In the Federal Register of November 2, 1999, FSA published a proposed rule to enunciate eligibility criteria for debt relief options for ITLAP loans. The comment period closed December 2, 1999, FSA is soliciting comments from interested persons concerning these elements.

FSA received one request from an indebted FSA ITLAP borrower to extend the comment period an additional 30 days. In response to the request, FSA is extending the comment period an additional 30 days.

Interested persons may, on or before May 1, 2000 submit to the Farm Loan Programs, Loan Servicing and Property Management Division (address above) written comments regarding the proposed rule. Two copies of any comments are to be submitted except that individuals may submit one copy. All written comments are available for public inspection from 9 a.m. to 4 p.m., Monday through Friday at the address listed above.

Interested persons are invited to participate in the making of the proposed 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 above. All communications received on or before the closing date for comments, specified above, will be considered before taking action on the proposed rule. The proposals contained in this notice may be changed in light of the comments received.

Comments are specifically invited on the overall regulatory, economic, environmental, and energy aspects of the proposed 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 summarizing each FAA-public contact concerned with the substance of this proposal will be filed in the Rules Docket.

Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this notice must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket Number 98-NM-380-AD.” The postcard will be date stamped and returned to the commenter.

Any person may obtain a copy of this NPRM by submitting a request to the FAA, Transport Airplane Directorate, ANM-114, Attention: Rules Docket No. 98-NM-380-AD, 1601 Lind Avenue, SW., Renton, Washington 98055-4056.

Transport Canada Civil Aviation (TCCA), which is the airworthiness authority for Canada, notified the FAA that an unsafe condition may exist on certain Bombardier Model DHC-8-100 and -300 series airplanes. TCCA advises that, during a Bombardier investigation of an operator query, inconsistencies were found between the effectivity tables for the bonding integrity inspection (BII) in the non-destructive testing manuals and the modification status record in the airplane Modification Log. As a result of these inconsistencies, some of the bonded skin panels on affected DHC-8 aircraft were not being inspected under the BII program even though they were manufactured with panels that require a bonding integrity inspection. Failure to conduct these inspections could allow damage to bonded skin panels to go undetected, which could result in failure of the bonded skin panels, and consequent loss of controllability of the airplane.

Bombardier has issued Service Bulletin S.B. 8-51-2, Revision ‘A,’ dated September 19, 1998, which describes procedures for revising the Aircraft Log Book to correct the airplane Production Modification List; performing an inspection to determine which bonded skin panels on the airplane require the BII program; and revising the Airworthiness Limitations List of the Approved Maintenance Plan to include the BII requirements.

Bombardier also has issued Part 5, sections 55-00-01 and 57-30-01 of Bombardier Production Support Manual (PSM) 1-8-7A, dated December 15, 1998 (for Model DHC-8-100 series airplanes); and Part 5, sections 55-00-01 and 57-30-01 of Bombardier PSM 1-83-7A, dated April 30, 1999 (for Model DHC-8-300 series airplanes) which describe procedures for repetitive ultrasonic bond inspections to detect disbonding of the affected airplane skin panels and repair, if necessary.

Accomplishment of the actions specified in the service bulletin and service information is intended to adequately address the identified unsafe condition. TCCA classified this service bulletin and service information as mandatory and issued Canadian airworthiness directive CF-98-31, dated September 1, 1998, in order to assure the continued airworthiness of these airplanes in Canada.

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

Since an unsafe condition has been identified that is likely to exist or develop on other airplanes of the same type design registered in the United States, the proposed AD would require accomplishment of the actions specified in the service information described previously, except as discussed below.

Operators should note that, although the service information specifies that the manufacturer may be contacted for disposition of certain repair conditions, this proposal would require the repair of those conditions to be accomplished in accordance with a method approved by the FAA.

Operators also should note that, although the Canadian airworthiness directive affects Bombardier Model DHC-8-314 series airplanes, Bombardier Model DHC-8-314 series airplanes are not type certificated in the United States. Therefore, the proposed AD does not affect those airplanes.

The FAA estimates that 41 airplanes of U.S. registry would be affected by this proposed AD, that it would take approximately 1 work hour per airplane to accomplish the proposed revisions to the Aircraft Log Book, Approved Maintenance Plan, and inspection, and that the average labor rate is $60 per work hour. Based on these figures, the cost impact of the actions proposed by this AD on U.S. operators is estimated to be $2,460, or $60 per airplane.

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

The regulations proposed herein would 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.

Therefore, in accordance with Executive Order 12612, it is determined that this proposal would not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.

For the reasons discussed above, I certify that this proposed regulation (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) if promulgated, 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 copy of the draft regulatory evaluation prepared for this action 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.

Accordingly, pursuant to the authority delegated to me by the Administrator, the Federal Aviation Administration proposes to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) as follows:

Interested persons are invited to participate in the making of the proposed 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 above. All communications received on or before the closing date for comments, specified above, will be considered before taking action on the proposed rule. The proposals contained in this notice may be changed in light of the comments received.

Comments are specifically invited on the overall regulatory, economic, environmental, and energy aspects of the proposed 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 summarizing each FAA-public contact concerned with the substance of this proposal will be filed in the Rules Docket.

Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this notice must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket Number 99-NM-26-AD.” The postcard will be date stamped and returned to the commenter.

Any person may obtain a copy of this NPRM by submitting a request to the FAA, Transport Airplane Directorate, ANM-114, Attention: Rules Docket No. 99-NM-26-AD, 1601 Lind Avenue, SW., Renton, Washington 98055-4056.

Transport Canada Civil Aviation (TCCA), which is the airworthiness authority for Canada, notified the FAA that an unsafe condition may exist on certain Bombardier Model CL-600-1A11 (CL-600) and CL-600-2A12 (CL-601) series airplanes. TCCA advises that a tire burst occurred on a number of airplanes during landing. Investigation revealed that the existing design of the main landing gear (MLG) allows water, slush, or snow from the runway to enter into the brake assemblies during takeoff. This condition, if not corrected, could result in the water freezing on the brake while the airplane is in flight, and consequently, a tire burst during landing of the airplane.

Bombardier has issued Canadair Challenger Service Bulletins 600-0369, Revision 4, dated June 27, 1984, including Attachment 1, dated December 6, 1983, and Attachment 2, dated January 11, 1984 [for Model CL-600-1A11 (CL-600) series airplanes]; and 601-0024, Revision 3, dated November 27, 1984, including Attachment 1, dated June 21, 1984, Attachment 2, dated December 6, 1983, and Attachment 3, dated January 11, 1984 [for Model CL-600-2A12 (CL-601) series airplanes]. These service bulletins describe procedures for modification of the MLG brake units and inboard MLG wheels; and a revision to the Normal and Limitation Sections of the Airplane Flight Manual (AFM) to include the increased cooling times for the brakes. The modification involves installation of a wheel disc on each inboard MLG wheel; replacement of screws securing the wheel disc on each outboard MLG wheel with longer screws; installation of a water barrier shield and water deflector to each MLG brake unit assembly; removal of balance weights, if fitted, from the main wheel assemblies; and reidentification of brake unit and main wheel assemblies. For certain airplanes, a sealing cap is also installed on each MLG trailing arm aperture.

Bombardier also has issued Canadair Challenger Service Bulletins 600-0662, dated November 30, 1995 [for Model CL-600-1A11 (CL-600) series airplanes]; and 601-0467, dated November 30, 1995 [for Model CL-600-2A12 (CL-601) series airplanes]. These service bulletins describe procedures for removal of the inboard and/or outboard wheel discs by installation of a placard to limit airplane operation on the ground and a revision to the Normal Procedures Section of the AFM to include information for operating the airplane with the wheel discs removed.

Accomplishment of the actions specified in the service bulletins is intended to adequately address the identified unsafe condition. TCCA classified these service bulletins as mandatory and issued Canadian airworthiness directive CF-84-04R2, dated July 24, 1998, in order to assure the continued airworthiness of these airplanes in Canada.

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

Since an unsafe condition has been identified that is likely to exist or develop on other airplanes of the same type design registered in the United States, the proposed AD would require accomplishment of the actions specified in the service bulletins described previously.

The FAA estimates that 131 airplanes of U.S. registry would be affected by this proposed AD.

It would take approximately 33 work hours [for Model CL-600-1A11 (CL-600) series airplanes] or 26 work hours [for Model CL-600-2A12 (CL-601) series airplanes] per airplane to accomplish the proposed modification, at an average labor rate of $60 per work hour. Required parts would cost approximately $2,977 per airplane. Based on these figures, the cost impact of this action proposed by this AD on U.S. operators is estimated to be $649,367 or $4,957 per airplane [for Model CL-600-1A11 (CL-600) series airplanes], and $594,347 or $4,537 per airplane [for Model CL-600-2A12 (CL-601) series airplanes].

It would take approximately 1 work hour per airplane to accomplish the proposed AFM revision, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of the AFM revision proposed by this AD on U.S. operators is estimated to be $7,860, or $60 per airplane.

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

Should an operator elect to accomplish the optional placard installation and AFM revision, it would take approximately 5 work hours per airplane to accomplish these actions, at an average labor rate of $60 per work hour. Required parts would cost approximately $75 per airplane. Based on these figures, the cost impact of these actions is estimated to be $375 per airplane, per modification cycle.

The regulations proposed herein 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. Therefore, it is determined that this proposal would not have federalism implications under Executive Order 13132.

For the reasons discussed above, I certify that this proposed regulation (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) if promulgated, 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 copy of the draft regulatory evaluation prepared for this action 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.

Accordingly, pursuant to the authority delegated to me by the Administrator, the Federal Aviation Administration proposes to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) as follows:

On March 14, 1996, the IRS issued proposed regulations (PS-6-95; REG-209753-95) relating to diesel fuel dye injection systems and the measurement of taxable fuel (61 FR 10490). The Treasury Department does not have any plans at the present time to issue final regulations relating to dye injection systems.

Accordingly, under the authority of 26 U.S.C. 7805, the notice of proposed rulemaking as it relates to dye injection systems that was published in the Federal Register on March 14, 1996 (61 FR 10490) is withdrawn.

North Dakota: On December 15, 1980, the Secretary of the Interior conditionally approved the North Dakota program. You can find background information on the North Dakota program, including the Secretary's findings, the disposition of comments, and conditions of approval of the North Dakota program in the December 15, 1980 Federal Register (45 FR 82214). You can also find later actions concerning North Dakota's program and program amendments at 30 CFR 934.15 and 934.16.

By letter dated March 16, 2000, North Dakota sent to us a proposed amendment to its program (Amendment number XXIX), administrative record No. ND-DD-01 under SMCRA (30 U.S.C. 1201 et seq. ). North Dakota sent the amendment to include changes made at its own initiative. The full text of the program amendment is available for you to read at the locations listed above under ADDRESSES.

Specifically, North Dakota proposes to revise its revegetation policy document to reflect changes in its approved State Program as follows: (1) to give mining companies the option of proving reclamation success for three out of five consecutive years, starting no sooner than the eighth year of the responsibility period; (2) that the time-in-place requirement for tree and shrub standards will be deemed satisfied if the mine operator demonstrates that no tree, shrub or half-shrub replanting has occurred during the last six years of the responsibility period; (3) to clarify the objectives section; (4) to add new provisions for adjusting North Dakota Agricultural Statistical Service crop yield to reflect certain management practices; (5) to include other factors, in addition to precipitation and temperature, in developing a cropland and/or tame pastureland regression equation to clinically adjust yield standards; (6) to add a statement to the native grassland section that established plant species must be predominantly native; (7) to provide more consistency for the standards on native grassland diversity and seasonality, (8) to clarify sampling procedures regarding when plant growth forms must be weighed separately; and (9) miscellaneous minor changes and additions.

Under the provisions of 30 CFR 732.17(h), we are requesting your comments on whether the amendment satisfies the applicable program approval criteria of 30 CFR 732.15. If we approve the amendment, it will become part of the North Dakota program.

Send your written comments to OSM at the address given above. We will make comments, including names and addresses of respondents, available for public review during normal business hours. We will not consider anonymous comments. If Individual respondents request confidentiality, we will honor their request to the extent allowable by law. Individual respondents who wish to withhold their name or address from public review, except for the city or town, must state this prominently at the beginning of their comments. We will make all submissions form organizations or businesses, and from individuals identifying themselves as representatives or officials of organizations or businesses, available for public review in their entirety.

Please submit Internet comments as an ASCII file avoiding the use of special characters and any form of encryption. Please also include “Attn: SPATS No. ND-040-FOR” and your name and return address in your Internet message. If you do not receive a confirmation that we have received your Internet message, contact the Casper Field Office at 307/261-6555.

Your written comments should be specific and pertain only to the issues proposed in this rulemaking, and include explanations in support of your recommendations. In the final rulemaking, we will not necessarily consider or include in the administrative record any comments received after the time indicated under DATES or at locations other than the Casper Field office.

If you wish to speak at the public hearing, contact the person listed under FOR FURTHER INFORMATION CONTACT by 4:00 p.m., m.s.t. on April 17, 2000. If you are disabled and need special accommodations to attend a public hearing, contact the person listed under FOR FURTHER INFORMATION CONTACT . We will arrange the location and time of the hearing with those persons requesting the hearing. We will not hold the public hearing if no one requests an opportunity to speak.

To assist the transcriber and ensure an accurate record, we request, if possible, that each person who speaks at a public hearing provide us with a written copy of his or her comments. The public hearing will continue on the specified date until everyone scheduled to speak has been heard. If you are in the audience and have not been scheduled to speak and wish to do so, you will be allowed to speak after those who have been scheduled. We will end the hearing after everyone scheduled to speak and others present in the audience who wish to speak, have been heard.

If only one person requests an opportunity to speak, we may hold a public meeting rather than a public hearing. If you wish to meet with us to discuss the amendment, please request a meeting by contracting the person listed under FOR FURTHER INFORMATION CONTACT . All such meetings are open to the public and, if possible, we will post notices of meetings at the locations listed under ADDRESSES . We will make a written summary of each meeting a part of the administrative record.

This rule is exempted from review by the Office of Management and Budget (OMB) under Executive Order 12866 (Regulatory Planning and Review).

The Department of the Interior has conducted the reviews required by section 3 of Executive Order 12988 (Civil Justice Reform) and has determined that this rule meets the applicable standards of subsections (a) and (b) of that section. However, these standards are not applicable to the actual language of State regulatory programs and program amendments since each such program is drafted and promulgated by a specific State, not by OSM. Under sections 503 and 505 of SMCRA (30 U.S.C. 1253 and 1255) and the Federal regulations at 30 CFR 730.11, 732.15, and 732.17(h)(10), decisions on proposed State regulatory programs and program amendments submitted by the States must be based solely on a determination of whether the submittal is consistent with SMCRA and its implementing Federal regulations and whether the other requirements of 30 CFR Parts 730, 731, and 732 have been met.

No environmental impact statement is required for this rule since section 702(d) of SMCRA (30 U.S.C. 1292(d)) provides that agency decisions on proposed State regulatory program provisions do not constitute major Federal actions within the meaning of section 102(2)(C) of the National Environmental Policy Act (42 U.S.C. 4332(2)(C)).

This rule does not contain information collection requirements that require approval by OMB under the Paperwork Reduction Act (44 U.S.C. 3507 et seq. ).

The Department of the Interior has determined that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). The State submittal that is the subject of this rule is based upon counterpart Federal regulations for which an economic analysis was prepared and certification made that such regulations would not have a significant economic effect upon a substantial number of small entities. Accordingly, this rule will ensure that existing requirements previously promulgated by OSM will be implemented by the State. In making the determination as to whether this rule would have a significant economic impact, the Department relied upon the data and assumptions for the counterpart Federal regulations.

This rule will not impose a cost of $100 million or more in any given year on any governmental entity or the private sector.

On January 19, 1981, the Secretary of the Interior conditionally approved the Oklahoma program. You can find background information on the Oklahoma program, including the Secretary's findings, the disposition of comments, and the conditions of approval in the January 19, 1981, Federal Register (46 FR 4902).You can find later actions concerning the Oklahoma program at 30 CFR 936.15 and 936.16.

By letter dated January 13, 2000 (Administrative Record No. OK-985.01), Oklahoma sent us an amendment to its program under SMCRA. Oklahoma sent the amendment in response to our letter dated December 6, 1999 (Administrative Record No. OK-985), that we sent to Oklahoma concerning regulation changes in its program that we did not approve. Oklahoma proposes to amend the Oklahoma Administrative Code (OAC). Below is a summary of the changes proposed by Oklahoma. The full text of the program amendment is available for your inspection at the locations listed above under ADDRESSES .

Oklahoma proposes to add new paragraph (4) to read as follows:

File all statements and supplements received pursuant to 45 O.S. Supp. 1980, Section 765, from members of advisory boards and the Oklahoma Mining Commission with the Oklahoma Governor's Office, Director of Appointments.

Oklahoma proposes to revise paragraph (a) and to add new paragraphs (b) and (c) to read as follows:

(a) The Director shall file his or her statement with the Director of OSM.

(b) Members of advisory boards and commissions representing multiple interests as provided in Section 460:20- 5-7, shall file their statement with the Governor's Office, Director of Appointments, or such other official as may be designated by State law or regulation.

(c) All other employees shall file his or her statement with the Department of Mines Director pursuant to the requirements of 45 O.S. Supp. 786 and this Subchapter.

Oklahoma proposes to revise paragraph (c)(3) to read as follows:

(3) The exceptions shown in the employee certification of the form must provide enough information for the Director of the Department or the Governor's Office, Director of Appointment, for Commission members, to determine the existence of a direct or indirect financial interest. Accordingly, the exceptions should:

Oklahoma proposes to make an editorial correction in the title of this section so that the title reads, “Resolving prohibited interests,” instead of “Resolving prohibited interstate.” Oklahoma also proposes to revise paragraph (b)(1) so that the second sentence reads:

Under the provisions of 30 CFR 732.17(h), we are seeking comments on whether the proposed amendment satisfies the applicable program approval criteria of 30 CFR 732.15. If we approve the amendment, it will become part of the Oklahoma program.

Written Comments: If you submit written or electronic comments on the proposed rule during the 30-day comment period, they should be specific, should be confined to issues pertinent to the notice, and should explain the reason for your recommendation(s). We may not be able to consider or include in the Administrative Record comments delivered to an address other than the one listed above (see ADDRESSES ).

Electronic Comments: Please submit Internet comments as an ASCII, WordPerfect, of Word file avoiding the use of special characters and any form of encryption. Please also include “Attn: SPATS NO. OK-027-FOR” and your name and return address in your Internet message. If you do not receive a confirmation that we have received your Internet message, contact the Tulsa Field Office at (918) 581-6430.

Availability of Comments: Our practice is to make comments, including names and home addresses of respondents, available for public review during regular business hours at OSM's Tulsa Field Office (see ADDRESSES ). Individual respondents may request that we withhold their home address from the administrative record, which we will honor to the extent allowable by law. There also may be circumstances in which we would withhold from administrative record a respondent's identity, as allowable by law. If you wish us to withhold your name and/or address, you must state this prominently at the beginning of your comment. However, we will not consider anonymous comments. We will make all submissions from organizations or businesses, and from individuals identifying themselves as representatives or officials of organizations or businesses, available for public inspection in their entirety.

Public Hearing: If you wish to speak at the public hearing, contact the person listed under FOR FURTHER INFORMATION CONTACT by 4 p.m., c.d.t. on April 17, 2000. We will arrange the location and time of the hearing with those persons requesting the hearing. If no one requests an opportunity to speak at the public hearing, the hearing will not be held.

