On May 4, 1999, the Animal and Plant Health Inspection Service (APHIS) published an advance notice of proposed rulemaking (ANPR) titled “Aquaculture: Farm-Raised Fin Fish” in the Federal Register (64 FR 23795-23796, Docket No. 98-085-1). We published this ANPR after receiving petitions 1 asking us to regulate aquaculture in various ways. Many petitioners asked us to define farmed aquatic animals as livestock. In general, the petitioners seemed to be interested in receiving the same services that domestic producers of livestock receive for animals moving in interstate and foreign commerce. However, based on the petitions alone, it was difficult for us to determine what segments of the industry want services and exactly what services they want. It was also difficult to determine the objectives sought by the petitioners who were requesting Federal regulation. We published the ANPR in an attempt to clarify the industry's needs, the nature of the services sought, and the concerns the petitioners had with regard to such regulations.

We received 55 comments 2 in response to the ANPR. A majority of the commenters supported the idea of APHIS regulation of cultured fin fish. Unfortunately, the commenters generally did not clearly distinguish between fin fish raised for food and ornamental fin fish. Commenters who wanted regulation were, however, very clear that they want programs to prevent and control disease and to support increased commerce, both domestic and export.

The commenters also suggested that any rulemaking initiated by APHIS be a negotiated rulemaking. In negotiated rulemaking, industry representatives and other interested persons meet with APHIS officials and draft proposed regulations together. The proposed regulations are then published for public comment. Negotiated rulemaking is designed to ensure that all interested persons are involved together from the start in the development of regulations.

Unfortunately, negotiated rulemaking is not suitable for all situations. It works well when there is a small number of interested parties and the parties are easy to identify. This is not the case with aquaculture. Because the aquaculture industry is large and diverse, we would have difficulty identifying everyone who should be represented in a negotiated rulemaking. In addition, many parties outside aquaculture would have a substantial interest in such a rulemaking. In our view, the number of people who would need to participate in a negotiated rulemaking would be too large and would suggest that negotiated rulemaking is not appropriate. Furthermore, a negotiated rulemaking would be expensive, and APHIS does not have adequate funds. Therefore, we have concluded that it would not be appropriate to pursue an aquaculture negotiated rulemaking.

However, we have not decided whether to pursue aquaculture rulemaking by other means. Before we make that decision, we want to have as much information as possible from all interested persons, and we want to provide you with as much opportunity as possible to discuss with us and inform us regarding the relevant issues.

Therefore, we are holding a series of public meetings. Public meetings allow all interested parties—industry representatives, producers, consumers, and others—to present their views and to exchange information among themselves and with APHIS.

There are no set agendas for the meetings. Any issues and concerns related to aquaculture and possible APHIS regulatory action can be discussed. However, we would like more information on three specific issues. These are issues that the people and organizations who commented on our ANPR either did not address or were unclear about. Specifically, if APHIS does propose regulations: (1) Should our program be mandatory or voluntary; (2) should we cover shell fish; and (3) should we cover ornamental fin fish?

Information elicited at the meetings could result in a new APHIS regulatory program or in changes to aquaculture-related services currently provided by APHIS.

We have scheduled this public meeting for Thursday, October 4, 2001, at the University of Arkansas at Pine Bluff, Pine Bluff, AR. If you wish to speak at the meeting, please register in advance by calling the Regulatory Analysis and Development voice mail at (301) 734-4339. Leave a message with your name, telephone number, organization, if any, and an estimate of the time you need to speak. On the day of the meeting, you may also register from 1 to 1:30 p.m. at the meeting site. Starting with the advance registrants, we will call speakers in the order in which they registered.

The meeting will begin at 1:30 p.m. and is scheduled to end at 4 p.m. We may end the meeting early if all the registered speakers have had a chance to speak and if no one else wants to speak. We may also extend the meeting or limit the time allowed for each speaker, if necessary, so all interested persons have an opportunity to participate.

An APHIS representative will preside at the meeting. The meeting will be recorded. We encourage speakers to present written statements, though it is not required. If you choose to present a written statement, please provide the chairperson with a copy. The complete record, including the transcript and all written comments, will be available to the public.

This meeting is part of our series of public meetings. The first public meeting was held on January 25, 2001, in Lake Buena Vista, FL. The second public meeting was held on February 16, 2001, in Hebron, KY. The third public meeting was held on April 5, 2001, in Machias, ME, and the fourth public meeting was held on June 8, 2001, in Twin Falls, ID. Recently, we announced three other meetings: Washington (September 19, 2001, in conjunction with the joint meeting of the Pacific Coast Shellfish Growers Association and the National Shellfish Association/Pacific Coast Section Conference); Pennsylvania (October 9, 2001, in conjunction with the annual meetings of the Pennsylvania Aquaculture Advisory Committee and the Pennsylvania Aquaculture Association); and Mississippi (October 10, 2001, in conjunction with the annual Board meeting of the Catfish Farmers of America). On July 27, 2001, we published a notice in the Federal Register (66 FR 39134-39136, Docket No. 98-085-6) announcing the dates, times, and locations of these three meetings. Transcripts of the proceedings of each meeting are available, as we receive them, on the Internet at www.aphis.usda.gov/ppd/rad/aquaculture.html.

Additionally, to provide interested persons with as much opportunity as possible to inform us of relevant issues, we are accepting written comments mailed to the address listed at the beginning of this document under ADDRESSES.

The NACMCF was established in April 1988, in response to a recommendation in a 1985 report of the National Academy of Sciences Committee on Food Protection, Subcommittee on Microbiological Criteria, “An Evaluation of the Role of Microbiological Criteria for Foods.” The Charter for the NACMCF is available for viewing on the FSIS internet web page at http://www.fsis.usda.gov/OA/programs/nacmcf_chart.htm.

The NACMCF provides scientific advice and recommendations to the Secretary of Agriculture and the Secretary of Health and Human Services on public health issues relative to the safety and wholesomeness of the U.S. food supply including development of microbiological criteria and review and evaluation of epidemiological and risk assessment data and methodologies for assessing microbiological hazards in foods. The Committee also provides advice to the Centers for Disease Control and Prevention and the Departments of Commerce and Defense. Dr. I. Kaye Wachsmuth, Deputy Administrator, Office of Public Health and Science, FSIS, is the Committee Chair, and Janice F. Oliver, Deputy Director, Center for Food Safety and Applied Nutrition, Food and Drug Administration, is the Co-Chair.

At the September 17-20, 2001, meeting announced in this document, the Committee will

• Discuss Salmonella performance standards in meat and poultry products;

• Discuss Escherichia coli O157:H7 in blade-tenderized, non-intact beef;

• Review Codex Alimentarius Commission Draft Guidelines for the Validation of Food Hygiene Control Measures;

• Introduce the evaluation of hot holding temperatures; and

• Introduce the scientific basis for establishing safety-based “use by” date labeling for refrigerated, ready-to-eat foods.

Public awareness of all segments of rulemaking and policy development is important. Consequently, in an effort to better ensure that minorities, women, and persons with disabilities are aware of this notice, FSIS will announce it and provide copies of this Federal Register publication in the FSIS Constituent Update. FSIS provides a weekly FSIS Constituent Update, which is communicated via fax to over 300 organizations and individuals. In addition, the update is available on-line through the FSIS web page located at http://www.fsis.usda.gov. The update is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, recalls, and any other types of information that could affect or would be of interest to our constituents/stakeholders. The constituent fax list consists of industry, trade, and farm groups, consumer interest groups, allied health professionals, scientific professionals, and other individuals that have requested to be included. Through these various channels, FSIS is able to provide information to a much broader, more diverse audience. For more information and to be added to the constituent fax list, fax your request to the Congressional and Public Affairs Office, at (202) 720-5704.

On March 2, April 13, June 15, June 29, July 13, 2001 the Committee for Purchase From People Who Are Blind or Severely Disabled published notices (66 F.R.13041, 19136, 32598, 36741, 34611, 34612) of proposed additions to the Procurement List.

The following comments pertain to Microfilming, U.S. Bureau of the Census, Washington, D.C. Comments were received from a microfilming corporation. The commenter raised several issues in objecting to the Committee's proposal to add this microfilming service for the Bureau of the Census to the Procurement List.

The commenter first questioned the Committee's certification that the proposed addition to the Procurement List will not have a significant impact on a substantial number of small entities.

The commenter indicated that the proposed addition would have a severe impact on small business entities in the computer output archival microfilm industry. The commenter also indicated that this Procurement List addition would set a precedent for other Government microfilm conversion projects in the future.

The commenter did not provide any information to indicate how many small business entities would be affected by this Procurement List addition. Without this information, the Committee cannot conclude that a substantial number of small business entities would be adversely affected. Any negative impact would probably be countered by the positive impact on the two small nonprofit entities that will be performing the service. The Committee is required to conduct a separate rulemaking proceeding, including an adverse impact determination, for each Procurement List addition, so this addition cannot be a precedent for later additions.

The commenter also indicated that a fair market price for the microfilming service may only be determined by a competitive procurement. The Committee believes that its fair market pricing procedures, which include price negotiations between the Bureau of the Census and the producing nonprofit agencies, will result in a fair market price that will represent a best value to the Government.

The commenter questioned the capability of the nonprofit agencies to perform the service, noting that time is of the essence because of potential deterioration of the magnetic media in which the census information is being stored. The nonprofit agencies have been found technically capable of performing the service, and the Bureau of the Census has accepted this finding.

The commenter, in questioning the Committee's certification that the proposed Procurement List addition would not result in additional reporting, recordkeeping, or compliance requirements for entities other than the producing nonprofit agencies, asked the Committee to conduct a study of the relative merits of the commenter's microfilming method and the other commercially available microfilming process. The Committee does not think such a study is necessary to support the addition of this service to the Procurement List, as it will provide no information needed to support the Committee's determination that the service is suitable for addition to the Procurement List that would justify the cost and delay which a study would entail. Finally, the commenter asked the Committee to consider an alternative approach by expanding the Committee's program to include for-profit entities as employers of people with severe disabilities. To the extent this alternative would involve for-profit entities as program participants, it is prohibited by the Committee's statute, which limits participation to nonprofit agencies. However, these nonprofit agencies are encouraged to subcontract with for-profit entities to obtain goods and services that do not create work for people with severe disabilities. In this situation, the designated nonprofit agencies have communicated with the commenter as a possible subcontractor on this or other projects to be added to the Procurement List. Consequently, the Committee believes that it is complying with the commenter's alternative approach to the extent it is permitted to do so.

The following material pertains to all of the items being added to the Procurement List. After consideration of the material presented to it concerning capability of qualified nonprofit agencies to provide the commodity and services and impact of the additions on the current or most recent contractors, the Committee has determined that the commodity and services listed below are suitable for procurement by the Federal Government under 41 U.S.C. 46-48c and 41 CFR 51-2.4.

I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:

1. The action will not result in any additional reporting, recordkeeping or other compliance requirements for small entities other than the small organizations that will furnish the commodity and services to the Government.

2. The action will not have a severe economic impact on current contractors for the commodity and services.

3. The action will result in authorizing small entities to furnish the commodity and services to the Government.

4. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 46-48c) in connection with the commodity and services proposed for addition to the Procurement List.

This action does not affect current contracts awarded prior to the effective date of this addition or options that may be exercised under those contracts.

This notice is published pursuant to 41 U.S.C. 47(a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the possible impact of the proposed actions.

If the Committee approves the proposed additions, the entities of the Federal Government identified in this notice for each commodity or service will be required to procure the commodity or service listed below from nonprofit agencies employing persons who are blind or have other severe disabilities.

I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:

1. The action will not result in any additional reporting, recordkeeping or other compliance requirements for small entities other than the small organizations that will furnish the commodity and service to the Government.

2. The action will result in authorizing small entities to furnish the commodity and service to the Government.

3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 46-48c) in connection with the commodity and service proposed for addition to the Procurement List. Comments on this certification are invited. Commenters should identify the statement(s) underlying the certification on which they are providing additional information.

The following commodity and service are proposed for addition to Procurement List for production by the nonprofit agencies listed:

Section 906 of the TSRA requires that exports of agricultural commodities, medicine or medical devices to Cuba or to the government of a country that has been determined by the Secretary of State to have repeatedly provided support for acts of international terrorism, or to any other entity in such a country, are made pursuant to one-year licenses issued by the U.S. Government, while further providing that the requirements of one-year licenses shall be no more restrictive than license exceptions administered by the Department of Commerce, except that procedures shall be in place to deny licenses for exports to any entity within such country promoting international terrorism. To meet the requirements of TSRA, BXA is imposing a prior notification procedure under new License Exception Agricultural Commodities (AGR). Exports and certain reexports of agricultural commodities will be authorized under License Exception AGR to Cuba.

Submitted on forms.

OMB Number: 0694-0123.

Form Number: BXA-748P.

Type of Review: Regular submission for extension of a currently approved collection.

Affected Public: Individuals, businesses or other for-profit and not-for-profit institutions.

Estimated Number of Respondents: 250.

Estimated Time Per Response: 52-57 minutes per response.

Estimated Total Annual Burden Hours: 926 hours.

Estimated Total Annual Cost: No start-up capital expenditures.

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they will also become a matter of public record.

This collection of information is required as the result of the amending of the Export Administration Regulations (15 CFR parts 730-799) (EAR) by revising the (EAR) requirements for exports and reexports contained in Sections 1211-1215 of the National Defense Authorization Act (NDAA) for fiscal year 1998 (P.L. 105-85, 111 Stat. 1629), signed by the President on November 18, 1997. There is one component of this information collection authorization, a post-shipment report on the export of high performance computers, as well as exports of items used to enhance previously exported or reexported computers, to Tier 3 countries, where the CTP is greater than 85,000 MTOPS for commodities shipped on or after March 20, 2001. (For commodities shipped prior to that date, lower reporting thresholds apply, per 15 CFR parts 740.7 and 742.12.) Exporters are required to provide a written report to BXA no later than the last day of the month following the month in which the export takes place. To simplify this process, BXA is developing an electronic form that will incorporate the relevant data elements and replace the written report, thereby standardizing the data format for the applicant, and enabling the use of information technology in the processing of the data.

Submitted on forms.

OMB Number: 0694-0107.

Form Number: BXA 742R, BXA 742S.

Type of Review: Regular submission for extension of a currently approved collection.

Affected Public: Individuals, businesses or other for-profit and not-for-profit institutions.

Estimated Number of Respondents: 5.

Estimated Time Per Response: 15 minutes per response.

Estimated Total Annual Burden Hours: 6 hours.

Estimated Total Annual Cost: No start-up capital expenditures.

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. In addition, the public is encouraged to provide suggestions on how to reduce and/or consolidate the current frequency of reporting.

Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they will also become a matter of public record.

Unless otherwise indicated, all citations to the statute are references to the provisions effective January 1, 1995, the effective date of the amendments made to the Tariff Act of 1930 (“the Act”) by the Uruguay Round Agreements Act. In addition, unless otherwise indicated, all citations to the Department's regulations are to the regulations codified at 19 CFR Part 351 (2000).

On April 26, 2001, the Department initiated antidumping duty investigations of imports of silicomanganese from Kazakhstan, India, and Venezuela. The notice of initiation stated that we would issue our preliminary determinations no later than 140 days after the date of initiation. See 66 FR 22209 (May 3, 2001). Currently, the preliminary determinations in these investigations are due on September 13, 2001.

On July 16, 2001, petitioners alleged, pursuant to section 733(e)(1) of the Act and 19 CFR 351.206, that critical circumstances exist with respect to imports of silicomanganese from India. On June 28, 2001 and July 5, 2001, respondent Transnational Company Kazchrome (“Kazchrome”) in the Kazakh silicomanganese investigation and the Government of Kazakhstan, respectively, requested revocation, effective January 1, 2000, of Kazakhstan's non-market economy status under section 771(18) of the Act and graduation to a market economy. Also, on July 12, 2001, Kazchrome requested that the Department make a determination that the silicomanganese industry in Kazakhstan operates as a market-oriented industry.

On August 17, 2001, petitioners made a timely request pursuant to 19 CFR 351.205(e) for a 30-day postponement, pursuant to section 733(c)(1)(A) of the Act. Petitioners stated that a postponement of the preliminary determinations is necessary in order to allow the Department to conduct more thorough investigations and to issue preliminary determinations based on a more complete record.

Under section 733(c)(1)(A) of the Act, if the petitioner makes a timely request for an extension of the period within which the preliminary determination must be made under subsection (b)(1), then the Department may postpone making the preliminary determination under subsection (b)(1) until not later than the 190th day after the date on which the administering authority initiates an investigation. Therefore, in accordance with petitioners' request for a postponement, the Department is postponing the preliminary determinations in these investigations for 30 days. Because the 30th day falls on a non-business day, these preliminary determinations will be due no later than October 15, 2001.

This notice is issued and published pursuant to section 733(c)(2) of the Act and 19 CFR 351.205(f).

On August 19, 1987, the Department published in the Federal Register (52 FR 31057) the countervailing duty order on industrial phosphoric acid from Israel. On August 16, 2000, the Department published a notice of “Opportunity to Request Administrative Review” (65 FR 49962) of this countervailing duty order. We received a timely request for review, and we initiated the review, covering the period January 1, 1999 through December 31, 1999, on October 2, 2000 (65 FR 58733). In accordance with 19 CFR 351.213(b), this review covers only those producers or exporters of the subject merchandise for which a review was specifically requested. Accordingly, this review covers Rotem-Amfert Negev Ltd. (Rotem).

Unless otherwise indicated, all citations to the statute are references to the provisions of the Tariff Act of 1930, as amended by the Uruguay Round Agreements Act (URAA) effective January 1, 1995 (the Act). The Department is conducting this administrative review in accordance with section 751(a) of the Act. All citations to the Department's regulations are to 19 CFR part 351 (2000).

Imports covered by this review are shipments of industrial phosphoric acid (IPA) from Israel. Such merchandise is classifiable under item number 2809.20.00 of the Harmonized Tariff Schedule (HTS). The HTS item number is provided for convenience and U.S. Customs Service purposes. The written description of the scope remains dispositive.

The period for which we are measuring subsidies is calendar year 1999.

In British Steel plc. v. United States, 879 F.Supp. 1254 (CIT 1995) (British Steel I), the U.S. Court of International Trade (the Court) ruled against the allocation period methodology for non-recurring subsidies that the Department had employed for the past decade, as it was articulated in the General Issues Appendix appended to the Final Countervailing Duty Determination; Certain Steel Products from Austria, 58 FR 37225 (July 9, 1993) (GIA). In accordance with the Court's decision, on remand, the Department determined that the most reasonable method of deriving the allocation period for nonrecurring subsides is a company-specific average useful life (AUL). This remand determination was affirmed by the Court on June 4, 1996. See British Steel plc. v. United States, 929 F.Supp 426, 439 (CIT 1996) (British Steel II).

However, in administrative reviews in which the Department examines non-recurring subsidies received prior to the POR which have been countervailed based on an allocation period established in an earlier segment of the proceeding, it is not practicable to reallocate those subsidies over a different period of time. When a countervailing duty rate in earlier segments of a proceeding was calculated based on a certain allocation period and resulted in a certain benefit stream, redefining the allocation period in later segments of the proceeding would entail taking the original grant amount and creating an entirely new benefit stream for that grant. (See, e.g., Certain Carbon Steel Products from Sweden; Final Results of Countervailing Duty Administrative Review, 62 FR 16549 (April 7, 1997)).

In this administrative review, the Department is considering non-recurring subsidies previously allocated in earlier administrative reviews under the old practice, non-recurring subsidies also previously allocated in recent administrative reviews under the new practice, and non-recurring subsidies received during the POR to which the current countervailing duty regulations apply. Under these circumstances, and as discussed below, the Department is using different allocation periods depending upon the date of receipt of the non-recurring subsidy. For non-recurring subsidies received prior to the 1995 administrative review (the first review for which the Department implemented the British Steel I decision), the Department is using the original allocation period of 10 years. For non-recurring subsidies received since 1995, Rotem has submitted in each subsequent administrative review, including this one, AUL calculations based on depreciation and values of productive assets reported in its financial statements. In accordance with the Department's practice, we derived Rotem's company-specific AUL for each respective administrative review since 1995, by dividing the aggregate of the annual average gross book values of the firm's depreciable productive fixed assets by the firm's aggregated annual charge to depreciation for a 10-year period. In the current review, this methodology has resulted in an AUL of 23 years. Pursuant to section 351.524(d)(2) of the Department's regulations, this company-specific AUL rebuts the presumptive use of the IRS tables. Therefore, for the purposes of these preliminary results, non-recurring subsidies received during the POR will be allocated over 23 years.

Israel Chemicals Limited (ICL), the parent company which owns 100 percent of Rotem's shares, was partially privatized in 1992, 1993, 1994, 1995, 1997 and 1998. In this administrative review, the Government of Israel (GOI) and Rotem reported that additional shares of ICL were sold in 1999. We have previously determined that the partial privatization of ICL represents a partial privatization of each of the companies in which ICL holds an ownership interest. See Final Results of Countervailing Duty Administrative Review; Industrial Phosphoric Acid from Israel, 61 FR 53351, 53352 (October 11, 1996) (1994 Final Results). In this review and prior reviews of this order, the Department found that Rotem and/or its predecessor, Negev Phosphates Ltd., received non-recurring countervailable subsidies prior to these partial privatizations.

On December 4, 2000, the Department announced a new privatization approach in a remand determination following the decision of the U.S. Court of Appeals for the Federal Circuit (CAFC) in Delverde Srl v. United States, 202 F.3d 1360, 1365 (Fed. Cir. 2000), reh'g en banc denied (June 20, 2000) (Delverde III). The Department applied this new approach in the final results of the prior administrative review of this order. See Final Results of Countervailing Duty Administrative Review; Industrial Phosphoric Acid from Israel, 66 FR 15839 (March 21, 2001) (1998 Final Results). Under this approach, the first requirement is to determine whether the person to which the subsidies were given is, in fact, distinct from the person that produced the subject merchandise exported to the United States. If the two persons are distinct, the original subsidies may not be attributed to the new producer/exporter. The Department would, however, consider whether any subsidy had been bestowed upon that producer/exporter as a result of the change-in-ownership transaction. On the other hand, if the original subsidy recipient and the current producer/exporter are considered to be the same person, that person benefits from the original subsidies, and its exports are subject to countervailing duties to offset those subsidies. In other words, we will determine that a “financial contribution” and a “benefit” have been received by the “person” that is the firm under investigation or review. Assuming that the original subsidy had not been fully amortized under the Department's normal allocation methodology as of the period of review (POR), the Department would then continue to countervail the remaining benefits of that subsidy.

In making the “person” determination, where appropriate and applicable, we analyze factors such as (1) continuity of general business operations, including whether the successor holds itself out as the continuation of the previous enterprise, as may be indicated, for example, by use of the same name, (2) continuity of production facilities, (3) continuity of assets and liabilities, and (4) retention of personnel. No single factor will necessarily provide a dispositive indication of any change in the entity under analysis. Instead, the Department will generally consider the post-sale entity to be the same person as the pre-sale entity if, based on the totality of the factors considered, we determine that the entity in question can be considered a continuous business entity because it was operated in substantially the same manner before and after the change in ownership.

Using the approach described above, we have analyzed the information provided by the GOI and Rotem to determine whether the subsidies received by Rotem continued to benefit Rotem during the POR. By applying this approach to the facts and circumstances of the instant countervailing duty administrative review of industrial phosphoric acid from Israel and the relevant privatization of ICL and its subsidiary, Rotem, we find that the pre-sale and post-sale entities are not distinct persons. Specifically, Rotem still maintains its plants and uses the same production facilities to manufacture and sell the same products; continues to rely on the same suppliers and customer base; and employs largely the same personnel and management. See the Department's June 13, 2001, letter to Rotem (with attached Change in Ownership Analysis Memorandum from the 1998 administrative review) and the 1998 Final Results and accompanying Decision Memorandum (section entitled Change in Ownership), for a complete discussion of our analysis of ICL's and Rotem's privatization. Therefore, we determine that the subsidies provided to Rotem, prior to the privatization of ICL, continue to benefit Rotem after ICL's privatization.

To calculate the benefit for the POR, we followed the same methodology used in the final results of prior administrative reviews. We converted Rotem's shekel-denominated grants into U.S. dollars, using the exchange rate in effect on the dates the grants were received. We then applied the grant methodology to determine the benefit for the POR. See e.g., Industrial Phosphoric Acid from Israel; Final Results of Countervailing Duty Administrative Review, 63 FR 13626, 13633 (March 20, 1998) (1995 Final Results).

As a result of our privatization approach and our determination that Rotem continues to benefit from subsidies received prior to the privatization of ICL, the non-recurring subsidies allocated over time in the instant and previous administrative reviews are no longer reduced by the pass-through percentages calculated under our old repayment methodology. Therefore, the full value of the benefit allocable to the 1999 POR from non-recurring subsidies is being used to calculate Rotem's net subsidy rate.

We considered Rotem's cost of long-term borrowing in U.S. dollars as reported in the company's financial statements for use as the discount rate used to allocate the countervailable benefit over time. However, this information includes Rotem's borrowing from its parent company, ICL, and thus does not provide an appropriate discount rate. Therefore, we have turned to ICL's cost of long-term borrowing in U.S. dollars in each year from 1984 through 1999 as the most appropriate discount rate. ICL's interest rates are shown in the notes to the company's financial statements, public documents which are in the record of this review. See Comment 9 in the 1995 Final Results.

The ECIL program is designed to encourage the distribution of the population throughout Israel, to create new sources of employment, to aid the absorption of immigrants, and to develop the economy's production capacity. To be eligible for benefits under the ECIL, including investment grants, capital grants, accelerated depreciation, reduced tax rates, and certain loans, applicants must obtain approved enterprise status. Investment grants cover a percentage of the cost of the approved investment, and the amount of the grant depends on the geographic location of eligible enterprises. For purposes of the ECIL program, Israel is divided into three zones; Development Zones A and B, and the Central Zone. In Final Affirmative Countervailing Duty Determination: Industrial Phosphoric Acid From Israel, 52 FR 25447 (July 7, 1987) (IPA Investigation), the Department found the ECIL grant program to be de jure specific because the program limits the availability of grants to enterprises located only in Development Zones A and B. In this review, no new information or evidence of changed circumstances has been submitted to warrant reconsideration of this determination.

Rotem is located in Development Zone A, and received ECIL investment and capital grants in disbursements over a period of years for several projects. In past reviews, we have treated these grants as non-recurring. The guidelines set forth in section 351.524 of Department's regulations support finding these grants to be non-recurring. As explained in the “Allocation Period” section above, for grants that have been allocated in prior administrative reviews, we are continuing to use the allocation period assigned to these grants. For grants received during the POR, we have used the AUL calculated by Rotem in this review. To calculate the benefit for the POR, we followed the same methodology used in the final results of the 1995 administrative review, as indicated in the “Grant Benefit Calculations” section above.

In prior reviews of this order, we applied the methodology described in our proposed countervailing duty regulations when determining whether to allocate non-recurring grants over time or expense them in the year of receipt (“the 0.5 percent test”). Accordingly, grant disbursements exceeding 0.5 percent of a company's sales in the year of receipt were allocated over time while grants below or equal to 0.5 percent of sales were countervailed in full (“expensed”) in the year of receipt (see Countervailing Duties (Proposed Rules), 54 FR 23366, 23384 (section 355.49(a)(3)) (May 31, 1989)). However, section 351.524 (b)(2) of our current regulations directs us to conduct the 0.5 percent test based on the company's sales in the year of authorization rather than the year of receipt. Where possible, we applied this new regulation; however, we did not redo the 0.5 percent test for disbursements received prior to the POR because we had already calculated a benefit stream for those disbursements in prior administrative reviews.

Pursuant to section 351.504(c) of our regulations, we used our standard grant methodology as noted above in the “Grant Benefit Calculations” section to calculate the countervailable subsidy from ECIL grants. We allocated some of these grants over time because they met the 0.5 percent test, as described above, and expensed others in the POR that did not pass this test.

To calculate the total subsidy in the POR, we first summed the grant amounts allocated to 1999. To derive the subsidy rates, as discussed in the 1995 Final Results, we attributed ECIL grants that were tied to a particular facility over the sales of the product produced by that facility plus sales of all products into which that product may be incorporated. The Department's practice is to countervail the value of the subsidies at the time they are provided to the company without regard to their actual use by that same company or their effect on its subsequent performance. See section 771(5)(C) of the Act which states that the Department “is not required to consider the effect of the subsidy in determining whether a subsidy exists.” See also section 351.525 of the Department's regulations on attribution of subsidy to a product. Accordingly, we attributed ECIL grants to Rotem's phosphate rock mines to total sales; we attributed grants to Rotem's green acid facility to total sales minus direct sales of phosphate rock; and, finally, we attributed grants to Rotem's IPA facilities to sales of IPA, MKP, fertilizers, and “IPA-Akonomika” and MKP-HCL (by-products of IPA production which contribute to Rotem's sales revenue). We summed the rates obtained on this basis, and preliminarily determine the net countervailable subsidy from ECIL grants to be 4.57 percent ad valorem for the POR.

During the 1999 review period, Rotem received an infrastructure grant to initiate and establish industrial areas in a certain geographical zone. Rotem previously received grants under this program during the 1996, 1997 and 1998 PORs. In the 1996 administrative review, the Department determined that infrastructure grants were specifically provided to Rotem, and that they conferred a benefit. See Industrial Phosphoric Acid from Israel; Final Results of Countervailing Duty Administrative Review, 63 FR 13626, 13633 (March 20, 1998). No new information or evidence of changed circumstances has been submitted to warrant reconsideration.

