Title: Regulations Governing the Application for Plant Variety Protection Certificate and Reporting Requirements under the Plant Variety Protection Act.

OMB Number: 0581-0055.

Expiration Date of Approval: April 30, 2003.

Type of Request: Extension and revision of a currently approved information collection.

Abstract: The Plant Variety Protection Act (PVPA) (7 U.S.C. 2321 et seq. ) was established “To encourage the development of novel varieties of sexually reproduced plants and make them available to the public, providing protection available to those who breed, develop, or discover them, and thereby promote progress in agriculture in the public interest.”

The PVPA is a voluntary user funded program which grants intellectual property rights protection to breeders of new, distinct, uniform, and stable seed reproduced and tuber propagated plant varieties. To obtain these rights the applicant must provide information which shows the variety is eligible for protection and that it is indeed new, distinct, uniform, and stable as the law requires. Application forms, descriptive forms, and ownership forms are furnished to applicants to identify the information which is required to be furnished by the applicant in order to legally issue a certificate of protection (ownership). The certificate is based on claims of the breeder and cannot be issued on the basis of reports in publications not submitted by the applicant. Regulations implementing the PVPA appear at 7 CFR part 92.

Form ST-470, Application for Plant Variety Protection Certificate, Form ST-470 series, Objective Description of Variety (Exhibit C to Form ST-470P), and Form ST-470-E, Statement of Basis of Applicant's Ownership, are the basis by which the determination, by experts at PVPO, is made as to whether a new, distinct, uniform, and stable seed reproduced or tuber-propagated variety in fact exists and is entitled to protection.

The information received on applications, with certain exceptions, is required by law to remain confidential until the certificate is issued (7 U.S.C. 2426).

The information collection requirements in this request are essential to carry out the intent of the PVPA, to provide applicants with certificates of protection, to provide the respondents the type of service they request, and to administer the program.

Estimate of Burden: Public reporting burden for this collection of information is estimated to average .87 hours per response.

Respondents: Businesses or other for-profit, not-for-profit institutions, and Federal Government.

Estimated Number of Respondents: 129.

Estimated Number of Responses per Respondent: 11.45.

Estimated Total Annual Burden on Respondents: 1,282.97.

Comments are invited on: (1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden of the proposed collection of information including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Comments may be sent to Paul Zankowski, Commissioner, Plant Variety Protection Office, Room 401, NAL Building, 10301 Baltimore Avenue, Beltsville, MD 20705. All comments received will be available for public inspection during regular business hours at the same address.

All responses to this notice will be summarized and included in the request for OMB approval. All comments will become a matter of public record.

Section 203 (c) of the Agricultural Marketing Act of 1946, as amended, directs and authorizes the Secretary of Agriculture “To develop and improve standards of quality, condition, quantity, grade, and packaging, and recommend and demonstrate such standards in order to encourage uniformity and consistency in commercial practices.” USDA is committed to carrying out this authority in a manner that facilitates the marketing of agricultural commodities. One way of achieving this objective is through the development and maintenance of voluntary standards by AMS.

Participants wishing to become USDA Verified for marketing claims based on these standards must provide the documentation and records necessary to verify the accuracy of the claims. Since the USDA Verified programs are specific to each participant, a standardized format for the documents and records will not be established.

AMS is proposing the adoption of new United States Standards for Livestock and Meat Marketing Claims, in accordance with procedures published in the August 13, 1997, Federal Register and that are contained in Part 36 of Title 7 of the Code of Federal Regulations (7 CFR Part 36).

This notice codifies industry consensus standards which have been used in “USDA Process Verified” programs under the Quality Systems Certification Program (QSCP). The QSCP is included in the current services of the Meat Grading and Certification Branch in 7 CFR Part 54.4 (63 FR 72102, Dec. 31, 1998). The information collection reporting requirements for those services were approved under Office of Management and Budget (OMB) Control No. 0581-0124, dated June 2, 2000.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the recordkeeping requirements and burden for the Livestock and Meat Marketing Claims Standards will be detailed in another anticipated rulemaking that will establish a new part in the Code of Federal Regulations for a Quality System Verification Program under the LS Program's Audit, Review, and Compliance Branch. AMS intends to have these recordkeeping burden requirements become a part of OMB Control No. 0581-0183. The Livestock and Meat Marketing Claims Standards recordkeeping burden will be incorporated when a request for a revision to and extension of OMB Control No. 0581-0183 is submitted to the Office of Management and Budget.

Since the late 1970's, some livestock and meat industry companies and individual producers have sought USDA services to increase the value of their products (live animals or meat products) by distinguishing them from competing commodity products. Advertising and promotions, which often highlight production and marketing practices, are examples of the methods companies and individuals have utilized to “set their products apart.”

Since 1978 the Livestock and Seed (LS) Program has provided certification for a number of claims related to product traits of beef, pork, and lamb carcasses, with or without accompanying claims for breed. Validity was added to the claims because the product was “USDA Certified”. Since 1996 the LS Program has offered a verification service to verify claims that cannot be ascertained by direct examination of the product. This verification program allows participants to declare “USDA Verified” for one or more system attributes such as feeding practices, or other pre- and post-harvest processes. Participants must have a documented quality management program covering all aspects of their system and must submit to periodic audits by AMS.

As multiple organizations began to seek USDA verification of the same or similar production practices, the LS Program determined it would be beneficial to establish minimum standards for common production/marketing claims. Certification service requests, along with information obtained during the administration of USDA Verified programs, led the LS Program to develop these proposed United States Standards for Livestock and Meat Marketing Claims. Standardization of these marketing and production claims will permit marketers and purchasers of these products to make informed decisions by using common trade language.

Many product labels that include these marketing claims must be submitted to the Food Safety and Inspection Service (FSIS), Labeling and Consumer Protection Staff (LCPS), for evaluation prior to use. LCPS is USDA's policy authority on domestic and imported meat, poultry, and egg product labeling, standards, and ingredients. Therefore, the LS Program and LCPS have cooperatively developed these marketing claim standards. Participants whose products or processes do not meet these minimum requirements will not be recognized as USDA Certified or USDA Verified by AMS, and LCPS will not approve labels citing certification of such claims. In addition, LCPS will refer to these standards as guidelines for approval of labels making such marketing claims.

The proposed marketing claim standards may be used in conjunction with existing regulations or voluntary USDA grade standards in USDA Certified and USDA Verified programs. Minimum breed claim criteria shall be established by national breed associations. Since National Pedigreed Livestock Council (NPLC) is the only multi-species organization for livestock breed associations, AMS will refer to NPLC members as the designated national breed association. Breed associations that are not members of NPLC may petition AMS for the purpose of establishing a national breed claim program. If a national breed association does not have minimum breed claim criteria, breed claims must be traceable to a parent registered with the national breed association.

Based on LS Program experience with USDA Certified and USDA Verified programs, research into standard practices and procedures, and requests from the livestock and meat industries, AMS identified the need to establish minimum standards for marketing and production claims. In addition to relying on their own expertise, LS Program marketing specialists obtained input from a number of individual experts in government, industry, and academia while drafting these proposed standards and their corresponding thresholds.

AMS is seeking public comment on the following proposed United States Standards for Livestock and Meat Marketing Claims. New participants in USDA Certified or USDA Verified programs will be required to adhere to the United States Standards for Livestock and Meat Marketing Claims immediately. A current participant in USDA Certified or USDA Verified programs, whose system does not comply with these standards, will have 60 days from the final publication of these standards to bring their system into compliance. If a participant fails to bring their system into compliance, AMS will withdraw its USDA Certified or USDA Verified approval and notify LCPS that the basis for their label approval is no longer valid. USDA Certified or USDA Verified program participants who are notified their programs will be withdrawn may submit a written appeal, within 30 days of program withdrawal notification, to the Deputy Administrator, Livestock and Seed Program, AMS. The Deputy Administrator will respond promptly with a written decision which will be final. Unless otherwise noted, these standards apply to cattle, sheep, swine, their carcasses, and meat products.

Antibiotic Claims—Background: To reduce the risk of antibiotic residues, the Food and Drug Administration (FDA) requires withdrawal of antibiotics from animals for a specified period prior to harvest. Existing antibiotic-residue testing technology can detect residues that exceed the FDA's minimum thresholds. These tests do not have the sensitivity to verify “antibiotic-free” or that no antibiotics were ever administered. After an antibiotic is administered for treatment, the body slowly depletes the traceable residue. “Antibiotic-free” marketing claims are not allowed by LCPS; however, LCPS will allow “no detectable antibiotic residue” claims if the product is tested and the science-based test protocol is provided to LCPS. Since some consumers prefer meat products from animals that have not been fed and/or treated with antibiotics and some producers are willing to provide additional assurances of compliance with regulatory requirements, other limited product claims regarding antibiotic treatments are allowed by LCPS. When such antibiotic claims are made, they must be supported by feed formulations, pharmaceutical invoices, or other appropriate documentation, that verifies animals have not received antibiotics in feed or water and whether they have been treated for illness. Procedures for handling sick animals must be documented.

Claim and Standard:

• No antibiotics used, or Raised without antibiotics. —Livestock have never received antibiotics from birth to harvest.

• No subtherapeutic antibiotics added, or Not fed antibiotics. “ Livestock are not fed subtherapeutic levels of antibiotics. They may receive treatment for illness provided the approved FDA withdrawal period is observed.

• No detectable antibiotic residue (analyzed by “method x”).—LCPS requires additional information on the label that clearly informs the consumer/purchaser that the animal may have been treated with antibiotics. Livestock may receive antibiotics during the production phase, provided:

(1) All antibiotics are withdrawn at least 30 days beyond the minimum FDA withdrawal requirement ( e.g. , if the FDA minimum withdrawal period is 10 days, the minimum withdrawal period for the United States Standard for Livestock and Meat Marketing Claims would be at least 40 days); and,

(2) Livestock and meat products contain no detectible antibiotic residue as verified by statistical sampling analysis using a science-based testing protocol. The specific test protocol and sensitivity of that method must be disclosed (“method x”).

Breed Claims.— Claims for breed of livestock must meet criteria established by an AMS-recognized U.S. breed association for the referenced breed. If the breed association does not establish criteria for this claim, animals must be traceable to a parent registered with a breed association.

Free Range Claims—Background: These claims relate to the practice of allowing livestock to have continuous and unconfined access to pasture throughout their life cycle. Producers must verify how livestock are cared for during normal and inclement weather conditions, birthing, or other conditions that would merit special protection. Since some consumers prefer products from animals that have been raised using these production practices, producers may seek to improve their returns by appealing to such market niches.

Claim and Standard:

• Free Range, Free Roaming, or Pasture Raised. “ Livestock that have had continuous and unconfined access to pasture throughout their life cycle, including:

Cattle *—Shall never be confined to a feedlot.

Sheep *—Shall never be confined to a feedlot.

Swine *—Shall have continuous access to pasture for at least 80% of their production cycle.

* FSIS requires product labels from red meat species with these claims also include the following further qualifying statement: “Free Range—Never Confined to Feedlot.”

Geographic Location Claims — Background: Producers, processors, and retail/foodservice operators may want to differentiate their products by identifying the geographic region where the product was produced. References to individual States, countries, or specific or general geographic areas ( e.g. , Dakotas, Western) will constitute geographic location claims.

Claim and Standard:

• Location of Raising ( e.g. , “Mid-Western Raised Lamb” or “Raised in Montana”).—The livestock are raised/grown in the specified geographic location from birth to harvest.

• Location of Finishing ( e.g. , “Rocky Mountain Fed Lamb” or “Nebraska Fed Beef”).—The livestock are fed/finished in the specified geographic location for at least the last 100 days prior to harvest.

Grain Fed Claims — Background: Livestock are finished on high concentrate rations (grain feeding) to enhance meat palatability. A high concentrate grain ration is any cereal plant product that meets or exceeds 60 Mega calories (Mcal) Net Energy for gain (NEg) per 100 pounds of ration dry matter (1996 NRC for cattle, 1998 NRC for swine).

Claim and Standard:

• Grain Fed ( e.g. , Corn Fed, if corn is the primary ingredient).—

Cattle—

(1) Average grain consumption must equal 50% or more of the ration;

(2) NEg must average at least 60 Mcal per 100 pounds of ration dry matter;

(3) Dry Matter Intake (DMI) during the finishing phase must be at least equal to: ((Cattle shrunk weight at the beginning of the finishing phase × 0.014) + 10 pounds). DMI tolerance cannot be less than 10% of this formula; and,

(4) Minimum number of days on feed is 100 days for slaughter steers and heifers and 30 days for cows.

Lambs—

(1) Average grain consumption must equal 50% or more of the ration; and,

(2) Minimum number of days on feed for slaughter lambs is 50 days.

Swine—

(1) Average grain consumption must equal: (a) 45% or more of the nursery phase (pig weight: 15-65 pounds) ration; and, (b) 65% or more of the finishing phase (pig weight: 65-300 pounds) ration.

(2) Minimum number of days on feed for slaughter hogs is 60 days.

Grass Fed Claims—Background: This claim refers to the feeding regimen for livestock raised on grass, green or range pasture, or forage throughout their life cycle, with only limited supplemental grain feeding allowed. Since it is necessary to assure the animal's well being at all times, limited supplementation is allowed during adverse environmental conditions. Grass feeding usually results in products containing lower levels of external and internal fat (including marbling) than grain-fed livestock products.

Claim and Standard:

• Grass Fed.—Grass, green or range pasture, or forage shall be 80% or more of the primary energy source throughout the animal's life cycle.

Hormone Claims—Background: Hormones * are synthetic or naturally occurring compounds which have been shown to improve gain and feed efficiency, stimulate growth, and/or control reproductive activity. Since all plants and animals produce hormones, a “hormone-free” plant or meat product is a misnomer and a “hormone-free” marketing claim cannot be made. However, since some consumers prefer meat products from animals that have not received supplemental hormones and some markets restrict the sale of hormone-treated products, the following claims and standards will be recognized.

Claim and Standard:

• No supplemental hormones * used, Raised without supplemental hormones*, or No added hormones*.—The livestock have never received supplemental hormones from birth to harvest.

• No hormones* administered during finishing.—The livestock have not received supplemental hormones during the feeding/finishing period.

* The terms “hormone,” “growth promotant,” “growth stimulant,” and “implant” are used interchangeably.

Livestock Identification Claims—Background: Livestock identification is used to establish ownership, ancestry, pedigree, or age; to trace origin of livestock; or to manage herd health, artificial insemination, and performance testing programs. Livestock identification from birth or a stated point of production through retail product outlets may also address consumer requests for more information about the characteristics of products they buy and increase returns to producers.

Claim and Standard:

• Source Verified.—Must include the following:

(1) Method of livestock identification;

(2) Location(s) where livestock are born, raised, fed, harvested, and processed; and,

(3) Identification of the producer(s).

• Individual Animal Identification.—Must fulfill the Source Verified requirements and also have unique, individual animal identification. The American Information Number (AIN) system or other numbering scheme that provides for unique identification of animals and verification of program claims may be used.

Preconditioning Claims—Background: Preconditioning of animals by livestock producers can yield advantages in the livestock raising process by reducing animal stress, mortality rates, shrinkage, and the transition time required to start animals on feed.

Claim and Standard:

• Preconditioned for “x” days (where “x” is the number of days prior to sale/shipping).—Animals for which a preconditioning claim is made must receive the following treatments (as appropriate) at least 45 days prior to their sale/shipment:

(1) Dehorning (when applicable);

(2) Castration (if male);

(3) Vaccinations;

(4) Treatment for control of parasites;

(5) Weaning; and,

(6) Training to eat and drink from feed and water bunks.

Vitamin E Claims —Background: Inclusion of Vitamin E in feed rations, in the form of alpha-tocopheryl acetate, has been shown to improve product color and case life. Promotion of Vitamin E use is limited to livestock producers, packers, and wholesalers. Retail-marketing claims, such as “Vitamin E fed” or “Vitamin E enhanced,” are not allowed by FSIS because consumers do not receive a supplemental level of Vitamin E by consuming Vitamin E-fed beef. Animal identification, reviewing feed rations and records, and testing feed samples and muscle tissue samples may be verification elements to support this claim.

Claim and Standard:

• Cattle have been fed supplemental levels of Vitamin E. (Promotion of Vitamin E use is limited to livestock producers, packers, and wholesalers.)—(1) Minimum of 50,000 International Units (IU)/head during feeding period (IU tolerance = ±15%); (2) Minimum feeding period of 30 days; and, (3) Minimum carcass alpha-tocopheryl acetate concentration from the neck muscle (rectus capiti dorsalis major) not less than 3.2 micrograms (μg) alpha-tocopheryl acetate/gram (g) of tissue. (Alpha-tocopheryl acetate concentration tolerance = ±15%).

Aged Meat Claims—Background: Aging is the process by which meat (carcasses or cuts) is held at a controlled temperature for a specified period, beginning at the time of harvest, to allow enzymatic activity to degrade complex proteins and promote the development of flavor and tenderness. When product is “dry aged” humidity control is also a critical element of the aging process.

Claim and Standard:

• Aged Meat Products. —Type of aging and length of postmortem aging (in days) must be specified. The actual number of days aged and type of aging (dry or wet) may also appear on the retail label.

Beef.—Must be wet aged for a minimum of 21 days or dry aged for a minimum of 35 days.

Electrical Stimulation Claims—Background: Electrical stimulation improves muscle tenderness by minimizing cold shortening, increasing enzyme activation at higher carcass temperatures (thereby accelerating the aging process), and by physical disruption of muscle fibers through extreme muscle contractions. It further results in an accelerated rate of postmortem pH decline as well as an accelerated onset of rigor mortis.

Claim and Standard:

• Electrically Stimulated Beef.—The electrical stimulation applied to the carcass must meet the following minimum requirements:

(1) The cross product of voltage and amperage (voltage multiplied by amperage) must be ≥ 500; and,

(2) Consist of at least three cycles with a minimum pulse of ≥ 1.5 seconds “on” and ≥ 1.0 second “off.”

Tenderness Claims—Background: Although individual perceptions vary, for most consumers increased tenderness and juiciness, as well as flavor intensity, contribute to an increase in overall palatability. Of all the palatability attributes, tenderness is the most critical to consumers. Results of objective measurements ( e.g. , mechanical measures, such as Warner-Bratzler Shear [WBS] or Instron tests) or subjective evaluations ( e.g. , taste panel scores) can be used to develop quantitative ranking systems which provide a relative level or degree of tenderness. Factors such as degree of doneness, physical size of a sample, and orientation of muscle fibers (among others) can dramatically affect the results of tenderness evaluations. Therefore, specific details of evaluation techniques and conditions used to establish tenderness claims must be fully documented.

Claim and Standard:

• “Company X's” Tender “Species.”—A tenderness management system must include at least 3 of the following controlled elements and must be statistically verified (P ≤ 0.05) to meet an objective tenderness evaluation of a WBS score ≤ 4.0 kg, using a 1/2 inch (1.27 cm) core, when cooked to 160°F (71°C).* The objective tenderness evaluation must be revalidated on an annual basis.

Controlled Elements: (1) Genetics; (2) Age of livestock; (3) Feeding management; (4) Electrical stimulation; (5) Aging; (6) Ingredients added to enhance tenderness; (7) Instrument assessment ( e.g. , validated carcass sorting system, pH values, etc.); or, (8) Mechanical ( e.g. , blade tenderization, etc.).

* Protocol shall be as established in the 1995 edition of the American Meat Science Association's Research Guidelines for Cookery, Sensory Evaluation, and Instrumental Tenderness Measurements of Fresh Meat. (Available from the National Cattlemen's Beef Association, Centennial, CO.)

Title: Report of Acreage for the Non-Insured Crop Disaster Assistance Program and the Tobacco Program.

OMB Number: 0560-0004.

Type of Request: Reinstatement with revision of a previously approved information collection.

Abstract: Crop and acreage information is collected from producers to determine eligibility for the Non-Insured Crop Disaster Assistance Program (NAP) and the Tobacco Program. NAP provides financial assistance to eligible producers affected by natural disasters. NAP assistance is available for crops for which federal crop insurance is not available. NAP operates under the regulations at 7 CFR part 1437. The tobacco programs establish marketing quotas for individual farms that directly control the amount of tobacco that a producer may sell and operate under the regulations at 7 CFR part 1464.

Respondents: Farmers who produce eligible crops under NAP and tobacco farmers.

Estimated Annual Number of Respondents: 772,000.

Estimated Annual Number of Forms per person: 1.5.

Estimated Average Time to Respond: .95 hours.

Estimated Total Annual Burden Hours: 1,094,513.

Title: Payers' Request for Identifying Number.

OMB Number: 0560-0121.

Type of Request: Reinstatement of a previously approved information collection.

Abstract: This collection of information is needed to obtain a Social Security, employer identification or IRS-assigned number from persons who receive CCC or FSA program payments who do not already have an identifying number on file with FSA. Such persons are required by the Internal Revenue to furnish identifying numbers to payers required to report such payments to the Internal Revenue Service. The form used for collecting the information is prepared by FSA and sent to the payee for completion with a self-addressed, postage-paid return envelope.

Respondents: Persons receiving payments from FSA.

Estimated Annual Number of Respondents: 250.

Estimated Annual Number of Responses Per Person: 1.

Estimated Average Time to Respond: 5 minutes.

Estimated Total Annual Burden Hours: 20.83 hours.

Title: Tobacco Marketing Quota Referenda and Receiving Station Information Reporting.

OMB Number: 0560-0182.

Type of Request: Reinstatement with revision of a previously approved information collection.

Abstract: Referenda are required by statute to be held every three years for each type of tobacco subject to marketing quotas to determine if quotas are to be in effect for the succeeding three years. The collection of information for the referenda consists of the ballots, which may also include other, tobacco-related questions required by Congress to solicit producers' opinions about other aspects of the tobacco program or to allow them to vote on some program provisions in some States. The referenda are operated under the regulations at 7 part 717. The information collected from receiving stations consists of receiving station registration and purchase information needed to ensure that tobacco marking quotas are effective. The regulations governing the receiving stations are at 7 CFR parts 723 and 1464.

Respondents: Tobacco producers and receiving stations.

Estimated Annual Number of Respondents: 325,000.

Estimated Annual Number of Responses Per Person: 1.

Estimated Average Time to Respond: 53 minutes.

Estimated Total Annual Burden Hours: 290,000.

Title: Assignments of Payments and Joint Payment Authorizations.

OMB Number: 0560-0183.

Type of Request: Reinstatement with revisions of a previously approved information collection.

Abstract: When the recipient of a CCC or FSA payment chooses to assign a payment to another party or have the payment made jointly with another party, the other party must be identified. This is a free service that is available upon request by the program payee. The regulations for assignment of payments are at 7 CFR part 1404.

Respondents: Persons receiving payments from CCC or FSA.

Estimated Annual Number of Respondents: 70,900.

Estimated Annual Number of Responses Per Person: 1.

Estimated Average Time to Respond: 10 minutes.

Estimated Total Annual Burden Hours: 11,816.

Title: Lamb Meat Adjustment Assistance Program.

OMB Number: 0560-0205.

Type of Request: Reinstatement of a previously approved information collection.

Abstract: This information collection is needed to obtain information from program participants on their sheep and lamb operations. The information is used to establish eligibility and determine payment amounts. The program is operated under the regulations at 7 CFR part 784.

Respondents: Sheep and lamb producers.

Estimated Annual Number of Respondents: 60,000.

Estimated Number of Responses Per Person: 5.05.

Estimated Average Time to Respond: 1.16 hours.

Estimated Total Annual Burden Hours: 351,257.

Title: Designation of Burley Tobacco Sales and Program Payment Applications.

OMB Number : 0560-0217.

Type of Request: Reinstatement of a previously approved information collection.

Abstract: This collection of information is needed to allow USDA to assign tobacco graders as needed to auction warehouses in order to grade tobacco that is delivered for sale. Information is collected on where burley tobacco producers intend to sell their tobacco and program applicant information for all kinds of tobacco, which is used to determine eligibility for benefits. The program is operated under the regulations at 7 CFR part 1464.

Respondents: Burley tobacco producers.

Estimated Annual Number of Respondents: 150,800.

Estimated Annual Number of Responses Per Person: 1.

Estimated Average Time to Respond: 1.25 hours.

Estimated Total Annual Burden Hours : 188,500 hours.

Title: Tobacco Farm Reconstitutions.

OMB Number: 0560-0025.

Expiration Date: March 31, 2003.

Type of Request: Extension with revision of a currently approved information collection.

Abstract: The reconstitution process is required when a producer wishes to increase acreage attributed to the farm from leases, change farm acreage records as a result of a sale of any part of a farm, combine a farm with another farm or divide a farm into multiple farming operations. The FSA country committee must approve or disapprove all proposed farm reconstitutions. The information is necessary to determine farmland, cropland, and changes to quotas or allotments resulting from combinations or divisions of farming operations.

Respondents: Tobacco farm owners and operators.

Estimated Annual Number of Respondents: 7,154.

Estimated Annual Number of Responses Per Person: 1.

Estimated Average Time to Respond: 45 minutes.

Estimated Total Annual Burden Hours: 5,365 hours.

Comments are invited on each of the information collections in this notice regarding (1) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of burden, including the validity of the methodology and assumption used: (3) ways to enhance the quality, utility and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

All comments received in response to this notice, including names and addresses when provided, will be a matter of public record. Comments will be summarized and included in the submission for OMB approval.

The Upper West Fork Weiser project area is located in the Upper Lost Creek, East fork Lost Creek, West Branch of the Weiser River, and East Branch of the Weiser River sub-watersheds on the New Meadows Ranger District. It is about ten miles north and west of New Meadows, and approximately 22,434 acres in size. The purpose and need for this activity is to (1) Maintain and restore a diverse and sustainable landscape structure, (2) Restore species composition, stand structure, and stand density to more closely mimic historic conditions, and (3) Maintain and restore stand health, growth, and yield.

The proposed action includes a variety of activities to meet the purpose and need. (1) Harvest timber on approximately 845 acres, producing approximately 5.7 million board feet (MMBF), using tractor and skyline logging systems. The silvicultural methods used would be overstory removal, reserve shelterwood/seed tree and some commercial thin. (2) Salvage dead and dying timber killed by fir engraver beetle and other pests, or weakened due to light, water, or nutrient competition. (3) Restore approximately 216 acres of unproductive soil by obliterating roads, skid trails, and/or landings to meet the 1988 Forest Plan Standard for Total Soil Resource Commitment (TSCR). (4) Improve approximately 56 miles of road to provide access for timber activities. (5) Ensure desired species composition by planting and/or natural regeneration of fire-tolerant Douglas-fir, ponderosa pine, and western larch seedlings on 457 acres following timber harvest activities. (6) Treat harvest-generated fuels on approximately 809 acres. Treatments would include machine piling and burning (excavator piling would be used where slopes exceed 35 percent), broadcast burning, and/or yarding tops. (7) Fence regeneration units on slopes less than 35% in cattle allotment. (8) Monitor and treat noxious weeds.

Preliminary issues for this project include effects on water quality, soil productivity, wildlife habitat, recreation, access management, visual quality, and fish habitat.

A range of reasonable alternatives will be considered. The non-action alternative will serve as a baseline for comparison of alternatives. The proposed action will be considered along with additional alternatives developed that meet the purpose and need and address major issues identified during scoping. Alternatives may have different amounts, locations, and types of project activities.

Comments received in response to this notice, including names and addresses of those who comment, will be part of the project record and available for public review.

The Forest Service is seeking information and comments from other Federal, State, and local agencies; Tribal governments; organizations; and individuals who may be interested in or affected by the proposed action. This input will be used in preparation of the draft EIS.

A draft EIS will be prepared for comment. The draft EIS will be filed with the Environmental Protection Agency (EPA) and is anticipated to be available for public review by fall 2003. The comment period on the draft EIS will be 45 days. It is important that those interested in the management of the Payette National forest participate during this initial scoping period and during the 45-day draft EIS comment period.

The Forest Service believes, at this early state, it is important to five reviewers notice of several court rulings related to public participation in the environmental review process. First, reviewers of draft EISs must structure their participation in the environmental review of the proposal so that it is meaningful and alerts an agency to the reviewer's position and contentions. Vermont Yankee Nuclear Power Corp. v. NRDC, 435 U.S. 519, 553 (1978). Also, environmental objections that could be raised at the draft environmental impact statement stage but that are not raised until after completion of the final environmental impact statement may be waived or dismissed by the courts. City of Angoon v. Hodel, 803 F. 2d 1016, 1002 (9th Cir. 1986) and Wisconsin Heritages, Inc. v. Harris, 490 F. Supp. 1334, 1338 (E.D. Wis. 1980). Because of these court rulings, it is important that those interested in this proposed action participate by the close of the 45 day comment period so that substantive comments and objections are made available to the forest Service at a time when it can meaningfully consider them and respond to them in the final environmental impact statement.

To assist the Forest Service in identifying and considering issues raised by the proposed action, comments on the draft EIS should be as specific as possible. It is also helpful if comments refer to specific pages or chapters of the draft statement. Comments may also address the adequacy of the draft environmental impact statement or the merits of the alternatives formulated and discussed in the statement. Reviewers may wish to refer to the Council on Environmental Quality Regulations for implementing the procedural provisions of the National Environmental Policy Act at 40 CFR 1503.3 in addressing these points.

