Title: Certificate for Quota Eligibility.

OMB Number: 0551-0014.

Expiration Date of Approval: February 29, 2004.

Abstract: The Harmonized Tariff Schedule of the United States (HTS) authorizes the Secretary of Agriculture to establish the quantity of raw cane sugar, which may be entered at the TRQ duty rates. The terms under which Certificates for Quota Eligibility (CQEs) will be issued to foreign countries that have been allocated a share of the TRQ are set forth in 15 CFR part 2011, Subpart A, Allocation of Tariff-rate Quota on Imported Sugars, Syrups, and Molasses. The authority for issuing CQEs is Additional U.S. Note 5(b)(iv) to chapter 17 of the HTS. The regulation, promulgated by the United States Trade Representative, provides for the issuance of CQEs by the Secretary of Agriculture, and in general prohibits sugar subject to the TRQ from being imported into the United States or withdrawn from a warehouse for consumption at the TRQ duty rates unless such sugar is accompanied by a CQE. CQEs are issued to foreign countries by the Director of the Import Policies and Programs Division, Foreign Agricultural Service, or his or her designee. The issuance of CQEs is in such amounts and at such times as the Director determines are appropriates to enable the foreign country to fill its quota allocation for such quota period in a reasonable manner, taking into account traditional shipping patterns, harvesting period, U.S. import requirements, and other relevant factors.

The information required to be collected on the CQE is used to monitor and control the imports of raw cane sugar. Proper completion of the CQE is mandatory for those foreign governments that are eligible and elect to export raw cane sugar to the United States under the TRQ.

Estimate of burden: The public reporting burden for the collection varies in direct relation to the number of CQEs issued.

Respondents: Foreign governments.

Estimated number of respondents: 40 (i.e., number of countries receiving a TRQ allocation).

Estimated number of responses per respondent: 30 per fiscal year.

Estimated total annual reporting burden: 200 hours.

Request for Comments: Send comments regarding: (a) Whether the information collection 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 of the collection of information 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 use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Copies of this information collection may be obtained from Kimberly Chisley, the Agency Information Collection Coordinator, at (202) 720-2568.

Comments may be sent to Richard Blabey, the Import Policies and Programs Division, Stop 1021, Foreign Agricultural Service, U.S. Department of Agriculture, 1400 Independence Ave., SW., Washington, DC 20250-1021, or Richard.Blabey@fas.usda.gov, or to the Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget, Washington, DC 20503. Persons with disabilities who require an alternative means of communication of information (Braille, large print, audiotape, etc.) should contact USDA's Target Center at (202) 720-2600 (voice and TDD). 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.

FAS is committed to complying with the Government Paperwork Elimination Act which requires Government agencies, to the maximum extent feasible, to provide the public with the option of electronically submitting an information collection. CQEs permit exporters to ship raw cane sugar to the United States at the U.S. price, which is significantly higher than the world price for raw cane sugar. Therefore, in contrast to most information collection documents, CQEs have a monetary value equivalent to the substantial profits to exporters who can fill their raw cane sugar allocations under the TRQ. CQEs have always been carefully handled as secure documents, and issued only to foreign government-approved certifying authorities. The Department does not plan to make CQEs available electronically in order to prevent a potential proliferation of invalid CQEs, which could undermine the integrity of the TRQ system.

Upon investigation, the Administrator determined that increased imports of frozen salmon fillets contributed importantly to a decline in the landed prices of salmon in Alaska and Washington by 34.6 and 32.6 percent, respectively, during January 2002 through December 2002, when compared with the previous 5-year average.

Producers certified as eligible for TAA may apply to the Farm Service Agency for benefits anytime prior to the application deadline of January 20, 2004. After submitting completed applications, producers shall receive technical assistance provided by the Extension Service at no cost and an adjustment assistance payment, if certain program criteria are met.

Producers of raw agricultural commodities wishing to learn more about TAA and how they may apply should contact the Department of Agriculture at the addresses provided below for General Information.

Producers Certified as Eligible for TAA, Contact: Local Farm Service Agency service center.

For General Information About TAA, Contact: Jean-Louis Pajot, Coordinator, Trade Adjustment Assistance for Farmers, FAS, USDA, (202) 720-2916. email: trade.adjustment@fas.usda.gov.

Upon investigation, the Administrator determined that increasing imports of wild blueberries contributed importantly to a decline in domestic producer prices of 33 percent during July 2002 through June 2003, when compared with the previous 5-year average.

Producers certified as eligible for TAA may apply to the Farm Service Agency county office for benefits anytime prior to the application deadline of January 20, 2004. After submitting completed applications, producers shall receive technical assistance provided by the Extension Service at no cost and an adjustment assistance payment, if certain program criteria are met.

Producers of raw agricultural commodities wishing to learn more about TAA and how they may apply should contact the Department of Agriculture at the addresses provided below for General Information.

Producers Certified as Eligible for TAA Contact: Local Farm Service Agency service center.

For General Information About TAA Contact: Jean-Louis Pajot, Coordinator, Trade Adjustment Assistance for Farmers, FAS, USDA, (202) 720-2916, e-mail: trade.adjustment@fas.usda.gov.

On February 4, 2000, the Department published an antidumping order on creatine monohydrate from the People's Republic of China (“PRC”). See Notice of Antidumping Duty Order: Creatine Monohydrate from the People's Republic of China, 65 FR 5583 (February 4, 2000). On February 3, 2003, the Department published in the Federal Register an Antidumping or Countervailing Duty Order, Finding, or Suspended Investigation; Opportunity to Request Administrative Review, 68 FR 5272 (February 3, 2003).

On February 28, 2003, in accordance with 19 CFR 351.213(b), a manufacturer/exporter of the subject merchandise, Suzhou Sanjian Nutrient & Health Products Co., Ltd. (“Sanjian”), requested that the Department conduct an administrative review of this order. On March 25, 2003, we published a notice of initiation of this review. See Initiation of Antidumping and Countervailing Duty Administrative Reviews and Requests for Revocations in Part, 68 FR 14394 (March 25, 2003). The period of this review (“POR”) is February 1, 2002, through January 31, 2003.

On April 14, 2003, we issued an antidumping questionnaire to Sanjian. We issued a supplemental questionnaire on July 18, 2003. We received responses to the original and supplemental questionnaires on May 21 and August 1, 2003, respectively.

Imports covered by this review are creatine monohydrate, which is commonly referred to as “creatine.” The chemical name for creatine monohydrate is N-(aminoiminomethyl)-N-methylgycine monohydrate. The Chemical Abstracts Service (“CAS”) registry number for this product is 6020-87-7. Creatine monohydrate in its pure form is a white, tasteless, odorless powder, that is a naturally occurring metabolite found in muscle tissue. Creatine monohydrate is provided for in subheading 2925.20.90 of the Harmonized Tariff Schedule of the United States (“HTSUS”). Although the HTSUS subheading and the CAS registry number are provided for convenience and customs purposes, the written description of the merchandise under review is dispositive.

The Department has treated the PRC as a nonmarket economy (“NME”) country in all previous antidumping cases. See, e.g., Notice of Final Determination of Sales at Less than Fair Value: Refined Brown Aluminum Oxide (Otherwise known as Refined Brown Artificial Corundum or Brown Fused Alumina) from the People's Republic of China, 68 FR 55589 (September 26, 2003). It is the Department's standard policy to assign all exporters of the merchandise subject to review in NME countries a single rate unless an exporter can demonstrate an absence of government control, both in law (de jure) and in fact (de facto), with respect to exports. To establish whether an exporter is sufficiently independent of government control to be entitled to a separate rate, the Department analyzes the exporter in light of the criteria established in the Final Determination of Sales at Less Than Fair Value: Sparklers from the People's Republic of China, 56 FR 20588 (May 6, 1991) (“ Sparklers ”), as amplified in the Final Determination of Sales at Less Than Fair Value: Silicon Carbide from the People's Republic of China, 59 FR 22585 (May 2, 1994) (“ Silicon Carbide ”). In this review, the sole respondent, Sanjian, is a PRC company; therefore, a separate rates analysis is necessary to determine whether its export activities are independent of government control.

Evidence supporting, though not requiring, a finding of de jure absence of government control over export activities includes: (1) An absence of restrictive stipulations associated with an individual exporter's business and export licenses; (2) any legislative enactments decentralizing control of companies; and (3) any other formal measures by the government decentralizing control of companies. See Sparklers, 56 FR at 20589.

A de facto analysis of absence of government control over exports is based on four factors—whether the respondent: (1) Sets its own export prices independent of the government and other exporters; (2) retains the proceeds from its export sales and makes independent decisions regarding the disposition of profits or financing of losses; (3) has the authority to negotiate and sign contracts and other agreements; and (4) has autonomy from the government regarding the selection of management. See Silicon Carbide, 59 FR at 22587; see also Notice of Final Determination of Sales at Less Than Fair Value: Furfuryl Alcohol from the People's Republic of China, 60 FR 22544, 22545 (May 8, 1995) (“ Furfuryl Alcohol ”).

In the Notice of Final Determination of Sales at Less Than Fair Value: Creatine Monohydrate from the People's Republic of China, 64 FR 71104, 71105 (December 20, 1999) (“ LTFV Investigation ”), we determined that there was de jure and de facto absence of government control of Suzhou Sanjian Fine Chemical Co. Ltd.”s (“Suzhou Chemical”) export activities and determined that Suzhou Chemical warranted a company-specific dumping margin. On April 18, 2003, we determined that Sanjian was the successor-in-interest to Suzhou Chemical. See Creatine Monohydrate from the People's Republic of China: Final Results of Changed Circumstances Review, 68 FR 19189 (April 18, 2003) (“ Changed Circumstances Review ”). For the POR, Sanjian responded to the Department's request for information regarding separate rates. We have found that the evidence on the record is consistent with the final determination in the LTFV Investigation and the Changed Circumstances Review, and Sanjian continues to demonstrate an absence of government control, both in law and in fact, with respect to its exports, in accordance with the criteria identified in Sparklers, Silicon Carbide, and Furfuryl Alcohol.

For U.S. sales made by Sanjian, we calculated export price (“EP”), in accordance with section 772(a) of the Tariff Act of 1930, as amended (“the Act”), because the subject merchandise was sold to unaffiliated purchasers in the United States prior to importation into the United States and the facts did not otherwise warrant use of constructed export price.

We calculated EP based on the price to unaffiliated purchasers in the United States. In accordance with section 772(c) of the Act, as appropriate, we deducted from the starting price foreign inland freight, international freight, marine insurance, U.S. inland freight, U.S. customs duties, and other U.S. transportation expenses. We valued the deductions for foreign inland freight using surrogate data based on Indian freight costs. We selected India as the surrogate country for the reasons explained in the “ Normal Value ” section of this notice, below. Because the respondent used a market-economy shipper for more than an insignificant portion of its sales and paid for the shipping in a market-economy currency, we used the average price paid by that respondent to the market economy shipper to value international freight for all of its sales. See the “Factors of Production Valuation Memorandum” dated October 31, 2003 (“ FOP memo ”); See also Tapered Roller Bearings and Parts Thereof, Finished and Unfinished, from the People's Republic of China; Preliminary Results of 2000-2001 Administrative Review, Partial Rescission of Review, and Notice of Intent to Revoke Order, in Part, 67 FR 45451, 45453 (July 9, 2002).

Section 773(c)(1) of the Act provides that the Department shall determine the normal value (“NV”) using a factors-of-production methodology if: (1) The merchandise is exported from an NME country; and (2) the information does not permit the calculation of NV using home-market prices, third-country prices, or constructed value (“CV”) under section 773(a) of the Act.

As discussed in the separate rates section, the Department considers the PRC to be an NME country. The Department has treated the PRC as an NME country in all previous antidumping proceedings. Furthermore, available information does not permit the calculation of NV using home-market prices, third-country prices, or CV under section 773(a) of the Act. In accordance with section 771(18)(C)(i) of the Act, any determination that a foreign country is an NME country shall remain in effect until revoked by the administering authority. We have no evidence suggesting that this determination should be changed. Therefore, we treated the PRC as an NME country for purposes of this review and calculated NV by valuing the factors of production in a surrogate country.