In past reviews, we determined these grants to be “non-recurring.” The guidelines set forth in section 351.524 of the Department's regulations support finding these grants to be non-recurring. Therefore, we calculated the benefit under this program using the methodology for non-recurring grants noted above in the “Grant Benefit Calculations” section. On this basis, we preliminarily determine the net subsidy from this program to be 0.21 percent ad valorem for the POR.

During the 1999 review period, Rotem received five EIRD disbursements. Among these disbursements, two were tied to research unrelated to IPA or any of its inputs. See section 351.525(b)(5) of the Department's countervailing duty regulations concerning the attribution of subsidies. In this review, we preliminarily determine that the three remaining disbursements received by Rotem were tied to research related to the production of IPA. Rotem previously received grants under this program for research related to IPA or its inputs during the 1995 and 1996 PORs. In the 1995 Final Results, we determined that EIRD grants were specifically provided to Rotem, and that they conferred a benefit. Therefore, we calculated the benefit under this program using the methodology for non-recurring grants noted above in the “Grant Benefit Calculations” section. On this basis, we preliminarily determine the net subsidy from this program to be 0.02 percent ad valorem for the POR.

We examined the following programs and preliminarily determine that the producer and/or exporter of the subject merchandise did not apply for or receive benefits under these programs during the POR:

A. Environmental Grant Program

B. Reduced Tax Rates under ECIL

C. ECIL Section 24 loans

D. Dividends and Interest Tax Benefits under Section 46 of the ECIL

E. ECIL Preferential Accelerated Depreciation

In its questionnaire response, Rotem reported that it had received a very small labor training grant as payment for hiring and training conducted in a prior period. In previous administrative reviews, we have found that this program was not used (see, e.g., 1994 Final Results and 1996 Final Results). Under section 351.524 of the Department's regulations, grants for worker training are normally considered recurring and are expensed in the year of receipt. For purposes of this administrative review, we expensed this labor training grant and have found that any subsidy which could be calculated for this program would be so small (significantly less than 0.005 percent ad valorem) that there would be no impact on the overall subsidy rate. Accordingly, because there would be no impact on the overall subsidy rate in the instant review, we do not consider it necessary to address the issue of specificity for purposes of this administrative review and have not further considered this program. See Final Results of Countervailing Duty Administrative Review: Live Swine from Canada, 63 FR 2210, 2211 (January 14, 1998) (regarding the Department's methodology in calculating the de minimis rate).

In accordance with 19 CFR 351.213(b), we calculated an individual subsidy rate for the producer/exporter subject to this administrative review. For the period January 1, 1999 through December 31, 1999, we preliminarily determine the net subsidy for Rotem to be 4.80 percent ad valorem. If the final results of this review remain the same as these preliminary results, the Department intends to instruct the U.S. Customs Service (Customs) to assess countervailing duties as indicated above.

As a result of the International Trade Commission's determination that revocation of this countervailing duty order would not likely lead to continuation or recurrence of material injury to an industry in the United States in the reasonably foreseeable future, the Department, pursuant to section 751(d)(2) of the Act, revoked the countervailing duty order on IPA from Israel. See Revocation Countervailing Duty Order: Industrial Phosphoric Acid from Israel, 65 FR 114 (June 13, 2000). Pursuant to section 751(c)(6)(A)(iv) of the Act and 19 CFR 351.222(i)(2)(ii), the effective date of revocation was January 1, 2000. Accordingly, the Department has instructed Customs to discontinue suspension of liquidation and collection of cash deposits on entries of the subject merchandise entered or withdrawn from warehouse on or after January 1, 2000. The Department, however, will complete this instant administrative review of subject merchandise entered during 1999, prior to the effective date of revocation.

Pursuant to 19 CFR 351.224(b), the Department will disclose to parties to the proceeding any calculations performed in connection with these preliminary results within five days after the date of publication of this notice. Pursuant to 19 CFR 351.309, interested parties may submit written comments in response to these preliminary results. Normally, case briefs are to be submitted within 30 days after the date of publication of this notice, and rebuttal briefs, limited to arguments raised in case briefs, are to be submitted no later than five days after the time limit for filing case briefs. Parties who submit argument in this proceeding are requested to submit with the argument: (1) A statement of the issues, and (2) a brief summary of the argument. Case and rebuttal briefs must be served on interested parties in accordance with 19 CFR 351.303(f). Also, pursuant to 19 CFR 351.310, within 30 days of the date of publication of this notice, interested parties may request a public hearing on arguments to be raised in the case and rebuttal briefs. Unless the Secretary specifies otherwise, the hearing, if requested, will be held two days after the date for submission of rebuttal briefs. Representatives of parties to the proceeding may request disclosure of proprietary information under administrative protective order no later than ten days after the representative's client or employer becomes a party to the proceeding, but in no event later than the date case briefs, under 19 CFR 351.309(c)(ii), are due. The Department will publish the final results of this administrative review, including the results of its analysis of issues raised in any case or rebuttal brief. These preliminary results are issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act (19 U.S.C. 1675(a)(1) and 19 U.S.C. 1677f(i)(1)).

Section 117 of the MMPA requires that NMFS complete stock assessment reports for all marine mammal stocks within U.S. waters. Each draft stock assessment report, based on the best scientific information available, shall, among other things, categorize the status of the stock as one that either has a level of human-caused mortality and serious injury that is not likely to cause the stock to be reduced below its optimum sustainable population or is a strategic stock, with a description of the reasons therefore. In addition, each report shall estimate the potential biological removal (PBR) level for the stock, describing the information used to calculate it, including the recovery factor.

The MMPA defines a strategic stock as a marine mammal stock: (1) for which the level of direct human-caused mortality exceeds the PBR level; (2) which, based on the best available scientific information, is declining and is likely to be listed as a threatened species under the Endangered Species Act of 1973 (ESA) within the foreseeable future; or, (3) which is listed as a threatened or endangered species under the ESA or is designated as depleted under the MMPA.

The MMPA defines a stock as depleted if that species or population is below its optimum sustainable population or if it is a species or population stock that is listed as endangered or threatened under the ESA.

The MMPA defines the PBR level to mean the maximum number of animals, not including natural mortalities, that may be removed from a marine mammal stock while allowing that stock to reach or maintain its optimum sustainable population. The PBR level is the product of the following factors: the minimum population estimate of the stock; one-half the maximum theoretical or estimated net productivity rate of the stock at a small population size; and, a recovery factor of between 0.1 and 1.0.

The MMPA defines optimum sustainable population to mean, with respect to any population stock, the number of animals which will result in the maximum productivity of the population or the species, keeping in mind the carrying capacity of the habitat and the health of the ecosystem of which they form a constituent element.

The Western North Atlantic stock of coastal bottlenose dolphins is designated as strategic under the MMPA because the direct human-caused mortality exceeds the PBR level. The fisheries that interact with this stock are listed later in this document. This stock is also designated as depleted under the MMPA.

Section 118 (f) of the MMPA requires the Secretary of Commerce (Secretary) to develop and implement a take reduction plan designed to assist in the recovery or prevent the depletion of each strategic stock which interacts with a Category I or II commercial fishery. Based on section 118 (c) of the MMPA, 50 CFR 229.2 defines a Category I fishery as a commercial fishery that causes frequent incidental mortality and serious injury to marine mammals and a Category II fishery as a commercial fishery that causes occasional incidental mortality and serious injury to marine mammals.

The immediate goal of a take reduction plan for a strategic stock is to reduce, within 6 months of plan implementation, the incidental mortality or serious injury of marine mammals incidentally taken in the course of commercial fishing operations to levels less than the PBR level established for that stock under section 117 of the MMPA. The long-term goal of the plan is to reduce, within 5 years of plan implementation, the incidental mortality or serious injury of marine mammals incidentally taken in the course of commercial fishing operations to insignificant levels approaching a zero mortality and serious injury rate, taking into account the economics of the fishery, the availability of existing technology, and existing state or regional fishery management plans.

As explained under section 118 (f)(7) of the MMPA, where human-caused mortality and serious injury from a strategic stock is estimated to be equal to or greater than the PBR level established under section 117 for such stock and such stock interacts with Category I or II fisheries, the following procedures shall apply in the development of the take reduction plan for the stock:

(A) Not later than 6 months after the date of establishment of a take reduction team for the stock, the team shall submit a draft take reduction plan for such stock to the Secretary. Such draft take reduction plan shall be developed by consensus. In the event that consensus cannot be reached, the team shall advise the Secretary in writing on the range of possibilities considered by the team, and the views of both the majority and the minority.

(B) The Secretary shall take the draft take reduction plan into consideration and, not later than 60 days after the submission of the draft plan by the team, the Secretary shall publish in the Federal Register the plan proposed by the team, any changes proposed by the Secretary with an explanation of the reasons therefor, and proposed regulations to implement such plan, for public review and comment during a period not to exceed 90 days. In the event that the take reduction team does not submit a draft plan to the Secretary within 6 months, the Secretary shall, not later than 8 months after the establishment of the team, publish in the Federal Register a proposed take reduction plan and implementing regulations, for public review and comment during a period not to exceed 90 days.

(C) Not later than 90 days after the close of the comment period, the Secretary shall issue a final take reduction plan and implementing regulations.

(D) The Secretary shall, during a period of 30 days after publication of a final take reduction plan, utilize newspapers of general circulation, fishery trade associations, electronic media, and other means of advising commercial fishermen of the requirements of the plan and how to comply with them.

(E) The Secretary and the take reduction team shall meet every 6 months, or at such other intervals as the Secretary deems are necessary, to monitor the implementation of the final take reduction plan until such time that the Secretary determines that the objectives of the plan have been met.

(F) The Secretary shall amend the take reduction plan and implementing regulations as necessary to meet the requirements of this section, in accordance with the procedures in this section for the issuance of such plans and regulations.

Section 118 (f)(6)(C) states that members of take reduction teams shall have expertise regarding the conservation or biology of the marine mammal species which the take reduction plan will address, or the fishing practices which result in the incidental mortality and serious injury of such species.

The MMPA further specifies that members of a take reduction team shall include representatives of Federal agencies, each coastal state which has fisheries which interact with the species or stock, appropriate Regional Fishery Management Councils, interstate fisheries commissions, academic and scientific organizations, environmental groups, all commercial and recreational fisheries groups and gear types which incidentally take the species or stock, Alaska Native organizations or Indian tribal organizations, and others as the Secretary deems appropriate. Take reduction teams shall, to the maximum extent practicable, consist of an equitable balance among representatives of resource user interests and nonuser interests. Members of take reduction teams serve without compensation, but may be reimbursed by the Secretary, upon request, for reasonable travel costs and expenses incurred in performing their duties as members of the team.

NMFS, through a letter dated September 27, 2001, has asked the following individuals to be members of the BDTRT: Mike Baker, Florida Gillnet Representative; Dave Beresoff, North Carolina Gillnet and Crab Pot Representative; Tina Berger, Atlantic States Marine Fisheries Commission; Paul Biermann, North Carolina Gillnet Representative; David Cupka, South Carolina Wildlife and Marine Resources; Joseph DeAlteris, University of Rhode Island, Fisheries Center; Martin Dunson, Florida Crab Pot Representative; Lewis Gillingham, Virginia Marine Resources Commission; Doug Guthrie, North Carolina Stop Net Representative; Bruce Halgren, New Jersey Division of Fish and Wildlife; Emily Hanson, NMFS Office of Protected Resources; Chris Hickman, Long Haul Seine Fishery Representative; Fulton Love, Georgia Shad Gillnet Representative; Richard Luedtke, New Jersey Gillnet Representative; Rick Marks, New Jersey Gillnet and Haul Seine Representative; Dave Martin, Maryland Gillnet Representative; Bill McLellan, University of North Carolina at Wilmington; Ken Moran, South Carolina Shad Gillnet Representative; Fentress Munden, North Carolina Division of Marine Fisheries; Robert Munson, New Jersey Gillnet, Crab Pot and Pound Net Representative; Peter Nickson, Virginia Gillnet, Beach Seine, Crab Pot, and Pound Net Representative; Kerry O’Malley, South Atlantic Fishery Management Council; William Outten, Maryland Department of Natural Resources; Mike Peele, North Carolina Beach Seine, Pound Net, and Gillnet Representative; Carl Poppell, Georgia Crab Pot Representative; Tim Ragen, Marine Mammal Commission; Andy Read, Duke University Marine Laboratory; John Reynolds III, Marine Mammal Commission; Jerry Schill, North Carolina commercial fisheries representative; Richard Seagraves, Mid-Atlantic Fishery Management Council; Larry Simns, Maryland Crab Pot Representative; Ann Spellman, Florida Fish and Wildlife Conservation Commission; Lee Spence, Delaware Division of Fish and Wildlife; Mark Swingle, Virginia Marine Science Museum; Leonard Voss, Delaware Gillnet and Crab Pot Representative; Chris Walker, Virginia Gillnet Representative; Kathy Wang, NMFS Southeast Regional Office; Rob West, North Carolina Gillnet, Pound Net, and Crab Pot Representative; A.D. Willis, North Carolina Recreational Crab Pot and Gillnet Representative; David Woolman, South Carolina Crab Pot Representative; Nina Young, The Ocean Conservancy; Sharon Young, The Humane Society of the United States; Chris Zeman, American Oceans Campaign; Barb Zoodsma, Georgia Coastal Resources, Georgia Department of Natural Resources. The BDTRT will be facilitated by Hans Neuhauser and Jim Feldt, Georgia Environmental Policy Institute.

Section 118 (f)(6)(A)(ii) of the MMPA requires NMFS to publish the full geographic range of the marine mammal stock for which a take reduction team is being convened and list all commercial fisheries that cause incidental mortality and serious injury of marine mammals from such stock.

Western North Atlantic coastal bottlenose dolphins range seasonally as far north as Long Island, NY and as far south as central Florida. Multiple stocks of Western North Atlantic coastal bottlenose dolphins exist, and include year-round residents, seasonal residents, and migratory groups. In addition to the coastal bottlenose dolphins, a distinct, offshore ecotype also exists. Research is underway to improve data about the stock structure of coastal bottlenose dolphins and to define the offshore range of coastal bottlenose dolphins.

Western North Atlantic coastal bottlenose dolphins are known to interact with the following Category II commercial fisheries: Mid-Atlantic coastal gillnet, North Carolina inshore gillnet, Southeast Atlantic gillnet, Southeastern U.S. Atlantic shark gillnet, Atlantic blue crab trap/pot, Mid-Atlantic haul/beach seine, North Carolina long haul seine, North Carolina roe mullet stop net, and Virginia pound net. Additional commercial fisheries, classified as Category III fisheries, are known to rarely cause incidental mortality and serious injury to Western North Atlantic coastal bottlenose dolphins. These fisheries are identified in the 2001 List of Fisheries (66 FR 42780, August 15, 2001). Interactions between Western North Atlantic coastal bottlenose dolphins and recreational fisheries have also been documented.

NMFS fully intends to conduct the BDTRT process in a way that provides for national consistency yet accommodates the unique regional needs and characteristics of the team. The data and analysis used to support the BDTRT will go through an external peer-review process, be reviewed by NMFS’ Scientific Review Groups, and be made available for public review and comment as a Stock Assessment Report. Take Reduction Teams are not subject to the Federal Advisory Committee Act (5 App. U.S.C.). Meetings are open to the public.

The Capacity Committee will discuss proposals for reducing latent effort and changing permit transfer restrictions in the Northeast Multispecies Fishery. The committee will consider Groundfish Advisory Panel comments on the proposals from their August 16, 2001 Advisory Panel meeting. The Council has directed the Committee to make recommendations on revising and combining these proposals for possible inclusion in Amendment 13 to the Multispecies Fishery Management Plan. The Committee will not make final decisions about the choice of alternatives, but will report its recommendations to the Council and the Council’s Groundfish Oversight Committee.

Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305 (c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency.

This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Paul J. Howard (see ADDRESSES) at least 5 days prior to the meeting dates.

The NPFMC’s EFH committee was formally established by the NPFMC's acting executive director in May 2001. The committee was established in response to the need to prepare a supplemental environmental impact statement (SEIS) for the EFH fishery management plan amendments. For further information about the SEIS, see the notice of intent to prepare an SEIS published in the Proposed Rules section of the Federal Register (66 FR 30396, June 6, 2001).

The function of the EFH Committee is to serve as a steering committee for the EFH EIS process. The Committee’s overarching goal is to facilitate input by the industry, conservation community, Council, and general public to the EFH EIS process. More specifically, the Committee will assist in identifying: (1) The “significant issues” used to develop and evaluate proposed alternatives; (2) The alternatives for describing, identifying, and protecting EFH; (3) The means of determining possible fishery impacts on habitat; (4) and Interpreting existing information for development and analysis of alternatives; (5) The alternatives for mitigating fishing gear impacts on habitat; (6) Alternative criteria and approaches that could be used to designate and manage HAPC areas; and (7) Identify and prioritize future research needs. Additionally, the committee will assist the agency with appointing and working with technical teams. This will be the third meeting of the EFH Committee. Prior meetings were held May 30 and August 13 and 14, 2001.

Agenda items for this meeting include:

1. Discussion of NMFS preliminary draft scoping report;

2. Committee recommendations to the NPFMC on significant issues;

3. Discussion of technical teams and their composition; and

4. EFH Committee tasks, timetable and next meeting.

Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the Council’s intent to take final action to address the emergency.

This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Cindy Hartmann, (907) 586-7235, at least 5 working days prior to the meeting date.

Issuance of permits and permit modifications, as required by the Endangered Species Act of 1973 (16 U.S.C. 1531-1543) (ESA), is based on a finding that such permits/modifications: (1) are applied for in good faith; (2) would not operate to the disadvantage of the listed species which are the subject of the permits; and (3) are consistent with the purposes and policies set forth in section 2 of the ESA. Scientific research and/or enhancement permits are issued under Section 10 (a)(1)(A) of the ESA. Authority to take listed species is subject to conditions set forth in the permits. Permits and modifications are issued in accordance with and are subject to the ESA and NMFS regulations governing listed fish and wildlife permits (50 CFR parts 222-226).

Those individuals requesting a hearing on an application listed in this document should set out the specific reasons why a hearing on that application would be appropriate (see ADDRESSES). The holding of such hearing is at the discretion of the Assistant Administrator for Fisheries, NOAA. All statements and opinions contained in the permit action summaries are those of the applicant and do not necessarily reflect the views of NMFS.

The following species are covered in this notice:

White Abalone (Haliotis sorenseni)

The applicant requests a 5-year permit to maintain captively bred white abalone for scientific research and enhancement at the CIMRI Hatchery. Research Activities include feeding studies, propagation studies and studies identified as goals for the long term recovery of the white abalone.

The MARLAP provides guidance for the planning, implementation and assessment phases of those projects which require the laboratory analysis of radionuclides. This guidance is intended for project planners, managers and laboratory personnel. The manual's basic goal is to provide guidance to ensure that radioanalytical laboratory data will meet a project's or program's data requirements and needs. The document uses a performance-based approach and will support a wide range of data collection activities including site characterization and cleanup; compliance demonstration; decommissioning of nuclear facilities; remedial and removal actions; environmental monitoring; and waste management activities. The MARLAP, when finalized, will be a multi-agency consensus document. MARLAP was developed collaboratively over the past five years by the technical staffs of seven Federal agencies. State participation in the development of the manual involved contributions from representatives from the Commonwealth of Kentucky and the State of California. Contractors to the DOE, EPA, and NRC, and members of the public have been present during the open meetings of the MARLAP work group.

Although Federal agency personnel are involved in the preparation of this document, the manual does not represent the official position of any participating agency at this time. An earlier draft of the document has been reviewed within the Federal agencies. The public review is a necessary step in the development of a final multi-agency consensus document. The document will also receive formal technical peer review. The draft has not been approved by the participating agencies for use in part or in whole and should not be used, cited, or quoted except for the purposes of providing comments as requested. In addition to providing comments on individual chapters and appendices, reviewers are also requested to address the following questions listed below while reviewing the MARLAP manual.

(1) Is the performance-based approach used in MARLAP for the planning, implementation and assessment phases of projects technically sound and is the approach reasonable in terms of ease of implementation by project managers and laboratories? Does the approach effectively link the three phases of a project and is the guidance on quality control appropriate and supportive of a performance-based approach?

(2) Is the guidance on laboratory operations in the Part II chapters technically accurate and useful?

(3) Are the concepts covered under measurement statistics, specifically measurement uncertainty, detection and quantification capability, presented accurately and appropriately?

(4) Is the information understandable and presented in logical sequence? How can the presentation of material be modified to improve the manual?

(5) Does the MARLAP manual provide benefits that are not currently available through other approaches? What are the costs associated with implementing the guidance in MARLAP in comparison with currently available alternatives?

Commentors are encouraged to use the website listed in the ADDRESSES section of this notice for their review. The website has detailed instructions on how to submit comments and has several features that should aid the review process.

Written comments may also be submitted. Commentors are encouraged to submit their written comments using the same general approach described in the website, http://www.eml.doe.gov/ marlap/. Comments should be accompanied by supporting bases, rationale, or data. To ensure efficient and complete comment resolution, commentors are requested to reference the page number and the line number of the MARLAP to which the comment applies. All comments received will be reviewed by the MARLAP Workgroup.

Section 3506 of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35) requires that the Office of Management and Budget (OMB) provide interested Federal agencies and the public an early opportunity to comment on information collection requests. OMB may amend or waive the requirement for public consultation to the extent that public participation in the approval process would defeat the purpose of the information collection, violate State or Federal law, or substantially interfere with any agency's ability to perform its statutory obligations. The Leader, Regulatory Information Management Group, Office of the Chief Information Officer, publishes that notice containing proposed information collection requests prior to submission of these requests to OMB. Each proposed information collection, grouped by office, contains the following: (1) Type of review requested, e.g., new, revision, extension, existing or reinstatement; (2) Title; (3) Summary of the collection; (4) Description of the need for, and proposed use of, the information; (5) Respondents and frequency of collection; and (6) Reporting and/or Recordkeeping burden. OMB invites public comment.

Type of Review:

Title: Survey on Internet Access in U.S. Public Schools, Fall 2001 (KA).

Frequency: One Time.

Affected Public: State, local or Tribal Gov't, SEAs or LEAs.

Reporting and Recordkeeping Hour Burden:

 Responses: 1,200

 Burden Hours: 400

Abstract: The FRSS survey on Internet Access in U.S. Public Schools will provide important information to the Department of Education and school districts in their roles to provide leadership for school access to the Internet. The Department has tracked access to the Internet and other advanced telecommunications in public schools since 1994 and updated information is needed regarding current levels of connectivity and usage for public elementary and secondary schools as well as trend data comparing levels of access and usage with previously obtained data.

Requests for copies of the proposed information collection request may be accessed from http://edicsweb.ed.gov, or should be addressed to Vivian Reese, Department of Education, 400 Maryland Avenue, SW., room 4050, Regional Office Building 3, Washington, DC 20202-4651. Requests may also be electronically mailed to the internet address OCIO_RIMG@ed.gov or faxed to 202-708-9346. Please specify the complete title of the information collection when making your request.

Comments regarding burden and/or the collection activity requirements should be directed to Kathy Axt at (540) 776-7742. Individuals who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339.

The package contains the following information:

(1) Current OMB control number: 1910-0068; (2) Package Title: Renewable Energy Production Incentives; (3) Summary: A three-year extension is requested, because this information is critical to ensure that the Government has sufficient information to ensure the proper use of public funds for these incentive payments; (4) Purpose: To provide required information to receive consideration for payment for qualified renewable energy electricity produced in the prior fiscal year; (5) Type of Respondents: State, municipal, county, and non-profit electric cooperative owners of qualified renewable energy generation facilities that produce electricity for sale; (6) estimated number of responses; (7) estimated total burden hours, including record keeping hours, required to provide the information; (8) purpose; and (9) number of collections.

Package Title: Renewable Energy Production Incentives.

Current 0MB No.: 1910-0068.

Type of Respondents: State, municipal, county, and non-profit electric cooperative owners of qualified renewable energy generation facilities that produce electricity for sale.

Estimated Total Burden Hours: 450.

Western is the lead Federal agency under NEPA for the Sundance Energy Project. No Federal, State, or Tribal organizations requested cooperator status. Western has decided to enter into interconnection agreements with Sundance, and to construct, operate, and maintain transmission system additions to provide the interconnection with its transmission system. The transmission system additions selected as part of the Proposed Action addressed in the Environmental Impact Statement (EIS) include a new 230-kV bay at Western's existing Coolidge Substation, an upgrade of the existing Coolidge-Signal 115-kV #2 Transmission Line to 230-kV, and an expansion of the existing Signal Substation. Western also selected new single- and double-circuit 230-kV transmission line additions as described under Alternative 3 in the EIS. Alternative 3 was selected over the Proposed Action transmission system additions and two transmission line alternatives because it would have less impact on agricultural activities. The selected transmission line would involve the construction of one new double-circuit 230-kV transmission line and one new single-circuit 230-kV transmission line, both heading north from the western edge of the powerplant towards Western's existing Liberty-Coolidge 230-kV Transmission Line. As the new transmission lines reach the South Side Canal, they would run northeast until they meet the Liberty-Coolidge 230-kV Transmission Line. The west circuit of the new double-circuit 230-kV transmission line would interconnect with Western's existing Liberty-Coolidge 230-kV Transmission Line, heading west to Liberty. The east circuit of the new double-circuit 230-kV transmission line would join the new single-circuit 230-kV transmission line and become a new double-circuit 230-kV transmission line on Western's existing Liberty-Coolidge 230-kV Transmission Line right-of-way, heading east towards Coolidge. The north circuit of this new double-circuit 230-kV transmission line would interconnect to the existing Liberty-Coolidge 230-kV Transmission Line and continue on the existing alignment north and then east to Coolidge. The south circuit of this new double-circuit 230-kV transmission line would become a single-circuit transmission line and continue east until it meets Western's existing Coolidge-Signal 115-kV #2 Transmission Line. The new 230-kV transmission line would combine with Western's existing Coolidge-Signal 115-kV #2 Transmission Line as a new double-circuit transmission line, heading north and east along the Coolidge-Signal 115-kV #2 Transmission Line alignment into Coolidge Substation.

This decision is based on a review of the environmental impacts of the project as addressed in the Draft and Final EIS, a review of all comments received during the 30-day waiting period after issuance of the Final EIS, and Western's abilities to continue to meet its current contractual obligations and customer needs, and maintain regional transmission reliability with the interconnection.

The Sundance Energy Project EIS (Draft issued March 2001, Final issued June 2001) addresses the effects of constructing and operating a nominal 540-megawatt, natural gas-fired, simple cycle, electrical generation peaking plant south of Coolidge, Arizona, in rural Pinal County. PPL Sundance Energy, LLC, owns the property on which it will build the powerplant. The project will include the construction of a natural gas transmission system for supplying fuel to the plant site, and a water transmission system for inlet air cooling, emission control, and on-site use. Western has no decision regarding these components of the project. Western did take into account the environmental ramifications of the whole project as addressed in the EIS in making its decision.

Under the no action alternative, Western would not grant an interconnection to its system. Without the ability to interconnect with Western's system, the proposed project and appurtenant facilities would not be built. Existing environmental conditions would not change, although there may be adverse economic impacts due to the absence of needed electricity to meet peak energy demands. The No Action Alternative would result in slightly fewer overall environmental impacts, however, it was not selected because it would not meet the needs defined in the Sundance Energy Project EIS. The No Action Alternative would not have allowed Western to meet its obligations defined by its own Open Access Transmission Tariff, which was implemented to meet the intent of the Federal Energy Regulatory Commission (FERC) order to open transmission line access (FERC Order Nos. 888 and 888-A).

Western dismissed from full analysis alternative sites to the generating facility. The State of Arizona Corporation Commission has jurisdiction over siting of powerplants and made no suggestion regarding alternative sites or systems during their siting process. Western has no decision regarding the siting of the generating facility.

There were no pipeline alternatives addressed in the EIS. Western has no decision regarding the proposed gas supply for the project.

Three routing alternatives, in addition to the proposed action, were evaluated. The proposed action addressed in the EIS would be a “loop-in-loop-out” from the existing Liberty-Coolidge 230-kV line to the Sundance facility. This would involve a double circuit 230-kV line due north out of the plant site, approximately 8 miles up Tweedy Road to the interconnection with Western's existing Liberty-Coolidge 230-kV line. The proposed action would also include building a new 230-kV transmission line from the Sundance facility to an expanded Signal Substation, 1.5 miles east of the Sundance facility, and upgrading the existing Coolidge-ED2 115-kV line to 230-kV from the Signal Substation to the Coolidge Substation. The proposed action was not selected due to higher impacts on agricultural activities compared to the selected alternative.

Alternative 1 would be identical to the proposed action with one new double-circuit 230-kV transmission line and one new single-circuit 230-kV transmission line. Alternative 1 would have all three circuits going north from the powerplant towards Western's existing Liberty-Coolidge 230-kV Transmission Line. The one new single-circuit 230-kV transmission line would follow the same alignment as the double circuit to the intersection of the Liberty-Coolidge line with Western's existing Coolidge-ED2 115-kV Transmission Line, where it would follow that route into the Coolidge Substation. This alternative was not selected due to higher impacts on agricultural activities.

Alternative 2 would be identical to Alternative 1 except that the new single-circuit 230-kV transmission line would follow the same alignment until it crosses Western's existing Coolidge-ED2 115-kV #1 Transmission Line. The new single-circuit 230-kV transmission line would continue east until it meets Western's existing Coolidge-Signal 115-kV #2 Transmission Line. The new single-circuit 230-kV transmission line alignment then heads north and east adjacent to the Coolidge-Signal 115-kV #2 Transmission Line into Coolidge Substation. This alternative was not selected due to higher impacts on agricultural activities.

