material. If promulgated, today's proposal would reduce annual loadings of these metals to the soil.

In addition, today's proposal may reduce natural resource damage and contamination to groundwater. EPA is aware of at least two damage incidents caused by land placement of hazardous waste prior to fertilizer production that resulted in contamination of either groundwater or surrounding surface water bodies adjacent to the site. (“Report of RCRA Compliance Inspection at American Microtrace Corporation,” US EPA Region VII, December 4, 1996, Editorial, The Atlanta Journal/Constitution, April 11, 1993). Today's proposal may increase non-use values for these environmental amenities as well.

The Agency also believes that this rule has the potential for reducing what may be considered low probability but high consequence adverse human health or environmental impact if contamination from hazardous secondary material used in fertilizer production should, because of geological conditions such as karst terrain, reach a major population drinking water source or sensitive environmental location. This rule should lessen the chances of this type of event even though the probabilities of such occurrences and the magnitude of any impacts are not known.

The RFA generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions.

For purposes of assessing the impacts of today's rule on small entities, small entity is defined as: (1) A small business that has fewer than 1000 or 100 employees per firm depending upon the SIC code the firm primarily is classified; (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.

After considering the economic impacts of today's final rule on small entities, we have determined that this action will not have a significant economic impact on a substantial number of small entities. In determining whether a rule has a significant economic impact on a substantial number of small entities, the impact of concern is any significant adverse economic impact on small entities, since the primary purpose of the regulatory flexibility analyses is to identify and address regulatory alternatives “which minimize any significant economic impact of the proposed rule on small entities” (5 U.S.C. 603 and 604). Thus, an agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, or otherwise has a positive economic effect on all of the small entities subject to the rule.

There is one small entity incurring incremental costs and offsetting increased revenues resulting from this rulemaking. This firm is Frit Inc, a zinc oxysulfate fertilizer producer. Frit has one facility co-located onsite with Nucor Steel's Norfolk, Nebraska facility. Frit has been producing zinc oxysulfate fertilizer from Nucor's baghouse dust (K061, a listed hazardous waste). As result of this rulemaking, Frit will no longer be able to make zinc oxysulfate from Nucor's dust. This is due to both the removal of the exemption of K061 derived fertilizer's from LDR requirements and metal limits on zinc fertilizers made from hazardous secondary materials. EPA understands that Frit is ceasing operations at the Norfolk, Nebraska facility. In the economic analysis of the proposed rulemaking, EPA had modeled Frit switching from zinc oxysulfate to zinc sulfate monohydrate at Nucor's facility as the most cost-effective post-regulatory alternative. In public comment on the proposed rulemaking, The Fertilizer Institute, a trade association of which Frit is a member, commented that EPA's economic analysis had not accounted for costs of switching and operating from zinc oxysulfate to zinc sulfate monohydrate. Although EPA agrees with some of The Fertilizer Institute's comments and disagrees with others (for more information see the Response to Comments document to today's rulemaking), when EPA reevaluated two possible alternative regulatory responses for Frit to this rulemaking (1. switching from zinc oxysulfate to zinc sulfate monohydrate, and 2. switching from hazardous secondary sources to nonhazardous secondary sources), we determined that switching to nonhazardous sources of zinc-bearing secondary materials would be more cost-effective for Frit than switching its production to ZSM. This is because although it costs more to purchase nonhazardous zinc-bearing secondaries, the fertilizers produced from the nonhazardous sources are sold at a higher price due to lower nonnutritive mineral content (i.e. lead and cadmium). Because Frit is ceasing operations at the Nucor site, EPA has modeled the firm consolidating its operations at another company facility to produce zinc oxysulfate from nonhazardous sources. EPA has estimated that Frit's costs for nonhazardous feedstocks will increase by $2.9 million. Also, Frit should realize increased revenues of $3.4 million that offset these costs and increase profit by $0.49 million. Thus, Frit should not be significantly impacted by this rule even though it will be required to incur additional costs when substituting to nonhazardous sources.