To assist the transcriber and ensure an accurate record, we request that you provide us with a written copy of your testimony if you speak at the public hearing. The public hearing will continue on the specified date until all persons scheduled to speak have been heard. If you are in the audience and have not been scheduled to speak and wish to do so, you will be allowed to speak after those who have been scheduled. We will end the hearing after all persons scheduled to speak and persons present in the audience who wish to speak have been heard.

If you are disabled and need a special accommodation to attend a public hearing, contact the person listed under FOR FURTHER INFORMATION CONTACT .

Public Meeting: If only one person requests an opportunity to speak at a hearing, a public meeting, rather than a public hearing, may be held. If you wish to meet with us to discuss the proposed amendment, request a meeting by contacting the person listed under FOR FURTHER INFORMATION CONTACT . All such meetings are open to the public and, if possible, we will post notices of meetings at the locations listed under ADDRESSES . We will also make a written summary of each meeting a part of the Administrative Record.

This rule is exempted from review by the Office of Management and Budget (OMB) under Executive Order 12866.

This rule does not have takings implications. This determination is based on the analysis performed for the counterpart federal regulation.

This rules does not have federalism implications. SMCRA delineates the roles of the federal and state governments with regard to the regulation of surface coal mining and reclamation operations. One of the purposes of SMCRA is to “establish a nationwide program to protect society and the environment from the adverse effects of surface coal mining operations.” Section 503(a)(1) of SMCRA requires that state laws regulating surface coal mining and reclamation operations be “in accordance with” the requirements of SMCRA, and section 503(a)(7) requires that state programs contain rules and regulations “consistent with” regulations issued by the Secretary pursuant to SMCRA.

The Department of the Interior has conducted the reviews required by section 3 of Executive Order 12988 and has determined that, to the extent allowed by law, this rule meets the applicable standards of subsections (a) and (b) of this section. However, these standards are not applicable to the actual language of state regulatory programs and program amendments since each such program is drafted and promulgated by a specific state, not OSM. Under sections 503 and 505 of SMCRA (30 U.S.C. 1253 and 1255) and 30 CFR 730.11, 732.15, and 732.17(h)(10), decisions on proposed state regulatory programs and program amendments submitted by the states must be based solely on a determination of whether the submittal is consistent with SMCRA and its implementing federal regulations and whether the other requirements of 30 CFR Parts 730, 731, and 732 have been met.

Section 702(d) of SMCRA (30 U.S.C. 1292(d)) provides that a decision on a proposed state regulatory program provision does not constitute a major federal action within the meaning of section 102(2)(C) of the National Environmental Policy Act (42 U.S.C. 4332(2)(C)). A determination has been made that such decisions are categorically excluded from the NEPA process (516 DM 8.4.A).

This rule does not contain information collection requirements that require approval by OMB under the Paperwork Reduction Act (44 U.S.C. 3507 et seq. ).

The Department of the Interior has determined that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). The State submittal which is the subject of this rule is based upon counterpart federal regulations for which an economic analysis was prepared and certification made that such regulations would not have a significant economic effect upon a substantial number of small entities. Therefore, this rule will ensure that existing requirements previously promulgated by OSM will be implemented by the state. In making the determination as to whether this rule would have a significant economic impact, the Department relied upon the data and assumptions for the counterpart federal regulations.

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

a. Does not have an annual effect on the economy of $100 million.

b. Will not cause a major increase in costs or prices for consumers, individual industries, federal, state, or local government agencies, or geographic regions.

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

This determination is based upon the fact that the state submittal which is the subject of this rule is based upon counterpart federal regulations for which an analysis was prepared and a determination made that the federal regulation was not considered a major rule.

This rule will not impose a cost of $100 million or more in any given year any government entity or the private sector.

The “American Inventors Protection Act of 1999” (Title IV of the “Intellectual Property and Communications Omnibus Reform Act of 1999” (S. 1948) as introduced in the 106th Congress on November 17, 1999) was incorporated and enacted into law on November 29, 1999, by § 1000(a)(9), Division B, of Public Law 106-113, 113 Stat. 1501 (1999). The “American Inventors Protection Act of 1999” contains a number of changes to title 35, United States Code. This notice proposes changes to the rules of practice to implement the provisions of §§ 4401 and 4402 of the “American Inventors Protection Act of 1999.” These provisions are effective on the date that is six months after the date of enactment of the “American Inventors Protection Act of 1999” (May 29, 2000) and apply to applications, other than for a design patent, filed on or after the date that is six months after the date of enactment of the “American Inventors Protection Act of 1999” (May 29, 2000).

Section 532 of the Uruguay Round Agreements Act (Public Law 103-465, 108 Stat. 4809 (1994)) amended 35 U.S.C. 154 to provide that the term of patent protection begins on the date of patent grant and ends on the date twenty years from the filing date of the application, or the earliest filing date for which a benefit is claimed under 35 U.S.C. 120, 121, or 365(c). Public Law 103-465 also contained provisions, codified at 35 U.S.C. 154(b), for patent term extension due to certain examination delays.

Section 4402 of the “American Inventors Protection Act of 1999” amends 35 U.S.C. 154(b)(1) to provide day-by-day patent term adjustment if the Office fails, within specified time periods, to: (1) initially act on the application; (2) respond to a reply or appeal to the Board of Patent Appeals and Interferences by the applicant; (3) act on an application containing allowed claims after a decision by the Board of Patent Appeals and Interferences or a Federal court; or (4) issue the application after the issue fee is paid in reply to a notice of allowance and all outstanding requirements are satisfied (35 U.S.C. 154(b)(1)(A)). Section 4402 of the “American Inventors Protection Act of 1999” also amends 35 U.S.C. 154(b)(1) to provide day-by-day patent term adjustment if, subject to a number of limitations, the Office fails to issue a patent within three years of the actual filing date of the application (35 U.S.C. 154(b)(1)(B)). Finally, § 4402 of the “American Inventors Protection Act of 1999” also amends 35 U.S.C. 154(b)(1) to provide day-by-day patent term adjustment for delays due to interference proceedings under 35 U.S.C. 135(a), imposition of a secrecy order under 35 U.S.C. 181, or successful appellate review by the Board of Patent Appeals and Interferences or a Federal court (35 U.S.C. 154(b)(1)(C)).

Section 4402 of the “American Inventors Protection Act of 1999” amends 35 U.S.C. 154(b)(2) to place limitations on the period of patent term adjustment granted under 35 U.S.C. 154(b)(1). First: to the extent that the periods of delay attributed to the grounds specified in 35 U.S.C. 154(b)(1) overlap, the period of adjustment shall not exceed the actual number of days the issuance of the patent was delayed. Second: no patent, the term of which has been disclaimed beyond a specified date, may be adjusted under 35 U.S.C. 154(b) beyond the expiration date specified in the disclaimer. Third: the period of patent term adjustment under 35 U.S.C. 154(b)(1) shall be reduced by a period equal to the period of time during which the applicant failed to engage in reasonable efforts to conclude prosecution (or processing or examination) of the application. Section 4402 of the “American Inventors Protection Act of 1999,” however, does not contain any limit ( e.g., of five or ten years) on the total extension or adjustment that may be granted under 35 U.S.C. 154(b).

An applicant is deemed to have failed to engage in reasonable efforts to conclude prosecution of the application with respect to any patent term adjustment under 35 U.S.C. 154(b)(1)(B) (failure to issue a patent within three years of the actual filing date of the application) for the cumulative total of any periods of time in excess of three months that are taken to reply to a notice of any rejection, objection, argument, or other request, measuring the three-month period from the date the notice was mailed or given. In addition, 35 U.S.C. 154(b)(2) directs the Office to prescribe regulations establishing the circumstances that constitute a failure of the applicant to engage in reasonable efforts to conclude processing or examination of the application.

Section 4402 of the “American Inventors Protection Act of 1999” also amends 35 U.S.C. 154(b)(3) to establish procedures for patent term adjustment determinations. 35 U.S.C. 154(b)(3) directs the Office to prescribe regulations establishing procedures for the application for and determination of patent term adjustment under 35 U.S.C. 154(b). 35 U.S.C. 154(b)(3), however, requires the Office to: (1) make a patent term adjustment determination and transmit a notice of that determination with the notice of allowance; and (2) provide the applicant with one opportunity to request reconsideration of that patent term adjustment determination. 35 U.S.C. 154(b)(3) also provides that the Office shall reinstate all or part of the cumulative period of time of an adjustment reduced under 35 U.S.C. 154(b)(2)(C) (for failure to reply to a notice of any rejection, objection, argument, or other request within three months of the date the notice was mailed or given) if, prior to issuance of the patent, the applicant makes a showing that, in spite of all due care, the applicant was unable to reply within the three-month period, except that the Office may not reinstate more than three additional months for each reply beyond the original three-month period. Section 4402 of the “American Inventors Protection Act of 1999” also amends 35 U.S.C. 154(b)(3) to provide that the Office shall proceed to grant the patent after completing its patent term adjustment determination, and amends 35 U.S.C. 154(b)(4) to provide for judicial review in the event that the applicant is dissatisfied with that patent term adjustment determination.

Section 4405(a) of the “American Inventors Protection Act of 1999” provides that § 4402 shall take effect on the date that is six months after the date of enactment of the “American Inventors Protection Act of 1999” (May 29, 2000) and shall apply to any application (other than a reissue or design) filed on or after the date that is six months after the date of enactment of the “American Inventors Protection Act of 1999” (May 29, 2000). Therefore, patents (other than reissue or design) issued on applications filed on or after June 8, 1995, but before May 29, 2000, are subject to the patent term extension provisions of 35 U.S.C. 154(b) as amended by § 532(a)(1) of Public Law 103-465 and § 1.701, whereas patents (other than reissue or design) issued on applications filed on or after May 29, 2000, are subject to the patent term adjustment provisions of 35 U.S.C. 154(b) as amended by § 4402 of the “American Inventors Protection Act of 1999” (as it is proposed to be implemented in §§ 1.702 through 1.705).

The filing date of a continued prosecution application (CPA) under § 1.53(d) is the date that the request for CPA is filed (§ 1.53(d)(2)), even though the Office uses the filing date of the prior application for identification purposes. Therefore, the patent term adjustment provisions of 35 U.S.C. 154(b) as amended by § 4402 of the “American Inventors Protection Act of 1999” apply to any CPA filed on or after May 29, 2000, regardless of the filing date of the prior application of the CPA. While an applicant may file a continuing application under § 1.53(b) on or after May 29, 2000, for the application to be subject to the patent term adjustment provisions of 35 U.S.C. 154(b) as amended by § 4402 of the “American Inventors Protection Act of 1999,” an applicant need only file a CPA under § 1.53(d) on or after May 29, 2000, for the application to be subject to the patent term adjustment provisions of 35 U.S.C. 154(b) as amended by § 4402 of the “American Inventors Protection Act of 1999.” The filing of a CPA on or after May 29, 2000, does not, however, entitle an applicant to receive term adjustment for Office delays before May 29, 2000.

The six-month lead time provided in § 4405(a) for implementing the patent term adjustment provisions of § 4402 of the “American Inventors Protection Act of 1999” is not sufficient to conduct a notice and comment rulemaking (giving a 60-day comment period) and adopt final rules by the effective date (May 29, 2000) of the patent term adjustment provisions of § 4402 of the “American Inventors Protection Act of 1999.” Nevertheless, the Office does not anticipate that any patent entitled to patent term adjustment based upon the provisions of § 4402 of the “American Inventors Protection Act of 1999” will issue until December of 2000, at the earliest. This notice of proposed rulemaking, however, places applicants on notice as to the actions or inactions that are considered by the Office (and may be adopted in the final rules) as circumstances constituting a failure to engage in reasonable efforts to conclude prosecution (processing or examination) of the application, and which will result in a reduction of any patent term adjustment.

Section 1.18(e) is proposed to be added to provide a $200.00 fee for filing an application for patent term adjustment under § 1.705. Section 1.18(f) is proposed to be added to provide a $450.00 fee for filing a request for reinstatement of all or part of the term reduced pursuant to § 1.704(b)(1) in an application for patent term adjustment under § 1.705. Section 1.18(d) is proposed to be added in a rulemaking to implement the eighteen-month publication provisions of the “American Inventors Protection Act of 1999.” The fees in proposed § 1.18(e) and (f) are set to recover the estimated average cost to the Office for processing and evaluating an application for patent term adjustment under § 1.705 ($200.00), and for processing and evaluating a request under 35 U.S.C. 154(b)(3)(C) for reinstatement of term reduced under 35 U.S.C. 154(b)(2)(C) ($450.00), respectively. See 35 U.S.C. 41(d). In view of these proposed additions to § 1.18, the heading of § 1.18 is also proposed to be amended to refer to patent “post-allowance (including issue) fees'( instead of only patent “issue fees”).

Subpart F of 37 CFR Part 1 is proposed to be amended to include a first undesignated center heading to read “ADJUSTMENT OF PATENT TERM DUE TO EXAMINATION DELAY” followed by an amended § 1.701 and newly added §§ 1.702 through 1.705 concerning patent term adjustment under 35 U.S.C. 154(b), and a second undesignated center heading to read “EXTENSION OF PATENT TERM DUE TO REGULATORY REVIEW” followed by current § 1.710 et seq. concerning patent term extension under 35 U.S.C. 156.

Section 1.701 is proposed to be amended by revising its heading to indicate that its provisions concern the term provisions of the Uruguay Round Agreements Act (Public Law 103-465), and to add a paragraph (e) to specify that the provisions of § 1.701 apply only to original patents issued on applications filed on or after June 8, 1995, and before May 29, 2000. As discussed above, the provisions of 35 U.S.C. 154(b) as amended by § 532(a)(1) of Public Law 103-465 and current § 1.701 apply to applications (other than for a reissue or design patent) filed on or after June 8, 1995, but before May 29, 2000, and the provisions of § 4402 of the “American Inventors Protection Act of 1999” and proposed §§ 1.702 through 1.705 apply to applications (other than for a reissue or design patent) filed on or after May 29, 2000.

Section 1.702 is proposed to be added to set forth the bases for patent term adjustment under 35 U.S.C. 154(b)(1). Section 1.702(a) as proposed indicates that a patent is entitled to patent term adjustment if the Office fails to perform certain acts of examination within specified time frames (35 U.S.C. 154(b)(1)(A)). Section 1.702(b) as proposed indicates that a patent is entitled to patent term adjustment if, subject to a number of limitations, the Office fails to issue a patent within three years of the actual filing date of the application (35 U.S.C. 154(b)(1)(B)). Section 1.702(c) as proposed indicates that a patent is entitled to patent term adjustment if the issuance of the patent was delayed by an interference proceeding (35 U.S.C. 154(b)(1)(C)(i)). Section 1.702(d) as proposed indicates that a patent is entitled to patent term adjustment if the issuance of the patent was delayed by the application being placed under a secrecy order under 35 U.S.C. 181 (35 U.S.C. 154(b)(1)(C)(ii)). Section 1.702(e) as proposed indicates that a patent is entitled to patent term adjustment if the issuance of the patent was delayed by successful appellate review under 35 U.S.C. 134, 141, or 145 (35 U.S.C. 154(b)(1)(C)(iii)). Section 1.702(f) as proposed provides that the provisions of §§ 1.702 through 1.705 apply only to original applications, except applications for a design patent, filed on or after May 29, 2000, and patents issued on such applications.

Section 1.703 as proposed specifies the period of adjustment if a patent is entitled to patent term adjustment under 35 U.S.C. 154(b)(1) and § 1.702.

Section 1.703(a) as proposed indicates that the period of adjustment under § 1.702(a) is the sum of the following periods (to the extent that such periods are not overlapping): (1) The number of days, if any, in the period beginning on the date fourteen months after the date on which the application was filed under 35 U.S.C. 111(a) or fulfilled the requirements of 35 U.S.C. 371 and ending on the mailing date of either an action under 35 U.S.C. 132, or a notice of allowance under 35 U.S.C. 151, whichever occurs first (a written restriction requirement, a written election of species requirement, and an action under Ex parte Quayle, 1935 Comm'r Dec. 11 (1935) are each an action under 35 U.S.C. 132); (2) the number of days, if any, in the period beginning on the date four months after the date a reply under § 1.111 was filed and ending on the mailing date of an action under 35 U.S.C. 132, or a notice of allowance under 35 U.S.C. 151, whichever occurs first; (3) the number of days, if any, in the period beginning on the date four months after the date a reply in compliance with § 1.113 ( i.e., only an after final reply that cancels all of the rejected claims and removes all outstanding objections and requirements or otherwise places the application in condition for allowance) was filed and ending on the date of mailing of an action under 35 U.S.C. 132, or a notice of allowance under 35 U.S.C. 151, whichever occurs first; (4) the number of days, if any, in the period beginning on the date four months after the date a notice of appeal to the Board of Patent Appeals and Interferences under 35 U.S.C. 134 and § 1.191 was filed and ending on the mailing date of an examiner's answer under § 1.193, an action under 35 U.S.C. 132, or a notice of allowance under 35 U.S.C. 151, whichever occurs first; (5) the number of days, if any, in the period beginning on the date four months after the date of a final decision by the Board of Patent Appeals and Interferences or by a Federal court in an appeal under 35 U.S.C. 141 or a civil action under 35 U.S.C. 145 or 146 in an application containing allowable claims and ending on the mailing date of either an action under 35 U.S.C. 132, or a notice of allowance under 35 U.S.C. 151, whichever occurs first; and (6) the number of days, if any, in the period beginning on the date four months after the date the issue fee was paid and all outstanding requirements were satisfied ( i.e., the date the issue fee was paid or the date all outstanding requirements were satisfied, whichever is later) and ending on the date a patent was issued.

Section 1.703(b) as proposed indicates that the period of adjustment under § 1.702(b) is the number of days, if any, in the period beginning on the date three years after the actual filing date of the application and ending on the date a patent was issued. Section 1.703(b) as proposed also sets forth the limitations on patent term adjustment specified in 35 U.S.C. 154(b)(1)(B)(i) and (ii). Section 1.703(b) as proposed specifically provides that the period of adjustment of the term of a patent under § 1.703(b) shall not include the period equal to the sum of the following periods: (1) The period of pendency consumed by continued examination of the application under 35 U.S.C. 132(b) (35 U.S.C. 154(b)(1)(B)(i)); (2) the period of pendency consumed by interference proceedings (35 U.S.C. 154(b)(1)(B)(ii)); (3) the period of pendency consumed by imposition of a secrecy order (35 U.S.C. 154(b)(1)(B)(ii)); and (4) the period of pendency consumed by appellate review under 35 U.S.C. 134, 141, 145, whether successful or unsuccessful (35 U.S.C. 154(b)(1)(B)(ii)). The provisions of 35 U.S.C. 154(b)(1)(B)(iii) concerning the period of pendency consumed by delays in the processing of the application requested by the applicant are treated in § 1.704 as such delays are also circumstances constituting a failure of an applicant to engage in reasonable efforts to conclude processing or examination of the application.

Section 1.703(c) as proposed indicates that the period of adjustment under § 1.702(c) is the sum of the following periods (to the extent that such periods are not overlapping): (1) The number of days, if any, in the period beginning on the date an interference was declared or redeclared to involve the application in the interference and ending on the date that the interference was terminated with respect to the application; and (2) the number of days, if any, in the period beginning on the date prosecution in the application was suspended by the Office due to interference proceedings under 35 U.S.C. 135(a) not involving the application and ending on the date of the termination of the suspension.