Three comment letters were received on the final EIS. Two comment letters stated that the change in air pollution control technology to Selective Catalytic Reduction (SCR) following issuance of the draft EIS required a supplement to the draft to allow the public to comment. The change to SCR technology was based on EPA Region IX and Pinal Country Air Quality Control District permit requirements. Western recognizes the concerns expressed by the commentors regarding ammonia transportation, storage, and use. Western will require the Sundance Energy Project to develop and implement an emergency response plan in accordance with State and local regulations.

The Environmental Protection Agency, Region IX (EPA), expressed concern over potential human health effects through the long-term use of Central Arizona Project (CAP) water mixed with waste water for irrigating crops. There is little potential for environmental or human health effects from the use of reclaimed waste water for irrigation. The only potential vector for the waste water to affect human health is the irrigation of food crops. The water would be used to irrigate alfalfa, Bermuda grass, cotton, and barley. Barley has the potential to be used in products for human consumption, and alfalfa could be fed to livestock ultimately consumed by humans. As shown in the Final EIS in Table 4-17, the waste water would be blended with CAP water to approximate the water quality in existing on-site ground water wells, currently used to irrigate the same lands where the blended waste water would be applied. Therefore, the potential to affect human health would be approximately the same as the current and past irrigation practices on the site and within the general area of Pinal County. For the reasons discussed above, and the fact that the waste water would be blended and stored in a lined pond prior to its discharge as irrigation water, the potential vectors for environmental effects would be limited. The liner would be designed to eliminate effects to ground water. There are no surface waters in the area other than the canals from which the CAP water would be extracted. There are no aquatic resources in the area and the ponds would be fenced to exclude wildlife. Waterfowl can land on the pond but the constituency of the water will not differ materially from that of local irrigation ponds, canals, effluent lakes, or other bodies of water currently available to them. Sundance Energy will be required to monitor the quality of waste water as part of the Arizona Department of Environmental Quality (ADEQ) Water Reuse Permit. The monitoring plan will ensure that waste water matches existing groundwater quality, thus minimizing potential adverse human health and environmental effects. If concentrations of any constituents approach levels known to be chronically toxic to wildlife, the sampling frequency will be increased to at least quarterly. Weekly observations of bird use at the ponds will be recorded, and the area around the pond would be monitored for wildlife mortalities. If concentrations of any constituents reach acutely toxic levels and the extended bird use of the ponds is high or substantial wildlife mortalities are recorded, Sundance will implement measures to reduce the toxicity by removing the toxic sediments or reducing wildlife use through exclusion or distraction devices.

EPA requested actual flow rates and chemical constituents of reclaimed water and waste water. The Draft EIS indicates that less than 1 million gallons per year of regeneration waste water will be produced and the constituents of that were listed in Table 4-17 in the Draft EIS and updated in Table 4-17 of the Final EIS.

Additionally, EPA requested the status of the various State water permits. The Aquifer Protection Permit Application and Wastewater Reuse Permit Application are currently being developed to submit to the Arizona Department of Environmental Quality. The Sundance Energy Project would not be operated without these permits. Both applications will be submitted in mid-August 2001. Sundance Energy would be required to monitor the quality of the wastewater as a part of the Reuse Permit.

EPA commented on the potential for wildlife to accumulate wastewater constituents, which is addressed above. Briefly, the waste water would be blended, if necessary, in order to bring all constituent levels to the level of existing available water. There would be no additional accumulation of heavy metals or trace elements beyond that which currently exists in the region. However, both the Arizona Department of Fish and Game and the U.S. Fish and Wildlife Service received copies of and had opportunities to review the Draft and Final EIS. Information on the toxicity of any of the constituents in the water can be found at or http://www.pwrc.usgs.gov/new/chrback.htm or http://www.oehha.org/cal_ecotox/.

EPA asked the status of consultations with the U.S. Army Corps of Engineers (COE) and the ADEQ regarding crossing of “Waters of the United States” with the transmission lines and pipelines. Any wetland disturbance that would occur as a result of pipeline or transmission line construction would be covered under Nationwide Permit 12. The EIS describes three potential gas interconnections: two onsite and one that would require the construction of a 14-mile pipeline offsite. It is currently anticipated that the two on-site interconnections would be sufficient to provide an adequate gas supply to the project and, if so, the off-site pipeline may not be needed. Therefore, permitting by COE for this pipeline has not been initiated and would be initiated only at such time that it is certain that it is needed for the project and a detailed pipeline design is developed as is required for the notification to the COE. Similarly, notification to the COE for the transmission lines would be submitted as detailed designs for them are completed. They are anticipated to affect wetlands or waters of the United States because the lines would not be designed to span all canals, mapped floodplains, or other wet areas.

EPA recommended the project commit to working with the local community and concerned public regarding an emergency response plan and measures. The Sundance Energy Project has already initiated contact with the Eleven Mile Corner School. Additionally, Sundance Energy would be working with the State and Pinal County to develop emergency response plans as required by the types and amounts of chemicals used and stored on the Project site. Western will ensure that a Spill Control and Countermeasure Plan is developed in accordance with applicable Federal, State, and local regulations and that an emergency response plan is developed.

EPA expressed concerns regarding noise levels that would be experienced by nine residences relatively close to the Project. Sundance Energy has completed the rezoning for the project and has received its industrial use permit from Pinal County. The project is currently working with Pinal County on local building and site issues. Currently, Pinal County has indicated that a berm would not be needed for visual or noise screening. Western will ensure that local noise ordinances are met.

EPA requested information regarding the Arizona Corporation Commission's (Commission) powerplant siting process. Generally, the Commission requires submitting an Application for a Certificate of Environmental Compatibility (ACEC). The ACEC requires the applicant to provide descriptions of the facilities it intends to develop, along with environmental information on air quality, biological, cultural, and recreational resources. Public meetings are held by the Arizona Power Plant and Line Siting Committee to recommend to the Commission whether or not to issue the Certificates. The Commission then holds public hearings to make its final determination. PPL Sundance Energy, LLC, has received a Certificate of Environmental Compatibility from the Commission. Through the Arizona power plant siting process, information was provided regarding other site options that were considered and evaluated by Sundance Energy. When siting a gas-fired powerplant, proximity to available gas and transmission are important for minimizing both costs and environmental impacts. In the case of Sundance Energy, the transmission interconnection point was the Coolidge Substation, and the nearest available gas was located at the two lines where the current site for the project is located. Therefore, the project could be located at the Coolidge Substation, on the existing pipelines, or some reasonable location between them. Sites at or near the Coolidge Substation were considered but were dismissed because of costs, proximity to the Gila River floodplain, proximity to the Casa Grande National Monument, proximity to the Gila River Indian Reservation, and increased potential for impacts to cultural resources. Sites between the two were dismissed because of proximity to the National Monument, the town of Coolidge, and other residential areas.

EPA requested a detailed description of the different alternatives developed for the high-voltage transmission line routes. These are detailed in Table S-1 in both the Draft and Final EIS. Briefly, the alternative selected as the environmentally preferred alternative, although slightly longer, impacts less agricultural land and has less potential to adversely affect local transportation. Transmission line routing options were all developed to try to utilize existing rights-of-way (canals, roads, pipelines, and transmission lines) and field lines to minimize establishing new rights-of-way that were not necessary and/or avoid needlessly traversing the middle of properties. The Proposed Action and Alternatives 1 and 2 were developed to take advantage of those various routing opportunities between the Project site and the Coolidge Substation. Alternative 3 was developed in direct response to comments from local landowners and the Arizona power plant and transmission line siting committee in order to mitigate concerns they had about the effects that the other transmission line alternatives would have on their continued use of their property. Alternative 3 was selected.

All measures addressed in the EIS to minimize adverse impacts from the transmission system additions have been adopted. Table 2-4 in the Draft EIS lists the standard mitigative measures that are part of Western's proposed action. These would be used for the transmission line additions. Some of the measures include restricting vehicular traffic to existing access roads or public roads, recontouring and reseeding disturbed areas, environmental awareness training for all construction and supervisory personnel, and mitigation of radio and television interference generated by transmission lines. Additionally, Spill Prevention Control and Countermeasure (SPCC) plans for modified facilities will be reviewed to ensure new equipment is addressed.

In addition, Western will ensure that PPL Sundance Energy, LLC, implements the following measures:

1. Detailed emergency response plan and SPCC plans that meet Federal, State, and local requirements.

2. Implement conditions of individual or nationwide 404 permits if needed for new pipeline construction across waters of the United States.

3. Conduct pre-construction surveys along the new pipeline route to ensure impacts to special status species do not occur.

A Mitigation Action Plan with annual reporting requirements will be developed for the project to comply with DOE regulations found at 10 CFR part 1021.33 and made available to the public.

Western is the lead Federal agency for compliance with Section 106 of the National Historic Preservation Act for all components of the project. All archaeological and traditional cultural properties determined significant in consultation with the Arizona State Historic Preservation Officer and interested tribes will be avoided. If they are somehow not avoided, a mitigation plan will be developed in consultation with the State Historic Preservation Officer and the interested tribes. Cultural resource monitoring, if needed, will take place during construction of new high voltage transmission lines and pipelines.

Western is also the lead for compliance with Section 7 of the Endangered Species Act. A biological assessment was prepared and submitted to the U.S. Fish and Wildlife Service (Service) with a determination that the project could affect but not adversely affect any candidate, proposed, or listed species. This Record of Decision is being issued based on verbal concurrence from the Service on Western's determination and written concurrence is expected soon. Additionally, during informal consultation, the Service requested, and Western has agreed, if the 14-mile long pipeline is built, the crossing of the Santa Cruz Wash would be enhanced for the cactus ferruginous pygmy owl. The enhancement will include planting mesquite trees on either side of the pipelines to facilitate emigration of the owl.

Construction of the Sundance Energy Project would not alter the natural drainage patterns on site. The immediately surrounding area is primarily agricultural and contains irrigation canals, which will move water around and away from the facility. No floodplain classifications for the site and surrounding area have been mapped. The storm water flows will be retained on site in constructed basins to minimize sheet flows.

The new gas pipeline would cross portions of the 100-year flood zone of the Santa Cruz Wash but is not anticipated to affect the floodplain. The ground surface would remain relatively unchanged from pre-development conditions.

All transmission system alternatives, including the selected transmission line alternative and the upgrade of the Coolidge-Signal line, would traverse the 100-year flood zone of McClellan Wash near Coolidge. A large portion of the floodplain is spanned by the existing transmission facility. It would not be practical to use existing transmission line structures and rights-of-way without going through the floodplain. No new transmission structures are expected to be placed in the floodplain. Instead, work would be confined to existing structures, resulting in short-term, temporary disturbances to the floodplain. If, after final project design, additional new structures are needed in the floodplain, they will be designed to conform to applicable Federal, State, and local floodplain protection standards.

A portion of the facility gets inundated during heavy rain events. A wetland delineation study was performed on the site and found none of the criteria needed to identify a wetland (i.e., soils, hydrology, and vegetation) existed. No wetlands would be affected by the proposed action.

Affected Entities: Entities potentially affected by this action are businesses and other members of the regulated community, technical assistance providers that receive or access EPA compliance assistance tools, regulating agencies, and state/local committees that are recipients of required compliance reports. Technical assistance providers are comprised of such groups as: state pollution prevention programs, state small business assistance programs, small business development centers. The request for information from these affected entities will be voluntary.

Title: Information Collection Request for Assessment of EPA Compliance Assistance Projects, EPA ICR Number 1860.01.

Abstract: The Environmental Protection Agency (EPA) is seeking reapproval for a three year generic clearance from Office of Management and Budget (OMB) to determine how well EPA compliance assistance tools and services meet customers needs and to determine the relevant outcomes. This will be a voluntary collection of information to gauge customer satisfaction with the compliance assistance projects, and measure any resulting changes in awareness and understanding, and in limited cases behavioral change and environmental and human health impacts. EPA proposes to use assessment surveys to provide the Agency with feedback on the compliance assistance documents, onsite visits, telephone assistance, Web sites, and compliance assistance seminars and workshops delivered by Headquarters and Regional compliance assistance programs to the regulated community This feedback will provide EPA with the necessary information for improving the quality and delivery of compliance assistance tools and services.

This ICR will only provide anecdotal data for the purpose of informing EPA of the outcomes of compliance assistance tools, and customer satisfaction with those tools. All assessments undertaken under this ICR will adhere to certain conditions to ensure that data is collected and used appropriately. The information collection is voluntary, and will be limited to non-sensitive data concerning the quality of compliance assistance activities. The data resulting from this ICR's assessment activities will not be treated as statistical and will not be used to make broad generalizations to the overall population. The Office of Compliance (OC) attempts to perform such evaluations will be undertaken under a separate ICR so that the public is allowed adequate public comment period on our proposed methodology. This process does not involve fact-finding for the purposes of regulatory development or enforcement.

By seeking a generic clearance of assistance assessments, EPA will have the flexibility it requires to expeditiously gather the views of EPA customers to determine how well the bulk of EPA compliance assistance tools and services meet customers needs and how to improve them. In FY 2000 alone, EPA conducted over 1300 workshops and trainings, over 2700 on-site visits and developed 140 compliance assistance tools. The generic clearance will facilitate the coordinated review and approval of surveys that solicit opinions from EPA customers on a voluntary basis. Every effort will be made to improve response rates to assessment surveys, and maximize the efficiency of data collection.

To ensure the proper use of the data from the surveys, OC will place the following conditions on the way the ICR is used:

• After compliance assistance is delivered, EPA will follow up on the quality of the assistance and the associated outcomes. During the compliance assistance activity, EPA should communicate how it intends to follow-up (e.g., phone, letter, email) and when.

• True behavioral changes will only be considered when they can be directly measured through on-site revisits, self-certifications or other direct observations. Behavioral changes expressed through surveys, training evaluations, and Internet questionnaires will be considered as indications of behavioral change.

• No use of comment cards as they often have low response rates.

• To ensure high response rates, all follow-up mail/email surveys must use the Dillman Tailored Design Method. Staff using phone surveys can also send out a postcard letting attendees know that EPA will be calling.

This action is directed to the public in general. This action may, however, be of interest to: Registrants and users of Bt corn under the Federal Food, Drug, and Cosmetic Act (FFDCA), or the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) as well as non-users of Bt corn and the public. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

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

To access information about the Office of Research and Development workshops on Bt corn IRM, go directly to the Home Page for Biopesticides at: http://www.epa.gov/pesticides/biopesticides, and select “ORDworkshops.”

2. In person. The Agency has established an administrative record for this meeting under docket control number OPP-00734. The administrative record consists of the documents specifically referenced in this notice, any public comments received during an applicable comment period, and other information related to the ORD Workshops on Bt Corn IRM, including any information claimed as Confidential Business Information (CBI). This administraive 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 administrative record, which includes printed, paper versions of any electronic comments that may be 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 a request to participate in this meeting through the mail, in person, or electronically. Do not submit any information in your request that is considered CBI. Your request must be received by EPA on or before September 4, 2001, for the third workshop on September 10th and 11th and October 22, 2001, for the fourth workshop on October 29th and 30th. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPP-00734, in the subject line on the first page of your request.

1. By mail. You may submit a request to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

2. In person or by courier. 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 request electronically by e-mail to: opp-docket@epa.gov. Do not submit any information electronically that you consider to be CBI. Use WordPerfect 6.1/8.0 or ASCII file format and avoid the use of special characters and any form of encryption. Be sure to identify by docket control number OPP-00734. You may also file a request online at many Federal Depository Libraries.

EPA, States, local governments and the private sector have made significant strides in reducing water pollution. Much of this progress is the result of controls on pollution from industries and sewage treatment facilities. Despite this progress, States report that about 30% of the waters they assess do not meet clean water goals. Today, water pollution problems are caused by a wide range of diffuse sources (e.g., pollutant runoff from agricultural lands, stormwater flows from cities, inadequate sewage treatment, and seepage into ground water). Many of these sources contribute microbial contaminants to waterbodies and this contamination impairs the use of waters for recreational, fishing, and shellfish growing purposes and limits use of waters as a source of drinking water.

In response to growing evidence of significant microbial contamination of waters, the Office of Water has prepared a draft Strategy for Waterborne Microbial Disease. This draft Strategy describes the microbial water pollution problem and identifies four areas of concern as the primary focus of efforts to reduce water pollution and threats to public health.

EPA seeks public comment on all aspects of the draft Strategy. Examples of questions that might be addressed by the public include:

(1) Does the draft Strategy appropriately describe the water pollution problem and public health risk posed by microbial contamination?

(2) The draft Strategy emphasizes four areas of concern. Are these four areas appropriate as the focus of the draft Strategy? If not, which other areas of concern should be addressed and why?

(3) Are the actions identified to strengthen water pollution control programs appropriate? What other actions should be considered?

EPA will produce a report that will summarize the meeting as well as capture all comments and suggestions. Submitted written comments will also be included in the document. Comments must be submitted to Ms. Harriet McCollum at Sciences, Inc., 1800 Diagonal Road, Suite 500, Alexandria, VA 23314; phone (703) 684-0123; fax (703) 684-2223, or email at hmccollum@sciences.com, by October 19, 2001.

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

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

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

2. In person. The Agency has established an official record for this action under docket control number OPP-30506. 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-30506 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, 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 Highway, 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-30506. 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 identified 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 registration activity.

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

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 received an application as follows to register a pesticide product containing an active ingredient not included in any previously registered products pursuant to the provision of section 3(c)(4) of FIFRA. Notice of receipt of this application does not imply a decision by the Agency on the application.

File Symbol: 73176-R. Applicant: AgriVir, LLC 1625 K Street, NW., Suite 1000, Washington, DC 20006. Product name: Nut GuardV/Fruit GuardV. Product type: Biological pesticide. Active ingredient: Indian Meal Moth Granulosis Virus and larval parts on milled wheat bran carrier at 96.4. Proposed classification/Use: for use on dried fruit, in shell and shelled nuts, for crack and crevice treatment of processing, packing and storage areas.

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

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

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

2. In person. The Agency has established an official record for this action under docket control number PF-1040. 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 Highway, 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 PF-1040 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, 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 Highway, 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 PF-1040. 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 identified 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. Make sure to submit your comments by the deadline in this notice.

7. 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 has received pesticide petitions as follows proposing the establishment and/or amendment of regulations for residues of certain pesticide chemicals in or on various food commodities under section 408 of the Federal Food, Drug, and Comestic Act (FFDCA), 21 U.S.C. 346a. EPA has determined that these petitions contain data or information regarding the elements set forth in section 408(d)(2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

Petitioner summaries of the pesticide petitions are printed below as required by section 408(d)(3) of the FFDCA. The summaries of the petitions were prepared by the petitioners and represent the views of the petitioners. EPA is publishing the petition summaries verbatim without editing them in any way. The petition summary announces the availability of a description of the analytical methods available to EPA for the detection and measurement of the pesticide chemical residues or an explanation of why no such method is needed.

EPA has received a pesticide petition (0F6121) from Bayer Corporation, 8400 Hawthorne Road, P. O. Box 4913, Kansas City, MO 64121-0013 proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 by establishing a tolerance for residues of trifloxystrobin in or on the raw agricultural commodity barley grain at 0.05 parts per million (ppm), straw at 0.05 ppm, barley hay at 0.2 ppm, citrus fruits group at 0.3 ppm, citrus oil at 7.0 ppm, corn forage at 0.05 ppm, corn stover at 7.0 ppm, aspirated grain fractions at 0.1 ppm, popcorn grain at 0.05 ppm, popcorn stover at 7.0 ppm, pecans at 0.05 ppm, rice grain at 3.5 ppm, rice straw at 7.5 ppm, stone fruits crops group at 2.0 ppm, and poultry (fat, kidney, liver, meat by-products, meats at 0.5 ppm). EPA has determined that the petition contains data or information regarding the elements set forth in section 408(d)(2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

1. Residue metabolism. The metabolism of trifloxystrobin in plants (cucumbers, apples, wheat, sugar beets and peanuts) is well understood. Identified metabolic pathways are substantially similar in plants and animals (goat, rat and hen). EPA has determined that trifloxystrobin parent and its metabolite CGA-321113 are the residue of concern for tolerance setting purposes.

2. Analytical method. A practical analytical methodology for detecting and measuring levels of trifloxystrobin in or on raw agricultural commodities has been submitted. The limit of detection (LOD) for each analyte of this method is 0.08 ng injected, and the limit of quantitation (LOQ) is 0.02 ppm. The method is based on crop specific cleanup procedures and determination by gas chromatography with nitrogen-phosphorous detection.

3. Magnitude of residues. Residue trials were performed for trifloxystrobin on a full geography of Citrus Fruit Crop Group (with oranges, lemons and grapefruit as representative citrus fruit crops), field corn, popcorn, and rice as representative crops from the cereal grain group, pecans, and Stone Fruits Crop Group (with peaches, plums, tart and sweet cherries as representative stone fruit crops). A study was conducted on indicator crops to assay for secondary residues in rotational crops. A three-level ruminant and poultry study was completed to determine the rate of transfer of residues of trifloxystrobin from residues in animal feed to ruminant and poultry commodities.

1. Acute Toxicity. Studies conducted with the technical material of trifloxystrobin:

• Rat acute oral toxicity study with a LD50 >5,000 mg/kg

• Mouse acute oral toxicity study with a LD50 >5,000 mg/kg

• Rabbit acute dermal toxicity study with a LD50 >2,000 mg/kg

• Rat acute dermal toxicity study with a LD50 >2,000 mg/kg

• Rat acute inhalation toxicity study with a LC50 >4.65 mg/L

• Rabbit eye irritation study showing slight irritation (Category III)

• Rabbit dermal irritation study showing slight irritation (Category IV)

• Guinea pig dermal sensitization study with Buehler's method showing negative findings

• Guinea pig dermal sensitization study with the Maximization method showing some positive findings

2. Genotoxicity. No genotoxic activity is expected of trifloxystrobin under in vivo or physiological conditions. The compound has been tested for its potential to induce gene mutation and chromosomal changes in five different test systems. The only positive finding was seen in the in vitro test system (Chinese hamster V79 cells) as a slight increase in mutant frequency at a very narrow range (250 - 278 μg/ml) of cytotoxic and precipitating concentrations (compound solubility in water was reported to be 0.61 μg/ml; precipitation was visually noted in culture medium at 150 μg/ml). The chemical was found to be non-mutagenic in the in vivo system or all other in vitro systems. Consequently, the limited gene mutation activity in the V79 cell line is considered a nonspecific effect under non-physiological in vitro conditions and not indicative of a real mutagenic hazard.

3. Reproductive and developmental toxicity. FFDCA section 408 provides that EPA may apply an additional safety factor for infants and children in the case of threshold effects to account for pre- and post-natal toxicity and the completeness of the database. Based on the current toxicological data requirements, the database on trifloxystrobin relative to pre- and post-natal effects for children is complete.

In assessing the potential for additional sensitivity of infants and children to residues of trifloxystrobin, data were considered from teratogenicity studies in the rat and the rabbit and a 2-generation reproduction studies in the rat. The teratogenicity studies were designed to evaluate adverse effects on the developing embryo as a result of chemical exposure during the period of organogenesis. Reproduction studies provide information on effects from chemical exposure on the reproductive capability of mating animals and systemic and developmental toxicity from in-utero exposure.

In the rat teratology study, reductions in body weight gain and food consumption were observed in the dam at ≥100 mg/kg. No teratogenic effects or any other effects were seen on pregnancy or fetal parameters except for the increased incidence of enlarged thymus, which is a type of variation, at 1,000 mg/kg. The developmental NOAEL was 100 mg/kg.

In the rabbit teratology study, body weight loss and dramatically reduced food consumption were observed in the dam at ≥2,050 mg/kg. No teratogenic effects or any other effects were seen on pregnancy or fetal parameters except for the increase in skeletal anomaly of fused sternebrae-3 and -4 at the top dose level of 500 mg/kg. This finding is regarded as a marginal effect on skeletal development that could have resulted from the 40-50% lower food intake during treatment at this dose level. The developmental NOAEL was 250 mg/kg.

In the 2-generation rate reproduction study, body weight gain and food consumption decreased at ≥750 ppm, especially in females during lactation. Consequently, the reduced pup weight gain during lactation (≥750 ppm) and the slight delay in eye opening (1,500 ppm) are judged to be a secondary effect of maternal toxicity. No other fetal effects or any reproductive changes were noted. The low developmental NOAEL, 50 ppm (5 mg/kg), seen in this study was probably due to the lack of intermediate dose levels between 50 and 750 ppm. Based on an evaluation of the dose-response relationship for pup weight at 750 ppm and 1,500 ppm, the NOAEL should have already been nearly ten-fold higher if such a dose was available.

Based on all these teratology and reproduction studies, the lowest NOAEL for developmental toxicity is 5 mg/kg while the lowest NOAEL in the subchronic and chronic studies is 2.5 mg/kg/day (from the rat chronic study). Therefore, no additional sensitivity for infants and children to trifloxystrobin is suggested by the database.

4. Subchronic toxicity. In subchronic studies, several mortality related changes were reported for the top dose in dogs (500 mg/kg) and rats (800 mg/kg). At these dose levels, excessive toxicity has resulted in body weight loss and mortality with the associated and nonspecific changes in several organs (such as atrophy in the thymus, pancreas, bone morrow, lymph node, and spleen) which are not considered specific target organs for the test compound. In the dog, specific effects were limited to hepatocellular hypertrophy at ≥150 mg/kg and hyperplasia of the epithelium of the gall bladder at 500 mg/kg. Target organ effects in the rat were noted as hepatocellular hypertrophy (≥200 mg/kg) and the related liver weight increase (≥50 mg/kg). In the mouse, target organ effects included single cell necrosis (≥300 mg/kg) and hypertrophy (1,050 mg/kg) in the liver and extramedullary hematopoiesis (≥300 mg/kg) and hemosiderosis in the spleen (1,050 mg/kg).

In general, definitive target organ toxicity, mostly in the liver, was seen at high feeding levels of over 100 mg/kg for an extended treatment period. At LOAEL, no serious toxicity was observed other than mostly non-specific effects including a reduction in body weight and food consumption or liver hypertrophy.

5. Chronic toxicity. The liver appears to be a major primary target organ based on the chronic studies conducted in mice, rats, and dogs. It was identified as a target organ in both the mouse and the dog studies with trifloxystrobin. However, no liver effect was seen in the chronic rat study which produced the lowest NOAEL of 2.5 mg/kg based on reduced body weight gain and food consumption seen at higher dose levels.

The compound did not cause any treatment-related increase in general tumor incidence, any elevated incidence of rare tumors, or shortened time to the development of palpable or rapidly lethal tumors in the 18-month mouse and the 24-month rat studies. Dosages in both studies were sufficient for identifying a cancer risk. In the absence of carcinogenicity, a Reference Dose approach is appropriate for quantitation of human risks.

6. Animal metabolism. Trifloxystrobin is moderately absorbed from the gastrointestinal tract of rats and is rapidly distributed. Subsequent to a single oral dose, the half life of elimination is about 2 days and excretion is primarily via bile. Trifloxystrobin is extensively metabolized by the rat into about 35 metabolites, but the primary actions are on the methyl ester (hydrolysis into an acid), the methoxyimino group (O-demethylation), and the methyl side chain (oxidation to a primary alcohol). Metabolism is dose dependent as it was almost complete at low doses but only about 60% complete at high doses.

In the goat, elimination of orally administered trifloxystrobin is primarily via the feces. The major residues were the parent compound and the acid metabolite (CGA-321113) plus its conjugates. In the hen, trifloxystrobin is found as the major compound in tissues and in the excreta, but hydroxylation of the trifluormethyl-phenyl moiety and other transformations, including methyl ester hydrolysis and demethylation of the methoxyimino group, are also seen. In conclusion, the major pathways of metabolism in the rat, goat, and hen are the same.

7. Metabolite toxicology. Metabolism of trifloxystrobin has been well characterized in plants, soil, and animals. In plants and soil, photolytically induced isomerization results in a few minor metabolites not seen in the rat; however, most of the applied materials remained as parent compound as shown in the apple and cucumber studies. All quantitatively major plant and/or soil metabolites were also seen in the rat. The toxicity of the major acid metabolite, CGA-321113 (formed by hydrolysis of the methyl ester), has been evaluated in cultured rat hepatocytes and found to be 20-times less cytoxic than the parent compound. Additional toxicity studies were conducted for several minor metabolites seen uniquely in plants and/or soil. The studies indicate that these metabolites, including CGA-357261, CGA-373466, and NOA-414412, are not mutagenic to bacteria and are of low acute toxicity (LD50 >2,000 mg/kg). In conclusion, the metabolism and toxicity profiles support the use of an analytical enforcement method that accounts for parent trifloxystrobin.

8. Endocrine disruption. CGA-279202 does not belong to a class of chemicals known for having adverse effects on the endocrine system. Developmental toxicity studies in rats and rabbits and reproduction study in rats gave no indication that CGA-279202 might have any effects on endocrine function related to development and reproduction. The subchronic and chronic studies also showed no evidence of a long-term effect related to the endocrine system.

i. Dietary exposure— a. Food. Acute and chronic dietary exposure assessments were performed on the crops that are the subject of this petition using field trial residue values on the citrus and stone fruit crop groups, corn, rice, barley, and pecans. In addition, established uses on sugar beets, almonds, fruiting vegetable (crop group), pome fruit (crop group), cucurbits (crop group), bananas, grapes, peanuts, potatoes, hops, and wheat were included in the assessment. All residues were generated from field trials conducted with a minimum pre-harvest interval and maximum application rate. In addition, if market share data were available, residues were adjusted for the percent crop treated. The residues in processed potatoes, sugar beets (molasses), tomatoes, oranges (juice), apples (juice), corn, rice, wheat fractions, peanuts, and grapes (juice) were adjusted using experimentally determined processing factors generated from processing studies. For all other processed fractions, USDA default processing factors were utilized. Residues in animal commodities were calculated from theoretical dietary burden calculations and transfers factors obtained from livestock and poultry feeding studies. Assessments were conducted utilizing the Dietary Exposure Evaluation Model (DEEM®) from Novigen Sciences and the 1994-96 Continuing Survey of Food Intake by Individuals (CSFII). Acute exposure for the U.S. population and all population subgroups were compared to an acute reference dose (aRfD) of 2.5 mg/kg/day based on a developmental no-observable adverse effect level (NOAEL) in rabbits and a 100-fold uncertainty factor. Although this endpoint is applicable to females only in the strictest sense, the developmental NOAEL was used for all populations due to the lack of a suitable toxicological endpoint. Chronic exposure was compared to a chronic RfD of 0.05 mg/kg/day based on a chronic study in dogs and a 100-fold uncertainty factor. Both acute and chronic toxicological endpoints were taken from the final pesticide tolerance rule for trifloxystrobin published in the Federal Register of September 27, 1999 (OPP-300922; FRL-6382-5).