Moreover, EPA does not believe that one regulated entity constitutes a substantial number of small entities in the zinc micronutrient industry. There are several other firms producing zinc micronutrient fertilizers, some of them small businesses. As discussed below, this rule will benefit many of these firms.

It is also likely that even in the absence of this rulemaking that opportunities to market K061 derived fertilizers would become more limited in response to decreased consumer demand for fertilizers with high non-nutritive mineral content. EPA notes that there is currently a market trend away from zinc fertilizers with high heavy metal content ( see www.chemexpo.com/news/newsframe.cfm?framebody=/news/profile.cfm as obtained April 12, 2002 for zinc sulfate). Therefore, it is likely that even in the absence of this rulemaking, the market for zinc fertilizers with relatively high heavy metal content, such as K061-derived zinc oxysulfate, is declining in favor of cleaner zinc fertilizers. And in the past 3 years, there has been a trend away from using K061 in fertilizer production. Two of the three firms that had used K061 in 1997 in zinc oxysulfate production had ceased using this hazardous feedstock prior to EPA's proposed fertilizer rulemaking.

EPA also notes that this rulemaking will assist many small businesses that either generate hazardous zinc-bearing secondary feedstocks or use those feedstocks in fertilizer production by opening up markets for these materials including brass dust, tire ash, and zinc oxides from steel waste. Brass foundries, brass mills, and brass ingot makers are examples of the types of small business generators likely to benefit from today's final rule. The Agency has received favorable public comments from trade associations representing small business generators of hazardous zinc-bearing secondaries. Other small business producers of zinc sulfate monohydrate such as Big River Zinc, and Madison Industries will benefit from increased supplies of zinc-bearing secondaries. For more information, please refer to the background document entitled “Economic Analysis for Regulatory Modifications to the Definition of Solid Waste For Zinc-Containing Hazardous Waste-Derived Fertilizers, Notice of Final Rulemaking,” which was placed in the docket for today's final rule.

For the reasons discussed above, I hereby certify that this rule will not have a significant adverse economic impact on a substantial number of small entities.

The information collection requirements in this final rule have been submitted for approval to the Office of Management and Budget (OMB) under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. An Information Collection Request (ICR) document has been prepared by EPA (ICR No. 1189.XX). A copy of this ICR may be obtained from Sandy Farmer, OPIA Regulatory Information Division, U.S. Environmental Protection Agency (2137), 1200 Pennsylvania Avenue, NW., Washington DC 20460, or by calling (202) 260-2740 and a copy may be obtained from Sandy Farmer by mail at OPPE Regulatory Information Division; U.S. Environmental Protection Agency (2137); 401 M St., SW.; Washington, DC 20460, by e-mail at farmer.sandy@epamail.epa.gov, or by calling (202) 260-2740. A copy may also be downloaded off the Internet at http://www.epa.gov/icr.

EPA has finalized the following conditions for reporting and recordkeeping by generators and manufacturers: The rule requires generators to submit a one-time notice to the EPA Regional Administrator (or the state Director in an authorized state) and to maintain all records of all shipments of excluded hazardous secondary materials for a minimum of three years As a condition of the exclusion, manufacturers will be required to submit a one-time notice, retain for a minimum of three years records of all shipments of excluded hazardous secondary materials that were received by the zinc fertilizer manufacturer during that period, and submit an annual report identifying the types, quantities and origins of all such excluded materials that were received by the manufacturer in the preceding year. The manufacturer will also be required to perform sampling and analysis of the fertilizer product to determine compliance with the contaminant limits for metals no less than every six months, and for dioxins no less than every twelve months. Additional testing will be required when changes to processes or feedstock materials are made that could significantly alter the composition of the fertilizer products. These conditions replace the current hazardous waste regulatory requirements for reporting and recordkeeping, and are designed to improve the accountability system, and government oversight capabilities, over the handling of secondary materials used to make zinc fertilizers.