Section 1.703(d) as proposed indicates that the period of adjustment under § 1.702(d) is the sum of the following periods (to the extent that such periods are not overlapping): (1) The number of days, if any, the application was maintained in a sealed condition under 35 U.S.C. 181; (2) the number of days, if any, in the period beginning on the date of mailing of an examiner's answer under § 1.193 in the application under secrecy order and ending on the date the secrecy order was removed; (3) the number of days, if any, in the period beginning on the date applicant was notified that an interference would be declared but for the secrecy order and ending on the date the secrecy order was removed; and (4) the number of days, if any, in the period beginning on the date of notification under § 5.3(c) and ending on the date of mailing of the notice of allowance under § 1.311.

Section 1.703(e) as proposed indicates that the period of adjustment under § 1.702(e) is the sum of the number of days, if any, in the period beginning on the date on which a notice of appeal to the Board of Patent Appeals and Interferences was filed under 35 U.S.C. 134 and § 1.191 and ending on the date of a final decision in favor of the applicant by the Board of Patent Appeals and Interferences or by a Federal court in an appeal under 35 U.S.C. 141 or a civil action under 35 U.S.C. 145.

Section 1.703(f) as proposed indicates that the adjustment will run from the expiration date of the patent as set forth in 35 U.S.C. 154(a)(2). Section 1.703(f) also indicates that to the extent that periods of adjustment attributable to the grounds specified in § 1.702 overlap, the period of adjustment will not exceed the actual number of days the issuance of the patent was delayed (35 U.S.C. 154(b)(2)(A)). Section 1.703(f) as proposed also specifically indicates that the term of a patent entitled to adjustment under § 1.702 and this section shall be adjusted for the sum of the periods calculated under § 1.703(a) through (e), to the extent that such periods are not overlapping, less the sum of the periods calculated under § 1.704. Section 1.703(f) as proposed also provides that the date indicated on any certificate of mailing or transmission under § 1.8 shall not be taken into account in this calculation. That is, while the date indicated on any certificate of mailing or transmission under § 1.8 will continue to be taken into account in determining timeliness, the date of filing (§ 1.6) will be the date used in a patent term adjustment calculation. Applicant may wish to consider the use of the “Express Mail Post Office to Addressee” service of the United States Postal Service (§ 1.10) for replies (as well as original applications) to be accorded the earliest possible filing date for patent term adjustment calculations.

Section 1.703(g) as proposed indicates that no patent, the term of which has been disclaimed beyond a specified date, shall be adjusted under §§ 1.702 and 1.703 beyond the expiration date specified in the disclaimer (35 U.S.C. 154(b)(2)(B)).

Section 1.704 as proposed implements the provisions of 35 U.S.C. 154(b)(2)(C). 35 U.S.C. 154(b)(2)(C) specifies certain circumstances as constituting a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application, and also provides for the Office to prescribe regulations establishing circumstances that constitute a failure of an applicant to engage in reasonable efforts to conclude processing or examination of the application.

Section 1.704(a) as proposed implements the provisions of 35 U.S.C. 154(b)(2)(C)(i) and indicates that the period of adjustment shall be reduced by a period equal to the period of time during which the applicant failed to engage in reasonable efforts to conclude prosecution ( i.e., processing or examination) of the application.

Section 1.704(b) as proposed provides that with respect to the ground for adjustments set forth in § 1.702(a) though (e), and in particular § 1.702(b), an applicant shall be deemed to have failed to engage in reasonable efforts to conclude prosecution for the cumulative total of any periods of time in excess of three months that are taken to reply to any notice or action by the Office making any rejection, objection, argument, or other request, measuring such three-month period from the date the notice or action was mailed or given to the applicant. A Notice of Omitted Items (PTO-1669) is not a notice or action by the Office making a rejection, objection, argument, or other request within the meaning of 35 U.S.C. 154(b)(2)(C)(ii) or § 1.704(b), since the Office does not require a reply to that notice to continue the processing and examination of the application. The three-month period in 35 U.S.C. 154(b)(2)(C)(ii) and § 1.704(b) applies regardless of the period for reply set in the Office action or notice. For example, if an Office action sets a one-month period for reply (restriction requirement), the applicant may obtain a two-month extension of time under § 1.136(a) before being subject to a reduction of patent term adjustment under 35 U.S.C. 154(b)(2)(C)(ii) and § 1.704(b). If, however, an Office action set a six-month period for reply, as is commonly set in applications subject to secrecy orders (see section 130 of the Manual of Patent Examining Procedure (7th ed. 1998) (MPEP)), the applicant is subject to a reduction of patent term adjustment under 35 U.S.C. 154(b)(2)(C)(ii) and § 1.704(b) if the applicant does not reply to the Office action within three months, notwithstanding that a reply may be timely filed six months after the mailing date of the Office action. Section 1.704(b) as proposed indicates that in such a case the period of adjustment set forth in § 1.703 shall be reduced by the number of days, if any, beginning on the date three months after the date of mailing of the Office communication notifying the applicant of the rejection, objection, argument, or other request and ending on the date the reply was filed.

Section 1.704(c) as proposed also establishes further circumstances that constitute a failure of an applicant to engage in reasonable efforts to conclude processing or examination of the application. Section 1.704(c)(1) through (c)(16) set forth actions or inactions by an applicant that interfere with the Office's ability to process or examine an application (and thus circumstances that constitute a failure of an applicant to engage in reasonable efforts to conclude processing or examination of the application), as well as the period by which a period of adjustment set forth in § 1.703 shall be reduced if an applicant engages in any of the enumerated actions or inactions. Sections 1.704(c)(1) through 1.704(c)(16) address situations that occur with sufficient frequency to warrant being specifically provided for in the rules of practice. An attempt to provide an exhaustive listing of actions or inactions that interfere with the Office's ability to process or examine an application, but do not occur with great frequency ( e.g., applicant files and persists in requesting reconsideration of a meritless petition under § 1.10 or when the scope of the broadest claim in the application at the time an application is placed in condition for allowance is substantially the same as suggested or allowed by the examiner more than six months earlier than the date the application was placed in condition for allowance), is impractical. Thus, the actions or inactions set forth in § 1.704(c) are exemplary circumstances that constitute a failure of an applicant to engage in reasonable efforts to conclude processing or examination of the application. The Office may also reduce a period of adjustment provided in § 1.703 on the basis of conduct that interferes with the Office's ability to process or examine an application under the authority provided in 35 U.S.C. 154(b)(2)(C)(iii), even if such conduct is not specifically addressed in § 1.704(c).

Section 1.704(c)(1) as proposed establishes suspension of action under § 1.103 at the applicant's request as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Obviously, if action is suspended at the applicant's request, the Office is precluded from processing or examining the application as a result of an action by the applicant. Section 1.704(c)(1) as proposed also provides that in such a case the period of adjustment set forth in § 1.703 shall be reduced by the number of days, if any, beginning on the date a request for suspension of action under § 1.103 was filed and ending on the date of the termination of the suspension.

Section 1.704(c)(2) as proposed establishes deferral of issuance of a patent under § 1.314 as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Obviously, if issuance of the patent is deferred under § 1.314, the Office is precluded from issuing the application as a result of an action by the applicant. When a petition under § 1.314 is granted, the petition decision generally states that the application will be held for a period of a month to await the filing of a paper. At the end of the period, the application is returned to the issue process without a further communication from the Office to the applicant. Section 1.704(c)(2) as proposed also provides that in such a case the period of adjustment set forth in § 1.703 shall be reduced by the number of days, if any, beginning on the date a request for deferral of issuance of a patent under § 1.314 was filed and ending on the issue date of the patent.

Section 1.704(c)(3) as proposed establishes abandonment of the application or late payment of the issue fee as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Obviously, if the application is abandoned (either by failure to prosecute or late payment of the issue fee), the Office is precluded from processing or examining the application as a result of an action or inaction by the applicant. Section 1.704(c)(3) as proposed also provides that in such a case the period of adjustment set forth in § 1.703 shall be reduced by the number of days, if any, beginning on the date of abandonment or the date after the day the issue fee was due and ending on the date of mailing of the decision reviving the application or accepting late payment of the issue fee.

Section 1.704(c)(4) as proposed establishes failure to file a petition to withdraw a holding of abandonment or to revive an application within two months from the mailing date of a notice of abandonment as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Any applicant who considers an application to have been improperly held abandoned (the reduction in § 1.704(c)(3) is applicable to the revival of an application properly held abandoned) is expected to file a petition to withdraw the holding of abandonment (or to revive the application) within two months from the mailing date of a notice of abandonment. See MPEP 711.03(c)(I). Section 1.704(c)(4) as proposed also provides that in such a case the period of adjustment set forth in § 1.703 shall be reduced by the number of days, if any, beginning on the date two months from the mailing date of a notice of abandonment and ending on the date a petition to withdraw the holding of abandonment or to revive the application was filed.

Section 1.704(c)(5) as proposed establishes conversion of a provisional application under 35 U.S.C. 111(b) to a nonprovisional application under 35 U.S.C. 111(a) (pursuant to 35 U.S.C. 111(b)(5)) as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Section 4801(a) of the “American Inventors Protection Act of 1999” provides for the conversion of a provisional application under 35 U.S.C. 111(b) and § 1.53(c) to a nonprovisional application under 35 U.S.C. 111(a) and § 1.53(b), and it is being implemented in a separate rulemaking. Conversion of a provisional application to a nonprovisional application will require the Office to reprocess the application (as a nonprovisional application) up to one year after the filing date that will be accorded to such nonprovisional application as a result of an action by the applicant. Section 1.704(c)(5) as proposed also provides that in such a case the period of adjustment set forth in § 1.703 shall be reduced by the number of days, if any, beginning on the date the application was filed under 35 U.S.C. 111(b) and ending on the date a request in compliance with § 1.53(c)(3) to convert the provisional application into a nonprovisional application was filed.

Section 1.704(c)(6) as proposed establishes failure to file the basic filing fee (§ 1.16(a) or (g)), any English translation required by § 1.52(d), or an oath or declaration (§ 1.63) executed by all of the inventors in an application under 35 U.S.C. 111(a) as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. The Office cannot act on an application until the applicant files the basic filing fee, an English translation (if the application is filed in a language other than English), and an oath or declaration (§ 1.63) executed in compliance with § 1.64 (by all of the inventors or applicants under §§ 1.42, 1.43, or 1.47). The rules of practice (§ 1.53(f) and 1.136(a)), however, currently permit an applicant to delay filing the basic filing fee, any English translation required by § 1.52(d), and oath or declaration by up to seven months from the date the applicant is notified that the application is missing the basic filing fee, English translation, or oath or declaration. To avoid changing these provisions and requiring that the basic filing fee and oath or declaration be filed when an application is filed under 35 U.S.C. 111(a), the Office is setting forth failure to file the basic filing fee (§ 1.16(a) or (g)), any English translation required by § 1.52(d), or an oath or declaration (§ 1.63) executed by all of the inventors in an application under 35 U.S.C. 111(a) as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing of the application. Section 1.704(c)(6) as proposed provides that in such a case the period of adjustment set forth in § 1.703 shall be reduced by the number of days, if any, beginning on the date the application was filed and ending on the later of the date the applicant supplied the basic filing fee (§ 1.16), an English translation (§ 1.52(d)), and an oath or declaration (§ 1.63) executed in compliance with § 1.64 and, if the oath or declaration was not executed by all of the inventors, the earliest of the date the application was accorded status under § 1.47, or four months after a grantable petition under § 1.47 was filed.

Section 1.704(c)(7) as proposed establishes failure to fulfill the requirements of 35 U.S.C. 371(c) and § 1.494 or § 1.495 in an international application as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing of an application. The three-year period in 35 U.S.C. 154(b)(1)(B) is measured from the “actual filing date of the application in the United States” and 35 U.S.C. 363 provides that an international application designating the United States has the same effect from its international filing date as a national application regularly filed in the United States (except as provided in 35 U.S.C. 102(e)). Nevertheless, the Office cannot act on an international application until the applicant fulfills the requirements of 35 U.S.C. 371(c) and § 1.494 or § 1.495, and the legislative history of 35 U.S.C. 154(b) makes clear that an applicant may not use the Patent Cooperation Treaty (PCT) application filing system to have the time period set forth in § 1.494 or § 1.495 count against the three-year time period in 35 U.S.C. 154(b)(1)(B). See 145 Cong. Rec. S14708, S14718 (daily ed. November 17, 1999) (statement of Sen. Lott); see also H.R. Rep. No. 106-464 at 126 (1999). Section 1.704(c)(7) as proposed also provides that in such a case the period of adjustment set forth in § 1.703 shall be reduced by the number of days, if any, beginning on the date the international application was filed under 35 U.S.C. 363 and the later of the date the application fulfilled the requirements of 35 U.S.C. 371(c) and §§ 1.494 or 1.495 and, if the oath or declaration was not executed by all of the inventors (§ 1.497), the earliest of the date the application was accorded status under § 1.47, or four months after a grantable petition under § 1.47 was filed.

Section 1.704(c)(8) as proposed establishes failure to request the national stage of processing in an international application if the application fulfills the requirements of 35 U.S.C. 371(c) and § 1.494 or § 1.495 before the expiration of the applicable time period set forth in § 1.494(b) or § 1.495(b) as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. The Office cannot act on an international application before the expiration of the applicable time period set forth in § 1.494(b) or § 1.495(b) without the applicant's express request (35 U.S.C. 371(f)), even if the application fulfills the requirements of 35 U.S.C. 371(c) and § 1.494 or § 1.495 prior to the expiration of the applicable time period set forth in § 1.494(b) or § 1.495(b). Section 1.704(c)(8) as proposed also provides that in such a case the period of adjustment set forth in § 1.703 shall be reduced by the number of days, if any, beginning on the date the international application was filed under 35 U.S.C. 363 and the earlier of the date of expiration of the applicable time period in § 1.494(b) or § 1.495(b) or the date on which an express request for national stage of processing is filed.

Section 1.704(c)(9) as proposed establishes failure to file an application with a specification on papers in compliance with § 1.52 and having a title and abstract in compliance with § 1.72, drawings in compliance with § 1.84 (if applicable), and a sequence listing in compliance with §§ 1.821 through 1.825 (if applicable) as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. The Office must require these items during its preexamination processing of an application to implement the pre-grant publication provisions of the “American Inventors Protection Act of 1999.” Therefore, the Office cannot act on an application until it contains a specification on papers in compliance with § 1.52 and having an abstract (§ 1.72(b)), drawings in compliance with § 1.84 (if applicable), and a sequence listing in compliance with §§ 1.821 through 1.825 (if applicable). Section 1.704(c)(9) as proposed also provides that in such a case the period of adjustment set forth in § 1.703 shall be reduced by the number of days, if any, beginning on the filing date of the application and ending on the date the application contains a specification on papers in compliance with § 1.52 and having an abstract (§ 1.72(b)), drawings in compliance with § 1.84 (if applicable), and a sequence listing in compliance with §§ 1.821 through 1.825 (if applicable).

Section 1.704(c)(10) as proposed establishes submission of a preliminary amendment or other preliminary paper less than one month before the mailing of an Office action under 35 U.S.C. 132 or a notice of allowance under 35 U.S.C. 151 that requires the mailing of a supplemental Office action or notice of allowance as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. If the submission of a preliminary amendment or other paper requires the Office to issue a supplemental Office action or notice of allowance, the submission of that preliminary amendment or other paper has interfered with the processing and examination of an application. Section 1.704(c)(10) as proposed also provides that in such a case the period of adjustment set forth in § 1.703 shall be reduced by the number of days, if any, beginning on the mailing date of the original Office action or notice of allowance and ending on the mailing date of the supplemental Office action or notice of allowance.

Section 1.704(c)(11) as proposed establishes submission of a reply having an omission (§ 1.135(c)) as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Submitting a reply having an omission requires the Office to issue an action under § 1.135(c) and await and process the applicant's reply before the initial reply (as completed) can be treated on its merits. Section 1.704(c)(11) as proposed also provides that in such a case the period of adjustment set forth in § 1.703 shall be reduced by the number of days, if any, beginning on the date the reply having an omission was filed and ending on the date that the omission was filed.

Section 1.704(c)(12) as proposed establishes submission of a supplemental reply or other paper after a reply has been filed as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. The submission of a supplemental reply or other paper ( e.g., IDS or petition) after an initial reply was filed requires the Office to restart consideration of the initial reply in view of the supplemental reply or other paper, which will result in a delay in the Office's response to the initial reply. Section 1.704(c)(12) as proposed also provides that in such a case the period of adjustment set forth in § 1.703 shall be reduced by the number of days, if any, beginning on the date the initial reply was filed and ending on the date that the supplemental reply or such other paper was filed.

Section 1.704(c)(13) as proposed establishes failure to file an appeal brief (and brief fee) in compliance with § 1.192 with the notice of appeal to the Board of Patent Appeals and Interferences under 35 U.S.C. 134 and § 1.191 as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. The examiner cannot prepare an examiner's answer in response to an appeal until the applicant files an appeal brief in compliance with § 1.192, and the rules of practice (§§ 1.192(a) and 1.136(a)) now allow the applicant to delay filing an appeal brief for up to seven months from the filing date of the notice of appeal under § 1.191. Thus, to continue to permit this time frame for filing an appeal brief, the Office must establish the failure to file an appeal brief (and brief fee) in compliance with § 1.192 with the notice of appeal to the Board of Patent Appeals and Interferences under 35 U.S.C. 134 and § 1.191 as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of the application. Section 1.704(c)(13) as proposed also provides that in such a case the period of adjustment set forth in § 1.703 shall be reduced by the number of days, if any, beginning on the date a notice of appeal under 35 U.S.C. 134 and § 1.191 was filed and ending on the day an appeal brief (and brief fee) in compliance with § 1.192 was filed, or, if no appeal brief under § 1.192 is filed, ending on the day an amendment in compliance with § 1.113 was filed.

Section 1.704(c)(14) as proposed establishes submission of an amendment or other paper in an application containing allowed claims after a decision by the Board of Patent Appeals and Interferences (other than a decision containing a rejection under § 1.196(b)) or a Federal court less than one month before the mailing of an Office action under 35 U.S.C. 132 or notice of allowance under 35 U.S.C. 151 that requires the mailing of a supplemental Office action or supplemental notice of allowance as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of the application. The submission of an amendment or other paper ( e.g., IDS or petition) in an application after a Board of Patent Appeals and Interferences or court decision requires the Office to restart consideration of the application in view of the amendment or other paper, which will result in a delay in the Office's taking action on the application. Section 1.704(c)(14) as proposed also provides that in such a case the period of adjustment set forth in § 1.703 shall be reduced by the number of days, if any, beginning on the mailing date of the original Office action or notice of allowance and ending on the mailing date of the supplemental Office action or notice of allowance.