Both acute and chronic exposure was minimal in all population subgroups. The acute results were obtained from a probabilistic, 1,000-iteration Monte Carlo assessment. Acute exposure was expressed at the 99.9th percentile of exposure and ranged from 0.17% to 0.08% of the aRfD with non-nursing infants (less than 1 year old) as the most sensitive population subgroup (0.80% of the RfD). The chronic exposure assessment was conducted by taking the mean field trial residue values and comparing to average daily consumption values. Chronic exposure ranged from 0.2% to 1.2% of the chronic RfD and the most sensitive population was non-nursing infants (less than 1 year old).

b. Drinking water—Estimated surface water concentration. The generic expected environmental concentration (GENEEC) estimated surface water concentrations for trifloxystrobin uses contributed little to the over exposure. These estimated concentrations were not adjusted for the estimated market share of percentage of use area. The highest day-56 expected environmental concentration (EEC) value was 0.27 parts per billion (ppb) provided by the established trifloxystrobin turf use. According to the EPA “OPP's Interim Approach for Addressing Drinking Water Exposure,” the average day-56 value is divided by three when correcting for overestimation of the GENEEC model. The EPA has accepted that the average day-56 EEC value is divided by six in the case when the product is applied to turf and accounts for the effects of grass/turf in decreasing runoff (EPA, 1998. EPA-730-F97-2, PB97-137806, page 15). This division by six was used to calculate the potential exposure via surface water from the trifloxystrobin turf application, 0.27 ppb/6=0.045 ppb.

Estimated ground water concentrations. The SCI-GROW estimated ground water concentrations for trifloxystrobin uses also contributed little to the overall exposure. The estimated concentrations were not adjusted for the estimated market share or percentage of use area. In each use scenario, the concentration of trifloxystrobin in ground water was predicted to be below 1 part per trillion. The highest estimated concentration of trifloxystrobin in the ground water was 0.000859 ppb provided by the trifloxystrobin turf use.

c. Drinking water levels of concern—Acute exposure. Based on the EPA's “Interim Guidance for Conducting Drinking Water Exposure and Risk Assessments” document (drafted 12/2/97), acute drinking water levels of comparison (DWLOCacute) were calculated for trifloxystrobin. The lowest acceptable Margin of Exposure (MOE) for any pesticide is 100. This value was used in the DWLOC calculations. Based on this analysis, the maximum estimated trifloxystrobin surface water at Peak Day-0 (2.54 ppb) and ground water (0.000859 ppb) concentrations, human drinking water exposures do not exceed the calculated acute DWLOC values (μg/L:24,8000 to 87,325). Therefore, acute human drinking water exposures to trifloxystrobin from the existing and newly proposed uses would not exceed the exposure allowable by the risk cup. From the acute dietary exposure analysis provided for the trifloxystrobin dietary assessment, the acute drinking water levels of comparison (DWLOCacute) were calculated for CGA-32113. Based on this analysis, the maximum estimated CGA-32114 in surface water at Peak Day-0 (38.73 ppb) and in ground water (4.944316 ppb) concentrations, human drinking water exposures do not exceed the calculated acute DWLOC values (μg/L:24800 to 87150). Therefore, acute human drinking water exposures to CGA-32114 from the existing and newly proposed trifloxystrobin uses would not exceed the exposure allowable by the risk cup.

Chronic exposure. The chronic drinking water levels of comparison (DWLOCchronic) were calculated for trifloxystrobin. The maximum estimated trifloxystrobin surface water (0.09 ppb) and ground water (0.000859 ppb) concentrations do not exceed the calculated chronic DWLOC values (μg/L:494 to 1747). Therefore, chronic human drinking water exposures to the existing and newly proposed trifloxystrobin uses would not exceed the exposure allowable by the risk cup. From the chronic dietary exposure analysis provided for the trifloxystrobin dietary assessment, the chronic drinking water levels of comparison (DWLOCchronic) were calculated for CGA-32113. Based on this analysis, the maximum estimated CGA-32113 in surface water at Day 56/3 (12.24 ppb) and in ground water (0.989 ppb) concentrations, human drinking water exposures do not exceed the calculated chronic DWLOC values (μg/L:494 to 1,745). Therefore, chronic human drinking water exposures to the existing and newly proposed trifloxystrobin uses would not exceed the exposure allowable by the risk cup.

ii. Non-dietary exposure. Non-dietary exposure to trifloxystrobin is considered negligible as the chemical is intended primarily for commercial and agricultural use. Post-application re-entry exposure to homeowners from professional use on residential ornamentals is considered negligible. For workers handling this chemical, acceptable margins of exposure (in the range of thousands) have been obtained for both acute and chronic scenarios.

Consideration of a common mechanism of toxicity is not appropriate at this time since there is no information to indicate that toxic effects produced by trifloxystrobin would be cumulative with those of any other types of chemicals. Furthermore, the oximinoacetate is a new type of fungicide and no compound in this general chemical class currently has a significant market share. Consequently, aggregate risk is the only potential exposure to trifloxystrobin.

1. U.S. population. To calculate acute aggregate risk, high-end exposures from food and drinking water sources are compared to the acute population adjusted dose (aPAD). Exposure to trifloxystrobin residues and the free form of its acid metabolite, CGA-321113 in food will occupy <1% of the aPAD for females 13+ years old (nursing). Acute dietary risk was calculated for females 13+ years old because the endpoint upon which the aPAD is based is on developmental effects. Estimated drinking water levels were calculated using drinking water models (SCI-GROW and GENEEC), and the values are considered overestimates due to the conservative assumptions built into the models. Estimated concentrations of trifloxystrobin residues in surface and ground water are lower than EPA's DWLOCs. Therefore, it is not expected that acute aggregate risk to trifloxystrobin residues from acute food and drinking water sources will exceed EPA's level of concern for acute aggregate risk.

Chronic exposure to residues of trifloxystrobin and the free form of its acid metabolite, CGA-321113, in food will occupy less than 0.5% of the chronic population adjusted dose (cPAD) for adult population subgroups (females 13+/nursing) and no more than 2.0% of the cPAD for infant/children subgroups (highest subgroup: non-nursing infants). Estimated concentrations of trifloxystrobin residues in surface and ground water are lower than EPA's DWLOCS. Estimated drinking water levels were calculated using drinking water models, and the values are considered overestimates due to the conservative assumptions built into the models. EPA has previously determined chronic residential exposure of trifloxystrobin is not expected. The established and pending uses of trifloxystrobin when combined in a chronic aggregate risk assessment for food, water and residential sources will not exceed EPA's level of concern for chronic aggregate risk.

Bayer concludes that there is a reasonable certainty that no harm will result from aggregate exposure to trifloxystrobin residue.

2. Infants and children. On June 21, 1999, the EPA FQPA Safety Factor Committee determined the 10x safety factor for the protection of infants and children should be removed for trifloxystrobin. The Committee's rationale for removing the FQPA Safety Factor is as follows:

i. The trifloxystrobin toxicology database is complete for FQPA assessment.

ii. There is no indication of increased susceptibility of rat or rabbits to trifloxystrobin.

In the developmental and reproductive toxicity studies, effects in the fetuses/offspring were observed only at or above treatment levels which resulted in evidence of parental toxicity.

Using the same exposure assumptions as employed for the determination in the general population, it has been calculated that the percent of the RfD that will be utilized by aggregate exposure to residues of trifloxystrobin is <2.0% for non-nursing infants (<1 year old)(the most impacted sub-population). Therefore, based on the completeness and reliability of the toxicity data base and the conservative exposure assessment, Bayer concludes that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to trifloxystrobin residues.

No Codex MRLs have been established for residues of trifloxystrobin.

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

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

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

2. In person. The Agency has established an official record for this action under docket control number PF-1041. 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 Highway, 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 PF-1041 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, 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 Highway, 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 PF-1013. 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 identified 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. Make sure to submit your comments by the deadline in this notice.

7. 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 has received a pesticide petition as follows proposing the establishment and/or amendment of regulations for residues of a certain pesticide chemical in or on various food commodities under section 408 of the Federal Food, Drug, and Comestic Act (FFDCA), 21 U.S.C. 346a. EPA has determined that this petition contains data or information regarding the elements set forth in section 408(d)(2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition.

The petitioner summary of the pesticide petition is printed below as required by section 408(d)(3) of the FFDCA. The summary of the petition was prepared by the petitioner and represents the view of the petitioners. EPA is publishing the petition summary verbatim without editing it in any way. The petition summary announces the availability of a description of the analytical methods available to EPA for the detection and measurement of the pesticide chemical residues or an explanation of why no such method is needed.

This notice announces the initial filing of pesticide petitions proposing the establishment of regulations for residues of a certain pesticide chemical in or on various food commodities. EPA has received pesticide petitions (PP 0F6169 and 1F6229) from Gowan Company, Yuma, AZ, 85364, and (PP 0E6206) from the Interregional Research Project #4, 681 U.S. Highway No.1 South, North New Brunswick, NJ 08902-3390, proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 by establishing tolerances for residues of the herbicide halosulfuron-methyl (methyl 5-[(4,6-dimethoxy-2-pyrimidinyl)amino] carbonyl aminosulfonyl-3-chloro-1-methyl-1H-pyrazole-4-carboxylate) in or on the fruiting vegetables (excluding cucurbits) Crop Group 8 at 0.05 parts per million (ppm) (PP 0F6169), asparagus at 0.8 ppm (PP 1F6229), and the melon subgroup Subgroup 9A at 0.1 ppm. EPA has determined that the petitions contain data or information regarding the elements set forth in section 408(d)(2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petitions. Additional data may be needed before EPA rules on the petitions.

1. Plant metabolism. The metabolism of halosulfuron-methyl as well as the nature of the residues in plants is adequately understood for purposes of these tolerances. Metabolism studies were conducted in three crops, viz.; field corn, sugarcane and soybeans. Metabolism depends on the mode of application. Preemergent applications result in rapid soil degradation of halosulfuron-methyl followed by crop uptake of the resulting pyrazole moiety. The pyrimidine ring binds tightly to soil and is eventually converted to carbon dioxide by microbial degradation. In postemergent applications, little metabolism and translocation take place resulting in unmetabolized parent compound as the major residue on the directly treated foliar surfaces. Very low residue levels of the metabolite 3-chloro-1-methyl-5-sulfamoylpyrazole-4-carboxylic acid (3-CSA) are found in the grain.

2. Analytical method. A practical analytical method, gas chromatography with a nitrogen specific detector (TSD) which detects and measures residues of halosulfuron-methyl, is available for enforcement purposes with a limit of detection that allows monitoring of food with residues at or above the levels set in these tolerances. This enforcement method has been submitted to the Food and Drug Administration for publication in the Pesticide Analytical Manual (PAM II). It has undergone independent laboratory validation and validation at the Beltsville laboratory. An Analytical Chemistry section of the EPA concluded that the method is adequate for enforcement. The analytical method is also available for analyzing meat by-products, which also underwent successful independent laboratory and Beltsville laboratory validations.

3. Magnitude of residues. In asparagus residue studies, the magnitude of the residues found in the raw agricultural commodity (RAC) was less than 0.8 ppm using an analytical method with limit of quantitation (LOQ) of 0.05 ppm; residues in cantaloupe were less than 0.1 ppm. In tomato and pepper residue studies, there were no quantifiable residues found in the RACs. There were also no detectable residues at a LOQ of 0.05 ppm found in tomato processed commodities at treatment rates of more than 2 times the maximum recommended rate per season.

1. Acute toxicity. Acute toxicological studies placed the technical-grade halosulfuron-methyl in Toxicity Category III. A 90-day feeding study in rats resulted in a lowest observed adverse effect level (LOAEL) of 497 milligrams/kilograms/day (mg/kg/day) in males and 640 mg/kg/day in females, and a no observed adverse effect level (NOAEL) of 116 mg/kg/day in males and 147 mg/kg/day in females.

2. Genotoxicity. Bacterial/mammalian microsomal mutagenicity assays were performed and found not to be mutagenic. Two mutagenicity studies were performed to test gene mutation and found to produce no chromosomal aberrations or gene mutations in cultured Chinese hamster ovary cells. An in vivo mouse micronucleus assay did not cause a significant increase in the frequency of micronucleated polychromatic erythrocytes in bone marrow cells. A mutagenicity study was performed on rats and found not to induce unscheduled DNA synthesis in primary rat hepatocytes.

3. Reproductive and developmental toxicity. A developmental toxicity study in rats resulted in a developmental LOAEL of 750 mg/kg/day, based on decreases in mean litter size and fetal body weight, and increases in resorptions, resorptions/dam, post-implantation loss and in fetal and litter incidences of soft tissue and skeletal variations, and a developmental NOAEL of 250 mg/kg/day. Maternal LOAEL was 750 mg/kg/day based on increased incidence of clinical observations, reduced body weight gains, and reduced food consumption and food efficiency. The maternal NOAEL was 250 mg/kg/day.

A developmental toxicity study in rabbits resulted in a developmental LOAEL of 150 mg/kg/day, based on decreased mean litter size and increases in resorptions, resorptions/dam and post-implantation loss, and a developmental NOAEL of 50 mg/kg/day. The maternal LOAEL was 150 mg/kg/day based on reduced body weight gain and reduced food consumption and food efficiency. The maternal NOAEL was 50 mg/kg/day.

A dietary 2-generation reproduction study in rats resulted in parental toxicity at 223.2 mg/kg/day in males and 261.4 mg/kg/day in females in the form of decreased body weights, decreased body weight gains, and reduced food consumption during the premating period. Very light effects were noted in body weight of the offspring at this dose. This effect was considered to be developmental toxicity (developmental delay) rather than a reproductive effect. No effects were noted on reproductive or other developmental toxicity parameters. The systemic/ developmental toxicity LOAEL was 223.2 mg/kg/day in males and 261.4 mg/kg/day in females; the systemic/developmental toxicity NOAEL was 50.4 mg/kg/day in males and 58.7 mg/kg/day in females. The reproductive LOAEL was greater than 223.2 mg/kg/day in males and 261.4 mg/kg/day in females; the reproductive NOAEL was equal to or greater than 223.2 mg/kg/day in males and 261.4 mg/kg/day in females.

4. Subchronic toxicity. A 21-day dermal toxicity study in rats resulted in a NOAEL of 100 mg/kg/day in males and greater than 1,000 mg/kg/day in females. The only treatment-related effect was a decrease in body weight gain of the 1,000 mg/kg/day group in males.

5. Chronic toxicity. A 1-year chronic oral study in dogs resulted in a LOAEL of 40 mg/kg/day based on decreased weight gain and a NOAEL of 10 mg/kg/day for systemic toxicity. A 78-week carcinogenicity study was performed on mice. Males in the 971.6 mg/kg/day group had decreased body weight gains and an increased incidence of microconcretion/mineralization in the testis and epididymis. No treatment-related effects were noted in females. Based on these results, a LOAEL of 971.9 mg/kg/day was established in males and NOAELs of 410 mg/kg/day in males and 1,214.6 mg/kg/day in females were established. The study showed no evidence of carcinogenicity. A combined chronic toxicity/carcinogenicity study in rats resulted in a LOAEL of 225.2 mg/kg/day in males and 138.6 mg/kg/day in females based on decreased body weight gains, and a NOAEL of 108.3 mg/kg/day in males and 56.3 mg/kg/day in females. The study showed no evidence of carcinogenicity.

6. Animal metabolism. EPA stated that the nature of the residue in ruminants was determined to be adequately understood. In the tissues and milk of goats, the major extractable residue was the unmetabolized parent compound. Based on the low residues of the parent compound in corn grain and the low transfer of residues in the metabolism study, tolerances on poultry products were not required. In the rat metabolism study, parent compound was absorbed rapidly but incompletely. Excretion was relatively rapid at all doses tested with majority of radioactivity eliminated in the urine and feces by 72 hours. Fecal elimination of parent was apparently the result of unabsorbed parent.

7. Metabolite toxicology. The toxicology studies listed below were conducted with the 3-CSA metabolite. Based on the toxicological data of the 3-CSA metabolite, EPA concluded that it has lower toxicity compared to the parent compound and that it should not be included in the tolerance expression. The residue of concern is the parent compound only.

i. A 90-day rat feeding study resulted in a LOAEL in males of >20,000 ppm and a NOAEL of 20,000 ppm (1,400 mg/kg/day). In females, the LOAEL is 10,000 ppm (772.8 mg/kg/day) based on decreased body weight gains and a NOAEL of 1,000 ppm (75.8 mg/kg/day).

ii. A developmental toxicity resulted in a LOAEL for maternal toxicity of 1,000 mg/kg/day based on the absence of systemic toxicity, a NOAEL of 1,000 mg/kg/day. The developmental LOAEL is >1,000 mg/kg/day and the NOAEL is 1,000 mg/kg/day

iii. The microbial reverse gene mutation did not produce any mutagenic effect while the mammalian cell gene mutation/Chinese hamster ovary cells did not show a clear evidence of mutagenic effect in the Chinese hamster ovary cells.

iv. The mouse micronucleus assay did not show any clastogenic or aneugenic effect.

8. Endocrine disruption. No specific tests have been conducted with halosulfuron-methyl to determine whether the chemical may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen or other endocrine effects. However, there were no significant findings in other relevant toxicity tests, i.e., teratology and multi-generation reproduction studies, which would suggest that halosulfuron-methyl produces effects characteristic of the disruption of the estrogenic hormone.

1. Dietary exposure. Tolerances have been established (40 CFR 180.479) for residues of halosulfuron-methyl in or on a variety of plant and animal RACs including field corn, grain sorghum (milo), sweet corn (kernel + cobs with husks removed), pop corn grain, sugarcane cane, tree nuts nutmeat, pistachio nuts nutmeat, cotton undelinted seed, and rice grain at 0.05 ppm; squash/cucumber subcrop group 9B at 0.5 ppm; and secondary tolerances in meat and meat by-products at 0.1 ppm (cattle, goats, hogs, horses, and sheep). Additional tolerances are being requested by Gowan for fruiting vegetables (except cucurbits) crop group 8 at 0.05 ppm and asparagus at 0.8 ppm, and by IR-4 for the melon subcrop group 9A at 0.1 ppm.

Food_a. Acute exposure. The acute Reference Dose (aRfD) for halosulfuron-methyl is 0.5 mg/kg/day. For purposes of assessing the potential dietary exposure from food under existing and proposed tolerances, aggregate exposure is based on the Theoretical Maximum Residue Contribution (TMRC) which is an estimate of the level of residues consumed daily if each food item contained pesticide residues equal to the tolerance. The calculated TMRC value using the 99.9th percentile consumption data was 0.006 mg/kg body weight/day for the general U.S. population. This value utilizes only 1.2% of the aRfD for all established and proposed tolerances for halosulfuron-methyl. TMRC is obtained by multiplying the tolerance levels for each commodity by the daily consumption of the food forms of that commodity eaten by the U.S. population and various population subgroups. In conducting this exposure assessment, conservative assumptions were made, e.g., 100% of all commodities will contain halosulfuron-methyl residues and those residues would be at the level of their respective tolerances. This results in a large overestimate of human exposure. Food consumption data from DEEM software (Novigen Sciences, Inc.) were used in the calculation. Field corn and sorghum forage and fodder are fed to animals, thus exposure of humans to residues from these commodities might result if such residues are transferred to meat, milk, poultry or eggs. However, based on the results of animal metabolism and the amount of halosulfuron-methyl expected in animal feeds, it can be concluded that there is no reasonable expectation that residues of halosulfuron-methyl will exceed existing tolerances in meat.

b. Chronic exposure. The chronic Reference Dose (cRfD) is 0.1 mg/kg/day. The calculated TMRC value using 99.9th percentile consumption data was 0.000779 mg/kg body weight/day for children 1-6 years, the most exposed subpopulation group. This value utilizes only 0.8% of the CRfD for all established and proposed tolerances for halosulfuron-methyl.

c. Short-term and intermediate-term exposure. The short-term NOAEL for females 13 + years and infants and children is 50 mg/kg/day. Comparing the NOAEL with the chronic food exposure from DEEM analysis of 0.00042 mg/kg/day for females 13+ and 0.00090 mg/kg/day for infants and children results in food MOEs of 119,000 and 55,600, respectively. The intermediate-term NOAEL is 10 mg/kg/day, comparing the NOAEL with the chronic food exposure from DEEM analysis of 0.00090 mg/kg/day for children (1-6 years old) results in a food MOE of 11,100.

d. Chronic risk-carcinogenic. Halosulfuron-methyl has been classified as a Group E chemical based upon the lack of evidence of carcinogenicity in mice and rats, and has been classified as a not likely human carcinogen.

e. Drinking water. There is no Maximum Contaminant Level (MCL) established for residues of halosulfuron-methyl. It is not listed for MCL development or drinking water monitoring under the Safe Drinking Water Act nor is it a target of EPA's National Survey of Wells for Pesticides. Gowan and IR-4 are not aware of any halosulfuron-methyl detections in any wells, ponds, lakes or streams resulting from its use in the United States. The estimated drinking water environmental concentrations (DWEC) in ground water (acute and chronic) is 0.008 μg/L. The estimated DWECs (acute and chronic) for surface water are 4.3 μg/L and 1.1 μg/L, respectively. These estimates are based on a maximum application rate of 0.063 lbs active per acre which may be applied twice per season.

f. Acute exposure and risk. Acute drinking water levels of concern (DWLOCs) have been calculated for exposure to halosulfuron-methyl in drinking water for the relevant population subgroups of females 13+ years and infants and children. The acute DWLOC is 15,000 μg/L for females 13+ years and 5,000 μg/L for infants and children. The calculated DWLOCs are significantly higher than the DWECs for ground water (0.008 μg/L) and surface water (4.3 μg/L).

g. Chronic exposure and risk. Chronic DWLOCs have been calculated for exposure to halosulfuron-methyl in drinking water for the U.S. population (48 states) and the relevant subgroups of females 13+ years and infants and children. The chronic DWLOC is 3,500 μg/L for the U.S. population, 3,000 μg/L for females 13+ years, and 1,000 μg/L for infants and children. The calculated DWLOCs are significantly higher than the DWECs for ground water (0.008 μg/L) and surface water (1.1 μg/L).

h. Short and intermediate term exposure and risk. Short-term and intermediate-term DWLOCs have been calculated for exposure to halosulfuron-methyl in drinking water for the relevant population subgroups. The short-term DWLOC is 10,000 μg/L for females 13+ years and 3,700 μg/L for infants and children. The intermediate-term DWLOC is 590 μg/L for adult males, 57 μg/L for females 13+ years, and 160 μg/L for infants and children. The calculated intermediate-term DWLOCs are significantly higher than the chronic DWECs for surface water (1.1 μg/L). The calculated short-term DWLOCs are significantly higher than the acute DWECs for ground water (0.008 μg/L) and surface water (4.3 μg/L).

i. Conclusion. EPA has concluded that potential levels of halosulfuron-methyl in soil and water do not appear to have significant toxicological effects on humans or animals and presents a negligible risk. Based on the very low level of mammalian toxicity, lack of other toxicological concerns and low use rates, there is reasonable certainty that no harm will result from exposure to halosulfuron-methyl via drinking water sources.

2. Non-dietary exposure. Halosulfuron-methyl is labeled for use on commercial and residential turf and other non-crop sites. For residential applicators, short-term and intermediate-term exposure may occur. Chronic exposure (>6 months of continuous exposure) are not expected.

i. Acute exposure and risk. There is potential for exposure to halosulfuron-methyl by homeowner. However, since endpoints for acute dermal or inhalation were not identified, the use of halosulfuron-methyl on residential non-food sites is not expected to pose an unacceptable acute risk.

ii. Chronic exposure and risk. Chronic exposures for residential use of halosulfuron-methyl are not expected and a chronic non-deitary endpoint was not identified, therefore, the use on residential non-food sites is not expected to pose an unacceptable chronic risk.

iii. Short-term and intermediate-term exposure and risk.re is potential for short-term or intermediate-term dermal exposure to residential handlers, therefore residential exposure assessments were conducted to assess the following post-application exposure scenarios: (a) Dermal exposure to residues on turf; (b) children's incidental non-dietary ingestion of residues on residential lawn from hand-to-mouth transfer; and (c) children's ingestion of pesticide-treated turfgrass.

The short-term dermal MOE for residential handlers is 4,200 which is significantly greater than the minimum acceptable MOE of 100.

The short-term dermal MOE for exposure from treated lawns for adult males, adult females, and children are 390, 330, and 420, respectively, which are significantly greater than the minimum acceptable MOE of 100. The intermediate-term dermal MOE for exposure from treated lawns for adult males, adult females, and children are 120, 100, and 130, respectively, which are significantly greater than the minimum acceptable MOE of 100. Therefore the use of halosulfuron-methyl on residential non-food sites is not expected to pose an unacceptable short-term or intermediate-term risk.

The short-term and intermediate- term oral MOE for hand-to-mouth transfer for children are 4,900 and 1,500, respectively, which are significantly greater than the minimum acceptable MOE of 100. Therefore, the use of halosulfuron-methyl on residential non-food sites is not expected to pose an unacceptable short-term or intermediate-term risk.

The short-term and intermediate-term oral MOE for incidental ingestion by children are 210,000 and 66,000, respectively, which are significantly greater than the minimum acceptable MOE of 100. Therefore, the use on residential non-food sites is not expected to pose an unacceptable short-term or intermediate- term risk.

Halosulfuron-methyl belongs to the sulfonyl urea class of chemistry. The mode of action of halosulfuron-methyl is the inhibition of the plant enzyme aceto lactase synthetase (ALS), which is essential for the production of required amino acid in plants. Although other registered sulfonyl ureas may have similar herbicidal mode of action, there is no information available to suggest that these compounds exhibit a similar toxicity profile in the mammalian system that would be cumulative with halosulfuron-methyl. Thus, consideration of a common mechanism of toxicity is not appropriate at this time. Gowan is considering only the potential risks of halosulfuron-methyl in its aggregate exposure assessment.

1. U.S. population_i. Acute risk. Aggregate exposure risk includes exposure from food and water. The risk from acute “food only” exposure is less than 2.9% of the RfD for all population groups which is less than the EPA's level of concern. The lowest DWLOC calculated was 5,000 μg/L for infants and children. The calculated DWLOC for females (13+ years) was 15,000 μg/L. For both subgroups, the DWLOC is significantly higher than the DWEC for acute ground water (0.008 g/L) and surface water (4.3 μg/L), therefore, the risk from aggregate exposure to halosulfuron-methyl residues from all anticipated dietary exposure routes does not pose appreciable risks to human health.

ii. Chronic risk. Aggregate chronic exposure to halosulfuron-methyl from “food only” utilizes less than 1% of the RfD for the most sensitive subgroup, children (1-6 years). The lowest DWLOC calculated was 1,000 μg/L for infants and children which is significantly higher than the DWEC for chronic ground water (0.008 g/L) and surface water (1.1 μg/L). Therefore, the aggregate risk from chronic exposure to halosulfuron-methyl residues from all anticipated dietary exposures does not pose appreciable risks to human health.

iii. Short-term and intermediate-term risk.

a. Short-term aggregate exposure takes into account chronic dietary food and water plus short-term residential exposure. For halosulfuron-methyl, the EPA has determined that it is appropriate to aggregate exposure via oral exposure route (food and water) with those via oral and dermal exposure routes from residential uses. The MOEs for “food only” and residential exposure routes are 13,859 and 310 for females 13+ years. Short-term DWLOC for females 13+ is 10,000 mu;g/L which is substantially higher than the DWEC for acute surface water (4.3 μg/L). The food only and residential (oral and dermal) MOEs are well above the acceptable short-term aggregate MOE of 100. Therefore, exposure to halosulfuron-methyl residues resulting from current and proposed uses does not pose a short-term aggregate risk.

b. Intermediate-term aggregate exposure takes into account chronic dietary food and water plus intermediate-term residential exposure. The MOEs for “food only” and residential exposure routes are 24,000 and 120 for adult males, and 23,800 and 100 for females 13+ years. The intermediate-term DWLOCs are 590 μg/L and 57 μg/L, respectively, for adult males and females 13+. Intermediate-term DWLOCs are substancially higher than the DWEC for chronic surface water (1.1 μg/L). The food only and residential (dermal) MOEs are above the acceptable short-term aggregate MOE of 100. Therefore, exposure to halosulfuron-methyl residues resulting from current and proposed uses does not pose a intermediate-term aggregate risk.

c. Aggregate cancer risk. Halosulfuron-methyl has been classified as a Group E chemical based upon the lack of evidence of carcinogenicity in mice and rats, and has been classified as a not likely human carcinogen.

d. Conclusion. Based upon these risk assessments, Gowan concluded that there is a reasonable certainty that no harm will result from aggregate exposure to halosulfuron-methyl residues resulting from current and proposed uses.

