Rules and Regulations. Correcting amendments

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BILLING CODE 4910-13-M SOCIAL SECURITY ADMINISTRATION 20 CFR Part 402 [Regulation No. 2; Docket No. SSA-2007-0020] RIN 0960-AG46 Technical Amendments To Correct Cross-References AGENCY: Social Security Administration. ACTION: Correcting amendments. SUMMARY: This document contains three technical corrections to our regulations. We are changing three cross-references because they are currently incorrect. EFFECTIVE DATE: Effective on March 29, 2007. FOR FURTHER INFORMATION CONTACT: Rosemarie A. Greenwald, Social Insurance Specialist, Office of Regulations, Social Security Administration, 6401 Security Boulevard, Baltimore, MD 21235-6401. Call

(410)966-7813 or TTY 1-800-325-0778 for information about these correcting amendments. For information on eligibility or filing for benefits, call our national toll-free numbers 1-(800)-772-1213 or TTY 1-(800)-325-0778. You may also contact Social Security online at *http://www.socialsecurity.gov/* . SUPPLEMENTARY INFORMATION: We are making corrections to our current regulations at 20 CFR 402.35(b)(2) which contain errors. The three cross-references in the last sentence of § 402.35(b)(2) incorrectly show §§ 404.984(b), 410.610c(b) and 416.1484(b). We are changing these to reflect the correct cross-references. (Catalog of Federal Domestic Assistance Programs Nos. 96.001 Social Security—Disability Insurance; 96.002 Social Security—Retirement Insurance; 96.004 Social Security—Survivors Insurance and 96.006 Supplemental Security Income. List of Subjects in 20 CFR Part 402 Administrative practice and procedure; Freedom of information. Dated: March 21, 2007. Paul Kryglik, Acting SSA Regulations Officer. For the reasons set out in the preamble, part 402 of chapter III of title 20 of the Code of Federal Regulations is corrected by making the following correcting amendments: PART 402—AVAILABILITY OF INFORMATION AND RECORDS TO THE PUBLIC 1. The authority citation for part 402 continues to read as follows: Authority: Secs. 205, 702(a)(5), and 1106 of the Social Security Act; (42 U.S.C. 405, 902(a)(5), and 1306); 5 U.S.C. 552 and 552a; 8 U.S.C. 1360; 18 U.S.C. 1905; 26 U.S.C. 6103; 30 U.S.C. 923(b); 31 U.S.C. 9701; E.O. 12600, 52 FR 23781, 3 CFR, 1987 Comp., p. 235. 2. Section 402.35 is corrected by revising the last sentence of paragraph (b)(2) to read as follows: § 402.35 Publication.

(b)* * *

(2)* * * For a description of Social Security Acquiescence Rulings, see 20 CFR 404.985(c), 410.670c(b), and 416.1485(c) of this title. [FR Doc. E7-5494 Filed 3-28-07; 8:45 am] BILLING CODE 4191-02-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 201 and 310 [Docket No. 1978N-0036L] (formerly Docket No. 1978N-036L) RIN 0910-AF38 Laxative Drug Products for Over-the-Counter Human Use; Psyllium Ingredients in Granular Dosage Forms AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration

(FDA)is issuing a final rule establishing that over-the-counter

(OTC)laxative drug products in granular dosage form containing the bulk-forming psyllium ingredients (psyllium (hemicellulose), psyllium hydrophilic mucilloid, psyllium seed, psyllium seed (blond), psyllium seed husks, plantago ovata husks, and plantago seed) are not generally recognized as safe and effective (GRASE) and are misbranded. This final rule includes, but is not limited to, any granules that are swallowed dry prior to drinking liquid; dispersed, suspended, or partially dissolved in liquid prior to swallowing; chewed, partially chewed, or unchewed, and then washed down (or swallowed) with liquid; or sprinkled over food. FDA is issuing this final rule after considering reports of esophageal obstruction associated with the use of psyllium laxatives in granular dosage form. These cases continue to occur despite efforts to promote safe use through label warnings and directions. This final rule does not apply to psyllium laxatives in nongranular dosage forms, such as powders, tablets, or wafers. This final rule is part of FDA's ongoing review of OTC drug products. DATES: *Effective Date* : This rule is effective October 1, 2007. *Compliance Date* : The compliance date for all products subject to this final rule, including products with annual sales less than $25,000, is October 1, 2007. ADDRESSES: For access to the docket to read background documents or comments received, go to *http://www.fda.gov/ohrms/dockets/default.htm* and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts, and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Reynold Tan, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, MS 5411, Silver Spring, MD 20993-0002, 301-796-2090. SUPPLEMENTARY INFORMATION: I. Background In the advance notice of proposed rulemaking (ANPRM) for OTC laxative, antidiarrheal, emetic, and antiemetic drug products (40 FR 12902 at 12906, March 21, 1975), the advisory review panel on OTC laxative, antidiarrheal, emetic, and antiemetic drug products (the Panel) recommended Category I (GRASE and not misbranded) status for the OTC bulk laxative psyllium ingredients, which included plantago seed, plantago ovata husks, psyllium (hemicellulose), psyllium hydrophilic mucilloid, psyllium seed, psyllium seed (blond), and psyllium seed husks. FDA concurred with the Panel's Category I classification of these ingredients in the tentative final monograph