Section 773(c)(4) of the Act requires the Department to value the NME producer's factors of production, to the extent possible, in one or more market economy countries that: (1) Are at a level of economic development comparable to that of the NME, and (2) are significant producers of comparable merchandise. The Department has determined that India, Pakistan, Indonesia, Sri Lanka, and the Philippines are countries comparable to the PRC in terms of overall economic development ( see Memorandum from Jeff May, Director, Office of Policy, to Blanche Ziv, Import Compliance Specialist, Group 1, April 10, 2003). Although we have no information to indicate that India produces creatine, it does produce other products within the same customs heading, and it produces other fine chemicals with nutritional characteristics. We have therefore determined that India is a significant producer of comparable merchandise. Accordingly, we have calculated NV using Indian values for the PRC producer's factors of production.

We have obtained and relied upon publicly available information, wherever possible. In many instances, we used the Monthly Statistics of the Foreign Trade of India; Volume II Imports (“ MSFTI ” ) to value factors of production, energy inputs and packing materials. Consistent with the Final Determination of Sales at Less than Fair Value: Certain Automotive Replacement Glass Windshields From the People's Republic of China, 67 FR 6482 (February 12, 2002) and accompanying Issues and Decision Memorandum at Comment 1, we excluded import data reported in the MSFTI for Korea, Thailand and Indonesia in our surrogate value calculations. In addition to the MSFTI data, we used Indian domestic prices from Indian Chemical Weekly (“ ICW ”) to value certain chemical inputs. See the FOP memo.

In accordance with section 773(c) of the Act, we calculated NV based on factors of production reported by Sanjian during the POR. To calculate NV, the reported unit factor quantities were multiplied by publicly available Indian surrogate values.

In selecting the surrogate values, we considered the quality, specificity, and contemporaneity of the data. As appropriate, we adjusted input prices to make them delivered prices. For the distances reported, we added to Indian CIF surrogate values a surrogate freight cost using the reported distances from the PRC port to the PRC factory, or from the domestic supplier to the factory. This adjustment is in accordance with the United States Court of Appeals for the Federal Circuit's (“CAFC”) decision in Sigma Corp. v. United States, 117 F. 3d 1401, 1407-1408 (Fed.Cir. 1997). For those values not contemporaneous with the POR, we adjusted for inflation using the appropriate wholesale or producer price index published in the International Monetary Fund's International Financial Statistics.

Sanjian reported that it purchased a portion of one its inputs, cyanamide, from a market economy supplier. Because we found that the amount of cyanamide purchased was insignificant, we did not use the price paid by Sanjian for this input, and instead used import values from the MSFTI. For further information, see the FOP memo.

Labor: We valued labor using the method described in 19 CFR 351.408(c)(3).

Electricity and Coal: Consistent with our approach in Manganese Metal from the People's Republic of China; Final Results of Antidumping Duty Administrative Review, 66 FR 15076 (March 15, 2001) (“ Manganese Metal ”), we calculated the surrogate value for electricity based on electricity rate data reported by the International Energy Agency (“ IEA ”), 4th quarter 2001. For coal, we used import values from the MSFTI.

Factory Overhead, Selling, General and Administrative Expenses (“SG&A”), and Profit: We based our calculation of factory overhead, SG&A, and profit on the 2002 financial statements of a producer of comparable merchandise, Riddhi Siddhi Gluco Boils Ltd. (“RSGB”), an Indian starch and dextrine producer.

Inland Freight Rates: To value truck freight rates, we used an average of trucking rates quoted in ICW.

Packing Materials: For packing materials we used import values from the MSFTI. For a complete analysis of surrogate values, see the FOP memo.

We preliminarily find the weighted average dumping margin for Sanjian for the period February 1, 2002, through January 31, 2003, to be zero percent.

Any interested party may request a hearing within 30 days of publication of this notice. See 19 CFR 351.310(c). Any hearing, if requested, will be held approximately 44 days after the date of publication of this notice, or the first working day thereafter. Interested parties may submit case briefs and/or written comments no later than 30 days after the date of publication of this notice. Rebuttal briefs and rebuttals to written comments, which must be limited to issues raised in such briefs or comments, may be filed not later than 37 days after the date of publication. Parties who submit arguments are requested to submit with the argument (1) a statement of the issue, (2) a brief summary of the argument, and (3) a table of authorities. The Department will issue a notice of final results of this administrative review, including the results of its analysis of issues raised in any such written comments, within 120 days of publication of these preliminary results.

Pursuant to 19 CFR 351.212(b), the Department calculates an assessment rate for each importer of the subject merchandise. Upon issuance of the final results of this administrative review, if any importer-specific assessment rates calculated in the final results are above de minimis ( i.e., at or above 0.5 percent), the Department will issue appraisement instructions directly to the CBP to assess antidumping duties on appropriate entries by applying the assessment rate to the entered value of the merchandise. For assessment purposes, we calculate importer-specific assessment rates for the subject merchandise by aggregating the dumping duties due for all U.S. sales to each importer and dividing the amount by the total entered value of the sales to that importer.

The following cash deposit requirements will be effective upon publication of the final results of this administrative review for all shipments of creatine entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided for by section 751(a)(1) of the Act: (1) The cash deposit rate for Sanjian will be the rate established in the final results of this administrative review; (2) for a company previously found to be entitled to a separate rate and for which no review was requested, the cash deposit rate will be the rate established in the most recent review of that company; (3) the cash deposit rate for all other PRC exporters will be 153.70 percent, the PRC-wide rate established in the LTFV investigation; and (4) the cash deposit rate for a non-PRC exporter of subject merchandise from the PRC will be the rate applicable to the PRC exporter that supplied that exporter. These cash requirements, when imposed, shall remain in effect until publication of the final results of the next administrative review.

This notice also serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.

We are issuing and publishing this determination in accordance with sections 751(a)(1) and 777(i)(1) of the Act.

On February 10, 2000, the Department published in the Federal Register the antidumping duty order on steel plate from Korea. See Notice of Amendment of Final Determinations of Sales at Less Than Fair Value and Antidumping Duty Orders: Certain Cut-To-Length Carbon-Quality Steel Plate Products From France, India, Indonesia, Italy, Japan and the Republic of Korea, 65 FR 6585 (February 10, 2000) ( Amended Final Determination and Order ). On February 3, 2003, the Department published a notice of “Opportunity to Request Administrative Review” of the antidumping duty order on steel plate from Korea. See Antidumping or Countervailing Duty Order, Finding, or Suspended Investigation; Opportunity to Request Administrative Review, 68 FR 5272 (February 3, 2003). On February 27, 2003, Nucor Corporation, a domestic producer, requested an administrative review of Dongkuk Steel Mill Co., Ltd. (DSM), Korea Iron & Steel Co., Ltd. (KISCO), Pohang Iron & Steel Co., Ltd. (Pohang) and Union Steel Manufacturing Co., Ltd. (Union) for the POR February 1, 2002, through January 31, 2003. Also, on February 27, 2003, IPSCO Steel, one of the petitioning firms in the steel plate investigations, requested an administrative review of DSM this review. On March 18, 2003, the Department initiated an administrative review of DSM, KISCO, and Union. See Initiation of Antidumping and Countervailing Duty Administrative Reviews and Requests for Revocation in Part, 68 FR 14394 (March 25, 2003). The Department did not initiate an administrative review of Pohang because Pohang is excluded from the antidumping order on steel plate from Korea. See Amended Final Determination and Order.

On April 10, 2003, the Department issued antidumping questionnaires to DSM, KISCO and Union. The Department received a letter from KISCO on June 6, 2003, in which it stated that it had shut down its steel plate mill in early 1998 and, thus, had no shipments of subject merchandise during the POR. In March and April 2003, Union reported that it did not produce the subject merchandise and had no shipments of subject merchandise during the POR. DSM responded to the Department's questionnaire responses in May and June 2003. The Department issued supplemental questionnaires to DSM in May, June, July, August, and September of 2003, and received responses from DSM in June, July, August, and September of 2003.

The products covered by the antidumping duty order are certain hot-rolled carbon-quality steel: (1) Universal mill plates ( i.e., flat-rolled products rolled on four faces or in a closed box pass, of a width exceeding 150 mm but not exceeding 1250 mm, and of a nominal or actual thickness of not less than 4 mm, which are cut-to-length (not in coils) and without patterns in relief), of iron or non-alloy-quality steel; and (2) flat-rolled products, hot-rolled, of a nominal or actual thickness of 4.75 mm or more and of a width which exceeds 150 mm and measures at least twice the thickness, and which are cut-to-length (not in coils). Steel products to be included in the scope of the order are of rectangular, square, circular or other shape and of rectangular or non-rectangular cross-section where such non-rectangular cross-section is achieved subsequent to the rolling process ( i.e., products which have been “worked after rolling”)—for example, products which have been beveled or rounded at the edges. Steel products that meet the noted physical characteristics that are painted, varnished or coated with plastic or other non-metallic substances are included within this scope. Also, specifically included in the scope of the order are high strength, low alloy (HSLA) steels. HSLA steels are recognized as steels with micro-alloying levels of elements such as chromium, copper, niobium, titanium, vanadium, and molybdenum. Steel products to be included in this scope, regardless of Harmonized Tariff Schedule of the United States (HTSUS) definitions, are products in which: (1) Iron predominates, by weight, over each of the other contained elements, (2) the carbon content is two percent or less, by weight, and (3) none of the elements listed below is equal to or exceeds the quantity, by weight, respectively indicated: 1.80 percent of manganese, or 1.50 percent of silicon, or 1.00 percent of copper, or 0.50 percent of aluminum, or 1.25 percent of chromium, or 0.30 percent of cobalt, or 0.40 percent of lead, or 1.25 percent of nickel, or 0.30 percent of tungsten, or 0.10 percent of molybdenum, or 0.10 percent of niobium, or 0.41 percent of titanium, or 0.15 percent of vanadium, or 0.15 percent zirconium. All products that meet the written physical description, and in which the chemistry quantities do not equal or exceed any one of the levels listed above, are within the scope of the order unless otherwise specifically excluded. The following products are specifically excluded from the order: (1) Products clad, plated, or coated with metal, whether or not painted, varnished or coated with plastic or other non-metallic substances; (2) SAE grades (formerly AISI grades) of series 2300 and above; (3) products made to ASTM A710 and A736 or their proprietary equivalents; (4) abrasion-resistant steels ( i.e., USS AR 400, USS AR 500); (5) products made to ASTM A202, A225, A514 grade S, A517 grade S, or their proprietary equivalents; (6) ball bearing steels; (7) tool steels; and (8) silicon manganese steel or silicon electric steel. The merchandise subject to the order is classified in the HTSUS under subheadings: 7208.40.3030, 7208.40.3060, 7208.51.0030, 7208.51.0045, 7208.51.0060, 7208.52.0000, 7208.53.0000, 7208.90.0000, 7210.70.3000, 7210.90.9000, 7211.13.0000, 7211.14.0030, 7211.14.0045, 7211.90.0000, 7212.40.1000, 7212.40.5000, 7212.50.0000, 7225.40.3050, 7225.40.7000, 7225.50.6000, 7225.99.0090, 7226.91.5000, 7226.91.7000, 7226.91.8000, 7226.99.0000. Although the HTSUS subheadings are provided for convenience and CBP purposes, the written description of the merchandise covered by the order is dispositive.

The POR is February 1, 2002 through January 31, 2003.

We are preliminarily rescinding this review, in part, with respect to KISCO and Union because they reported that they made no shipments of subject merchandise during the POR. The Department reviewed CBP data, which supports the claims that these companies did not export subject merchandise during the POR.

Section 751(a)(4) of the Tariff Act of 1930, as amended (the Act), provides for the Department, if requested, to determine during an administrative review initiated two or four years after the publication of the order, whether antidumping duties have been absorbed by a foreign producer or exporter, if the subject merchandise is sold in the United States through an affiliated importer. Nucor Corporation requested that the Department make a duty absorption determination with respect to each respondent. Because the instant review was not initiated two or four years after publication of the order, the Department will not make a duty absorption determination in this review.

During the POR, DSM sold subject merchandise to Dongkuk Industries Co., Ltd. (DKI), a Korean trading company, which, in turn, resold the merchandise to Dongkuk International, Inc. (DKA), a U.S. importer that is affiliated with DSM. The Department has preliminarily determined that DSM and DKI are under the common control of a family grouping. According to section 771(33)(F) of the Act, “{t}wo or more persons directly or indirectly controlling, controlled by, or under common control with, any person” shall be considered to be affiliated. Thus we have preliminarily found DSM and DKI to be affiliated parties. For a complete discussion of this issue see the memorandum from the Team to Thomas F. Futtner, Acting Office Director, concerning Affiliation Analysis for Dongkuk Steel Mill Company, Ltd., dated concurrently with this notice.