2. Infants and children._i. Safety factor. FFDCA section 408 provides that EPA may apply an additional safety factor (up to 10) in the case of threshold effects for infants and children to account for pre-natal and post-natal toxicity and the completeness of the data base. Except for the pending request for a developmental neurotoxicity study, the toxicity data base is complete for halosulfuron-methyl. Based upon reliable toxicity data, the use of an additional 10x safety factor is not warranted. Dietary assessments do not indicate a level of concern for potential risks to infants and children based upon the low use rates of halosulfuron-methyl and that the results of field and animal RAC studies conclude that detectable residues are not expected in human foods.

ii. Acute risk. The acute RfD was determined to be 0.5 mg/kg/day based upon the developmental rabbit study. The percent of the RfD occupied is 2.9% for the most sensitive population subgroup, nursing infants (<1 year). The drinking water level of comparison (DWLOC) for acute exposure for infants and children is 5,000 μg/L and is significantly greater than the maximum concentration of halosulfuron-methyl in drinking water (0.008 μg/L in ground water and 4.3 μg/L in surface water).

iii. Chronic risk. The chronic RfD was determined to be 0.1 mg/kg/day based upon the chronic dog study. The percent of RfD occupied is 0.9% for the most sensitive subgroup, children (1-6 years old). The DWLOC for chronic exposure for infants and children is 1,000 μg/L and is significantly greater than the maximum concentration of halosulfuron-methyl in drinking water (0.008 μg/L in ground water and 1.1 μg/L in surface water).

iv. Short-term and intermediate-term risk. An aggregate exposure estimate and risk assessment was calculated for post-application exposure to halosulfuron-methyl from treated lawns. Short-term MOEs for food, residential oral, and residential dermal are 55,600, 4,900, and 420, respectively, for infants and children. Intermediate-term MOEs for food, residential oral, and residential dermal are 11,100, 1,500, and 130, respectively, for children and infants. The short-term and intermediate-term DWLOCs for infants and children were 3,700 and 160 mu;g/L, respectively, which are substancially higher than the DWECs for acute surface water (4.3 μg/L) and chronic surface water (1.1 μg/L).

v. Conclusion. Therefore, based on complete and reliable toxicity data and the conservative exposure assessment, Gowan concludes that there is reasonable certainty that no harm will result to infants and children from aggregate exposure to halosulfuron-methyl residues with respect to the proposed new uses.

Maximum residue levels have not been established for residues of halosulfuron-methyl on any food or feed crop by the Codex Alimentarius Commission.

The President established the National Bioethics Advisory Commission (NBAC) on October 3, 1995 by Executive Order 12975 as amended. The functions of NBAC are as follows:

(a) Provide advice and make recommendations to the National Science and Technology Council and to other appropriate government entities regarding the following matters:

(1) The appropriateness of departmental, agency or other governmental programs, policies, assignments, missions, guidelines, and regulations as they relate to bioethical issues arising from research on human biology and behavior; and

(2) applications, including the clinical applications, of that research.

(b) Identify broad principles to govern the ethical conduct of research, citing specific projects only as illustrations for such principles.

(c) Shall not be responsible for the review and approval of specific projects.

(d) In addition to responding to requests for advice and recommendations from the National Science and Technology Council, NBAC also may accept suggestions of issues for consideration from both the Congress and the public. NBAC may also identify other bioethical issues for the purpose of providing advice and recommendations, subject to the approval of the National Science and Technology Council. The members of NBAC are as follows:

Protecting the rights and welfare of those who volunteer to participate in research is a fundamental tenet of ethical research. A great deal of progress has been made in recent decades in changing the culture of research to incorporate more fully this ethical responsibility into protocol design and implementation. In the 1960s and 1970s, a series of scandals concerning social science research and medical research conducted with the sick and the illiterate underlined the need to systematically and rigorously protect individuals in research (Beecher 1966; Faden and Beauchamp 1986; Jones 1981; Katz 1972; Tuskegee Syphilis Study Ad Hoc Advisory Panel 1973). However, the resulting system of protections that evolved out of these rising concerns—although an improvement over past practices—is no longer sufficient. It is a patchwork arrangement associated with the receipt of federal research funding or the regulatory review and approval of new drugs and devices. In addition, it depends on the voluntary cooperation of investigators, research institutions, and professional societies across a wide array of research disciplines. Increasingly, the current system is being viewed as uneven in its ability to simultaneously protect the rights and welfare of research participants and promote ethically responsible research.

Research involving human participants has become a vast academic and commercial activity, but this country's system for the protection of human participants has not kept pace with that growth. On the one hand, the system is too narrow in scope to protect all participants, while on the other hand, it is often so unnecessarily bureaucratic that it stifles responsible research. Although some reforms by particular federal agencies and professional societies are under way,1 it will take the efforts of both the executive and legislative branches of government to put in place a streamlined, effective, responsive, and comprehensive system that achieves the protection of all human participants and encourages ethically responsible research.

Clearly, scientific investigation has extended and enhanced the quality of life and increased our understanding of ourselves, our relationships with others, and the natural world. It is one of the foundations of our society's material, intellectual, and social progress. For many citizens, scientific discoveries have alleviated the suffering caused by disease or disability. Nonetheless, the prospect of gaining such valuable scientific knowledge need not and should not be pursued at the expense of human rights or human dignity. In the words of philosopher Hans Jonas, “progress is an optional goal, not an unconditional commitment, and . . . its tempo . . . compulsive as it may become, has nothing sacred about it” (Jonas 1969, 245).

Since the 1974 formation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and the activities in the early 1980s of the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, American leaders have consistently tried to enhance the protections for human research participants. The research community has, in large part, supported the two essential protections for human participants: independent review of research to assess risks and potential benefits and an opportunity for people to voluntarily and knowledgeably decide whether to participate in a particular research protocol.

The charter of the National Bioethics Advisory Commission (NBAC), a presidential commission created in 1995, makes clear the Commission's focus: “As a first priority, NBAC shall direct its attention to consideration of protection of the rights and welfare of human research subjects.” In our first five years, we focused on several issues concerning research involving human participants, issuing five reports and numerous recommendations that, when viewed as a whole, reflect our evolving appreciation of the numerous and complex challenges facing the implementation and oversight of any system of protections.2 The concerns and recommendations addressed in these reports reflect our dual commitment to ensuring the protection of those who volunteer for research while supporting the continued advance of science and understanding of the human condition. This report views the oversight system as a whole, provides a rationale for change, and offers an interrelated set of recommendations to improve the protection of human participants and enable the oversight system to operate more efficiently.

Whether testing a new medical treatment, interviewing people about their personal habits, studying how people think and feel, or observing how they live within groups, research seeks to learn something new about the human condition. Unfortunately, history has also demonstrated that researchers sometimes treat participants not as persons but as mere objects of study. As Jonas observed: “Experimentation was originally sanctioned by natural science. There it is performed on inanimate objects, and this raises no moral questions. But as soon as animate, feeling beings become the subject of experiment * * * this innocence of the search for knowledge is lost and questions of conscience arise” (Jonas 1969, 219).

How, then, should people be studied? For over half a century, since the revelations of medical torture under the guise of medical experimentation were described at the Nuremberg Trials,3 it has been agreed that people should participate in research only when the study addresses important questions, its risks are justifiable, and an individual's participation is voluntary and informed.

The principles underlying the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (Belmont Report) (National Commission 1979) have served for over 20 years as a leading source of guidance regarding the ethical standards that should govern research with human participants in the United States. The Belmont Report emphasized that research must respect the autonomy of participants, must be fair in both conception and implementation, and must maximize potential benefits while minimizing possible harms. The report's recommendations provided a coherent rationale for the federal policies and rules that created the current U.S. system of decentralized, independent research review coupled with some degree of federal oversight. But although the Belmont Report is rightly hailed as a key source of guidance on informed consent, assessment of risk, and the injustice of placing individuals (and groups) in situations of vulnerability, the principles the report espouses and the regulations adopted as federal policy 20 years ago have often fallen short in achieving their overarching goal of protecting human research participants. Moreover, since the Belmont Report was published, additional concerns have arisen that require much-needed attention today.

A central protection for research participants is the guarantee that someone other than the investigator will assess the risks of the proposed research. No one should participate in research unless independent review concludes that the risks are reasonable in relation to the potential benefits. In the United States, the Institutional Review Board, or IRB, has been the principal structure responsible for conducting such reviews.

Independent review of research is essential because it improves the likelihood that decisions are made free from inappropriate influences that could distort the central task of evaluating risks and potential benefits. Certainly, reviewers should not have a financial interest in the work, but social factors may be just as crucial. Reviewers may feel constrained because they are examining the work of their colleagues or their supervisors, and they should not participate in protocol review unless they are able to separate these concerns from their task. All reviewers who themselves are members of the research community should recognize that their familiarity with research and (perhaps) their predilection to support research are factors that could distort their judgment.

Truly independent and sensitive review requires more involvement of individuals drawn from the ranks of potential research participants or those who can adequately represent the interests of potential research participants.

A critical purpose of independent review is to ensure that risks are reasonable in relation to potential personal and societal benefits. This is a precondition to offering people the opportunity to volunteer, since informed consent alone cannot justify enrollment. When reviewed for risks and potential benefits, research studies must be evaluated in their entirety. Studies often include different components, however, and the risks and potential benefits of each should also be examined separately, lest the possibility of great benefit or monetary enticement in one component cause potential participants or IRBs to minimize or overlook risk in another. No matter what potential benefit is offered to individual participants or society at large, the possibility of benefit from one element of a study should not be used to justify otherwise unacceptable elements.

In our view, IRBs should appreciate that for some components of a study, participants might incur risks with no personal potential benefit, for example, when a nondiagnostic survey is included among the components of a psychotherapy protocol or when placebos are given to some participants in a drug trial. For these elements, there should be some limitation on the amount of social and physical risk that can be imposed, regardless of the participants' willingness to participate or the monetary (or other) enticement being offered. Further, the possibility of some benefit from one element of a study should not be used to justify otherwise unacceptable elements of research whose potential benefits, if any, accrue, solely to society at large. If aspects of a study present unacceptable risks, protocols should not be approved until these elements are eliminated. If removing the risky component would impair the study as a whole, then the entire study should be redesigned so that each of its elements presents risks that are reasonable in relation to potential benefits.

Other parts of studies can obscure risks, such as when standard medical interventions are compared in a patient population, leading some participants and researchers to discount the risks because they are associated with known therapies. It is essential that participants and investigators not be led to believe that participating in research is tantamount to being in a traditional therapeutic relationship. Regardless of whether there is the possibility or even the likelihood of direct benefit from participation in research, such participation still alters the relationship between a professional and the participant by introducing another loyalty beyond that to the participant, to wit, loyalty to doing good science. It is too often forgotten that even though the researchers may consider participants' interests to be important, they also have a serious, and perhaps conflicting, obligation to science.

Years of experience with the current system of independent review have demonstrated that there are enduring questions about how to arrive at such impartial judgments and how to go about deciding when potential benefits justify risks that are incurred solely by participants or the community from which they come. In recent years, increasing strains on the system have undermined the practice of independent review. IRBs are over-burdened by the volume of research coming before them, a strain that is compounded by concerns about training of IRB members and possible conflicts of interest. In addition, the constantly changing nature of research challenges existing notions about what constitutes risks and potential benefits.

Because IRBs are so central to the current oversight system, they need better guidance on how to review and monitor research, how to assess potential benefits to research participants and their communities, and how to distinguish among levels of risk. This report provides such guidance in the following areas: determining the type of review necessary for minimal risk research; ensuring that research participants are able to make voluntary decisions and are appropriately informed prior to giving consent; providing adequate protections for privacy and confidentiality; identifying appropriate measures needed when participants are susceptible to coercion or are otherwise placed in vulnerable situations; and monitoring ongoing research. In addition, the report recommends that IRB members and staff complete educational and certification programs on research ethics before being permitted to review research studies.

Even when risks are reasonable, however, no one should participate in research without giving voluntary informed consent (except in the case of an appropriate authorized representative or a waiver). Investigators must make appropriate disclosures and ensure that participants have a good understanding of the information and their choices, not only at the time of enrollment, but throughout the research. Engaging in this process is one of the best ways researchers can demonstrate their concern and respect for those they aim to enroll in a study. It also serves as the best means for those who do not wish to participate to protect themselves.4

Recommendations from our previous reports are reinforced in this report, which emphasizes the process of providing information and ensuring comprehension rather than the form of documentation of the decision to give consent. Both the information and the way it is conveyed—while meeting full disclosure requirements—must be tailored to meet the needs of the participants in the particular research context. In addition, documentation requirements must be adapted for varying research settings, and the criteria for deciding when informed consent is not necessary must be clarified so that participants—rights and welfare are not endangered.

The decision to participate in research must not only be informed, it must be voluntary. Even when risks are reasonable and informed consent is obtained, it may nonetheless be wrong to solicit certain people as participants. Those who are not fully capable of resisting the request to become participants—such as prisoners and other institutionalized or otherwise vulnerable persons—should not be enrolled in studies merely because they are easily accessible or convenient. This historic emphasis on protecting people from being exploited as research participants, however, has failed to anticipate a time when, at least for some areas of medical research, people would be demanding to be included in certain studies because they might provide the only opportunity for receiving medical care for life-threatening diseases.

Vulnerable individuals need additional protection in research. Although certain individuals and populations are more vulnerable as human participants than others, people whose circumstances render them vulnerable should not be arbitrarily excluded from research for this reason alone. This includes those viewed as more open to harm (e.g., children), more subject to coercion (e.g., institutionalized persons), more “complicated” (e.g., women, who are considered more biologically complicated than men), or more inconvenient (e.g., women with small children, who are viewed as less reliable research participants due to conflicting demands on time). Calling competent people intrinsically “vulnerable” can be both insulting and misleading. It is not their gender or other group designation that exposes them to injury or coercion, but rather their situation that can be exploited by ethically unacceptable research. That is, it is their circumstances, which are situational, that create the vulnerability. At other times it is the intrinsic characteristics of the person—for example, children or those with certain mental or developmental disorders—that make them generally vulnerable in the research setting.

The response, whenever possible, should not be to exclude people from research, but instead to change the research design so that it does not create situations in which people are unnecessarily harmed. To do otherwise is to risk developing knowledge that helps only a subset of the population. To the extent that the results are not generalizable, the potential societal benefits that justify doing the research are attenuated. Research participants must be treated equally and with respect. Whenever possible, research should be designed to encourage the participation of all groups while protecting their rights and welfare.

To accomplish this, we recommend that rather than focusing primarily on categorizing groups as vulnerable, investigators and IRBs should also recognize and avoid situations that create susceptibility to harm or coercion. Such situations may be as varied as patients being recruited by their own physicians; sick and desperate patients seeking enrollment in clinical trials; participants being recruited by those who teach or employ them; or studies involving participants with any characteristic that may make them less likely to receive care and respect from others (e.g., convicted criminals or intravenous drug users). In these circumstances, rather than excluding whole groups of people, researchers should design studies that reduce the risk of exploitation, whether by using a different method of recruitment, by using a recruiter who shares the participants' characteristics, or by some other technique. This is not always easy. It requires researchers to consider carefully their research design and the potential pool of participants. At times, it will mean anticipating that otherwise seemingly benign situations may become more complex because a particular participant or group of participants will be unusually susceptible to harm or manipulation in this situation. At other times, the nature of the vulnerability may require using a different research design. Ethical research does not avoid complexity. Rather, it acknowledges the full range and realities of the human condition.

Despite all these precautions, however, some research participants might be harmed. Participants who are harmed as a direct result of research should be cared for and compensated. This is simple justice. The fact that they offered to participate in no way alters the view that mere decency calls for us to take care of these volunteers. Unfortunately, this is a greater challenge than it might appear. For those who endure harm while participating in research, it is often very difficult to separate injuries traceable to the research from those that stem from the underlying disease or social condition being studied. For others, appropriate care and compensation would be far beyond the means of the researchers, their sponsors, and their institutions. Two decades ago, the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research called for pilot studies of compensation programs—a recommendation that was not pursued. It is time to reconsider the need for some type of compensation program and to explore the possible mechanisms that could be used were one to be adopted. Regardless of individual motives, research participants are providing a service for society, and justice requires that they be treated with great respect and receive appropriate care for any related injuries. It should always be remembered that it is a privilege for any researcher to involve human participants in his or her research.

In the United States, government regulations, professional guidelines, and the general principles highlighted in the Belmont Report (1979) form the basis of the current system of protections. In the earliest stages of adoption, the federal regulations were fragmented and confusing. Even today, they apply to most—but not all—research funded or conducted by the federal government, but have inconsistent and sometimes no direct application to research funded or conducted by state governments, foundations, or industry. They apply to medical drugs and devices and vaccines approved for interstate sale, but not to some medical innovations that would remain wholly within state borders. And they apply to other research only when the investigators and their institutions volunteer to abide by the rules.

A comprehensive and effective oversight system is essential to uniformly protect the rights and welfare of participants while permitting ethically and scientifically responsible research to proceed without undue delay. A fundamental flaw in the current oversight system is the ethically indefensible difference in the protection afforded participants in federally sponsored research and those in privately sponsored research that falls outside the jurisdiction of the Food and Drug Administration (FDA). As a result, people have been subjected to experimentation without their knowledge or informed consent in fields as diverse as plastic surgery, psychology, and infertility treatment. This is wrong. Participants should be protected from avoidable harm, whether the research is publicly or privately financed. We have repeated this assertion throughout our deliberations, and recommendations in this regard appear in four previous reports (NBAC 1997; NBAC 1999a; NBAC 1999b; NBAC 2001).

In this report, we recommend that the protections of an oversight system extend to the entire private sector for both domestic and international research. A credible, effective oversight system must apply to all research, and all people are entitled to the dignity that comes with freely and knowingly choosing whether to participate in research, as well as to protection from undue research risks. This is consistent with our 1997 resolution that no one should be enrolled in research absent the twin protections of independent review and voluntary informed consent.

Even when current protections apply, the interpretation of the federal regulations can vary unpredictably, depending on which federal agency oversees the research. Even the most basic, common elements of the federal rules took a decade to develop into regulations, because there was no single authority within the government to facilitate and demand cooperation and consistency. There still is no such single authority.5 This has slowed the diffusion of basic protections and made it almost impossible to develop consistent interpretations of the basic protections or those relevant to especially problematic research, such as studies involving children or the decisionally impaired. Nor has there been a unified response to emerging areas of research, such as large-scale work on medical records and social science databases or on stored human biological materials.

Today's research protection system cannot react quickly to new developments. Efforts to develop rules for special situations, such as research on those who can no longer make decisions for themselves, have languished for decades in the face of bureaucratic hurdles, and there is no reason to believe that efforts to oversee other emerging research areas will be any more efficient. In addition, the current system leaves people vulnerable to new, virtually uncontrolled experimentation in emerging fields, such as some aspects of reproductive medicine and genetic research.

Indeed, some areas of research are not only uncontrolled, they are almost invisible. In an information age, poor management of research using medical records, human tissue, or personal interview data could lead to employment and insurance discrimination, social stigmatization, or even criminal prosecution.6 The privacy and confidentiality concerns raised by this research are real, but the federal response has often been illusory. There is almost no guidance and certainly no coordination on these topics. The time has come to have a single source of guidance for these emerging areas, one that would be better positioned to effect change across all divisions of the government and private sector, as well as to facilitate development of specialized review bodies, as needed.

In this report we propose a new independent oversight office that would have clear authority over all other segments of the federal government and extend protections to the entire private sector for both domestic and international research. A single office would decide how to introduce consistency or reforms, and only that office would develop mechanisms to provide specialized review when needed. We recognize the challenges to such a proposal. For example, an independent office might lack the political support accorded an existing cabinet-level department. Although assigning one department, such as the Department of Health and Human Services (DHHS), the role of “first among equals” would allow it to advocate forcefully for uniform rules across the government, without special provisions it would not have the authority to require other departments to comply, nor is it certain to escape the temptation to develop rules premised on a traditional, biomedical model rather than the wider range of research to be covered.

Federal research protections should be uniform across all government agencies, academe, and the private sector, but they should be flexible enough to be applied in widely different research settings or to emerging areas of research. Furthermore, any central coordinating body should be open to public input, have significant political or legal authority over research involving human participants—whether in the public or private sector—and have the support of the executive and legislative branches of government.

Currently, federal protections depend on a decentralized oversight system involving IRBs, institutions, investigators, sponsors, and participants. We endorse the spirit and intent of this approach, specifically its contention that the ethical obligation to protect participants lies first with researchers, their sponsors, and the IRBs that review their research. Protecting research participants is a duty that researchers, research institutions, and sponsors cannot delegate completely to others or to the government. In addition, merely adhering to a set of rules and regulations does not fulfill this duty. Rather, it is accomplished by acting within a culture of concern and respect for research participants.

It is unrealistic to think that ethical obligations can be fully met without guidance and resources. To help researchers and IRBs fulfill their responsibilities, the federal government should promote the development of education, certification, and accreditation systems that apply to all researchers, all IRB members and staff, and all institutions. These tools should help researchers craft and IRBs review studies that pose few problems and to know when their work requires special oversight. Today, investigators and IRBs are rightly confused over issues as basic as which areas of inquiry should be reviewed and who constitutes a human participant.

Education is the foundation of the oversight system and is essential to protecting research participants. In all of our reports, we have highlighted the need to educate all those involved in research with human participants, including the public, investigators, IRB members, institutions, and federal agencies. In Cloning Human Beings (1997), we recommended federal support of public education in biomedical sciences that increasingly affect our cultural values. In Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity (1998), we called for practice guidelines and ethics education on special concerns regarding this population. In Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries (2001), we recommended measures to help developing countries build their capacity for designing and conducting clinical trials, for reviewing the ethics and science of proposed research, and for using research results after a trial is completed.

In this report, we again acknowledge the inadequacy of educational programs on research ethics in the United States. This deficiency begins at the highest level within the federal oversight system and extends to the local level at individual institutions. We recommend that investigators and IRB members and staff successfully complete educational programs on research ethics and become certified before they perform or review research, that research ethics be taught to the next generation of scientists, and that research ethics be included in continuing education programs.

Many areas of scientific inquiry are “research,” and many of these involve human participants, but only some need federal oversight, while others might be better regulated through professional ethics, social custom, or other state and federal law. For example, certain types of surveys and interviews are considered research, but they can be well managed to avoid harms without federal oversight, as the risks are few and participants are well situated to decide for themselves whether to participate. On the other hand, certain studies of medical records, databases, and discarded surgical tissue are often perceived as something other than human research, even when the information retrieved is traceable to an identifiable person. Such research does need oversight to avoid putting people at risk of identity disclosure or discrimination without their knowledge. Federal policies should clearly identify the kinds of research that are subject to review and the types of research participants to whom protections should apply. When research poses significant risks or when its risks are imposed on participants without their knowledge, it clearly requires oversight. However, meaningless or overly rigid oversight engenders disdain on the part of researchers, creates an impossible and pointless workload for IRBs, and deters ethically sound research from going forward.

Even within areas of research that need oversight, many individual studies will involve little or no risk to participants. Although current federal policies allow for some distinction between research involving minimal risk and research involving more than minimal risk, the distinction operates mostly in terms of how the research will be reviewed—that is, how procedures are to be followed. But the distinction should be based on how the research is pursued, how the participants are treated, and how the work is monitored over time. Overall, the emphasis should be on knowing how to protect participants rather than on knowing how to navigate research regulations. Instead of focusing so much on the period during which a research design is reviewed, oversight should also include an ongoing system of education and certification that helps researchers to anticipate and minimize research risks. Oversight should also make it easier for researchers to collaborate with their colleagues here and abroad without the burden of redundant reviews. Research review and monitoring should be intensified as the risk and complexity of the research increase and at all times should emphasize protecting participants rather than following rigid rules. In addition, the review process should facilitate rather than hinder collaborative research among institutions and across national boundaries, provided that participants are protected.

Creating a system that protects the rights and welfare of participants and facilitates responsible research demands political and financial support from the federal government as well as the presence of a central coordinating body to provide guidance and oversee education and accreditation efforts. The oversight system should be adequately funded at all levels to ensure that research continues in a manner that demonstrates respect and concern for the interests of research participants.

This report proposes 30 recommendations for changing the oversight system at the national and local levels to ensure that all research participants receive the appropriate protections. The adoption of these recommendations, which are directed at all who are involved in the research enterprise, will not only lead to better protection for the participants of research, but will also serve to promote ethically sound research while reducing unnecessary bureaucratic burdens. Achieving these goals will, in turn, restore the respect of investigators for the system used to oversee research, support the public's trust in the research enterprise, and enhance public enthusiasm for all research involving human beings.

The entitlements due to all research participants of a prior independent review of risks and potential benefits and the opportunity to exercise voluntary informed consent are the most basic and essential protections for all research participants. However, not all research participants receive these entitlements and not all are protected by the existing oversight system. The commitment to protect participants should not be voluntary, nor should requirements be in place for only some human research. Extending current protections to all research, whether publicly or privately funded, and making uniform all federal regulations and guidance cannot be accomplished within the current oversight system, in which no entity has the authority to act on behalf of all research participants. Thus, to facilitate the extension of the same protections to all humans participating in research, a unified, comprehensive federal policy promulgated and interpreted by a single office is needed.

Recommendation 2.1: The federal oversight system should protect the rights and welfare of human research participants by requiring 1) independent review of risks and potential benefits and 2) voluntary informed consent. Protection should be available to participants in both publicly and privately sponsored research. Federal legislation should be enacted to provide such protection.

Recommendation 2.2: To ensure the protection of the rights and welfare of all research participants, federal legislation should be enacted to create a single, independent federal office, the National Office for Human Research Oversight (NOHRO), to lead and coordinate the oversight system. This office should be responsible for policy development, regulatory reform (see Recommendation 2.3), research review and monitoring, research ethics education, and enforcement.

Recommendation 2.3: A unified, comprehensive federal policy embodied in a single set of regulations and guidance should be created that would apply to all types of research involving human participants (see Recommendation 2.2).

Determining whether particular research activities involving human participants should be subject to a federal oversight system has been a source of confusion for some time. No regulatory definition of covered research can be provided that has the sensitivity and specificity required to ensure that all research activities that include human participants that should be subject to oversight are always included and all activities that should be excluded from oversight protections are always excluded. Clarification and interpretation of the definition of what constitutes research involving human participants will invariably be required if the oversight system is to work effectively and efficiently. Moreover, there will always be cases over which experts disagree about the research status of a particular activity. One of the important leadership roles the proposed oversight office should fulfill is that of providing guidance on determining whether an activity is research involving human participants and is therefore subject to oversight.

Recommendation 2.4: Federal policy should cover research involving human participants that entails systematic collection or analysis of data with the intent to generate new knowledge. Research should be considered to involve human participants when individuals (1) are exposed to manipulations, interventions, observations, or other types of interactions with investigators or (2) are identifiable through research using biological materials, medical and other records, or databases. Federal policy also should identify those research activities that are not subject to federal oversight and outline a procedure for determining whether a particular study is or is not covered by the oversight system.

The proposed federal office should initiate a process in which representatives from various disciplines and professions (e.g., social science, humanities, business, public health, and health services) contribute to the development of the definition and the list of research activities subject to the oversight system.

Although the definition of research involving human participants should be applied to all disciplines, the risks differ both qualitatively and quantitatively across the spectrum of research. Therefore, the oversight system should ensure that all covered research is subject to basic protections'such as a process of informed consent'with the exceptions of the specified conditions for which these protections can be waived, including protection of privacy and confidentiality and minimization of risks. Because the proposed oversight system may include more research activities, it is more critical than ever that review mechanisms and criteria for various types of research are suited to the nature of the research and the likely risks involved. More specific guidance is needed for review of different types of research, including appropriate review criteria and IRB composition. For example, procedures other than full board review could be used for minimal risk research, and national level reviews could supplement local IRB review of research involving novel or controversial ethical issues.

Recommendation 2.5: Federal policy should require research ethics review that is commensurate with the nature and level of risk involved. Standards and procedures for review should distinguish between research that poses minimal risk and research that poses more than minimal risk. Minimal risk should be defined as the probability and magnitude of harms that are normally encountered in the daily lives of the general population (see Recommendation 4.2). In addition, the federal government should facilitate the creation of special, supplementary review bodies for research that involves novel or controversial ethical issues.

Protecting the rights and welfare of research participants is the major ethical obligation of all parties involved in the oversight system, and to provide these protections, all parties must be able to demonstrate competence in research ethics'that is, conducting, reviewing, or overseeing research involving human participants in an ethically sound manner. Such competence entails not only being knowledgeable about relevant research ethics issues and federal policies, but also being able to identify, disclose, and manage conflicting interests for institutions, investigators, or IRBs. Finally, the oversight system must include a sufficiently robust monitoring process to provide remedies for lapses by institutions, IRBs, and investigators.

Recommendation 3.1: All institutions and sponsors engaged in research involving human participants should provide educational programs in research ethics to appropriate institutional officials, investigators, Institutional Review Board members, and Institutional Review Board staff. Among other issues, these programs should emphasize the obligations of institutions, sponsors, Institutional Review Boards, and investigators to protect the rights and welfare of participants. Colleges and universities should include research ethics in curricula related to research methods, and professional societies should include research ethics in their continuing education programs.

Recommendation 3.2: The federal government, in partnership with academic and professional societies, should enhance research ethics education related to protecting human research participants and stimulate the development of innovative educational programs. Professional societies should be consulted so that educational programs are designed to meet the needs of all who conduct and review research.

Educating all parties in research ethics and human participant protections is effective only when it results in the necessary competence for designing and conducting ethically sound research, including analyzing, interpreting, and disseminating results in an ethically sound manner. Such competence, however, cannot be assumed to follow from exposure to an educational course or program. As the complexion of research continues to change and as technology advances, new and challenging ethical dilemmas will emerge. And, as more people become involved in research as investigators or in roles that are specifically related to oversight, it becomes increasingly important for all parties to be able to demonstrate competence in the ethics of research involving human participants.