Section 1.704(c)(15) as proposed establishes submission of an amendment under § 1.312 or other paper after a notice of allowance has been given or mailed as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. The submission of amendments (or other papers) after an application is allowed causes substantial interference with the patent issue process. See Filing of Continuing Applications, Amendments, or Petitions after Payment of Issue Fee, Notice, 1221 Off. Gaz. Pat. Office 14 (April 6, 1999); and Patents to Issue More Quickly After Issue Fee Payment, Notice, 1220 Off. Gaz. Pat. Office 42 (March 9, 1999). Thus, to continue to permit applicants to submit an amendment or other paper after a notice of allowance is mailed or given, the Office must establish submission of an amendment under § 1.312 or other paper after a notice of allowance has been given or mailed as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of the application. Section 1.704(c)(15) as proposed also provides that in such a case the period of adjustment set forth in § 1.703 shall be reduced by the lesser of: (1) The number of days, if any, beginning on the date the amendment under § 1.312 was filed and ending on the mailing date of the Office action or notice in response to the amendment under § 1.312 or such other paper; or (2) four months. The “lesser of * * * or four months” provision is to provide a four-month cap for reductions under § 1.704(c)(15).

Section 1.704(c)(16) as proposed establishes further prosecution via a continuing application as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of the application. Currently, a continuing application may be used to: (1) Obtain further examination of an invention disclosed and claimed in the prior application (continuation application); (2) obtain examination (for the first time) of an invention disclosed but not claimed or not elected for examination in the prior application (divisional application); or (3) obtain examination of an invention neither disclosed nor claimed in the prior application (continuation-in-part application). The provisions of 35 U.S.C. 132(b) (which are being implemented in a separate rulemaking) will permit an applicant to obtain further or continued examination of an invention disclosed and claimed in an application, which renders it unnecessary for an applicant whose application is eligible for patent term adjustment under 35 U.S.C. 154(b) to file a continuing application to obtain further examination of an invention disclosed and claimed in an application. If an applicant is filing a continuing application to obtain examination (for the first time) of an invention disclosed but not claimed or not elected for examination in the prior application or an invention neither disclosed nor claimed in the prior application, it is not appropriate for that applicant to obtain any benefit in the continuing application for examination delays that might have occurred in the prior application. Thus, the Office is establishing further prosecution via a continuing application as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of the application, in that the period of adjustment set forth in § 1.703 shall not include any period that is prior to the actual filing date of the application that resulted in the patent. Thus, if the application that resulted in the patent is a CPA, the period of adjustment set forth in § 1.703 (if any) will not include any period that is prior to the filing date of the request for that CPA.

As discussed above, an applicant may file a CPA under § 1.53(d) on or after May 29, 2000, for the application to be subject to the patent term adjustment provisions of 35 U.S.C. 154(b) as amended by § 4402 of the “American Inventors Protection Act of 1999.” The period of patent term adjustment § 1.703 (if any), however, will not include any period that is prior to the filing date of the request for that CPA.

These are three examples of how 35 U.S.C. 154(b) and the proposed rules to implement 35 U.S.C. 154(b) would apply. For purposes of clarity and ease of calculation, the examples illustrate mailing of some Office actions on non-business days, and granting of patents on days other than Tuesdays.

In a first example: (1) A first application (“Application A”) is filed on January 2, 1998; (2) a second application (“Application B”) is filed as a continued prosecution application (CPA under § 1.53(d)) of Application A on May 29, 2000, without payment of the filing fee or providing a deposit account authorization for payment of the filing fee; (3) a “Notice to File Missing Parts of Application (CPA)” is mailed on July 25, 2000, requiring the filing fee, and setting a two-month period for reply; (4) the filing fee is paid on September 25, 2000; (5) a written restriction requirement is mailed on November 13, 2000; (6) a petition for a four-month extension of time and an election are filed on April 6, 2001; (7) an Office action (first action on the merits) is mailed on September 10, 2001; (8) an amendment is filed in reply (§ 1.111) to that Office action on November 1, 2001; (9) a notice of allowability requiring a biological material deposit (§ 1.809(c)) and notice of allowance are mailed on December 3, 2001; (10) the issue fee is paid on February 28, 2002; (11) the biological material deposit is made on March 15, 2002, with a one-month extension of time; and (12) the patent issues on July 9, 2002.

The fourteen-month time period set forth in 35 U.S.C. 154(b)(1)(A)(i)(§ 1.702(a)(1) and § 1.703(a)(1)) was met by the mailing of the written restriction requirement on November 13, 2000, within fourteen months of the filing date of the application (May 29, 2000). The four-month time period set forth in 35 U.S.C. 154(b)(1)(A)(ii)(§ 1.702(a)(2) and § 1.703(a)(2)) was not met for acting on the reply (election) of April 6, 2001, but was met for acting on the reply (amendment) of November 1, 2001. The four-month time period for acting on the reply of April 6, 2001, expired on August 6, 2001; however, the Office's response to the reply of April 6, 2001, was not mailed until September 10, 2001, the difference in time between August 6, 2001, and September 10, 2001, being 35 days. The four-month time period set forth in 35 U.S.C. 154(b)(1)(A)(iii)(§ 1.702(a)(2) through (a)(3) and § 1.703(a)(3) through (a)(4)) is not applicable in this example. The four-month time period set forth in 35 U.S.C. 154(b)(1)(A)(iv)(§ 1.702(a)(4) and § 1.703(a)(6)) was met as all formal requirements were satisfied on March 15, 2002, and the patent was issued on July 9, 2002 (within four months of March 15, 2002). As the application (Application B) was pending for less than three years (from May 29, 2000, until July 9, 2002), there is no adjustment pursuant to 35 U.S.C. 154(b)(1)(B)(§ 1.702(b) and § 1.703(b)). In addition, as there was also no interference, secrecy order or appellate review in the application, there is no adjustment pursuant to 35 U.S.C. 154(b)(1)(C)(§ 1.702(b) through (e) and § 1.703(c) through (e)).

35 U.S.C. 154(b)(2)(C)(i) provides that the period of adjustment shall be reduced by the period of time during which applicant failed to engage in reasonable efforts to conclude prosecution of the application. Section 1.704(b) as proposed sets forth that any time periods in excess of three months taken to reply to any notice or action by the Office shall each be deemed failures to engage in reasonable efforts to conclude prosecution of an application, and that the period of adjustment shall be reduced by the period of time beginning on the date three months after the date of mailing of the Office communication notifying the applicant of the rejection, objection, argument, or other request and ending on the date the reply was filed. In this example, the period of time from three months after the written restriction (February 13, 2001) until the reply (April 6, 2001) is 52 days, and the period of time from three months after the notice of allowance (March 3, 2002) and the date the biological material deposit was made (March 15, 2002) is 12 days, for a total reduction under § 1.704(b) of 64 days. Sections 1.704(c)(1) through 1.704(c)(16) as proposed set forth actions or inactions, each of which further constitutes a failure by the applicant to engage in reasonable efforts to conclude prosecution of an application. As applicable in this example, proposed § 1.704(c)(6) provides that a failure to file the basic filing fee of an application on filing will result in a reduction of any period of adjustment (§ 1.703) by the period between the application filing date and the submission of the basic filing fee, and proposed § 1.704(c)(16) provides that the period of adjustment (§ 1.703) shall not include any period that is prior to the actual filing date of the application that resulted in the patent. In this example, the period of time from filing of Application B (May 29, 2000) until submission of the basic filing fee (September 25, 2000) is 119 days, and the period of adjustment does not include any period that is prior to May 29, 2000 (the actual filing date of Application B).

Accordingly, the total period during which applicant failed to engage in reasonable efforts to conclude prosecution would be 64 days (1.704(b)) plus 119 days (1.704(c)) for a total of 183 days. It should be noted that the reduction attributed to the extension of time (§ 1.704(b)) may be reduced if a proper showing pursuant to § 1.705(c) is submitted after mailing of the notice of allowance and before or with payment of the issue fee.

In this example, the period of adjustment pursuant to 35 U.S.C. 154(b)(1)(§ 1.702 and § 1.703) is 35 days, which is reduced by the 183-day period in which applicant failed to engage in reasonable efforts to conclude prosecution (§ 1.704). Since 35 is less than 183, there is no adjustment to the term of the patent issuing on Application B, whose projected expiration date remains January 2, 2018.

In a second example: (1) An application is filed which includes a sequence listing as required by § 1.821(c) on March 1, 2001; (2) a PTOL-1661 Notice stating that the computer readable form (CRF) was not in compliance with the requirements of § 1.824 was mailed by the Office on April 1, 2001; (3) Applicant submits a substitute or corrected CRF on May 1, 2001; (4) a second PTOL-1661 Notice stating that the corrected or substitute CRF is not in compliance with the requirements of § 1.824 was mailed by the Office on June 1, 2001; (5) a second corrected CRF is submitted on July 1, 2001; (6) a third PTOL-1661 Notice stating that the corrected or substitute CRF is not in compliance with the requirements of § 1.824 was mailed by the Office on September 1, 2001; (7) a third corrected CRF is submitted on October 1, 2001; (8) a fourth PTOL-1661 Notice stating that the corrected or substitute CRF is not in compliance with the requirements of § 1.824 was mailed by the Office on December 1, 2002; (9) a fourth corrected CRF is submitted on January 1, 2002; (10) a fifth PTOL-1661 Notice stating that the corrected or substitute CRF is not in compliance with the requirements of § 1.824 was mailed by the Office on February 1, 2002; (11) a proper CRF submission is filed on March 1, 2002; (12) an Office action (first action on the merits) is mailed on July 1, 2002; (13) an amendment is filed in reply (§ 1.111) to that Office action on October 1, 2002; (14) a second Office action is mailed on February 1, 2003; (15) an amendment is filed in reply to the second Office action on May 1, 2003; (16) a third (final) Office action is mailed on September 1, 2003; (17) an amendment is filed, which adopts the allowable subject matter noted in the final Office action, on November 1, 2003; (18) a notice of allowance and notice of allowability are mailed by the Office on December 1, 2003; (19) applicant provides the issue fee on January 1, 2004; (20) the patent issues on March 1, 2004.

The fourteen-month period set forth in 35 U.S.C. 154(b)(1)(A)(i) (§§ 1.702(a)(1) and 1.703(a)(1)) was not met by the mailing of the first Office action on July 1, 2002, by a 61-day period. The four-month time period set forth in 35 U.S.C. 154(b)(1)(A)(ii) (§ 1.702(a)(2) and § 1.703(a)(2)) was met for acting on the replies of October 1, 2002, May 1, 2003, and November 1, 2003. The four-month time period set forth in 35 U.S.C. 154(b)(1)(A)(iv)(§ 1.702(a)(4) and § 1.703(a)(6)) was met as all formal requirements were satisfied on January 1, 2004, and the patent was issued on March 1, 2004 (within four months of January 1, 2004). As the application was pending for three years (from March 1, 2001, to March 1, 2004), there is no adjustment pursuant to 35 U.S.C. 154(b)(1)(B)(§ 1.702(b) and § 1.703(b)). In addition, as there was also no interference, secrecy order or appellate review in the application, there is no adjustment pursuant to 35 U.S.C. 154(b)(1)(C)(§ 1.702(b) through (e) and § 1.703(c) through (e)).

35 U.S.C. 154(b)(2)(C)(i) provides that the period of adjustment shall be reduced by the period of time during which applicant failed to engage in reasonable efforts to conclude prosecution of the application. Sections 1.704(b) and 1.704(c)(1) through 1.704(c)(16) as proposed set forth actions or inactions, each of which constitutes a failure by the applicant to engage in reasonable efforts to conclude prosecution of an application. As applicable in this example, proposed § 1.704(c)(9) provides that a failure to file an application with a sequence listing in compliance with §§ 1.821 through 1.825 will result in a reduction of any period of adjustment (§ 1.703) by the period between the application filing date and the date a sequence listing in compliance with §§ 1.821 through 1.825 is submitted. In this example, the period of time from filing date (March 1, 2001) and the filing of the correct CRF submission (March 1, 2002) is 365 days.

In this example, the period of adjustment pursuant to 35 U.S.C. 154(b)(1)(§ 1.702 and § 1.703) is 61 days, which is reduced by the 365-day period in which applicant failed to engage in reasonable efforts to conclude prosecution (§ 1.704). Since 61 is less than 365, there is no adjustment to the term of the patent, whose projected expiration date remains March 1, 2021.

In a third example: (1) An international application is filed in the United States Receiving Office on January 1, 2001; (2) a Demand for international preliminary examination is filed on July 1, 2002; (3) the documents and fees to fulfill the requirements of 35 U.S.C. 371(c) (§ 1.495) were filed on July 1, 2003; (4) an Office action is mailed on November 1, 2003; (5) a reply to the first Office action is filed May 1, 2004, with a three-month extension of time; (6) a notice of allowance and notice of allowability are mailed on February 1, 2009; (7) applicant pays the issue fee on March 1, 2009; (8) patent issues on July 1, 2010.

The fourteen-month period set forth in 35 U.S.C. 154(b)(1)(A)(i) (§§ 1.702(a)(1) and 1.703(a)(1)) was met by the mailing of the first Office action on November 1, 2003, since the fourteen-month period is measured from the date on which the international application fulfilled the requirements of 35 U.S.C. 371 (35 U.S.C. 154(b)(1)(A)(i)(II)). The four-month time period set forth in 35 U.S.C. 154(b)(1)(A)(ii) (§ 1.702(a)(2) and § 1.703(a)(2)) was not met for acting on the reply of May 1, 2004, by a period of 1,614 days. The four-month time period set forth in 35 U.S.C. 154(b)(1)(A)(iv)(§ 1.702(a)(4) and § 1.703(a)(6)) was not met as all formal requirements were satisfied on March 1, 2009, and the patent was issued on July 1, 2010, 365 days after the expiration of the four-month time period (on July 1, 2009) for issuing the patent. The application was pending for more than three years from January 1, 2001, to July 1, 2010, without continued examination under 35 U.S.C. 132(b), a proceeding under 35 U.S.C. 135(a) (interference), an order under 35 U.S.C. 181 (secrecy order), or appellate review.

Therefore, there is an adjustment pursuant to 35 U.S.C. 154(b)(1)(B) (§ 1.702(b) and § 1.703(b)) of 2,373 days. As there was no interference, secrecy order or appellate review in the application, there is no adjustment pursuant to 35 U.S.C. 154(b)(1)(C)(§ 1.702(c) through (e) and § 1.703(c) through (e)).

35 U.S.C. 154(b)(2)(C)(i) provides that the period of adjustment shall be reduced by the period of time during which applicant failed to engage in reasonable efforts to conclude prosecution of the application. Section 1.704(c) as proposed sets forth that any time periods in excess of three months taken to reply to any notice or action by the Office shall each be deemed failures to engage in reasonable efforts to conclude prosecution of an application, and that the period of adjustment shall be reduced by the period of time beginning on the date three months after the date of mailing of the Office communication notifying the applicant of the rejection, objection, argument, or other request and ending on the date the reply was filed. In this example, the period of time from three months after the Office action (November 1, 2003) until the reply (May 1, 2004) is 90 days. Sections 1.704(c)(1) through 1.704(c)(16) as proposed set forth actions or inactions, each of which further constitutes a failure by the applicant to engage in reasonable efforts to conclude prosecution of an application. As applicable in this example, proposed § 1.704(c)(7) provides that a failure to fulfill the requirements of 35 U.S.C. 371(c) and § 1.494 or § 1.495 in an international application will result in a reduction of any period of adjustment (§ 1.703) by the period between the date the application was filed under 35 U.S.C. 363 and the later date the application fulfilled the requirements of 35 U.S.C. 371(c) and § 1.494 or § 1.495 or, if the oath or declaration (§ 1.497) is not executed by all of the inventors, the earliest of the date the application was accorded status under § 1.47, or four months after a grantable petition under § 1.47 was filed. In this example, the period of time from filing (January 1, 2001) and fulfillment of 35 U.S.C. 371(c) and § 1.494 or § 1.495 (July 1, 2003) is 911 days. The total period during which applicant failed to engage in reasonable efforts to conclude prosecution would be 90 days (1.704(b)) plus 911 days (1.704(c)) for a total of 1,001 days.

As set forth in § 1.703(f), the term adjustment is the sum of the periods calculated under § 703(a)-(e), to the extent the periods are not overlapping, less the sum of the periods calculated under § 1.704. In this example, the period of adjustment pursuant to 35 U.S.C. 154(b)(1)(§ 1.703(b)) of 2,373 days overlaps entirely with the period of adjustment pursuant to 35 U.S.C. 154(b)(1)(§ 1.703(a)) of 1,979 days. Consequently, 1,001 days (the sum of the periods in which applicant failed to engage in reasonable efforts to conclude prosecution (§ 1.704)) is deducted from 2,373 days, which leaves a term adjustment of 1,372 days. As a result, the projected expiration date of the patent is adjusted from January 1, 2021, to October 4, 2024.

Section 1.705 as proposed implements the provisions of 35 U.S.C. 154(b)(3) and (b)(4)(B).

Section 1.705(a) as proposed indicates that the notice of allowance will include notification of any patent term adjustment under 35 U.S.C. 154(b) (35 U.S.C. 154(b)(3)(B)(i)).

Section 1.705(b) as proposed provides that any request for review or reconsideration of the patent term adjustment indicated in the notice of allowance (except as provided in § 1.705(d)) and any request for reinstatement of all or part of the term reduced pursuant to § 1.704(b)(1) must be filed no later than payment of the issue fee but may not be filed earlier than the date of mailing of the notice of allowance. Section 1.705(b) as proposed provides that any such request must be by way of an application for patent term adjustment accompanied by the fee set forth in § 1.18(e) and a statement of the facts involved. Section 1.705(b) as proposed also provides that such statement of facts must specify: (1) The basis or bases under § 1.702 for the adjustment; (2) the relevant dates as specified in § 1.703(a) through (e) for which an adjustment is sought and the adjustment as specified in § 1.703(f) to which the patent is entitled; (3) whether the patent is subject to a terminal disclaimer and any expiration date specified in the terminal disclaimer; and (4) any circumstances during the prosecution of the application resulting in the patent that constitute a failure to engage in reasonable efforts to conclude processing or examination of such application as set forth in § 1.704 (or that there were no such circumstances). Since the Office must complete its determination of patent term adjustment before proceeding to issue the patent (35 U.S.C. 154(b)(3)(D)), the Office must require that such application for patent term adjustment be filed within a non-extendable time period and set forth with particularity why the Office's patent term adjustment determination is not correct. In the absence of these requirements, the issuance of the patent will be further delayed by a protracted patent term adjustment determination proceeding.

Section 1.705(c) as proposed implements the provisions of 35 U.S.C. 154(b)(3)(C). Section 1.705(c) as proposed specifically provides that a request for reinstatement of all or part of the time reduced pursuant to § 1.704(b)(1) for failing to reply to a rejection, objection, argument, or other request within three months of the date of mailing of the Office communication notifying the applicant of the rejection, objection, argument, or other request must include: (1) the fee set forth in § 1.18(f); and (2) a showing to the satisfaction of the Director that, in spite of all due care, the applicant was unable to reply to the rejection, objection, argument, or other request within three months of the date of mailing of the Office communication notifying the applicant of the rejection, objection, argument, or other request. Section 1.705(c) as proposed also provides that the Office shall not grant any request for reinstatement for more than three additional months for each reply beyond three months of the date of mailing of the Office communication notifying the applicant of the rejection, objection, argument, or other request (35 U.S.C. 154(b)(3)(C)).