The Department notes that merchandise subject to this review is subject to duties imposed under section 201 of the Act (section 201 duties). Because the Department has not previously addressed the appropriateness of deducting section 201 duties from export price and constructed export price (CEP), on September 9, 2003, the Department published a request for public comments on this issue (68 FR 53104). All comments were due on October 9, 2003. Rebuttal comments are due by November 7, 2003. See 68 FR 60079 (October 21, 2003). Since the Department has not made a determination on this issue at this time, for purposes of these preliminary results, no adjustment has been made.

To determine whether the respondent's sales of steel plate from Korea to the United States were made at less than normal value (NV), we compared the CEP to the NV, as described in the “Constructed Export Price” and “Normal Value” sections of this notice, below. We first attempted to compare contemporaneous U.S. and comparison-market sales of products that are identical with respect to the following characteristics: paint, quality, grade, heat treatment, thickness, width, patterns in relief and descaling. Where we were unable to compare sales of identical merchandise, we compared U.S. sales to contemporaneous comparison-market sales of the most similar merchandise based on the above characteristics, which are listed in order of importance for matching purposes.

In calculating U.S. price, the Department used CEP, as defined in section 772(b) of the Act, because the merchandise was sold, after importation, by DSM's U.S. affiliate, DKA, to unaffiliated purchasers in the United States. We calculated CEP based on delivered prices to unaffiliated customers in the United States. We made deductions from the starting price, where appropriate, for foreign and U.S. brokerage and handling, foreign and U.S. inland freight, international freight, marine insurance, U.S. duties, and direct and indirect selling expenses to the extent that they are associated with economic activity in the United States in accordance with sections 772(c)(2)(A) and 772(d)(1)(B) and (D) of the Act. The direct selling expenses included credit expenses. We added duty drawback received on imported materials pursuant to section 772(c)(1)(B) of the Act. In accordance with section 772(d)(3) of the Act, we made a deduction for CEP profit. Finally, pursuant to section 772(c)(1)(C) of the Act, we increased U.S. price by the amount of the export subsidy found in the countervailing duty investigation on steel plate from Korea. See Final Affirmative Countervailing Duty Determination: Certain Cut-to-Length Carbon-Quality Steel Plate From the Republic of Korea, 64 FR 73176 (December 29, 1999).

In accordance with section 773(a)(1)(B) of the Act, to the extent practicable, we determined NV based on sales in the comparison-market at the same level of trade (LOT) as the CEP sales. The NV LOT is that of the starting-price sales in the comparison-market. For CEP sales, the U.S. LOT is the level of the constructed sale from the exporter to the importer. The Department adjusts the CEP, pursuant to section 772(d) of the Act, prior to performing its LOT analysis, as articulated by the Department's regulations at section 351.412(c)(1)(ii). See Micron Technology, Inc. v. United States, 243 F.3rd 1301, 1315 (Fed. Cir. 2001).

To determine whether NV sales are at a different LOT than the CEP sales, we examined stages in the marketing process and selling activities along the chain of distribution between the producer and the unaffiliated customer. If the comparison-market sales are at a different LOT than that of the U.S. sale, and the difference affects price comparability, as manifested in a pattern of consistent price differences between the sales on which NV is based and comparison-market sales at the LOT of the export transaction, we make an LOT adjustment under section 773(a)(7)(A) of the Act. For CEP sales, if the NV LOT is more remote from the factory than the CEP LOT and there is no basis for determining whether the difference in the levels between NV and CEP affects price comparability, we adjust NV under section 773(a)(7)(B) of the Act (the CEP offset provision). See Notice of Final Determination of Sales at Less Than Fair Value: Certain Cut-to Length Carbon Steel Plate from South Africa, 62 FR 61731 (November 19, 1997).

In determining whether separate LOTs exist, we obtained information from DSM about the marketing stages for the reported U.S. and comparison-market sales, including a description of the selling activities performed by DSM for each channel of distribution. In identifying LOTs for CEP sales, we considered the selling functions reflected in the starting price, as adjusted under section 772(d) of the Act. See section 351.412(c)(1)(ii) of the Department's regulations. We expect that, if claimed LOTs are the same, the selling functions and activities of the seller at each level should be similar. Conversely, if a party claims that LOTs are different for different groups of sales, the selling functions and activities of the seller for each group of sales should be dissimilar.

In its questionnaire responses, DSM reported that it sold the foreign like product through one channel of distribution in the comparison-market and subject merchandise through several channels of distribution in the United States. We found that DSM engaged in similar selling activities for almost all sales in the comparison-market, and thus, we have preliminarily determined that there is one LOT in the comparison-market. Moreover, we found that the sales activities performed in the U.S. channels of distribution are substantially similar and, thus there is one LOT in the U.S. market. Further, we compared the single LOT in the comparison-market to the single LOT in the U.S. market, and have preliminarily determined that they are substantially similar. Thus, we have determined that the LOTs in the comparison and U.S. markets are the same LOT. Because the LOT is the same in both markets, we have denied DSM's request for a CEP offset, and not considered an LOT adjustment. See memorandum to the File from the Team concerning Level of Trade Analysis: Dongkuk Steel Mill Co., Ltd., dated concurrently with this notice.

After testing home market viability and whether home market sales failed the cost test, we calculated NV as noted in subsection 5, “Calculation of NV,” below.

In order to determine whether there is a sufficient volume of sales in the home market to serve as a viable basis for calculating NV ( i.e., whether the aggregate volume of home market sales of the foreign like product is equal to or greater than five percent of the aggregate volume of U.S. sales), we compared the respondent's volume of home market sales of the foreign like product to the volume of its U.S. sales of subject merchandise, in accordance with section 773(a)(1) of the Act. Because the respondent's aggregate volume of home market sales of the foreign like product is greater than five percent of its aggregate volume of U.S. sales of subject merchandise, we determined that the home market is viable for the respondent, and have used the home market as the comparison-market.

DSM reported home market sales of “overrun” merchandise ( i.e., sales of a greater quantity of steel plate than the customer ordered due to overproduction). Section 773(a)(1)(B) of the Act provides that NV shall be based on the price at which the foreign like product is first sold, inter alia, in the ordinary course of trade. Section 771(15) of the Act defines ordinary course of trade as the conditions and practices which, for a reasonable time prior to the exportation of the subject merchandise, have been normal in the trade under consideration with respect to merchandise of the same class or kind. In past cases, the Department has examined a number of factors to determine whether “overrun” sales are in the ordinary course of trade. These factors include: (1) Whether the merchandise is “off-quality” or produced according to unusual specifications; (2) the comparative volume of sales and number of buyers in the home market; (3) the average quantity of an overrun sale compared to the average quantity of a commercial sale; and (4) price and profit differentials in the home market. Based on our analysis of these factors and the terms of sale, we found all overrun sales to be outside the ordinary course of trade. See memorandum to the File from the Team concerning Overrun Sales Analysis: Dongkuk Steel Mill Co., Ltd., dated concurrently with this notice.

DSM reported no home market sales to affiliates.

In the investigation of steel plate from Korea, the Department disregarded DSM's sales that were found to have failed the cost test. See Preliminary Determination of Sales at Less Than Fair Value: Certain Cut-to-Length Carbon-Quality Steel Plate Products From the Republic of Korea, 64 FR 41224 (July 29, 1999); Amended Final Determination and Order (no change from the preliminary results). Accordingly, the Department, pursuant to section 773(b) of the Act, initiated a cost of production (COP) investigation of the respondent for purposes of this administrative review. We conducted the COP analysis as described below.

In accordance with section 773(b)(3) of the Act, we calculated the weighted-average COP, by model, for the POR, based on the sum of materials and fabrication costs, general and administrative (G&A) expenses, and packing costs.

As required under section 773(b) of the Act, we compared the weighted-average COPs to the home market sales of the foreign like product, in order to determine whether these sales had been made at prices below the COP within an extended period of time in substantial quantities, and whether such prices were sufficient to permit the recovery of all costs within a reasonable period of time. On a product-specific basis, we compared the COP to home market prices, less any applicable movement charges and direct and indirect selling expenses.

Pursuant to section 773(b)(2)(C) of the Act, where less than 20 percent of DSM's sales of a given product were made at prices below the COP, we did not disregard any below-cost sales of that product because the below-cost sales were not made in “substantial quantities.” Where 20 percent or more of DSM's sales of a given product were made at prices below the COP, we determined that such sales were made in substantial quantities within an extended period of time ( i.e. , a period of one year). Further, because we compared prices to POR-average costs, we determined that the below-cost prices would not permit recovery of all costs within a reasonable time period, and thus, we disregarded the below-cost sales in accordance with sections 773(b)(1) and (2) of the Act.

We found that for certain products, DSM made home market sales at prices below the COP within an extended period of time in substantial quantities. Further, we found that these sales prices did not permit the recovery of costs within a reasonable period of time. We therefore excluded these sales from our analysis in accordance with section 773(b)(1) of the Act.

We determined price-based NVs for DSM as follows: We calculated NV based on packed, delivered and ex-factory prices to home market customers. Where appropriate, we increased the starting price for interest and duty drawback revenue received from customers. We made deductions from the starting price for foreign inland freight, where appropriate, pursuant to sections 773(a)(6)(B)(ii) of the Act. Pursuant to section 773(a)(6)(C)(iii) of the Act and § 351.410(c) of the Department's regulations, we made circumstance-of-sale adjustments to the starting price, where appropriate, for differences in credit, warranty, and bank expenses.

We deducted home market packing costs from, and added U.S. packing costs to, the starting price, in accordance with section 773(a)(6)(A) and (B) of the Act. Where appropriate, we made adjustments to NV to account for differences in the physical characteristics of the merchandise sold in the U.S. and home market, in accordance with section 773(a)(6)(C)(ii) of the Act and § 351.411 of the Department's regulations.

Pursuant to section 773A(a) of the Act, we made currency conversions into U.S. dollars based on the exchange rates in effect on the dates of the U.S. sales as certified by the Federal Reserve Bank.

As a result of this review, we preliminarily determine that the following weighted-average margin exists for the period February 1, 2002, through January 31, 2003:

We will disclose the calculations used in our analysis to parties to this proceeding within five days of the publication date of this notice. See § 351.224(b) of the Department's regulations. Any interested party may request a hearing within 30 days of the publication date of this notice. See § 351.310(c) of the Department's regulations. If requested, a hearing will be held 44 days after the date of publication of this notice, or the first workday thereafter. Interested parties may submit case briefs within 30 days of the date of publication of this notice. Rebuttal briefs, limited to issues raised in the case briefs, may be filed not later than 7 days after the deadline for filing case briefs. Interested parties are invited to comment on the preliminary results. Parties who submit arguments are requested to submit with each argument: (1) A statement of the issue, (2) a brief summary of the argument and (3) a table of authorities. Further, we would appreciate it if parties submitting written comments would provide the Department with a copy of the public version of any such comments on a diskette. The Department will issue the final results of this administrative review, which will include the results of its analysis of issues raised in any written comments, within 120 days from the publication date of this notice.

Upon completion of this administrative review, the Department will determine, and CBP shall assess, antidumping duties on all appropriate entries. In accordance with § 351.212(b)(1) of the Department's regulations, we have calculated an importer-specific assessment rate for merchandise subject to this review. Where the importer-specific assessment rate is above de minimis , we will instruct the CBP to assess the importer-specific rate uniformly on all entries made during the POR. The Department will issue appropriate assessment instructions directly to CBP within 15 days of publication of the final results of review. If these preliminary results are adopted in the final results of review, we will direct CBP to assess the resulting assessment rates against the entered customs values for the subject merchandise on each of the importers' entries during the review period.

The following cash deposit requirements will be effective upon publication of these final results for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of these final results of administrative review, as provided by section 751(a)(1) of the Act: (1) The cash deposit rate for the reviewed company will be the rate listed above (except that if the rate is de minimis , i.e. , less than 0.5 percent, a cash deposit rate of zero will be required); (2) for previously investigated or reviewed companies not listed above, the cash deposit rate will continue to be the company-specific rate published for the most recent period; (3) if the exporter is not a firm covered in this review, a prior review, or the original less than fair value (LTFV) investigation, but the manufacturer is, the cash deposit rate will be the rate established for the most recent period for the manufacturer of the merchandise; and (4) the cash deposit rate for all other manufacturers or exporters will continue to be the “all others” rate of 0.98 percent, which is the “all others” rate established in the LTFV investigation, adjusted for the export subsidy rate in the countervailing duty investigation. See Amended Final Determination and Order. These deposit requirements, when imposed, shall remain in effect until publication of the final results of the next administrative review.