After the 45-day comment period ends, the Forest Service will analyze comments received and address them in the final EIS. The final EIS is scheduled to be completed in 2004. The Responsible Official is the Payette National Forest Supervisor. The decision will be documented, including the rationale for the decision, in a Record of Decision (ROD). The decision will be subject to review under the Forest Service Appeal Regulations at 36 CFR 215.

Payette National Forest completed Draft EISs (DEISs) and Final EISs (FEISs) for five projects between August 1998 and December 2001. The Forest Supervisor signed Record of Decisions (RODs) for each. Each project proceeded through the administrative appeal process (36 CFR 215) and was affirmed by the Deputy Regional Forester. In June 2002, the projects were named in a court complaint filed by the group Neighbors of Cuddy Mountain (Civ. 02-244-MJW) in District Court for the District of Idaho. After a series of hearings, on November 8, 2002, the Court ordered an injunction against the five projects based on the issue of old growth habitat retention.

Habitat and population monitoring has provided a body of data indicating the population trends of the pileated woodpecker on the Forest. The purpose of the supplemental environmental impact statements (SEISs) is to provide additional environmental analysis on the projects' compliance with the Forest Plan's old growth retention standard in light of the body of available data, to disclose that analysis to the public for review and comment, and to provide a basis for the original or new project decisions.

The preliminary issue for these SEISs is the effect of the proposed timber harvest on old growth habitat for pileated woodpecker, the management indicator for old growth habitat on the Payette National Forest.

A range of reasonable alternatives will be considered. The no-action alternative will serve as a baseline for comparison of alternatives. The proposed action will be considered along with additional alternative(s) needed to address major issues identified during scoping while meeting the meet the purpose and need of the projects defined in the original EISs.

Comments received in response to this notice, including names and addresses of those who comment, will be part of the project record and available for public review.

The Forest Service is seeking information and comments from other Federal, State, and local agencies; Tribal governments; organization; and individuals who may be interested in or affected by the proposals. This input will be used in preparation of the SEISs.

Comments will be appreciated throughout the analysis process. The draft SEISs will be filed with the Environmental Protection Agency (EPA) and are anticipated to be available for public review by January, 2003. The comment period on the draft SEISs will be 45 days. It is important that those interested in the management of the Payette National Forest participate at that time.

The Forest Service believes, at this early stage, it is important to give reviewers notice of several court rulings related to public participation in the environmental review process. First, reviewers of draft environmental impact statements must structure their participation in the environmental review of the proposal so that it is meaningful and alerts an agency to the reviewer's position and contentions. Vermont Yankee Nuclear Power Corp. v. NRDC , 435 U.S. 519, 553 (1978). Also, environmental objections that could be raised at the draft environmental impact statement stage but that are not raised until after completion of the final environmental impact statement may be waived or dismissed by the courts. City of Angoon v. Hodel , 803 F. 2d 1016, 1002 (9th Cir. 1986) and Wisconsin Heritages, Inc. v. Harris , 490 F. Supp. 1334, 1338 (E.D. Wis. 1980). Because of these court rulings, it is important that those interested in this proposed action participation by the close of the 45-day comment period so that substantive comments and objections are made available to the Forest Service at a time when it can meaningfully consider them and respond to them in the final environmental impact statement.

To assist the Forest Service in identifying and considering issues raised by the proposed actions, comments on the draft environmental impact statements should be as specific as possible. It is also helpful if comments refer to specific pages or chapters of the draft statements. Comments may also address the adequacy of the draft statements or the merits of the alternatives formulated and discussed in the statements. Reviewers may wish to refer to the Council on Environmental Quality Regulations for implementing the procedural provisions of the National Environmental Policy Act at 40 CFR 1503.3 in addressing these points.

After the 45-day comment period ends on the draft EIS, the Forest Service will analyze comments received and address them in the final supplemental EISs (FSEISs). The FSEISs are scheduled to be completed in April 2003. The Responsible Official is the Payette National Forest Supervisor. For each project, if different from the original decision, the new decision will be documented, including the rationale for the decision, in a Record of Decision (ROD). Any decision will be subject to review under the Forest Service Appeal Regulations at 36 CFR 215.

The existing trail system in the Interface Area developed primarily as a result of users adopting old logging and mining roads, skid trails, fuel breaks, and abandoned water ditches for their trail use. Over time, users constructed additional trails to access new areas, avoid impassable sections of existing trails, form loops and connectors with other trails, and provide the desired variety of challenges and experiences.

Over the last 30 years, local residents, second homeowners, and their friends have used and enjoyed this system of routes for both non-motorized and motorize recreation. During the mid-1990s, the need for a designed trail system and a site-specific management analysis for the Interface Area became evident. Increased trails use, resource impacts on some trail segments, trail-user conflict, and complaints from residents such as those with homes near Forest Road 5N95Y or near trail system access points from subdivisions prompted the Forest Service to begin project-level analysis and planning in the area.

The purpose or goal in designing the recreation route system, designating uses, and developing resource protection measures is to provide a variety of recreation opportunities for all trail users, while protecting natural resources, minimizing conflicts between trail users and others.

The proposed project is located in Calaveras County, California within the Calaveras Ranger District of the Stanislaus National Forest in portions of sections 1, 2, 11, 12, 13, 14, 23, 24, 26, T.4N., R.14E., a portion of section 18, T.4N., R.15E., portions of sections 13, 24, 25, 26, 35, 36, T.5N., R.14E., and portions of sections 7, 8, 17, 18, 19, 20, 29, 30, T.5N., R.15E., MDB&M. It is adjacent to the western boundary of the communities of Hathaway Pines, Avery, Arnold, and White Pines.

Under the current proposal being analyzed, non-motorized and motorized recreation use (shared use) will continue to be allowed on 19.5 miles of existing trails and roads. 16.6 miles of existing trails and roads will be designated and available for non-motorized recreation use only. 17.4 miles of existing roads will be routes for highway-licensed vehicles only. There will be 10.0 miles of multiple use routes and 10.7 miles of non-motorized trails constructed. 26.5 miles of existing trails and roads will be closed. Five gates will be closed to public motorized traffic. One mile of Forest Road 5N95Y will be chipsealed. Parking areas will be established on Forest Road 5N52, and County Road 323 to access the trail system. A low-water crossing and approach will be constructed at Slick Rock Crossing. Street legal vehicles only zones that are a minimum of 1/4 mile wide will be established adjacent to subdivisions. A permanent public easement for the segment of the trail that crosses private land located in the SW 1/4 of the NE 1/4 of section 30, T.5N., R.15E. will be sought from the landowner. Regulatory orders will be developed to enforce trail use restrictions, trail closures, street legal zone restrictions, and gate closures.

A range of alternatives to the proposed action will be considered. The alternatives will be designed to provide different ways to address and respond to significant issues and to fulfill the purpose and need for action. A reasonable range of alternatives will be evaluated and reasons given for eliminating some alternatives from detailed study. A no action alternative is required. Under the no action alternative, the recreation route system, recreation route uses, and Forest Service management practices would continue unchanged, just as they are today.

The Forest Supervisor, Stanislaus National Forest, 19777 Greenley Road, Sonora, California, 95370-5909 is the Responsible Official who will decide what actions are to be implemented to provide a variety of recreation opportunities for route users within the project area. He will document his decisions and rationale in a Record of Decision.

The decision to be made is whether to implement the proposed action as described above, to meet the purpose and need for action through some other combination of activities, or take no action at this time.

This revised notice of intent is not a solicitation for public comment. The comment period for this analysis closed January 8, 2001 and no additional comments will be considered until the draft environmental impact statement is available for public review. The scoping process was used to identify potential issues related to the proposed action, significant issues to be analyzed in depth, alternatives to the proposed action, and potential environmental effects of the proposed action and its alternatives.

Three preliminary issues have been identified: (1) Disturbances by human presence and noise on the trails and roads may adversely impact wildlife species, (2) sounds of motorized vehicles on the trails and roads may have a negative impact on adjacent landowners, and (3) opportunities for recreation may be affected by the trail and road mileage available as well as by the uses allowed on each route.

This Revised Notice of Intent is not a solicitation for public comment. The comment period for this analysis closed January 8, 2001 and no additional commnets will be considered until the draft environmental impact statement is made available for public review.

A draft environmental impact statement will be prepared for comment. The comment period on the draft environmental impact statement will be 45 days from the date the Environmental Protection Agency publishes the notice of availability in the Federal Register .

The Forest Service believes, it is important to give reviewers notice of several court rulings related to public participation in the environmental review process. First, reviewers of draft environmental impact statements must structure their participation in the environmental review of the proposal so that it is meaningful and alerts an agency to the reviewer's position and contentions. Vermont Yankee Nuclear Power Corp. v. NRDC, 435 U.S. 519, 553 (1978). Also, environmental objections that could be raised at the draft environmental impact statement stage but that are not raised until after completion of the final environmental impact statement may be waived or dismissed by the courts. City of Angoon v. Hodel, 803 F.2d 1016, 1022 (9th Cir. 1986) and Wisconsin Heritages, Inc. v. Harris, 490 F. Supp. 1334, 1338 (E.D. Wis. 1980). Because of these court rulings, it is very important that those interested in this proposed action participate by the close of the 45-day comment period so that substantive comments and objections are made available to the Forest Service at a time when it can meaningfully consider them and respond to them in the final environmental impact statement.

To assist the Forest Service in identifying and considering issues and concerns on the proposed action, comments on the draft environmental impact statement should be as specific as possible. It is also helpful if comments refer to specific pages or chapters of the draft statement. Comments may also address the adequacy of the draft environmental impact statement or the merits of the alternatives formulated and discussed in the statement. Reviewers may wish to refer to the Council on Environmental Quality Regulations for implementing the procedural provisions of the National Environmental Policy Act at 40 CFR 1503.3 in addressing these points.

The meeting is open to the public. Committee discussion is limited to Forest Service staff and Committee members. However, persons who wish to bring matters to the attention of the Committee may file written statements with the Committee staff before or after the meeting. Public input sessions will be provided and individuals who made written requests by January 21 will have the opportunity to address the Committee at those sessions.

Agenda items to be covered include: (1) Round 1 project status update reports; (2) Replacement member update; (3) Review remaining Round 1 and 2 project proposal to determine future status; (4) Review and vote on one new project submittal; (5) Determine due date for Round 3 project proposals; (6) Determine purpose and dates of future meetings. This meeting is open to the public.

Title: 7 CFR Part 1755, Telecommunications Standards and Specifications.

OMB Control Number: 0572-New.

Type of Request: New collection.

Abstract: Manufactures wishing to sell their products to RUS borrowers, request RUS consideration for acceptance of their products and submit data demonstrating their products' compliance with RUS specifications. Compliance with RUS specifications and standards is demonstrated to a large extent via presentation of laboratory tests results and other informational data upon which the determination of acceptability can be made. RUS evaluates this data to determine that the quality of the products is acceptable and that their use will not jeopardize loan security. In the telecommunications program, because of the complex and highly technical nature of equipment, services and system architectures, RUS also requires a manufacturer to demonstrate successful product use in a working telecommunications system.

RUS Bulletin 345-2, establishes Agency policy that materials and equipment purchased by RUS telecommunications borrowers or accepted as contractor-furnished material, must conform to RUS standards and specifications where they have been established and, if included in RUS IP 344-2, “List of Materials Acceptable for Use on Telecommunications Systems of RUS Borrowers” (List of Materials), must be selected from that list or must have received technical acceptance from RUS.

Estimate of Burden: Public reporting burden for this collection of information is estimated to average 20 hour per response.

Respondents: Business or other for-profit and non-profit institutions.

Estimated Number of Respondents: 49.

Estimated Number of Responses per Respondent: 2.

Estimate Total Annual Burden on Respondents: 2,580 hours.

Copies of this information collection can be obtained from Dawn Wolfgang, Program Development and Regulatory Analysis, Rural Utilities Service at (202) 720-0812. Comments are invited on (a) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of burden including the validity of the methodology and assumption used; (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 those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques on other forms of information technology.

All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.

Title: 7 CFR Part 1753, Telecommunications System Construction Policies and Procedures.

OMB Control Number: 0572-0059.

Type of Request: Reinstatement of a previously approved collection for which approval has expired.

Abstract: In order to facilitate the programmatic interest of the RE Act, and, in order to assure that loans made or guaranteed by RUS are adequately secured, RUS, as a secured lender, has established certain forms for materials, equipment and construction of electric and telecommunications systems. The use of standard forms, construction contracts, and procurement procedures helps assure RUS that appropriate standards and specifications are maintained, RUS' loan security is not adversely affected; and the loan and loan guarantee funds are used effectively and for the intended purposes.

Estimate of Burden: Public reporting burden for this collection of information is estimated to average 1 hour per response.

Respondents: Business or other for-profit and non-profit institutions.

Estimated Number of Respondents: 150.

Estimated Number of Responses per Respondent: 1.

Estimate Total Annual Burden on Respondents: 3,011 hours.

Copies of this information collection can be obtained from Dawn Wolfgang, Program Development and Regulatory Analysis, Rural Utilities Service at (202) 720-0812. Comments are invited on (a) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of burden including the validity of the methodology and assumption used; (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 those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques on other forms of information technology.

All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.

Title: Telecommunications Field Trials.

OMB Control Number: 0572-New.

Type of Request: New collection.

Abstract: Title 7 CFR 1755.3 prescribes the conditions and provisions of a field trial. A field trial consists of limited filed installation of a qualifying product in closely monitored situations designed to determine, to RUS' satisfaction, the products effectiveness under actual field conditions. Field trials are used only as a means for determining, to RUS' satisfaction, the operational effectiveness of a new or revised product where such experience does not already exist. The field trial process allows manufacturers a means of immediate access to the RUS borrower market, allows RUS borrowers opportunity to immediately utilize advance products, and allows RUS a means to safely, in a controlled manner, obtain necessary information on technically advanced products which will address the products suitability for use in the harsh environment of rural America.

Estimate of Burden: Public reporting burden for this collection of information is estimated to average 4 hours per response.

Respondents: Business or other for-profit and non-profit institutions.

Estimated Number of Respondents: 6.

Estimated Number of Responses per Respondent: 2.

Estimate Total Annual Burden on Respondents: 56 hours.

Copies of this information collection can be obtained from Dawn Wolfgang, Program Development and Regulatory Analysis, Rural Utilities Service at (202) 720-0812. Comments are invited on (a) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of burden including the validity of the methodology and assumption used; (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 those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques on other forms of information technology.

All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.

At the Board meeting, the Access Board will consider the following agenda items.

All meetings are accessible to persons with disabilities. Sign language interpreters and an assistive listening system are available at all meetings. Persons attending Board meetings are requested to refrain from using perfume, cologne, and other fragrances for the comfort of other participants.

Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361 et seq. ) direct the Secretary of Commerce to allow, upon request, the incidental, but not intentional taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if certain findings are made and either regulations are issued or, if the taking is limited to harassment, notice of a proposed authorization is provided to the public for review.

Permission may be granted if NMFS finds that the taking will have no more than a negligible impact on the species or stock(s) and will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses and that the permissible methods of taking and requirements pertaining to the monitoring and reporting of such taking are set forth.

On April 10, 1996 (61 FR 15884), NMFS published an interim rule establishing, among other things, procedures for issuing incidental harassment authorizations (IHAs) under section 101(a)(5)(D) of the MMPA for activities in Arctic waters. For additional information on the procedures to be followed for this authorization, please refer either to that document or to 50 CFR 216.107.

Deep seismic surveys use the “reflection” method of data acquisition. Reflection seismic exploration is the process of gathering information about the subsurface of the earth by measuring acoustic (sound or seismic) waves, which are generated on or near the surface. Acoustic waves reflect at boundaries in the earth that are characterized by acoustic impedance contrasts. The acoustic impedance of a rock layer is its density multiplied by its acoustic velocity. Geologists and geophysicists commonly attribute different acoustic impedances to different rock characteristics. Seismic exploration uses a controlled energy source to generate acoustic waves that travel through the earth (including sea ice and water, as well as subsea geologic formations), and then uses ground sensors to record the reflected energy transmitted back to the surface. Energy that is directed into the ground takes on numerous forms. When acoustic energy is generated, compression (p) and shear (s) waves form and travel in and on the earth. The compression and shear waves are affected by the geological formations of the earth as they travel in it and may be reflected, refracted, diffracted or transmitted when they reach a boundary represented by an acoustic impedance contrast.

The basic components of a seismic survey include an energy source (either acoustic or vibratory), which generates a seismic signal; hydrophones or geophones, which receive the reflected signal; and electronic equipment to amplify and record the signal. The number and placement of sensors, the energy sources, the spacing and placement of energy input locations, and the specific techniques of recording reflected energy are broadly grouped as “parameters” of a given exploration program.

In modern reflection seismology, many sensors are used to record each energy input event. The number of sensors in use for each event varies widely according to the type of survey being conducted and the recording equipment available. Common numbers of groups of sensors are 240, 480, and 1040, and some new recording instruments may use as many as 4000 groups of sensors at the same time. The sensors are normally placed in one or more long lines at specified intervals. In North America the common group placement intervals are multiples of 55 feet (17 meters), 110 feet (33.5 meters) and 220 feet (67 meters).

Vibroseis seismic operations use large trucks with vibrators that systematically put variable frequency energy into the earth. At least 1.2 m (4 ft) of sea ice is required to support heavy vehicles used to transport equipment offshore for exploration activities. These ice conditions generally exist from 1 January until 31 May in the Beaufort Sea. The exploration techniques are most commonly used on landfast ice, but they can be used in areas of stable offshore ice. Several vehicles are normally associated with a typical vibroseis operation. One or two vehicles with survey crews move ahead of the operation and mark the energy input points. Crews with rubber-tire or rubber-track vehicles often require trail clearance with bulldozers for adequate access to and within the site. Crews with rubber-tracked vehicles are typically limited by heavy snow cover, and may require trail clearance beforehand.

A typical wintertime exploration seismic crew consists of 40-110 personnel. Roughly 75 percent of the personnel routinely work on the active seismic crew, with approximately 50 percent of those working in vehicles and the remainder outside laying and retrieving geophones and cable.

With the vibroseis technique, activity on the surveyed seismic line begins with the placement of sensors. All sensors are connected to the recording vehicle by multi-pair cable sections. The vibrators move to the beginning of the line, and recording begins. The vibrators move along a source line, which will be at some angle to a sensor line. The vibrators begin vibrating in synchrony via a simultaneous radio signal to all vehicles.

In a typical survey, each vibrator will vibrate four times at each location. The entire formation of vibrators subsequently moves forward to the next energy input point (e.g., 67 m (220 ft) in most applications) and repeat the process. In a typical 16- to 18-hour day, 4 to 10 linear miles (6 to 16 km) in 2D seismic operations and 15 to 40 linear miles (24 to 64 km) in a 3D seismic operation are conducted. A detailed description of the work proposed for 2003 is contained in this document and in the application which is available upon request (see ADDRESSES ).

CPA is requesting an IHA for the taking of ringed seals ( Phoca hispida ) and bearded seals ( Erignathus barbatus ) for a period of 5 months beginning January 1 (upon the expiration of the existing regulations covering the Alaskan North Slope on 31 December 2002 (see 63 FR 5277, February 2, 1998) and ending on about May 31, 2003). On-ice seismic operations are ordinarily confined to this five-month period since this is the period when ice is sufficiently thick (4 - 5 ft; 1.2 - 1.5 m) to safely support the equipment.

The geographic region of activity in 2003 encompasses a 846-square mile (2,190 km2) area extending from approximately Cape Halkett on the west to Oliktok Point on the east and to approximately 4-20 nm (7.4 - 37 km) offshore the coast. Water depths in most (> 60 percent) of the area are less than 10 ft (3 m), but drop to 30 ft (9 m) along the northern fringe of the region of activity. Few seals inhabit water less than 10 ft (3 m) during winter, since water typically freezes to or near the bottom at this depth or what water is available supports few food resources (Miller et al. , 1998 and Link et al. , 1999).

A detailed description of the Beaufort Sea ecosystem can be found in several documents (Corps of Engineers, 1999; NMFS, 1999; Minerals Management Service (MMS), 1992, 1996) and is not repeated here.

The Beaufort/Chukchi Seas support a diverse assemblage of marine mammals, including bowhead whales ( Balaena mysticetus ), gray whales ( Eschrichtius robustus ), beluga ( Delphinapterus leucas ), ringed seals, spotted seals ( Phoca largha ) and bearded seals. Descriptions of the biology and distribution of these species and of others can be found in NMFS (1998, 1999), Western Geophysical (2000) and several other documents (Corps of Engineers, 1999; Lentfer, 1988; MMS, 1992, 1996; Angliss et al. (2001)). Angliss et al. (2001) is available online at: http://www.nmfs.noaa.gov/prot_res/PR2/ #Stock_Assessment_Program/sars.htmlStock Assessment Reports.

Ringed and to a lesser degree bearded seals could be affected by on-ice seismic activities. These species as well as other marine mammal species in the Beaufort Sea appear to have stable to increasing populations, which is a condition indicative of a healthy ecosystem. Polar bears, which prey on these species, are believed to be stable or increasing in numbers in the Beaufort Sea (U.S. Fish and Wildlife Service (USFWS), 2000 a, b). Similarly, the most recent estimate of bowhead whales shows the population has steadily increased annually at a growth rate of 3.2-3.3 percent to 9,860 (7,700-12,600) animals (International Whaling Commission, 2002). These increases are occurring in concert with subsistence harvest of these species including a five-year harvest quota of 255 bowheads. The status of these marine mammal populations reflects the high quality of the habitat, which supports abundant and diverse prey populations.

Ringed seals are year-round residents in the Beaufort Sea. They are the most abundant and widely distributed species of marine mammal in the Beaufort Sea (Frost et al. , 1988). The world-wide population is estimated at 6 to 7 million (Stirling and Calvert, 1979). The Alaska stock of the Bering-Chukchi-Beaufort Sea area is roughly estimated at between 1 to 1.5 (Frost, 1985) to 3.3 to 3.6 million seals (Frost et al. , 1988). Although there are no recent population estimates in the Beaufort Sea, Bengston et al. (2000) estimated ringed seal abundance from Barrow south to Shismaref in a portion of the Chukchi Sea to be 245,048 animals from aerial surveys flown in 1999. In Angliss et al. (2001), marine mammal scientists state that there are at least that many ringed seals in the Beaufort Sea. Frost et al. (1999) reported that observed densities within the area of industrial activity along the Beaufort Sea coast were generally similar between 1985-87 and 1996-98, suggesting that the regional population has been relatively stable during this 13-year period of industrial activity.

During winter and spring, ringed seals inhabit landfast ice and offshore pack ice. Seal densities are highest on stable landfast ice but significant numbers of ringed seals also occur in pack ice (Wiig et al. , 1999). Seals congregate at holes and along cracks or deformations in the ice (Frost et al., 1999). Breathing holes are established in landfast ice as the ice forms in autumn and maintained by seals throughout the winter. Adult ringed seals maintain an average of 3.4 holes per seal (Hammill and Smith, 1989). Some holes may be abandoned as winter advances probably in order for seals to conserve energy by maintaining fewer holes (Brueggeman and Grialou, 2001). As snow accumulates, ringed seals excavate lairs in snowdrifts surrounding their breathing holes, which they use for resting and for the birth and nursing of their single pups in late March to May (McLaren, 1958; Smith and Stirling, 1975; Kelly and Quakenbush, 1990). Pups have been observed to enter the water, dive to over 10 m (32.8 ft), and return to the lair as early as 10 days after birth (Brendan Kelly, personal communication, June 2002), suggesting pups can survive the cold water temperatures at a very early age. Mating occurs in late April and May. From mid-May through July, ringed seals haul out in the open air at holes and along cracks to bask in the sun and molt.

The seasonal distribution of ringed seals in the Beaufort Sea is affected by a number of factors but a consistent pattern of seal use has been documented since monitoring began over 20 years ago by using aerial surveys. Seal densities have historically been substantially lower in the western than the eastern part of the Beaufort Sea (Burns and Kelly, 1982; Kelly, 1988). Frost et al. (1999) reported consistently lower ringed seal densities in the western versus eastern sectors they surveyed in the Beaufort Sea during 1996, 1997, and 1998. The relatively low densities appear to be related to much of the area occurring between the shore and the barrier islands, which is generally shallow. This area of historically low ringed seal density is also the focus for much of the recent on-ice seismic surveys.

The estimated number of ringed seals likely to be in the 846-square mile (2,190 km 2 ) activity area is less than 3,900 animals. This estimate is based on a density of 1.73 seals per km 2 , which was derived from the most current aerial surveys of the region. Frost and Lowry (1999) reported an observed density of 0.61 ringed seals per km 2 on the fast ice from aerial surveys conducted in spring 1997 of an area (Sector B2) overlapping the activity area, which is in the range of densities (0.28-0.66) reported for the Northstar project from 1997 to 2001 (Moulton et al. , 2001). This value (0.61) was adjusted to account for seals hauled out but not sighted by observers (x 1.22, based on Frost et al. (1988)) and seals not hauled out during the surveys (x 2.33, based on Kelly and Quakenbush (1990)) to obtain the density of 1.73 seals/km 2 . This estimate covered an area from the coast to about 2-20 miles beyond the activity area, and it assumed that habitat conditions were uniform and, therefore, it was not adjusted for water depth. Since a high proportion (> 60 percent) of the activity area is within water less than 3 m (9.8 ft) deep, which Moulton et al. (2001) reported for Northstar supported about five times fewer seals (0.12 0.13 seals/km 2 ) than the 0.61 seals reported by Frost and Lowry, the actual number of ringed seals is probably closer to slightly more than half of the 3,900 seals or about 2,000 seals. This estimate is calculated as follows: (1) 1,314 km 2 x 0.13 x 1.22 x 2.33 = 486 seals in area having water depths of 0-3 meter (60 percent) in activity area; (2) 876 km 2 x 0.61 x 1.22 x 2.33 = 1,519 seals in area having water depths over 3 meters (40 percent) in activity area; and (3) combining the two numbers gives an estimate of 2,005 seals or approximately 2,000 for the entire activity area. Observed densities of ringed seals reported over 15 years ago in the region of the activity area from 1985 through 1987 (0.85, 1.09, and 1.11 seals per km2) were not used in this analysis, since an estimate was available within the last five years (Frost and Lowry, 1999).

The bearded seal inhabits the Bering, Chukchi, and Beaufort seas (Burns and Frost, 1979). Numbers are considerably higher in the Bering and Chukchi seas, particularly during winter and early spring. Early estimates of bearded seals in the Bering and Chukchi seas range from 250,000 to 300,000 (Popov, 1976; Burns, 1981). Reliable estimates of bearded seal abundance in Alaska waters are unavailable. Since there is no evidence of a decline in the population, the population is presumed to be healthy. Bearded seals are generally associated with pack ice and only rarely use shorefast ice (Burns and Harbo, 1972). Bearded seals occasionally have been observed maintaining breathing holes in annual ice and even hauling out from holes used by ringed seals (Mansfield, 1967; Stirling and Smith, 1977). However, since bearded seals are normally found in broken ice that is unstable for on-ice seismic operation, bearded seals will be rarely encountered during seismic operations.

There are no reliable estimates for bearded seals in the Beaufort Sea or in the activity area (Angliss et al., 2001), but recent surveys show that few bearded seals inhabit the activity area during December through May. An indication of their low numbers is provided by the results of aerial surveys conducted east of the activity area near the Northstar and Liberty development sites. Three to 18 bearded seals were observed in these areas compared to 1,911 to 2,251 ringed seals in the spring of 1999 through 2001 (Moulton et al., 2001; Moulton and Elliott 2000; Moulton et al. , 2000). Similarly small numbers of bearded seals would be expected to occur in the activity area, where habitat is even less favorable because of the high proportion of shallow water area.

NMFS and CPA anticipate that only small numbers of ringed seals and, if encountered, very small numbers of bearded seals will be affected. Any takes that occur would result from short-term disturbances by noise and physical activity associated with on-ice seismic operations. While operations have the potential to disturb and temporarily displace some seals, any impacts will likely be confined to small numbers of seals in the immediate vicinity of the activities.

Burns and Kelly (1982) concluded that displacement of ringed seals in close proximity (within 150 m (492 ft)) to seismic lines does occur, and ringed seal pupping in shorefast ice habitats within this distance of an on-ice shot line in favorable ringed seal habitat are likely to be disturbed by vibroseis operations. However, considering (1) the limited area of seismic surveys, (2)

the non-random distribution of ringed seals, (3) avoidance by seismic operator of optimal seal habitat (i.e., areas of extensive pressure ridging and snow accumulation) due to safety and operational constraints,(4) occurrence of most of the on-ice seismic surveys in shallow and near shore waters where ringed seal densities are low, (5) the relatively large size of the ringed seal population in the Beaufort Sea and throughout Alaska, and (6) the lack of evidence of on-ice seismic activity negatively affecting the reproductive viability or distribution of the ringed seal population, the disturbance is not likely to have any effect on the ringed or bearded seal populations as a whole.