Since the Office is obligated to provide a determination of patent term adjustment under 35 U.S.C. 154(b) in the notice of allowance ( i.e., before the actual patent issue date), the Office must project (or estimate) the actual patent issue date and base its patent term adjustment determination on that projection. Thus, § 1.705(d) as proposed provides for a request to change the period of patent term adjustment in the event that the patent is issued on a date other than the projected date of issue and this change necessitates a revision of the patent term adjustment indicated in the notice of allowance. Section 1.705(d) specifically provides that if the patent is issued on a date other than the projected date of issue and this change necessitates a revision of the patent term adjustment indicated in the notice of allowance, the patent will indicate the revised patent term adjustment. Section 1.705(d) also provides that if the patent indicates a revised patent term adjustment due to the patent being issued on a date other than the projected date of issue, any request for reconsideration of the patent term adjustment indicated in the patent must be filed within thirty days of the date the patent issued and must comply with the requirements of § 1.705(b)(1) and § 1.705(b)(2).

Section 1.705(e) as proposed provides that the periods set forth in this section are not extendable. As discussed above, the Office must set non-extendable time periods in § 1.705 to avoid delay in the issuance of the patent.

Section 1.705(f) as proposed implements the provisions of 35 U.S.C. 154(b)(4)(B), and provides that no submission or petition on behalf of a third party concerning patent term adjustment under 35 U.S.C. 154(b) will be considered by the Office, and that any such submission or petition, will be returned to the third party, or otherwise disposed of, at the convenience of the Office.

The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy, Small Business Administration, that the changes proposed in this notice, if adopted, would not have a significant impact on a substantial number of small entities (Regulatory Flexibility Act, 5 U.S.C. 605(b)). This rulemaking implements the provisions of §§ 4401 and 4402 of the “American Inventors Protection Act of 1999.” The changes proposed in this notice (if adopted) would provide procedures for the Office's patent term adjustment determination and for filing an application to request reconsideration of the Office's patent term adjustment determination.

The Office mails a notice of allowance in roughly 160,000 applications each year. The Office's patent term adjustment determination will be a calculation based upon time periods involving the dates of various actions by the Office and the applicant during the application process. Because of the number of actions by the Office and the applicant during the application process, the Office anticipates that there will be disagreement on at least one of these dates in roughly fifteen percent of applications (24,000). Based upon the percentage of applicants who are small entities (thirty percent), the Office expects that 7,200 small entities will file an application requesting reconsideration of a patent term adjustment determination each year. Since a small entity applicant who exercises reasonable due care or diligence should be able to reply to any Office action or notice within three months, the Office does not anticipate that any small entities will file a request for reinstatement of reduced patent term adjustment (based upon a showing that the applicant was unable to reply to an Office action or notice within three months in spite of all due care).

Filing an application requesting reconsideration of a patent term adjustment determination (as well as a request for reinstatement of reduced patent term adjustment) is optional. To obtain any benefit from an application requesting reconsideration of the Office's patent term adjustment determination, the applicant must plan to pay the three maintenance fees required by law (35 U.S.C. 41(b)) to maintain a patent in force until the end of the non-adjusted patent term as specified in 35 U.S.C. 154. The current first, second, and third maintenance fees are $415.00, $950.00, and $1,455.00, respectively. Since the fee ($200.00) for filing an application requesting reconsideration of the Office's patent term adjustment determination is less than one-tenth of the combined cost of these three maintenance fees (and the fee ($450.00) for filing a request for reinstatement of reduced patent term adjustment is less than one-sixth of the combined cost of these three maintenance fees), there will not be a significant economic impact on a substantial number of small entities due to the procedures for requesting reconsideration of the Office's patent term adjustment determination.

This rulemaking does not contain policies with federalism implications sufficient to warrant preparation of a Federalism Assessment under Executive Order 13132 (August 4, 1999).

This rulemaking has been determined to be not significant for purposes of Executive Order 12866 (September 30, 1993).

This notice of proposed rulemaking involves information collection requirements which are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ). The collection of information involved in this notice of proposed rulemaking has been reviewed and previously approved by OMB under OMB control number 0651-0020.

As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)), the Patent and Trademark Office has submitted an information collection package to OMB for its review and approval of the proposed information collections under OMB control number 0651-0020. The Patent and Trademark Office is submitting this information collection to OMB for its review and approval because this notice of proposed rulemaking will add the request for reconsideration of a patent term adjustment determination by the Patent and Trademark Office and the request for reinstatement of reduced patent term adjustment (based upon a showing that the applicant was unable to reply to an Office action or notice within three months in spite of all due care) provided for in 35 U.S.C. 154(b)(3) to that collection.

The title, description, and respondent description of the information collection is shown below with an estimate of the annual reporting burdens. Included in this estimate is the time for reviewing instructions, gathering, and maintaining the data needed, and completing and reviewing the collection of information. The principal impact of the changes in this notice of proposed rulemaking is to implement the changes to Office practice necessitated by § 4402 of the “American Inventors Protection Act of 1999” (enacted into law by § 1000(a)(9), Division B, of Public Law 106-113).

OMB Number: 0651-0020.

Title: Patent Term Extension.

Form Numbers: None.

Type of Review: Approved through September of 2001.

Affected Public: Individuals or households, businesses or other for-profit, not-for-profit institutions, farms, Federal Government, and state, local, or tribal governments.

Estimated Number of Respondents: 26,857.

Estimated Time Per Response: 1.15 hour.

Estimated Total Annual Burden Hours: 30,902 hours.

Needs and Uses: The information supplied to the Patent and Trademark Office by an applicant requesting reconsideration of a patent term adjustment determination under 35 U.S.C. 154(b) (proposed § 1.702 et seq. ) is used by the Patent and Trademark Office to determine whether its determination of patent term adjustment under 35 U.S.C. 154(b) is correct, and whether the applicant is entitled to reinstatement of reduced patent term adjustment. The information supplied to the Patent and Trademark Office by an applicant seeking a patent term extension under 35 U.S.C. 156 (§ 1.710 et seq. ) is used by the Patent and Trademark Office, the Department of Health and Human Services, and the Department of Agriculture to determine the eligibility of a patent for extension and to determine the period of any such extension. The applicant can apply for patent term and interim extensions, petition the Patent and Trademark Office to review final eligibility decisions, withdraw patent term applications, and declare his or her eligibility to apply for a patent term extension.

Comments are invited on: (1) Whether the collection of information is necessary for proper performance of the functions of the agency; (2) the accuracy of the agency's estimate of the burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information to respondents.

Interested persons are requested to send comments regarding these information collections, including suggestions for reducing this burden, to Robert J. Spar, Director, Special Program Law Office, Patent and Trademark Office, Washington, D.C. 20231, or to the Office of Information and Regulatory Affairs of OMB, New Executive Office Building, 725 17th Street, N.W., Room 10235, Washington, D.C. 20503, Attention: Desk Officer for the Patent and Trademark Office.

Notwithstanding any other provision of law, no person is required to respond to nor shall a person be subject to a penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a currently valid OMB control number.

For the reasons set forth in the preamble, 37 CFR Part 1 is proposed to be amended as follows:

The rules being proposed for disapproval are Antelope Valley Air Pollution Control District (AVAPCD) and South Coast Air Quality Management District (SCAQMD) Rule 118, Emergencies. Rule 118 was submitted to EPA by the California Air Resources Board on March 10, 1998 and May 18, 1998, respectively.

This document addresses EPA's proposed action for Antelope Valley Air Pollution Control District (AVAPCD) and South Coast Air Quality Management District (SCAQMD) Rule 118, Emergencies. These rules were adopted by AVAPCD on August 19, 1997 and by SCAQMD on December 7, 1995. These rules were found to be complete on May 21, 1998 for AVAPCD and on July 17, 1998 for SCAQMD, pursuant to EPA's completeness criteria that are set forth in 40 CFR part 51, appendix V. 1

In determining the approvability of a rule, EPA must evaluate the rule for consistency with the requirements of the CAA and EPA regulations, as found in section 110 and part D of the CAA and 40 CFR part 51 (Requirements for Preparation, Adoption and Submittal of Implementation Plans). EPA's interpretation of these requirements, which forms the basis for this action, appears in EPA policy guidance documents. In general, the guidance documents have been set forth to ensure that submitted rules meet Federal requirements, are fully enforceable, and strengthen or maintain the SIP.

There is currently no version of Antelope Valley or South Coast Rule 118, Emergencies, in the SIP. The submitted rules include the following:

• Definitions of various terms used in the rule;

• Executive Officer authority to suspend AQMD rules; regulations, or orders in the event of a state or federally-declared State of Emergency; and

• Guidelines for suspending or modifying compliance with existing rules, regulations, or permit conditions, and provisions allowing extension of suspension beyond the state of emergency.

Rules submitted to EPA for approval as revisions to the SIP must be fully enforceable, must maintain or strengthen the SIP, and must conform with EPA policy in order to be approved by EPA. AVAPCD and SCAQMD Rules 118 weaken, rather than strengthen or maintain the SIP. Under the Clean Air Act, EPA does not have the authority to approve SIP provisions which would allow Executive Officers' discretion to suspend federally enforceable requirements. AVAPCD and SCAQMD Rule 118, if approved, would impact EPA's ability to seek injunctive relief and penalties in appropriate instances and would allow the districts to waive federally enforceable requirements contrary to section 110 of the Clean Air Act. These deficiencies undermine the prerogatives retained by EPA for protecting the NAAQS, PSD increments, and other air quality related values under section 110 and part D. Therefore, in order to maintain the SIP, EPA is proposing a disapproval of these rules. Because these rules are not required under section 110 or part D, their disapproval will not trigger sanctions or FIP requirements pursuant to section 179.

Nothing in this action should be construed as permitting or allowing or establishing a precedent for any future request for revision to any State implementation plan. Each request for revision to the State Implementation Plan shall be considered separately in light of specific technical, economic and environmental factors and in relation to relevant statutory and regulatory requirements.

The Office of Management and Budget (OMB) has exempted this regulatory action from Executive Order 12866, Regulatory Planning and Review.

Federalism (64 FR 43255, August 10, 1999) revokes and replaces Executive Orders 12612, Federalism and 12875, Enhancing the Intergovernmental Partnership. Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” Under 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.

This proposed rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it merely approves a state rule implementing a federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. Thus, the requirements of section 6 of the Executive Order do not apply to this rule.

Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), applies to any rule that: (1) Is determined to be “economically significant” as defined under Executive Order 12866, and (2) concerns an environmental health or safety risk that EPA has reason to believe may have 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 by the Agency. This rule is not subject to Executive Order 13045 because it is does not involve decisions intended to mitigate environmental health or safety risks.

Under Executive Order 13084, Consultation and Coordination with Indian Tribal Governments, EPA may not issue a regulation that is not required by statute, that significantly or uniquely affects the communities of Indian tribal governments, and that imposes substantial direct compliance costs on those communities, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by the tribal governments, or EPA consults with those governments. If EPA complies by consulting, Executive Order 13084 requires EPA to provide to the Office of Management and Budget, in a separately identified section of the preamble to the rule, a description of the extent of EPA's prior consultation with representatives of affected tribal governments, a summary of the nature of their concerns, and a statement supporting the need to issue the regulation. In addition, Executive Order 13084 requires EPA to develop an effective process permitting elected officials and other representatives of Indian tribal governments “to provide meaningful and timely input in the development of regulatory policies on matters that significantly or uniquely affect their communities.” Today's rule does not significantly or uniquely affect the communities of Indian tribal governments. Accordingly, the requirements of section 3(b) of Executive Order 13084 do not apply to this rule.

The Regulatory Flexibility Act (RFA) generally requires an agency to conduct a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements 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 not-for-profit enterprises, and small governmental jurisdictions. This final rule will not have a significant impact on a substantial number of small entities because SIP approvals under section 110 and subchapter I, part D of the Clean Air Act do not create any new requirements but simply approve requirements that the State is already imposing. Therefore, because the Federal SIP approval does not create any new requirements, I certify that this action will not have a significant economic impact on a substantial number of small entities. Moreover, due to the nature of the Federal-State relationship under the Clean Air Act, preparation of flexibility analysis would constitute Federal inquiry into the economic reasonableness of state action. The Clean Air Act forbids EPA to base its actions concerning SIPs on such grounds. Union Electric Co. , v. U.S. EPA , 427 U.S. 246, 255-66 (1976); 42 U.S.C. 7410(a)(2).

Under section 202 of the Unfunded Mandates Reform Act of 1995 (“Unfunded Mandates Act”), signed into law on March 22, 1995, EPA must prepare a budgetary impact statement to accompany any proposed or final rule that includes a Federal mandate that may result in estimated annual costs to State, local, or tribal governments in the aggregate; or to private sector, of $100 million or more. Under section 205, EPA must select the most cost-effective and least burdensome alternative that achieves the objectives of the rule and is consistent with statutory requirements. Section 203 requires EPA to establish a plan for informing and advising any small governments that may be significantly or uniquely impacted by the rule.

EPA has determined that the approval action promulgated does not include a Federal mandate that may result in estimated annual costs of $100 million or more to either State, local, or tribal governments in the aggregate, or to the private sector. This Federal action approves pre-existing requirements under State or local law, and imposes no new requirements. Accordingly, no additional costs to State, local, or tribal governments, or to the private sector, result from this action.

As required under title V of the Clean Air Act (Act) as amended (1990), EPA has promulgated rules that define the minimum elements of an approvable state operating permits program and the corresponding standards and procedures by which the EPA will approve, oversee, and withdraw approval of state operating permits programs (see 57 FR 32250 (July 21, 1992)). These rules are codified at 40 CFR part 70 (part 70). Title V requires states to develop, and submit to EPA, programs for issuing operating permits to all major stationary sources and to certain other sources.

The Act requires that states develop and submit title V programs to EPA by November 15, 1993, and that EPA act to approve or disapprove each program within 1 year after receiving the submittal. The EPA's program review occurs pursuant to section 502 of the Act and the part 70 regulations, which together outline criteria for approval or disapproval. Where a program substantially, but not fully, meets the requirements of part 70, EPA may grant the program interim approval for a period of up to 2 years. If EPA has not fully approved a program by the end of an interim program, it must establish and implement a federal program.

On June 28, 1989 (54 FR 27274), EPA published criteria for approving and incorporating into the SIP regulatory programs for the issuance of federally enforceable state operating permits. Permits issued pursuant to an operating permit program meeting these criteria and approved into the SIP are considered federally enforceable. EPA has encouraged states to consider developing such programs in conjunction with title V operating permit programs for the purpose of creating federally enforceable limits on a source's potential to emit. This mechanism would enable sources to reduce their potential to emit to below the title V applicability thresholds and avoid being subject to title V. (See the guidance document entitled, “Limitation of Potential to Emit with Respect to Title V Applicability Thresholds”, dated September 18, 1992, from John Calcagni, Director of EPA's Air Quality Management Division.) On November 3, 1993, EPA announced in a guidance document entitled, “Approaches to Creating Federally Enforceable Emissions Limits,” signed by John S. Seitz, Director of EPA's Office of Air Quality Planning and Standards (OAQPS), that this mechanism could be extended to create federally enforceable limits for emissions of hazardous air pollutants (HAPs) if the program were approved pursuant to section 112(l) of the Act.

Antelope Valley is a new air district created by the state legislature in 1997. Sources in Antelope Valley were previously under the jurisdiction of the South Coast Air Quality Management District. This document focuses on specific elements of Antelope Valley's title V operating permits program submittal that must be corrected to meet the minimum requirements of 40 CFR part 70. The full program submittal, the Technical Support Document containing a detailed analysis of the full program, and other relevant materials are available as part of the public docket.

Antelope Valley's title V program was submitted by the California Air Resources Board (CARB) on January 26, 1999 and found by EPA to be complete on March 26, 1999. The Governor's letter requesting source category-limited interim approval, California enabling legislation, and Attorney General's legal opinion were submitted by CARB for all districts in California and therefore were not included separately in Antelope Valley's submittal. The Antelope Valley submission does contain a complete program description, District implementing and supporting regulations, and all other program documentation required by § 70.4.

The Antelope Valley's title V regulations were adopted on March 17, 1998. They consist of Regulation XXX (Federal Operating Permits). The District also submitted supporting materials including the following rules: Rule 219 (Equipment Not Requiring a Permit, adopted July 21, 1998), Rule 225 (Federal Operating Permit Requirement, adopted March 17, 1998), Rule 226 (Limitation on Potential to Emit, adopted July 21, 1998), Rule 301 (Permit Fees, adopted March 17, 1998), Rule 312 (Fees for Federal Operating Permits, adopted May 19, 1998), and Rule 430 (Breakdown Provisions, adopted March 17, 1998). These regulations “substantially meet” the requirements of 40 CFR 70.2 and 70.3 for applicability; §§ 70.4, 70.5, and 70.6 for permit content, including operational flexibility; § 70.7 for public participation and minor permit modifications; § 70.5 for complete application forms; and § 70.11 for enforcement authority. While the regulations substantially meet part 70 requirements, there are several program deficiencies, or interim approval issues. These issues are outlined below. Recommended changes are detailed further in the Technical Support Document.

Variances —Antelope Valley has authority under State and local law to issue a variance from State and local requirements. Sections 42350 et seq. of the California Health and Safety Code and District Regulation 1, sections 431-433 allow the District to grant relief from enforcement action for permit violations. The EPA regards these provisions as wholly external to the program submitted for approval under part 70, and consequently, is proposing to take no action on these provisions of State and local law.

The EPA has no authority to approve provisions of state or local law, such as the variance provisions referred to, that are inconsistent with the Act. The EPA does not recognize the ability of a permitting authority to grant relief from the duty to comply with a federally enforceable part 70 permit, except where such relief is granted through procedures allowed by part 70. A part 70 permit may be issued or revised (consistent with part 70 permitting procedures) to incorporate those terms of a variance that are consistent with applicable requirements. A part 70 permit may also incorporate, via part 70 permit issuance or modification procedures, the schedule of compliance set forth in a variance. However, EPA reserves the right to pursue enforcement of applicable requirements notwithstanding the existence of a compliance schedule in a permit to operate. This is consistent with 40 CFR 70.5(c)(8)(iii)(C), which states that a schedule of compliance “shall be supplemental to, and shall not sanction noncompliance with, the applicable requirements on which it is based.”

Insignificant Activities —§ 70.4(b)(2) requires states to include in their part 70 programs any criteria used to determine insignificant activities or emission levels for the purpose of determining complete applications. Section 70.5(c) states that an application for a part 70 permit may not omit information needed to determine the applicability of, or to impose, any applicable requirement, or to evaluate appropriate fee amounts. Section 70.5(c) also states that EPA may approve, as part of a state program, a list of insignificant activities and emissions levels which need not be included in permit applications. Under part 70, a state must request and EPA must approve as part of that state's program any activity or emission level that the state wishes to consider insignificant. Part 70, however, does not establish appropriate emission levels for insignificant activities, relying instead on a case-by-case determination of appropriate levels based on the particular circumstances of the part 70 program under review.

In Rule 219 (Equipment Not Requiring a Permit) Antelope Valley provided both threshold emissions levels and a list of specific equipment which would not require a permit. This rule also clearly states that equipment need not be listed in a permit application for a federal operating permit if it falls below the threshold, is on the list of equipment in the rule, is not subject to an applicable requirement, and is not included in the equipment list solely due to size or production rate.

Rule 219 set the threshold criteria for equipment to be exempt from a federal operating permit as 10% of the applicable threshold for determination of a major source, or 5 tons per year of any regulated air pollutant (whichever is less), and for HAPs any de minimis level, any significance level, or 0.5 tons per year (whichever is less). The levels established by Rule 219 exceed levels EPA has accepted for other state and district programs: 2 tons per year for criteria pollutants and the lesser of 1000 pounds per year, section 112(g) de minimis levels, or other title I significant modification levels for HAPs and other toxics (40 CFR 52.21(b)(23)(i)).