This notice also serves as a preliminary reminder to importers of their responsibility under § 351.402(f)(2) of the Department's regulations to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of the antidumping duties occurred and the subsequent assessment of double antidumping duties.

This administrative review and this notice are in accordance with sections 751(a)(1) and 777(i)(1) of the Act.

On February 10, 2000, the Binational Panel issued an order which affirmed the final remand determination of the United States International Trade Administration (“ITA”) concerning Gray Portland Cement and Clinker from Mexico. The Secretariat was instructed to issue a Notice of Completion of Panel Review on the 31st day following the issuance of the Notice of Final Panel Action, if no request for an Extraordinary Challenge was filed. A request for an Extraordinary Challenge Committee was filed on March 23, 2000. On October 30, 2003 the Extraordinary Challenge Committee rendered a decision to affirm the February 10, 2000 panel decision. Based on Article 1904 Panel Rules , the Panel Review was completed and the panelists discharged from their duties effective October 30, 2003.

Section 101(a)(5)(A) of the MMPA (16 U.S.C. 1361 et seq. ) directs 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 regulations are issued.

Permission may be granted for periods of 5 years or less 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. In addition, NMFS must prescribe regulations that include permissible methods of taking and other means effecting the least practicable adverse impact on the species and its habitat, and on the availability of the species for subsistence uses, paying particular attention to rookeries, mating grounds, and areas of similar significance. The regulations must include requirements pertaining to the monitoring and reporting of such taking.

Regulations governing the taking of marine mammals incidental to the power plant operations were published on May 25, 1999 (64 FR 28114), and remain in effect until June 30, 2004. For detailed information on this action, please refer to that document. These regulations include mitigation, monitoring, and reporting requirements for the incidental taking of marine mammals by power plant operations.

On October 3, 2003, NMFS received an application from FPL Energy Seabrook, LLC for an LOA under the regulations issued on May 25, 1999 (64 FR 28114), and effective on July 1, 1999. This application requested authorization to take, by harassment, under section 101(a)(5)(A) of the MMPA, small numbers of marine mammals incidental to routine operations of the Seabrook Station nuclear power plant in Seabrook, New Hampshire for a period not to exceed one year.

Accordingly, NMFS issued an LOA to FPL Energy Seabrook, LLC on October 31, 2003, authorizing the taking of small numbers of marine mammals incidental to routine operations of the Seabrook Station nuclear power plant. Issuance of this LOA is based on findings, described in the preamble to the final rule (64 FR 28114, May 25, 1999), that the total takings by this activity will result in small numbers of marine mammals being taken, have no more than a negligible impact on marine mammal stocks, and will not have an unmitigable adverse impact on the availability of the affected marine mammal stocks for subsistence uses.

This LOA remains valid until June 30, 2004, provided that FPL Energy Seabrook, LLC is in conformance with the conditions of the regulations and the LOA, and the mitigation, monitoring, and reporting requirements described in 50 CFR 216.130-216.137 (64 FR 28114, May 25, 1999) and in the LOA is undertaken.

The Personal check Cashing Agreement Form is designed exclusively to help the DoD disbursing offices expedite the collection process of dishonored checks. The front of the form will be completed and signed by the authorized individual requesting check cashing privileges. By signing the form, the individual is freely and voluntarily consenting to the immediate collection from their current pay, without prior notice, for the face value of any check cased, plus any charges assessed against the government by a financial institution, in the event the check is dishonored. In the event the check is dishonored, the disbursing office will complete and certify the reverse side of the form and forward the form to the applicable payroll office for collection from the individual's current pay.

Panel to Assess the Capabilities for Domestic Response to Terrorist Attacks Involving Weapons of Mass Destruction will meet from 8:30 a.m. until 5 p.m. on November 17, 2003 and from 8:30 a.m. until 3 p.m. on November 18, 2003.

Time will be allocated for public comments by individuals or organizations at the end of the meeting on November 18. Public comment presentations will be limited to two minutes each and must be provided in writing prior to the meeting. Mail written presentations and requests to register to attend the open public session to: Hillary Peck, RAND, 1200 South Hayes Street, Arlington, VA 22202-5050. Public seating for this meeting is limited, and is available on a first-come, first-served basis.

In accordance with 5 U.S.C. 4314(c)(4), the officials appointed to serve as members of the DTRA PRB are set forth below:

The following DTRA officials will serve as alternate members of the DTRA PRB, as appropriate.

The Corps, the Cochiti de Pueblo (Pueblo), and the Bureau of Indian Affairs (BIA) are investigating modifying the easement for the operation of the Cochiti Dam Outlet Works/Al Black Recreation Area. Specifically, the recreation easement would be rescinded but the Corps would retain the original dam operation and maintenance easement. Public access to the recreation area would no longer be allowed. All public-oriented facilities and other amenities that have no bearing on operation or maintenance of the Outlet Works would be removed and surplused or disposed of following Federal guidelines. The Corps would restore the site as prescribed by the Pueblo. The Cochiti Dam Outlet Works operation and maintenance easement granted to the Corps would remain in effect. Corps, Middle Rio Grande Conservancy District, and U.S. Bureau of Reclamation (BOR) personnel would have access to the area for operation and maintenance purposes. Members of the Pueblo would continue to access the area for religious and cultural ceremonies. This Federal action would satisfy a November 8, 2001, understanding between the Corps, Pueblo and BIA.

Construction of the Cochiti Dam and Lake (Project) was authorized for flood and sediment control in the Upper Rio Grande Basin by the Flood Control Act of 1960 (Pub. L. 86-645). Various Pueblo/Corps lease agreements defined the use and management of the Project land owned by the Pueblo including Corps construction of public use recreation facilities at various locations that the Pueblo would operate and maintain. In a lease amendment dated June 12, 1984, the Pueblo transferred the operation and maintenance of the Outlet Channel Area/Al Black Recreation Area to the Corps.

All private interests and Federal, State, local agencies, and tribes having an interest in the project are hereby notified of the proposed action and are invited to comment at this time. The scoping process will consist of public notification to explain and describe the proposed action, early identification of resources that should be considered during the study, and public review periods. Coordination with the public and with other agencies will be carried out through public announcements, letters, report review periods telephone conversations, and meetings.

The Corps prepared a Draft Environmental Assessment on the proposed action and held a public meeting on August 28, 2003 in Rio Rancho, NM. Additional information and evidence gathered during that meeting and expressed public resistance to establishing a recreation facility at Pena Blanca, NM resulted in the decision to prepare an EIS for the proposed action. All Federal, State and local agencies, affected Indian tribes, and other interested private organizations and parties will be notified of the meeting and will be provided copies of the Draft EIS (DEIS) for comment.

Significant issues to be discussed in the DEIS include the alternatives analysis for the possible relocation of the Al Black Recreation Area and other avenues for replacing lost recreation opportunities incurred as a result of the proposed action.

The lead agency for this project is the U.S. Army Corps of Engineers, Albuquerque District. Cooperating agency status has not been assigned, nor requested, by any other agency.

The EIS is being prepared in accordance with the requirements of the National Environmental Policy Act of 1969, as amended, and will address the project's relationship to all other applicable Federal and State laws and Executive Orders.

Scoping meetings will be held in Peña Blanca, Albuquerque and other locations as deemed necessary. Specific information regarding location and time of the meetings will be published in local newspapers. It is anticipated that the DEIS will be available for public review and comment by February 1, 2004.

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

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.

Type of Review: New.

Title: Survey for the Study of the Ronald E. McNair Postbaccalaureate Achievement Program Participants.

Frequency: One time.

Affected Public: Individuals or households.

Reporting and Recordkeeping Hour Burden:

Responses: 2,313. Burden Hours: 3,000.

Abstract: Follow-up survey data from current and former McNair program participants to determine program completion, employment status.

Requests for copies of the proposed information collection request may be accessed from http://edicsweb.ed.gov, by selecting the “Browse Pending Collections” link and by clicking on link number 2368. When you access the information collection, click on “Download Attachments” to view. Written requests for information should be addressed to Vivian Reese, Department of Education, 400 Maryland Avenue, SW., Room 4050, Regional Office Building 3, Washington, DC 20202-4651 or to the e-mail address vivian_reese@ed.gov. Requests may also be electronically mailed to the internet address OCIO_RIMG@ed.gov or faxed to 202-708-9346. Please specify the complete title of the information collection when making your request.

Comments regarding burden and/or the collection activity requirements should be directed to Sheila Carey at her e-mail address Sheila.Carey@omb.eop.gov. Individuals who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339.

You may be potentially affected by this notice if you are an EPA registrant with any approved product registration(s). Although this action may be of particular interest to persons who produce or use pesticides, 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 information in this notice, consult the person listed in the FOR FURTHER INFORMATION CONTACT section.

1. Electronically . You may obtain electronic copies of this document and various other related documents that might be available from the EPA Internet Home Page at http://www.epa.gov/fedrgstr/ .

The Agency has established an official record record for this Action under docket control number OPP-2003-0339. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as Confidential Business Information (CBI). The official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information that is claimed as CBI. The public version of the official record, which includes printed paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Room 119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

Section 4(i)(5) of FIFRA as amended in October, 1988 (Public Law 100-532), December, 1991 (Public Law 102-237), and again in August, 1996 (Public Law 104-170), requires that all pesticide registrants pay an annual registration maintenance fee, due by January 15 of each year, to keep their registrations in effect. This requirement applies to all registrations granted under section 3 as well as those granted under section 24(c) to meet special local needs. Registrations for which the fee is not paid are subject to cancellation by order and without a hearing.

The Food, Agriculture, Conservation, and Trade Act Amendments of 1991, Public Law 102-237, amended FIFRA to allow the Administrator to reduce or waive maintenance fees for minor agricultural use pesticides when she determines that the fee would be likely to cause significant impact on the availability of the pesticide for use. The Agency has waived the fee for 141 minor agricultural use registrations at the request of the registrants.

In fiscal year 2003, maintenance fees were collected in two billing cycles. During the first cycle, the Agency was operating under a continuing resolution which authorized the Agency to collect $17 million. In late December 2002, all holders of either section 3 registrations or section 24(c) registrations were sent lists of their active registrations, along with forms and instructions for responding. They were asked to identify which of their registrations they wished to maintain in effect, and to calculate and remit the appropriate maintenance fees. Recipients of these initial bills were also notified that a second final bill would also be issued if the Agency's Appropriations Bill authorized collection of more than $17 million. Most responses were received by the statutory deadline of January 15. A notice of intent to cancel was sent in mid-February to companies who did not respond and to companies who responded, but paid for less than all of their registrations.

The Agency's Appropriations Bill was passed by Congress in March, 2003. This Appropriations Bill authorized the Agency to collect $21.5 million in maintenance fees. To collect the additional $4.5 million, the Agency initiated a second billing in early May. Final payments were due on June 15, 2003.

Since mailing the notices, EPA has maintained a toll-free inquiry number through which the questions of affected registrants have been answered.

Maintenance fees have been paid for about 15,120 section 3 registrations, or about 93 percent of the registrations on file in December. Fees have been paid for about 2,258 section 24(c) registrations, or about 86 percent of the total on file in December. Cancellations for non-payment of the maintenance fee affect about 599 section 3 registrations and about 265 section 24(c) registrations.

The cancellation orders generally permit registrants to continue to sell and distribute existing stocks of the canceled products until January 15, 2004, 1 year after the date on which the fee was due. Existing stocks already in the hands of dealers or users, however, can generally be distributed, sold, or used legally until they are exhausted. Existing stocks are defined as those stocks of a registered pesticide product which are currently in the United States and which have been packaged, labeled and released for shipment prior to the effective date of the action.

The exceptions to these general rules are cases where more stringent restrictions on sale, distribution, or use of the products have already been imposed, through Special Reviews or other Agency actions. These general provisions for disposition of stocks should serve in most cases to cushion the impact of these cancellations while the market adjusts.

Table 1 lists all of the Section 24(c)registrations, and Table 2 Lists all of the Section 3 registrations which were canceled for non-payment of the 2003 maintenance fee. These registrations have been canceled by order and without hearing. Cancellation orders were sent to affected registrants via certified mail in the past several days. The Agency is unlikely to rescind cancellation of any particular registration unless the cancellation resulted from Agency error.