Aerial survey data collected from 1985 to 1987 and 1997 indicate that ringed seal densities in the fast ice of the region of the activity area as well as among different section of the Beaufort Sea are highly variable among years (Frost et al. , 1999). The reported inter-annual variability in overall average density during these years in the region of the activity area was 0.61 to 1.11 seals per km 2 . Based on an estimated rate of temporary displacement determined by Burns (1981) of 0.6 ringed seals per nm 2 (0.52 per mile) of area subjected to seismic activity, a maximum of 832 seals could be displaced from 1,600 mi (2,575 km) of seismic surveys assuming a uniform distribution. However, since the distribution is not uniform and most of the activity area is marginal habitat for ringed seals, considerably fewer seals would likely be temporarily displaced by the seismic operations. Furthermore, the proposed seismic operations will be concentrated in 143 mi 2 (378 km 2 ) or about 17 percent of the 846 mi 2 (2,190 km 2 ) activity area. Consequently, a more accurate maximum limit of the potential take of ringed seals by the proposed seismic operations is 340 (17 percent x 2000) seals, which would be considerably higher than any incidental take of seals in birthing lairs.

Pup mortality could occur if any of these animals were nursing and displacement was protracted. However, due to mitigation measures undertaken by the industry and because it is highly unlikely that a nursing female would abandon her pup given the normal levels of disturbance from the proposed activities and the typical movement patterns of ringed seal pups among different holes as reported by Lydersen and Hammill (1993), pup mortality is unlikely. Similarly, Kelly and Quakenbush (1990) observed that radio-tagged seals used as many as four lairs spaced as far as 3,437 m (11,276 ft) apart, with mean distances for males equaling 1,997 m (6,552 ft) and for females 634 m (2,080 ft). In addition, seals have multiple breathing holes. Pups may use more holes than adults (mean 8.7), but the holes are generally closer together (Lydersen and Hammill, 1993). Holes have been found as far apart as 0.9 km (0.56 mi). This pattern of use indicates that adult seals and pups can move away from seismic activities, particularly since the seismic equipment does not remain in any specific area for a prolonged time. Given the small proportion (<1 percent) of the population potentially disturbed by the proposed activity, impacts are expected to be negligible for the overall ringed and also bearded seal populations.

Masking effects on pinniped vocalizations and other natural sounds are expected to be limited. Although pulse repetition rates will be high during vibroseis surveys, the source levels of those pulses will be considerably lower than during open-water seismic surveys. This will considerably reduce the potential for masking.

Residents of the village of Nuiqsut are the primary subsistence users in the activity area. The subsistence harvest during winter and spring is primarily ringed seals, but during the open-water period both ringed and bearded seals are taken. Nuiqsut hunters may hunt year round; however, in more recent years most of the harvest has been in open water instead of the more difficult hunting of seals at holes and lairs (McLaren, 1958; Nelson, 1969). The most important area for Nuiqsut hunters is off the Colville River Delta, between Fish Creek and Pingok Island, which corresponds to approximately the eastern half to the activity area. Seal hunting occurs in this area by snow machine before spring break-up and by boat during summer. Subsistence patterns are reflected in harvest data collected in 1992 where Nuiqsut hunters harvested 22 of 24 ringed seals and all 16 bearded seals during the open water season from July to October (Fuller and George, 1997). Only a small number of ringed seals was harvested during the winter to early spring period, which corresponds to the time of the proposed on-ice seismic operations.

Based on harvest patterns and other factors, on-ice seismic operations in the activity area are not expected to have an unmitigable adverse impact on subsistence uses of ringed and bearded seals because:

(1) Operations would end before spring breakup, after which subsistence hunters harvest most of their seals.

(2) Operations would temporarily displace relatively few seals, since most of the habitat in the activity area is marginal to poor and supports relatively low densities of seals during winter. Displaced seals would likely move a short distance and remain in the area for potential harvest by native hunters (Frost and Lowry, 1988; Kelly e3, 1988).

(3) The area where seismic operations would be conducted is small compared to the large Beaufort Sea subsistence hunting area associated with the extremely wide distribution of ringed seals.

In order to ensure the least practicable adverse impact on the species and the subsistence use of ringed seals, all activities will be conducted as far as practicable from any observed ringed seal structure, and crews will be required to avoid hunters and the locations of any seals being hunted in the activity area, whenever possible. Finally, the applicant will consult with subsistence hunters of Nuiqsut and provide the community, the North Slope Borough, and the Inupiat Community of the North Slope with information about its planned activities (timing and extent) before initiating any on-ice seismic activities.

Similar to work in previous years, NMFS expects the following mitigation will be undertaken by the applicant to ensure that any taking will be at the lowest level practicable. All activities will be required to be conducted in a manner that minimizes adverse effects on ringed and bearded seals and their habitat. Activities must be conducted as far as practicable from any observed ringed seals or ringed seal lair. For example, no energy source may be placed over an observed ringed seal lair and only vibrator-type energy-source equipment will be used. Seismic crews will receive training so that they can recognize potential ringed seal lairs and adjust their seismic operations. Furthermore, if seismic operations go beyond March 20, 2003 in waters deeper than 3 m (9.8 ft), a survey using trained dogs will be completed to identify active seal holes/ birthing lairs or hole/lair habitats so they can be avoided by seismic operations to the greatest extent practicable. If trained dogs are not available, then potential habitat will be identified by trained marine mammal biologists based on the characteristics of the ice (i.e., deformation, cracks, etc.).

Ringed seal pupping occurs in lairs from late March to mid-to-late April (Smith and Hammill, 1981). Prior to commencing on-ice seismic surveys after March 20 th , a survey using experienced field personnel and trained dogs will be conducted to identify potential seal structures along the planned on-ice seismic transmission routes. The seal structure survey will be conducted before selection of precise transit routes to ensure that seals, particularly pups, are not injured by equipment. The locations of all seal structures will be recorded by Global Positioning System (GPS), staked, and flagged with surveyor's tape. Surveys will be conducted 150 m (492 ft) to each side of the transit routes. Actual width of route may vary depending on wind speed and direction, which strongly influence the efficiency and effectiveness of dogs locating seal structures. Survey will only be conducted in the portions of the activity area where water depths exceed 3 m (9.8 ft). Few, if any, seals inhabit ice-covered waters below 3 m (9.8 ft) due to water freezing to the bottom or poor prey availability caused by the limited amount of ice-free water.

The level of take, while anticipated to be negligible, will be assessed by conducting a second seal structure survey immediately after the end of the seismic surveys. A single on-ice survey will be conducted by biologists on snowmachines using a GPS to relocate and determine the status of seal structures located during the initial survey. The status (active vs. inactive) of each structure will be determined to assess the level of incidental take by seismic operations. The number of active seal structures abandoned between the initial survey and the final survey will be the basis for enumerating take. If dogs are not available for the initial survey, take will be determined by using observed densities of seal on ice reported by Moulton et al. (2001) for the Northstar project, which is approximately 20 nm (37 km) from the eastern edge of the proposed activity area.

In the event that seismic surveys can be completed in that portion of the activity area deeper than 3 m (9.8 ft) before mid-March, no field surveys would be conducted of seal structures. Under this scenario, surveys would be completed before pups are born and disturbance would be negligible. Therefore, take estimates would be determined for only that portion of the activity area exposed to seismic surveys after March 20, which would be in water 3 m (9.8 ft) or less deep. Take for this area would be estimated by using the observed density (13/100 km2) reported by Moulton et al. (2001) for water depths between 0 to 3 m (0 to 9.8 ft) in the Northstar project area, which is the only source of a density estimate stratified by water depth for the Beaufort Sea. This would be an overestimation requiring a substantial downward adjustment to reflect the actual take of seals using lairs, since few if any of the structures in these water depths would be used for birthing, and Moulton et al. (2001) estimate includes all seals.

This monitoring program was reviewed at the fall 2002 on-ice meeting sponsored by the National Marine Mammal Laboratory, NMFS in Seattle and found acceptable.

An annual report must be submitted to NMFS within 90 days of completing the year's activities.

As a result of the information provided in EAs prepared in 1993 and 1998 for winter seismic activities, NOAA concluded that implementation of either the preferred alternative or other alternatives identified in the EA would not have a significant impact on the human environment. Therefore, an Environmental Impact Statement was not prepared. Accordingly, because the proposed action discussed in this document is not substantially different from the 1992 and 1998 actions, and because a reference search has indicated that no significant new scientific information or analyses have been developed in the past several years significant enough to warrant new NEPA documentation, this action is categorically excluded from further review under NOAA Administrative Order 216-6. A copy of the 1998 EA and FONSI is available upon request (see ADDRESSES ).

NMFS has determined that no species listed as threatened or endangered under the ESA will be affected by issuing an authorization under section 101(a)(5)(D) of the MMPA.

The anticipated impact of winter seismic activities on the species or stock of ringed and bearded seals is expected to be negligible for the following reasons:

(1) The activity area supports a small proportion (<1 percent) of the ringed seal populations in the Beaufort Sea;

(2) Most of the winter-run seismic lines will be on ice over shallow water where ringed seals are absent or present in very low abundance. Over 60 percent of the activity area is near shore and/or in water less than 3 m (9.8 ft) deep, which is generally considered poor seal habitat. Moulton et al. (2001) reported that only 6 percent of 660 ringed seals observed on ice in the Northstar project area were in water between 0 to 3 m (0 to 9.8 ft)deep.

(3) Seismic operators will avoid moderate and large pressure ridges, where seal and pupping lairs are likely to be most numerous, for reasons of safety and because of normal operational constraints;

(4) Many of the on-ice seismic lines and connecting ice roads will be laid out and explored during January and February when many ringed seals are still transient and considerably before the spring pupping season;

(5) The sounds from energy produced by vibrators used during on-ice seismic programs typically are at frequencies well below those used by ringed seals to communicate (1000 Hz). Thus, ringed seal hearing is not likely to be very good at those frequencies and seismic sounds are not likely to have strong masking effects on ringed seal calls. This effect is further moderated by the quiet intervals between seismic energy transmissions.

(6) There has been no major displacement of seals away from on-ice seismic operations (Frost and Lowry, 1988). Further confirmation of this lack of major response to industrial activity is illustrated by the fact that there has been no major displacement of seals near the Northstar Project. Studies at Northstar have shown a continued presence of ringed seals throughout winter and creation of new seal structures (Williams et al. 2001).

(7) Although seals may abandon structures near seismic activity, studies have not demonstrated a cause and effect relationship between abandonment and seismic activity or biologically significant impact on ringed seals. Studies by Williams et al. (2001), Kelley et al. (1986, 1988) and Kelly and Quakenbush (1990) have shown that abandonment of holes and lairs and establishment or re-occupancy of new ones is an ongoing natural occurrence, with or without human presence. Link et al. (1999) compared ringed seal densities between areas with and without vibroseis activity and found densities were highly variable within each area and inconsistent between areas (densities were lower for 5 days, equal for 1 day, and higher for 1 day in vibroseis area), suggesting other factors beyond the seismic activity likely influenced seal use patterns. Consequently, a wide variety of natural factors influence this patterns of seal use including time of day, weather, season, ice deformation, ice thickness, accumulation of snow, food availability and predators as well as ring seal behavior and populations dynamics.

In winter, bearded seals are restricted to cracks, broken ice, and other openings in the ice. On-ice seismic operations avoid those areas for safety reasons. Therefore, any exposure of bearded seals to on-ice seismic operations would be limited to distant and transient exposure. Bearded seals exposed to a distant on-ice seismic operation might dive into the water. Consequently, no significant effects on individual bearded seals or their population are expected, and the number of individuals that might be temporarily disturbed would be very low.

As a result, CPA believes the effects of on-ice seismic are expected to be limited to short-term and localized behavioral changes involving relatively small numbers of seals. As NMFS came to a similar finding in the EA prepared in 1998 for on-ice seismic activity in the Beaufort Sea, NMFS has preliminarily determined that these changes in behavior are expected to be negligible (NMFS, 1998). Therefore, the potential effects of the proposed on-ice seismic operations during 2003 are unlikely to result in more than small numbers of seals being affected, have no more than a negligible impact on ringed and bearded seal stocks and not have an unmitigable adverse impact on subsistence uses of these two species.

NMFS requests interested persons to submit comments, and information, concerning this request (see ADDRESSES ).

Tuesday, January 14, 2003, 9:30 a.m. Research Steering Committee Meeting.

Location: Sheraton Colonial, One Audubon Road, Wakefield, MA 01880; telephone: (781) 245-9300.

The committee will receive an update on the status of current projects, recent contract awards and funding for the NOAA Fisheries Cooperative Research Partners Initiative, including progress on the development of a Request for Proposals concerning fisheries habitat research. They will discuss the development of procedures for tracking cooperative research projects, evaluation of final reports, and particularly the integration of results into the management process. There will be discussion of the status of the experimental fishing permit program, if time allows.

Wednesday, January 22, 2003, 9:30 a.m. Groundfish Oversight Committee Meeting.

Location: Holiday Inn, 31 Hampshire Street, Mansfield, MA 02048; telephone: (508) 339-2200.

The Groundfish Oversight Committee will meet to consider a number of issues related to the development of Amendment 13 to the Northeast Multispecies Fishery Management Plan (FMP). They will review timelines for continued development of the amendment and will plan the actions that must be taken in order to meet a May 1, 2004 implementation date. This review will include a discussion of the analysis of different rebuilding time periods and the alternatives that will be considered under each alternative. This discussion may include development of recommendations to the Council to eliminate management alternatives from further consideration. The Committee will also work on additional details for the total allowable catch alternatives and the implementation of a resource sharing understanding with Canada for transboundary stocks of cod, haddock, and yellowtail. The Committee will review information on bycatch of groundfish in a proposed whiting grate fishery and will develop a recommendation to the Council for Framework 38, the action that will implement that fishery. Finally, the Committee may develop suggestions for a days at sea (DAS) leasing program that the Council may ask the NMFS to implement in advance of the adoption of Amendment 13.

Friday, January 24, 2003, 10 a.m. Social Science Advisory Committee Meeting.

Location: Weston Public Library, 87 School Street, Weston, MA 02493; telephone: (781) 893-3312.

The committee will meet to discuss how to assist the Council in the development of amendments to the Monkfish and Groundfish FMPs. They will also discuss and possibly develop comments on the Scallop Draft Supplementary Environmental Impact Statement; elect a Chair, Vice Chair and discuss organizational issues.

Although non-emergency issues not contained in these agendas may come before this group for discussion, those issues may not be the subject of formal action during these meetings. 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.

These meetings are 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 requested amendment has been granted under the authority of the Marine Mammal Protection Act of 1972, as amended (16 U.S.C. 1361 et seq. ), the provisions of § 216.39 of the Regulations Governing the Taking and Importing of Marine Mammals (50 CFR part 216), the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 et seq. ), the provisions of § 222.306 of the regulations governing the taking, importing, and exporting of endangered and threatened species (50 CFR parts 222-226).

Issuance of this amendment, as required by the ESA was based on a finding that such permit: (1) Was applied for in good faith; (2) will not operate to the disadvantage of the endangered species which is the subject of this permit; and (3) is consistent with the purposes and policies set forth in section 2 of the ESA.

Authority:

Section 204 of the Agricultural Act of 1956, as amended (7 U.S.C. 1854); Executive Order 11651 of March 3, 1972, as amended.

The Bilateral Textile Memorandum of Understanding dated February 17, 2000, as extended on December 20, 2002, between the Governments of the United States and Belarus establishes a limit and a sublimit for Category 622 and Sub-Category 622-L, respectively, for the period January 1, 2003 through January 31, 2003.

This limit and sublimit may be revised if Belarus becomes a member of the World Trade Organization (WTO) and the United States applies the WTO agreement to Belarus.

In the letter published below, the Chairman of CITA directs the Commissioner of Customs to establish the limit and sublimit. A description of the textile and apparel categories in terms of HTS numbers is available in the CORRELATION: Textile and Apparel Categories with the Harmonized Tariff Schedule of the United States (see Federal Register notice 66 FR 65178, published on December 18, 2001). Information regarding the availability of the 2003 CORRELATION will be published in the Federal Register at a later date.

The Committee for the Implementation of Textile Agreements (CITA) has determined that Fieldston Clothes, Inc. has violated the requirements for participation in the Special Access Program and has suspended Fieldston Clothes, Inc. from participation in the Program for the one-year period, January 1, 2003 through December 31, 2003.

Through the letter to the Commissioner of Customs published below, CITA directs the Commissioner to prohibit entry of products under the Special Access Program by or on behalf of Fieldston Clothes, Inc. during the period from January 1, 2003 through December 31, 2003, and to prohibit entry by or on behalf of Fieldston Clothes, Inc. under the Special Access Program of products manufactured from fabric exported from the United States during that period.

Requirements for participation in the Special Access Program are available in Federal Register notice 63 FR 16474, published on April 3, 1998.

The above forms are initially prepared by military authorities and presented to the next-of-kin or sponsor to fill-in the reimbursable costs or desired disposition of remains. Without the information on these forms the government would not be able to respond to the survivor's wishes or justify its expenses in handling the deceased. Also available at government expense is transportation of the remains to a port of entry in the United States is authorized.

The DA Form 3126-1 is initiated by the school desiring to host a unit and is countersigned by a representative of the Secretary of the Army. The contract is necessary to establish a mutual agreement between the secondary institution and the U.S. Government. The Commanding General, U.S. Total Army Personnel Command, is responsible for administering the JROTC program and overall policy. Region commanders are responsible for operating and administering the JROTC training conducted within the areas.

The International Military Student Information (IMSI) is utilized by the military departments and pertains only to non U.S. citizens who are members of a foreign army that have been designated by their government to attend training at a military facility. The IMSI is utilized by the gaining organization to provide background information on the individual in order that a military and civilian sponsor may be assigned to assist the individual during his/her stay in the United States.

The purpose of the information is to provide prospect referral data to a Professor of Military Science to contact individuals who have expressed an interest in Army ROTC. If Goldminers did not collect referral information, we would suffer a negative impact on the recruiting effort and subsequent commissioning of new officers for the U.S. Army.

Any licenses granted shall comply with 35 U.S.C. 209 and 37 CFR part 404.

U.S. Patent Number 5,665,970, filed on July 3, 1996, entitled, “Directional Radiation Detector and Imager,” was issued to Kronenberg et al. on September 9, 1997. This U.S. Patent was assigned to the United States of America, as represented by the Secretary of the Army, and provides a new type of radiation sensor and radiation imager that is formed by sandwiching two materials having different atomic numbers (Z) around a radiation detector, such as scintillator or Geiger-Mueller type radiation counters, or solid state radiation detectors, such as those made of silicon. Pursuant to 35 U.S.C. 209(e) any interested party may file written comments or objections to this intended exclusive patent license at the above address. Written comments or objections must be filed within fifteen (15) days from the date of the publication of this notice in the Federal Register.

Anyone wishing to object to the grant of this license can file written objections along with supporting evidence, if any, within 15 days from the date of this publication. Written objections are to be filed with the Command Judge Advocate (see addresses ).

On August 28, 2001, the Corps of Engineers published a Notice of Intent to prepare a Draft Environmental Impact Statement (DEIS) for the Las Americas Transshipment Port Complex being proposed by the Puerto Rico Infrastructure Financing Authority (AFI) acronym in Spanish, the original applicant. On September 20, 2002, the Corps issued the Notice of Availability of the DEIS for the Proposed Port of the Americas. In the DEIS, the applicant's preferred alternative consisted in the development of terminals at the Guayanilla and Ponce harbors to accommodate Post-Panamax vessels. In the Guayanilla-Peñuelas area, this alternative would include the following:

• Construction of a new pier with a maximum length of 6,000 feet, with support facilities capable of handling as many as four Post-Panamax vessels;

• Discharge of fill material in approximately 110 acres of shallow navigable waters, including approximately 12 acres of mangrove coastal wetlands in the Punta Gotay area, for the development of loading-unloading storage areas and other support facilities;

• Development for value-added activities of as much as 300 acres of a parcel owned by Union Carbide in Peñuelas adjoining Punta Guayanilla;

• Development and/or improvements to other infrastructure within the Guayanilla-Peñuelas area to operate the terminal efficiently, including water, sewers, power, highways and communication services.

In Ponce, the Applicant's Preferred Alternative would include:

• Expansion of the existing transshipment pier to a maximum length of about 3,610 feet to allow simultaneous handling of as many as two Post-Panamax vessels;

• Immediate dredging of the navigation channel and berthing areas to a minimum depth of 45 feet and a maximum of 53 feet to allow the navigation of Post-Panamax vessels;

• Disposal of part of the dredged material at the EPA designated offshore disposal site south of Ponce, while reclaiming for beneficial use for either the fill at the Guayanilla Harbor or fill at uplands in the vicinity;

• Development of approximately 132 acres of upland adjacent to the port for value-added activities.

The applicant (Port of the Americas) notified the Corps of Engineers of their decision to modify their preferred alternative as follows:

a. The elimination of the proposed fill in the Guayanilla Harbor;

b. The reduction in length of the proposed pier in the Guayanilla Harbor to a maximum length of 3,000 feet to service Panamax vessels; and

c. The proposal to fill approximately 70 acres of waters of the U.S. at the Ponce harbor adjacent to the proposed expansion of pier number 8.

Because the proposed changes are significant changes to what was previously proposed, a Supplemental Draft Environmental Impact Statement (S-DEIS) for the Port of the Americas Port Complex will be prepared.

Pursuant to section 10 of the Rivers and Harbors Act structures the Corps of Engineers has regulatory authority over structures and/or work in or affecting navigable waters of the United States. Under section 404 of the Clean Water Act, the Corps of Engineers has regulatory authority to permit the discharge of dredged or fill material into wetlands and other waters of the United States. Also, under section 103 of the Marine Protection, Research and Sanctuaries Act, the Corps of Engineers has regulatory authority over the transportation of dredged material for the purpose of dumping it in ocean waters at dumping sites designated under 40 CFR part 228. The guidelines pursuant to section 404(b) of the act require that impacts to the aquatic environment be avoided and minimized to the extent practicable. Permit applications for the transportation of dredged material for the purpose of dumping it in ocean waters will be evaluated to determine whether the proposed dumping will unreasonably degrade or endanger human health, welfare, amenities, or the marine environment, ecological systems or economic potentialities.

In determining whether to issue a permit, the Corps must also comply with other requirements including, but not limited to, the Endangered Species Act, the National Environmental Policy Act, the Coastal Zone Management Act, the Magnunson-Stevens Fishery Conservation and Management Act Section 401 of the Clean Water Act, and other applicable Federal laws. Modifying land for new uses also involves zoning, land use planning, water management, and other regulatory/planning requirements at the local, Commonwealth, and Federal level.

Issues: During the scoping process for the preparation of the DEIS, several issues of relevance associated with the development of the PTA were identified. These issues were evaluated in detail in the DEIS for each of the alternatives considered, including the no-action alternative. Each issue was evaluated in terms of a list of measurement indicators to complete a thorough evaluation of the environmental impacts associated with each issue. The following issues were evaluated in detail as part of this DEIS; Fish and Wildlife Resources; Marine Resources/Special Aquatic Sites; Essential Fish Habitat; Threatened or Endangered Species; Ecologically Sensitive Areas; Wetlands, Coastal Zone; Flooding, Water and Sediment Quality; Air Quality; Cultural Resources; Socio-Economic Impacts; Hazardous, Toxic, and Radioactive Wastes; Dredging and Disposal of Dredged Material; Navigation; Infrastructure; Marine Currents; and Noise. The DEIS evaluated the potential direct, indirect, and cumulative environmental consequences. As a result of the comments provided by the resource agencies in reviewing the DEIS, the new applicant's preferred alternative is being developed. The same issues identified in the scoping process for the DEIS will be considered in the S-DEIS. However, the Corps of Engineers will consider any additional scoping issues provided to us.

Scoping: On October 31, 2002, the Corps of Engineers and the applicant met with Federal and Commonwealth resources agencies to discuss the alternative to discharge fill in Ponce. As result of the comments provided by the resource agencies in reviewing the DEIS, the new applicant's preferred alternative is being developed. The Corps of Engineers may hold additional scoping meeting(s) with Federal and State Agencies. At this time, there are no plans for a public scoping meeting. If a public scoping meeting is held by the Corps of Engineers, it will be announced. In addition Federal, State and local agencies, as well as interested private organizations and individuals are encouraged to suggest additional issues not listed above for consideration to submit comments.

Public Involvement: We invite the participation of affected Federal, State, and local agencies, and other interested private organizations and individuals that have additional issues not listed above to submit written comments to the information contact provided in this notice no later than 30 days from the date of this notice.

Coordination: The proposed action is being coordinated with a number of Federal, Commonwealth, and local agencies including but not limited to the following: U.S. Fish and Wildlife Service, National Marine Fisheries Service, U.S. Environmental Protection Agency, U.S. Coast Guard, Puerto Rico Department of Natural and Environmental Resources, Puerto Rico Environmental Quality Board, Puerto Rico Planning Board, Puerto Rico State Historic Preservation Officer, and other agencies as previously identified in scoping, public involvement, and agency coordination.

Other Environmental Review and Consultation: The proposed action would involve evaluation for compliance with guidelines pursuant to section 404(b) of the Clean Water Act, public interest review, application for Water Quality Certification pursuant to section 401 of the Clean Water Act, and determination of Coastal Zone Management Act consistency.

S-DEIS Preparation: We estimate that the S-DEIS will be available to the public on or about March 14, 2003.

1. Title: System and Method for Remotely Monitoring an Interface Between Dissimilar Materials. A system for efficiently and cost effectively monitoring the status of the interface between two dissimilar media is provided. In a preferred embodiment, the system uses principles applied from the theory of time domain reflectometry (TDR), together with novel circuitry and low cost narrow band telemetry, to provide real time monitoring on a continuous basis, as needed. The circuitry involved permits operation of the system without relying on relative values of signal amplitude while employing a novel feedback function that sets the pulse repetition frequency instantaneously to permit an optimum data collection rate as well as a separate measure of the status based on the system operating parameters. It has particular application to real time monitoring and alerting to the effect of scour events in waterways.

Serial No.: 09/879,001.

Date: 6/13/2001.

2. Title: Natural Cue Surface Bypass Collector. A method that employs natural hydraulic cues to guide migrating fish, in particular juvenile fish, to bypass channels to circumvent barriers to their downstream migration, such as booms, weirs, dams, hydroelectric powerhouses, and sluice gates. The flow entering into the turbines of the powerhouse are slightly modified to create a hydraulic gradient in the strain rate hydraulic variables that guides fish to the entrance of a surface bypass collector.

Serial No.: 10/045,381.

Date: 1/15/2002.

3. Title: Mycoherbicidal Compositions and Methods of Preparing and Using the Same. A more environmentally safe measure to control aquatic weeds is also cost-efficient and relies on biological agents in the form of mycoherbicides. Mycoherbicides are typically formulated with one or more fungal pathogens or metabolites, or both thereof with herbicidal activity. The fungal pathogens are typically specific to infecting a certain spectrum of plant types, thus providing useful targeted delivery. It would be an advance in the art of bioherbicides to develop a mycoherbicidal composition, which may be applied either in wet or dry form, comprising an effective population control agent efficacious against a broad range of aquatic weeds including hydrilla. It would be a further advance in the art to develop a mycoherbicidal composition with enhanced biological viability and stability, specifically comprising a fungal pathogen as the population control agent that is extremely desiccant-tolerant, is capable of germinating both sporogenically and vegetatively, and is highly efficacious against hydrilla and other aquatic weeds, while being easy and relatively inexpensive to prepare and to use. It would also be desirable to provide a method of preparing such fungal pathogens in the form of a micro sclerotium that can efficiently and effectively maximize the biomass production thereof.

Serial No.: 10/138,579.

Date: 5/6/2002.

4. Title: Mapping Patterns of Movement Based on the Aggregation of Spatial Information Contained in Wireless Transmissions. Time-tagged coordinates from session-unique transmissions of wireless devices are collected routinely and stored for later analysis. From this data, one may derive a sequence of wireless device operation from which attributes may be ascertained. Sequences are accumulated until a dense aggregate pattern is formed over a geographic area. Aggregate data is sorted into ranges representing speed of movement and then converted to pixels representing cells in an aggregate matrix. Heavily weighted values are assigned to cells that represent a location within a pre-specified spatial error about a data point. Lower values are assigned to cells representing paths, or corridors, connecting these better-identified locations. As more transmission sessions are added to the matrix, the largest weight values cluster as individual cells representing a most likely path. Thus precise topographic attributes may be derived based on these spatial clusters, overlapping paths connecting them, or combinations thereof.

Serial No.: 10/206,757.

Date: 7/29/2002.

5. Title: Multi-purpose Mat and Method of Deploying Thereof. Multipurpose panels having L-shaped tabs are interconnected using durable connectors to form a multipurpose mat that facilitates mobility over otherwise unstable terrain. In one embodiment, four-sided panels are fabricated from laminations of fiberglass-reinforced plastic (FRP) with radiused rectangular holes machined in each of two adjacent edges and a recessed L-shaped tab formed along opposing adjacent edges. The connectors are fabricated from corrosion resistant metal and assembled to precise specifications prior to insertion in the rectangular holes machined in pre-specified types of panel. Top and bottom plates of durable connectors are fabricated from 6061-T6 aluminum stock. A threaded bolt used to tie the plates together, to which a liquid threadlocker is applied, is fabricated from a steel alloy suitable for use with aluminum. Two specifically fabricated tools, a spacer guide and an alignment tool, may be used to optimize installation. These also may be fabricated from 6061-T6 aluminum stock.