During discussions between Antelope Valley and EPA staff on this issue, the District stated that the District would wait for a CAPCOA/EPA Workgroup on insignificant activities to publish its recommendations, before revising Rule 219 to address EPA's concerns. On February 19, 1999, the Workgroup issued the “Model List of Insignificant Activities for Title V Permit Program.” In this document, the general insignificant activity criteria for emissions were set as: no more than 0.5 ton/year of a federal HAP and no more than 2 tons/year of a regulated pollutant that is not a HAP. Consequently, the District stated that Rule 219 will be amended to lower the insignificant activity threshold to 2 tons per year for a regulated air pollutant. This issue is identified below as an interim approval deficiency.

Section 502(b)(3) of the Act requires that each permitting authority collect fees sufficient to cover all reasonable direct and indirect costs required to develop and administer its title V operating permits program. Each title V program submittal must contain either a detailed demonstration of fee adequacy or a demonstration that aggregate fees collected from title V sources meet or exceed $33.82 per ton of emissions per year (adjusted from 1989 by the Consumer Price Index (CPI)). The $33.82 per ton amount is presumed, for program approval, to be sufficient to cover all reasonable program costs and is thus referred to as the “presumptive minimum.” See § 70.9(b)(2)(i).

Antelope Valley has opted to make a presumptive minimum fee demonstration. Antelope Valley's existing fee schedule (Element 7) requires title V facilities to pay an amount approximately equal to $217 per ton in annual operating fees. This amount meets EPA's presumptive minimum (CPI adjusted). The $217 per ton amount is based on dividing the current fee revenues for title V work (40% of the total permit fees) plus a flat annual surcharge that covers the additional costs posed by title V by the total emissions (based on the 1996 inventory). It should be noted that the $217 per ton figure may change as Antelope Valley is a new district with no prior operating history and a fee structure inherited from the South Coast Air Quality Management District, from which it separated in 1997. The annual fee number will be adjusted to reflect actual and more accurate operating data as it becomes available. Antelope Valley will maintain an accounting system and is prepared to increase fees, as needed, to reflect actual program implementation costs.

a. Section 112—Antelope Valley has demonstrated in its title V program submittal adequate legal authority to implement and enforce all section 112 requirements through the title V permit. This legal authority is contained in the State of California enabling legislation and in regulatory provisions defining “applicable requirements” and “federally enforceable” and mandating that all federal air quality requirements must be incorporated into permits. EPA has determined that this legal authority is sufficient to allow Antelope Valley to issue permits that assure compliance with all section 112 requirements. For further discussion, please refer to the Technical Support Document accompanying this action and the April 13, 1993 guidance memorandum entitled, “Title V Program Approval Criteria for Section 112 Activities,” signed by John Seitz.

b. Title IV—Antelope Valley Governing Board adopted Rule 3010 (Acid Rain Provision of Federal Operating Permits) on March 17, 1998, which incorporates the pertinent provisions of part 72, either by reference or in specific language in the rule. EPA interprets “pertinent provisions” to include all provisions necessary for the permitting of affected sources.

a. Proposed Interim Approval —The EPA is proposing to grant interim approval to the operating permits program submitted by CARB on behalf of Antelope Valley on January 26, 1999. Following interim approval, Antelope Valley must make the following changes to receive full approval:

(1) Section 70.7(f)(1)(i) provides that no reopening of the permit is required if the effective date of a new, applicable requirement is later than the permit expiration date, unless the original permit or any of its terms and conditions has been extended per § 70.4(b)(10). Section 70.4(b)(10) provides that the original permit shall remain in effect until the renewal permit has been issued or denied, if a timely and complete application is submitted for a permit renewal.

Antelope Valley's Rule 3006(A)(1)(a)(i) states that no reopening is required if an additional requirement's effective date is later than the permit's expiration date, unless the permit or any of its terms has been extended per Rule 3002(E)(2)(b). However, Rule 3002(E)(2)(b) only provides that all terms and conditions in the original permit shall remain in effect, until a permit renewal has been issued, denied, or the original permit has been terminated for cause. This provision did not address the important § 70.4(b)(10) requirement that the original permit can only remain in effect, if a timely and complete application is submitted for a permit renewal. Still, a broader examination of Rule 3002(E)(2) reveals that the timely application requirement is covered in 3002(E)(2)(a). Therefore, in order to ensure complete compliance with § 70.4(b)(10) requirements, Antelope Valley must revise Rule 3006(A)(1)(a)(i) to state that no reopening is required if an additional requirement's effective date is later than the permit's expiration date, unless the permit or any of its terms has been extended per Rule 3002(E)(2). (Antelope Valley indicated that this was an oversight and will be corrected at the earliest opportunity to revise Rule 3002.)

(2) Revise Antelope Valley's Rule 219 to lower the insignificant activity emission cutoff for a regulated pollutant that is not a HAPs to 2 tons/year, as recommended by EPA and the CAPCOA/EPA Workgroup on Insignificant Activities.

b. Legislative Source Category — Limited Interim Approval Issue —In addition to the District-specific issues arising from Antelope Valley's program submittal and locally adopted regulations, California State law currently exempts agricultural production sources from permit requirements. Because of this exemption, California programs are only eligible for source category-limited interim approval. In order for this program to receive full approval (and avoid a disapproval upon the expiration of this interim approval), the California Legislature must revise the Health and Safety Code to eliminate the exemption of agricultural production sources from the requirement to obtain a permit.

c. Implications of Interim Approval —The above described program and legislative deficiencies must be corrected before Antelope Valley can receive full program approval. For additional information, please refer to the Technical Support Document, which contains a detailed analysis of Antelope Valley's operating permits program, and California's enabling legislation.

Interim approval, which may not be renewed, would extend for a period of 2 years. During the interim approval period, the District would be protected from sanctions, and EPA would not be obligated to promulgate a federal permits program in Antelope Valley. Permits issued under a program with interim approval would have full standing with respect to part 70, and the 1-year time period for submittal of permit applications by subject sources would begin upon EPA's final rulemaking granting interim approval, as would the 3-year time period for processing initial permit applications.

Following final interim approval, if Antelope Valley should fail to submit a complete corrective program for full approval by the date 6 months before expiration of the interim approval, EPA would start an 18-month clock for mandatory sanctions. Then, if Antelope Valley should fail to submit a corrective program that EPA found complete before the expiration of that 18-month period, EPA would be required to apply one of the sanctions in section 179(b) of the Act, which would remain in effect until EPA determined that the District has corrected the deficiency by submitting a complete corrective program. If, six months after application of the first sanction, the Antelope Valley still had not submitted a corrective program that EPA found complete, a second sanction would be required.

If, following final interim approval, EPA were to disapprove Antelope Valley's complete corrective program, EPA would be required to apply one of the section 179(b) sanctions on the date 18 months after the effective date of the disapproval unless prior to that date the District submitted a revised program and EPA determined that it corrected the deficiencies that prompted the disapproval. Again, if, six months after EPA applied the first sanction, Antelope Valley had not submitted a revised program that EPA determined corrected the deficiencies, a second sanction would be required. In addition, discretionary sanctions may be applied where warranted any time after the end of an interim approval period if a state or district has not submitted a timely and complete corrective program or EPA has disapproved a submitted corrective program. Moreover, if EPA has not granted full approval to a state or district program by the expiration of an interim approval, EPA must promulgate, administer and enforce a federal permits program for that state or district upon interim approval expiration.

EPA has decided that it is not reasonable to expect the states and districts to implement section 112(g) before a rule is issued. EPA therefore published an interpretive document in the Federal Register regarding section 112(g) of the Act: 60 FR 8333 (February 14, 1995). This document outlines EPA's revised interpretation of 112(g) applicability prior to EPA's issuing the final 112(g) rule. The document states that major source modifications, constructions, and reconstructions will not be subject to 112(g) requirements until the final rule is promulgated.

The document further explains that EPA is considering whether the effective date of section 112(g) should be delayed beyond the date of promulgation of the Federal rule so as to allow States and Districts time to adopt rules implementing the Federal rule, and that EPA will provide for any such additional delay in the final section 112(g) rulemaking. Unless and until EPA provides for such an additional postponement of section 112(g), Antelope Valley must be able to implement section 112(g) during the period between promulgation of the Federal section 112(g) rule and adoption of implementing District regulations. For this reason, EPA is proposing to approve the use of Antelope Valley's preconstruction review programs as a mechanism to implement section 112(g) during the transition period between promulgation of the section 112(g) rule and adoption by the nineteen districts of rules specifically designed to implement section 112(g). However, since approval is intended solely to confirm that Antelope Valley has a mechanism to implement section 112(g) during the transition period, the approval itself will be without effect if EPA decides in the final section 112(g) rule that there will be no transition period. The EPA is limiting the duration of its approval of the use of preconstruction programs to implement 112(g) to 12 months following promulgation by EPA of the section 112(g) rule.

Requirements for part 70 program approval, specified in 40 CFR 70.4(b), encompass section 112(l)(5) requirements for approval of a program for delegation of section 112 standards as promulgated by EPA as they apply to part 70 sources. Section 112(l)(5) requires that the District's program contain adequate authorities, adequate resources for implementation, and an expeditious compliance schedule, which are also requirements under part 70. Therefore, the EPA is also proposing to grant approval under section 112(l)(5) and 40 CFR 63.91 of Antelope Valley's program for receiving delegation of section 112 standards that are unchanged from the federal standards as promulgated. California Health and Safety Code section 39658 provides for automatic adoption by CARB of section 112 standards upon promulgation by EPA. Section 39666 of the Health and Safety Code requires that districts then implement and enforce these standards. Thus, when section 112 standards are automatically adopted pursuant to section 39658, Antelope Valley will have the authority necessary to accept delegation of these standards without further regulatory action by the District.

On March 31, 1995, CARB submitted for approval into the Antelope Valley's portion of the California State Implementation Plan (SIP) a local operating permit program designed to create federally enforceable limits on a source's potential to emit. This District program is referred to as a synthetic minor operating permit program, and it consists of regulations that will be integrated with the District's existing, non-federally enforceable, operating permit program. Such programs are also referred to as federally enforceable state operating permit (FESOP) programs. This synthetic minor or FESOP mechanism will allow sources to reduce their potential to emit to below the title V applicability thresholds and avoid being subject to title V.

Antelope Valley's synthetic minor regulations were adopted on March 17, 1998 and codified in Rule 225 (Federal Operating Permit Requirement). EPA found the initial SIP submittal administratively complete by default.

The five criteria for approving a state operating permit program into a SIP were set forth in the June 28, 1989 Federal Register notice (54 FR 27282): (1) The program must be submitted to and approved by EPA; (2) the program must impose a legal obligation on the operating permit holders to comply with the terms and conditions of the permit, and permits that do not conform with the June 28, 1989 criteria shall be deemed not federally enforceable; (3) the program must contain terms and conditions that are at least as stringent as any requirements contained in the SIP or enforceable under the SIP or any other section 112 or other Clean Air Act standard or requirement; (4) permits issued under the program must contain conditions that are permanent, quantifiable, and enforceable as a practical matter; and (5) permits issued under the program must be subject to public participation.

Permits issued under an approved program are federally enforceable and may be used to limit the potential to emit of sources of criteria pollutants. Antelope Valley's synthetic minor provisions of Rule 225 meet the June 28, 1989 criteria by ensuring that the limits will be permanent, quantifiable, and practically enforceable and by providing adequate notice and comment to EPA and the public. Therefore, EPA is proposing to approve, pursuant to part 52 and the approval criteria specified in the June 28, 1989 Federal Register notice, Rule 225 (Federal Operating Permit Requirement), which was submitted to create the synthetic minor operating permit program. Please refer to the Technical Support Document for a thorough analysis of the June 28, 1989 criteria as applied to the Antelope Valley's syntheticminor program.

On November 10, 1999, Antelope Valley requested approval of its synthetic minor program, consisting of the rule specified above, under section 112(l) of the Act for the purpose of creating federally enforceable limitations on the potential to emit of hazardous air pollutants (HAPs). The separate request for approval under section 112(l) is necessary because the proposed SIP approval discussed above only provides a mechanism for controlling criteria pollutants. While federally enforceable limits on criteria pollutants ( i.e., VOCs or PM-10) may have the incidental effect of limiting certain HAPs listed pursuant to section 112(b), 1 section 112 of the Act provides the underlying authority for controlling HAPs emissions that are not criteria pollutants. As a legal matter, no additional program approval by EPA is required in order for these criteria pollutant limits to be recognized as federally enforceable. EPA has determined that the five approval criteria for approving FESOP programs into the SIP, as specified in the June 28, 1989 Federal Register notice, are also appropriate for evaluating and approving the programs under section 112(l). The June 28, 1989 notice does not address HAPs because it was written prior to the 1990 amendments to section 112 (which injected the concept of major HAPs sources versus non-major or area HAPs sources into the permit) and not because it establishes requirements unique to criteria pollutants. Hence, the five criteria outlined above are applicable to FESOP approvals under section 112(l).

In addition to meeting the criteria in the June 28, 1989 notice, a FESOP program that will control HAPs emissions must meet the statutory criteria for approval under section 112(l)(5). Section 112(l)(5) allows EPA to approve a program only if it: (l) contains adequate authority to assure compliance with any section 112 standard or requirement; (2) provides for adequate resources; (3) provides for an expeditious schedule for assuring compliance with section 112 requirements; and (4) is otherwise likely to satisfy the objectives of the Act.

The EPA plans to codify the approval criteria for programs limiting potential to emit of HAPs in subpart E of part 63 (subpart E), the regulations promulgated to implement section 112(l) of the Act. The EPA currently anticipates that these criteria, as they apply to FESOP programs controlling HAPs, will mirror those set forth in the June 28, 1989 document, with the addition that the state's authority must extend to all HAPs, instead of, or in addition to, VOCs and PM-10. The EPA currently anticipates that FESOP programs that are approved pursuant to section 112(l) prior to the subpart E revisions will have had to meet these criteria, and hence, will not be subject to any further approval action.

The EPA believes it has authority under section 112(l) to approve programs to limit potential to emit of HAPs directly under section 112(l) prior to this revision to subpart E. Section 112(l)(5) requires EPA to disapprove programs that are inconsistent with guidance required to be issued under section 112(l)(2). This might be read to suggest that the “guidance” referred to in section 112(l)(2) was intended to be a binding rule. Even under this interpretation, the EPA does not believe that section 112(l) requires this rulemaking to be comprehensive. That is, it need not address all instances of approval under section 112(l). Given the severe timing problems posed by impending deadlines set forth in MACT standards and for submittal of title V applications, EPA believes it is reasonable to read section 112(l) to allow for approval of programs to limit potential to emit prior to issuance of a rule specifically addressing this issue.

EPA proposes approval of Antelope Valley's synthetic minor program pursuant to section 112(l) because the program meets all of the approval criteria specified in the June 28, 1989 Federal Register notice and in section 112(l)(5) of the Act. Please refer to the Technical Support Document for a complete discussion of how the June 28, 1989 criteria are met by Antelope Valley. Regarding the statutory criteria of section 112(l)(5) referred to above, the EPA believes Antelope Valley's synthetic minor program contains adequate authority to assure compliance with section 112 requirements since the third criterion of the June 28, 1989 notice is met: The program does not provide for waiving any section 112 requirement. Sources would still be required to meet section 112 requirements applicable to non-major sources. Furthermore, EPA believes that Antelope Valley's synthetic minor program provides for an expeditious schedule for assuring compliance because it allows a source to establish a voluntary limit on potential to emit and avoid being subject to a federal Clean Air Act requirement applicable on a particular date. Nothing in Antelope Valley's program would allow a source to avoid or delay compliance with a federal requirement if it fails to obtain the appropriate federally enforceable limit by the relevant deadline. Finally, Antelope Valley's synthetic minor program is consistent with the objectives of the section 112 program because its purpose is to enable sources to obtain federally enforceable limits on potential to emit to avoid major source classification under section 112. The EPA believes this purpose is consistent with the overall intent of section 112, which is to decrease the amount of HAPs being emitted; by committing to stay below a certain emission level for HAPs, a source with a synthetic minor permit is achieving this goal.

The EPA is requesting comments on all aspects of this proposed interim approval. Copies of Antelope Valley's submittal and other information relied upon for the proposed interim approval are contained in a docket maintained at the EPA Regional Office. The docket is an organized and complete file of all the information submitted to, or otherwise considered by, EPA in the development of this proposed interim approval. The principal purposes of the docket are:

(1) To allow interested parties a means to identify and locate documents so that they can effectively participate in the approval process, and

(2) To serve as the record in case of judicial review. The EPA will consider any comments received by May 1, 2000.

The Office of Management and Budget (OMB) has exempted this regulatory action from Executive Order 12866, Regulatory Planning and Review.

Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999), revokes and replaces Executive Orders 12612, Federalism, and 12875, Enhancing the Intergovernmental Partnership. Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” Under 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.

This proposed rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it merely approves a state rule implementing a federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. Thus, the requirements of section 6 of the Executive Order do not apply to this rule.

Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), applies to any rule that: (1) is determined to be “economically significant” as defined under Executive Order 12866, and (2) concerns an environmental health or safety risk that EPA has reason to believe may have 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 by the Agency. This rule is not subject to Executive Order 13045 because it is does not involve decisions intended to mitigate environmental health or safety risks.

Under Executive Order 13084, Consultation and Coordination with Indian Tribal Governments, EPA may not issue a regulation that is not required by statute, that significantly or uniquely affects the communities of Indian tribal governments, and that imposes substantial direct compliance costs on those communities, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by the tribal governments, or EPA consults with those governments. If EPA complies by consulting, Executive Order 13084 requires EPA to provide to the Office of Management and Budget, in a separately identified section of the preamble to the rule, a description of the extent of EPA's prior consultation with representatives of affected tribal governments, a summary of the nature of their concerns, and a statement supporting the need to issue the regulation. In addition, Executive Order 13084 requires EPA to develop an effective process permitting elected officials and other representatives of Indian tribal governments “to provide meaningful and timely input in the development of regulatory policies on matters that significantly or uniquely affect their communities.” Today's rule does not significantly or uniquely affect the communities of Indian tribal governments. Accordingly, the requirements of section 3(b) of Executive Order 13084 do not apply to this rule.

The Regulatory Flexibility Act (RFA) generally requires an agency to conduct a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements 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 not-for-profit enterprises, and small governmental jurisdictions. This final rule will not have a significant impact on a substantial number of small entities because SIP approvals under section 110 and subchapter I, part D of the Clean Air Act do not create any new requirements but simply approve requirements that the State is already imposing. Therefore, because the Federal SIP approval does not create any new requirements, I certify that this action will not have a significant economic impact on a substantial number of small entities. Moreover, due to the nature of the Federal-State relationship under the Clean Air Act, preparation of flexibility analysis would constitute Federal inquiry into the economic reasonableness of state action. The Clean Air Act forbids EPA to base its actions concerning SIPs on such grounds. Union Electric Co., v. U.S. EPA, 427 U.S. 246, 255-66 (1976); 42 U.S.C. 7410(a)(2).