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

•  Crop Production (NAICS Code 111)

• Animal Production (NAICS Code 112)

• Food Manufacturing (NAICS Code 311)

• Pesticide Manufacturing (NAICS Code 32532)

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

1. Docket . EPA has established an official public docket for this action under docket identification (ID) number OPP-2003-0208. 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 Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805.

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. 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 OPP-2003-0208. 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 opp-docket@epa.gov , Attention: Docket ID Number OPP-2003-0208. 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.

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

The petitioner summary of the pesticide petition is printed below as required by FFDCA section 408(d)(3). The summary of the petition was prepared by the petitioner and represents the view of the petitioner. The petition summary announces the availability of a description of the analytical methods available to EPA for the detection and measurement of the pesticide chemical residues or an explanation of why no such method is needed.

EPA has received pesticide petitions (PP 2F6434 and 3F6580) from BASF Corporation, Research Triangle Park, NC, proposing pursuant to section 408(d) of the Federal Food, Drug and Cosmetic Act (FFDCA), 21 U.S.C 346a(d), to amend 40 CFR part 180 by establishing tolerances for residues of Boscalid (3-pyridinecarboxamide, 2-chloro- N -(4′-chloro(1,1′-biphenyl)-2-yl) in or on the following raw agricultural and processed commodities: pome fruit at 3.0 ppm; apple pomace at 20.0 ppm and hops at 35.0 ppm, and soybean aspirated grain fraction at 2.5 ppm. EPA has determined that the petitions contain data or information regarding the elements set forth in section 408(d)(2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition.

These individual summaries are printed below as they were received from the petitioner.

1. Plant metabolism . Nature of the residue studies (OPPTS Harmonized Guidline 860.1300) were conducted in grapes, lettuce and beans as representative crops in order to characterize the fate of BAS 510 F in all crop matrices. In all three crops the BAS 510 F Residues of Concern (ROC) were characterized as parent (BAS 510 F). A confined rotational crop study also determined that parent was the residue of concern in the representative crops of radish, lettuce and wheat.

2. Analytical method . In plants the parent residue is extracted using an aqueous organic solvent mixture followed by liquid/liquid partitioning and a column clean up. Quantitation is by gas chromatography using mass spectrometry (GC/MS). In livestock the residues are extracted with methanol. The extract is treated with enzymes in order to release the conjugated glucuronic acid metabolite. The residues are then isolated by liquid/liquid partition followed by column chromatography. The hydroxylated metabolite is acetylated followed by a column clean-up. The parent and acetylated metabolite are quantitated by gas chromatography with electron capture detection.

3. Magnitude of the residues . Field trials were carried out in order to determine the magnitude of the residue in the apples, pears and hops. Field trials were conducted in the United States in the required regions. Field trials were carried out using the maximum label rate, the maximum number of applications, and the minimum preharvest interval for each crop or crop group. In addition, a processing study was conducted on apples to determine concentration factors during normal processing of the raw agricultural commodity into the processed commodities.

1. Acute toxicity . Based on available acute toxicity data BAS 510 F and its formulated products do not pose acute toxicity risks. The acute toxicity studies place technical BAS 510 F in toxicity category IV for acute oral; category III for acute dermal and category IV for acute inhalation. BAS 510 F is category IV for both eye and skin irritation, and it is not a dermal sensitizer. Two formulated end use products are proposed, a wettable granule (WG) termed BAS 510 02 F containing 70% BAS 510 F and a wettable granule (WG) termed BAS 516 02 F containing a 2:1 mixture of BAS 510 F and BAS 500 F. BAS 510 02 F has an acute oral toxicity category of III, acute dermal of category III, acute inhalation of category IV, eye irritation of category III, skin irritation of category IV, and is not a dermal sensitizer. BAS 516 02 F has an acute oral toxicity category of III, acute dermal of category III, acute inhalation of category IV, eye irritation of category III, skin irritation of category IV, and is not a dermal sensitizer.

2. Genotoxicity . Ames Test (1 Study; point mutation): Negative; In Vitro CHO/HGPRT Locus Mammalian Cell Mutation Assay (1 Study; point mutation): Negative; In Vitro V79 Cell Cytogenetic Assay (1 Study; Chromosome Damage): Negative; In Vivo Mouse Micronucleus (1 Study; Chromosome Damage): Negative; In Vitro Rat Hepatocyte (1 Study; DNA damage and repair): Negative. BAS 510 F has been tested in a total of 5 genetic toxicology assays consisting of in vitro and in vivo studies. It can be stated that BAS 510 F did not show any mutagenic, clastogenic or other genotoxic activity when tested under the conditions of the studies mentioned above. Therefore, BAS 510 F does not pose a genotoxic hazard to humans.

3. Reproductive and developmental toxicity . The reproductive and developmental toxicity of BAS 510 F was investigated in a two-generation rat reproduction study as well as in rat and rabbit teratology studies.

There were no adverse effects on reproduction in the two-generation study at any dose tested. Pup effects were observed, with parental toxicity, at the highest dose tested only. In both parental generations, reduced food consumption and reduced bodyweight gain were observed at 10,000 ppm. Both absolute and relative liver weights were increased 21% in F 1 generation parental females at the high dose of 10,000 ppm only. Hepatocellular centrilobular hypertrophy (usually slight) was observed in many animals of both sexes in both the F 0 and F 1 generations at 1,000 ppm, and in all animals of both sexes at 10,000 ppm. Additionally, some of the parental male rats at 10,000 ppm, in both generations, displayed centrilobular liver cell degeneration. Developmental toxicity was seen at 1,000 ppm in the form of decreased pup weights in the F 2 males, and at 10,000 ppm in the form of decreased pup weight for both males and females of both the F 1 and F 2 generations. The parental systemic and developmental toxicity NOAEL's are both 100 ppm (12 mg/kg/day).

No teratogenic effects were noted in either the rat or rabbit developmental studies. In the rat study, evidence of maternal or developmental toxicity were not observed at any dose (highest dose tested of 1,000 mg/kg/day). Neither a maternal nor developmental LOAEL were found since the highest dose tested was the NOAEL in both studies. In the rabbit teratology study, maternal toxicity observed at the mid dose of 300 milligrams/kilogram of body weight (mg/kg bw) consisted of discolored/reduced feces in one dam and an abortion in one dam. This finding is not necessarily indicative of a definitive test substance related adverse effect. The dam which displayed the fecal alterations and abortion also displayed decreased body weight and body weight gain - compared to the group mean - during gestation. These decreases occurred even prior to compound administration. Food consumption was also dramatically decreased in this dam compared to the other animals in the group. Every day from gestation day (GD) 1-12, this dam had food consumption values which were less than half the mean for the group (compound administration began on GD 7). From GD 13 to 26 (when the animal aborted and was sacrificed) this dam ate essentially nothing (food consumption during this time period was less than or equal to 1.5 grams/day). These decreases in body weight, body weight gain, and food consumption, prior to compound administration, all indicate an animal in poor health and this poor state of health, rather than compound exposure, was likely the reason for the fecal alterations and abortion.

At the high dose of 1,000 mg/kg bw a maternal body weight gain decrease compared to controls of 81% was observed during the treatment period. Reduced food consumption, reduced body weight and abortions in three dams, were also seen at 1,000 mg/kg/day. Evidence of developmental toxicity was not seen at any dose tested.

Developmental neurotoxicity was not observed at any dose in the developmental neurotoxicity study. No maternal toxic effects were noted at any dose in this study. No developmental toxicity was seen at the low dose of 12 mg/kg/day (100 ppm). Reduced body weights and body weight gains were seen at 118 mg/kg/day (1,000 ppm) during post natal day (PND) 1-4. Reduced body weights and body weight gains were seen at 1,183 mg/kg/day (10,000 ppm) as well as decreased absolute pup brain weight at day 11 post partum (p.p.) (both sexes) and decreased brain length (males only) at day 11 p.p. The reduced pup brain weights and decreased brain length go hand-in-hand and both are due to the decreased pup weights seen at this dose. In this respect, it should be noted that pup brain weights relative to body weight at p.p. 11 were not significantly different from controls at this dose. Though no maternal toxicity was seen in this study, other studies using similar doses of BAS 510 resulted in maternal toxicity. A dose of 118 mg/kg/day in female rats of the same strain in the multigeneration study, resulted in an increased incidence of hepatic centrilobular hypertrophy - a parameter which could not have been detected in the developmental neurotoxicity (DNT) study as liver histopathology on parental animals was not performed in the DNT study.

4. Subchronic toxicity . The subchronic toxicity of BAS 510 F was investigated in 90-day feeding studies with rats, mice and dogs, and in a 28-day dermal administration study in rats. A 90-day neurotoxicity study in rats was also performed. Generally, mild toxicity was observed. At high dose levels (doses above the LOAELs) in feeding studies, all three species displayed alterations in various clinical chemistry parameters. These clinical chemistry alterations were likely secondary to general toxicity. Statistically significant increased absolute and relative thyroid weights were observed in male rats only at doses at and above the LOAEL. Increased absolute and relative liver weights were observed in both sexes at doses above the LOAEL in rats and dogs. Increased absolute and relative liver weights were seen in both sexes of the mouse at lower doses. However, the increases in liver weights at these lower doses in the mouse were not deemed to be compound related due to the unusually low concurrent control liver weight values. At doses above the LOAELs, liver weight increases were supported by histopathology alterations in the rat and mouse, but not in the dog. Overall, only mild toxicity was observed in oral subchronic testing.

In the 28-day repeat dose dermal study, no systemic effects were noted up to the highest dose tested of 1,000 mg/kg/day.

In a 90-day rat neurotoxicity study, there was no mortality, signs of clinical toxicity, or adverse effects on food consumption or body weight at any dose level in either sex. No signs of neurotoxicity were observed during clinical observations, functional observation batteries, motor activity measurements of neuropathology. Therefore, there were no selective neurotoxic effects. Adverse effects were not seen even at the highest dose level tested. A LOAEL was not found and the NOAEL is the highest tested of 15,000 ppm (1,050 mg/kg/day in males; 1,272 mg/kg/day in females).

5. Chronic toxicity . Based on review of the available data, the Reference Dose (RfD) for BAS 510 F will be based on a 24-month feeding study in rats with a threshold no observed effect level (NOEL) of 5 mg/kg/day. Using an uncertainty factor of 100, the RfD is calculated to be 0.05 mg/kg/day. The following are summaries of chronic toxicity studies submitted to EPA.

The chronic toxicity/oncogenicity studies with BAS 510 F include a 12-month feeding study with Beagle dogs, an 18-month B63CF1 mouse feeding study, a 24-month Wistar rat chronic feeding study and a 24-month Wistar rat oncogenicity study.

At the highest dose tested in dogs, effects observed consisted primarily of increased liver and thyroid weights and some serum clinical chemistry changes. The NOAEL was 800 ppm (21.8 mg/kg bw males; 22.1 mg/kg bw females).

Decreased body weights were seen in males in the mouse chronic study at doses of 400 ppm and above. Decreased female body weight was seen at doses of 2,000 ppm and above. The target organ in this study was the liver. In both the rat chronic and oncogenicity studies, the highest dose tested of 15,000 ppm exceeded a maximum tolerated dose (MTD) and was discontinued after 17 months. Effects observed at the next highest dose of 2,500 ppm primarily centered around the thyroid and liver.

Overall, mild toxicity was observed with chronic exposure to BAS 510 F. No evidence of treatment-induced oncogenicity was observed in the mouse or dog studies. A slight increase in thyroid follicular cell adenomas was seen in both sexes at the high dose when the data from both rat bioassays are combined.

A mode of action (MOA) for the thyroid follicular cell adenomas has been proposed. This MOA is based on the EPA publication “Assessment of Thyroid Follicular Cell Tumors,” March 1998, EPA/630/R-97/002. This document describes the criteria which must be met in order for a compound to be considered under the MOA described in that publication. BASF Corporation believes that BAS 510 F has met the cited criteria.

6. Threshold effects . Based on a review of the available chronic toxicity data, BASF believes EPA will establish the RfD for BAS 510 F at 0.05 mg/kg/day. This RfD for BAS 510 F is based on the 2-year chronic and 2-year oncogenicity studies in rats with a threshold average NOEL of 5 mg/kg/day for males and females. Using an uncertainty factor of 100, the RfD is calculated to be 0.05 mg/kg/day. Based on the acute toxicity data, BASF believes that 510 F does not pose any acute dietary risks.