Serial No.: 10/211,515.

Date: 8/5/2002.

6. Title: System and Method for Automated Alerting to Geospatial Anomalies. An inexpensive system and reliable method for detecting spatial anomalies in real time detects hidden anomalies efficiently and safely. In a preferred embodiment, an FM-CW radar front-end communicates with a personal computer incorporating specific filter and processing circuitry, including an AID converter and a DSP. A target volume is illuminated from just above its top surface and return signals processed using the PC as programmed with a purpose-built algorithm. Data are down-converted to audio frequencies for ease in handling using inexpensive audio frequency circuitry. For use in avoiding bridged (hidden) crevasses during operation in snowfields, a version is mounted on a long boom extending from the front of the platform on which it is installed, typically a lead vehicle of a convoy. Heretofore, expensive systems requiring full-time monitoring by an operator were the only safe and reliable solution to insure safe traversal of snowfields.

Serial No.: 10/256,182.

Date: 9/27/2002.

7. Title: Motion Detection and Alerting System. A compact, autonomous motion detecting and alerting system alerts to the movement of objects of interest. Mounted on an environmentally sealed PC board are a transceiver such as a CW radar front-end, connectors, signal processors and a communications device. The system provides early warning of movement of an ice sheet or rubble field via the communication device that may be a cellular telephone. This system is mounted proximate the target surface under observation, oriented at pre-specified offset angles both laterally and in elevation. The target is illuminated and energy reflected therefrom is mixed with a portion of the transmitted signal to produce a difference frequency signal that is processed to establish existence of motion within a pre-specified velocity range. Upon verification of motion, notification is sent to a responsible authority. An autonomous or semi-autonomous power source and integral power management function may be incorporated on the same PC board.

Serial No.: 10/255,763.

Date: 9/27/2002.

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 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.

The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology.

The following is specific information about each of the programs or competitions covered by this notice:

Exports of electricity from the United States to a foreign country are regulated and require authorization under section 202(e) of the Federal Power Act (FPA) (16U.S.C. 824a(e)).

On November 28, 2002, the Office of Fossil Energy (FE) of the Department of Energy (DOE) received an application from WPSC to transmit electric energy from the United States to Canada. WPSC is an investor-owned electric utility having its principal place of business in Green Bay, Wisconsin. WPSC is a wholly-owned subsidiary of WPS Resources and is engaged in the generation, distribution and sale of electric energy.

The electric energy to be sold by WPSC will be excess to its native load or purchased from generators, power marketers or Federal power marketing agencies. WPSC proposes to arrange for the delivery of electric energy to Canada over the existing international transmission facilities presently owned by Basin Electric Power Cooperative, Bonneville Power Administration, Citizens Utilities Co., International Transmission Company, Eastern Maine Electric Cooperative, Joint Owners of the Highgate Project, Long Sault, Inc., Maine Electric Power Company, Maine Public Service Company, Minnesota Power and Light Inc., Minnkota Power Cooperative, New York Power Authority, Niagara Mohawk Power Corporation, Northern States Power, and Vermont Electric Transmission Company. The construction, operation, maintenance, and connection of each of the international transmission facilities to be utilized by WPSC, as more fully described in the application, has previously been authorized by a Presidential permit issued pursuant to Executive Order 10485, as amended.

Procedural Matters: Any person desiring to become a party to this proceeding or to be heard by filing comments or protests to this application should file a petition to intervene, comment or protest at the address provided above in accordance with §§ 385.211 or 385.214 of the FERC's Rules of Practice and Procedures (18 CFR 385.211, 385.214). Fifteen copies of each petition and protest should be filed with the DOE on or before the date listed above.

Comments on the WPSC application to export electric energy to Canada should be clearly marked with Docket EA-274. Additional copies are to be filed directly with William L. Bourbonnais, Manager, Rates and Economic Evaluation, Wisconsin Public Service Corporation, 700 North Adams Street, PO Box 19001, Green Bay, WI 54307-9001 And David Martin Connelly, Esquire, Bruder, Gentile & Marcoux, L.L.P., 1100 New York Avenue, NW., Suite 510 East, Washington, DC 20005-3934.

A final decision will be made on this application after the environmental impacts have been evaluated pursuant to the National Environmental Policy Act of 1969, and a determination is made by the DOE that the proposed action will not adversely impact on the reliability of the U.S. electric power supply system.

Copies of this application will be made available, upon request, for public inspection and copying at the address provided above or by accessing the Fossil Energy Home Page at http://www.fe.doe.gov . Upon reaching the Fossil Energy Home page, select “Regulatory” Programs,” then “Electricity Regulation,” and then “Pending Proceedings” from the options menus.

Entities potentially affected by this action are the fifty States, Puerto Rico, and the recipients of assistance in each of these jurisdictions.

Title: Safe Drinking Water Act State Revolving Fund Program; OMB Control No. 2040-0185; EPA ICR No. 1803.04; expiration date June 30, 2003.

Abstract: The Safe Drinking Water Act (SDWA) Amendments of 1996 (Public Law 104-182) authorize the creation of Drinking Water State Revolving Fund (DWSRF) programs in each State and Puerto Rico to assist public water systems to finance the costs of infrastructure needed to achieve or maintain compliance with SDWA requirements and to protect public health. Section 1452 authorizes the Administrator of the U.S. Environmental Protection Agency (EPA) to award capitalization grants to the States and Puerto Rico which, in turn, provide low-cost loans and other types of assistance to eligible drinking water systems. States can also reserve a portion of their grants to conduct various set-aside activities.

The information collection activities will occur primarily at the program level through the: (1) Capitalization Grant Application and Agreement/State Intended Use Plan; (2) Biennial Report; (3) Annual Audit; and (4) Assistance Application Review. Information collected is needed for input into the DWSRF National Information Management System.

(1) Capitalization Grant Application and Agreement/State Intended Use Plan: The State must prepare a Capitalization Grant Application that includes an Intended Use Plan (IUP) outlining in detail how it will use all the funds covered by the capitalization grant. States may, as an alternative, develop the IUP in a two part process with one part identifying the distribution and uses of the funds among the various set-asides in the DWSRF program and the other part dealing with project assistance from the Fund.

(2) Biennial Report: The State must agree to complete and submit a Biennial Report on the uses of the capitalization grant. The scope of the report must cover assistance provided by the DWSRF Fund and all other set-aside activities included under the Capitalization Grant Agreement. States which jointly administer DWSRF and the Clean Water State Revolving Fund (CWSRF) programs, in accordance with section 1452(g)(1), may submit reports (according to the schedule specified for each program) which cover both programs.

(3) Annual Audit: A State must comply with the provisions of the Single Audit Act Amendments of 1996. Best management practices suggest and EPA recommends that a State conduct an annual independent audit of its DWSRF program. The scope of the report must cover the DWSRF Fund and all other set-aside activities included in the Capitalization Grant Agreement. States which jointly administer DWSRF and CWSRF programs, in accordance with section 1452(g)(1), may submit audits which cover both programs but which report financial information for each program separately.

(4) Assistance Application Review: Local applicants seeking financial assistance must prepare and submit DWSRF loan applications. States then review completed loan applications and verify that proposed projects will comply with applicable federal and state requirements.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.

2003: 51 States × 400 Hours = 20,400 Burden Hours.

2004: 51 States × 400 Hours = 20,400 Burden Hours

2005: 51 States × 400 Hours = 20,400 Burden Hours

2003: 25 States × 275 Hours = 6,875 Burden Hours.

2004: 26 States × 275 Hours = 7,150 Burden Hours.

2005: 25 States × 275 Hours = 6,875 Burden Hours.

2003: 51 States × 80 Hours = 4,080 Burden Hours.

2004: 51 States × 80 Hours = 4,080 Burden Hours.

2005: 51 States × 80 Hours = 4,080 Burden Hours.

2003: 51 States × 27 Applications × 40 Hours = 55,080 Burden Hours.

2004: 51 States × 27 Applications × 40 Hours = 55,080 Burden Hours.

2005: 51 States × 27 Applications × 40 Hours = 55,080 Burden Hours.

The annual reporting and recordkeeping hour burden by state and local respondents is 196,687 hours.

Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

1. Docket. EPA has established an official public docket for this ICR under Docket ID No. OW-2002-0059. The official public docket is the collection of materials that is available for public viewing at the Water Docket in the EPA Docket Center, (EPA/DC), EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Water Docket is (202) 566-2426.

2. Electronic Access. You may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr/.

You may use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Once in the system, select “search,” then key in the docket identification number.

Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI, and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.C.

For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket.

Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the Docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff.

You may submit comments electronically, by mail, or through hand delivery/courier. To ensure proper receipt by EPA, identify the appropriate docket identification number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked “late.” EPA is not required to consider these late comments in formulating a final decision.

1. Electronically. If you submit an electronic comment as prescribed below, EPA recommends that you include your name, mailing address, and an e-mail address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment.

i. EPA Dockets. Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket, and follow the online instructions for submitting comments. Once in the system, select “search,” and then key in Docket ID No. OW-2002-0059. The system is an “anonymous access” system, which means EPA will not know your identity, e-mail address, or other contact information unless you provide it in the body of your comment.

ii. E-mail. Comments may be sent by electronic mail (e-mail) to OW-docket@epa.gov, Attention Docket ID No. OW-2002-0059. In contrast to EPA's electronic public docket, EPA's e-mail system is not an “anonymous access” system. If you send an e-mail comment directly to the Docket without going through EPA's electronic public docket, EPA's e-mail system automatically captures your e-mail address. E-mail addresses that are automatically captured by EPA's e-mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket.

iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the mailing address identified in Unit I.C. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption.

2. By Mail. Send an original and three number of copies of your comments to: Water Docket, Environmental Protection Agency, Mail Code: 4101T, 1200 Pennsylvania Ave., NW., Washington, DC, 20460, Attention Docket ID No. OW-2002-0059.

3. By Hand Delivery or Courier. Deliver your comments to: EPA Docket Center, EPA West, Room B102, 1301 Constitution Avenue, NW., Washington, DC, Attention Docket ID No. OW-2002-0059. Such deliveries are only accepted during the Docket's normal hours of operation as identified in Unit I.C.

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 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 your estimate.

5. Provide specific examples to illustrate your concerns.

6. Offer alternatives.

7. Make sure to submit your comments by the comment period deadline identified.

8. To ensure proper receipt by EPA, identify the appropriate docket identification number in the subject line on the first page of your response. It would also be helpful if you provided the name, date, and Federal Register citation related to your comments.

Pursuant to section 3506(c)(2)(A) of the PRA, EPA specifically solicits comments and information to enable it to:

1. Evaluate whether the proposed collections of information are necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility.

2. Evaluate the accuracy of the Agency's estimates of the burdens of the proposed collections of information.

3. Enhance the quality, utility, and clarity of the information to be collected.

4. Minimize the burden of the collections of information on those who are to respond, including through the use of appropriate automated or electronic collection technologies or other forms of information technology, e.g. , permitting electronic submission of responses.

EPA has submitted the following ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. On May 23, 2001 (66 FR 28461), EPA sought comments on this ICR pursuant to 5 CFR 1320.8(d). EPA received no comments.

EPA has established a public docket for this ICR under Docket ID No. OAR-2002-0090, which is available for public viewing at the Air and Radiation Docket and Information Center in the EPA Docket Center (EPA/DC), EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is (202) 566-1744, and the telephone number for the Air and Radiation Docket and Information Center is (202) 566-1742. An electronic version of the public docket is available through EPA Dockets (EDOCKET) at http://www.epa.gov/edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select “search,” then key in the docket ID number identified above.

Any comments related to this ICR should be submitted to EPA and OMB within 30 days of this notice, and according to the following detailed instructions: (1) Submit your comments to EPA online using EDOCKET (our preferred method), by e-mail to www.epa.gov/oar/docket.html , or by mail to: EPA Docket Center, Environmental Protection Agency, Mailcode: 6102T, 1200 Pennsylvania Ave., NW., Washington, DC 20460, and (2) Mail your comments to OMB at: Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street, NW., Washington, DC 20503.

EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EDOCKET as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose public disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EDOCKET. The entire printed comment, including the copyrighted material, will be available in the public docket. Although identified as an item in the official docket, information claimed as CBI, or whose disclosure is otherwise restricted by statute, is not included in the official public docket, and will not be available for public viewing in EDOCKET. For further information about the electronic docket, see EPA's Federal Register notice describing the electronic docket at 67 FR 38102 (May 31, 2002), or go to www.epa.gov/edocket.

Title: Recordkeeping and Reporting Requirements for the Fuel Quality Regulations for Diesel Fuel Sold in 2001 and Later Years (Final Rule) (OMB Control No. 2060-0308, EPA ICR Number 1718.04). This is a request for a revised collection. Under the OMB regulations, the Agency may continue to conduct or sponsor the collection of information while this submission is pending at OMB.

Abstract: The pollution emitted by diesel engines contributes greatly to our nation's continuing air quality problems. New emissions standards for these engines and vehicles will apply starting with model year 2007. Since the new technology requires low sulfur diesel fuel containing 15 parts per million (ppm) sulfur or less, the regulations at 40 CFR part 80, subpart I, require the availability of 15 ppm by no later than 2006, with all motor vehicle diesel fuel required to meet the 15 ppm standard by 2010. The recordkeeping and reporting requirements associated with this program are necessary to ensure its environmental benefits. They are designed to be consistent with existing requirements. Many reporting items represent one-time burdens, including applications for exemptions or specific flexibilities (including small refiner status). In addition, annual reporting requirements associated with this program cease after 2010, when all motor vehicle diesel fuel must meet the 15 ppm standard.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15, and are identified on the form and/or instrument, if applicable.

Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 166 hours per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

Respondents/Affected Entities: Domestic and foreign refiners, importers, and fuel additives manufacturers.

Estimated Number of Respondents: 450

Frequency of Response: On occasion/annual

Estimated Total Annual Hour Burden: 72,648 hours.

Estimated Total Annual Cost: $9,208,880, includes $4,800,000 annualized capital or O&M costs.

Changes in the Estimates: This rule increases the estimate by 72,648 hours over the burden currently identified in the OMB Inventory of Approved ICR Burdens for this program.

Title: Regional Haze Regulations, ICR number 1813.04., and OMB Control Number 2060-0421, expiration date: December 31, 2002. This is a request for extension of a currently approved collection.

Abstract: This ICR is for activities related to the implementation of EPA's 1999 regional haze rule, for the time period between October 1, 2002 and September 30, 2005. This ICR renews the previous ICR, which addressed the three year time period immediately after the rule was promulgated. The regional haze rule, as authorized by sections 169A and 169B of the Clean Air Act, requires States to develop implementation plans to protect visibility in 156 federally-protected Class I area. Tribes may choose to develop implementation plans. For this time period, States will be conducting technical analyses in support of development of reasonable progress goals and strategies for regional haze as required by the rule. EPA is encouraging States to work together in regional planning organizations to development and implement multi-state strategies.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15. The Federal Register document required under 5 CFR 1320.8(d), soliciting comments on this collection of information was published on July 31, 2002. No comments were received.

Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 219 hours per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

Respondents/Affected Entities: State air quality agencies; local air quality agencies, regional planning organizations; certain facilities built between 1962 and 1977.

Frequency of Response: annually.

Estimated Total Annual Hour Burden: 44,917.

Estimated Total Annualized Capital, O&M Cost Burden: $0.

Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the addresses listed above.

Please refer to EPA ICR No. 1813.04 and OMB Control No. 2060-0421 in any correspondence.

EPA has submitted the following ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. On June 21, 2002 (67 FR 42251), EPA sought comments on this ICR pursuant to 5 CFR 1320.8(d). EPA received no comments.

EPA has established a public docket for this ICR under Docket ID No. RCRA-2002-0022, which is available for public viewing at the RCRA Docket in the EPA Docket Center (EPA/DC), EPA West, Room B102, 1301 Constitution Ave., NW, Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the RCRA Docket is (202) 566-0270. An electronic version of the public docket is available through EPA Dockets (EDOCKET) at http://www.epa.gov/edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select “search,” then key in the docket ID number identified above.

Any comments related to this ICR should be submitted to EPA and OMB within 30 days of this notice, and according to the following detailed instructions: (1) Submit your comments to EPA online using EDOCKET (our preferred method), by e-mail to RCRA-docket@epa.gov , or by mail to: RCRA Docket in the EPA Docket Center, (mailcode 5305T) EPA West Basement, Room B102, 1301 Constitution Ave., NW., Washington, DC 20460; and (2) Mail your comments to OMB at: Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street, NW., Washington, DC 20503.

EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EDOCKET as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose public disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EDOCKET. The entire printed comment, including the copyrighted material, will be available in the public docket. Although identified as an item in the official docket, information claimed as CBI, or whose disclosure is otherwise restricted by statute, is not included in the official public docket, and will not be available for public viewing in EDOCKET. For further information about the electronic docket, see EPA's Federal Register notice describing the electronic docket at 67 FR 38102 (May 31, 2002), or go to www.epa.gov./edocket .

Title: Reporting and Recordkeeping Requirements under EPA's National Waste Minimization Partnership Program (EPA ICR Number 2076.01). This is a request for a new collection. Under the OMB regulations, the Agency may continue to conduct or sponsor the collection of information while this submission is pending at OMB.

Affected Entities: Any generator, treater, storer, and/or disposer of RCRA-regulated hazardous waste may participate in the National Waste Minimization Partnership Program.

Abstract: EPA is establishing a national program to encourage the minimization of hazardous waste through source reduction and recycling. Participation in the National Waste Minimization Partnership Program is completely voluntary. EPA will use two forms to collect information from participants, called partners, which can be prepared and submitted by hard copy or electronically. Participation begins when an Enrollment Form is submitted and received by EPA. The form asks for basic site identification information as well as information on the company's waste minimization goals under the program. Once in the program, partners can submit an optional Accomplishments Form when they have accomplished steps toward reaching the goal(s) established during their enrollment in the program. The Accomplishments Form asks for a description of the waste minimization accomplishment and whether the partner would like the information posted on the EPA Waste Minimization Program's website. Once the waste minimization goal(s) are reached, partners may choose to submit an optional, one-time Case Study. All Case Studies submitted will be available on EPA's National Waste Minimization Program website, and each will describe a partner's waste minimization techniques, implementation problems, lessons learned, benefits, and relevant implications. The authority under which the Agency will conduct the program is the Pollution Prevention Act of 1990, which directs EPA to “facilitate the adoption of source reduction techniques by businesses * * *, foster the exchange of information regarding source reduction techniques * * *, and [foster] the provision of technical assistance to businesses” (42 U.S.C. 13101).

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15, and are identified on the form and/or instrument, if applicable.

Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 14 hours per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

Respondents/Affected Entities: Generators, Storers, Treaters, and Disposers of RCRA Hazardous Waste.

Estimated Number of Respondents: 150.

Frequency of Response: One-time.

Estimated Total Annual Hour Burden: 3,235 hours.

Estimated Total Annual Cost: $200,633, includes no annualized capital or O&M costs.

EPA has submitted the following ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. On March 7, 2002 (47 FR 10401), EPA sought comments on this ICR pursuant to 5 CFR 1320.8(d). EPA received no comments.

EPA has established a public docket for this ICR under Docket ID No. OAR-2002-0091, which is available for public viewing at the Air and Radiation Docket and Information Center Docket in the EPA Docket Center (EPA/DC), EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is (202) 566-1744, and the telephone number for the Air and Radiation Docket and Information Center Docket is (202) 566-1742. An electronic version of the public docket is available through EPA Dockets (EDOCKET) at http://www.epa.gov/edocket . Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select “search,” then key in the docket ID number identified above.

Any comments related to this ICR should be submitted to EPA and OMB within 30 days of this notice, and according to the following detailed instructions: (1) Submit your comments to EPA online using EDOCKET (our preferred method), by e-mail to http://www.epa.gov/oar/docket.html , or by mail to: EPA Docket Center, Environmental Protection Agency, Mailcode: (C339-02), 1200 Pennsylvania Ave., NW., Washington, DC 20460, and (2) Mail your comments to OMB at: Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street, NW., Washington, DC 20503.

EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EDOCKET as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose public disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EDOCKET. The entire printed comment, including the copyrighted material, will be available in the public docket. Although identified as an item in the official docket, information claimed as CBI, or whose disclosure is otherwise restricted by statute, is not included in the official public docket, and will not be available for public viewing in EDOCKET. For further information about the electronic docket, see EPA's Federal Register notice describing the electronic docket at 67 FR 38102 (May 31, 2002), or go to www.epa.gov./edocket .

Title: Ambient Air Quality Surveillance, (OMB Control No. 2060-0084, EPA ICR Number 0940.17). This is a request to renew an existing approved collection that will expire December 20, 2002 . Under OMB regulations, the Agency may continue to conduct or sponsor the collection of information while this submission is pending at OMB.

Abstract: The general authority for the collection of ambient air quality data is contained in sections 110 and 319 of the Clean Air Act (42 U.S.C. 1857). Section 110 makes it clear that State generated air quality data is central to the air quality management process through a system of State implementation plans (SIP). Section 319 was added via the 1977 Amendments to the Act and spells out the key elements of an acceptable monitoring and reporting scheme. To a large extent, the requirements of section 319 had already been anticipated in the detailed strategy document prepared by EPA's Standing Air Monitoring Work Group (SAMWG). The regulatory provisions to implement these recommendations were developed through close consultation with the State and local agency representatives serving on SAMWG and through reviews by ad-hoc panels from the State and Territorial Air pollution Program Administrators and the Association of Local Air Pollution Control Officials. These modifications to the previous regulations were issued as final rules on May, 10, 1979 (44 FR 27558) and are contained in 40 CFR part 58.

Major amendments which affect the hourly burdens, were made in 1983 for lead, 1987 for PM-10, 1993 for the enhanced monitoring for ozone, and 1997 for PM-2.5. The specific required activities for the burden include establishing and operating ambient air monitors and samplers, conducting sample analyses for all pollutants for which a national ambient air quality standard (NAAQS) has been established, preparing, editing, and quality assuring the data, and submitting the ambient air quality data and quality assurance data to EPA.

Some of the major uses of the data are for judging attainment of the NAAQS, evaluating progress in achieving/maintaining the NAAQS or State/local standards, developing or revising SIP's, evaluating control strategies, developing or revising national control policies, providing data for model development and validation, supporting enforcement actions, documenting episodes and initiating episode controls, documenting population exposure, and providing information to the public and other interested parties.

Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 18,497 hours per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.

Respondents/Affected Entities: State/local Agencies

Estimated Number of Respondents : 130

Frequency of Response : Quarterly

Estimated Total Annual Hour Burden : 2,404,606.

Estimated Total Annual Cost : $196,406,873, includes $81,327,810 annualized capital or O&M costs.

Changes in the Estimates: There is no change in hours in the total estimated burden currently identified in the OMB Inventory of Approved ICR Burdens.

The Act affords EPA a 45-day period to review and, as appropriate, to object to operating permits proposed by state permitting authorities under title V of the Act, 42 U.S.C. 7661-7661f. Section 505(b)(2) of the Act and 40 CFR 70.8(d) authorize any person to petition the EPA Administrator to object to a title V operating permit within 60 days after the expiration of EPA's 45-day review period if EPA has not objected on its own initiative. Petitions must be based only on objections to the permit that were raised with reasonable specificity during the public comment period provided by the state, unless the petitioner demonstrates that it was impracticable to raise these issues during the comment period or the grounds for the issues arose after this period.

GCLPI submitted a petition on behalf of the Sierra Club to the Administrator on February 4, 2002, requesting that EPA object to a state title V operating permit issued by EPD to WCCEF. The Petitioner maintains that the WCCEF permit is inconsistent with the Act because of: (1) The permit's lack of a requirement for a case-by-case maximum achievable control technology determination; (2) the inadequacy of the test method used to determine compliance with a carbon monoxide emission limit; (3) the identification of Georgia Rule 391-3-1-.03(2)(c) as “State Only Enforceable”; (4) the omission of a short-term best available control technology limit covering startup and shutdown periods; and (5) EPD's improper issuance of the permit to a company with other facilities that are operating out of compliance with their respective permits.

On November 15, 2002, the Administrator issued an order denying this petition. The order explains the reasons behind EPA's conclusion that the Petitioner has failed to demonstrate that the WCCEF permit is not in compliance with the requirements of the Act on the grounds raised.

The Act affords EPA a 45-day period to review and, as appropriate, to object to operating permits proposed by state permitting authorities under title V of the Act, 42 U.S.C. 7661-7661f. Section 505(b)(2) of the Act and 40 CFR 70.8(d) authorize any person to petition the EPA Administrator to object to a title V operating permit within 60 days after the expiration of EPA's 45-day review period if EPA has not objected on its own initiative. Petitions must be based only on objections to the permit that were raised with reasonable specificity during the public comment period provided by the state, unless the petitioner demonstrates that it was impracticable to raise these issues during the comment period or the grounds for the issues arose after this period.

GCLPI submitted a petition on behalf of Georgia Forest Watch to the Administrator on November 26, 2001, requesting that EPA object to a state title V operating permit issued by EPD to Shaw. The Petitioner maintains that the Shaw permit is inconsistent with the Act because of: (1) The inadequacy of the public participation process and related public notice; (2) the permit's apparent limitation of enforcement authority and credible evidence; (3) the inadequacy of the monitoring and reporting requirements; and (4) the incompleteness of the permit itself as well as the corresponding narrative.

On November 15, 2002, the Administrator issued an order denying this petition. The order explains the reasons behind EPA's conclusion that the Petitioner has failed to demonstrate that the Shaw permit is not in compliance with the requirements of the Act on the grounds raised.

The Act affords EPA a 45-day period to review and, as appropriate, to object to operating permits proposed by state permitting authorities under title V of the Act, 42 U.S.C. 7661-7661f. Section 505(b)(2) of the Act and 40 CFR 70.8(d) authorize any person to petition the EPA Administrator to object to a title V operating permit within 60 days after the expiration of EPA's 45-day review period if EPA has not objected on its own initiative. Petitions must be based only on objections to the permit that were raised with reasonable specificity during the public comment period provided by the state, unless the petitioner demonstrates that it was impracticable to raise these issues during the comment period or the grounds for the issues arose after this period.

GCLPI submitted a petition on behalf of Georgia Forest Watch to the Administrator on November 26, 2001, requesting that EPA object to a state title V operating permit issued by EPD to Shaw. The Petitioner maintains that the Shaw permit is inconsistent with the Act because of: (1) The inadequacy of the public participation process and related public notice; (2) the permit's apparent limitation of enforcement authority and credible evidence; (3) the inadequacy of the monitoring and reporting requirements; and (4) the incompleteness of the permit itself as well as the corresponding narrative.

On November 15, 2002, the Administrator issued an order denying this petition. The order explains the reasons behind EPA's conclusion that the Petitioner has failed to demonstrate that the Shaw permit is not in compliance with the requirements of the Act on the grounds raised.

This action is directed to the public in general, and may be of particular interest to those persons who are or may be required to conduct testing of chemical substances under the Toxic Substances Control Act (TSCA), the Federal Food, Drug and Cosmetic Act (FFDCA), the Safe Drinking Water Act (SDWA), or the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). 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 technical person listed under FOR FURTHER INFORMATION CONTACT .

1. Docket . EPA has established an official public docket for this action under docket identification (ID) number OPPT-2002-0066. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the EPA Docket Center, Rm. B102-Reading Room, EPA West, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The EPA Docket Center Reading Room telephone number is (202) 566-1744 and the telephone number for the OPPT Docket, which is located in EPA Docket Center, is (202) 566-0280.

2. Electronic access . You may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr/ .

An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. Once in the system, select “search,” then key in the appropriate docket ID number.

Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket.

For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket.

Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff.

You may submit comments electronically, by mail, or through hand delivery/courier. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked “late.” EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit I.D. Do not use EPA Dockets or e-mail to submit CBI or information protected by statute.

1. Electronically . If you submit an electronic comment as prescribed in this Unit, EPA recommends that you include your name, mailing address, and an e-mail address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment.

i. EPA Dockets . Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket , and follow the online instructions for submitting comments. Once in the system, select “search,” and then key in docket ID number OPPT-2002-0066. The system is an “anonymous access” system, which means EPA will not know your identity, e-mail address, or other contact information unless you provide it in the body of your comment.

ii. E-mail . Comments may be sent by e-mail to oppt.ncic@epa.gov , Attention: Docket ID Number OPPT-2002-0066. In contrast to EPA's electronic public docket, EPA's e-mail system is not an “anonymous access” system. If you send an e-mail comment directly to the docket without going through EPA's electronic public docket, EPA's e-mail system automatically captures your e-mail address. E-mail addresses that are automatically captured by EPA's e-mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket.

iii. Disk or CD ROM . You may submit comments on a disk or CD ROM that you mail to the mailing address identified in Unit I.C.2. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption.

2. By mail . Send your comments to: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

3. By hand delivery or courier . Deliver your comments to: OPPT Document Control Office (DCO) in EPA East Building Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. Attention: Docket ID Number OPPT-2002-0066. The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the DCO is (202) 564-8930.

Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e-mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI (if you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is 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 docket and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the technical person listed under FOR FURTHER INFORMATION CONTACT .

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

1. Explain your views as clearly as possible.

2. Describe any assumptions that you used.

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

4. Provide specific examples to illustrate your concerns.

5. Offer alternative ways to improve the proposed approach.

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 ID 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.