EPA estimates that the total annual respondent burden for the new paperwork requirements in the rule is approximately 61 hours per year and the annual respondent cost for the new paperwork requirements in the rule is approximately $12,653. However, in addition to the new paperwork requirements in the rule, EPA also estimated the burden and cost savings that generators and manufacturers could expect as a result of no longer needing to comply with the existing RCRA hazardous waste information collection requirements for the excluded materials. This cost savings of $21,149 minus the $12,653 cost for the new paperwork requirements will result in an overall cost savings $8,496. The net cost to EPA of administering the rule was estimated at approximately $244 per year. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

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. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR Chapter 15.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, establishes requirements for Federal Agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. Under section 202 of the UMRA, EPA must prepare a written analysis, including a cost-benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures to State, local, and tribal governments, in the aggregate, or to the private sector, of $100 million or more in any one year. Before promulgating an EPA rule for which a written statement is needed, section 205 of the UMRA requires EPA to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective, or least burdensome alternative that achieves the objectives of the rule. The provisions of § 205 do not apply when they are inconsistent with applicable law. Before EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including tribal governments, it must have developed under § 203 of the UMRA a small government agency plan. The plan must provide for notifying potentially affected small governments, enabling officials to have meaningful and timely input in the development of regulatory proposals, and informing, educating, and advising small governments on compliance with the regulatory requirements.

This rule does not include a Federal mandate that may result in expenditures of $100 million or more to State, local, or tribal governments in the aggregate, because this rule imposes no enforceable duty on any State, local, or tribal governments. EPA also has determined that this rule contains no regulatory requirements that might significantly or uniquely affect small governments. In addition, as discussed above, the private sector is not expected to incur costs exceeding $100 million. Therefore, today's proposed rule is not subject to the requirements of Sections 202, 203, and 205 of UMRA.

Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.”

Under Section 6 of Executive Order 13132, EPA may not issue a regulation that has federalism implications, that imposes substantial direct compliance costs, and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by State and local governments, or EPA consults with State and local officials early in the process of developing the proposed regulation. EPA also may not issue a regulation that has federalism implications and that preempts State law, unless the Agency consults with State and local officials early in the process of developing the proposed regulation.

Section 4 of the Executive Order contains additional requirements for rules that preempt State or local law, even if those rules do not have federalism implications ( i.e., the rules will not have substantial direct effects on the States, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government). Those requirements include providing all affected State and local officials notice and an opportunity for appropriate participation in the development of the regulation. If the preemption is not based on express or implied statutory authority, EPA also must consult, to the extent practicable, with appropriate State and local officials regarding the conflict between State law and Federally protected interests within the agency's area of regulatory responsibility.

This rule does not have federalism implications. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. This rule directly affects primarily zinc micronutrient producers and generators of hazardous wastes used in zinc fertilizer production. There are no State and local government bodies that incur direct compliance costs by this rulemaking. And State and local government implementation expenditures are expected to be less than $500,000 in any one year (for more information, please refer to the background document entitled “Federalism Analysis (Executive Order 13132) for Zinc-Containing Hazardous Waste-Derived Fertilizers, Notice of Proposed Rulemaking: Substantial Direct Effects”, August 2000). Thus, the requirements of section 6 of the Executive Order do not apply to this rule.

This rule preempts State and local law that is less stringent for these zinc-bearing hazardous wastes. Under the Resource Conservation and Recovery Act (RCRA), 42 U.S.C. 6901 to 6992k, the relationship between the States and the national government with respect to hazardous waste management is established for authorized State hazardous waste programs, 42 U.S.C. 6926 (section 3006), and retention of State authority, 42 U.S.C. 6929 (section 3009). Under section 3009 of RCRA, States and their political subdivisions may not impose requirements less stringent for hazardous waste management than the national government.

Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” This final rule does not have tribal implications, as specified in Executive Order 13175. Today's rule does not significantly or uniquely affect the communities of Indian tribal governments, nor would it impose substantial direct compliance costs on them. Thus, Executive Order 13175 does not apply to this rule.

The Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997) applies to any rule that EPA determines (1) is “economically significant” as defined under Executive Order 12866, and (2) the environmental health or safety risk addressed by the rule has a disproportionate effect on children. If the regulatory action meets both criteria, the Agency must evaluate the environmental health or safety effects of the planned rule on children; and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered.

This final rule is not subject to the Executive Order because it is not economically significant as defined in Executive Order 12866, and because the Agency does not have reason to believe the environmental health or safety risks addressed by this rule present a disproportionate risk to children. EPA's fertilizer risk assessment modeled a number of pathways by which farmers and their children could be exposed to metals and dioxins in fertilizer products applied at recommended rates and frequencies. Exposure was modeled through both direct and indirect pathways. The direct pathways considered were the inhalation pathway, including inhalation of windblown emissions, and from emissions during product application and tilling. Direct ingestion of soils amended with fertilizers was also modeled. The indirect exposure pathways considered were ingestion of plants (vegetables, fruits, and root vegetables) grown on soils amended with fertilizer products containing metals and dioxins, ingestion of beef and dairy products produced on land amended with these products, and ingestion of home-caught fish from a stream adjacent to the farmer's agricultural field.

EPA's fertilizer risk assessment used a probabilistic methodology to estimate incremental lifetime cancer and non-cancer risks to farmers and farm children. The general conclusion of the risk assessment was that fertilizers generally do not pose harm to human health or the environment. Since today's final rule is expected to reduce the overall levels of contaminants in zinc fertilizers made from hazardous secondary materials, the Agency expects that the impacts of this rule on childrens' health will be positive, albeit relatively small.

Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (“NTTAA”), Public Law No. 104-113, section 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards. This rule establishes a conditional exclusion for zinc fertilizers based on contaminant levels for metals and dioxins. After considering alternatives, EPA has determined that it would be impractical and inappropriate to use voluntary consensus standards in this rulemaking, for the reasons discussed in more detail in in Section III.D of this preamble.

EPA is committed to addressing environmental justice concerns and is assuming a leadership role in environmental justice initiatives to enhance environmental quality for all populations in the United States. The Agency's goals are to ensure that no segment of the population, regardless of race, color, national origin, or income bears disproportionately high and adverse human health or environmental impacts as a result of EPA's policies, programs, and activities, and that all people live in safe and healthful environments. In response to Executive Order 12898 and to concerns voiced by many groups outside the Agency, EPA's Office of Solid Waste and Emergency Response formed an Environmental Justice Task Force to analyze the array of environmental justice issues specific to waste programs and to develop an overall strategy to identify and address these issues (OSWER Directive No. 9200.3-17).

Today's rule pertains to hazardous wastes used in zinc micronutrient production, and is intended to reduce risks of excluded hazardous secondary materials, and benefit all populations. As such, this rule is not expected to cause any disproportionately high and adverse impacts to minority or low-income communities versus non-minority or affluent communities.

Excluded hazardous secondary materials will be subject to protective conditions regardless of where they are generated and regardless of where they may be managed. Although the Agency understands that the exclusion may affect where these wastes are managed in the future, the Agency's decision to conditionally exclude these materials is independent of any decisions regarding the location of waste generators and the siting of waste management facilities. Today's rule will reduce loadings of toxic non-nutritive constituents to the soil, and will ensure proper management of secondary materials at affected facilities. EPA believes that these provisions of the rule will benefit all populations in the United States, including low-income and minority communities.

This rule is not a “significant energy action” as defined in Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355 (May 22, 2001)) because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. This rule applies to a discrete sector of the economy and potentially adversely affects fewer than 20 firms. This rule reduces regulatory burden and creates markets for hazardous zinc-bearing secondary materials. It thus does not adversely affect energy supply, distribution or use.

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A Major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2). This rule will be effective on July 24, 2002, except for the amendment to 40 CFR 266.20(b), which eliminates the exemption from treatment standards for fertilizers made from recycled electric arc furnace dust. The effective date for that provision in today's final rule is January 24, 2003.