BAS 510 F was shown to be non-carcinogenic in mice and dogs. There was a slight increase in thyroid follicular cell ademonas at the high dose in both sexes in the rat. A threshold-based MOA for these tumors based on the EPA publication “Assessment of Thyroid Follicular Cell Tumors” (EPA/630/R-97/002, March, 1998), has been proposed. BASF believes the data to support this proposed mode of action are strong, and that the thyroid tumors seen in the rat following BAS 510 exposure have a threshold. In addition, a battery of genotoxicity studies demonstrated that BAS 510 F has no genotoxic or clastogenic potential. Therefore, BASF believes that the threshold approach to regulating BAS 510 F is appropriate. Also, it should be noted that, while the Agency has in the past considered tumors of this type to be potential human carcinogens, the European Union has published a policy which considers these tumor types, when they occur at low incidence rates in the rat, to not be relevant to man. (The publication: European Commission, European Chemicals Bureau, ECBI/49/99 - Add. 1 Rev. 2; “Draft Summary Record, Commission Group of Specialized Experts in the fields of Carcinogenicity, Mutagenicity and Reprotoxicity” Meeting at Arona, 1 - 2 September 1999), Therefore, BASF believes that these tumors are not likely relevant to humans and, if these tumors are to be considered relevant to humans, the threshold approach to cancer risk assessment is appropriate.

7. Animal metabolism . In the rat, the predominat route of excretion of BAS 510 F is fecal with urinary excretion being minor. The half life of BAS 510 F is less than 24 hours. Saturation of absorption appears to be occurring at the high dose level. BAS 510 F is rapidly and intensively metabolized to a large number of biotransformation products. The hydroxylation of the diphenyl moiety was the quantitatively most important pathway. Second most important was the substitution of the Cl of the 2-chloropyridine part against SH by conjugation with glutathione. No major differences were observed. In hens and goats the residues of concern were determined to be parent, the hydroxylated metabolite M510 F01 (2-chloro- N -(4′chloro-5-hydroxy-biphenyl-2-yl)nicotinamide), and the glucuronic acid of the metabolite M510 F02.

8. Metabolite toxicology . No additional studies were required for metabolite toxicology.

Endocrine disruption . No specific tests have been conducted with BAS 510 F to determine whether the chemical may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen or other endocrine effects. However, there were no significant findings in other relevant toxicity studies (i.e., subchronic and chronic toxicity, teratology and multi-generation reproductive studies) which would suggest that BAS 510 F produces endocrine related effects.

1. Dietary exposure —i. Food . A chronic dietary exposure analysis was conducted for BAS 510 F to include the proposed uses of apples and hops. The dietary exposure included prior tolerances for beet root, root vegetables, tuberous and corm vegetables, bulb vegetables, leafy vegetables, head and stem brassica, leafy brassica greens, legume vegetables, fruiting vegetables, cucurbit vegetables, stonefruit, berries, tree nuts, pistachios, cereal grains, mint, grapes, raisins, strawberries, peanut, peanut meal, peanut oil, cotton seed, soybean seed, canola, flax seed and sunflower seed in addition to the new tolerances for apples and hops. The analysis assumed 100% of the crops were treated, default processing factors (even though much lower experimentally-derived processing factors are available), and used the tolerance value for residues. The one exception to the use of defaults was for the apple processing, where an average calculated processing factor of 0.09 was used for apple juice. For apple juice concentrate, the juice factor of 0.09 was adjusted by the ratio of the default concentrate (3.9) and default juice (1.3) processing factors, which led to an estimated processing factor of 0.27 for apple juice concentrate. Even with these worst-case assumptions, it was determined that the Theoretical Maximum Residue Contribution (TMRC) was only 34.0% of the reference dose for the U.S. population and 77.1% for children 1-6 years (the highest exposed age-related subpopulation).

Based on the toxicology results, an acute dietary risk assessment for BAS 510 F is most likely not required, but if so, only for non-nursing infants < 1 year old. For dietary exposure estimation, 100% crop treated and tolerance values for residues were used. The resulting acute exposure prediction for non-nursing infants (the highest exposed age-related subpopulation) resulted in an acceptable 10.6% of the acute reference dose at the 95th percentile. If a more realistic scenario were used assuming percent crop treated and the range of residues, a much lower exposure would be obtained.

ii. Drinking water. Estimates of ground and surface water levels were determined using SCIGROW and FIRST models, respectively. The drinking water level of concerns (DWLOCs) for chronic exposure are obtained by subtracting the chronic dietary food. This is outlined in the following table.

Overall, using worst-case parameters the predicted aggregate exposure by all potential routes for both adults and children is less than the chronic reference dose.

2. Non-dietary exposure . BAS 510 F is not currently planned for residential uses. Thus, residential exposure is not aggregated into the risk assessment.

Section 408(b)(2)(D)(v) requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” BAS 510 F is a foliar fungicide chemically belonging to the carboxin class of fungicides. BAS 510 F acts in the fungal cell by inhibiting mitochondrial respiration through inhibition of the succinate-ubiquinone oxidase reductase system in Complex II of the mitochondrial electron transport chain. BAS 510 F shares this mode of action with only one other currently registered U.S. pesticide - carboxin.

The EPA is currently developing methodology to perform cumulative risk assessments. At this time, there is no available data to determine whether BAS 510 F has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, BAS 510 F does not appear to produce a toxic metabolite produced by other substances.

1. U.S. population . Using the conservative exposure assumptions described above and based on the completeness and the reliability of the toxicity data, BASF has estimated that aggregate exposure to BAS 510 F will utilize 34.1% of the RfD for the U.S. population. For the highest exposed age-related subpopulation (children 1-6 years), the maximum aggregate exposure is predicted to be 77.4% of the reference dose. BASF concludes that there is a reasonable certainty that no harm will result from the aggregate exposure to residues of BAS 510 F, including anticipated dietary and drinking water exposures and non-occupational exposures.

2. Infants and children —i. Developmental toxicity in the Rat . A developmental study was conducted via oral gavage in rats with dosages of 0, 100, 300 and 1,000 mg/kg bw/day with a maternal and developmental No-Adverse-Effect Level (NOAEL) of 1,000 mg/kg. No evidence of developmental toxicity was observed up to the highest dose tested.

ii. Developmental toxicity in the rabbit . A developmental study was conducted via oral gavage in rabbits with dosages of 0, 100, 300 and 1,000 mg/kg bw/day. The NOAEL for maternal toxicity was 100 mg/kg bw/day and was 1,000 mg/kg/day for developmental toxicity. As noted above in section B.3. (Reproductive and developmental toxicity), this NOAEL is based on fecal alterations and an abortion in a single dam at the next highest dose of 300 mg/kg/day. The dam which displayed the fecal alterations and abortion also displayed decreased body weight, body weight gain and food consumption, compared to the group mean, during gestation. These decreases occurred even prior to compound administration. These decreases in body weight, body weight gain, and food consumption, prior to compound administration, all indicate an animal in poor health and this poor state of health, rather than compound exposure, was likely the reason for the fecal alterations and abortion. No teratogenic effects were observed at any dose level.

iii. Reproductive toxicity . A two-generation reproduction study in rats was conducted with dosages of 0, 12, 118, and 1,183 mg/kg bw/day. No impairment of reproductive function was noted at any dose. The parental and developmental NOAEL are both 12 mg/kg/day. Mild effects in both the parents and pups were noted at 118 mg/kg/day and consisted of an increased incidence of hepatic centrilobular hypertrophy in parents and, in the pups, slightly decreased body weight and body weight gain (7%) in F 2 generation only, and only in males. At 1,183 mg/kg/day paternal effects included decreased body weights and food consumption, increased liver weights and increased incidence of hepatic centrilobular hypertrophy and degeneration. Pup effects at this dose were an increase in pup mortality in the F 2 only and a decreased body weight in F 1 and F 2 .

iv. Reference dose . In all reproductive studies, the NOAEL's for developmental effects were either equal to or higher than those for the parents. Therefore, BAS 510 F shows no selective toxicity for the young. In addition, there were no direct neurotoxicity effects noted in either the acute or subchronic neurotoxicity studies.

Based on these results, no additional safety factors to protect children are warranted. Since the reproductive studies NOAEL's are higher than the RfD calculated from the chronic rat study, BASF believes the Reference Dose of 0.05 mg/kg/day is also appropriate to measure safety for infants and children. Therefore, the chronic Population Adjusted Dose (cPAD) is also 0.05 mg/kg bw/day.

A maximum residue level (MRL) has not been established for BAS 510 F in any crop by the Codex Alimentarius Commission.

1. Plant metabolism . Nature of the residue studies (OPPTS Harmonized Guideline 860.1300) were conducted in grapes, lettuce and beans as representative crops in order to characterize the fate of Boscalid (BAS 510 F) in all crop matrices. In all three crops the BAS 510 F Residues of Concern (ROC) were characterized as parent BAS 510 F. A confined rotational crop study also determined that parent was the residue of concern in the representative crops of radish, lettuce and wheat.

2. Analytical method . In plants the parent residue is extracted using an aqueous organic solvent mixture followed by liquid/liquid partitioning and a column clean up. Quantitation is by GC/MS. The extract is treated with enzymes in order to release the conjugated glucuronic acid metabolite. The residues are then isolated by liquid/liquid partition followed by column chromatography. The hydroxylated metabolite is acetylated followed by a column clean-up. The parent and acetylated metabolite are quantitated by GC/ECD.

3. Magnitude of the residues . Field trials were carried out in order to determine the magnitude of the residue in soybean and soybean aspirated grain fraction. Field trials were conducted in the United States and Canada in the required regions. Field trials were carried out using the maximum label rate, the maximum number of applications, and the minimum preharvest interval. In addition, a processing study was conducted on the soybean to determine concentration factors. Tier III field rotational crop studies were conducted to support rotational crop tolerances for soybean.

1. Acute toxicity . Based on available acute toxicity data BAS 510 F and its formulated products do not pose acute toxicity risks. The acute toxicity studies place technical BAS 510 F in toxicity category IV for acute oral; category III for acute dermal and category IV for acute inhalation. BAS 510 F is category IV for both eye and skin irritation, and it is not a dermal sensitizer. Two formulated end use products are proposed, a Water Dispersible Granule (WG) termed BAS 510 02F containing 70% BAS 510 F and a Water Dispersible Granule (WG) termed BAS 516 02F containing a 2:1 mixture of BAS 510 F and BAS 500F. BAS 510 02F has an acute oral toxicity category of III, acute dermal of III, acute inhalation of IV, eye irritation of III, skin irritation of IV, and is not a dermal sensitizer. BAS 516 02F has an acute oral toxicity category of III, acute dermal of III, acute inhalation of IV, eye irritation of III, skin irritation of IV, and is not a dermal sensitizer.

2. Genotoxicity . Ames Test (1 Study; point mutation): Negative; In Vitro CHO/HGPRT Locus Mammalian Cell Mutation Assay (1 Study; point mutation): Negative; In Vitro V79 Cell Cytogenetic Assay (1 Study; Chromosome Damage): Negative; In Vivo Mouse Micronucleus (1 Study; Chromosome Damage): Negative; In Vitro Rat Hepatocyte (1 Study; DNA damage and repair): Negative. BAS 510 F has been tested in a total of 5 genetic toxicology assays consisting of in vitro and in vivo studies. It can be stated that BAS 510 F did not show any mutagenic, clastogenic or other genotoxic activity when tested under the conditions of the studies mentioned above. Therefore, BAS 510 F does not pose a genotoxic hazard to humans.

3. Reproductive and developmental toxicity . The reproductive and developmental toxicity of BAS 510 F was investigated in a two-generation rat reproduction study as well as in rat and rabbit teratology studies.

There were no adverse effects on reproduction in the two-generation study at any dose tested. Pup effects were observed, with parental toxicity, at the highest dose tested only. In both parental generations, reduced food consumption and reduced bodyweight gain were observed at 10,000 ppm. Both absolute and relative liver weights were increased 21% in F 1 generation parental females at the high dose of 10,000 ppm only. Hepatocellular centrilobular hypertrophy (usually slight) was observed in many animals of both sexes in both the F 0 and F 1 generations at 1,000 ppm, and in all animals of both sexes at 10,000 ppm. Additionally, some of the parental male rats at 10,000 ppm, in both generations, displayed centrilobular liver cell degeneration. Developmental toxicity was seen at 1,000 ppm in the form of decreased pup weights in the F 2 males, and at 10,000 ppm in the form of decreased pup weight for both males and females of both the F 1 and F 2 generations. The parental systemic and developmental toxicity NOAEL's are both 100 ppm (12 mg/kg/day).