In this notice, EPA is setting forth, and requesting public comment on, the approach EPA plans to use for selecting an initial group of chemicals to be screened in the Agency's EDSP. EPA anticipates that it will modify its chemical selection approach for subsequent Tier 1 screening lists based on experience gained from the results of testing of chemicals on the initial list, the feasibility of incorporating different categories of chemicals (e.g., non-pesticide substances) and additional pathways of exposure, and the availability of new priority-setting tools (e.g., HTPS or QSAR models). EPA developed its EDSP in response to a Congressional mandate in section 408(p) of FFDCA “to determine whether certain substances may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or such other effects as [EPA] may designate” (21 U.S.C. 346a(p)). When carrying out the program, the statute requires EPA to “provide for the testing of all pesticide chemicals.” The statute also provides EPA with discretionary authority to “provide for the testing of any other substance that may have an effect that is cumulative to an effect of a pesticide chemical if the Administrator determines that a substantial population may be exposed to such a substance.” In addition, section 1457 of SDWA provides EPA with discretionary authority to provide for testing, under the FFDCA section 408(p) screening program, “of any other substances that may be found in sources of drinking water if the Administrator determines that a substantial population may be exposed to such substance.”

EPA is following a tiered approach in implementing the requirements of section 408(p) of FFDCA. The core elements of the tiered approach are priority setting, Tier 1 screening, and Tier 2 testing. Tier 1 will be comprised of a battery of screening assays to identify substances that have potential to interact with the estrogen, androgen, or thyroid hormone systems. The purpose of Tier 2 is to determine whether the substance may cause endocrine-mediated effects via or involving estrogen, androgen, or thyroid hormone systems, determine the consequences to the organism of the activities observed in Tier 1, and establish the relationship between doses of an endocrine-active substance administered in the test and the effects observed. ( Federal Register issue of December 28, 1998 (63 FR 71542, FRL-6052-9, Docket Control Number OPPTS-42208).

At the request of EPA, a joint subcommittee of the EPA Science Advisory Board (SAB) and the FIFRA Scientific Advisory Panel (SAP) reviewed a set of scientific issues related to the development of the Agency's EDSP. One of the recommendations of the SAB/SAP Subcommittee (Ref. 1) was that EPA should initiate the Tier 1 screening program with a set of 50 to 100 chemicals and then convene a panel of independent scientists to review the screening data for the purpose of evaluating and optimizing the Tier 1 screening battery. EPA is proposing to adopt this SAB/SAP recommendation to initially select and screen approximately 50 to 100 chemicals to help the Agency further refine the EDSP. The Agency intends to submit the data received from the screening to an independent external panel of experts and request an evaluation of whether the program could be improved or optimized, and if so, how.

EPA has stated its intention to consider a broad universe of chemicals as potential candidates for testing under the EDSP including pesticide chemicals, non-pesticide commercial chemicals, mixtures, and environmental contaminants (63 FR 71542). However, for the first group of chemicals to be tested, EPA is intending to focus only on pesticide active ingredients and high production volume (HPV) chemicals with some pesticidal inert uses (i.e., the chemicals that are specifically mandated for testing under section 408(p) of FFDCA). The pesticide inerts to be considered are those with relatively large overall production volumes considering both pesticide and non-pesticide uses. This approach will allow EPA to focus its initial endocrine screening efforts on a smaller and more manageable universe of chemicals that emphasizes early attention to the pesticide chemicals that Congress specifically mandated EPA to test for possible endocrine effects.

The purpose of this notice is to describe the approach that EPA plans to use to select this initial set of chemicals to undergo Tier 1 screening. EPA is proposing to use an approach based in part on the compartment-based priority setting approach described in the December 28,1998, Federal Register notice (FRL-6052-9) in which EPA provided details about, and requested comment on, its EDSP. The proposed approach focuses on human exposure-related factors rather than using a combination of exposure- and effects-related factors. The approach would, however, exclude from the first group of chemicals to undergo Tier 1 screening any chemical for which the available effects information clearly shows an endocrine-mediated effect. Such chemicals would be considered for proposed Tier 2 tests, mechanistic or special studies, or hazard assessment. Similarly, the approach for this initial list also would exclude substances that EPA anticipates have low potential to cause endocrine disruption (e.g., certain FIFRA List 4 inerts, most polymers with number average molecular weight greater than 1,000 daltons, strong mineral acids, and strong mineral bases). Although EPA's general focus in this approach is on pesticide active ingredients and inerts with relatively greater potential human exposure, EPA believes that the proposed approach will also identify chemicals with high potential for exposure of humans from non-pesticide uses and/or chemicals with widespread environmental exposures to other organisms. EPA does not intend to develop an ordinal ranking of priorities of the chemicals within any list developed using the proposed approach.

Because the list of chemicals produced using the proposed approach will be a list of chemicals that the Agency, in its discretion, has decided should be tested first, based primarily upon exposure potential, it should not be construed as a list of known or likely endocrine disruptors nor characterized as such. Nothing in the approach for selecting the initial list would provide a basis to infer that any of the chemicals selected for the list interferes with or is suspected to interfere with the endocrine systems of humans or other species.

EPA has decided to defer consideration of nominations from the public until subsequent testing lists in order to keep this initial effort administratively simpler and ensure that a set of test results can be obtained in a relatively prompt timeline to aid the Agency in a mid-course evaluation of the EDSP Tier 1 screening battery. In addition, EPA has decided that the prudent approach would be to gain experience with the Tier 1 screening battery on single chemicals before the tests are used with mixtures. EPA also is proposing to exclude from consideration for the initial Tier 1 screening list chemicals that are no longer produced or used in the United States. The Agency thinks that the added administrative complexity of determining who should be responsible for testing such chemicals could unnecessarily delay EPA's selection of an initial list for Tier 1 screening.

In this notice, EPA is proposing an approach for selecting an initial set of chemicals to go through endocrine disruptor screening. EPA has a number of authorities at its disposal to require screening and testing for endocrine disrupting effects. As explained previously, FFDCA section 408(p) requires EPA “to determine whether certain substances may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or such other effects as [EPA] may designate.” (21 U.S.C. 346a(p)). The statute requires EPA to “provide for the testing of all pesticide chemicals.” It defines “pesticide chemical” as “any substance that is a pesticide within the meaning of the Federal Insecticide, Fungicide, and Rodenticide Act, including all active and inert ingredients of such pesticide.” (FFDCA section 201(q)(1) (21 U.S.C. 231(q)(1)). The statute also provides EPA with discretionary authority to “provide for the testing of any other substance that may have an effect that is cumulative to an effect of a pesticide chemical if the Administrator determines that a substantial population may be exposed to such a substance” (21 U.S.C. 346a(p)(3)). In addition, section 1457 of SDWA provides EPA with discretionary authority to provide for testing, under the FFDCA section 408(p) screening program, “of any other substances that may be found in sources of drinking water if the Administrator determines that a substantial population may be exposed to such substance.” (42 U.S.C. 300j-17). Several other Federal statutes also provide EPA with authority to require testing of certain substances, including FIFRA and TSCA. EPA may use any or all of these authorities to require testing of substances to determine whether a substance may cause endocrine effects.

EPA initially set forth the EDSP in the Federal Register issue of August 11, 1998 (63 FR 42852, FRL-6021-3, Docket Control Number OPPTS-42206) and solicited public comment on the program in the December 28, 1998, Federal Register notice (FRL-6052-9). The program set forth in these notices was based on the recommendations of the Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC) which was a committee chartered under the Federal Advisory Committee Act. The Committee was comprised of members representing the commercial chemical and pesticides industries, Federal and State agencies, worker protection and labor organizations, environmental and public health groups, and research scientists. EPA charged EDSTAC to advise the Agency regarding:

1. Methods for chemical selection and priorities for screening,

2. A set of available, validated screening assays for early application,

3. Ways to identify new and existing screening assays and mechanisms for their validation,

4. Processes and criteria for deciding when additional tests beyond screening would be needed and how to validate such tests, and

5. Processes for communicating to the public about EDSTAC's agreements, recommendations, and information developed during priority setting, screening, and testing.

In response to this charge, EDSTAC recommended that EPA's EDSP address both potential human and ecological effects; examine effects on estrogen, androgen, and thyroid hormone-related processes; and include non-pesticide chemicals, contaminants, and mixtures in addition to pesticides (Ref. 2). Based on these recommendations, EPA developed a tiered approach for the EDSP. The core elements of the proposed approach are: Priority setting, Tier 1 screening, and Tier 2 testing. Tier 1 is envisioned as a battery of screening assays that would identify substances that have the potential to interact with the estrogen, androgen, and thyroid hormone systems. The purpose of Tier 2 is to determine whether the substance could, in fact, cause endocrine effects mediated by estrogen-, androgen-, and thyroid-related processes, and establish the relationship between doses of an endocrine-active substance administered in the test and any effects observed (December 28, 1998, Federal Register notice (FRL-6052-9)).

In addition, based on EDSTAC's recommendations, EPA proposed in the December 28, 1998, Federal Register notice (FRL-6052-9) an approach to establish the priority of chemicals for Tier 1 screening. The approach reflected the concern that the quantity and quality of exposure and effects information would be uneven across chemicals. EPA wanted to ensure that data-rich and data-poor chemicals were not directly compared in the priority setting process because data-poor chemicals might tend to be ranked low under such an approach. Thus, the approach set forth in the December 28, 1998, Federal Register notice (FRL-6052-9) was to set up categories of information relating to the production, release, exposure and hazard of chemicals and to group the chemicals according to what data were available. This approach was termed a “compartment-based approach.” The compartment-based approach was based on exposure- and effects-related compartments even though it was recognized that effects or toxicity data relevant to endocrine disruption would be extremely limited for the majority of chemicals. To partly compensate for the lack of relevant toxicity data, EPA proposed to conduct a HTPS on all non-pesticide active ingredient chemicals with a production volume in excess of 10,000 pounds per year. HTPS activities are discussed more fully in Unit IV.C. EPA developed the Endocrine Disruptor Priority Setting Data Base (EDPSD) to assist in assigning chemicals to compartments and setting priorities. More information on the EDPSD is available at: http://www.epa.gov/scipoly/oscpendo/prioritysetting/ .

EPA currently is implementing its EDSP in three major parts. The Agency is:

1. Developing and validating Tier 1 screening level assays, selecting the appropriate screening assays for the Tier 1 battery based on the validation data, and developing and validating Tier 2 tests.

2. Developing an approach for selecting an initial set of chemicals to go through Tier 1 screening.

3. Developing the procedures the Agency will use to require screening.

This notice deals only with the development of the approach that EPA will use to select the initial set of chemicals for Tier 1 screening.

EPA asked the SAB and the SAP to review jointly the Agency's proposed EDSP as described in the December 28, 1998 Federal Register notice (FRL-6052-9). The Agency's charge to the SAB/SAP Subcommittee was broad and complex consisting of 18 questions in four broad areas:

1. Scope of the program.

2. Priority setting.

3. HTPS.

4. Screening and testing.

The Subcommittee met on March 30-April 1, 1999. Its report was published the following July (Ref. 1). In general, the SAB/SAP Subcommittee agreed with the program that EPA had developed for conducting endocrine disruptor screening. The following are recommendations from the Subcommittee with respect to the scope of the program and setting of priorities for Tier 1 screening.

In the December 28, 1998, Federal Register notice (FRL-6052-9), EPA explained that it was considering 87,000 substances as potential candidates for testing under the EDSP. The SAP/SAB Subcommittee expressed some reservations about the ambitious scope of the universe of chemicals that EPA envisioned as potentially being included in the Program. The Subcommittee felt that developing massive amounts of screening data on a large universe of chemicals would not necessarily expedite the development of the appropriate underpinning that the Agency needs before it proceeds with the screening of the large universe of chemicals that it anticipates will be included in the EDSP. The Subcommittee also expressed concern that it did not see a provision for mid-course correction or optimization of the Program. Thus, the Subcommittee recommended that the EPA implement the EDSP on 50 to 100 compounds and submit the data to independent review with an eye toward eliminating methods that do not work and optimizing the program.

The Subcommittee also recommended against including mixtures in the initial set of chemicals to be tested. The Subcommittee thought that the question of testing mixtures should be deferred until accepted single-compound methods had been successfully completed.

The Subcommittee also found that the compartment-based approach to priority setting was supportable when ranking is based on both effect and exposure data. It suggested that the greatest weight should be given to chemicals for which there are data that indicate actual human or environmental exposure and effects. Lower weight should be given to agents for which the data are indicative of probable exposure (in food or drinking water) or probable effects (from animal studies). The lowest weight and priority should be given to chemicals for which the data are indicative of possible exposure (based on release or production volume) or possible effects (from in vitro or HTPS assays). The Subcommittee expressed concern that the lack of effects data on the universe of chemicals currently in commercial use would lead to a database that only identifies known problem chemicals that are already well studied. To overcome this obstacle, the Subcommittee encouraged the development of new techniques including QSAR and molecular modeling to help identify the bio-available, potentially active compounds for further testing in the EDSP. The Subcommittee supported the concept of nominations by citizens but recommended that the process needed further definition.

Finally, the Subcommittee agreed with EPA's assessment that the HTPS system, which EPA subjected to a demonstration project, was not ready for use but that the concept was still valuable. The Subcommittee encouraged EPA to be open to other types of assays for HTPS including receptor binding, gene chip and microassays, and computer modeling. The Subcommittee also gave some guidance regarding further development and employment of HTPS including the need for standardization and validation of any system to be used in priority setting.

In addition to comments provided by the SAB/SAP Subcommittee, comments provided by the public on priority setting in response to EPA's EDSP Proposed Statement of Policy in the December 28, 1998, Federal Register notice (63 FR 71542, FRL-6052-9, Docket Control Number OPPTS-42208) and at two public meetings on the Endocrine Disruptor Priority Setting Data Base held on January 20, 1999 ( Federal Register issue of December 28, 1998 (63 FR 71568, FRL-6052-8, Docket Control Number OPPTS-42207)) and June 5-6, 2000 ( Federal Register issue of May 19, 2000 (65 FR 31900, FRL-6559-9, Docket Control Number OPPTS-42212)) have been helpful to the Agency in developing the approach presented in this notice for selecting the first group of chemicals to be screened in the EDSP.

On the basis of EPA's experience to date and comments received from the SAB/SAP Subcommittee and the public, EPA is setting forth its approach for selecting the first group of chemicals to be screened in the EDSP. Based on the SAB/SAP recommendations, EPA is proposing to select and screen approximately 50 to 100 chemicals drawn from pesticide active ingredients and HPV chemicals with some pesticidal inert uses (HPV/Inert chemicals) to help the Agency further refine the EDSP. As recommended by the SAP/SAB Subcommittee, the Agency intends to submit the data received from the screening to an independent external panel of experts and request an evaluation of whether the program could be improved or optimized, and if so, how. EPA does not intend to develop an ordinal ranking of priorities of the chemicals within this initial list.

EPA is proposing to use an approach based in part on the compartment-based priority setting approach described in the December 28, 1998, Federal Register notice (FRL-6052-9) that provided details about the EDSP. That document proposed approach focuses on exposure-related factors rather than using a combination of exposure- and effects-related factors. The approach would, however, exclude from the first group of chemicals to undergo Tier 1 screening any chemical for which the available effects information clearly shows an endocrine-mediated effect. Such chemicals would be considered for proposed Tier 2 tests, mechanistic or special studies, or hazard assessment. Similarly, the approach for this initial list also would exclude substances that EPA anticipates have low potential to cause endocrine disruption (e.g., certain FIFRA List 4 inerts, most polymers with number average molecular weight greater than 1,000 daltons, strong mineral acids, and strong mineral bases). Although EPA proposes to use in this approach many of the exposure-data sets previously identified for use in the EDPSD, EPA is not proposing to directly use the EDPSD itself at this time in light of the narrower scope and focus of this initial list. EPA anticipates that it will modify its chemical selection approach for subsequent Tier 1 screening lists based on experience gained from the results of testing of chemicals on the initial list, the feasibility of incorporating different categories of chemicals (e.g., non-pesticide substances), and the availability of new priority-setting tools (e.g., HTPS and QSAR models).

EPA is proposing to use several bodies of data to identify pesticide active ingredients for screening in the first use of the Tier 1 battery. These data focus on human exposure by different pathways:

1. As a consequence of consumption of food containing pesticide residues.

2. As a consequence of consumption of drinking water containing pesticide residues.

3. As a consequence of residential use of pesticide products.

4. Through occupational contact with pesticide-treated surfaces.

EPA is proposing to use a generally similar approach to identify HPV/Inert chemicals to be included in the initial list for screening in the Tier 1 battery. However, EPA generally has more extensive information of known quality available to assess potential exposure to pesticide active ingredients via food, water, occupational and residential exposure pathways than is available to assess exposure to HPV/Inert chemicals. In addition, EPA generally has more extensive information available on usage (including both agricultural and residential) of active ingredients than is available for HPV/Inert chemicals (including both pesticidal and non-pesticidal uses of those same substances). For these reasons, the specific data and approaches EPA has identified for selecting an initial set of HPV/Inert chemicals for endocrine disruptor screening differs somewhat from those proposed for selecting pesticide active ingredients.

For HPV/Inert chemicals, EPA will focus on several indicators of the potential for human exposure, including production volume, specific pathways of exposure, and presence in human tissues. First, EPA will review existing databases to identify chemicals that are both pesticide inerts and HPV (defined as chemicals that are manufactured or imported into the United States for all uses in amounts equal to or greater than 1 million pounds per year) chemicals (HPV/Inert). This first step will focus initial Tier 1 screening of pesticide inerts on chemicals with higher potential human exposure on the basis of large amounts produced or imported each year in the United States. Second, EPA will review existing data to identify HPV/Inert chemicals that have been found to be present in: Human tissue, ecological tissues that have human food uses (i.e., fish tissues), drinking water, and/or indoor air. Using this approach, an HPV/Inert chemical appearing in monitoring data from one or more of these media, would be a higher priority for testing than an HPV/Inert chemical that does not appear in monitoring data from any of the media. Details on this priority setting approach for HPV/Inert chemicals are presented in Unit VI.

While EPA's general focus in this approach is on pesticide active ingredients and HPV/Inert chemicals with relatively greater potential human exposure, this focus does not necessarily mean that the list developed using this approach will not contain substances which also have potentially high levels of environmental exposure to ecological receptors. As explained in Units V. and VI., EPA believes that the approach proposed to select an initial list of pesticide active ingredients and HPV/Inert chemicals for screening, while focused on human exposure, will also capture many chemicals with widespread environmental exposures to other organisms.

This proposed approach for selecting the initial list of chemicals to undergo Tier 1 screening differs from the more general EDSP priority setting approach outlined in EPA's December 28, 1998, Federal Register notice (FRL-6052-9) in several aspects: EPA would focus chemical selection for this initial list on the subset of chemicals subject to a statutory mandate for screening (i.e., pesticide chemicals); EPA would use exposure data as the primary basis for chemical selection rather than using HTPS, QSARs or other hazard data in conjunction with exposure data; EPA would defer consideration of nominations from the public; and EPA would not include mixtures in this initial list. The reasons for these proposed changes are as follows:

For the initial Tier 1 screening list, EPA is proposing to focus only on pesticide active ingredients and HPV chemicals with some pesticidal inert uses (i.e., the chemicals that are specifically mandated for testing under section 408(p) of FFDCA) as candidates. The pesticide inerts to be considered are those with relatively large overall production volumes considering both pesticide and non-pesticide uses. This approach will allow EPA to focus its initial endocrine screening efforts on a smaller and more manageable universe of chemicals that emphasizes early attention to the pesticide chemicals that Congress specifically mandated EPA to test for possible endocrine effects.

In response to the recommendations of EDSTAC, EPA had stated its intention to incorporate effects information into an overall chemical prioritization scheme in conjunction with exposure information for identifying chemicals to undergo screening and testing for endocrine disruption potential. However, in light of the limited availability of data for many chemicals that would indicate their relative potential for disrupting endocrine systems and the delays in identifying adequate HTPS or QSAR approaches that are discussed in Units IV.C. and IV.D., the Agency is proposing to use a simpler and narrower approach based primarily on exposure for this initial selection of a limited number of chemicals for screening under the EDSP.

A relatively broad range of toxicity data generally are available for pesticide active ingredients regulated under FIFRA, but in most cases it has not yet been established how the available data might be confidently used to predict the endocrine disruption potentials of these chemicals. This may be due, for example, to the non-specific nature of an effect or effects observed, questions related to whether the mode of action of a given effect or effects is or are endocrine system-mediated in whole or in part, or the lack of relevant data to make a judgement altogether. A more limited set of toxicity data generally is available for pesticide inert ingredients.

Nevertheless, for certain chemicals the available data may provide a sufficiently clear indication of an endocrine-mediated effect or perturbation to warrant exclusion from the first group of chemicals to undergo Tier 1 testing. Such chemicals would be considered for proposed Tier 2 tests, mechanistic or special studies, or hazard assessment. Similarly, based on a review of the available information, there are certain other substances which EPA anticipates have low potential to cause endocrine disruption (e.g., certain FIFRA List 4 inerts, most polymers with number average molecular weight greater than 1,000 daltons, strong mineral acids, and strong mineral bases). EPA anticipates also excluding certain of these substances from the first group of chemicals to undergo Tier 1 testing.

Therefore, except for purposes of exclusion (e.g., there are sufficient data to determine that a chemical has endocrine-mediating activity), effects data are not being considered in this approach for identifying the initial group of chemicals for Tier 1 screening. This does not necessarily mean, however, that toxicity data will not be used in identifying subsequent groups of chemicals for Tier 1 screening.

Because the list of chemicals produced using the proposed approach will be a list of chemicals that the Agency, in its discretion, has decided should be tested first based primarily upon exposure potential, it should not be construed as a list of known or likely endocrine disruptors nor characterized as such. Nothing in the approach for selecting the initial list would provide a basis to infer that any of the chemicals selected for the list interferes with or is suspected to interfere with the endocrine systems of humans or other species.

Recognizing the limitations on existing hazard data, EPA proposed in the December 28, 1998, Federal Register notice (FRL-6052-9) the use of in vitro HTPS to assist in sorting and priority setting. The plan was to use HTPS to pre-screen up to 15,000 chemicals that are produced in quantities exceeding 10,000 pounds per year. HTPS data would define one of the compartments in the EDPSD and provide a criterion for identifying high priority chemicals. EPA sponsored a limited demonstration of an HTPS system utilizing reporter gene assays for the estrogen receptor (ER), androgen receptor (AR), and thyroid receptor (TR). The reporter gene assays used in this demonstration project employed a human cell line that naturally contains the receptor. A reporter element was then introduced into these cells so that when a substance binds to a receptor it would activate the genetic machinery in the cell. This activation could be detected in a quantitative manner. The SAB/SAP Subcommittee agreed with EPA that the demonstration HTPS system did not work well enough in its present form to serve as a tool for priority setting (Ref. 1). The assays had too much variability and too low of a response to be useful without modifications to boost their sensitivity. EPA concluded that the HTPS approach still holds promise but that it has potential for success only after substantial additional research. EPA decided to defer its plans for using HTPS and to explore the potential for using QSAR models to address the problem of inadequate hazard data to prioritize chemicals. Nonetheless, the SAB/SAP Subcommittee believed that HTPS is a promising tool for priority setting and EPA agrees. EPA has issued a Request For Application (RFA) under its Science to Achieve Results (STAR) research grants program to solicit new approaches that may lead to the development of HTPS to assist in the prioritization of chemicals for screening for endocrine disrupting activity ( http://es.epa.gov/ncer/rfa/current/2003high_throughput.html ). EPA is also following the work being conducted in Japan on ER and AR transcriptional activation-based HTPS systems. EPA will consider the applicability of new HTPS approaches to future priority setting in the EDSP as those approaches are further developed and refined.

At the time EPA decided to suspend its efforts under the EDSP on HTPS, it was aware of at least two QSAR models that were being developed to predict the potential of a chemical to bind to cellular ER. QSAR offers one important advantage over HTPS. It could provide data on thousands of chemicals without testing them in the laboratory. Such a tool could save millions of dollars in chemical testing costs, but still, if valid, be able to predict whether a new molecule that had never been synthesized or an untested existing chemical would be likely to interact with the ER or AR. EPA designed a program to validate two QSAR models within a defined chemical domain and activity range of interest to EPA. The comparative molecular field analysis (CoMFA) model developed by Federal Food and Drug Administration's (FDA) National Center for Toxicological Research and the common reactivity pattern (COREPA) model developed at the University of Bourgas were evaluated. EPA asked each of the modeling teams to predict the relative ER binding of 6,649 high production chemicals on the TSCA inventory. EPA selected 50 chemicals predicted to be positive by each model and approximately 200 chemicals selected from the 6,649 at random and tested almost all in an ER binding assay. Thus, a total of nearly 300 chemicals were tested to validate the models. Each model predicted about 300 of the 6,649 chemicals to be positive. There were 78 chemicals that were predicted to be positive by both models (Ref. 3). A comparison of model predictions with laboratory results did not meet EPA's expectations because, although both models demonstrated relatively high specificity, both models also demonstrated low sensitivity. EPA believes that the performance problems associated with the models are likely due to the chemical training set being significantly dissimilar in terms of structures and binding potency ranges compared to the TSCA HPV chemicals. EPA is continuing to encourage the development and refinement of QSARs and beginning in Fiscal Year 2002 redirected $4 million to a computational toxicology initiative to integrate modern computing and information technology, not limited to just QSARs, with the technology of molecular biology and chemistry to improve EPA's ability to prioritize chemicals for screening and testing, and its risk assessments.

For the initial Tier 1 screening list, EPA proposes to focus on pesticide active ingredients and HPV chemicals with some pesticidal inert uses (i.e., the chemicals that are specifically mandated for testing under section 408(p) of FFDCA) as candidates. EPA believes that nominations from the public are important because they provide a mechanism to identify chemicals which may result in high exposures in local communities but which would not otherwise receive national attention. However, EPA has decided to defer consideration of nominations from the public until subsequent testing lists in order to keep this initial effort administratively simpler and ensure that a set of test results can be obtained in a relatively prompt timeline to aid the Agency in a mid-course evaluation of the EDSP Tier 1 screening battery.

EPA has decided that the prudent approach would be to gain experience with these tests on a variety of single chemicals before it addresses mixtures. This judgement is consistent with advice from the SAB/SAP Subcommittee (Ref. 1).

EPA also is proposing to exclude from the initial Tier 1 screening list any chemicals that are no longer produced or used in the United States. The Agency thinks that such chemicals would not warrant high priority for testing at this time. Although some of the databases that EPA proposes to consider may report past detections of such chemicals, the discontinuation of their use and manufacture means that exposure to these substances is likely declining. Moreover, EPA anticipates that it will have to resolve significant practical difficulties (such as determining who EPA could require to conduct the testing) before it attempts to require testing of these substances. This combination of reasons leads the Agency to propose excluding discontinued chemicals from the initial group of chemicals to undergo testing in the Tier 1 screening battery.

EPA is proposing to use several sets of criteria for identifying pesticide active ingredients to be given priority for screening in EPA's initial application of the Tier 1 battery. These criteria would focus on human exposure by different pathways: As a consequence of consumption of food containing pesticide residues; as a consequence of consumption of drinking water containing pesticide residues; as a consequence of residential use of pesticide products; and through occupational contact with pesticide-treated surfaces. For each of the four pathways, EPA would review existing databases that can help the Agency to identify active ingredients generally expected to be among those having either widespread or high levels of human exposure.

While EPA's general focus is on pesticide active ingredients with relatively greater potential human exposure, this focus does not necessarily mean that the list of active ingredients will not contain substances which also have potentially high levels of environmental exposure to ecological receptors. Many of the pesticide active ingredients having greater potential for human exposure will also have greater potential for exposure to wildlife. For example, one pathway of human exposure, drinking water, is also a pathway through which aquatic life and many terrestrial species are exposed. Most of the databases that EPA will consider in evaluating active ingredients for exposure through drinking water contain monitoring data collected on raw surface water, i.e., before the water enters a Community Water System. Thus, these monitoring data show the levels of pesticide residues which fish, amphibians, and other aquatic species will encounter. Similarly, when data show higher and more widely distributed levels of pesticide residues in food, EPA thinks that such residues generally tend to reflect greater usage and/or persistence of the pesticide on crops and thus, greater environmental loads. Accordingly, EPA believes that the approach proposed to evaluate pesticide active ingredients, while focused on human exposure, will also capture many active ingredients with widespread environmental exposures.

Every person eats food and a significant portion of food contains some amount of pesticide residues, although usually at very low levels. Therefore, pesticide residues in food have the potential to cause widespread human exposure. Pesticides have different use patterns and have different physical and chemical properties that affect how they move in the environment and how quickly they break down. As a result, there are often significant differences among pesticides in the proportion of food containing residues and in the levels of such residues. People also consume different amounts of different foods. All of these factors mean that people ingest greater quantities of some pesticide active ingredients than of others.