The Federal Communications Commission published a document amending parts 15 and 18 in the Federal Register of July 10, 2002, (67 FR 45666). This document corrects the Federal Register as it appeared. In FR Doc. 02-17264 published on July 10, 2002, (67 FR 45666), the Commission is correcting the “ DATES : Effective August 9, 2002 of the Commission's rules to reflect the correct DATES : Effective September 9, 2002.”

In rule FR Doc. 02-17264 published on July 10, 2002 (67 FR 45666) make the following correction:

On page 45666, in the third column correct Dates: Effective August 9, 2002 to read as DATES : Effective September 9, 2002.

When filing comments, please reference CC Docket No. 98-67. Comments may be filed using the Commission's Electronic Comment Filing System (ECFS) or by filing paper copies. See Electronic Filing of Documents in Rulemaking Proceedings, 63 FR 24121 (1998). Comments filed through the ECFS can be sent as an electronic file via the Internet to < http://www.fcc.gov/e-file/ecfs.html >. Generally, only one copy of an electronic submission must be filed. If multiple docket or rulemaking numbers appear in the caption of the proceeding, however, commenters must transmit one electronic copy of the comments to each docket or rulemaking number referenced in the caption. In completing the transmittal screen, commenters should include their full name, Postal Service mailing address, and the applicable docket or rulemaking number. Parties may also submit an electronic comment by Internet e-mail. To get filing instructions for e-mail comments, commenters should send an e-mail to ecfs@fcc.gov, and should include the following words in the body of the message, “get form <your e-mail address>.” A sample form and directions will be sent in reply. Parties who choose to file by paper must file an original and four copies of each filing. If more than one docket or rulemaking number appears in the caption of the proceeding, commenters must submit two additional copies for each additional docket or rulemaking number. Filings can be sent by hand or messenger delivery, by commercial overnight courier, or by first-class or overnight U.S. Postal Services mail (although we continue to experience delays in receiving U.S. Postal Service mail). The Commission's contractor, Vistronix, Inc., will receive hand-delivered or messenger-delivered paper filings for the Commission's Secretary at 236 Massachusetts Avenue, NE., Suite 110, Washington, DC 20002. The filing hours at this location are 8:00 a.m. to 7 p.m. All hand deliveries must be held together with rubber bands or fasteners. Any envelopes must be disposed of before entering the building. Commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9300 East Hampton Drive, Capitol Heights, MD 20743. U.S. Postal Service first-class mail, Express Mail, and Priority Mail should be addressed to 445 12th Street, SW, Washington, DC 20554. All filings must be addressed to the Commission's Secretary, Marlene H. Dortch, Office of the Secretary, Federal Communications Commission, 445 12th Street, SW, Room TW-A325 Washington, DC 20554. Parties who choose to file by paper should also submit their comments on diskette. These diskettes should be submitted to: Dana Jackson, Federal Communications Commission, 445 12th Street, SW, Room 6-C410, Washington DC 20554. Such a submission should be on a 3.5 inch diskette formatted in an IBM compatible format using Word 97 or compatible software. The diskette should be accompanied by a cover letter and should be submitted in “read only” mode. The diskette should be clearly labeled with the commenter's name, proceeding (including the lead docket number in this case, CC Docket No. 98-67), type of pleading (comment or reply comment), date of submission, and the name of the electronic file on the diskette. The label should also include the following phrase “Disk Copy—Not an Original.” Each diskette should contain only one party's pleadings, preferably in a single electronic file. In addition, commenters must send diskette copies to the Commission's copy contractor, Qualex International, Portals II, 445 12th Street, SW, Room CY-B402, Washington, DC 20554. This proceeding shall be treated as a “permit-but-disclose” proceeding in accordance with the Commission's ex parte rules. See 47 CFR 1.1200 and 1.1206. Persons making oral ex parte presentations are reminded that memoranda summarizing the presentations must contain summaries of the substance of the presentations and not merely a listing of the subjects discussed. More than a one or two sentence description of the views and arguments presented is generally required. See 47 CFR 1.1206(b). Other rules pertaining to oral and written ex parte presentations in permit-but-disclose proceedings are set forth in § 1.1206(b) of the Commission's rules, 47 CFR 1.1206(b). Alternative formats (computer diskette, large print, audio recording and Braille) are available to persons with disabilities by contacting Brian Millin, of the Consumer and Governmental Affairs Bureau, at (202) 418-7426, TTY (202) 418-7365, or e-mail at bmillin@fcc.gov. This Public Notice can also be downloaded in Text and ASCII formats at: http://www.fcc.gov/cgb/dro.