No teratogenic effects were noted in either the rat or rabbit developmental studies. In the rat study, evidence of maternal or developmental toxicity was not observed at any dose (highest dose tested of 1,000 mg/kg/day). Neither a maternal nor developmental LOAEL were found since the highest dose tested was the NOAEL in both studies.

In the rabbit teratology study, maternal toxicity observed at the mid dose of 300 mg/kg bw consisted of discolored/reduced feces in one dam and an abortion in one dam. This finding is not necessarily indicative of a definitive test substance related adverse effect. The dam which displayed the fecal alterations and abortion also displayed decreased body weight and body weight gain - compared to the group mean - during gestation. These decreases occurred even prior to compound administration. Food consumption was also dramatically decreased in this dam compared to the other animals in the group. Every day from gestation day 1 to 12, this dam had food consumption values, which were less than half the mean for the group (compound administration began on day GD 7) From gestation day 13 to 26 (when the animal aborted and was sacrificed) this dam ate essentially nothing (food consumption during this time period was less than or equal to 1.5 grams/day). These decreases in body weight, body weight gain, and food consumption, prior to compound administration, all indicate an animal in poor health and this poor state of health, rather than compound exposure, was likely the reason for the fecal alterations and abortion.

At the high dose of 1,000 mg/kg bw a maternal body weight gain decrease compared to controls of 81% was observed during the treatment period. Reduced food consumption, reduced body weight and abortions in three dams, were also seen at 1,000 mg/kg/day. Evidence of developmental toxicity was not seen at any dose tested.

Developmental neurotoxicity was not observed at any dose in the developmental neurotoxicity study. No maternal toxic effects were noted at any dose in this study. No developmental toxicity was seen at the low dose of 12 mg/kg/day (100 ppm). Reduced body weights and body weight gains were seen at 118 mg/kg/day (1,000 ppm) during PND 1-4. Reduced body weights and body weight gains were seen at 1,183 mg/kg/day (10,000 ppm) as well as decreased absolute pup brain weight at day 11 p.p. (both sexes) and decreased brain length (males only) at day 11 p.p. The reduced pup brain weights and decreased brain length go hand-in-hand and both are due to the decreased pup weights seen at this dose. In this respect, it should be noted that pup brain weights relative to body weight at p.p. 11 were not significantly different from controls at this dose.

Though no maternal toxicity was seen in this study, other studies using similar doses of BAS 510 F resulted in maternal toxicity. A dose of 118 mg/kg/day in female rats of the same strain in the multigeneration study, resulted in an increased incidence of hepatic centrilobular hypertrophy — a parameter which could not have been detected in the DNT study as liver histopathology on parental animals was not performed in the DNT study.

4. Subchronic toxicity . The subchronic toxicity of BAS 510 F was investigated in 90-day feeding studies with rats, mice and dogs, and in a 28-day dermal administration study in rats. A 90-day neurotoxicity study in rats was also performed. Generally, mild toxicity was observed. At high dose levels (doses above the LOAELs) in feeding studies, all three species displayed alterations in various clinical chemistry parameters. These clinical chemistry alterations were likely secondary to general toxicity. Statistically significant increased absolute and relative thyroid weights were observed in male rats only at doses at and above the LOAEL. Increased absolute and relative liver weights were observed in both sexes at doses above the LOAEL in rats and dogs. Increased absolute and relative liver weights were seen in both sexes of the mouse at lower doses. However, the increases in liver weights at these lower doses in the mouse were not deemed to be compound related due to the unusually low concurrent control liver weight values. At doses above the LOAELs, liver weight increases were supported by histopathology alterations in the rat and mouse, but not in the dog. Overall, only mild toxicity was observed in oral subchronic testing.

In the 28-day repeat dose dermal study, no systemic effects were noted up to the highest dose tested of 1,000 mg/kg/day.

In a 90-day rat neurotoxicity study, there was no mortality, signs of clinical toxicity, or adverse effects on food consumption or body weight at any dose level in either sex. No signs of neurotoxicity were observed during clinical observations, functional observation batteries, or motor activity measurements of neuropathology. Therefore, there were no selective neurotoxic effects. Adverse effects were not seen even at the highest dose level tested. A LOAEL was not found and the NOAEL is the highest tested of 15,000 ppm (1,050 mg/kg/day in males; 1,272 mg/kg/day in females).

5. Chronic toxicity . Based on review of the available data, the Reference Dose (RfD) for BAS 510 F will be based on a 24-month feeding study in rats with a threshold No-Effect Level (NOEL) of 5 mg/kg/day. Using an uncertainty factor of 100, the RfD is calculated to be 0.05 mg/kg/day. The following are summaries of chronic toxicity studies submitted to EPA.

The chronic toxicity/oncogenicity studies with BAS 510 F include a 12-month feeding study with Beagle dogs, an 18-month B63CF1 mouse feeding study, a 24-month Wistar rat chronic feeding study and a 24-month Wistar rat oncogenicity study.

At the highest dose tested in dogs, effects observed consisted primarily of increased liver and thyroid weights and some serum clinical chemistry changes. The NOAEL was 800 ppm (21.8 mg/kg bw males; 22.1 mg/kg bw females).

Decreased body weights were seen in males in the mouse chronic study at doses of 400 ppm and above. Decreased female body weight was seen at doses of 2000 ppm and above. The target organ in this study was the liver. In both the rat chronic and oncogenicity studies, the highest dose tested of 15,000 ppm exceeded a maximum tolerated dose (MTD) and was discontinued after 17 months. Effects observed at the next highest dose of 2,500 ppm primarily centered around the thyroid and liver.

Overall, mild toxicity was observed with chronic exposure to BAS 510 F. No evidence of treatment-induced oncogenicity was observed in the mouse or dog studies. A slight increase in thyroid follicular cell adenomas was seen in both sexes at the high dose when the data from both rat bioassays are combined.

A mode of action (MOA) for the thyroid follicular cell adenomas has been proposed. This MOA is based on the EPA publication “Assessment of Thyroid Follicular Cell Tumors,” March 1998, EPA/630/R-97/002. This document describes the criteria, which must be met in order for a compound to be considered under the MOA described in that publication. BASF Corporation believes that BAS 510 F has met the cited criteria.

6. Threshold effects . Based on a review of the available chronic toxicity data, BASF believes EPA will establish the Reference Dose (RfD) for BAS 510 F at 0.05 mg/kg/day. This RfD for BAS 510 F is based on the 2-year chronic and 2-year oncogenicity studies in rats with a threshold average NOEL of 5 mg/kg/day for males and females. Using an uncertainty factor of 100, the RfD is calculated to be 0.05 mg/kg/day. Based on the acute toxicity data, BASF believes that 510 F does not pose any acute dietary risks.

BAS 510 F was shown to be non-carcinogenic in mice and dogs. There was a slight increase in thyroid follicular cell adenomas at the high dose in both sexes in the rat. A threshold-based mode of action for these tumors based on the EPA publication “Assessment of Thyroid Follicular Cell Tumors” (EPA/630/R-97/002, March, 1998) has been proposed. BASF believes the data to support this proposed mode of action are strong, and that the thyroid tumors seen in the rat following BAS 510 exposure have a threshold. In addition, a battery of genotoxicity studies demonstrated that BAS 510 F has no genotoxic or clastogenic potential. Therefore, BASF believes that the threshold approach to regulating BAS 510 F is appropriate. Also, it should be noted that, while the Agency has in the past considered tumors of this type to be potential human carcinogens, the European Union has published a policy which considers these tumor types, when they occur at low incidence rates in the rat, to not be relevant to man. (The publication: “European Commission, European Chemicals Bureau, ECBI/49/99 — Add. 1 Rev. 2; Draft Summary Record, Commission Group of Specialized Experts in the fields of Carcinogenicity, Mutagenicity and Reprotoxicity, Meeting at Arona, 1 - 2 September 1999).” Therefore, BASF believes that these tumors are not likely relevant to humans and, if these tumors are to be considered relevant to humans, the threshold approach to cancer risk assessment is appropriate.

7. Animal metabolism . In the rat, the predominant route of excretion of BAS 510 F is fecal with urinary excretion being minor. The half-life of BAS 510 F is less than 24 hours. Saturation of absorption appears to be occurring at the high dose level. BAS 510 F is rapidly and intensively metabolized to a large number of biotransformation products. The hydroxylation of the diphenyl moiety was the quantitatively most important pathway. Second most important was the substitution of the Cl of the 2-chloropyridine part against SH by conjugation with glutathione. No major differences were observed with regard to label, sex, and dose level.

In hens and goats the residues of concern were determined to be parent, the hydroxylated metabolite M510 F01 (2-chloro- N -(4′chloro-5-hydroxy-biphenyl-2-yl)nicotinamide), and the glucuronic acid of the metabolite M510 F02.

8. Metabolite toxicology . No additional studies were required for metabolite toxicology.

9. Endocrine disruption . No specific tests have been conducted with BAS 510 F to determine whether the chemical may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen or other endocrine effects. However, there were no significant findings in other relevant toxicity studies (i.e., subchronic and chronic toxicity, teratology and multi-generation reproductive studies) which would suggest that BAS 510 F produces endocrine related effects.

1. Dietary exposure —i. Food . A chronic dietary exposure analysis was conducted for BAS 510 F including crops which are target uses as well as inadvertent residues in rotational crops. The analysis assumed 100% of the crops were treated, default processing factors (even though much lower experimentally-derived processing factors are available), and used the tolerance value for residues. Even with these worst-case assumptions, it was determined that the Theoretical Maximum Residue Contribution (TMRC) was only 30.1% of the reference dose for the U.S. population and 62.5% for children 1-6 years (the highest exposed age-related subpopulation).

Based on the toxicology results, an acute dietary risk assessment for BAS 510 F is most likely not required, but if so only for children 1-6 years. For dietary exposure estimation, 100% crop treated and tolerance values for residues were used. The resulting acute exposure prediction for children 1-6 years (the highest exposed age-related subpopulation) resulted in an acceptable 8.8% of the acute reference dose at the 95th percentile. If a more realistic scenario were used assuming percent crop treated and the range of residues, a much lower exposure would be obtained.

ii. Drinking water . Estimates of ground and surface water levels were determined using SCIGROW and FIRST models, respectively. The drinking water level of concerns (DWLOCs) for chronic exposure is obtained by subtracting the chronic dietary food. This is outlined in the following table.

Overall, using worst-case parameters the predicted aggregate exposure by all potential routes for both adults and children is less than the chronic reference dose.

2. Non-dietary exposure . BAS 510 F is not currently planned for residential uses. Thus, residential exposure is not aggregated into the risk assessment.

Section 408(b)(2)(D)(v) requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” BAS 510 F is a foliar fungicide chemically belonging to the carboxin class of fungicides. BAS 510 F acts in the fungal cell by inhibiting mitochondrial respiration through inhibition of the succinate-ubiquinone oxidase reductase system in Complex II of the mitochondrial electron transport chain. BAS 510 F shares this mode of action with only one other currently registered U.S. pesticide — carboxin.

The EPA is currently developing methodology to perform cumulative risk assessments. At this time, there is no available data to determine whether BAS 510 F has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, BAS 510 F does not appear to produce a toxic metabolite produced by other substances.

1. U.S. population . Using the conservative exposure assumptions described above and based on the completeness and the reliability of the toxicity data, BASF has estimated that aggregate exposure to BAS 510 F will utilize 30.2% of the RfD for the U.S. population. For the highest exposed age-related subpopulation (children 1-6 years), the maximum aggregate exposure is predicted to be 62.8% of the reference dose. BASF concludes that there is a reasonable certainty that no harm will result from the aggregate exposure to residues of BAS 510 F, including anticipated dietary and drinking water exposures and non-occupational exposures.

2. Infants and children —i. developmental toxicity in the Rat . A developmental study was conducted via oral gavage in rats with dosages of 0, 100, 300 and 1,000 mg/kg bw/day with a maternal and developmental No-Adverse-Effect Level (NOAEL) of 1,000 mg/kg. No evidence of developmental toxicity was observed up to the highest dose tested.