To evaluate the interplay of these different variables, EPA proposes to identify the pesticide active ingredients which are most frequently found as residues on the top twenty foods that people consume. First, EPA will examine the most recent Continuing Survey of Food Intake by Individuals (CSFII) to determine the mean amount of each raw agricultural commodity consumed in the general population. The CSFII is a database derived from a survey performed by the U. S. Department of Agriculture (USDA) in 1994-1996 and supplemented with additional survey responses collected in 1998. USDA collected food diary information from over 20,000 individuals who were interviewed on two non-consecutive days, generally spaced 3 to 10 days apart. After appropriate statistical weighting, the survey, in the aggregate, is representative of the U. S. population in terms of age, gender, major ethnic groups, and socio-economic status. Moreover, sampling was representative of different days of the week, seasons of the year, and parts of the country. Extensive quality control procedures assured that the data collected in the survey were accurate and reliable. More information on USDA's food surveys and the CSFII (`94-`96) is available through http://www.barc.usda.gov/bhnrc/foodsurvey .

Using the CSFII information, EPA has converted the reported food consumption for each survey respondent into the constituent raw agricultural commodities. For example, if a person reported having eaten 6 ounces of beef stew, EPA estimated the amount of beef, carrot, potato, and each other raw agricultural commodity used in making that quantity of beef stew. EPA made similar conversions for each of the different finished foods reported in the CSFII—from apple pie to yogurt. Then EPA estimated the total amount of each of the various raw agricultural commodities eaten over the course of the day, for example summing the amount of apple consumed from drinking cider and eating apple sauce. This individual food consumption database provides the basis for identifying the top twenty foods consumed, in terms of mean daily consumption for the general population. List 1 of this unit lists these raw agricultural commodities.

Having identified the top 20 foods, EPA would characterize the pesticide residue levels on these foods using information collected by two Federal agency monitoring programs, the USDA Pesticide Data Program (PDP) and the Surveillance Monitoring Program conducted by FDA's Center for Food Safety and Applied Nutrition. PDP has been collecting pesticide residue data since 1991. PDP is designed to provide a nationally representative database on the distribution of pesticide residues in food as close as possible to the actual time of consumption as practical. Using analytical methods that have been standardized and validated, and following strict quality control procedures, USDA has focused on foods highly consumed by children throughout the year. Over the years of operation, PDP has collected data on over 290 different pesticides and 50 different commodities. Additional information can be found at http://www.ams.usda.gov/science/pdp/index.htm . The FDA Surveillance Monitoring Program is designed primarily for enforcement of pesticide tolerances on imported foods and domestic foods shipped in interstate commerce. Domestic samples are collected as close as possible to the point that the food enters the distribution system. FDA samples imported food at the port of entry into the United States. Additional information on the FDA program appears at http://www.cfsan.fda.gov/~dms/pesrpts.html .

Because of the differences in how samples are collected and handled, EPA would rely on the PDP database when both sources cover the same pesticides and commodities. The FDA Surveillance data covers different pesticides and commodities in different years from the PDP monitoring. (For example, in 1999, FDA used analytical methods capable of detecting 366 different active ingredients.) Therefore, in making its weight-of-the-evidence judgment, EPA would consider the FDA information as a supplement to the information from the PDP database.

EPA proposes to examine the PDP and FDA Surveillance databases to identify the pesticide active ingredients which appear on the largest proportion of the samples, focusing on the twenty foods which make up the largest part of the U.S. diet. Generally, EPA would give higher weight to pesticides that appear frequently on multiple foods. In reviewing these data, EPA will take into account qualitatively any risk mitigation measures implemented since residues levels were monitored.

EPA recognizes that this approach would be more likely to give higher priority to the pesticides which are the subject of routine monitoring in either PDP or FDA's Surveillance program. Both programs rely primarily on “multi-residue methods” that are capable of detecting many different chemical substances using a single analytical procedure. Active ingredients which require specialized analytical methodology may not be looked for and thus would be unlikely to be included for consideration in the food pathway. This limitation particularly applies to newer pesticide active ingredients. Notwithstanding these limitations, EPA believes that the approach described is a practicable approach for identifying pesticide active ingredients with widespread or high levels of exposure.

Significant portions of the general population may be exposed to pesticide residues in drinking water. Although monitoring data indicate that most pesticide active ingredients are rarely detected, analytical surveys in virtually every region of the country have detected a number of active ingredients in ground and surface water used as sources of drinking water. Monitoring also indicates that, even when found in water, residue levels vary significantly both seasonally and regionally for a single pesticide, as well as across pesticides. Particularly for surface water, residues tend to occur in pulses that can last days to weeks to months, depending on the type of water body and the pesticide. Because almost every person consumes some water every day, either in prepared foods or beverages (e.g., coffee, tea, or reconstituted juice) or simply by drinking water, exposure to pesticides through the drinking water pathway can be widespread and repeated. And, while such exposure is usually neither as widespread nor of the same magnitude as pesticide exposure through food, a significant portion of the population in a particular region of the country can be exposed.

To assess relative exposure to different pesticides in water, EPA would examine a number of different databases that contain the results of programs to monitor surface and ground water for the presence of pesticide residues. These databases, which contain data collected by Federal and State agencies, academicians, pesticide companies, and others, are summarized in this unit:

1. EPA Pesticides in Ground Water Database (PGWDB) . The PGWDB was created to provide a more complete picture of ground-water monitoring for pesticides in the United States. It is a collection of ground-water monitoring studies conducted by Federal, State, and local governments; the pesticide industry; and private institutions between 1971-1991. The PGWDB compiles, in tabular format, data from monitoring of raw ground-water 1 and contains data only from studies in which pesticides were included as analytes. Some of the data limitations include: age of the data; differences in the design of studies; lack of historical pesticide use or hydrological information; and lack of information on well use, sampling practices, and laboratory procedures. Further details can be found in EPA Pesticides in Ground Water Database, A Compilation of Monitoring Studies: 1971-1991 National Summary (Ref. 4).

2. EPA Chemical-Specific Monitoring Data . Pesticide registrants have conducted and submitted to the Agency targeted surface water and ground water monitoring studies for approximately 50 pesticide active ingredients. The Agency decides whether to require monitoring of raw surface or ground water for a pesticide based on the environmental fate characteristics (persistence and mobility) of the pesticide; the current or proposed use patterns for the pesticide; and other information that would indicate potentially significant levels of the pesticide could be present in water. The design of monitoring studies takes into consideration application rate, crops, and the location of potentially more vulnerable use sites. These studies are performed under Good Laboratory Practice regulations, and contain internal quality assurance procedures. When submitted, the monitoring data undergo primary and secondary review by Agency scientists.

3. Heidelberg College's Monitoring Data . Heidelberg College's Water Quality Laboratory (WQL) conducts research, monitoring and educational programs that address the impacts of agricultural and urban land use on the water resources of Ohio, the Midwest, and the Lake Erie and Great Lakes ecosystems. The WQL began studying pesticides in 1981. These studies now provide the longest and most detailed record of pesticide residues in raw water available for any river system in the United States. The WQL maintains a modern, highly automated water chemistry laboratory with capabilities rarely found within academic research settings. While much of the WQL's program is organized within the context of a large-scale, long-term agricultural ecosystem study, the lab also conducts research related to public drinking water supplies (finished water), urban runoff, industrial and municipal pollution sources and changing biological communities in Lake Erie. Further details can be found on the web at: http://www.heidelberg.edu/WQL/index.html .

4. U.S. Geological Survey (USGS)/EPA Reservoir Monitoring Study . The USGS/EPA Reservoir Monitoring study was a pilot monitoring program initiated by USGS and EPA to provide information on pesticide concentrations in drinking water and to assist in the implementation of the Food Quality Protection Act (FQPA) of 1996. Drinking-water utilities that withdrew water from reservoirs were sampled in 1999 and 2000. Water samples were collected from raw water (at the intake point) and from finished drinking-water (at the tap prior to entering the distribution system). At some sites, samples were also collected at the reservoir outflow. Sampling frequencies were designed to measure long-term mean and short-term peak concentrations of pesticides in drinking water. The analytical methods used for analyzing the pesticides in the water samples included 178 different pesticides and degradation products. Additional information on the USGS/EPA Reservoir Monitoring Study can be found in Pesticides in Select Water Supply Reservoirs and Finished Drinking Water, 1990-2000: Summary of Results from a Pilot Monitoring Program (Ref. 5).

5. Environmental Monitoring and Assessment Program (EMAP) . EMAP is an EPA research initiative designed to support the development of tools necessary to monitor and assess the status and trends of national ecological resources. Research is conducted on various ecosystems (e.g., estuaries, forests, rangelands, and lakes). Sediment samples were collected in 18 States at various times between 1990 and 1998. This data source provides information about the contaminants present in sediment/soil which humans and wildlife may contact. EMAP includes relevant data for over 170 chemicals and three separate data sets for estuary sediments. Extensive field and laboratory QA/QC procedures were performed during the collection and analysis of the samples. Further details can be found on the web at: http://www.epa.gov/emap/ .

6. National Sediment Inventory (NSI) . The Water Resources Development Act (WRDA) of 1992 directed EPA, in consultation with the National Oceanic and Atmospheric Administration (NOAA) and the U.S. Army Corps of Engineers (USACE), to conduct a national survey of data regarding the quality of sediments in the United States. To comply with the WRDA mandate, EPA's Office of Science and Technology initiated the NSI. The NSI is a database that documents the composition of sediment in rivers, lakes, oceans, and estuaries. The NSI tissue residues studies (primarily fish) help assess sediment quality and can be used to assess potential exposure of humans to these chemicals through the consumption of fish. Also, sediment chemistry data are evaluated for theoretical bioaccumulation potential. The NSI includes data collected by a variety of Federal, State, regional, local, and other monitoring programs from 1980 through 1999. It includes over 4.6 million analytical observations for over 50,000 monitoring stations across the country of sediment chemistry, tissue residues, and sediment toxicity data. NSI's minimum data requirements include monitoring program identification, sampling date, latitude and longitude coordinates, and measured units. EPA retains additional data such as QA/QC information, if available, but did not require that information for a data set to be included in NSI. Additional limitations of the compiled data include the mixture of data sets derived using different sampling strategies, incomplete sampling coverage, and the age and quality of the data. Because the data analyzed in this report were collected over a relatively long period of time, conditions may have changed since the sediment was sampled. Further details on the NSI database and the National Sediment Quality Survey, which the NSI was developed to support, can be found at: http://www.epa.gov/waterscience/cs/nsidbase.html and http://www.epa.gov/waterscience/cs/draft/survey.html .

7. National Drinking Water Chemical Occurrence Database (NCOD) . NCOD is a repository of drinking water quality data, mandated by Congress in the 1996 SDWA Amendments. NCOD contains national occurrence data from public water systems and from ambient water from the USGS National Water Information System. It includes information on regulated and unregulated contaminants, containing physical, chemical, microbial, and radiological information for both detects and non-detects. NCOD-drinking water contains relevant data for over 120 chemicals, and includes samples from both raw and finished water. Currently, NCOD-drinking water contains occurrence only for those water systems that have been reported by States to EPA's Safe Drinking Water Information System. While data sets will be updated over time, they may reflect a lag time of at least six months. Further details can be found on the web at: http://www.epa.gov/safewater/data/ncodgateway.html .

8. National Stream Quality Accounting Network (NASQAN) Data . NASQAN, a monitoring and data-collection program conducted by the USGS, is designed to characterize raw surface water in large sub-basins of rivers, determine regional source areas for chemicals, and assess the effects of human influences on observed concentrations and amounts of chemicals. Since 1995, NASQAN has focused on monitoring the water quality of four of the nation's largest river systems: the Mississippi, the Columbia, the Colorado, and the Rio Grande. A network of 40 stations monitors the concentrations of a broad range of chemicals including pesticides, major ions, and trace elements. NASQAN contains relevant data for over 70 chemicals. NASQAN samplers collect quality control (QC) samples to evaluate the quality of sampling data. However, the data in NASQAN do not characterize ambient water quality throughout the United States, only for four river basins and sub-basins. Further details can be found on the web at: http://water.usgs.gov/nasqan/ .

9. The National Water Quality Assessment Program (NAWQA) . Congress appropriated funds in 1986 for the USGS to design and implement a program to address questions related to status and long-term trends in raw surface- and ground-water quality at national, regional, and local scales. The USGS began a pilot program in seven project areas to develop and refine a plan for the National Water-Quality Assessment (NAWQA) Program. In 1991, the USGS began full implementation of the program. The NAWQA program builds upon an existing base of water-quality studies of the USGS, as well as those of other Federal, State, and local agencies. The NAWQA Program was designed to study 60 of the Nation's most important river basins and aquifer systems, which are referred to as study units. A national map of these study units shows that they are distributed throughout the Nation and cover a diversity of hydrogeologic settings. More than two-thirds of the Nation's freshwater use occurs within the study units and more than two-thirds of the people served by public water-supply systems live within their boundaries. The 60 study units have been divided into groups of 20 study units each, and their intensive data-collection phases have been staggered to allow efficient and effective use of resources. The first 20 studies began in 1991, the second group began in 1994, and the third group began study in 1997. Due to funding constraints, only 14 of the original first group of 20 study units began a second cycle of study in the year 2000. The cycle is intended to continue into the future with a total of 52 study units so as to provide both short-term information necessary for today's water-resource management decisions, and the long-term information needed for policy decisions. Further details can be found on the web at: http://wwwga.usgs.gov/nawqa/main.nawqa.html .

EPA notes that most of the monitoring databases report results from samples of “raw,” or untreated, water, rather than “finished” drinking water prepared by a drinking water facility for its customers. To the extent that treatment methodologies (such as flocculation, softening, filtration, chlorination, sedimentation, etc.) either remove or transform the pesticide residue in the source water, residues found in the raw water may not represent exposure of the public consuming the finished water. EPA has considered the impacts of various treatment methodologies on different classes of pesticides found in raw water and concluded that conventional water treatment processes (such as coagulation/flocculation, sedimentation, and filtration) can have little or no effect on the removal of certain pesticides (Ref. 6). Thus, the Agency regards the results of monitoring raw or ambient water as an appropriate indicator of potential human exposure.

Many other factors affect the interpretation of a set of water monitoring data. Monitoring is most likely to detect the presence of pesticide residues in water if it is conducted in an area where the pesticide has been used, and samples are collected at a time when residues are likely to occur. Moreover, the analysis must employ methods sensitive enough to detect any residue. Often, however, monitoring reports lack sufficient information to evaluate how well these factors were considered. Consequently, evaluation of water monitoring data requires considerable judgment. See the discussion of considerations affecting the evaluation of water monitoring data in Estimating the Drinking Water Component of a Dietary Exposure Assessment (Ref. 7) and the EPA Background Paper for the FIFRA Scientific Advisory Panel Meeting on Monitoring Strategies for Pesticides in Surface-Derived Drinking Water (Ref. 8).

The limitations on an individual data set can be overcome, to some extent, by consideration of multiple sets of data and multiple databases. EPA thinks that, when considered collectively, the databases discussed in Unit V.B. are not as vulnerable to criticism as a single data set. Generally, all of these databases include studies with high levels of quality control, and together they provide wide temporal and spatial coverage for a large number of pesticides. Thus, the Agency believes the databases in Unit V.B. would provide a reliable basis for drawing conclusions about the relative potential of different active ingredients to leach into ground water or run off into surface water in different parts of the country.

In light of these considerations, EPA proposes to review the multiple databases to identify those active ingredients which appear relatively more frequently and/or in more geographical areas than other pesticides. Because the scope of monitoring varies from pesticide to pesticide, EPA would use a weight-of-the-evidence approach to assess the frequency and geographic distribution of pesticide residues in water.

EPA's reliance on these databases would necessarily have some limitations. For example, most monitoring looks only for the “parent” compound, i.e., the pesticide active ingredient, rather than for environmental degradation products or compounds formed by chemical reactions during the treatment of raw water sources in a drinking water facility. Further, like food residue monitoring programs, monitoring efforts rely on multi-residue methods that may not detect certain compounds or classes or compounds. Notwithstanding these limitations, EPA believes that the approach described is a practicable approach for identifying pesticide active ingredients generally expected to be among those having either widespread or high levels of human exposure.

Human exposure to pesticides may occur as the result of use of pesticidal products in and around homes, schools, businesses, public areas, golf courses, and similar sites. Such use patterns, collectively referred to as “residential use,” include: Lawn and garden treatments, insect repellants, termite, and other indoor insect control, fumigation products, products applied to pets for flea or tick control, household sanitizers and disinfectants, and many more.

EPA proposes to use pesticide product labeling information as the primary indicator of pesticides whose use involves potential human exposure by this pathway. EPA would review its databases and identify those active ingredients approved for residential use. Aside from products approved only for limited exposure uses, such as rodenticides applied in tamper resistant bait boxes, all currently registered residential use pesticides would be identified as having higher priority with respect to the residential use pathway.

The Agency recognizes that registration of a pesticide for residential use does not necessarily mean that it would be widely used or that its use would entail significant levels of human exposure. EPA, however, generally lacks information to compare the extent of application of different active ingredients for residential uses. Moreover, EPA does not have a basis for distinguishing among various residential use patterns on the basis of which consistently have potential for higher levels of human exposure. Thus, EPA does not regard its proposed basis for selecting priority chemicals for this pathway as being as effective in setting priorities among active ingredients as the criteria proposed for the other pathways. Nonetheless, residential use pesticides involve potential exposures to the general population, the Agency believes it would be appropriate to consider giving priority to some of these products.

Occupational exposure can occur either as a person mixes, loads, or applies a pesticide product (i.e., during pesticide use), or as a person, during some other occupational activity, comes in direct, repeated contact with pesticide residues present on previously treated surfaces (i.e., post-application exposure). Although numerically smaller than the populations exposed to pesticides through food, drinking water, and residential use, individuals receiving occupational exposures generally experience significantly higher levels of exposure than the larger groups encounter by the other pathways. Based on available data and current agricultural practices, the number of workers exposed through post-application is greater than the number of workers exposed through mixing, loading, and applying pesticides. As a result, EPA proposes to focus on post-application exposures.

Many factors affect the post-application exposure of agricultural workers, most notably the type of work activity and the level of residue present on pesticide-treated surfaces. As will be discussed in more detail in Unit V.D., different activities involve differing levels of contact with pesticide-treated surfaces and therefore can lead to different levels of exposure. Exposure levels also depend on the amount of residue available on a treated surface. This, in turn, depends on the amount of pesticide initially applied, how quickly the material degrades or is taken up by the plant, and how soon after application the worker contacts the treated surface. Pesticides show a large range of variation in application rates, application timing, and environmental fate characteristics with the result that there are significant differences in the levels of dislodgeable residues on treated surfaces encountered by workers.

In identifying active ingredients for priority consideration by this pathway, EPA proposes to rank pesticides on the basis of their potential for post-application exposure of agricultural workers. This group includes farmers and farmworkers who reenter pesticide-treated fields and orchards to care for or harvest the crop. A relatively recent database developed by the Agricultural Reentry Task Force (ARTF) clearly indicates that certain work activities in particular crops lead to higher levels of exposure than other post-application work activities (Ref. 9). For example, harvesting fruit in orchards or pruning vines in a grape vineyard requires extensive contact with plant foliage that is likely to contain pesticide residues. When the worker touches the foliage, a certain amount of the residue transfers to the worker's skin or clothing. The greater the contact is, the higher the residue transferred and the higher the ensuing exposure.

EPA will review the ARTF's transfer coefficient studies to identify those work activities and crops which have the highest potential for post-application exposure. The ARTF is a consortium of pesticide companies that formed a joint venture to develop data for use in EPA assessments of worker risk. The ARTF conducted a series of carefully controlled studies that measured the amount of pesticide residue present on workers' clothing after a specific period of time working in a crop with known amounts of pesticide residue on the crop foliage. The ARTF set of data is very extensive, covering over 100 different crops —essentially all crops, including greenhouses and ornamental crops, in which workers might come into contact with pesticide-treated leaf surfaces. The studies permit the calculation of a standardized “transfer coefficient” for the crop and activity. 2 Activities having higher transfer coefficients should result in higher levels of worker exposure, all other factors being equal.

EPA proposes to identify the crops having approximately the dozen highest transfer coefficients and then to identify the pesticides having the highest levels of use on those crops. Specifically, EPA would estimate the total number of acre treatments for each pesticide on all of the top crops and then rank the pesticides on the basis of the highest totals. 3 The Agency would obtain information about the number of acre-treatments for each pesticide from a variety of public and private data sources including USDA's National Agriculture Statistics Service, California's Department of Pesticide Regulation, and Doane Marketing Research.

The USDA's National Agricultural Statistics Service (NASS) has, for more than 10 years, conducted annual surveys of pesticide use in a large number of crops, surveying thousands of agricultural producers in any given year. NASS conducts their use survey every year for a set of row crops. NASS also surveys pesticide usage on other crops, alternating every year between a group of fruit and nut crops and a group of vegetable crops (i.e., selected fruits/nuts were surveyed in 1997, 1999, 2001; selected vegetables were surveyed in 1996, 1998, and 2000). NASS surveys states representing a majority of national production for a crop and reports a number of statistics for insecticide, fungicide, and herbicide use including: percent crop treated, application rate, numbers of applications, acreage grown. Using these data, EPA can estimate the total acre-treatments for the pesticides used on crops with the highest transfer coefficients. More information on NASS pesticide use data can be found at: http://www.pestmanagement.info/nass/ .

The State of California has reported annually on all agricultural pesticide usage in the State for almost 10 years. This data collection effort is managed by the California Department of Pesticide Regulation (CDPR), and includes an extensive array of treatment information on crops including timing, location, area, and rate. These data allow EPA to calculate acre-treatments for pesticides on crops grown in California. In cases where crops with high transfer coefficients are grown in California, but not reported by NASS, CDPR data would be extremely useful. For those crops reported by both CDPR and NASS, data from both sources would serve to validate estimates. More information on CDPR pesticide usage data can be found at: http://www.cdpr.ca.gov/docs/pur/purmain.htm .

EPA's third major source of pesticide use information is AgroTrak TM , a product of Doane Marketing Research, Inc. (referred to here simply as Doane). Doane maintains a proprietary national database of agricultural pesticide use summarizing data from surveys of thousands of agricultural producers across a wide range of row and specialty crops. Doane has conducted an annual survey for more than 15 years, and among the statistics they publish for a given crop/chemical combination are acres grown, acres treated, and acre-treatments. These data represent an important source of data, and can be compared to NASS and CDPR data to fill data gaps, or serve as another point of validation. Doane's survey can be particularly useful because their national survey covers fruits and vegetables producers every year. More information on Doane Marketing Research can be found at: http://www.doanemr.com/ .

Basing its priorities for this pathway on the number of acre-treatments of crops with worker activities having high transfer coefficients should identify pesticides that have potential for relatively higher worker exposure. The combined criteria of crops with high transfer coefficients and pesticides used on such crops should identify those active ingredients with potential for high worker exposures. The use of the additional criterion of total acre-treatments should identify pesticides with the widest use, and thus the potential for exposures for the largest number of workers.

The proposed criteria, however, would not account for any of the characteristics specific to the use of a particular pesticide on a crop that could decrease or increase the potential for exposure—application rate, application timing, and environmental fate characteristics. Consequently, the priority listing may not completely reflect where the highest post-application exposures exist.

Nevertheless, EPA believes that the approach described is a practicable approach for identifying those pesticide active ingredients with the potential for either widespread or high levels of exposure to post-application workers.

This unit addresses how EPA would integrate the information developed on priorities through the analysis of the four exposure pathways discussed in Units V.A. through V.D. As its first step, the Agency would apply the criteria proposed for each pathway to produce four lists of candidate chemicals for potential screening in the endocrine disruptor Tier 1 battery. EPA expects that a number of pesticide active ingredients would be identified for more than one pathway, and that some chemicals will appear only on the list for a single pathway. In choosing which active ingredients it would recommend for screening, EPA would give higher priority to chemicals that appeared on multiple lists, with the substances appearing on four lists receiving the highest priority, followed by the group of chemicals appearing on three lists, followed by chemicals on only two lists. To the extent necessary to establish priorities within these four groups, EPA would propose to give greater priority to chemicals which appear on the list for the food pathway (which generally involves the most widespread exposure of the four pathways), followed by the list for the occupational pathway (which generally involves the highest per capita levels of exposure of the different pathways). As a final step, EPA would review the available effects information to identify any chemical for which the information clearly indicates an endocrine-mediated effect/perturbation. Such chemicals would be considered for proposed Tier 2 tests, mechanistic or special studies, or hazard assessment. During this step, EPA also would identify substances that EPA anticipates would have low potential to cause endocrine disruption. EPA would consider excluding substances in either category from the first group of chemicals to undergo Tier 1 testing.

EPA is proposing to use several sets of criteria for identifying HPV/Inert chemicals that should be given priority for screening in the Tier 1 battery. In general, the Agency is proposing an approach for HPV/Inert chemicals that is similar to that proposed for pesticide active ingredients. EPA will focus on several indicators of the potential for human exposure including production volume, specific pathways of exposure, and presence in human tissues. While EPA's general focus is on HPV/Inert chemicals with relatively greater potential human exposure, this focus does not necessarily mean that the list of chemicals produced will contain no substances which have potentially high levels of environmental exposure to ecological receptors. Many of the HPV/Inert chemicals having greater potential for human exposure will also have greater potential for exposure to wildlife. For example, the databases to be reviewed for ecological biological monitoring data will directly identify certain chemicals to which aquatic organisms have been exposed (see Unit VI.B.). Similarly, several of the monitoring databases that will be reviewed for the drinking water pathway contain monitoring data collected on raw surface water, i.e., before the water enters a Community Water System (see Unit VI.C.). Thus, these surface water monitoring data will show the levels of chemical to which fish, amphibians, and other aquatic species are exposed. Accordingly, EPA believes that the approach proposed to evaluate pesticide HPV/Inert chemicals, while focused on human exposure, will also capture HPV/Inert chemicals with widespread environmental exposures.

EPA generally has more extensive information of known quality available to assess potential exposure to pesticide active ingredients via food, water, occupational and residential exposure pathways than is available to assess exposure to HPV/Inert chemicals. In addition, EPA generally has more extensive information available on usage (including both agricultural and residential) of active ingredients than is available for HPV/Inert chemicals (including both pesticidal and non-pesticidal uses of inerts). For these reasons, the databases available to evaluate potential human exposure of the two classes also differ.

First, EPA will review existing databases to identify chemicals that are both pesticide inerts and HPV chemicals (HPV/Inert). HPV chemicals are those chemicals manufactured or imported into the United States in amounts equal to or greater than one million pounds per year. The HPV chemicals are identified through information collected under the TSCA Inventory Update Rule (IUR). Organic chemicals that are manufactured or imported into the United States in amounts equal to or greater than 10,000 pounds per year are subject to reporting under TSCA IUR every 4 years. Second, EPA will review existing data bases to identify HPV/Inert chemicals that are present in human tissue, or ecological tissues that have human food uses, or drinking water or indoor air. Third, EPA will prioritize these chemicals based on the number of data bases in which that the chemical was found. Thus, HPV/Inert chemicals appearing in four types of monitoring data would be given higher priority than those appearing in only one type of monitoring data. EPA may also give higher priority to those HPV/Inert chemicals that appear in human tissues than to those chemicals that only appear in water, air, or ecological tissues.

As a final step, EPA would review the available effects information to identify any chemical for which the information clearly indicates an endocrine-mediated effect/perturbation. Such chemicals would be considered for proposed Tier 2 tests, mechanistic or special studies, or hazard assessment. During this step, EPA also would identify substances that EPA anticipates would have low potential to cause endocrine disruption (e.g., certain FIFRA List 4 inerts, most polymers with number average molecular weight greater than 1,000 daltons, strong mineral acids, and strong mineral bases). EPA would consider excluding substances in either category from the first group of chemicals to undergo Tier 1 testing.

EPA proposes to review the following data sources to determine which HPV/Inert chemicals have been detected in human biological samples.

1. Third National Health and Nutrition Examination Survey (NHANES III) . The Third National Health and Nutrition Examination Survey (NHANES III) was conducted between 1988 and 1994 on 33,994 people. The survey was designed to obtain nationally representative information on the health and nutritional status of the U.S. population through interviews and direct physical examinations. Several studies (e.g., high blood pressure, immunization status, nutritional blood measures, etc.) were conducted under NHANES III. One study relevant to this priority setting exercise is Ashley et al (1994) (Ref. 10). This NHANES volatile organic compound (VOC) article contains relevant human biomonitoring data for over 40 chemicals. Standard quality assurance/quality control (QA/QC) procedures such as sample duplicates and blanks were used in the NHANES III study. The study participants in the special study are not statistically representative of the U.S. population.

2. National Report on Human Exposure to Environmental Chemicals . The National Report on Human Exposure (Ref. 11) is a Centers for Disease Control and Prevention (CDC) report that provides exposure information about people participating in an ongoing national survey of the general U.S. population—the NHANES. This report provides information on concentrations of 27 environmental chemicals measured in blood and/or urine in the U.S. population. These chemicals include metals; organophosphate pesticide metabolites; phthalate metabolites and cotinine, a marker of exposure to tobacco smoke. This report will be updated with additional biomonitoring data for these same or different chemicals on an annual basis. It is anticipated that a second report will be issued in late 2002 with human biomonitoring information on an additional 75 chemicals.