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

The 2002 TAC of northern rockfish for the Central Regulatory Area was established as 4,170 metric tons (mt) by an emergency rule implementing 2002 harvest specifications and associated management measures for the groundfish fisheries off Alaska (67 FR 956, January 8, 2002 and 67 FR 34860, May 16, 2002).

In accordance with § 679.20(d)(1)(i), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the 2002 TAC for northern rockfish in the Central Regulatory Area will be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 4,120 mt, and is setting aside the remaining 50 mt as bycatch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance will soon be reached. Consequently, NMFS is prohibiting directed fishing for northern rockfish in the Central Regulatory Area of the GOA.

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

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA, finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is contrary to the public interest. This requirement is contrary to the public interest as it would delay the closure of the fishery, lead to exceeding the TAC, and therefore reduce the public's ability to use and enjoy the fishery resource.

The Assistant Administrator for Fisheries, NOAA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.

This action is required by § 679.20 and is exempt from review under Executive Order 12866.

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

The 2002 TAC of Pacific ocean perch for the Western Aleutian District was established as 5,236 metric tons (mt) by an emergency rule implementing 2002 harvest specifications and associated management measures for the groundfish fisheries off Alaska (67 FR 956, January 8, 2002).

In accordance with § 679.20(d)(1)(i), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the 2002 TAC for Pacific ocean perch in the Western Aleutian District will be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 4,436 mt, and is setting aside the remaining 800 mt as bycatch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for Pacific ocean perch in the Western Aleutian District of the BSAI.

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

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA, finds that the need to immediately implement this action to avoid exceeding the 2002 TAC of Pacific ocean perch for the Western Aleutian District of the BSAI constitutes good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) and 50 CFR 679.20(b)(3)(iii)(A). These procedures are unnecessary and contrary to the public interest because the need to implement these measures in a timely fashion to avoid exceeding the 2002 TAC of Pacific ocean perch for the Western Aleutian District of the BSAI constitutes good cause to find that the effective date of this action cannot be delayed for 30 days. Accordingly, under 5 U.S.C. 553(d)(3), a delay in the effective date is hereby waived.

This action is required by § 679.20 and is exempt from review under Executive Order 12866.

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

The 2002 TAC of pelagic shelf rockfish for the Central Regulatory Area was established as 3,480 metric tons (mt) by an emergency rule implementing 2002 harvest specifications and associated management measures for the groundfish fisheries off Alaska (67 FR 956, January 8, 2002 and 67 FR 34860, May 16, 2002).

In accordance with § 679.20(d)(1)(i), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the 2002 TAC for pelagic shelf rockfish in the Central Regulatory Area will be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 3,450 mt, and is setting aside the remaining 30 mt as bycatch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance will soon be reached. Consequently, NMFS is prohibiting directed fishing for pelagic shelf rockfish in the Central Regulatory Area of the GOA.

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

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA, finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is contrary to the public interest. This requirement is contrary to the public interest as it would delay the closure of the fishery, lead to exceeding the TAC, and therefore reduce the public's ability to use and enjoy the fishery resource.

The Assistant Administrator for Fisheries, NOAA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.

This action is required by § 679.20 and is exempt from review under Executive Order 12866.