Although accreditation and certification do not always guarantee the desired outcomes, these programs, which generally involve experts and peers developing a set of standards that represents a consensus of best practices, can be helpful in improving performance. Therefore, the choice of standards for these programs and the criteria for evaluating whether an institution has met them are critically important. Accreditation and certification programs should emphasize providing education and assuring that appropriate protections are in place, while avoiding excessively bureaucratic procedures.

Recommendation 3.3: All investigators, Institutional Review Board members, and Institutional Review Board staff should be certified prior to conducting or reviewing research involving human participants. Certification requirements should be appropriate to their roles and to the area of research. The federal government should encourage organizations, sponsors, and institutions to develop certification programs and mechanisms to evaluate their effectiveness. Federal policy should set standards for determining whether institutions and sponsors have an effective process of certification in place.

Recommendation 3.4: Sponsors, institutions, and independent Institutional Review Boards should be accredited in order to conduct or review research involving human participants. Accreditation should be premised upon demonstrated competency in core areas through accreditation programs that are approved by the federal government.

Assessing institutional, IRB, and investigator compliance can help to ensure that standards are being followed consistently. Current mechanisms for assessment include assurances of compliance issued by DHHS and several other federal departments, site inspections of IRBs conducted by FDA, other types of site inspections for participant protection, and institutional audits. In addition, some institutions have established ongoing mechanisms for assessing investigator compliance with regulations. However, institutions vary considerably in their efforts and abilities to monitor investigator compliance, from those that have no monitoring programs to those that conduct random audits. Assessing the behavior of investigators is an important part of protecting research participants and should be taken seriously as a responsibility of each institution. Investigators, IRBs, and institutions should discuss the many practical issues involved in monitoring investigators as they conduct their research studies and provide input into the regulatory process.

Recommendation 3.5: The process for assuring compliance with federal policy should be modified to reduce any unnecessary burden on institutions conducting research and to register institutions and Institutional Review Boards with the federal government. The assurance process should not be duplicative of accreditation programs for institutions (see Recommendation 3.4).

Recommendation 3.6: Institutions should develop internal mechanisms to ensure Institutional Review Board compliance and investigator compliance with regulations, guidance, and institutional procedures. Mechanisms should be put in place for reporting noncompliance to all relevant parties.

A research setting that involves human participants necessarily creates a conflict of interest for investigators who seek to develop or revise knowledge by enrolling individuals in research protocols to obtain that knowledge. Overzealous pursuit of scientific results could lead to harm if, for example, investigators design research studies that pose unacceptable risks to participants, enroll participants who should not be enrolled, or continue studies even when results suggest they should have been modified or halted. Conflicts of interest can also exist for IRB members or the institutions in which the research will be conducted. Thus, it is important to address prospectively the potentially harmful effects on participants that conflicts of interest might cause.

Organizations, particularly academic institutions, should become more actively involved in managing investigators' and IRB members' conflicts of interest and increase their efforts for self-regulation in this arena. IRB review of research studies is one method for identifying and dealing with conflicts of interest that might face investigators. By having IRBs review research studies prospectively and follow an IRB-approved protocol, investigators and IRBs together can manage conflict between the investigators' desire to advance scientific knowledge and to protect the rights and welfare of research participants. Financial and other obvious conflicts for IRB members, such as collaboration in a research study, are often less difficult to identify and manage than some of the more subtle and pervasive conflicts. Guidance should be developed to assist IRBs in identifying various types of conflict.

Recommendation 3.7: Federal policy should define institutional, Institutional Review Board, and investigator conflicts of interest, and guidance should be issued to ensure that the rights and welfare of research participants are protected.

Recommendation 3.8: Sponsors and institutions should develop policies and mechanisms to identify and manage all types of institutional, Institutional Review Board, and investigator conflicts of interest. In particular, all relevant conflicts of interest should be disclosed to participants. Policies also should describe specific types of prohibited relationships.

Appropriate composition of IRB membership ensures that research studies are reviewed with the utmost regard for protecting the rights and welfare of research participants. Current federal regulations require that each IRB have “at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution” (45 CFR 46.107(d); 21 CFR 56.107(d)). The regulations also require that each IRB include “at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas.” Some have raised the concern of whether only 1 unaffiliated member on an IRB is sufficient to avoid institutional influence, especially when IRBs have 15 to 21 members on average. In addition, unaffiliated members do not have to be present for an IRB to conduct review and approve research studies. Thus, IRBs can approve research with only institutional representation present as long as a nonscientist and a quorum are also present. IRBs should strive to complement their membership by having clearly recognizable members who are unaffiliated with the institutions, members who are nonscientists, and members who represent the perspectives of participants. However, it is difficult to require that IRBs increase the presence and participation of more unaffiliated members to reduce the influence of institutional interests on IRB decisionmaking, because finding them can be difficult. Currently, there are no rules or guidance that describe criteria for meeting the definition of an unaffiliated member, that specify how long such members should serve, or that provide guidance regarding under what circumstances they may be removed or what payment should be provided. Institutions should be careful to select unaffiliated members who are truly separated from the institution, except for their role on the IRB. Procedures for the selection and removal of unaffiliated members should be established in a way that empowers the independent voices of those members. In addition, providing reasonable payment to IRB members who are otherwise unaffiliated with the institution can be a valuable way to strengthen these members' role.

Recommendation 3.9: Federal policy should establish standards and criteria for the selection of Institutional Review Board members. The distribution of Institutional Review Board members with relevant expertise and experience should be commensurate with the types of research reviewed by the Institutional Review Board (see Recommendation 3.10).

Recommendation 3.10: Institutional Review Boards should include members who represent the perspectives of participants, members who are unaffiliated with the institution, and members whose primary concerns are in nonscientific areas. An individual can fulfill one, two, or all three of these categories. For the purposes of both overall membership and quorum determinations 1) these persons should collectively represent at least 25 percent of the Institutional Review Board membership and 2) members from all of these categories should be represented each time an Institutional Review Board meets (see Recommendation 3.9).

In addition to protecting the rights and welfare of research participants, it is equally important to protect them from avoidable harm. Thus, an IRB's assessment of the risks and potential benefits of research is central to determining whether a research study is ethically acceptable. Yet, this assessment can be a difficult one to make, as there are no clear criteria for IRBs to use in judging whether the risks of research are reasonable in terms of what might be gained by the individual or society. IRBs should be able to identify whether a clear and direct benefit to society or the research participants might result from participating in the study. However, IRBs should be cautious in classifying procedures as offering the prospect of direct benefit. In fact, if it is not clear that a procedure also offers the prospect of direct benefit, IRBs should treat the procedure as one solely designed to answer the research question(s). A major advantage of this approach is that it avoids justifying the risks of procedures that are designed solely to answer the research question(s) based on the likelihood that another procedure in the protocol would provide a benefit.

Recommendation 4.1: An analysis of the risks and potential benefits of study components should be applied to all types of covered research (see Recommendation 2.4). In general, each component of a study should be evaluated separately, and its risks should be both reasonable in themselves as well as justified by the potential benefits to society or the participants. Potential benefits from one component of a study should not be used to justify risks posed by a separate component of a study.

Determining whether a study poses more than minimal risk is a central ethical and procedural function of the IRB. The definition of minimal risk in federal regulations (45 CFR 46.102(i); 21 CFR 56.102(i)) provides an ambiguous standard by which risks involved in a research study are compared to those encountered in daily life. However, it is unclear whether this applies to those risks found in the daily lives of healthy individuals or those of individuals who belong to the group targeted by the research. If it refers to the individuals to be involved in the research, then the same intervention could be classified as minimal risk or greater than minimal risk, depending on the health status of those participants and their particular experiences. According to this understanding, the standard for minimal risk is a relative one.

This report recommends that IRBs use a standard related to the risks of daily life that are familiar to the general population for determining whether the level of risk is minimal or more than minimal, rather than using a standard that refers to the risks encountered by particular persons or groups. These common risks would include, for example, driving to work, crossing the street, getting a blood test, or answering questions over the telephone. Thus, research would involve no more than minimal risk when it is judged that the level of risk is no greater than that encountered in the daily lives of the general population.

Recommendation 4.2: Federal policy should distinguish between research studies that pose minimal risk and those that pose more than minimal risk (see Recommendation 2.5). Minimal risk should be defined as the probability and magnitude of harms that are normally encountered in the daily lives of the general population. If a study that would normally be considered minimal risk for the general population nonetheless poses higher risk for any prospective participants, then the Institutional Review Board should approve the study only if it has determined that appropriate protections are in place for all prospective participants.

All segments of society should have the opportunity to participate in research, if they wish to do so and if they are considered to be appropriate participants for a given protocol. However, some individuals may need additional protections before they can fully participate in the research study; otherwise they might be more susceptible to coercion or exploitation. Individuals might be considered vulnerable within the research context because of intrinsic characteristics (e.g., they are children or have mental illness or retardation) or because of the situation in which they find themselves (e.g., they are impoverished, unemployed, or incarcerated). Recognizing various types of vulnerability and providing adequate safeguards can prove challenging for IRBs.

Appropriate and specific safeguards should be established to protect persons who are categorized as vulnerable. Once safeguards are established, investigators should not exclude persons categorized as vulnerable from research involving greater than minimal risk because this would deprive them of whatever potential direct benefits they might receive from the research and deprive their communities and society from the benefit of the knowledge such research might generate.

Recommendation 4.3: Federal policy should promote the inclusion of all segments of society in research. Guidance should be developed on how to identify and avoid situations that render some participants or groups vulnerable to harm or coercion. Sponsors and investigators should design research that incorporates appropriate safeguards to protect all prospective participants.

Rather than focusing on the ethical standard of informed consent and what is entailed in the process of obtaining informed consent, IRBs and investigators have followed the lead of the federal regulations and have tended to focus on the disclosures found in the consent form. However, from an ethics perspective, the informed consent process, not the form of its documentation, is the critical communication link between the prospective participant and the investigator throughout a study, beginning when the investigator initially approaches the participant. Informed consent should be an active process through which both parties share information and during which the participant at any time can freely decide whether to withdraw from or continue to participate in the research. It is time to place the emphasis on the process of informed consent to ensure that information is fully disclosed, that competent participants fully understand the research in order to make informed choices, and that decisions to participate or not are always made voluntarily.

Recommendation 5.1: Federal policy should emphasize the process of informed consent rather than the form of its documentation and should ensure that competent participants have given their voluntary informed consent. Guidance should be issued about how to provide appropriate information to prospective research participants, how to promote prospective participants' comprehension of such information, and how to ensure that participants continue to make informed and voluntary decisions throughout their involvement in the research.

Obtaining voluntary informed consent should not be a requirement for every research study. In fact, waiving the informed consent process is justifiable in research studies that include no interaction between investigators and participants, such as in studies using existing identifiable data (e.g., studies of records) and in studies in which risks generally are not physical. In these kinds of research, risks are likely to arise from the acquisition, use, or dissemination of information resulting from the study and are likely to involve threats to privacy and breaches in confidentiality. The criteria for waiving informed consent in such instances should be revised, so that if such studies have protections in place for both privacy and confidentiality, IRBs may waive the requirement for informed consent.

Recommendation 5.2: Federal policy should permit Institutional Review Boards in certain, limited situations (e.g., some studies using existing identifiable data or some observational studies) to waive informed consent requirements if all of the following criteria are met:

(a) All components of the study involve minimal risk or any component involving more than minimal risk must also offer the prospect of direct benefit to participants;

(b) The waiver is not otherwise prohibited by state, federal, or international law;

(c) There is an adequate plan to protect the confidentiality of the data;

(d) There is an adequate plan for contacting participants with information derived from the research, should the need arise; and

(e) In analyzing risks and potential benefits, the Institutional Review Board specifically determines that the benefits from the knowledge to be gained from the research study outweigh any dignitary harm associated with not seeking informed consent.

Although the federal regulations may have been intended to reflect a legal standard for documentation of informed consent, NBAC is aware of no case law in which a signed, written consent form is required. To fulfill the substantive ethical standard of informed consent, depending on the type of research proposed, it may be more appropriate to use other forms of documentation, such as audiotape, videotape, witnesses, or telephone calls to participants verifying informed consent and participation in the research study.

Recommendation 5.3: Federal policy should require investigators to document that they have obtained voluntary informed consent, but should be flexible with respect to the form of such documentation. Especially when individuals can easily refuse or discontinue participation, or when signed forms might threaten confidentiality, Institutional Review Boards should permit investigators to use other means of verifying that informed consent has been obtained.

Privacy and confidentiality are complex and poorly understood concepts in the context of some research. Privacy refers to the ways and circumstances under which investigators access information from participants. Because privacy concerns vary by type and context of research and the culture and individual circumstances of participants, investigators should be well informed and mindful of the cultural norms of the participants. In addition, investigators should be aware of the various research procedures and methods that can be used to respect privacy. Needed is a clear, comprehensive regulatory definition of privacy along with guidance for protecting privacy in various types of research.

Like privacy concerns, concerns about confidentiality vary by the type and context of the research. No one set of procedures can be developed to protect confidentiality in all research contexts. Thus, IRBs and investigators must tailor confidentiality protections to the specific circumstances and methods used in each specific research study. Further, IRBs and investigators are encouraged to consider the use of strong confidentiality protections, which can also reduce some of the violations associated with privacy. A clear, comprehensive definition of confidentiality is needed, along with guidance for protecting confidentiality in various types of research.

Recommendation 5.4: Federal policy should be developed and mechanisms should be provided to enable investigators and institutions to reduce threats to privacy and breaches of confidentiality. The feasibility of additional mechanisms should be examined to strengthen confidentiality protections in research studies.

Continual review and monitoring of research that is in progress is a critical element of the oversight system. Such review is necessary to ensure that emerging data or evidence have not altered the risks/potential benefits assessment so that risks are no longer reasonable. In addition, mechanisms are needed to monitor adverse events, unanticipated problems, and changes to the protocol. IRBs can do a better job in this area with the appropriate guidance and some restructuring of the review and monitoring process.

Currently, the requirement of continuing review is overly broad. The frequency and need for continuing review vary depending on the nature of research, with some protocols not requiring continuing review. In research involving high or unknown risks, the first few trials of a new intervention may substantially affect what is known about the risks and potential benefits of that intervention. Even if the knowledge does not warrant changes in study design, it may warrant changes in the information presented to prospective and enrolled participants.

On the other hand, the ethics issues and participant protections necessary in minimal risk research are unlikely to be affected by developments from within or outside the research—for example, research involving the use of existing data or research that will no longer involve contact with participants because it is in the data analysis phase.

Continuing review of such research should not be required because it is unlikely to provide any additional protection to research participants and merely increases the burden of IRBs. However, because minimal risk research does involve some risk, IRBs may choose to require continuing review. In these cases, other types of monitoring may be more appropriate, such as assessing investigator compliance with the approved protocol or reporting of protocol changes and unanticipated problems. Clarifying the nature of the continuing review requirements would allow IRBs to better focus their efforts on reviewing riskier research and would increase protections for participants where they are most needed.

Recommendation 6.1: Federal policy should describe how sponsors, institutions, and investigators should monitor ongoing research.

Recommendation 6.2: Federal policy should describe clearly the requirements for continuing Institutional Review Board review of ongoing research. Continuing review should not be required for research studies involving minimal risk, research involving the use of existing data, or research that is in the data analysis phase when there is no additional contact with participants. When continuing review is not required, other mechanisms should be in place for ensuring compliance of investigators and for reporting protocol changes or unanticipated problems encountered in the research.

Recommendation 6.3: Federal policy should clarify when changes in research design or context require review and new approval by an Institutional Review Board.

Assessing adverse events reports can be a major burden for IRBs and investigators because of the high volume and ambiguous nature of such events and the complexity of the pertinent regulatory requirements. Investigators have reported frustration in attempting to understand what constitutes an adverse event, the required reporting times, and to whom adverse events should be reported. The regulations need to be simplified, and one set of regulations should be available for safety monitoring. Regulations and guidance should be written so that investigators and sponsors understand what constitutes an adverse event, what type of event must be reported within what time period, and to whom it should be reported. In addition, regulations and guidance should be clear regarding whose responsibility it is to analyze and evaluate adverse event reports and should describe the required communication and coordination channels for these reports among IRBs and safety monitoring entities, such as Data Safety Monitoring Boards, investigators, sponsors, and federal agencies.

Recommendation 6.4: The federal government should create a uniform system for reporting and evaluating adverse events occurring in research, especially in multi-site research. The reporting and evaluation responsibilities of investigators, sponsors, Institutional Review Boards, Data Safety Monitoring Boards, and federal agencies should be clear and efficient. The primary concern of the reporting system should be to protect current and prospective research participants.

One of the greatest burdens on IRBs and investigators is the review of multi-site studies. Requiring multiple institutions to review the same protocol is unnecessarily taxing and provides no additional protection to participants. In addition, such review poses problems in the initial stages of review as well as in the continual review and monitoring stages and is especially problematic in the evaluation of adverse events in clinical research. Innovative and creative alternative mechanisms and processes for reviewing protocols in multi-site research are needed. To allow for such projects and to support a change in the current system toward a more flexible review system, federal policy should be clear about the functions that must be performed, but be less restrictive about who performs each function.

Recommendation 6.5: For multi-site research, federal policy should permit central or lead Institutional Review Board review, provided that participants' rights and welfare are rigorously protected.

Participants who volunteer to be in a research study and are harmed as a direct result of that study should be cared for and compensated. However, no adequate database exists that describes the number of injuries or illnesses that are suffered by research participants, the proportion of these illnesses or injuries that are caused by the research, and the medical treatment and rehabilitation expenses that are subsequently borne by the participants. It may be argued that regardless of the magnitude of the problem, the costs of research injuries should never be borne by participants. If individuals are injured by research participation, those who benefit from the research (e.g., institutions and sponsors) bear some obligation to compensate those who risked and suffered injury on their behalf. At this time, injured research participants alone bear both the cost of lost health and the expense of medical care, unless they have adequate health insurance or successfully pursue legal action to gain compensation from the specific individuals or organizations that were involved in conducting the research.

A comprehensive system of oversight of human research should include a mechanism to compensate participants for medical and rehabilitative costs resulting from research-related injuries.

Recommendation 6.6: The federal government should study the issue of research-related injuries to determine if there is a need for a compensation program. If needed, the federal government should implement the recommendation of the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (1982) to conduct a pilot study to evaluate possible program mechanisms.

Adopting the recommendations made in this report will generate additional costs for institutions, sponsors, and the federal government (through the establishment of a new federal oversight office). Sponsors of research, whether public or private, should work together with institutions carrying out the research to make the necessary funds available.

Recommendation 7.1: The proposed oversight system should have adequate resources to ensure its effectiveness and ultimate success in protecting research participants and promoting research:

(a) Funds should be appropriated to carry out the functions of the proposed federal oversight office as outlined in this report.

(b) Federal appropriations for research programs should include a separate allocation for oversight activities related to the protection of human participants.

(c) Institutions should be permitted to request funding for Institutional Review Boards and other oversight activities.

(d) Federal agencies, other sponsors, and institutions should make additional funds available for oversight activities.

This report raises many questions about ethical issues that cannot be answered because of insufficient or nonexistent empirical evidence. Current thinking about ethical issues in research—such as analysis of risks and potential benefits, informed consent, privacy and confidentiality, and vulnerability—would greatly benefit from additional research. Deserving of more study, for example, are questions regarding the development of effective approaches for assessing cognitive capacity, for evaluating what participants want to know about research, and for determining how to ascertain best practices for seeking informed consent. Clearer and more effective guidance could be developed from a stronger knowledge base. In general, understanding the ethical conduct of research would be advanced by increased interdisciplinary discussion that would include biomedical and social scientists, lawyers, and historians.

Recommendation 7.2: The federal government, in partnership with academic institutions and professional societies, should facilitate discussion about emerging human research protection issues and develop a research agenda that addresses issues related to research ethics.

The Secretary of the Department of Health and Human Services (the Secretary) is mandated by section 1868 of the Social Security Act to appoint a Practicing Physicians Advisory Council (the Council) based on nominations submitted by medical organizations representing physicians. The Council meets quarterly to discuss certain proposed changes in regulations and carrier manual instructions related to physicians' services, as identified by the Secretary. To the extent feasible and consistent with statutory deadlines, the consultation must occur before publication of the proposed changes. The Council submits an annual report on its recommendations to the Secretary and the Administrator of the Centers for Medicare and Medicaid Services not later than December 31 of each year.

The Council consists of 15 physicians, each of whom has submitted at least 250 claims for physicians' services under Medicare or Medicaid in the previous year. Members of the Council include both participating and nonparticipating physicians, and physicians practicing in rural and underserved urban areas. At least 11 members must be doctors of medicine or osteopathy authorized to practice medicine and surgery by the States in which they practice. Members have been invited to serve for overlapping 4-year terms. In accordance with section 14 of the Federal Advisory Committee Act, terms of more than 2 years are contingent upon the renewal of the Council by appropriate action before the end of the 2-year term.

The Council held its first meeting on May 11, 1992.

The current members are: Jerold M. Aronson, M.D.; Richard Bronfman, D.P.M.; Joseph Heyman, M.D.; Sandral Hullett, M.D.; Stephen A. Imbeau, M.D.; Angelyn L. Moultrie, D.O.; Derrick K. Latos, M.D. (Pending re-appointment); Dale Lervick, O.D.; Sandra B. Reed, M.D.; Amilu Rothhammer, M.D.; Victor Vela, M.D.; Kenneth M. Viste, Jr., M.D.; and Douglas L. Wood, M.D. The Council Chairperson and three seats on the Council are pending selection.

Council members will be updated on the earlier recommendations.

The agenda will provide for discussion and comment on the following topics:

• Update-Physician Regulatory Issues Team (PRIT) including a discussion of the Medicare and You 2002 Physician Insert, the Clinical Environment Appraisal Program, and the Physicians Issues Project.

• Discussion of the Participating Physicians Fact Sheet.

• Update-Evaluation and Management Documentation Guidelines.

• Documentation Requirements for Teaching Physicians

• Advanced Beneficiary Notice (provider education materials/carrier instructions).

For additional information and clarification on the topics listed, call the contact person in the “For Further Information Contact” section of this notice.

Individual physicians or medical organizations that represent physicians wishing to make 5-minute oral presentations on agenda issues should contact the Executive Director by 12 noon, September 7, 2001, to be scheduled. Testimony is limited to listed agenda issues only. The number of oral presentations may be limited by the time available. A written copy of the presenter's oral remarks should be submitted to the Executive Director no later than 12 noon, September 7, 2001, for distribution to Council members for review prior to the meeting. Physicians and organizations not scheduled to speak may also submit written comments to the Executive Director and Council members. The meeting is open to the public, but attendance is limited to the space available. Individuals requiring sign language interpretation for the hearing impaired or other special accommodation should contact John Lanigan at (202) 690-7418 at least 10 days before the meeting.

(Section 1868 of the Social Security Act (42 U.S.C. 1395ee) and section 10(a) of Public Law 92-463 (5 U.S.C. App. 2, section 10(a)); 45 C.F.R. part 11)

In the Federal Register of June 11, 2001 (66 FR 31146), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0472. The approval expires on August 31, 2004. A copy of the supporting statement for this information collection is available on the Internet at http://www.fda.gov/ohrms/dockets.

In the Federal Register of May 29, 2001 (66 FR 29141), FDA published a notice soliciting comments on reporting and recordkeeping requirements associated with 21 CFR part 510. To give interested persons additional time to submit comments on the proposed data collection, the agency is reopening the comment period until October 15, 2001.

Interested persons may submit to the Dockets Management Branch (address above) written comments by October 15, 2001. Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

In the Federal Register of June 29, 2001 (66 FR 34685), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0027. The approval expires on August 31, 2004. A copy of the supporting statement for this information collection is available on the Internet at http://www.fda.gov/ohrms/dockets.

In the Federal Register of June 11, 2001 (66 FR 31165), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0474. The approval expires on August 31, 2004. A copy of the supporting statement for this information collection is available on the Internet at http://www.fda.gov/ohrms/dockets.

In the Federal Register of June 29, 2001 (66 FR 34685), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0216. The approval expires on August 31, 2004. A copy of the supporting statement for this information collection is available on the Internet at http://www.fda.gov/ohrms/dockets.

In the Federal Register of June 5, 2001 (66 FR 30218), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0320. The approval expires on August 31, 2004. A copy of the supporting statement for this information collection is available on the Internet at http://www.fda.gov/ohrms/dockets.

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Under section 903(d)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)), FDA is authorized to conduct research relating to regulated articles and to collect information relating to responsibilities of the agency. Executive Order 12866, the Regulatory Flexibility Act (RFA), and the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA) direct Federal agencies to conduct regulatory impact analysis, and to consider flexible regulatory approaches. In order to perform the mandatory analysis it is often necessary to survey: (1) Regulated producers to determine existing practices and the changes in those practices likely under various policy options, (2) both consumers and manufacturers to explore attitudes towards policy proposals, and (3) industry experts to solicit expert opinions. FDA is seeking OMB clearance to conduct future surveys to implement Executive Order 12866, RFA, and SBREFA. Participation in the surveys will be voluntary. This request covers regulated entities, such as food processors, dietary supplement manufacturers, health professionals or other experts, and consumers.

FDA will use the information gathered from these surveys to identify current business practices, expert opinion, and consumer or manufacturer attitudes towards existing or proposed policy. FDA projects approximately 2 to 6 surveys per year, with a sample of between 10 and 1,000 respondents each for mail and telephone surveys, and a sample of up to 3,000 respondents for cable or Internet surveys.

In the Federal Register of June 15, 2001 (66 FR 32625), the agency requested comments on the proposed collection of information. No comments were received.

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

These estimates are based on the expected number of respondents necessary to obtain a statistically significant stratification of the average to large size industries—including small business entities covered by FDA regulations—and consumers of regulated products.

The Delaware & Lehigh National Heritage Corridor Commission was established by Public Law 100-692, November 18, 1988 and extended through Public Law 105-355, November 13, 1998.

Title: Coal Washing and Transportation Allowances.

OMB Control Number: 1010-0074.

Bureau Form Number: Forms MMS-4292 and MMS-4293.

Abstract: The Department of the Interior (DOI) is responsible for matters relevant to mineral resource development on Federal and Indian Lands and the Outer Continental Shelf (OCS). The Secretary of the Interior (Secretary) is responsible for managing the production of minerals from Federal and Indian lands and the OCS; for collecting royalties from lessees who produce minerals; and for distributing the funds collected in accordance with applicable laws. The Secretary also has an Indian trust responsibility to manage Indian lands and seek advice and information from Indian beneficiaries. MMS performs the royalty management functions for the Secretary.

When a company or an individual enters into a lease to explore, develop, produce, and dispose of coal from Indian lands, that company or individual agrees to pay the Indian tribe or allottee a share (royalty) of the value received from production from the leased lands. Royalty rates are specified in the lease instrument. To determine whether the amount of royalty tendered represents the proper royalty due, it is first necessary to establish the proper value of the coal that is being sold or otherwise disposed of in some other manner, as well as the proper costs associated with allowable deductions.

The lease creates a business relationship between the lessor and the lessee. The lessee is required to report various kinds of information to the lessor relative to the disposition of the leased minerals. Such information is similar to data that is reported to private and public mineral interest owners and are generally available within the records of the lessee or others involved in developing, transporting, processing, purchasing, or selling of such minerals. The information collected includes data necessary to assure that the royalties that are computed and paid are appropriate.

The product valuation and allowance determination process is essential to assure that Indians receive payment on the proper value of the minerals removed from tribal and allottee land. To determine whether the amount of royalty tendered represents the proper royalty due, it is necessary to establish the proper value of the coal sold, or otherwise disposed of. Of equal importance is the proper determination of costs associated with the allowable deductions from the value of coal.

Under certain circumstances, a lessee may be authorized to deduct certain costs in the calculation of royalties due. An allowance may be granted from royalties to compensate the lessee for the reasonable actual cost of washing the royalty portion of the coal. Also, when the sales point is not in the immediate vicinity of a lease or mine area, an allowance may be granted to compensate the lessee for the reasonable actual cost of transporting the royalty portion of the coal to a sales point not on the lease or mine area. We have developed forms for industry use when reporting or applying for a coal washing or transportation allowance.

Submission of the information in this collection (Forms MMS-4292 and MMS-4293) is necessary when claiming a coal washing or transportation allowance on an Indian lease. MMS is requesting OMB approval for minor revisions necessary to make Forms MMS-4292 and MMS-4293 compatible with our reengineered financial and compliance systems. Proprietary information that is submitted is protected, and there are no questions of a sensitive nature included in this information collection.

Frequency: Annually.

Estimated Number and Description of Respondents: 1 Indian lessee.

Estimated Annual Reporting and Recordkeeping “Hour” Burden: 4 hours. In estimating the burden, we assumed that respondents perform certain functions, such as records maintenance, in the normal course of their business activities. These functions are considered usual and customary and therefore are not listed in the following estimate even though records maintenance is an MMS regulatory requirement. The following chart lists the components of the burden estimate.

Estimated Annual Reporting and Recordkeeping “Non-hour Cost” Burden: We have identified no “non-hour cost” burden.

Comments: The PRA (44 U.S.C. 3501, et seq.) provides that an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Before submitting an ICR to OMB, PRA section 3506(c)(2)(A), requires each agency “* * * to provide notice * * * and otherwise consult with members of the public and affected agencies concerning each proposed collection of information * * *” Agencies must specifically solicit comments to (a) evaluate whether the proposed collection of information is necessary for the agency to perform its duties, including whether the information is useful; (b) evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) enhance the quality, usefulness, and clarity of the information to be collected; and (d) minimize the burden on the respondents, including the use of automated collection techniques or other forms of information technology.