Under section 202 of the Unfunded Mandates Reform Act of 1995 (“Unfunded Mandates Act”), signed into law on March 22, 1995, EPA must prepare a budgetary impact statement to accompany any proposed or final rule that includes a Federal mandate that may result in estimated annual costs to State, local, or tribal governments in the aggregate; or to private sector, of $100 million or more. Under section 205, EPA must select the most cost-effective and least burdensome alternative that achieves the objectives of the rule and is consistent with statutory requirements. Section 203 requires EPA to establish a plan for informing and advising any small governments that may be significantly or uniquely impacted by the rule.

EPA has determined that the approval action promulgated does not include a Federal mandate that may result in estimated annual costs of $100 million or more to either State, local, or tribal governments in the aggregate, or to the private sector. This Federal action approves pre-existing requirements under State or local law, and imposes no new requirements. Accordingly, no additional costs to State, local, or tribal governments, or to the private sector, result from this action.

Environmental protection, Administrative practice and procedure, Air pollution control, Hazardous substances, Intergovernmental relations, Operating permits, Reporting and recordkeeping requirements.

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

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

1. Electronically . You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/. To access this document, on the Home Page select “Laws and Regulations” and then look up the entry for this document under the “ Federal Register —Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/.

2. In person. The Agency has established an official record for this action under docket control number OPP-300985. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPP-300985 in the subject line on the first page of your response.

1. By mail. Submit your comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 20460.

2. In person or by courier . Deliver your comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. The PIRIB is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

3. Electronically. You may submit your comments electronically by e-mail to: “opp-docket@epa.gov,” or you can submit a computer disk as described above. Do not submit any information electronically that you consider to be CBI. Avoid the use of special characters and any form of encryption. Electronic submissions will be accepted in WordPerfect 6.1/8.0 or ASCII file format. All comments in electronic form must be identified by docket control number OPP-300985. Electronic comments may also be filed online at many Federal Depository Libraries.

Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT.

You may find the following suggestions helpful for preparing your comments:

1. Explain your views as clearly as possible.

2. Describe any assumptions that you used.

3. Provide copies of any technical information and/or data you used that support your views.

4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide.

5. Provide specific examples to illustrate your concerns.

6. Offer alternative ways to improve the proposed rule or collection activity.

7. Make sure to submit your comments by the deadline in this document.

8. To ensure proper receipt by EPA, be sure to identify the docket control number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

EPA is proposing to revoke specific meat, milk, poultry and egg tolerances for residues of fenthion, methidathion, naled, phorate, and profenofos because the Agency has concluded that there is no reasonable expectation of finite residues in or on the commodities associated with those tolerances.

The determinations to revoke the tolerances listed in this document were made based on feeding studies submitted since the time that the tolerances were originally established. These feeding studies used exaggerated amounts of the compound (10x the dietary burden) and did not show measurable residues of the pesticides tested. Because there is no reasonable expectation of finite residues, these 67 tolerances are not required under the FFDCA and can be revoked. The Agency originally made the determination that there is no reasonable expectation of finite residues on fenthion, methidathion, naled, phorate, or profenophos for the 67 commodities listed below on July 11, 1999. EPA published a notice in the Federal Register on August 2, 1999 (64 FR 41933) (FRL-6097-3) that these 67 tolerances were considered reassessed and had already been counted toward meeting the tolerance reassessment requirements listed in FFDCA section 408(q).

1. Fenthion . EPA is proposing to revoke the tolerances in 40 CFR 180.214 for residues of fenthion in or on poultry, fat; poultry, meat byproducts (mbyp); and poultry, meat. In 40 CFR 180.214, EPA is also proposing to remove the “N” designation from all entries to conform to current Agency administrative practice ( “N” designation means negligible residues).

2. Methidathion . EPA is proposing to revoke the tolerances in 40 CFR 180.298 for residues of methidathion in or on cattle, fat; cattle, mbyp; cattle, meat; goats, fat; goats, mbyp; goats, meat; hogs, fat; hogs, mbyp; hogs, meat; horses, fat; horses, mbyp; horses, meat; poultry, fat; poultry, mbyp; poultry, meat; sheep, fat; sheep, mbyp; sheep, meat; milk; and eggs. In 40 CFR 180.298, EPA is also proposing to remove the “N” designation from all entries to conform to current Agency administrative practice.

3. Naled . EPA is proposing to revoke the tolerances in 40 CFR 180.215 for residues of naled in or on cattle, fat; cattle, mbyp; cattle, meat; goats, fat; goats, mbyp; goats, meat; hogs, fat; hogs, mbyp; hogs, meat; horses, fat; horses, mbyp; horses, meat; poultry, fat; poultry, mbyp; poultry, meat; sheep, fat; sheep, mbyp; sheep, meat; milk; and eggs.

4. Phorate . EPA is proposing to revoke the tolerances in 40 CFR 180.206 for residues of phorate in or on cattle, fat; cattle, mbyp; cattle, meat; goats, fat; goats, mbyp; goats, meat; hogs, fat; hogs, mbyp; hogs, meat; horses, fat; horses, mbyp; horses, meat; poultry, fat; poultry, mbyp; poultry, meat; sheep, fat; sheep, mbyp; sheep, meat; milk; and eggs.

5. Profenofos . EPA is proposing to revoke the tolerances in 40 CFR 180.404 for residues of profenofos in or on poultry, fat; poultry, mbyp; poultry, meat; and eggs.

A “tolerance” represents the maximum level for residues of pesticide chemicals legally allowed in or on raw agricultural commodities and processed foods. Section 408 of FFDCA, 21 U.S.C. 301 et seq ., as amended by the FQPA of 1996, Public Law 104-170, authorizes the establishment of tolerances, exemptions from tolerance requirements, modifications in tolerances, and revocation of tolerances for residues of pesticide chemicals in or on raw agricultural commodities and processed foods (21 U.S.C. 346(a)). Without a tolerance or exemption, food containing pesticide residues is considered to be unsafe and therefore “adulterated” under section 402(a) of the FFDCA. If food containing pesticide residues is considered to be “adulterated,” you may not distribute the product in interstate commerce (21 U.S.C. 331(a) and 342(a)). For a food-use pesticide to be sold and distributed, the pesticide must be registered under FIFRA (7 U.S.C. et seq .) Food-use pesticides not registered in the United States have tolerances for residues of pesticides in or on commodities imported into the United States.

When EPA establishes tolerances for pesticide residues in or on raw agricultural commodities, consideration must be given to the possible residues of those chemicals in meat, milk, poultry, and/or eggs produced by animals that are fed agricultural products (for example, grain or hay) containing pesticide residues (40 CFR 180.6). When considering this possibility, EPA can conclude that:

1. Finite residues will exist in meat, milk, poultry and/or eggs.

2. There is a reasonable expectation that finite residues will exist.

3. There is a reasonable expectation that finite residues will not exist. If there is no reasonable expectation of finite pesticide residues in or on meat, milk, poultry, or eggs, tolerances do not need to be established for these commodities (40 CFR 180.6(b) and 40 CFR 180.6(c)).

EPA has evaluated the meat, milk, poultry, and egg tolerances listed in the table in this proposed rule and has concluded that there is no reasonable expectation of finite residues of the listed organophosphate pesticides in or on those commodities.

EPA is proposing that these actions become effective 90 days following publication of a final rule in the Federal Register . EPA has proposed delaying the effectiveness of these revocations for 90 days following the publication of a final rule to ensure that all affected parties receive notice of EPA's actions. If you have comments regarding the effective date, please submit comments as described under the SUPPLEMENTARY INFORMATION section of this document.

By law, EPA is required to reassess 66% or about 6,400 of the tolerances in existence on August 2, 1996, by August 2002. EPA is also required to assess the remaining tolerances by August 2006. As of February 1, 2000, EPA has reassessed 3,430 tolerances. While this document proposes to revoke 67 tolerances, those 67 tolerances have been previously counted as reassessed and none are counted here toward the August 2002 review deadline of FFDCA section 408(q), as amended by FQPA in 1996.

The tolerance revocations in this proposal are not discriminatory. EPA has evaluated the meat, milk, poultry, and egg tolerances listed in the table in the regulatory text and has concluded that there is no reasonable expectation of finite residues of the listed organophosphate pesticides in or on those commodities, whether domestic or imported.

EPA is working to ensure that the U.S. tolerance reassessment program under FQPA does not disrupt international trade. EPA considers Codex Maximum Residue Limits (MRLs) in setting U.S. tolerances and in reassessing them. MRLs are established by the Codex Committee on Pesticide Residues, a committee within the Codex Alimentarius Commission, an international organization formed to promote the coordination of international food standards. It is EPA's policy to harmonize U.S. tolerances with Codex MRLs to the extent possible, provided that the MRLs achieve the level of protection required under FFDCA. EPA's effort to harmonize with Codex MRLs is summarized in the tolerance reassessment section of individual Reregistration Eligibility Decision documents.

In this document, EPA is proposing to revoke specific meat, milk, poultry, and egg tolerances established under FFDCA section 408. The Office of Management and Budget (OMB) has exempted this type of action, i.e., a tolerance revocation for which extraordinary circumstances do not exist, from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq ., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any prior consultation as specified by Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments (63 FR 27655, May 19, 1998); special considerations as required by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or require OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq .), the Agency previously assessed whether revocations of tolerances might significantly impact a substantial number of small entities and concluded that, as a general matter, these actions do not impose a significant economic impact on a substantial number of small entities. The factual basis and the Agency's certification under section 605(b) for tolerance revocations published on December 17, 1997 (62 FR 66020), and was provided to the Chief Counsel for Advocacy of the Small Business Administration. Since no extraordinary circumstances exist as to the present revocation that would change EPA's previous analysis, the Agency is able to reference the general certification. Any comments about the Agency's determination should be submitted to EPA along with comments on the proposal, and will be addressed prior to issuing a final rule.

In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4).

Therefore, it is proposed that 40 CFR part 180 be amended as follows:

Section 102(c) of the Marine Protection, Research, and Sanctuaries Act of 1972 (MPRSA), as amended, 33 U.S.C. 1403 et seq. , gives the Administrator the authority to designate sites where ocean dumping may be permitted. On October 1, 1986, the Administrator delegated the authority to designate ocean dumping sites to the Regional Administrator of the Region in which the site is located. This site designation is being made persuant to that authority.

The EPA Ocean Dumping Regulations (40 CFR Chapter I, subchapter H, section § 228.4) state that ocean dumping sites will be designated by publication in part 228. A list of “Approved and Final Ocean Dumping Sites” was published on January 11, 1977 (42 FR 2461 et seq. ) and was last updated on July 1, 1999 (40 CFR 228.15(n)(2), (n)(3), and (n)(4)). A total of three ocean dumping sites off of Coos Bay (Site E, Site F, and site H) were designated in 1986 ( 51 FR 29927 et seq. ). This proposed rule designates a new Site F which incorporates the 1986-designated Site F but appreciably expands it. Interested persons may participate in this proposed rulemaking by submitting written comments within 45 days of the date of this publication to the address given above.

Section 102(c) of the National Environmental Policy Act of 1969, 42 U.S.C. 4321 et seq. , (NEPA) requires that Federal agencies prepare an Environmental Impact Statement (EIS) on proposals for legislation and other major Federal actions significantly affecting the quality of the human environment. The object of NEPA is to build into agency decision-making processes careful consideration of all environmental aspects of proposed actions.

The U.S. Army Corps of Engineers (Corps) has prepared the Feasibility Report on Navigation Improvements with Environmental Impact Statement (1994) (Channel Deepening) for Coos Bay, Oregon, with the EPA Region 10 as a cooperating agency in the EIS preparation. The action discussed in the EIS is the designation of a larger Site F for ocean disposal of dredged material. The other two sites (E and H) are not affected by this rule. The purpose of the designation is to provide an environmentally acceptable location for ocean disposal of dredged material. The appropriateness of ocean disposal is determined on a case-by-case basis as part of the process of issuing permits for ocean disposal.

Existing Site F was designated in 1986 and in 1989 the area available for disposal of dredged material was doubled by the Corps using its section 103 authority of the MPRSA. The expansion was to the north to prevent excessive mounding and to reduce potential sediment transport back into the entrance channel. In 1995 Site F was again expanded by the Corps in order to accommodate less than anticipated sediment dispersion and to prevent excessive mounding. The size and location of Site F herein proposed for final designation is the same as that established by the Corps 103 action in 1995.

The EIS provides documentation to support final designation of a larger Site F as an ocean dredged material disposal site (ODMDS) for continuing use. Site designation studies were conducted by the Portland District, Corps of Engineers, in consultation with EPA, Region 10. The ODMDS site proposed for designation is located in the area best suited for dredged material disposal in terms of environmental and navigational safety factors. No significant or long-term adverse environmental effects are predicted to result from the designation. The designated ODMDS would continue to receive sediments dredged by the Corps to maintain the federally authorized navigation project at Coos Bay, Oregon, and for disposal of material dredged during other actions authorized in accordance with section 103 of the MPRSA. Before any disposal may occur, a specific evaluation by the Corps must be made using EPA's ocean dumping criteria. EPA makes an independent evaluation of the proposal and can disapprove the actual disposal.

The studies and final designation process are being conducted in accordance with the MPRSA, the Ocean Dumping Regulations, and other applicable federal environmental legislation.

The center of the proposed site is located approximately 1.6 miles offshore with an east-west site dimension of 14,500 feet and a north-south site dimension of 8,000 feet (Figure 1.) The coordinates of the site are as follows (NAD 83):

If at any time disposal operations at the site cause unacceptable adverse impacts, further use of the site will be restricted or terminated.

Five general criteria are used in the selection and approval of ocean disposal sites for continuing use. Sites are selected so as to minimize interference with other marine activities, to keep any temporary perturbations from the dumping from causing impacts outside the disposal site, and to permit effective monitoring to detect any adverse impacts at an early stage. Where feasible, locations off the Continental Shelf are chosen. If at any time disposal operations at a site cause unacceptable adverse impacts, the use of that site will be terminated as soon as suitable alternate sites can be designated. The general criteria are given in 40 CFR 228.5 of the EPA Ocean Dumping Regulations. Eleven specific criteria, given in 40 CFR 228.6, are used in evaluating a proposed disposal site to assure that the general criteria are met. The evaluations of the general and specific criteria, given below, are based on information published in the site designation EIS, monitoring studies, and the Channel Deepening EIS.

The location of proposed ODMDS F is based on reasonable distance from the Coos Bay entrance, depth of water, biological conditions, historical use, and estimated amount and type of dredged material. Disposal activities are not expected to result in more than minimal interference with the typical marine activities such as navigation and commercial and recreational fishing. Use of the nearshore portion could conflict with crab fishing, but timing of disposal to occur after the season closes minimizes interference.

The material to be disposed consists of clean sand and silt. As described in the EIS, sediment test results indicate this material is suitable for ocean disposal. Testing and evaluation of material proposed for disposal would occur as necessary to insure suitability.

Not applicable; the existing Site F was designated on an interim basis in 1977 and received final designation status in 1986. The site did not have sufficient capacity to meet long-term need without mounding, leading to the need for an expanded site.

The size of the designated Site F has proven to be inadequate. By the Corps' Section 103 authority, Site F was twice expanded (1989 and 1995) to its presently proposed dimensions to limit mound development caused by inadequate sediment dispersion. The enlarged Site F proposed for designation is anticipated to adequately accommodate disposal of current and future maintenance dredging by using a larger placement area and by using the more active nearshore dispersal areas.

Such sites were eliminated during site evaluation for the 1986 site designation EIS. Conditions have not changed to offer any environmental advantage to the use of a site off the continental shelf. Transportation costs, sampling and testing costs, and post-disposal monitoring costs associated with disposal at a continental shelf site would greatly increase over present costs. In addition, there is greater uncertainty over impacts associated with continental shelf disposal, compared to disposal at existing sites which are known low impact areas. Therefore, disposal at a site off the continental shelf is not considered necessary or practical.

Transporting dredged material off the continental shelf presents potentially significant environmental concerns. Benthic and pelagic ecosystems near the shelf contain important fishery resources and the effects of disposal operations on them are not well understood. Fine-grained sediment and rocky habitats would be directly impacted by disposal. These deep-water areas are stable and generally not disturbed by wave action or sediment movement. Consequently, the benthic invertebrate communities in these deep, offshore environments are adapted to very stable conditions and would be less able to survive disturbance from the immediate impact of disposal and the long-term alteration of substrate type. Little is known of the ecology of benthic communities on the continental slope; however, disposal onto those communities would cause severe and long-term impacts. Bottom gradients can be 5 to 25 percent on the continental slope, making accumulated unconsolidated sediments susceptible to slumping. Deposited sediments could be transported long distances downslope as turbidity currents and offshore by near-bottom currents, potentially affecting organisms outside of any designated site.

The cost for site evaluation necessary to designate a site and subsequent baseline and monitoring, along with unanswered environmental concerns about the effects of disposal in such areas, makes off-shelf disposal undesirable as well as infeasible. Further, disposal off the continental shelf would remove natural sediments from the nearshore littoral transport system, a system that functions with largely non-renewable quantities of sand.

The proposed site lies in 20 to 160 feet (6 to 51 m) of water, approximately 1.6 miles offshore with an east-west dimension of 14,500 feet and a north-south dimension of 8,000 feet. Coordinates are (NAD 83):

In general, bottom contours of the proposed site slope at a rate of 10/1000 feet to the WNW.

Sediments in proposed Site F and adjoining areas are clean fine sands of marine origin with median grain diameters of 0.15 to 0.20 millimeters.

Aquatic resources of the proposed Site F are described in detail in the EISs (1986, 1994). The inshore high-dispersive area (depth to 15 meters) are populated by species tolerant of a high energy wave environment that are adapted to continued disturbance. Deeper areas are generally less dispersive and are populated by species generally less adapted to continued disturbance. Most organisms display seasonal changes of abundance typical of coastal Oregon and Pacific Northwest waters.

Based on analyses of benthic samples, proposed Site F and vicinity contains benthic fauna characteristic of oceanic coastal Pacific Northwest environs. By utilizing the more dispersive shallower areas and, when appropriate, deeper areas of the proposed site, the disturbance or burial of benthic organisms would be minimized. Various management options described in the site Management and Monitoring plan (SMMP) over a larger site area would further avoid or minimize these impacts. Most organisms and communities which are adapted to a higher energy environment tend to recolonize quickly following the disposal operation. No unique biological communities would be impacted.

The dominant commercially and recreationally important macroinvertebrate species in the coastal area are shellfish, Dungeness crab and shrimp. A variety of demersal and pelagic fish species are present. Common demersal fish are flatfish, sole, and smelt. Anadromous salmon, herring, and anchovy are representative of pelagic fishes present in the coastal waters.

The proposed Site F is in an area where numerous species of birds and marine animals occur in the pelagic nearshore and shoreline habitats.

In summary, the proposed ODMDS contains living resources that could be affected by disposal activities. However, evaluation of past disposal activities does not indicate that unacceptable adverse effects to these resources have occurred. Appropriate future management should minimize the potential of adverse impacts and make this proposed site acceptable for final designation.

The nearshore limit of proposed Site F is located within 2000 feet of the shoreline. Sediments disposed near that site boundary would be in an active transport zone and would disperse rapidly both onshore and alongshore. Limited onshore transport would be expected due to the nature of currents and wave transport in that vicinity. Proper management could detect any onshore effects and modify disposal actions accordingly. Placement in the nearshore could help to reduce erosion on the beach near the Coos Bay North Jetty.