3. Developmental toxicity in the rabbit . A developmental study was conducted via oral gavage in rabbits with dosages of 0, 100, 300 and 1,000 mg/kg bw/day. The NOAEL for maternal toxicity was 100 mg/kg bw/day and was 1,000 mg/kg/day for developmental toxicity. As noted above in section 3.0, this NOAEL is based on fecal alterations and an abortion in a single dam at the next highest dose of 300 mg/kg/day. The dam which displayed the fecal alterations and abortion also displayed decreased body weight, body weight gain and food consumption, compared to the group mean, during gestation. These decreases occurred even prior to compound administration. These decreases in body weight, body weight gain, and food consumption, prior to compound administration, all indicate an animal in poor health and this poor state of health, rather than compound exposure, was likely the reason for the fecal alterations and abortion. No teratogenic effects were observed at any dose level.

i. Reproductive toxicity . A two-generation reproduction study in rats was conducted with dosages of 0, 12, 118, and 1,183 mg/kg bw/day. No impairment of reproductive function was noted at any dose. The parental and developmental NOAEL are both 12 mg/kg/day. Mild effects in both the parents and pups were noted at 118 mg/kg/day and consisted of an increased incidence of hepatic centrilobular hypertrophy in parents and, in the pups, slightly decreased body weight and body weight gain (7%) in F 2 generation only, and only in males. At 1,183 mg/kg/day paternal effects included decreased body weights and food consumption, increased liver weights and increased incidence of hepatic centrilobular hypertrophy and degeneration. Pup effects at this dose were an increase in pup mortality in the F 2 only and decreased body weight in F 1 and F 2 .

ii. Reference dose . In all reproductive studies, the NOAEL's for developmental effects were either equal to or higher than those for the parents. Therefore, BAS 510 F shows no selective toxicity for the young. In addition, there were no direct neurotoxicity effects noted in either the acute or subchronic neurotoxicity studies.

Based on these results, no additional safety factors to protect children are warranted. Since the reproductive studies NOAEL's are higher than the RfD calculated from the chronic rat study, BASF believes the Reference Dose of 0.05 mg/kg/day is also appropriate to measure safety for infants and children. Therefore, the chronic Population Adjusted Dose (cPAD) is also 0.05 mg/kg bw/day.

A maximum residue level (MRL) has not been established for BAS 510 F in any crop by the Codex Alimentarius Commission.

Section 103(d) of the Americans with Disabilities Act of 1990, 42 U.S.C. 12113(d), requires the Secretary of Health and Human Services to:

1. Review all infectious and communicable diseases which may be transmitted through handling the food supply;

2. Publish a list of infectious and communicable diseases which are transmitted through handling the food supply;

3. Publish the methods by which such diseases are transmitted; and

4. Widely disseminate such information regarding the list of diseases and their modes of transmissibility to the general public.

Additionally, the list is to be updated annually.

Since the last publication of the list on September 27, 2002 (67 FR 61109), new information has been reviewed and added. Norwalk and Norwalk-like viruses, previously listed in Part l, are now identified as Noroviruses so as to conform with current scientific nomenclature.

The contamination of raw ingredients from infected food-producing animals and cross-contamination during processing are more prevalent causes of foodborne disease than is contamination of foods by persons with infectious or contagious diseases. However, some pathogens are frequently transmitted by food contaminated by infected persons. The presence of any one of the following signs or symptoms in persons who handle food may indicate infection by a pathogen that could be transmitted to others through handling the food supply: Diarrhea, vomiting, open skin sores, boils, fever, dark urine, or jaundice. The failure of food-handlers to wash hands (in situations such as after using the toilet, handling raw meat, cleaning spills, or carrying garbage, for example), wear clean gloves, or use clean utensils is responsible for the foodborne transmission of these pathogens. Non-foodborne routes of transmission, such as from one person to another, are also major contributors in the spread of these pathogens. Pathogens that can cause diseases after an infected person handles food are the following:

Other pathogens are occasionally transmitted by infected persons who handle food, but usually cause disease when food is intrinsically contaminated or cross-contaminated during processing or preparation. Bacterial pathogens in this category often require a period of temperature abuse to permit their multiplication to an infectious dose before they will cause disease in consumers. Preventing food contact by persons who have an acute diarrheal illness will decrease the risk of transmitting the following pathogens:

In the Federal Register of July 11, 2003, (68 FR 41384), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0516. The approval expires on October 31, 2006. A copy of the supporting statement for this information collection is available on the Internet at http://www.fda.gov/ohrms/dockets.

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 (the 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 (21 CFR 314.162). Regulations also provide that the agency must make a determination as to 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 (§ 314.161(a)(1) (21 CFR 314.161(a)(1))). FDA may not approve an ANDA that does not refer to a listed drug.

Lachman Consultant Services, Inc., submitted a citizen petition dated December 5, 2002 (Docket No. 02P-0506/CP1), under 21 CFR 10.30 to FDA requesting that the agency determine whether hyaluronidase for injection was withdrawn from sale for reasons of safety or effectiveness. On January 8, 2003, Amphastar Pharmaceuticals, Inc., submitted a citizen petition (Docket No. 03P-0021/CP1) requesting the same action. On July 15, 2003, Merchant-Taylor International, Inc. (MTI), on behalf of Hyalozyme Therapeutics, Inc., filed a comment to both citizen petitions requesting that FDA determine that hyaluronidase for injection was withdrawn from sale for reasons of safety and effectiveness. Hyaluronidase for injection is the subject of approved NDA 6-343, formerly held by Wyeth Pharmaceuticals, Inc. (Wyeth), now held by Baxter Healthcare Corp. Hyaluronidase for injection is a protein enzyme and is a preparation of highly purified bovine testicular hyaluronidase used to increase the absorption and dispersion of other injected drugs. Wyeth ceased manufacture of hyaluronidase for injection in December 2001, and it was moved from the prescription drug product list to the “Discontinued Drug Product List” section of the Orange Book.

FDA has reviewed its records and the comment filed by MTI and, under § 314.161, has determined that hyaluronidase for injection was not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the agency will continue to list hyaluronidase for injection 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 hyaluronidase for injection may be approved by the agency; however, FDA recommends that in considering whether to file an ANDA for this drug product, future applicants be advised that such an application is likely to raise complex issues regarding the characterization of the active ingredient under section 505(j) of the act (see docket on conjugated estrogen drug products, Docket No. 98P-0311).

MDUFMA (Public Law 107-250) was signed into law on October 26, 2002. Section 201 of MDUFMA adds a paragraph “g” to section 704 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 374), directing FDA to accredit third parties (accredited persons or APs) to conduct inspections of eligible manufacturers of class II or class III devices. Participation in the program is voluntary. Manufacturers may continue to have FDA perform inspections or, if eligible, they may utilize an accredited person. The new law requires FDA, within 180 days from the date MDUFMA was signed into law, to publish in the Federal Register , criteria to accredit or deny accreditation to persons who request to perform these inspections (section 704(g)(2) of the act). FDA published the criteria it used to accredit persons for the purpose of conducting inspections of eligible manufacturers of class II and class III devices in the Federal Register of April 28, 2003 (68 FR 22400).

The new law also directed FDA to accredit up to 15 third parties to conduct inspections by no later than 1 year after MDUFMA was enacted and to publish on the FDA Internet site a list of persons who are accredited (21 U.S.C. 374(g) (4)). Under the new provision, FDA must update this list to ensure that the identity of each accredited person, and the particular activities for which the person is accredited, is known to the public. Under this new provision, FDA must also update the list no later than 1 month after the accreditation of a person, or the suspension or withdrawal of accreditation, or the modification of the particular activities for which the person is accredited.

FDA is currently developing guidance to help establishments determine whether they are qualified to participate in the third party inspection program. Because all accredited persons will have to complete training before conducting independent inspections under the new program, these APs will not be available to companies for several months. FDA plans to make the guidance available before the APs have completed the training. In the meantime, any company that is interested in participating in the third party inspection program may contact the contact person (see FOR FURTHER INFORMATION CONTACT ) to get more information about eligibility.

Persons interested in obtaining a copy of the list of accredited persons may also do so by using the Internet. The CDRH Web site may be accessed at http://www.fda.gov/cdrh . The list of accredited persons is available at http://www.fda.gov/cdrh/ap-inspection/ .

In the Federal Register January 30, 1998 (63 FR 4571), FDA revised 21 CFR 814.44(d) and 814.45(d) to discontinue individual publication of PMA approvals and denials in the Federal Register . Instead, the agency now posts this information to FDA's home page at http://www.fda.gov on the Internet. FDA believes that this procedure expedites public notification of these actions because announcements can be placed on the Internet more quickly than they can be published in the Federal Register , and FDA believes that the Internet is accessible to more people than the Federal Register .

In accordance with section 515(d)(4) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360e(d)(4) and (e)(2)), notification of an order approving, denying, or withdrawing approval of a PMA will continue to include a notice of opportunity to request review of the order under section 515(g) of the act. The 30-day period for requesting reconsideration of an FDA action under § 10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a PMA begins on the day the notice is placed on the Internet. Section 10.33(b) provides that FDA may, for good cause, extend this 30-day period. Reconsideration of a denial or withdrawal of approval of a PMA may be sought only by the applicant; in these cases, the 30-day period will begin when the applicant is notified by FDA in writing of its decision.

The regulations provide that FDA publish a quarterly list of available safety and effectiveness summaries of PMA approvals and denials that were announced during that quarter. The following is a list of approved PMAs for which summaries of safety and effectiveness were placed on the Internet from April 1, 2003, through June 30, 2003. There were no denial actions during this period. The list provides the manufacturer's name, the product's generic name or the trade name, and the approval date.

Persons with access to the Internet may obtain the documents at http://www.fda.gov/cdrh/pmapage.html .

The Program provides a system of no-fault compensation for certain individuals who have been injured by specified childhood vaccines. Subtitle 2 of Title XXI of the PHS Act, 42 U.S.C. 300aa-10 et seq., provides that those seeking compensation are to file a petition with the U.S. Court of Federal Claims and to serve a copy of the petition on the Secretary of Health and Human Services, who is named as the respondent in each proceeding. The Secretary has delegated his responsibility under the Program to HRSA. The Court is directed by statute to appoint special masters who take evidence, conduct hearings as appropriate, and make initial decisions as to eligibility for, and amount of, compensation.

A petition may be filed with respect to injuries, disabilities, illnesses, conditions, and deaths resulting from vaccines described in the Vaccine Injury Table (the Table) set forth at section 2114 of the PHS Act or as set forth at 42 CFR 100.3, as applicable. This Table lists for each covered childhood vaccine the conditions which will lead to compensation and, for each condition, the time period for occurrence of the first symptom or manifestation of onset or of significant aggravation after vaccine administration. Compensation may also be awarded for conditions not listed in the Table and for conditions that are manifested after the time periods specified in the Table, but only if the petitioner shows that the condition was caused by one of the listed vaccines.

Section 2112(b)(2) of the PHS Act, 42 U.S.C. 300aa-12(b)(2), requires that the Secretary publish in the Federal Register a notice of each petition filed. Set forth below is a list of petitions received by HRSA on April 1, 2003, through June 30, 2003.

Section 2112(b)(2) also provides that the special master “shall afford all interested persons an opportunity to submit relevant, written information” relating to the following:

1. The existence of evidence “that there is not a preponderance of the evidence that the illness, disability, injury, condition, or death described in the petition is due to factors unrelated to the administration of the vaccine described in the petition,” and

2. Any allegation in a petition that the petitioner either:

(a) “Sustained, or had significantly aggravated, any illness, disability, injury, or condition not set forth in the Table but which was caused by” one of the vaccines referred to in the Table, or

(b) “Sustained, or had significantly aggravated, any illness, disability, injury, or condition set forth in the Table the first symptom or manifestation of the onset or significant aggravation of which did not occur within the time period set forth in the Table but which was caused by a vaccine” referred to in the Table.

This notice will also serve as the special master's invitation to all interested persons to submit written information relevant to the issues described above in the case of the petitions listed below. Any person choosing to do so should file an original and three (3) copies of the information with the Clerk of the U.S. Court of Federal Claims at the address listed above (under the heading “For Further Information Contact”), with a copy to HRSA addressed to Director, Division of Vaccine Injury Compensation Program, Office of Special Programs, 5600 Fishers Lane, Room 16C-17, Rockville, MD 20857. The Court's caption (Petitioner's Name v. Secretary of Health and Human Services) and the docket number assigned to the petition should be used as the caption for the written submission.

Chapter 35 of title 44, United States Code, related to paperwork reduction, does not apply to information required for purposes of carrying out the Program.