3. National Human Adipose Tissue Survey (NHATS) . The EPA's OPPT operated the National Human Monitoring Program (NHMP) until the early 1990s. The NHMP's primary activity was conducting NHATS, which analyzed human adipose tissue specimens to monitor human exposure to potentially toxic chemicals. A nationwide network of pathologists and medical examiners from 47 standard metropolitan statistical areas (SMSAs) collected tissue specimens from cadavers and surgical patients that were then analyzed for certain chemicals. Throughout the 1970s and early 1980s, the chemical residues of primary interest were organochlorine pesticides and polychlorinated biphenyls (PCBs). In 1982, VOCs and semivolatile organic compounds (SVOCs) were included in the survey. NHATS contains relevant human biomonitoring data for over 150 chemicals. Quality control samples, such as method and equipment blank samples, control samples, and spike samples, were collected to evaluate the quality of sampling data. Data are available for years 1970 through 1987; however, a standard set of summarized data parameters are not available. (Refs. 12-25).

4. Total Exposure Assessment Methodology Study (TEAM Study) . The TEAM Study was designed to develop methods to measure individual total exposure (exposure through air, food, and water) and resulting body burden of toxic and carcinogenic chemicals, and to apply these methods within a probability-based sampling framework to estimate the exposures and body burdens of urban populations in several U.S. cities. The TEAM Study reports the results of eight monitoring studies performed in five communities during different seasons of the year. Breath, personal air, outdoor air, and water samples were collected for 30 VOCs. (Refs. 26-28).

Established methods were used to collect and analyze TEAM Study data. Quality control and quality assurance samples collected and analyzed include reagent blanks, field blanks, duplicate samples, and spiked samples. Data were reported for water using units of measure different than those used for air and breath samples. Environmental and biological data are generally lognormally distributed; thus, the data's central tendency is generally best represented using a geometric mean. Geometric means are provided for all compounds that were measured in 50% or more of the samples. For most of the compounds that were measured in less than 50% of the samples, a minimum quantifiable limit that can be used for ranking the data was provided.

EPA proposes to review the following data sources to determine which HPV/Inert chemicals have been detected in non-human tissues potentially relevant to human ingestion exposure.

1. National Sediment Inventory Fish Tissue Data (NSI Fish Tissue Data) . This database is described in Unit V.B.

2. National Fish Tissue Study . EPA is conducting a screening-level study to estimate the national distribution of selected persistent, bioaccumulative and toxic chemical residues in fish tissue from lakes and reservoirs of the continental United States. This 4-year study will define the national background levels for 265 chemicals in fish, establish a baseline to track the progress of pollution control activities, and identify areas where contaminant levels are high enough to warrant further investigation. The national fish tissue survey is the first survey of fish tissue to be based on a random sampling design. This sampling design will allow EPA to develop national estimates of the mean levels of persistent, bioaccumulative, and toxic chemicals in fish tissue. It will also provide data on the largest set of persistent, bioaccumulative, and toxic chemicals ever studied in fish. More details can be found at: http://www.epa.gov/waterscience/fishstudy/results.htm .

EPA proposes to review the following data sources to determine which HPV/Inert chemicals have been detected in drinking water and in potential sources of drinking water.

1. National Drinking Water Chemical Occurrence Data Base (NCOD Data Base) . This database is described in Unit V.B.

2. National Human Exposure Assessment Survey (NHEXAS) . EPA designed the NHEXAS program to address some of the limitations of single-chemical and single-media exposure route studies. The purpose of NHEXAS is to evaluate comprehensive human exposure to multiple chemicals from multiple routes on both a community and regional scale, as well as its association with environmental concentrations and personal activities. EPA completed Phase 1 field sample collection and laboratory analyses of NHEXAS in 1998. EPA used established methods to collect and analyze NHEXAS data. Quality control and quality assurance samples collected and analyzed include reagent blanks, field blanks, duplicate samples, and spiked samples. Samples were split and analyzed in multiple laboratories; when appropriate audit samples were available, they were also analyzed. Data are reported for different media using different units of measure and different measures of central tendency. For example, arsenic concentrations are reported in micrograms per kilogram (μg/Kg) for beverages and food and in micrograms per liter (μg/L) for water. Sometimes the central tendency value is reported as an arithmetic mean, sometimes as a median, and sometimes as a 90 th percentile. (Refs. 29-32).

3. Total Exposure Assessment Methodology Water Data (TEAM Water Data) . The TEAM Study is described in Unit VI.A.

4. National Stream Quality Accounting Network (NASQAN) Data . This database, which contains information on surface water monitoring studies, is described in Unit V.B.

5. The National Water Quality Assessment Program (NAWQA) . This database, which contains information on surface water and ground water monitoring studies, is described in Unit V.B.

EPA proposes to review the following data sources to determine which HPV/Inert chemicals have been detected in residential indoor air.

1. Office of Research and Development Published Literature . The following eight EPA/ORD-authored journal articles and reports provide indoor air monitoring data: Brown et al. (1994), Daisey et al. (1994), Kelly et al. (1994), Immerman and Schaum. (1990), Samfield (1992), Shah et al. (1988), Sheldon et al. (1992), and Shields et al. (1996). (Refs. 33-40).

2. NHEXAS . The NHEXAS program was designed to evaluate comprehensive human exposure via indoor and outdoor air to multiple chemicals on a community and regional scale. Samples were collected of both the indoor and outdoor air that people breathe. Preliminary results of Phase I of NHEXAS were reported in 15 journal articles published in 1999. Four of these 15 journal articles provided information that is applicable to indoor air monitoring. (Refs. 30-32, 41).

3. Total Exposure Assessment Methodology (TEAM) . The TEAM Study is described in Unit VI.A.

This unit addresses how EPA would integrate the information developed on priorities through the analysis of the four types of exposure monitoring data discussed in Units VI.A through VI.D (human biological data, ecological biological data relevant to human exposure, drinking water data, and indoor air data). As its first step, the Agency would produce four lists of candidate chemicals, one for each type of monitoring data, for potential screening in the endocrine disruptor Tier 1 battery. EPA expects that a number of chemicals will be identified in more than one type of monitoring data and that some chemicals will appear only in a single type of monitoring data. In choosing which HPV/Inert chemicals it would recommend for screening, EPA would give higher priority to chemicals that appeared in multiple types of monitoring data, with the HPV/Inerts appearing in four types receiving the highest priority, three types the next highest priority, etc. To the extent it becomes necessary to establish priorities within these four types of monitoring data, EPA would propose to give greater priority to HPV/Inerts which appear in human biological monitoring data followed by drinking water/indoor air monitoring data (weighted equally), followed by ecological biological monitoring data relevant to human exposure. As a final step, EPA would review the available effects information to identify any chemical for which the information clearly indicates an endocrine-mediated effect/perturbation. Such chemicals would be considered for proposed Tier 2 tests, mechanistic or special studies, or hazard assessment. During this step, EPA also would identify substances that EPA anticipates would have low potential to cause endocrine disruption (e.g., certain FIFRA List 4 inerts, most polymers with number average molecular weight greater than 1,000 daltons, strong mineral acids, and strong mineral bases). EPA would consider excluding substances in either category from the first group of chemicals to undergo Tier 1 testing.

In developing this proposed approach for selecting the first group of chemicals to be screened in the Agency's EDSP, EPA discussed a number of alternative approaches and identified a series of questions to elicit information from the public that would help in the evaluation of alternative approaches. In addition to the specific questions in this unit, EPA invites comment on additional alternative approaches.

1. Focusing on the subset of chemicals subject to a statutory mandate for screening . EPA is intending to focus only on pesticide active ingredients and HPV chemicals with some pesticidal inert uses (i.e., the chemicals that are specifically mandated for testing under section 408(p) of FFDCA) as candidates for the first group of chemicals to be screened. The pesticide inerts to be considered are those with relatively large overall production volumes considering both pesticide and non-pesticide uses. This approach will allow EPA to focus its initial endocrine screening efforts on a smaller and more manageable universe of chemicals that emphasizes early attention to the pesticide chemicals that Congress specifically mandated EPA to test for possible endocrine effects. Please comment on this proposed decision.

2. Limited use of effects information . Because the amount and type of toxicological data available to identify or characterize endocrine-related human health or ecological effects is not considered by the Agency to be adequate to support determinations of the endocrine disruption potential of most pesticide chemicals, EPA has proposed an approach that would use effects information only to exclude certain chemicals from the first group of chemicals to undergo Tier 1 screening. The approach would exclude from the first group of chemicals to undergo Tier 1 screening any chemical for which the available effects information is determined by EPA to clearly shows an endocrine-mediated effect. Such chemicals would be considered for proposed Tier 2 tests, mechanistic or special studies, or hazard assessment. Similarly, the approach for this initial list also would exclude substances that EPA anticipates have low potential to cause endocrine disruption (e.g., certain FIFRA List 4 inerts, most polymers with number average molecular weight greater than 1,000 daltons, strong mineral acids, and strong mineral bases). Please comment on this proposed decision and comment on the types of studies/data which could be evaluated by the Agency to aid in making exclusion decisions.

3. Focus on human exposure; no separate criteria pertaining to exposure of ecological receptors . While EPA's general focus in this approach is on pesticide active ingredients and HPV/Inerts with relatively greater potential for human exposure, this focus does not necessarily mean that the list developed using this approach will not contain substances which have potentially high levels of environmental exposure to ecological receptors. EPA believes that the proposed approach, while focused on human exposure, will also identify many chemicals with widespread environmental exposures to other organisms. If EPA should consider such exposures separately, please identify databases and criteria appropriate for setting priorities.

4. Deferring consideration of nominations from the public . For the initial Tier 1 screening list, EPA proposes to focus on pesticide active ingredients and HPV chemicals with some pesticidal inert uses. EPA believes that nominations from the public are important because they provide a mechanism to identify chemicals which may result in high exposures in local communities but which would not otherwise receive national attention. However, EPA has decided to defer consideration of nominations from the public until subsequent testing lists are proposed by EPA to keep this initial effort administratively simpler and ensure that a set of test results can be obtained in a relatively prompt timeline to aid the Agency in a mid-course evaluation of the EDSP Tier 1 screening battery. Please comment on this proposed decision.

5. Defer testing of mixtures . EPA believes that experience with the Tier 1 tests on a variety of single chemicals needs to be attained before the tests are used with mixtures. Therefore, EPA is proposing to defer consideration of testing of mixtures until subsequent testing lists are proposed by EPA. This judgement is consistent with advice from the SAB/SAP Subcommittee. Please comment on this proposed decision.

6. Excluding chemicals that are no longer produced or used in the United States . EPA also is proposing to exclude from the initial Tier 1 screening list any chemicals that are no longer produced or used in the United States. The Agency thinks that the added administrative complexity of determining who should be responsible for testing such chemicals could unnecessarily delay EPA's selection of an initial list for Tier 1 screening. Please comment on this proposed decision.

7. Number of chemicals to be selected for the initial testing list . The SAB/SAP Joint Subcommittee which reviewed EPA's proposed EDSP in 1999 felt that developing massive amounts of screening data on a large universe of chemicals would not necessarily expedite the development of the appropriate underpinning that the Agency needs to broaden this effort. The Subcommittee also expressed concern that it did not see a provision that would allow for mid-course correction or optimization of the Program. Thus, the Subcommittee recommended that EPA should initiate the Tier 1 testing program with a set of 50 to 100 chemicals and then convene an external panel of independent scientists to review the screening data for the purpose of evaluating whether the Tier 1 screening program could be improved or optimized, and if so, how. EPA is proposing to adopt this SAB/SAP recommendation. Please comment on this proposed decision.

8. Integration of lists generated by the pesticide active ingredient approach and the pesticide inert approach . As discussed in Unit IV, EPA is proposing to use similar but somewhat different sets of criteria for identifying pesticide active ingredients and inerts that should be given priority for screening in the Tier 1 battery. EPA generally has more extensive information of known quality available to assess usage and potential exposure to pesticide active ingredients than is available to assess exposure to HPV/Inert chemicals. Thus, the databases available to evaluate potential human exposure of the two classes also differ. EPA has not yet decided on the method to use to select the initial list of chemicals for screening from the separate lists that will be generated by the proposed approaches for pesticide active ingredients and HPV/Inert chemicals. Several alternative methods are being considered including the following. After looking at the separate lists, once they are generated, there may be natural break points. For example, if the top category for pesticide active ingredients (i.e., those chemicals which appear on lists for each of the four pathways) yields 60 actives and the top category for HPV/Inert chemicals (i.e., those chemicals which appear on lists for each of the three pathways and in human biomonitoring samples) yields 30, the Agency may select these 90 chemicals. Another approach being considered is a simple ratio approach. Because there are approximately an equal number of pesticide actives as HPV/Inerts, one way to produce a combined list would be to select approximately 50% of the chemicals from the active list and 50% from the HPV/Inert chemicals list. Please comment on these and other approaches that EPA could use to integrate the lists.

1. The Agency considered approaches that did not focus on the four separate pathways of human exposure. Please comment on the following issues.

i. The advantages and disadvantages of setting priorities based on the overall extent of pesticide use, for example total pounds applied or total acres treated.

ii. Should all four pathways be considered? If not, please comment on which pathways should and should not be included.

2. Within separate pathways, EPA considered a variety of alternative approaches. Please comment on the following issues.

i. Food pathway. Would ranking pesticides by the extent of use on the top 20 crops be appropriate, given that it would be simpler and more quantitative than the approach proposed in this Notice?

ii. Water pathway. With regards to the proposed databases, should other databases be included, and should any be dropped?

iii. Residential use pathway. Should any additional criteria be used to set priorities within the universe of active ingredients with residential uses? For example, should EPA give higher or lower priority to particular use patterns because they are consistently likely to lead to greater or lesser levels of human exposure? Are there databases that could provide information on the extent of residential use of pesticides that would support setting priorities within this group?

iv. Occupational pathway. Are there criteria that would recognize how the differences in rate and timing of application of a pesticide or its environmental fate properties might affect levels of post-application exposure? Also, please comment on whether EPA should employ criteria to set priorities for active ingredients based on their levels of exposure for mixers, loaders, and applicators. If EPA should consider such exposure in setting priorities for the occupational pathway, please identify databases and criteria appropriate for setting priorities. Also, please comment on whether EPA should consider criteria for the occupational pathway that employs data from reports on the incidence of adverse effects among workers, such as data collected by the California's Pesticide Illness Surveillance Program (PISP) (see, for example, the PISP report for 2000, http://www.cdpr.ca.gov/docs/dprdocs/pisp/2000pisp.htm ) or the National Institute of Occupational Safety and Health's Sentinel Event Notification System for Occupational Risk (see http://www.cdc.gov/niosh/pestsurv/default.html ).

3. EPA's proposed approach to setting its overall priority for pesticide active ingredients that combines the analysis for each of the four pathways generally gives each pathway equal weight. Alternative approaches are also possible. Please comment on the following issues.

i. Should a different approach be used to integrate the information from the four different pathways, for example by assigning different weights to the pathways?

ii. Should there be any limit on the number of active ingredients included on the list for a single pathway?

iii. Should any factors other than the pathway lists and the hazard-based considerations be included in the integrative step?

iv. Should EPA attempt to explicitly consider magnitude of the environmental concentrations of chemicals in this approach and, if so, how?

1. EPA's proposed approach for setting screening priorities for pesticide inert ingredients that are also HPV chemicals uses four types of monitoring data. These are human biomonitoring data, ecological biomonitoring data relevant to human exposure, water monitoring data and indoor air monitoring data. Please comment on the following issues.

i. Should the selection of priority HPV/Inert chemicals be based upon all four types of monitoring data? If not, please comment on which type of monitoring data should and should not be included.

ii. Should other types of exposure information be used instead of or in addition to monitoring data?

2. Within the four separate types of monitoring data, EPA identified and selected sources of monitoring data for use in priority setting for HPV/Inert chemicals. Please comment on the following issues.

i. The appropriateness of the data sources identified in this proposed approach.

ii. For human biological monitoring data, are there additional sources of data that EPA should consider?

iii. For ecological biological monitoring data relevant to human exposure, are there additional sources of data that EPA should consider?

iv. For water monitoring data, are there additional sources of data that EPA should consider?

v. For indoor air monitoring data, are there additional sources of data that EPA should consider?

3. EPA's proposed approach to setting its priorities for HPV/Inert chemicals combines the analysis for each of the four types of monitoring data and generally gives each type of monitoring data equal weight. However, if necessary to establish priorities within these four types of monitoring data, higher weight would be assigned to human biomonitoring data than to the other three types of monitoring data. Alternative approaches are also possible. Please comment on the following issues.

i. Should a different approach be used to integrate the information from the four different types of monitoring data, for example by assigning different weights initially to all types of monitoring data?

ii. Should there be any limit on the number of HPV/Inert chemicals included on the list for a single type of monitoring data?

iii. Should any factors other than the lists of HPV/Inert chemicals found in the four types of monitoring data and the hazard-based considerations be included in the integrative step?

The Agency's actions are supported by the references listed in this unit and cited in this notice. These references are available in the public record for this notice under docket ID number OPPT-2002-0066. (See Unit I.B. for information on how to access this docket).

1. EPA, Science Advisory Board. Review of EPA's Proposed Environmental Endocrine Disruptor Screening Program. July 1999. EPA-SAB-EC-99-013. Available at: http://www.epa.gov/science1/pdf/ec13.pdf .

2. EPA. Endocrine Disruptor Screening and Testing Advisory Committee Final Report. August 1998. Available at: http://www.epa.gov/scipoly/oscpendo/history/finalrpt.htm .

3. EPA. Evaluation of SAR Predictions of Estrogen Receptor Binding Affinity. EPA Contract No. 68-W-01-023, Work Assignment No. 2-3, Battelle Memorial Institute. August 1, 2002.

4. EPA. EPA Pesticides in Ground Water Database, A Compilation of Monitoring Studies: 1971-1991 National Summary, EPA 734-12-92-001. September 1992.

5. USGS. Pesticides in Select Water Supply Reservoirs and Finished Drinking Water, 1999-2000: Summary of Results from a Pilot Monitoring Program. 2001. USGS Open File Report 01-456.

6. EPA. The Incorporation of Water Treatment Effects on Pesticide Removal and Transformation in Food Quality Protection Act Drinking Water Assessments. November 21, 2001. Available at: http://www.epa.gov/pesticides/trac/science/#drinking .

7. EPA. Estimating the Drinking Water Component of a Dietary Exposure Assessment. Revised November 2, 1999. Available at: http://www.epa.gov/pesticides/trac/science/#drinking .

8. EPA. EPA Background Paper for the FIFRA Scientific Advisory Panel Meeting on Monitoring Strategies for Pesticides in Surface-Derived Drinking Water. June 2002. Available at: http://www.epa.gov/scipoly/sap/2000/june/drinkingwatersurvey.pdf .

9. EPA. Science Advisory Council on Exposure, Policy Number 003.1, Agricultural Transfer Coefficients.

10. Ashley, David L.; Bonin, Michael A.; Cardinall, Frederick L.; McCraw, Joan M.; and Wootan, Joe V. Blood Concentrations of Volatile Organic Compounds (VOCs) in a Nonoccupationally Exposed U.S. Population and in Groups with Suspected Exposure. Clinical Chemistry (1994) 40: 1401-1404.

11. CDC. National Report on Human Exposure to Environmental Chemicals. March 2001. http://www.cdc.gov/nceh/dls/report/reportsummary.htm .

12. EPA. Chlorinated Dioxins and Furans in the General U.S. Population: NHATS FY87 Results—Executive Summary. EPA-560/5-91-003. May 1991.

13. Cramer, Paul H.; Stanley, John S.; Bauer, Karin; Ayling, Randy E.; Thornburg, Kelly R.; and Schwemberger, John. Brominated Dioxins and Furans in Human Adipose Tissue: Final Report. EPA-560/5-90-005 (NTIS PB91-103507). April 11, 1990.

14. Cramer, Paul H.; Stanley, John S.; and Thornburg, Kelly R. Mass Spectral Confirmation of Chlorinated and Brominated Diphenylethers in Human Adipose Tissues: Final Report. EPA-560/5-90-012 (NTIS PB91-159699). June 15, 1990.

15. Mack, Gregory A. and Mohadjer, Leyla. Baseline Estimates and Time Trends for Beta-benzene hexachloride, Hexachlorobenzene, and Polychlorinated Biphenyls in Human Adipose Tissue 1970-1983. EPA-560/5-85-025. September 30, 1985.

16. Onstot, J.D.; Ayling, R.E.; and Stanley, J.S. Characterization of HRGC/MS Unidentified Peaks from the Analysis of Human Adipose Tissue: Volume I—Technical Approach. EPA-560/5-87-002A (NTIS PB88-100367). May 1987.

17. Onstot, J.D.; Ayling, R.E.; and Stanley, J.S. Characterization of HRGC/MS Unidentified Peaks from the Analysis of Human Adipose Tissue: Volume II —Appendices. EPA-560/5-87-002B (NTIS PB88-100375). May 1987.

18. Onstot, J.D. and Stanley, J.S. Identification of SARA Compounds in Adipose Tissue. EPA-260/5-89-003 (NTIS PB90-132564). August 1989.

19. Orban, John E.; Stanley, John S.; Schwemberger, John G.; and Remmers, Janet C. Dioxins and Dibenzofurans in Adipose Tissue of the General US Population and Selected Subpopulations. American Journal of Public Health . (1994) 84: 439-445.

20. EPA. Semivolatile Organic Compounds in the General U.S. Population: NHATS FY86 Results—Volume I. EPA-747-R-94-001. July 1994.

21. Stanley, John S. Broad Scan Analysis of the FY82 National Human Adipose Tissue Survey Specimens: Volume I—Executive Summary. EPA-560/5-86-035 (NTIS PB87-177218). December 1986.

22. Stanley, John S. Broad Scan Analysis of the FY82 National Human Adipose Tissue Survey Specimens: Volume II—Volatile Organic Compounds. EPA-560/5-86-036 (NTIS PB87-177226). December 1986.

23. Stanley, John S. Broad Scan Analysis of Human Adipose Tissue: Volume III—Semivolatile Organic Compounds: Final Report. EPA-560/5-86-037 (NTIS PB87-180519). December 1986.

24. Stanley, John S. Broad Scan Analysis of Human Adipose Tissue: Volume IV— Polychlorinated Dibenzo-p-Dioxins (PCDDs) and Polychlorinated Dibenzofurans (PCDFs): Final Report. EPA-560/5-86-038 (NTIS PB87-177234). December 1986.

25. Stanley, John S. and Stockton, Rodney A. Broad Scan Analysis of the FY82 National Human Adipose Tissue Survey Specimens: Volume V—Trace Elements. EPA-560/5-86-039 (NTIS PB87-180527). December 1986.

26. EPA. The Total Exposure Assessment Methodology (TEAM) Study: Elizabeth and Bayonne, New Jersey, Devils Lake, North Dakota, and Greensboro, North Carolina: Volume II. Part 2. EPA-600/6-87/002b (NTIS PB88-100078). June 1987.

27. EPA. The Total Exposure Assessment Methodology (TEAM) Study: Selected Communities in Northern and Southern California: Volume III. EPA-600/6-87/002c (NTIS PB88-00086). June 1987.

28. Wallace, Lance. Project Summary: The Total Exposure Assessment Methodology (TEAM) Study. EPA/600/S6-87/002. September 1987.

29. Thomas, Kent W.; Pelizzari, Edo D.; and Berry, Maurice R. Population-based dietary intakes and tap water concentrations for selected elements in EPA Region V National Human Exposure Assessment Survey (NHEXAS). Journal of Exposure Analysis and Environmental Epidemiology . (1999) 9: 402-413.

30. Clayton, C.A.; Pellizzari, E.D.; Whitmore, R.W.; Perritt, R.L.; and J.J. Quackenboss. National Human Exposure Assessment Survey (NHEXAS): distributions and associations of lead, arsenic and volatile organic compounds in EPA Region 5. Journal of Exposure Analysis and Environmental Epidemiology . (1999) 9: 381-392.

31. O'Rourke, Mary Kay; Van de Water, Peter K.; Jin, Shan; Rogan, Seumas P.; Weiss, Aaron D.; Gordon, Sydney M.; Moschandreas, Demetrios M.; and Lebowitz, Michael D. Evaluations of primary metals from NHEXAS Arizona: distributions and preliminary exposures. Journal of Exposure Analysis and Environmental Epidemiology . (1999) 9: 435-445.

32. Robertson, Gary L.; Lebowitz, Michael D.; O'Rourke, Mary Kay; Gordon, Sydney; and Moschandreas, Demetrios. The National Human Exposure Assessment Survey (NHEXAS) study in Arizona—introduction and preliminary results. Journal of Exposure Analysis and Environmental Epidemiology . (1999) 9: 427-434.

33. Brown, S.K.; Sim, M.R.; Abramson, M.J.; and Gray, C.N. Concentrations of Volatile Organic Compounds in Indoor Air—A Review. Indoor Air . (1994) 4: 123-124.

34. Daisey, J.M.; Hodgson, A.T.; Fisk, W.J.; Mendell, M.J.; and Brinke, J. Ten. Volatile Organic Compounds In Twelve California Office Buildings: Classes, Concentrations and Sources. Atmospheric Environment . (1994) 28: 3557-3562.

35. Kelly, Thomas J.; Mukund, R.; Spicer, Chester W.; and Pollack, Albert J. Concentrations and Transformations of Hazardous Air Pollutants. Environmental Science and Technology . (1994) 28: 378A-387A.

36. Immerman, Frederick W. and Schaum, John L. Final Report of the Nonoccupational Pesticide Exposure Study (NOPES). EPA/600/3-90/003 (NTIS PB90-152224). January 1990.

37. Samfield, Max M. Indoor Air Quality Data Base for Organic Compounds. EPA-600-R-92-025 (NTIS PB92-158468). February 1992.

38. Shah, Jitendra J. and Singh, Hanwant B. Distribution of Volatile Organic Chemicals in Outdoor and Indoor Air. A National VOCs Data Base. Environmental Science and Technology . (1988) 22: 1381-1388.

39. Sheldon, L.; Clayton, A.; Jones, B.; Keever, J.; Perritt, R.; Smith, D.; Whitaker, D.; and Whitmore, R. Indoor Pollutant Concentrations and Exposures: Final Report. California Air Resources Board, Contract A833-156. January 1992.

40. Shields, Helen C.; Fleischer, Daniel M.; and Weschler, Charles J. Comparisons among VOCs Measured in Three Types of U.S. Commercial Buildings with Different Occupant Densities. Indoor Air . (1996) 6: 2-17.

41. Gordon, Sydney M.; Callahan, Patrick J.; Nishioka, Marcia G.; Brinkman, Marielle C.; O'Rourke, Mary Kay; Lebowitz, Michael D.; and Moschandreas, Demetrios J. Residential Environmental Measurements in the National Human Exposure Assessment Survey (NHEXAS) Pilot Study in Arizona: Preliminary Results for Pesticides and VOCs. Journal of Exposure Analysis and Environmental Epidemiology . (1999) 9: 546-470.

This notice is not subject to review by the Office of Management and Budget (OMB) under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Nevertheless, OMB participated in an interagency review of this notice and any comments or suggestions received during that review, have been addressed.

Since this notice does not impose any requirements, and instead seeks comments and suggestions for the Agency to consider in developing its approach for selecting the first group of chemicals to be screened in the Agency's EDSP, the various other review requirements that apply when an agency imposes requirements do not apply to this notice. As a part of your comments on this document, however, you may include any comments or information that would facilitate the Agency's consideration of approaches for selecting the first group of chemicals to be screened in the Agency's EDSP, including but not limited to potential impacts on small entities covered by the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq .), the availability of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note), and potential paperwork burden and costs, as well as any suggested methods for minimizing respondent burden, including through the use of automated collection techniques, related to the collection of this information as described by the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq .). The Agency will consider such comments during the development of the approach and will take appropriate steps to address any applicable requirements.

Arizona's application was described in the Federal Register (67 FR 49916) on August 1, 2002, in which EPA requested comments. Notice of Arizona's application was published in the Arizona Republic on August 13, 2002. A public hearing on the application was held on September 4, 2002, in Phoenix, AZ.

Section 402 (c)(1) of the CWA provides that ninety days after a State has submitted an application to administer the NPDES program, EPA's authority to issue such permits is suspended unless EPA disapproves or approves the State's application. 40 CFR 123.21(b)(1). This ninety day statutory review period ended on October 8, 2002. However, because of the many complex issues that were raised with respect to the State's program and the need to address them in a comprehensive manner, EPA was unable to make a final decision by October 8, 2002. Thus, EPA suspended issuance of NPDES permits in Arizona on October 8, 2002. However, failure to make a decision by the October 8, 2002 deadline did not mean that the State automatically gained NPDES authority. It is EPA's interpretation that a State agency does not gain NPDES authority unless and until EPA approves the State program, consistent with CWA section 402(b) and 40 CFR 123.1. As of December 5, 2002, the ADEQ is now authorized to issue AZPDES permits under the CWA in all areas within the State, except for in Indian country.

The AZPDES program is a partial program which conforms to the requirements of section 402(n)(3) of the CWA. Specifically, Arizona is being approved to administer both the NPDES permit program covering point source dischargers to State waters and the pretreatment program covering industrial sources discharging to publicly owned treatment works.