To comply with public consultation requirements, on November 9, 2000, we published a Federal Register notice (65 FR 67399) announcing that we would submit this ICR to OMB for approval. The notice provided the required 60-day comment period. We did not receive any comments. We have posted a copy of the ICR at our Internet web site http://www.mrm.mms.gov/Laws_R_D/FRNotices/FRInfColl.htm. We will also provide a copy of the ICR to you without charge upon request.

If you wish to comment in response to this notice, send your comments directly to the offices listed under the ADDRESSES section of this notice. OMB has up to 60 days to approve or disapprove the information collection but may respond after 30 days. Therefore, to ensure maximum consideration, OMB should receive your comments by October 1, 2001. The PRA provides that an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

Public Comment Policy: We will post all comments received in response to this notice on our Internet web site at http://www.mrm.mms.gov/Laws_R_D/InfoColl/InfoColCom.htm for public review. We also make copies of these comments, including names and home addresses of respondents, available for public review during regular business hours at our offices in Lakewood, Colorado.

Individual respondents may request that we withhold their home address from the record, which we will honor to the extent allowable by law. There may be circumstances in which we would withhold from the record a respondent's identity, as allowable by the law. If you wish us to withhold your name and/or address, you must state this prominently at the beginning of your comments. 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.

MMS Information Collection Clearance Officer: Jo Ann Lauterbach, telephone (202) 208-7744.

MMS prepares EA's and FONSI's for proposals which relate to exploration for and the development/production of oil and gas resources on the Gulf of Mexico OCS. The EA's examine the potential environmental effects of activities described in the proposals and present MMS conclusions regarding the significance of those effects. Environmental Assessments are used as a basis for determining whether or not approval of the proposals constitutes major Federal actions that significantly affect the quality of the human environment in the sense of NEPA Section 102(2)(C). A FONSI is prepared in those instances where MMS finds that approval will not result in significant effects on the quality of the human environment. The FONSI briefly presents the basis for that finding and includes a summary or copy of the EA.

This notice constitutes the public notice of availability of environmental documents required under the NEPA Regulations.

This table lists all proposals for which the Gulf of Mexico OCS Region prepared a FONSI during the period 04/24/01 to 07/13/01.

Persons interested in reviewing environmental documents for the proposals listed above or obtaining information about EA's and FONSI's prepared for activities on the Gulf of Mexico OCS are encouraged to contact MMS at the address or telephone in the FOR FURTHER INFORMATION CONTACT section.

Section 244(b)(3)(A) of the Immigration and Nationality Act (Act) states that, at least 60 days before the end of a designation or extension thereof, the Attorney General must review conditions in the foreign state for which the designation is in effect. 8 U.S.C. 1254a(b)(3)(A). If the Attorney General does not determine that the foreign state no longer meets the conditions for designation, the period of designation is extended automatically for 6 months pursuant to section 244(b)(3)(C) of the Act, although the Attorney General may exercise his discretion to extend the designation for a period of 12 or 18 months. 8 U.S.C. 1254a(b)(3)(C). With respect to Burundi, such an extension makes TPS available only to persons who have been continuously physically present since November 9, 1999, and have continuously resided in the United States since November 9, 1999.

On November 4, 1997, the Attorney General designated Burundi under the TPS program for a period of 12 months. 62 FR 59735. The Attorney General has since extended the TPS designation two times and redesignated Burundi once after determining that the conditions warranting such designation continued to be met each time. See 65 FR 67404 (Nov. 9, 2000) (extension); 64 FR 61123 (Nov. 9, 1999) (extension and redesignation); 63 FR 59334 (Nov. 3, 1998) (extension).

Since the date of the last extension, the Departments of Justice and State have continued to review conditions in Burundi. The review has resulted in a consensus that a further 12-month extension is warranted. The State Department reports that the armed conflict within Burundi persists: “While negotiations yielded a framework for a peace in August 2000, no cease-fire is in effect and there are currently no negotiations between the government and rebel leaders. Ethnic violence and divisions over the distribution of power continue.” Recommendation for Extension of Temporary Protected Status, INS/DOS Consultation for Burundi (July 12, 2001). Recent failed coup attempts by Tutsi military officers underscore the tenuousness of the situation. Id. The State Department also reports that one effect of the peace process in the Democratic Republic of the Congo (DRC) has been to push rebel groups from the DRC into Burundi, further destabilizing the latter. Id. Unpredictable rebel attacks and government counter-attacks are prevalent, and serious human rights abuses continue to be committed by both sides. Id. The State Department concludes that “Burundi is insecure throughout, and the prospects for a cease-fire in the near future are uncertain.” Id.

Based on this review, the Attorney General finds that the conditions that prompted designation of Burundi under the TPS program continue to be met. 8 U.S.C. 1254a(b)(3)(A). The Attorney General concludes that the TPS designation for Burundi should be extended for a period of 12 months. 8 U.S.C. 1254a(b)(3)(C). There is an ongoing armed conflict within Burundi, and due to such conflict, requiring the return of aliens who are nationals of Burundi (or aliens having no nationality who last habitually resided in Burundi) would pose a serious threat to their personal safety. 8 U.S.C.1254a(b)(1)(A). Furthermore, there exist extraordinary and temporary conditions in Burundi that prevent nationals of Burundi (and aliens having no nationality who last habitually resided in Burundi) from returning home in safety. 8 U.S.C. 1254a(b)(1)(C). Finally, permitting nationals of Burundi to remain temporarily in the United States is not contrary to the national interest of the United States. 8 U.S.C. 1254a(b)(1). On the basis of these findings, the Attorney General concludes that the TPS designation for Burundi should be extended for an additional 12-month period. 8 U.S.C 1254a(b)(3)(C).

If you have already been granted TPS through the Burundi TPS program, your TPS will expire on November 2, 2001. Persons previously granted TPS under the Burundi program may apply for an extension by filing (1) the Form I-821, Application for Temporary Protected Status, without the fee, (2) the Form I-765, Application for Employment Authorization, and (3) two identification photographs (11/2 inches × 11/2 inches). To determine whether you must submit the one hundred dollar ($100) filing fee with the Form I-765, see the chart below. Children beneficiaries of TPS who have reached the age of 14 but were not previously fingerprinted must pay the twenty-five dollar ($25) fingerprint fee upon their next application for extension.

Submit the re-registration package to the Immigration and Naturalization Service (Service) district office that has jurisdiction over your place of residence during the 90-day re-registration period that begins August 31, 2001, and will remain in effect until November 29, 2001.

An application for TPS does not affect an application for asylum or any other immigration benefit. Denial of an application for asylum or any other immigration benefit does not necessarily affect disposition of a separate TPS application, though grounds for denying one form of relief may serve as the basis for denying TPS as well. For example, a person who has been convicted of a particularly serious crime is ineligible for both asylum and TPS. 8 U.S.C. 1158(b)(2); 8 U.S.C. 1254a(c)(2)(B).

No. This is a notice of an extension of the TPS designation for Burundi, not a notice of redesignation of Burundi under the TPS program. An extension of TPS does not change the required dates of continuous residence and continuous physical presence in the United States and, thus, does not expand TPS availability to include nationals of Burundi (or aliens having no nationality who last habitually resided in Burundi) who have not been continuously physically present in, and have not continuously resided in, the United States since November 9, 1999.

Yes. Some persons may be eligible for late initial registration under 8 CFR 244.2(f)(2). To apply for late initial registration an applicant must:

(1) Be a national of Burundi (or an alien who has no nationality and who last habitually resided in Burundi);

(2) Have been continuously physically present in the United States since November 9, 1999;

(3) Have continuously resided in the United States since November 9, 1999; and,

(4) Be both admissible as an immigrant, except as otherwise provided under section 244(c)(2)(A) of the Act, and not ineligible under section 244(c)(2)(B) of the Act.

Additionally, the applicant must be able to demonstrate that, during the redesignation registration period from November 9, 1999 through November 2, 2000, he or she:

(1) Was a nonimmigrant or had been granted voluntary departure status or any relief from removal;

(2) Had an application for change of status, adjustment of status, asylum, voluntary departure, or any relief from removal or change of status pending or subject to further review or appeal;

(3) Was a parolee or had a pending request for reparole; or

(4) Was the spouse or child of an alien currently eligible to be a TPS registrant.

An applicant for late initial registration must register no later than 60 days from the expiration or termination of the conditions described above. 8 CFR 244.2(g).

By the authority vested in me as Attorney General under sections 244(b)(1), (b)(3)(A), and (b)(3)(C) of the Act, I have consulted with the appropriate government agencies and determine that the conditions that prompted designation of Burundi for TPS continue to be met. 8 U.S.C. 1254a(b)(3)(A). Accordingly, I order as follows:

(1) The designation of Burundi under section 244(b) of the Act is extended for an additional 12-month period from November 2, 2001 to November 2, 2002.

(2) I estimate that there are approximately 1,000 nationals of Burundi (or aliens who have no nationality and who last habitually resided in Burundi) who have been granted TPS and who are eligible for re-registration.

(3) In order to be eligible for TPS during the period from November 2, 2001 through November 2, 2002, a national of Burundi (or an alien who has no nationality and who last habitually resided in Burundi) who has already received a grant of TPS under the Burundi TPS designation must re-register for TPS by filing (1) The new Form I-821, Application for Temporary Protected Status, (2) the Form I-765, Application for Employment Authorization, and (3) two identification photographs (11/2 inches × 11/2 inches) within the 90-day period beginning on August 31, 2001 and ending on November 29, 2001. There is no fee for a Form I-821 filed as part of the re-registration application. If the applicant requests employment authorization, he or she must submit one hundred dollars ($100) or a properly documented fee waiver request, pursuant to 8 CFR 244.20, with the Form I-765. An applicant who does not request employment authorization must nonetheless file the Form I-765 along with the Form I-821, but is not required to submit the fee. The twenty-five dollar ($25) fingerprint fee is required only for children beneficiaries of TPS who have reached the age of 14 but were not previously fingerprinted. Failure to re-register without good cause will result in the withdrawal of TPS. 8 CFR 244.17(c). Some persons who had not previously applied for TPS may be eligible for late initial registration under 8 CFR 244.2(f)(2).

(4) At least 60 days before this extension terminates on November 2, 2002, the Attorney General will review the designation of Burundi under the TPS program and determine whether the conditions for designation continue to be met. 8 U.S.C. 1254a(b)(3)(A). Notice of that determination, including the basis for the determination, will be published in the Federal Register. 8 U.S.C. 1254a(b)(3)(A).

(5) Information concerning the Burundi TPS program will be available at local Service offices upon publication of this notice and on the Service website at http://www.ins.usdoj.gov.

Section 244(b)(3)(A) of the Immigration and Nationality Act (Act) states that, at least 60 days before the end of a designation or extension thereof, the Attorney General must review conditions in the foreign state for which the designation is in effect. 8 U.S.C. 1254a(b)(3)(A). If the Attorney General does not determine that the foreign state no longer meets the conditions for designation, the period of designation is extended automatically for 6 months pursuant to section 244(b)(3)(C) of the Act, although the Attorney General may exercise his discretion to extend the designation for a period of 12 or 18 months. 8 U.S.C. 1254a(b)(3)(C). With respect to Sierra Leone, such an extension makes TPS available only to persons who have been continuously physically present since November 9, 1999, and have continuously resided in the United States since November 9, 1999.

On November 4, 1997, the Attorney General designated Sierra Leone under the TPS program for a period of 12 months. 62 FR 59736. The Attorney General has since extended the TPS designation two times and redesignated Sierra Leone once after determining that the conditions warranting such designation continued to be met each time. See 65 FR 67405 (Nov. 9, 2000) (extension); 64 FR 61125 (Nov. 9, 1999) (extension and redesignation); 63 FR 59336 (Nov. 3, 1998) (extension).

Since the date of the last extension, the Departments of Justice and State have continued to review conditions in Sierra Leone. The review has resulted in a consensus that a further 12-month extension is warranted. The State Department reports that the armed conflict within Sierra Leone persists: “Though characterized by a tenuous ceasefire, and with many combatants entering a disarmament and demobilization program, conflicts and battles between competing elements and factions continue to occur, often causing casualties and deaths among the civilian population.” Recommendation for Extension of Temporary Protected Status, INS/DOS Consultation for Sierra Leone (July 12, 2001). The United Nations (UN) peacekeeping operation, United Nations Mission in Sierra Leone, is gradually extending its deployment, but many areas of the country are without effective civil control. Id. The State Department also referred to a May 23, 2001 statement by UN Secretary General Kofi Annan, in which he cautioned that conditions for promoting return of refugees from neighboring countries did not exist since portions of Sierra Leone remain in the hands of the Revolutionary United Front and beyond the reach of humanitarian aid organizations. Id.

Based on this review, the Attorney General finds that the conditions that prompted designation of Sierra Leone under the TPS program continue to be met. 8 U.S.C.1254a(b)(3)(A). The Attorney General concludes that the TPS designation for Sierra Leone should be extended for a period of 12 months. 8 U.S.C. 1254a(b)(3)(C). There is an ongoing armed conflict within Sierra Leone and, due to such conflict, requiring the return of aliens who are nationals of Sierra Leone (or aliens having no nationality who last habitually resided in Sierra Leone) would pose a serious threat to their personal safety. 8 U.S.C. 1254a(b)(1)(A). Furthermore, there exist extraordinary and temporary conditions in Sierra Leone that prevent nationals of Sierra Leone (and aliens having no nationality who last habitually resided in Sierra Leone) from returning home in safety. 8 U.S.C. 1254a(b)(1)(C). Finally, permitting nationals of Sierra Leone to remain temporarily in the United States is not contrary to the national interest of the United States. 8 U.S.C. 1254a(b)(1). On the basis of these findings, the Attorney General concludes that the TPS designation for Sierra Leone should be extended for an additional 12-month period. 8 U.S.C. 1254a(b)(3)(C).

If you have already been granted TPS through the Sierra Leone TPS program, your TPS will expire on November 2, 2001. Persons previously granted TPS under the Sierra Leone program may apply for an extension by filing (1) the Form I-821, Application for Temporary Protected Status, without the fee, (2) the Form I-765, Application for Employment Authorization, and (3) two identification photographs (11/2 inches x 11/2 inches). To determine whether you must submit the one hundred dollar ($100) filing fee with the Form I-765, see the chart below. Children beneficiaries of TPS who have reached the age of 14 but were not previously fingerprinted must pay the twenty-five dollar ($25) fingerprint fee upon their next application for extension.

Submit the re-registration package to the Immigration and Naturalization Service (Service) district office that has jurisdiction over your place of residence during the 90-day re-registration period that begins August 31, 2001, and will remain in effect until November 29, 2001.

An application for TPS does not affect an application for asylum or any other immigration benefit. Denial of an application for asylum or any other immigration benefit does not necessarily affect disposition of a separate TPS application, though grounds for denying one form of relief may serve as the basis for denying TPS as well. For example, a person who has been convicted of a particularly serious crime is ineligible for both asylum and TPS. 8 U.S.C. 1158(b)(2); 8 U.S.C.1254a(c)(2)(B).

No. This is a notice of an extension of the TPS designation for Sierra Leone, not a notice of redesignation of Sierra Leone under the TPS program. An extension of TPS does not change the required dates of continuous residence and continuous physical presence in the United States and, thus, does not expand TPS availability to include nationals of Sierra Leone (or aliens having no nationality who last habitually resided in Sierra Leone) who have not been continuously physically present in, and have not continuously resided in, the United States since November 9, 1999.

Yes. Some persons may be eligible for late initial registration under 8 CFR 244.2(f)(2). To apply for late initial registration an applicant must:

(1) Be a national of Sierra Leone (or an alien who has no nationality and who last habitually resided in Sierra Leone);

(2) Have been continuously physically present in the United States since November 9, 1999;

(3) Have continuously resided in the United States since November 9, 1999; and,

(4) Be both admissible as an immigrant, except as otherwise provided under section 244(c)(2)(A) of the Act, and not ineligible under section 244(c)(2)(B) of the Act.

Additionally, the applicant must be able to demonstrate that, during the redesignation registration period from November 9, 1999 through November 2, 2000, he or she:

(1) Was a nonimmigrant or had been granted voluntary departure status or any relief from removal;

(2) Had an application for change of status, adjustment of status, asylum, voluntary departure, or any relief from removal or change of status pending or subject to further review or appeal;

(3) Was a parolee or had a pending request for reparole; or

(4) Was the spouse or child of an alien currently eligible to be a TPS registrant. 8 CFR 244.2(f)(2).

An applicant for late initial registration must register no later than 60 days from the expiration or termination of the conditions described above. 8 CFR 244.2(g).

By the authority vested in me as Attorney General under sections 244(b)(1), (b)(3)(A), and (b)(3)(C) of the Act, I have consulted with the appropriate government agencies and determine that the conditions that prompted designation of Sierra Leone for TPS continue to be met. 8 U.S.C.1254a(b)(3)(A). Accordingly, I order as follows:

(1) The designation of Sierra Leone under section 244(b) of the Act is extended for an additional 12-month period from November 2, 2001 through November 2, 2002. 8 U.S.C. 1254a(b)(3)(C).

(2) I estimate that there are approximately 6,102 nationals of Sierra Leone (or aliens who have no nationality and who last habitually resided in Sierra Leone) who have been granted TPS and who are eligible for re-registration.

(3) In order to be eligible for TPS during the period from November 2, 2001 through November 2, 2002, a national of Sierra Leone (or an alien who has no nationality and who last habitually resided in Sierra Leone) who has already received a grant of TPS under the Sierra Leone TPS designation must re-register for TPS by filing (1) the new Form I-821, Application for Temporary Protected Status, (2) the Form I-765, Application for Employment Authorization, and (3) two identification photographs (11/2 inches × 11/2 inches), within the 90-day period beginning on August 31, 2001 and ending on November 29, 2001. There is no fee for a Form I-821 filed as part of the re-registration application. If the applicant requests employment authorization, he or she must submit one hundred dollars ($100) or a properly documented fee waiver request, pursuant to 8 CFR 244.20, with the Form I-765. An applicant who does not request employment authorization must nonetheless file the Form I-765 along with the Form I-821, but is not required to submit the fee. The twenty-five dollar ($25) fingerprint fee is required only for children beneficiaries of TPS who have reached the age of 14 but were not previously fingerprinted. Failure to re-register without good cause will result in the withdrawal of TPS. 8 CFR 244.17(c). Some persons who had not previously applied for TPS may be eligible for late initial registration under 8 CFR 244.2(f)(2).

(4) At least 60 days before this extension terminates on November 2, 2002, the Attorney General will review the designation of Sierra Leone under the TPS program and determine whether the conditions for designation continue to be met. 8 U.S.C. 1254a(b)(3)(A). Notice of that determination, including the basis for the determination, will be published in the Federal Register. 8 U.S.C. 1254a(b)(3)(A).

(5) Information concerning the Sierra Leone TPS program will be available at local Service offices upon publication of this notice and on the Service website at http://www.ins.usdoj.gov.

Section 244(b)(3)(A) of the Immigration and Nationality Act (Act) states that at least 60 days before the end of a designation or extension thereof, the Attorney General must review conditions in the foreign state for which the designation is in effect. 8 U.S.C. 1254a(b)(3)(A). If the Attorney General does not determine that the foreign state no longer meets the conditions for designation, the period of designation is extended automatically for 6 months pursuant to section 244(b)(3)(C) of the Act, although the Attorney General may exercise his discretion to extend the designation for a period of 12 or 18 months. 8 U.S.C. 1254a(b)(3)(C). With respect to Sudan, such an extension makes TPS available only to persons who have been continuously physically present since November 9, 1999, and have continuously resided in the United States since November 9, 1999.

On November 4, 1997, the Attorney General designated Sudan under the TPS program for a period of 12 months. 62 FR 59737. The Attorney General has since extended the TPS designation two times and redesignated Sudan once after determining that the conditions warranting such designation continued to be met each time. See 65 FR 67407 (Nov. 9, 2000) (extension); 64 FR 61128 (Nov. 9, 1999) (extension and redesignation), 63 FR 59337 (Nov. 3, 1998) (extension).

Since the date of the last extension, the Departments of Justice and State have continued to review conditions in Sudan. The review has resulted in a consensus that a further 12-month extension is warranted. The State Department reports that: “Civil war continues in Sudan and has reportedly worsened in the past year, with increased fighting and bombings * * * . The 1998 cease-fire is now long defunct, and the [Government of Sudan] has reportedly indiscriminately bombed overwhelmingly civilian populations on an almost weekly basis. There have been substantial human rights abuses by both Government and rebel forces.” Recommendation for Temporary Protected Status, INS/DOS Consultation for Sudan (July 12, 2001). This has caused extensive displacement of populations. Id. The State Department indicates that: “Insecurity and forced population relocations have destroyed most of the indigenous trading and production systems. The risk of famine continues as fighting impedes relief efforts.” Id.

Based on this review, the Attorney General finds that the conditions that prompted designation of Sudan under the TPS program continue to be met. 8 U.S.C. 1254a(b)(3)(A). There is an ongoing armed conflict within Sudan and, due to such conflict, requiring the return of aliens who are nationals of Sudan (or aliens having no nationality who last habitually resided in Sudan) would pose a serious threat to their personal safety. 8 U.S.C. 1254a(b)(3)(A). Furthermore, there exist extraordinary and temporary conditions in Sudan that prevent nationals of Sudan (and aliens having no nationality who last habitually resided in Sudan) from returning home in safety. 8 U.S.C. 1254a(b)(1)(C). Finally, permitting nationals of Sudan to remain temporarily in the United States is not contrary to the national interest or the United States. 8 U.S.C. 1254a(b)(1). On the basis of these findings, the Attorney General concludes that the TPS designation for Sudan should be extended for a period of 12 months.

If you have already been granted TPS through the Sudan TPS program, your TPS will expire on November 2, 2001. Persons previously granted TPS under the Sudan program may apply for an extension by filing (1) the Form I-821, Application for Temporary Protection Status, without the fee, (2) the Form I-765, Application for Employment Authorization, and (3) two identification photographs (11/2 inches x 11/2 inches). To determine whether you must submit the one hundred dollar ($100) filing fee with the Form I-765, see the chart below. Children beneficiaries of TPS who have reached the age of 14 but were not previously fingerprinted must pay the twenty-five dollar ($25) fingerprint fee upon their next application for extension.

Submit the re-registration package to the Immigration and Naturalization Service (Service) district office that has jurisdiction over your place of residence during the 90-day re-registration period that begins August 31, 2001 and will remain in effect until November 29, 2001.

An application for TPS does not affect an application for asylum or any other immigration benefit. Denial of an application for asylum or any other immigration benefit does not necessarily affect disposition of a separate TPS application, though grounds for denying one form of relief may serve as the basis for denying TPS as well. For example, a person who has been convicted of a particularly serious crime is ineligible for both asylum and TPS. 8 U.S.C. 1158(b)(2); 8 U.S.C. 1254a(c)(2)(B).

No. This is a notice of an extension of the TPS designation for Sudan, not a notice of redesignation of Sudan under the TPS program. An extension of TPS does not change the required dates of continuous residence and continuous physical presence in the United States and, thus, does not expand TPS availability to include nationals of Sudan (or aliens having no nationality who last habitually resided in Sudan) who have not been continuously physically present in, and have not continuously resided in, the United States since November 9, 1999.

Yes. Some persons may be eligible for late initial registration under 8 CFR 244.2(f)(2). To apply for late initial registration an applicant must:

(1) Be a national of Sudan (or an alien who has no nationality and who last habitually resided in Sudan);

(2) Have been continuously physically present in the United States since November 9, 1999;

(3) Have continuously resided in the United States since November 9, 1999; and

(4) Be both admissible as an immigrant, except as otherwise provided under section 244(c)(2)(A) of the Act, and also not ineligible under section 244(c)(2)(B) of the Act.

Additionally, the applicant must be able to demonstrate that, during the redesignation registration period from November 9, 1999, through November 2, 2000, he or she:

(1) Was a nonimmigrant or had been granted voluntary departure status or any relief from removal;

(2) Had an application for change of status, adjustment of status; asylum, voluntary departure, or any relief from removal of status pending or subject to further review or appeal;

(3) Was a parolee or had a pending request for reparole; or

(4) Was the spouse or child of an alien currently eligible to be a TPS registrant. 8 CFR 244.2(f)(2).

An applicant for late initial registration must register no later than 60 days from the expiration or termination of the conditions described above. 8 CFR 244.2(g).

By the authority vested in me as Attorney General under sections 244(b)(1), (b)(3)(A), and (b)(3)(C) of the Act, I have consulted with the appropriate government agencies and determine that the conditions that prompted designation of Sudan for TPS continue to be met. 8 U.S.C. 1254a(b)(3)(A). Accordingly, I order as follows:

(1) The designation of Sudan under section 244(b) of the Act is extended for an additional 12-month period from November 2, 2001 through November 2, 2002. 8 U.S.C. 1254a(b)(3)(C).

(2) I estimate that there are approximately 1,903 nationals of Sudan (or aliens who have no nationality and who last habitually resided in Sudan) who have been granted TPS and who are eligible for re-registration.

(3) In order to be eligible for TPS during the period from November 2, 2001 to November 2, 2002, a national of Sudan (or an alien who has nationality and who last habitually resided in Sudan) who has already received a grant of TPS under the Sudan TPS designation must re-register for TPS by filing (1) the new Form I-821, Application for Temporary Protected Status, (2) the Form I-765, Application for Employment Authorization, and (3) two identification photographs (11/2 inches × 11/2 inches), within the 90-day period beginning on August 31, 2001 and ending on November 29, 2001. There is no fee for a Form I-821 filed as part of the re-registration application. If the applicant requests employment authorization, he or she must submit one hundred dollars ($100) or a properly documented fee waiver request, pursuant to 8 CFR 244.20, with the Form I-765. An applicant who does not request employment authorization must nonetheless file the Form I-765 along with the Form I-821, but is not required to submit the fee. The twenty-five dollar ($25) fingerprint fee is required only for children beneficiaries of TPS who have reached the age of 14 but were not previously fingerprinted. Failure to re-register without good cause will result in the withdrawal of TPS. 8 CFR 244.17(c). Some persons who had not previously applied for TPS may be eligible for late initial registration under 8 CFR 244.2(f)(2).

(4) At least 60 days before this extension terminates on November 2, 2002, the Attorney General will review the designation of Sudan under the TPS program and determine whether the conditions for designation continue to be met. 8 U.S.C. 1254a(b)(3)(A). Notice of that determination, including the basis for the determination, will be published in the Federal Register 8 U.S.C. 1254a(b)(3)(A).

(5) Information concerning the Sudan TPS program will be available at local Service offices upon publication of this notice and on the Service website at http://www.ins.usdoj.gov.

Pursuant to the Paperwork Reduction Act of 1995 (Public Law 104-13), NARA invites the general public and other Federal agencies to comment on proposed information collections. NARA published a notice of proposed collection for this information collection on June 8, 2001 (66 FR 30954 and 30955). No comments were received. NARA has submitted the described information collection to OMB for approval.

In response to this notice, comments and suggestions should address one or more of the following points: (a) Whether the proposed information collection is necessary for the proper performance of the functions of NARA; (b) the accuracy of NARA's estimate of the burden of the proposed information collection; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including the use of information technology. In this notice, NARA is soliciting comments concerning the following information collection:

OMB number: 3095-0035.

Agency form number: None.

Type of review: Regular.

Affected public: Business or other for-profit, not-for-profit institutions, Federal government.

Estimated number of respondents: 5.

Estimated time per response: 3 hours.

Frequency of response: On occasion.

Estimated total annual burden hours: 15 hours.

Abstract: The information collection is prescribed by 36 CFR 1254.71(e). Respondents are organizations that want to make paper-to-paper copies of archival holdings with their personal copiers. NARA uses the information to determine whether the request meets the criteria in 36 CFR 1254.71(e) and to schedule the limited space available.

The following is a summary of the application. The complete application is available for a fee from the SEC's Public Reference Branch at 450 Fifth Street, NW., Washington, DC 20549-0102 [tel. (202) 942-8090].

1. United is a stock life insurance company organized under the laws of the State of Nebraska in 1926. It is authorized to sell life insurance and annuities in all states (except New York) and the District of Columbia. United is a wholly owned subsidiary of Mutual of Omaha Insurance Company (“Mutual”), a mutual life insurance company organized under the laws of the State of Nebraska.

2. Companion is a stock life insurance company organized under the laws of the State of New York. It is authorized to sell life insurance and annuities in Connecticut, New Jersey and New York. Companion is a direct subsidiary of United and an indirect subsidiary of Mutual.

3. United of Omaha Separate Account C was established on December 1, 1993 as a separate account under Nebraska law for the purpose of funding variable annuity policies issued by United. It is a segregated asset account of United and is registered with the Commission as a unit investment trust under the Act.

4. Companion Life Separate Account C was established on February 18, 1994 as a separate account under New York law for the purpose of funding variable annuity policies issued by Companion. It is a segregated asset account of Companion and is registered with the Commission as a unit investment trust under the Act.

5. MOIS is the principal underwriter of the Policies. MOIS is registered with the Commission as a broker-dealer under the Securities Exchange Act of 1934 and is a member of the NASD. The Policies are sold by registered representatives of broker-dealers that have entered into distribution agreements with MOIS, and by registered representatives of MOIS. MOIS is an indirect wholly owned subsidiary of Mutual.

6. The minimum initial purchase payment is $10,000. A Policy owner may make additional purchase payments of at least $500 at any time ($100 if the purchase payment is made by an electronic funds transfer). Additional purchase payments may be made at any time until the Policy anniversary following the Policy owner's 95th birthday.

7. Policy owners can elect an enhanced credit rider to the Policy. If elected, this rider will add the Enhanced Credit, which is equal to the following percentage of purchase payments made during the first seven Policy years.