For purposes of maintaining the existing federal channel, an average of approximately 1.38 million cubic yards (cy) of sediment is annually dredged from the estuary and placed in designated ODMDSs (Sites F and H) offshore of the entrance to Coos Bay. About half is classified as sand and the remainder as fine-grained material (silt). In the recent past the fine-grained material has been disposed at Site H and the sand at Site F although both sites have been designated to receive sand and silt. Since the recent channel deepening, Site H has shown evidence of mounding and its long-term viability to receive significant disposal volumes, without exceeding site boundaries, is being analyzed. Whether expansion of Site H, a shift to greater reliance on proposed Site F, or another management option is appropriate, is presently being studied.

For the present, proposed disposal site F will receive dredged materials transported by either government or private contractor hopper dredges or ocean-going barges. The dredges typically release dredged material while moving slowly through the disposal site. Mounding should be minimized by dispersing the disposal in such a manner and by placing material in both the nearshore and the offshore part of the proposed site, as appropriate.

Small quantities of non-Federal material are annually disposed at site F or H in accordance with Department of the Army permits. These disposals are determined to comply with the ocean dumping criteria.

Surveillance of the proposed disposal site can be made from shore facilities or vessels. Approaches to the Coos Bay entrance, including the disposal area, are surveyed annually by the Corps. Surveillance during heavy weather conditions is expected to be unnecessary since heavy sea conditions curtail ocean disposal operations.

The Corps and EPA have developed a site management plan which addresses post-disposal monitoring.

Average currents in the region generally flow parallel to the bathymetric contours with downslope components predominating over upslope components near the bottom. Local current strength and direction, however, reflect the variability of local winds. During disposal operations in the summer months the predominant direction of material transport is southward, but with a stronger northward component the remainder of the year. At proposed site F dispersal characteristics range greatly depending on depth; the nearshore areas are very dispersive whereas dispersion in the offshore areas is minimal.

Disposal at designated Site F has resulted in significant mounding, as much as 20 feet by 1989, and in the Corps' 103 expanded Site F (1989) as much as 24 feet by 1994. No material from the Federal navigation project has been disposed in the designated Site F and the 1989 expansion area since 1994. Dredged material from other dredging has been placed at the EPA designated site under Department of the Army permits. Material dredged from the Federal navigation project has been managed since 1995 by placement further offshore, nearshore, and to the north within the area of the presently proposed for designation. Material placed into the nearshore portion of the proposed site has moved out between dredging cycles.

No significant biological impacts have been associated with any disposal at the Coos Bay sites.

The only known commercial and recreational uses occurring in the vicinity of proposed Site F are fishing and marine navigation. No significant impact to these activities has occurred in the past or is anticipated for the future. Commercial crabbing occurs in the area, especially in the nearshore portion. Timing of disposal in that portion has been scheduled to occur after the crabbing season has closed to minimize interference.

Water and sediment quality analyses conducted in the study area and experience with past disposals in this region have not identified any adverse water quality impacts from ocean disposal of dredged material.

The ecology of the offshore area is a Northeast Pacific mobile sand community. This determination is based mainly on fisheries and benthic data. Neither the pelagic or benthic communities should sustain irreparable harm due to their mobility and widespread occurrence off the Oregon coast.

Nuisance species are considered as any undesirable organism not previously existing at the disposal site. They are either transported to or recruited to the site because the disposal of dredged material created an environment where they could establish. The major component of dredged material which might attract nuisance species is the organic material. The only material containing any appreciable amounts of organic material is that dredged between RM 12 and 15. This material has historically been disposed at Site H. No nuisance species have been observed at this site in more than 10 years of monitoring.

The cutural resource most likely to be directly impacted by the proposed project would be submerged shipwrecks at or near proposed Site F. Potential impacts may include exposure and destruction of remnants of shipwrecks if present in the location of areas scheduled for dredging or impacts from disposal at the disposal site. Proposed Site F and vicinity has been investigated and no shipwrecks have been found.

The 1994 EIS concluded that the proposed site may be appropriately designated for use. The proposed site is compatible with the general criteria and specific factors used for site evaluation.

The designation of the larger Coos Bay Site F as approved Ocean Dumping Site is being published as proposed rulemaking. Management of this site will be delegated to the Regional Administrator of EPA Region 10.

It should be emphasized that, if an ocean dumping site is designated, such a designation does not constitute or imply EPA's approval of actual disposal of material at sea. Before ocean dumping of dredged material at the site may commence, the Corps of Engineers must evaluate the proposed Corps action or a permit application according to EPA's ocean dumping criteria. EPA has the right to disapprove the actual dumping, if it determines that environmental concerns under MPRSA have not been met.

The designation of proposed Site F has been determined by the Corps and EPA to be consistent with the acknowledged local comprehensive plans and the State of Oregon Coastal Zone Management Program. The State of Oregon, Department of Land Conservation and Development, reviewed this consistency determination and concurred (1994 EIS).

Federally listed species, under the administration of the National Marine Fishery Service (NMFS), which may occur in or near the proposed disposal site include: gray, fin, humpback, blue, sei, sperm and right whales, Steller sea lions, leatherback, loggerhead and green sea turtles, Snake River sockeye salmon, Snake River fall and spring/summer chinook salmon and Sacramanto River winter-run chinook salmon. They are normally present in offshore waters and occur in limited numbers on a seasonal basis. Biological Assessments have been prepared and concurrence letters from NMFS received.

Five Federally listed species administered by the U.S. Fish and Wildlife Service (USFWS) occur in the coastal area. Species present are the brown pelican, peregrine falcon, bald eagle, western snowy plover, and the marbled murrelet. The peregrine falcon and the bald eagle are proposed for de-listing. Biological Assessments have been prepared and concurrence received.

Under Executive Order 12866 (58 FR 51735, October 4,1993), EPA must determine whether the regulatory action is “significant”, and therefore subject to OMB review and other requirements of the Executive Order. The Order defines “significant regulatory action” as one that is likely to lead to a rule that may:

This proposed rule does not entail “significant regulatory action” as defined. Consequently EPA has determined that this proposed rule is not a “significant regulatory action” under the terms of Executive Order 12866.

Under Executive Order 13084, EPA may not issue a regulation that is not required by statute that significantly or uniquely affects the communities of Indian tribal governments, and that imposes substantial direct compliance costs on those communities, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by the tribal governments, or EPA consults with those governments. If EPA complies by consulting, Executive Order 13084 requires EPA to provide to the Office of Management and Budget in a separately identified section of the preamble to the rule, a description of the extent of EPA's prior consultation with representatives of affected tribal governments, a summary of the nature of their concerns, and a statement supporting the need to issue the regulation. In addition, Executive Order 13083 requires EPA to develop an effective process permitting elected officials and other representatives of Indian tribal governments “to provide meaningful and timely input in the development of regulatory policies on matters that significantly or uniquely affect their communities”.

This proposed rule does not significantly or uniquely affect the communities of Indian tribal governments. Tribal governments are not affected in any fashion. Accordingly, the requirements of section 3(b) of Executive Order 13084 do not apply to this rule.

Under the Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq. , as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA), federal agencies generally are required to conduct an initial regulatory flexibility analysis (IRFA) describing the impact of the regulatory action on small entities as part of a proposed rulemaking. However, under section 605(b) of the RFA, if the Administrator for the agency certifies that the proposed rule will not have a significant economic impact on a substantial number of small entities, the agency is not required to prepare an IRFA. The Administrator certifies, pursuant to section 605(b) of the RFA, that this proposed rule will not have a significant economic impact on a substantial number of small entities. Therefore, the agency did not prepare an initial regulatory flexibility analysis.

The RFA requires analysis of the impacts of a rule on the small entities subject to the rule's requirements. See United States Distribution Companies v. FERC, 88 F.3d 1105, 1170 (D.C. Cir. 1996). Today's proposed rule establishes no requirements applicable to small entities, and so is not susceptible to regulatory flexibility analysis as described by the RFA. (“No [regulatory flexibility] analysis is necessary when an agency determines that the rule will not have a significant economic impact on a substantial number of small entities that are subject to the requirements of the rule,” United Distribution at 1170, quoting Mid-Tex Elec. Co-op v. FERC , 773 F. 2d. 327, 342 (D.C. Cir. 1985) (emphasis added by United Distribution court).) The Agency is thus certifying that today's proposed rule will not have a significant economic impact on substantial number of small entities, within the meaning of the RFA.

The Paperwork Reduction Act, 44 U.S.C. 3501 et seq. , is intended to minimize the reporting and record-keeping burden on the regulated community, as well as to minimize the cost of Federal information collection and dissemination. In general, the Act requires that information requests and record-keeping requirements affecting ten or more non-Federal respondents be approved by OPM. Since the proposed Rule does not establish or modify any information or record-keeping requirements, but only clarifies existing requirements, it is not subject to the provisions of the Paperwork Reduction Act.

Title II of the Unfunded Mandates Reform Act (UMRA) of 1995 (Pub. L. 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 generally must prepare a written statement, 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 year. Before promulgating an EPA rule for which a written statement is needed, Section 205 of the UMRA generally 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 section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows EPA to adopt an alternative other than the least costly, most cost-effective or least burdensome alternative if the Administrator publishes with the final rule an explanation why the alternative was not adopted. Before EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including tribal governments, it must have developed under section 203 of the UMRA a small government agency plan. The plan must provide for notifying potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of EPA regulatory proposals with significant Federal intergovernmental mandates, and informing, educating, and advising small governments on compliance with the regulatory requirements.

This proposed rule contains no Federal mandates (under the regulatory provisions of Title II of the UMRA) for State, local or tribal governments or the private sector. It imposes no new enforceable duty on any State, local or tribal governments or the private sector. Similarly, EPA has also determined that this Rule contains no regulatory requirements that might significantly or uniquely affect small government entities. Thus, the requirements of section 203 of the UMRA do not apply to this rule.

Today's proposed rule does not create a mandate on State, local or tribal governments. The rule does not impose any enforceable duties on these entities. Accordingly, the requirements of section 1(a) of the Executive Order do not apply to this Rule.

The Executive Order applies to any rule that: (1) Is determined to be “economically significant” as defined under E.O. 12866, and (2) Concerns an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children.

EPA interprets E.O. as applying only to those regulatory actions that are based on health or safety risks, such that the analysis required under section 5-501 of the Order has the potential to influence the regulation. This proposed rule is not subject to E.O. 13045 because it is not economically significant as defined under E.O. 12866 and, further, it does not establish an environmental standard intended to mitigate health or safety risks.

To the greatest extent practicable and permitted by law, and consistent with the principles set forth in the report on the National Performance Review, each Federal agency must make achieving environmental justice part of its mission by identifying and addressing, as appropriate, disproportionately high and adverse human health and environmental effects of its programs, policies, and activities on minority populations and low-income populations in the United States and its territories and possessions, the District of Columbia, the Commonwealth of Puerto Rico, and the Commonwealth of the Mariana Islands.

Because this proposed rule addresses ocean dumping (away from inhabited land areas), with no anticipated significant adverse human health or environmental effects, the rule is not subject to Executive Order 12898.

For the reasons set out in the preamble, Chapter I of title 40 is amended as set forth below:

This is a summary of the Commission's Notice of Inquiry, ET Docket 00-47, FCC 00-103, adopted March 17, 2000, and released March 22, 2000. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC Reference Information Center, Room Cy-A257, 445 12th Street, SW, Washington, DC, and also may be purchased from the Commission's duplication contractor, International Transcription Services, Inc. (202) 857-3800, 1231 20th Street, NW, Washington, DC 20036.

1. The Commission initiated this Notice of Inquiry (“NOI”) to obtain comments from the public on a variety of issues related to software defined radios. Software defined radios could offer tremendous advantages to consumers over currently available wireless equipment. These benefits include lower cost, a greater variety of features, and the ability to adapt to multiple communication standards. They could also offer advantages to manufacturers, such as increased economies of scale in production, increased worldwide market opportunities, and a decrease in the number of devices that must be maintained in inventory. Software defined radios could expand access to broadband communications for all persons and increase competition among telecommunication service providers. Through this inquiry, we seek input to help us evaluate the current state of software defined radio technology, and to determine whether changes to the Commission's rules are necessary to facilitate the deployment of this technology. Upon review of the responses to this inquiry, we will determine whether to propose any changes to the rules.

2. Software defined radio technology was originally developed for the United States military. The “SPEAKeasy” project was undertaken by the Department of Defense with the goal of developing a multi-band, multi-mode software. The SPEAKeasy project showed that a software defined radio is feasible. Nevertheless, there are many technological hurdles that must be overcome before software defined radios can be widely deployable. For example, there are limitations on the speed and dynamic range of current analog to digital converters, physical limitations on the frequency range over which an antenna can operate, and speed and cost constraints on digital signal processing circuitry. In addition, standards that would allow interoperability between hardware and software produced by different manufacturers are still under development. Therefore, in order to assist us in understanding the current state of software defined radio technology, we seek comment in the following areas.

3. Interoperability. The Commission's rules are divided up into a number of parts that contain the requirements for various licensed radio services. The rules for each service specify the operating frequencies and other technical requirements for radio equipment in that particular service. In some cases there is overlap between these frequencies and other requirements, so equipment can be developed to operate in more than one service. However, in most cases, equipment designed to operate in one service can not communicate with equipment designed to operate in another service, and in some cases can not even communicate with other equipment in the same service due to lack of common transmission standards or operating frequencies.

4. The inability of users to communicate due to non-uniform standards within services or between services can be a serious problem. The ability of software defined radios to change frequency and transmission standards would appear to be a way to overcome the lack of interoperability between different wireless systems. We are therefore asking for comment on the following questions.

5. Improving spectrum efficiency and spectrum sharing. The Commission allocates bands of spectrum to the various radio services in the rules, and maintains a table of these frequency allocations. In order to operate within a service, a license issued by the Commission is required. The rules for each service specify eligibility requirements for obtaining a license, and the technical requirements for operation, including location, power and frequency. Licenses may be issued through an application process, or through a competitive bidding process.

6. Because of the ability to be easily reprogrammed, a software defined radio would not be limited to operation within a single fixed frequency band or on a limited set of pre-programmed channels. It could have the capability of operating on any frequency within the limits of its design, and could operate on channels of varying widths with varying modulation formats. Further, it should be possible to design the equipment with some “intelligence,” which would let it monitor the spectrum to detect usage by other parties and transmit on open frequencies. These capabilities could open up new possibilities in the area of spectrum allocation and licensing.

7. The use of software defined radios may also enable new types of spectrum sharing that are currently precluded by today's conventional equipment. For example, our PCS rules permit wide flexibility in terms of the services offered and technology employed in the PCS spectrum. In the event that a PCS licensee has spectrum available in excess of its immediate needs, it could lease that spectrum on a short-term basis to a third party. Software defined radio could facilitate such sharing. A third party could, for example, acquire from a manufacturer software defined radio equipment capable of being configured to offer different services in the various frequency ranges. Having negotiated for spectrum use, it would be in a position to rent a package of equipment and “airtime” to end users needing communications capacity on a short-term basis. It would load the appropriate software to properly configure the equipment at the time the end user enters into the rental agreement. Another alternative would be for the end user to contract directly with the licensee for the necessary spectrum and then rent the properly configured software defined radio equipment. With today's technology, such short-term sharing is difficult or impossible to accomplish due to the difficulties associated with quickly configuring radios for different applications in novel spectrum configurations. As a result, we believe that significant public benefits might flow from software defined radio technology. The public benefits include increased communications capacity for end users and better utilization of the spectrum resource. We seek comments regarding these potential benefits and what regulatory steps we might take to

8. Functions described in the NOI have the potential to allow spectrum to be utilized more efficiently. We are therefore seeking comment on the following areas related to frequency allocation and licensing.

9. Equipment approval process. Section 302 of the Communications Act of 1934, as amended, authorizes the Commission to make reasonable regulations, consistent with the public interest, governing the interference potential of equipment that emits radio frequency energy. The Commission carries out its responsibilities under this section by establishing technical regulations for transmitters and other equipment to minimize their potential for causing interference to radio services, and by administering an authorization program to ensure that equipment reaching the market complies with the technical requirements. The authorization program requires that equipment be tested either by the manufacturer or at a private test laboratory to ensure that it complies with the technical requirements. The majority of radio transmitters require the submission of an application that must be reviewed and approved before the equipment can be marketed, although certain transmitters may be authorized through a manufacturer's self-approval process.

10. A transmitter is approved to a specific set of technical parameters, including the operating frequencies, output power, and types of radio frequency emissions. If a manufacturer changes these parameters after a piece of equipment has been authorized, the FCC issues a new approval before the unit may be marketed with the changes. By design, the operating parameters of a software defined radio can be readily changed in the field by altering its software. Such a change could violate the terms of the transmitter's equipment authorization by causing it to operate in modes for which it has not been approved. Also, our rules do not allow parties other than the grantee of the equipment authorization to make modifications to approved equipment without obtaining a new approval. Even if a new approval were obtained by the original grantee, the rules require the modified transmitter to be labeled with a new FCC identification number, which would be impractical for software modification of equipment that is already in the field. We therefore seek comments on the following issues related to the authorization of software defined radio transmitters.

11. One possible scenario for an approval process for software defined radios could be as follows. The software could be tested and approved to ensure that the transmitter meets the applicable technical requirements under all operating conditions. In order to ensure that untested and unapproved software could not be loaded, such transmitters would have an authentication system that checks the software for an authentication code added to it by the FCC or a Telecommunications Certification Body (TCB). The software itself would be submitted for approval in a process similar to today's application process except that a copy of the object code would be supplied in machine-readable form. Upon approving the software application, which would involve a test of the hardware and software together similar to today's tests, the FCC or TCB would compute the authentication code for the submitted source code and send it to the applicant. The authentication system would be a two key system in which the key needed to compute the authentication code would be known to only the FCC or TCB, and the key needed to check in a transmitter object code which is being loaded would be publicly available.

12. In an analogy to the current requirement for labeling a transmitter, there may be a need for a method to allow users to determine whether the desired operating software is currently loaded in a transmitter, and to allow Commission enforcement personnel to verify that the software has been approved. To meet this need, the transmitter could display information about the software installed by a means such as a liquid crystal display (LCD) screen in response to an input from a keypad. The identification information about the software installed in the radio could include such information as the technical operating parameters, the source of the software, and the name of the body that approved it. The user manual and the authorization application would describe how to access this information. Since such radios are expected to have displays for user information and input mechanisms for the user in normal use, we do not think this requirement would be burdensome. We seek comments on the following questions about this possible approval method.

13. Other matters. The questions raised in this notice are intended to solicit information to assist the Commission in deciding whether to propose rule changes as a result of the developing software defined radio technology. We realize that these questions do not necessarily encompass all of the issues raised by this technology. Commenters may want to address whether software defined radio technology could help parties comply with Sections 255 and 251(a) of the Communications Act. These sections require manufacturers of telecommunications equipment and providers of telecommunications services to ensure that such equipment and services are accessible to persons with disabilities, if readily achievable. Commenters may also wish to address how we would enforce any new rules for software defined radios. Accordingly, comments are invited on any other matters or issues that may be pertinent to software defined radios.

This is a synopsis of the Commission's Report and Order, MM Docket No. 99-212, adopted March 8, 2000, and released March 17, 2000. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC's Reference Information Center (Room CY-A257), 445 Twelfth Street, SW., Washington, DC. The complete text of this decision may also be purchased from the Commission's copy contractor, International Transcription Service, Inc., 1231 20th Street, NW., Washington, DC 20036, (202) 857-3800.