Pursuant to CWA section 402(d), in specified circumstances EPA retains the right to object to AZPDES permits proposed by ADEQ, and if the objections are not resolved, to issue the permits itself. EPA also will retain jurisdiction over all NPDES permits it has issued in Arizona until ADEQ reissues them as AZPDES permits. Finally, EPA and State have agreed that EPA may retain permitting authority in certain limited circumstances, as set forth in the Memorandum of Agreement between EPA and ADEQ.

As part of operating the approved program, ADEQ generally will have the lead responsibility for enforcement. However, EPA will retains its full statutory enforcement authorities under CWA sections 308, 309, 402(i) and 504. Thus, EPA may continue to bring federal enforcement action under the CWA in response to any violation of the CWA, as appropriate. In particular, if EPA determines that the State has not taken timely and/or appropriate enforcement action against a violator in Arizona, EPA may take its own enforcement action.

The EPA received numerous public comments concerning the Arizona program.

Several commenters urged the EPA to approve the State's program. The EPA agrees that the State program should be approved at this time outside Indian country.

Several commenters were concerned about impacts on endangered species and historic properties associated with EPA's approval of the AZPDES program. In addition, a few commenters urged that the EPA reject Arizona's program application on a variety of grounds.

All public comments are addressed in EPA's Response to Comments Document, dated December 5, 2002. In addition, EPA actions taken in accordance with the requirements of the Endangered Species Act and the National Historic Preservation Act are described below in Section C.

Section 7(a)(2) of the Endangered Species Act (ESA), 16 U.S.C. 1536(a)(2), requires that federal agencies ensure, in consultation with the United States Fish & Wildlife Service (FWS) that actions they authorize, fund, or carry out are not likely to jeopardize the continued existence of listed threatened or endangered species (listed species) or result in the destruction or adverse modification of critical habitat designated for such listed species.

EPA consulted with the FWS under section 7(a)(2) of the ESA regarding the effects of the AZPDES program approval on listed species and designated critical habitat. On December 3, 2002, the Service issued a biological opinion concluding that EPA's approval of Arizona's NPDES application is not likely to jeopardize the continued existence of listed threatened or endangered species or result in the destruction or adverse modification of their critical habitat. In the opinion, the FWS also stated that it does not anticipate that EPA's action will result in the incidental take of listed species. Issuance of the biological opinion with these findings concludes the consultation process required by ESA section 7(a)(2) and reflects the Service's agreement with EPA that the approval of the State program meets the substantive requirements of the ESA.

Section 106 of the National Historic Preservation Act (NHPA), 16 U.S.C. 470(f), requires Federal agencies to take into account the effects of their undertakings on historic properties and to provide the Advisory Council on Historic Preservation (ACHP) an opportunity to comment on such undertakings. Under the ACHP's regulations (36 CFR part 800), the Agency consults with the appropriate State Historic Preservation Officer (SHPO) and/or Tribal Historic Preservation Officer on federal undertakings that have the potential to affect historic properties listed or eligible for listing in the National Register of Historic Places. During EPA's review of the Arizona NPDES application, EPA engaged in discussions with the Arizona SHPO regarding EPA's determination that approval of the State permitting program would have no effect on historic properties.

On August 23, 2002, EPA provided the Arizona SHPO's Office with EPA's determination that approval of Arizona's application would have no effect on historic properties in Arizona. As part of the coordination process, the SHPO's Office raised certain issues regarding approval of the Arizona program for further discussions. By letter dated September 23, 2002, the SHPO withdrew these issues for consideration and informed EPA that it was working with ADEQ to coordinate its activities in the protection of Arizona's cultural resources. On October 18, 2002, the SHPO and ADEQ entered into a Memorandum of Understanding (MOU) assuring the SHPO that it would receive notices of certain proposed permit actions. This MOU further provides for coordination between ADEQ and the SHPO to resolve any identified issues to ensure that AZPDES permits will comply with Arizona water quality standards and Arizona laws protecting historic properties. For those permits with the potential to adversely affect historic properties, ADEQ and the SHPO agreed to seek ways to avoid, minimize or mitigate any adverse effects to historic properties stemming from the proposed permit. EPA believes that the agreement between ADEQ and the SHPO is consistent with EPA's determination that approval of the State permitting program would have no effect on historic properties.

Based on General Counsel Opinion 78-7 (April 18, 1978), EPA has long considered a determination to approve or deny a State NPDES program submission to constitute an adjudication because an “approval,” within the meaning of the APA, constitutes a “license,” which, in turn, is the product of an “adjudication.” For this reason, the statutes and Executive Orders that apply to rulemaking action are not applicable here. Among these are provisions of the Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq. Under the RFA, whenever a Federal agency proposes or promulgates a rule under section 553 of the Administrative Procedure Act (APA), after being required by that section or any other law to publish a general notice of proposed rulemaking, the Agency must prepare a regulatory flexibility analysis for the rule, unless the Agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. If the Agency does not certify the rule, the regulatory flexibility analysis must describe and assess the impact of a rule on small entities affected by the rule. Even if the NPDES program approval were a rule subject to the RFA, the Agency would certify that approval of the State's proposed AZPDES program would not have a significant economic impact on a substantial number of small entities. EPA's action to approve an NPDES program merely recognizes that the necessary elements of an NPDES program have already been enacted as a matter of State law; it would, therefore, impose no additional obligations upon those subject to the State's program. Accordingly, the Regional Administrator would certify that this program, even if a rule, would not have a significant economic impact on a substantial number of small entities.

I hereby provide public notice that EPA has taken final action authorizing Arizona to implement the NPDES program in all areas of the State except for Indian Country.

All interested parties are invited to submit written comments on this determination and may request a public hearing. All comments will be considered, and, if necessary, EPA will issue a response. Frivolous or insubstantial requests for a hearing may be denied by the Regional Administrator. However, if a substantial request for a public hearing is made by January 29, 2003, a public hearing will be held. A request for public hearing shall include the following: (1) The name, address, and telephone number of the individual, organization, or other entity requesting a hearing; (2) a brief statement of the requesting person's interest in the Regional Administrator's determination and of information that the requesting person intends to submit at such a hearing; and (3) the signature of the individual making the request; or, if the request is made on behalf of an organization or other entity, the signature of a responsible official of the organization or other entity.

The notice of a major disaster declaration for the Territory of Guam is hereby amended to include Individual Assistance for The Territory of Guam determined to have been adversely affected by the catastrophe declared a major disaster by the President in his declaration of December 8, 2002:

The notice of a major disaster declaration for the State of North Carolina is hereby amended to include the following areas among those areas determined to have been adversely affected by the catastrophe declared a major disaster by the President in his declaration of December 12, 2002:

Notice is hereby given that, in a letter dated December 12, 2002, the President declared a major disaster under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5206 (the Stafford Act), as follows:

Notice is hereby given that pursuant to the authority vested in the Director of the Federal Emergency Management Agency under Executive Order 12148, I hereby appoint Michael Bolch of the Federal Emergency Management Agency to act as the Federal Coordinating Officer for this declared disaster.

I do hereby determine the following areas of the State of North Carolina to have been affected adversely by this declared major disaster:

Notice is hereby given that, in a letter dated December 11, 2002, the President declared a major disaster under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5206 (the Stafford Act), as follows:

Notice is hereby given that pursuant to the authority vested in the Director of the Federal Emergency Management Agency under Executive Order 12148, I hereby appoint David Fukutomi of the Federal Emergency Management Agency to act as the Federal Coordinating Officer for this declared disaster.

I do hereby determine the following area of the Commonwealth of the Northern Mariana Islands to have been affected adversely by this declared major disaster:

All areas within the Commonwealth of the Northern Mariana Islands are eligible to apply for assistance under the Hazard Mitigation Grant Program.

The notice of a major disaster declaration for the State of Ohio is hereby amended to include the following areas among those areas determined to have been adversely affected by the catastrophe declared a major disaster by the President in his declaration of November 18, 2002:

The notice of a major disaster declaration for the State of Texas is hereby amended to include the following area among those areas determined to have been adversely affected by the catastrophe declared a major disaster by the President in his declaration of November 5, 2002:

Walker County for Individual Assistance.

The role and functions of the FRPCC are described in 44 CFR 351.10(a) and 351.11(a). The Agenda for the upcoming FRPCC meeting is expected to include: (1) Introductions, (2) reports from FRPCC subcommittees, (3) old and new business, and (4) business from the floor.

The meeting is open to the public, subject to the availability of space. Reasonable provision will be made, if time permits, for oral statements from the public of not more than five minutes in length. Any member of the public who wishes to make an oral statement at the January 28, 2003, FRPCC meeting should request time, in writing, from W. Craig Conklin, FRPCC Chair, FEMA, 500 C Street, SW., Washington, DC 20472. The request should be received at least five business days before the meeting. Any member of the public who wishes to file a written statement with the FRPCC should mail the statement to: Federal Radiological Preparedness Coordinating Committee, c/o Pat Tenorio, FEMA, 500 C Street, SW., Washington, DC 20472.

Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Under section 903(d)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 393(d)(2)), the Commissioner of Food and Drugs is authorized to implement general powers (including conducting research) to carry out effectively FDA's mission. Section 510 of the act (21 U.S.C. 360) requires that domestic establishments engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of medical devices intended for human use and commercial distribution register their establishments and list the devices they manufacture with FDA. Section 522 of the act (21 U.S.C. 360(l)) authorizes FDA to require manufacturers to conduct postmarket surveillance of medical devices. Section 705(b) of the act (21 U.S.C. 375(b)) authorizes FDA to collect and disseminate information regarding medical products or cosmetics in situations involving imminent danger to health, or gross deception of the consumer. These sections of the act enable FDA to enhance consumer protection from risks associated with medical devices usage that are not foreseen or apparent during the premarket notification and review process.

Subsequent to the events of September 11, 2001, FDA began planning for handling device-related issues related to counter-terrorism. One of the activities related to planning for addressing terrorism-related medical device shortages is that FDA, working with medical experts and medical device industry organizations, developed a medical device formulary that identifies which medical devices would be needed in responding to terrorist incidents. The National Pharmaceutical Stockpile Program managed by the Centers for Disease Control (CDC) appears to have not given adequate consideration to medical devices. Therefore, FDA has developed a plan to ensure adequate availability of medical devices in case of terrorist incidents.

Most particularly, consumable supplies or disposable devices are supplied through large regional distributors. Adequate supplies should be available through these existing commercial supply chains. Problems in supplying these items will be due to logistics. In an emergency, FDA plans to ensure adequate availability of these types of devices by working with industry/distributor organizations. These organizations have actively pursued working relationships with appropriate government agencies to facilitate adequate response in emergency situations.

However, there are more sophisticated or specialized devices, for example, ventilators, defibrillators, portable x-ray machines, that are sold directly by the manufacturer, that are not through independent distributors. For these devices, FDA plans to maintain a database of device manufacturers so that specific contact information can be supplied to Emergency Response personnel as needed. FDA has identified 17 of these devices and has identified 205 manufacturers.

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

FDA has based these estimates on conversations with industry and trade association representatives, and from internal FDA experience and estimates.

The total number of medical device manufacturers regulated by FDA is estimated to be 70,000. Because most of the medical devices which might be needed in a terrorist attack are available through regular commercial channels, FDA focused this collection of information on the 250 manufacturers who manufacture 17 medical devices. Therefore, FDA estimates that approximately 150 manufacturers would be contacted in a 1-year period. It is also estimated from FDA experience that the survey will take approximately 20 to 30 minutes to complete over the telephone.

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

The regulations in § 12.45 (21 CFR 12.45), issued under section 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371), sets forth the format and procedures for any interested person to file a petition to participate in a formal evidentiary hearing, either personally or through a representative. Section 12.45 requires that any person filing a notice of participation state their specific interest in the proceedings, including the specific issues of fact about which the person desires to be heard. Section 12.45 also requires that the notice include a statement that the person will present testimony at the hearing and will comply with specific requirements in 21 CFR 12.85, or in the case of a hearing before a Public Board of Inquiry (21 CFR 13.25), concerning disclosure of data and information by participants. In accordance with § 12.45(e), the presiding officer may omit a participant's appearance. The presiding officer and other participants will use the collected information in a hearing to identify specific interests to be presented. This preliminary information serves to expedite the prehearing conference and commits participation. The respondents are individuals or households, State or local governments, not-for-profit institutions, and businesses or other for-profit groups and institutions.

In the Federal Register of July 18, 2002 (67 FR 47387), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received.

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

The agency bases this estimate on past notices filed in which each notice of participation took an estimated 3 hours to complete.

In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. FDA has participated in many meetings designed to enhance harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies.

ICH was organized to provide an opportunity for tripartite harmonization initiatives to be developed with input from both regulatory and industry representatives. FDA also seeks input from consumer representatives and others. ICH is concerned with harmonization of technical requirements for the registration of pharmaceutical products among three regions: The European Union, Japan, and the United States. The six ICH sponsors are the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; the Centers for Drug Evaluation and Research and Biologics Evaluation and Research, FDA; and the Pharmaceutical Research and Manufacturers of America. The ICH Secretariat, which coordinates the preparation of documentation, is provided by the International Federation of Pharmaceutical Manufacturers Associations (IFPMA).

The ICH Steering Committee includes representatives from each of the ICH sponsors and the IFPMA, as well as observers from the World Health Organization, Health Canada's Health Products and Food Branch, and the European Free Trade Area.

In accordance with FDA's good guidance practices (GGPs) regulation (21 CFR 10.115), this document is being called a guidance, rather than a guideline.

To facilitate the process of making ICH guidances available to the public, the agency has changed its procedure for publishing ICH guidances. As of April 2000, we no longer include the text of ICH guidances in the Federal Register . Instead, we publish a notice in the Federal Register announcing the availability of an ICH guidance. The ICH guidance will be placed in the docket and can be obtained through regular agency sources (see ADDRESSES ). Draft guidances are left in the original ICH format. The final guidance is reformatted to conform to the GGP style before publication.

In October 2001, FDA made available the ICH guidance M4 CTD, which describes a harmonized format for new product applications (including applications for biotechnology-derived products) for submission to the regulatory authorities in the three ICH regions. The M4 CTD guidance was made available in four parts as follows: (1) A description of the organization of the M4 CTD; (2) the Quality section; (3) the Safety, or nonclinical, section; and (4) the Efficacy, or clinical, section.

In September 2002, the ICH Steering Committee agreed that a draft guidance entitled “Common Technical Document—Quality: Questions and Answers/Location Issues” should be made available for public comment. The draft guidance is the product of the CTD-Quality Implementation Working Group of the ICH. Comments about this draft will be considered by FDA and the CTD-Quality Implementation Working Group.

The draft guidance provides further clarification for preparing the quality components of an application in the CTD-Quality format. The draft guidance addresses the relationship between linked sections for certain parameters, such as polymorphism and particle size. The draft guidance also addresses location issues by indicating the section in which to place requested information. The draft guidance is intended to ease the preparation of paper and electronic submissions, facilitate regulatory reviews, and simplify the exchange of regulatory information among regulatory authorities.

This draft guidance, when finalized, will represent the agency's current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

Interested persons may submit to the Dockets Management Branch (see ADDRESSES ) written or electronic comments on the draft guidance. Two copies of any mailed 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. The draft guidance and received comments may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

Persons with access to the Internet may obtain the document at http://www.fda.gov/ohrms/dockets/default.htm , http://www.fda.gov/cder/guidance/index.htm , or http://www.fda.gov/cber/publications.htm .

In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products approved under an ANDA procedure. ANDA sponsors must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the “listed drug,” which is a version of the drug that was previously approved under a new drug application (NDA). Sponsors of ANDAs do not have to repeat the extensive clinical testing otherwise necessary to gain approval of an NDA. The only clinical data required in an ANDA are data to show that the drug that is the subject of the ANDA is bioequivalent to the listed drug.

The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is generally known as the “Orange Book.” Under FDA regulations, drugs are withdrawn from the list if the agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (§ 314.162) (21 CFR 314.162)). Under § 314.161(a)(1) (21 CFR 314.161(a)(1)), the agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness before an ANDA that refers to that listed drug may be approved. FDA may not approve an ANDA that does not refer to a listed drug.

Diazepam Autoinjector is the subject of NDA 20-124. Diazepam Autoinjector is an automatic injection drug product indicated for the management of anxiety disorders and the treatment of epileptic and other convulsive seizures. FDA approved NDA 20-124, held by the U.S. Army (Army), on December 5, 1990. The Diazepam Autoinjector is manufactured for the Army by Meridian Medical Technologies, Inc. (MMT), and has always been listed in the “Discontinued Drug Product List” of the Orange Book because it is not commercially available.

On November 30, 2001, MMT submitted a citizen petition (Docket No. 01P-0542/CP1) under 21 CFR 10.30 requesting that the agency determine whether Diazepam Autoinjector was withdrawn from sale for reasons of safety or effectiveness.

The agency has determined that Diazepam Autoinjector was not withdrawn from sale for reasons of safety or effectiveness. The Army has never commercially marketed Diazepam Autoinjector. In previous instances (see, e.g., 61 FR 25497, May 21, 1996 (addressing a relisting request for glyburide tablets)), FDA has concluded that, for purposes of §§ 314.161 and 314.162, never marketing an approved drug product is equivalent to withdrawing the drug from sale. There is no indication that the Army's decision not to market Diazepam Autoinjector commercially is a function of safety or effectiveness concerns, and the petitioner has identified no data or other information suggesting that Diazepam Autoinjector poses a safety risk. FDA's independent evaluation of relevant information has uncovered nothing that would indicate this product was withdrawn for reasons of safety or effectiveness.

After considering the citizen petition and reviewing agency records, FDA has determined that, for the reasons outlined previously, Diazepam Autoinjector was not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the agency will continue to list Diazepam Autoinjector (diazepam for injection) 5 mg/mL in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to Diazepam Autoinjector (diazepam for injection) 5 mg/mL may be approved by the agency.

The Department is submitting the proposed information collection to OMB for review, as required by the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35, as amended).

This Notice is soliciting comments from members of the public and affected agencies concerning the proposed collection of information to: (1) Evaluate whether the proposed collection is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond; including the use of appropriate automated collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

Title of Proposal: Home Mortgage Disclosure Act (HMDA) Loan/Application Register.

OMB Control Number, if applicable: 2502-0539.

Description of the need for the information and proposed use: The HMDA Loan/Application Register collects information from mortgage lenders on application for, and originations and purchases of, mortgage and home improvement loans. Non-depository mortgage lending institutions are required to use the information generated as a running log throughout the calendar year, and send the information to HUD by March 1 of the following calendar year.

Agency form numbers, if applicable: FR HMDA-LAR.

Estimation of the total numbers of hours needed to prepare the information collection including number of respondents, frequency of response, and hours of response: The estimated total number of hours needed to prepare the information collection is 177,777; the number of respondents is 1,800 generating approximately 1,800 annual responses; the frequency of response is on occasion and annually; and the estimated time needed to prepare the response varies from 10 hours to 15,000 hours with an average of 98.75 hours.

Status of the proposed information collection: Extension of a currently approved collection.

The Department is submitting the proposed information collection to OMB for review, as required by the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35, as amended).

This Notice is soliciting comments from members of the public and affected agencies concerning the proposed collection of information to: (1) Evaluate whether the proposed collection is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information; (3) enhance the quality, utility, and clarity of the information to be collected; and (4) minimize the burden of the collection of information on those who are to respond; including the use of appropriate automated collection techniques or other forms of information technology, e.g. , permitting electronic submission of responses.

Title of Proposal: Request for Acceptance of Changes in Approved Drawings and specifications.

OMB Control Number, if applicable: 2502-0117.

Description of the need for the information and proposed use: Builders who request changes to HUD's accepted drawings and specifications for proposed construction properties as required by homebuyers, or determined by the builder use the information collection. The lender reviews the changes and amends the approved exhibits. These changes may affect the value shown on the HUD commitment. HUD requires the builder to use form HUD-92577 to request changes for proposed construction properties. HUD's collection of this information is for the purpose of ascertaining that HUD does not insure a mortgage on property that poses a risk to health or safety of the occupant.

Agency form numbers, if applicable: HUD-92577.

Estimation of the total numbers of hours needed to prepare the information collection including number of respondents, frequency of response, and hours of response: The estimated total number of hours needed to prepare the information collection is 5,000; the number of respondents is 10,000 generating approximately 10,000 annual responses; the frequency of response is on occasion; and the estimated time needed to prepare the response is 30 minutes.

Status of the proposed information collection: Reinstatement, without change, of a previously approved collection for which approval has expired.

The Department has submitted the proposal for the collection of information, as described below, to OMB for review, as required by the Paperwork Reduction Act (44 U.S.C. Chapter 35). The Notice lists the following information: (1) The title of the information collection proposal; (2) the office of the agency to collect the information; (3) the OMB approval number, if applicable; (4) the description of the need for the information and its proposed use; (5) the agency form number, if applicable; (6) what members of the public will be affected by the proposal; (7) how frequently information submissions will be required; (8) an estimate of the total number of hours needed to prepare the information submission including number of respondents, frequency of response, and hours of response; (9) whether the proposal is new, an extension, reinstatement, or revision of an information collection requirement; and (10) the name and telephone number of an agency official familiar with the proposal and of the OMB Desk Officer for the Department.

Title of Proposal: Hispanic-Serving Institutions Assisting Communities.

OMB Approval Number: 2528-0198.

Form Numbers: HUD-424, HUD-424-B, HUD-424-C, HUD-2880, HUD-2990, HUD-2991, HUD-2992, HUD-2993, HUD-2994, HUD-3004, HUD-50070, HUD-50071, and Standard Form-LLL.

Description of the Need for the Information and its Proposed use: Grants to assist Hispanic-serving institutions expand their role and effectiveness in addressing community development needs in their localities, including neighborhood revitalization.

Respondents: Individuals or households, Not-for-profit institutions.

Frequency of Submission: On occasion, Semi-annually, Other once per application.

Total Estimated Burden Hours: 4,160.

Status: Extension of a currently approved collection.

The Department has submitted the proposal for the collection of information, as described below, to OMB for review, as required by the Paperwork Reduction Act (44 U.S.C. Chapter 35). The Notice lists the following information: (1) The title of the information collection proposal; (2) the office of the agency to collect the information; (3) the OMB approval number, if applicable; (4) the description of the need for the information and its proposed use; (5) the agency form number, if applicable; (6) what members of the public will be affected by the proposal; (7) how frequently information submissions will be required; (8) an estimate of the total number of hours needed to prepare the information submission including number of respondents, frequency of response, and hours of response; (9) whether the proposal is new, an extension, reinstatement, or revision of an information collection requirement; and (10) the name and telephone number of an agency official familiar with the proposal and of the OMB Desk Officer for the Department.

Title of Proposal: Repayments Agreement.

OMB Approval Number: 2502-0483.

Form Numbers: HUD-56146.

Description of the Need for the Information and its Proposed use: Once a Debt Servicing Representative has a clear understanding of the debtor's attitude about repayment, and the debtor's ability to repay the debt; attempts should be made to secure a signed repayment agreement.

Respondents: On occasion, Annually.

Frequency of Submission: Individuals or households.

Reporting Burden:

Total Estimated Burden Hours: 250.

Status: Extension of a currently approved collection.

The Department has submitted the proposal for the collection of information, as described below, to OMB for review, as required by the Paperwork Reduction Act (44 U.S.C. Chapter 35). The Notice lists the following information: (1) The title of the information collection proposal; (2) the office of the agency to collect the information; (3) the OMB approval number, if applicable; (4) the description of the need for the information and its proposed use; (5) the agency form number, if applicable; (6) what members of the public will be affected by the proposal; (7) how frequently information submissions will be required; (8) an estimate of the total number of hours needed to prepare the information submission including number of respondents, frequency of response, and hours of response; (9) whether the proposal is new, an extension, reinstatement, or revision of an information collection requirement; and (10) the name and telephone number of an agency official familiar with the proposal and of the OMB Desk Officer for the Department.

Title of Proposal: Housing Agency Calculation of Occupancy. Percentage for Requested Budget Year PHA-Owned Rental Housing, Performance Funding System.

OMB Approval Number: 2577-0066.

Form Numbers: HUD-52728.

Description of the Need for the Information and its Proposed use:

Housing Agencies provide information developing an appropriate and justifiable projection of occupancy for the requested budget year. The project occupancy percentage that is developed will be used as one element in the calculation of operating subsidy under the Performance Funding System.

Respondents: State, Local or Tribal Government.

Frequency of Submission: Annually.

Reporting Burden:

Total Estimated Burden Hours: 41,385.

Status: Extension of a currently approved collection.

The Department has submitted the proposal for the collection of information, as described below, to OMB for review, as required by the Paperwork Reduction Act (44 U.S.C. Chapter 35). The Notice lists the following information: (1) The title of the information collection proposal; (2) the office of the agency to collect the information; (3) the OMB approval number, if applicable; (4) the description of the need for the information and its proposed use; (5) the agency form number, if applicable; (6) what members of the public will be affected by the proposal; (7) how frequently information submissions will be required; (8) an estimate of the total number of hours needed to prepare the information submission including number of respondents, frequency of response, and hours of response; (9) whether the proposal is new, an extension, reinstatement, or revision of an information collection requirement; and (10) the name and telephone number of an agency official familiar with the proposal and of the OMB Desk Officer for the Department.

Title of Proposal: Public Housing Homeownership Program.

OMB Approval Number: 2577-0233.

Form Numbers: None.

Description of the Need for the Information and its Proposed use: Under the Public Housing Homeownership Program, Public Housing Agencies (PHAs) make available public housing dwelling units; public housing projects, and other housing projects available for purchase by low-income families for use as principal residences by such families. Families who are interested in purchasing a unit must submit applications to the PHA or purchase and resale entities (PREs). A PRE must prepare and submit to the PHA and HUD a homeownership program before the PRE may purchase any public housing units or projects. The PRE must demonstrate legal and practical capability to carry out the program, provide a written agreement that specifies the respective rights and obligations of the PHA and the PRE. The PHA must develop a homeownership program and obtain HUD approval before it can be implemented, provide supporting documentation and additional supporting documentation for acquisition of nonpublic housing for homeownership. PHA applications can be submitted electronically via the Internet. PHAs will be required to maintain report annually on the public homeownership program.

Respondents: Local and State Governments; individuals and households.

Frequency of Submission: Annually and on occasion.

Total Estimated Burden Hours: 9,720.

Status: Extension of a currently approved collection.

HUD invites all interested parties to attend a one-day meeting to discuss a set of model documents developed to facilitate the preparation and review of certain evidentiary materials required for mixed-finance transactions pursuant to 24 CFR part 941 subpart F. The model documents may be viewed at http:www.hud.gov/offices/pih/programs/ph/hope6/mfph/mf_modeldocs.cfm. The meeting will be held on Tuesday, January 7, 2003, 9 am-4:30 pm, at Marriott Metro Center, 775 12th Street NW., Washington DC. A panel of HUD staff will conduct this meeting to provide participants an opportunity to present comments and ask questions about the documents. In advance of the meeting, HUD welcomes and encourages written comments on the documents.

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

These information collections are necessary to assess the need for tribally controlled community college programs as required by 25 CFR part 41 and Public Law 95-471. A 60-day request for public comments on this information collection was published in the Federal Register on Wednesday, August 28, 2002 (67 FR 55271). No comments were received. Copies of the collection of information may be obtained by contacting the Bureau's clearance officer at 202-208-2574.

Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of the burden (hours and cost) of the collection of information, including the validity of the methodology and assumptions used; (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 the information on the respondents, including through the use of automated collection techniques or other forms of information technology.

If you wish your name or address withheld from public review of comments, you must state this prominently at the beginning of your comments. We will honor your request as allowed by law.

The Office of Management and Budget (OMB) has up to 60 days to approve or disapprove the information collection but may respond after 30 days; therefore, comments submitted in response to this notice should be submitted to OMB within 30 days in order to assure their maximum consideration.

All comments received are subject to public inspection. If you wish to have your name and address withheld from the public, you must state this prominently at the beginning of your comment. The requested information to be withheld will be honored to the extent of the law.

Title: Grants Application for Community Colleges Form.

OMB approval number: 1076-0018.

Frequency: Annually.

Description of respondents: Tribal Boards, Tribal College Administrators.

Estimated completion time: 1 hour.

Annual responses: 25.

Annual Burden hours: 25 hours.

Title: Grants, Tribal Colleges and Universities Annual Report Form.

OMB approval number: 1076-0105.

Frequency: Annually.

Description of respondents: Tribal Boards, Tribal College Administrators.

Estimated completion time: 3 hours.

Annual responses: 25.

Annual Burden hours: 75 hours.

The workshop, through its keynote addresses, theme presentations, working groups and networking will share worldwide pipeline operating knowledge and identify what critical pipeline issues still need to be addressed. The workshop will be 2.5 days in duration and structured to allow maximum interface among industry experts and general attendees to discuss major issues that affect the offshore pipeline industry worldwide. This will be accomplished by breaking out the attendees into various Working Groups to facilitate parallel discussions of all major industry issues. Working groups will be further broken down into sub-groups to maximize the coverage of major issues. This will allow individual attendees ample opportunity to provide their input and insights to actively participate in workgroup discussion. Participation will include international pipeline interest from the following: Government Agencies, Oil and Gas Industry, Consulting Firms, Construction Contractors, Fabrication Contractors, Manufacturers, Academic and Research Institutions, Other Related Entities.