8. The Companies will allocate Enhanced Credits pro rata among the fixed and variable investment options available under the Policy in the same ratio as the related purchase payment is allocated. The Companies will fund Enhanced Credits from their general account assets.

9. The annual charge for the enhanced credit rider is .50% of the Policy owner's total accumulation value in the variable and fixed accounts of the Policy. The Companies assess the charge daily on the assets in the investment options to which a Policy owner's purchase payments are allocated. The Companies will discontinue deducting the charge eight years from the date the Policy is issued.

10. The enhanced credit rider can only be elected on the Policy application, and cannot be elected after the Policy is issued. Once the enhanced credit rider is elected, it cannot be cancelled, and will only terminate (i) at the end of the first eight Policy years or (ii) the date the Policy terminates.

11. The Enhanced Credit will be recaptured if the Policy owner exercises the free look provision available under the Policy. In addition, unless prohibited by state low, all or part of the Enhanced Credit will be recaptured if the Policy owner makes a cash surrender or a partial withdrawal in excess of the annual 10% free withdrawal amount during the first seven Policy years. The 10% free withdrawal provision allows a Policy owner to withdraw up to 10% annually of the accumulation value of the Policy without a withdrawal charge or interest adjustment being assessed. The amount of the bonus forfeited will equal the amount of the bonus, multiplied by the amount of the cash surrender or partial withdrawal in excess of the 10% free withdrawal amount, divided by the sum of all purchase payments made under the Policy, multiplied by the percentage of the Enhanced Credit which is not vested. Enhanced Credits that are not vested will be recaptured according to the following schedule:

12. The amount of any account value, step-up value or roll-up value death benefit will not include any Enhanced Credits given within the twelve months prior to the date of a Policy owner's death.

13. Regardless of whether or not the Enhanced Credit is recaptured, all gains attributable to such Enhanced Credit are part of the Policy owner's Policy value and will not be recaptured.

14. Policy owners can elect to receive a renewal credit to the accumulation value of their Policy at any time after the end of the eighth Policy year and at the end of each renewal credit period thereafter. A renewal credit period is a five-year term that begins on the day a Policy owner elects to receive a renewal credit. The Companies will allocate the renewal credit pro rata among the fixed and variable investment options available under the Policy in same ratio as accumulation value of the Policy is allocated. The Companies will fund the renewal credit from their general account assets.

15. There is no charge for the renewal credit and the Companies will not recapture the renewal credit.

16. The free look period is the 10-day period (or longer if required by state law) during which a Policy owner may return a Policy after it has been delivered and receive a full refund of the Policy accumulation value, less any Enhanced Credits applied. Unless the law requires that the full amount of the purchase payment be refunded, less any withdrawals, the Policy owner bears the investment risk from the time of purchase until he or she returns the Policy and the refund amount may be more or less than the purchase payment the Policy owner made. The Enhanced Credit will be recaptured if the free look provision is exercised.

17. A Policy owner may make withdrawals from the Policy before annuitization. The minimum withdrawal amount is $500. If the enhanced credit rider is elected, any withdrawal in excess of the annual 10% free withdrawal amount during the first seven Policy years will be subject to the recapture of some or all Enhanced Credits applied to the Policy and also may be subject to withdrawal charges and interest adjustments.

18. The withdrawal charge applied to a partial withdrawal or cash surrender will be the applicable withdrawal charge percentage listed below, subject to a maximum of 9% of the sum of all purchases made by the Policy owner. The withdrawal charge percentages for the first eight Policy years are as follows:

The withdrawal charges for all Policy years following the eighth Policy year will be 5% during any renewal credit period (which is the five-year term following the date the Policy owner elects to receive the renewal credit). Otherwise, no withdrawal charge is applicable after the eighth Policy year.

19. The interest adjustment may be applied to a cash surrender or partial withdrawal from the Policy's 5-Year Fixed Account or 8-Year Fixed Accounts for amounts in excess of the annual 10% free withdrawal amount. This adjustment is intended to adjust the interest received in these accounts to a market rate of interest. The adjustment will never result in a credited interest rate that will yield less than 3% per annum.

20. Withdrawal charges and interest adjustments will no longer apply as of the first policy anniversary following the annuitant's 90th birthday. In addition, the withdrawal charges and interest adjustments do not apply to (a) any death benefit received under the Policy, (b) when the waiver of withdrawal charges provision of the Policy is exercised and (c) in certain other very limited circumstances set forth in the Policy.

21. The Policy provides for a basic death benefit. An enhanced death benefit is also available. Any Enhanced Credits to the Policy given within the twelve months prior to the date of a Policy owner's death will be recaptured when the death benefit is based on account value, step-up value or roll-up value. However, the accumulation value of the Policy will reflect all gains and losses attributed to all Enhanced Credits to the Policy, including those recaptured.

22. Owners of the Policies may allocate their purchase payments among thirty-one variable investment options and four fixed investment options. Each sub-account of the Accounts is a variable investment option that will invest in shares of a corresponding portfolio of The Alger American Fund, Deutsche Asset Management VIT Funds, Federated Insurance Series, Fidelity Variable Insurance Products Fund, MFS Variable Insurance Trust, Morgan Stanley Universal Institutional Funds, Inc., Pioneer Variable Contracts Trust, Scudder Variable Life Investment Fund, T. Rowe Price Equity Series, Inc., T. Rowe Price Fixed Income Series, Inc. and T. Rowe Price International Series, Inc. or other investment companies.

23. The Companies, at a later day, may decide to create additional subaccounts to invest in any additional funding media as may now or in the future be available. The Companies, from time to time, also may combine or eliminate subaccounts or transfer assets to and from subaccounts.

24. The Policy provides for a death benefit, enhanced death benefit options, annuity benefits and annuity payout options, as well as transfer privileges, dollar cost averaging, asset allocation and other features. In addition to the withdrawal charge and interest adjustment discussed above, the Policy has the following charges: (a) For Policies that have an accumulation value of less than $100,000, an administrative expense charge equal to .15% per annum of the Policy's investment in the subaccounts, deducted on a daily basis; (b) an annual policy fee of $40 for Policies that have an accumulation value of less than $50,000; (c) a mortality and expense risk charge equal to 1.25% per annum of Policy's accumulation value, deducted on a daily basis; (d) a transfer fee of $20 for each transfer after twelve transfers made during a Policy year; (e) if elected, the charge for the enhanced credit rider which is equal to 0.50% per annum of accumulation value of the Policy, deducted on a daily basis for the first eight Policy years; (f) if elected, the charge for the enhanced death benefit rider which is equal to 0.30% per annum of the accumulation value in the subaccounts, deduced on a daily basis; and (g) any applicable state premium tax. In addition, assets invested in the subaccounts are charged with the annual operating expenses of the underlying portfolios.

1. Section 6(c) of the Act authorizes the Commission to exempt any person, security or transaction, or any class or classes or persons, securities or transactions from the provisions of the Act and the rules promulgated thereunder if and to the extent that such exemption is necessary or appropriate in the public interest and consistent with the protection of investors and the purposes fairly intended by the policy and provisions of the Act.

2. Applicants request that the Commission pursuant to Section 6(c) of the Act grant the exemptions requested below with respect to the Policy and any Future Policies issued by the Companies, funded by the Accounts or Other Accounts, and underwritten or distributed by MOIS or Affiliated Broker-Dealers. Applicants undertake that Future Policies will be substantially similar to the Policies in all material respects. Applicants believe that the requested exemptions are appropriate in the public interest and consistent with the protection of investors and the purposes fairly intended by the policy and provisions of the Act.

3. Applicants seek exemptions pursuant to Section 6(c) from Sections 2(a)(32), 22(c), and 27(i)(2)(A) of the Act and Rule 22c-1 thereunder to the extent deemed necessary to permit the Companies to recapture that portion of an Enhanced Credit which is not vested, as described above, in the following instances: (a) When a Policy owner exercises the Policy's free look provision; (b) when a Policy owner makes a cash surrender or a withdrawal in excess of the annual 10% free withdrawal amount within the first seven Policy years; and (c) any Enhanced Credits received within twelve months of the date of death of a Policy owner when the death benefit is based on account value, step-up value or roll-up value.

4. Applicants represent that it is not administratively feasible to track an Enhanced Credit in the Accounts after the Enhanced Credit is applied. Accordingly, the asset-based charges applicable to the Accounts will be assessed against the entire amount held in the Accounts, including the Enhanced Credit, during the free look period and the recapture period. As a result during such periods, the aggregate asset-based charges assessed against a Policy owner's accumulation value, which includes all assets in the sub-accounts and the fixed accounts, including any Enhanced Credit, will be higher than those that would be charged if the Policy owner's accumulation value did not include the Enhanced Credit.

5. Subsection (i) of Section 27 of the Act provides that Section 27 does not apply to any registered separate account funding variable insurance contracts, or to the sponsoring insurance company and principal underwriter of such account, except as provided in paragraph (2) of the subsection. Paragraph (2)(A) provides that it shall be unlawful for such a separate account or sponsoring insurance company to sell a contract funded by the registered separate account unless such contract is a redeemable security. Section 2(a)(32) defines “redeemable security” as any security, other than short-term paper, under the terms of which the holder, upon presentation to the issuer, is entitled to receive approximately his or her proportionate share of the issuer's current net assets, or the cash equivalent thereof.

6. Applicants assert that the recapture of an Enhanced Credit in the circumstances set forth above would not deprive a Policy owner of his or her proportionate share of the issuer's current net assets. According to the Applicants, a Policy owner's interest in an Enhanced Credit allocated to his or her Policy value upon receipt of a purchase payment made during the seven years of the Policy is not fully vested until the end of the seventh Policy year. Unless and until the full amount of an Enhanced Credit is vested, the Companies retain at least a partial right and interest in the Enhanced Credit, although not in the earnings attributable to that amount. Thus, when the Companies recapture an Enhanced Credit, they are merely retrieving their own assets and the Policy owner has not been deprived of a proportionate share of the applicable Accounts' assets because his or her interest in the Enhanced Credit has not vested.

7. In addition, Applicants assert that permitting a Policy owner to retain an Enhanced Credit under a Policy upon the exercise of the free look provision would not only be unfair, but would also encourage individuals to purchase a Policy, with no intention of keeping it, and return it for a quick profit. Furthermore, the recapture of Enhanced Credits applied to purchase payments made within the first seven Policy years is designed to provide the Companies with a measure of protection against anti-selection. The anti-selection risk is that a Policy owner could collect the Enhanced Credit and then cancel the Policy soon thereafter, thereby leaving the Companies little time to recover the cost of the Enhanced Credit. As noted earlier, the amounts recaptured equal the Enhanced Credits provided by the Companies from their general account assets, and any gain would remain a part of the Policy owner's accumulation value.

8. For the foregoing reasons, Applicants submit that the provisions for recapture of Enhanced Credits under the Policies and Future Policies do not violate Sections 2(a)(32) and 27(i)(2)(A) of the Act. The application of an Enhanced Credit to purchase payments made under the Policies should not raise any questions as to the Companies' compliance with the provisions of Section 27(i). However, to avoid any uncertainty as to full compliance with the Act, Applicants request an exemption from Sections 2(a)(32) and 27(i)(2)(A), to the extent deemed necessary, to permit the recapture of any Enhanced Credit under the circumstances described in this application without the loss of relief from Section 27 provided by Section 27(i).

9. Section 22(c) of the Act authorizes the Commission to make rules and regulations applicable to registered investment companies and to principal underwriters of, and dealers in, the redeemable securities of any registered investment company to accomplish the same purposes as contemplated by Section 22(a). Rule 22c-1 under the Act prohibits a registered investment company issuing any redeemable security, a person designated in such issuer's prospectus as authorized to consummate transactions in any such security, and a principal underwriter of, or dealer in, such security, from selling, redeeming, or repurchasing any such security except at a price based on the current net asset value of such security next computed after receipt of a tender of such security for redemption or of an order to purchase or sell such security.

10. The Companies' recapture of an Enhanced Credit might arguably be viewed as resulting in the redemption of redeemable securities for a price other than one based on the current accumulation unit value of the Accounts. Applicants contend, however, that the recapture of the Enhanced Credit does not violate Section 22(c) or Rule 22c-1.

11. Applicants argue that the recapture of the Enhanced Credit does not involve either of the problems that Rule 22c-1 was intended to eliminate or reduce, namely (a) the dilution of the value of outstanding redeemable securities of registered investment companies through their sale at a price below net asset value or repurchase at a price above it, and (b) other unfair results, including speculative trading practices. These problems were the result of backward pricing, the practice of basing the price of a mutual fund share on the net asset value per share determined as of the close of the market on the previous day. Backward pricing allowed investors to take advantage of increases or decreases in net asset value that were not yet reflected in the price, thereby diluting the values of outstanding mutual fund shares.

12. Applicants state that the proposed recapture of the Enhanced Credit does not pose such a threat of dilution. To effect a recapture of an Enhanced Credit, the Companies will redeem interests in a Policy at a price determined on the basis of the current accumulation unit value(s) of the sub-account(s) to which the Policy owner's accumulation value is allocated. The amount recaptured will never exceed the amount of the Enhanced Credit paid out of the Companies' general account assets. Although the Policy owner will be entitled to retain any investment gain attributable to the Enhanced Credit, the amount of that gain will be determined on the basis of the current accumulation unit values of the applicable subaccounts. Thus, no dilution will occur upon the recapture of the Enhanced Credit. Applicants also state that the second harm that Rule 22c-1 was designed to address, namely speculative trading practices calculated to take advantage of backward pricing, will not occur as a result of the recapture of the Enhanced Credit.

13. Applicants submit that because neither of the harms that Rule 22c-1 was meant to address is found in the recapture of the Enhanced Credit, Rule 22c-1 and Section 22(c) should not apply to any Enhanced Credit. However, to avoid any uncertainty as to full compliance with the Act, Applicants request an exemption from the provisions of Section 22(c) and Rule 22c-1 to the extent deemed necessary to permit them to recapture the Enhanced Credit under the Policies and Future Policies.

14. Applicants represent that the Companies will offer the renewal credit subject to the following conditions:

a. Election Letter. In connection with the renewal credit, the Companies will send a letter (the “Letter”) that prominently discloses in concise plain English that (a) the renewal credit is most suitable for Policy owners who expect to continue their Policies for five or more years, and (b) if he Policy is surrendered or if accumulation value is withdrawn during the five-year renewal credit period, then the Policy owner may be worse off in certain circumstances than if the or she had not elected the renewal credit. The Letter will disclose exactly how a Policy owner who surrenders a Policy or makes a withdrawal during the renewal credit period could be worse off as a result of poor separate account investment performance than if he or she had not elected the renewal credit.

b. Written Election. The Companies will send the Letter directly to Policy owners eligible to elect the renewal credit and elections to receive the renewal credit will only be effective upon receipt by the Companies of an election signed by the Policy owner on a duplicate copy of the Letter. The Companies will distribute such duplicate Letters with election signature forms along with the Letter. If the Letter is more than two pages in length, the Companies will use a separate document to obtain the Policy owner's elections of the renewal credit, which document will prominently disclose in concise plain English the statements required in condition 1 above.

c. Records. The Companies will maintain the following separately identifiable records in an easily accessible place for review by the Commission staff: (a) copies of any form of the Letter and any other written materials or scripts for presentations by representatives regarding the renewal credit, including the dates used, (b) records showing the number and percentage (on a calendar quarter basis) of eligible Policy owners that elect the renewal credit, (c) records showing the name and Policy number of each Policy owner who elects a renewal credit, the amount of the Policy owner's accumulation value at the time the renewal credit is elected, the amount of the renewal credit, the Policy owner's name, address, telephone number and date of birth, the date the Policy owner signed the Letter or election form, the signed Letters or separate documents that reflect the Policy owner's election of the renewal credit, and where a commission (or other compensation) is paid to a registered representative on or after the date of the election of the renewal credit, the amount of the commission (or other compensation), and the name of any sales representative involved with the solicitation of the election of the renewal credit or who receives any compensation in connection with the Policy after the date of the election of the renewal credit and her or his CRD number, firm affiliation, telephone number, and branch office address, (d) records of persistency information for Policies whose Policy owners have elected the renewal credit, including the date(s) of any subsequent surrender or withdrawal of accumulation value and the amount of any withdrawal charge, and (e) logs recording any Policy owner complaints about the renewal credit, state insurance department inquiries about the same, or litigation, arbitration or other proceedings regarding the renewal credit. The logs will include the date of the complaint (or of commencement of any proceeding), the name and address of the person making the complaint or commencing the proceeding, the nature of the complaint or proceeding and the persons involved in the complaint or proceeding. The forgoing records will be retained for the longer of: (1) six years after the later of their creation or their last use, or (2) two years after the end of the relevant renewal credit period.

15. Applicants request an order pursuant to Section 6(c) for an exemption from Sections 2(a)(32), 22(c), and 27(i)(2)(A) of the Act and Rule 22c-1 thereunder to the extent deemed necessary to permit the Companies to recapture Enhanced Credits as described herein. Applicants represent that the Enhanced Credit will be attractive to and in the interest of investors because it will permit Policy owners to put from 104% to 101% of each of their purchase payments in the first seven years of the Policy to work for them in the selected investment options. In addition, the Policy owners will retain any earnings attributable to the Enhanced Credit, as well as the principal amount of the Enhanced Credit once vested.

16. Applicants further submit that the recapture of any Enhanced Credit only applies in relation to the risk of anti-selection against the Companies. Anti-selection can generally be described as a risk that Policy owners obtain an undue advantage. This undue advantage is based on elements of fairness to the Companies and the actuarial and other factors taken into account in designing the Policies and Future Policies. The Companies provide the Enhanced Credit from their general account assets on a guaranteed basis. Thus, they undertake a financial obligation that contemplates the retention of the Policies and Future Policies by their owners over an extended period, consistent with the long-term nature of retirement planning. The Companies generally expect to recover their costs, including Enhanced Credits, over an anticipated duration while a Policy or Future Policy is in force. The right to recapture Enhanced Credits applied to purchase payments made within the first seven Policy years protects the Companies against the risk that a Policy owner will purchase a Policy or Future Policy or make larger or additional payments with the intent to hold the Policy or Future Policy for speculative purposes or for a short period of time.

17. With respect to refunds paid upon the return of a Policy or Future Policy within the free look period, Applicants assert that the amount payable by the Companies must be reduced by the amount of the Enhanced Credit. Otherwise, investors, purchase a Policy or Future Policy for the sole purpose of exercising the free look provision and making a quick profit equal to 4% of their investment.

18. Applicants submit that their request for an order that applies to the Accounts and any Other Accounts established by the Companies, in connection with the issuance of the Policies and Future Policies, is appropriate in the public interest. Such an order would promote competitiveness in the variable annuity market by eliminating the need to file redundant exemptive applications, thereby reducing administrative expenses and maximizing the efficient use of Applicants' resources. Investors would not receive any benefit or additional protection by requiring Applicants to repeatedly seek exemptive relief that would present no issue under the Act that has not already been addressed in this application. Having Applicants file additional applications would impair Applicants' ability to take advantage of business opportunities as they arise. Further, if Applicants were required repeatedly to seek exemptive relief with respect to the same issues addressed in this application, investors would not receive any benefit or additional protection thereby.

19. Applicants undertake that Future Policies funded by the Accounts or by Other Accounts, which seek to rely on the order issued pursuant to this application, will be substantially similar to the Policies in all material respects.

For the reasons summarized above, Applicants assert that the requested exemptions are necessary and appropriate in the public interest and consistent with the protection of investors and the purposes fairly intended by the policy and provisions of the Act.

The African Growth and Opportunity Act (Title I of the Trade and Development Act of 2000, Pub. L. No. 106-200) (AGOA) provides preferential tariff treatment for imports of certain textile and apparel products of beneficiary sub-Saharan African countries. The textile and apparel trade benefits under the AGOA are available to imports of eligible products from countries that the President designates as “beneficiary sub-Saharan African countries,” provided that these countries (1) have adopted an effective visa system and related procedures to prevent unlawful transshipment and the use of counterfeit documents, and (2) have implemented and follow, or are making substantial progress toward implementing and following, certain customs procedures that assist the Customs Service in verifying the origin of the products.

In Proclamation 7350 (Oct. 2, 2000), the President designated Botswana as a “beneficiary sub-Saharan African country.” Proclamation 7350 delegated to the United States Trade Representative (USTR) the authority to determine whether designated countries have met the two requirements described above. The President directed the USTR to announce any such determinations in the Federal Register and to implement them through modifications of the Harmonized Tariff Schedule of the United States (HTS). Based on actions that Botswana has taken, I have determined that Botswana has satisfied these two requirements.

Accordingly, pursuant to the authority vested in the USTR by Proclamation 7350, U.S. note 7(a) to subchapter II of chapter 98 of the HTS and U.S. note 1 to subchapter XIX of chapter 98 of the HTS are each modified by inserting “Botswana” in alphabetical sequence in the list of countries. The foregoing modifications to the HTS are effective with respect to articles entered, or withdrawn from warehouse for consumption, on or after the effective date of this notice. Importers claiming preferential tariff treatment under the AGOA for entries of textile and apparel articles should ensure that those entries meet the applicable visa requirements. See Visa Requirements Under the African Growth and Opportunity Act, 66 FR 7837 (2001).

This notice announces that the FAA has given its overall approval to the Noise Compatibility Program for the Williams Gateway Airport, effective August 17, 2001. Under Section 104(a) of the Aviation Safety and Noise Abatement Act of 1979 (hereinafter referred to as “the Act”), an airport operator who has previously submitted a Noise Exposure Map, may submit to the FAA, a Noise Compatibility Program which sets forth the measures taken or proposed by the airport operator for the reduction of existing noncompatible land uses and prevention of additional noncompatible land uses within the area covered by the Noise Exposure Maps. The Act requires such programs to be developed in consultation with interested and affected parties including local communities, government agencies, airport users, and FAA personnel.

Each airport Noise Compatibility Program developed in accordance with FAR part 150 is a local program, not a federal program. The FAA does not substitute its judgment for that of the airport proprietor with respect to which measures should be recommended for action. The FAA's approval or disapproval of FAR part 150 program recommendations is measured according to the standards expressed in FAR part 150 and is limited to the following determinations:

a. The Noise Compatibility Program was developed in accordance with the provisions and procedures of FAR part 150;

b. Program measures are reasonably consistent with achieving the goals of reducing existing noncompatible land uses around the airport and preventing the introduction of additional noncompatible land uses;

c. Program measures would not create an undue burden on interstate or foreign commerce, unjustly discriminate against types or classes of aeronautical uses, violate the terms of airport grant agreements, or intrude into areas preempted by the Federal Government; and

d. Program measures relating to the use of flight procedures can be implemented within the period covered by the program without derogating safety, adversely affecting the efficient use and management of the navigable airspace and air traffic control systems, or adversely affecting other powers and responsibilities of the Administrator prescribed by law.

Specific limitations with respect to FAA's approval of an airport Noise Compatibility Program are delineated in FAR part 150, section 150.5. Approval is not a determination concerning the acceptability of land uses under Federal, State, or local law. Approval does not by itself constitute a FAA implementing action. A request for Federal action or approval to implement specific noise compatibility measures may be required, and a FAA decision on the request may require an environmental assessment of the proposed action. Approval does not constitute a commitment by the FAA to financially assist in the implementation of the program nor a determination that all measures covered by the program are eligible for grant-in-aid funding from the FAA. Where Federal funding is sought, requests for project grants must be submitted to the FAA Airports Division office in Hawthorne, California.

The Williams Gateway Airport authority submitted the Noise Exposure Maps, descriptions, and other documentation produced during the noise compatibility planning study conducted from February 1999 through December 2000 to the FAA on December 16, 1999. The Williams Gateway Airport Noise Exposure Maps were determined by FAA to be in compliance with applicable requirements on May 2, 2000. Notice of this determination was published in the Federal Register on May 15, 2000.

The Williams Gateway Airport study contains a proposed Noise Compatibility Program comprised of actions designed for implementation by airport management and adjacent jurisdictions. It was requested that the FAA evaluate and approve this material as a Noise Compatibility Program as described in Section 104(b) of the Act. The FAA began its review of the program on February 20, 2001 and was required by a provision of the Act to approve or disapprove the program within 180 days (other than the use of new flight procedures for noise control). Failure to approve or disapprove such program within the 180-day period shall be deemed to be an approval of such program.

The submitted program contained twenty-three proposed actions for noise mitigation on and off the airport. The FAA completed its review and determined that the procedural and substantive requirements of the Act and FAR Part 150 have been satisfied. The Acting Associate Administrator for Airports approved the overall program effective August 17, 2001.

Twenty of the twenty-three program measures have been approved. The following seven measures were approved as voluntary measures: Continue Calm Wind Runway 30 L/C/R Use Program; Continue using Runway 12R-30L for Light Piston Aircraft and Runways 12C/L-30C/R for Large Turbojet Aircraft Operations; Continue to Encourage use of NBAA [National Business Aviation Association] Noise Abatement Procedures; Continue to Promote use of AOPA [Aircraft Owner and Pilots Association] Noise Awareness Steps by light single and twin-engine aircraft; Continue to Promote the Departure Procedure for the AANG [Arizona Air National Guard] 161st Air Refueling Wing KC-135 Aircraft and Aircraft less than 12,500 pounds; Develop Helicopter Reporting Points and Arrival and Departure Routes; and, Request Aircraft Using Runway 12R-30L Traffic Pattern To Remain East of the Southern Pacific Railroad. The following thirteen measures were approved outright: Support 161st Air Refueling Wing of the Arizona Air National Guard's efforts to re-engine KC-135 Aircraft; Update General Plans to Reflect the “Land Use Planning Scenario” noise contours and Airport Planning Area as a basis for noise compatibility Planning; Retain compatible land use designations for undeveloped land within the Airport Planning Area; Develop a new mixed-use category that does not allow residential within the planned mixed-use areas inside the planning scenario's 60-DNL boundary and immediately north of the airport; Establish noise compatibility guidelines for the review of development projects within the “planning scenario” 60 DNL noise contour; Encourage rezoning areas within the “Planning Scenario” noise contours and Airport Planning Area (APA) to Match the Compatible land use designations in the general plans; Amend Airport Over flight Zoning Ordinance, reflect planning scenario noise contours and Airport Planning Area (APA), require fair disclosure covenants and amend sound insulation standards; Amend subdivision regulations to require recording of fair disclosure covenants and granting of avigation easements in Airport Planning Area; Amend building codes to add sound insulation standards supporting the Airport Planning Area (APA) over flight zoning requirements; Maintain and update the system for receiving, analyzing, and responding to noise complaints and community outreach; Acquire noise monitors; Review Noise Compatibility Plan implementation; and, Update Noise Exposure Maps and Noise Compatibility Program. The following Two measures were disapproved pending the submission of additional information: Install PAPI-4 Lighting on Runway 12R-30L; and, Encourage Use of AC 91.53A Noise Abatement Departure Procedures by Air Carrier Jets. The following measure was disapproved for the purposes of Part 150: Relocate Instrument Landing System to Runway 30R.

These determinations are set forth in detail in a Record of Approval endorsed by the Acting Associate Administrator for Airports on August 17, 2001. The Record of Approval, as well as other evaluation materials and the documents comprising the submittal are available for review at the FAA office listed above and at the administrative offices of the Williams Gateway Airport Authority, Mesa, Arizona.

The proposed CTAP changes could affect flights to and from airports within the Chicago region. The project is not associated with any airport development projects and does not require construction of any physical facilities. The changes proposed by CTAP are designed to improve traffic flows and reduce airborne and ground delays. They would enhance safety and efficiency by maximizing controller flexibility and simplifying operations for pilots. CTAP has the potential to enhance air quality by reducing en route mileage. As disclosed in the FEIS, CTAP would not result in significant adverse impacts to any resource category.

Council on Environmental Quality Regulations for Implementing the Procedural Provisions of the National Environmental Policy Act set forth that no decision on a proposed action shall be made by a Federal agency until 30 days after the Environmental Protection Agency publishes, in the Federal Register, a notice that the FEIS has been filed with them.

The FAA will assess and consider any written correspondence it receives on the CTAP FEIS until close of business, Tuesday, October 9, 2001. Late received correspondence will be considered to the extent feasible. This document will be available during normal business hours at the following locations.:

Information is also available on the Internet at the web site address http://www.faa.gov/ctap.html.

The Federal Aviation Administration published a Notice of Intent on June 1, 2001 to prepare and consider an EIS for implementation of proposed projects at the Juneau International Airport. Major projects proposed to be assessed in the EIS include: creation of additional Runway Safety Area (RSA) centered about the runway that is 500 feet wide by the length of the runway plus 1,000 feet beyond each runway end; installation of a Medium Approach Lighting System with Rails (MALSR) to improve the approach to Runway 26; construction of a Snow Removal Equipment Building to provide needed storage space for the snow removal fleet; and construction of additional Aviation Development Areas to provide adequate facilities to accommodate the growing demand and tourism needs of helicopters and fixed wing aircraft. A supplemental NOI was subsequently published on August 20, 2001, extending the public scoping comment period through September 30, 2001, and announced that the EIS would also evaluate a proposed new fuel tank farm access road.

Juneau International Airport has identified a number of habitat modification proposals and wildlife management activities to reduce and control wildlife hazards to aircraft. FAA has reviewed these actions and determined that the pending Wildlife Hazard Management Plan should be evaluated as a major proposed action in the EIS. FAA will continue to accept written comments concerning the scope of the EIS through September 30, 2001. Comments may be submitted in writing to the address identified in FOR FURTHER INFORMATION CONTACT or through the comment submittal form found on the project web site at www.jnu-eis.org. An additional public scoping meeting will be held in Juneau on September 18, 2001 at the Vocational Training and Resource Center, 3239 Hospital Drive, Juneau, Alaska from 5:00 pm to 9:00 pm.