(TFM)published in the **Federal Register** of January 15, 1985 (50 FR 2124 at 2152). In the ANPRM, the Panel recommended a warning statement (21 CFR 334.52(a)(1)) for bulk-forming laxatives that advised drinking a full glass, 8 ounces (oz), of liquid with each dose and direction statements (§ 334.10(f)) advising adequate fluid intake (40 FR 12902 at 12942). The Panel concluded that adequate fluid intake was necessary for the proper use of bulk-forming laxatives, because esophageal and intestinal obstruction had occurred from ingesting bulk-forming laxatives with insufficient water or in the presence of certain disease conditions (40 FR 12908). FDA discussed in comments 36 and 37 of the TFM (50 FR 2124 at 2131 and 2132) the risk of esophageal obstruction from certain bulk laxative ingredients, including water-soluble gums, and the need for adequate fluid intake (8 oz) with each dose. FDA proposed the direction “Drink a full glass (8 oz) of liquid with each dose” to define adequate fluid intake. In the **Federal Register** of October 1, 1986 (51 FR 35136), FDA amended the TFM and proposed that daily doses of bulk-forming laxative ingredients be administered in divided doses, rather than a single dose. The amendment was based on data that indicated the maximum daily dose of some bulk-forming laxatives was so large that it could pose a risk of esophageal obstruction if taken at one time (51 FR 35136). Subsequently, cases of esophageal obstruction due to ingestion of laxative products containing water-soluble gums, hydrophilic gums, and hydrophilic mucilloids, including psyllium, were reported and FDA published a proposed rule in the **Federal Register** of October 30, 1990 (55 FR 45782) to require a warning in the labeling of all OTC drug products containing water-soluble gums as active ingredients. FDA added the warning to alert users to take adequate fluid and to avoid using these products if the person had previously experienced any difficulty in swallowing. FDA followed up by publishing a final rule requiring new warning and direction statements in the **Federal Register** of August 26, 1993 (58 FR 45194) and amended that rule in the **Federal Register** of March 17, 1999 (64 FR 13254 at 13292). The current warnings and directions (in § 201.319(b) (21 CFR 201.319(b)) state: “‘Choking’ [highlighted in bold type]: Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention;” and “‘Directions’ [highlighted in bold type]:” (Select one of the following, as appropriate: “Take” or “Mix”) “this product (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. See choking warning.” FDA later considered data and other information about the safety of laxative products in granular dosage form containing psyllium, one of the active ingredients included in the water-soluble gum category. FDA tentatively concluded that these products posed an unacceptable safety risk, because esophageal obstructions continued to occur with these products despite requiring label warnings and directions. In the **Federal Register** of August 5, 2003 (68 FR 46133), FDA proposed an amendment to the laxative TFM to reclassify psyllium laxatives in granular dosage form from Category I to Category II (not GRASE or misbranded). In response to the proposed amendment, one manufacturer of a psyllium laxative product in a granular dosage form submitted a comment that is discussed in section II of this document. II. FDA's Conclusions on the Comment (Comment 1) The comment disagreed with FDA's proposal to reclassify psyllium laxative products in granular dosage form from Category I to Category II. The comment argued that the proposed rule should be withdrawn for the following reasons: • FDA's analysis overstated the risks of granular psyllium. The comment stated that the number of events potentially related to psyllium products in granular dosage form is small relative to the number of doses taken by consumers. Further, of the 78 total cases of esophageal obstruction recorded for the company's granular dosage form product in FDA's Adverse Event Reporting System by the year 2000 (Ref. 1), only 17 cases had occurred since 1989. The comment's product was introduced to the U.S. market in 1980. Therefore, the comment contended that the 17 cases that occurred from 1989 to 2000 was not a basis for increased safety concern considering that 61 cases occurred from 1980 to 1989. • FDA's analysis concentrated improperly on the granular dosage form of psyllium products. The comment argued that the data reviewed by FDA contained information suggesting that psyllium products in powder dosage forms may present more serious safety problems (e.g., asphyxiation) than granular dosage forms. The comment further contended that because FDA published the August 26, 1993, final rule requiring warning and direction statements for all water-soluble gum products, FDA has focused solely on psyllium products in granular dosage form and ignored serious adverse effects associated with other dosage forms. The comment argued that the failure to use the same methods to obtain adverse events data for psyllium products in both granular and nongranular dosage forms undermines FDA's conclusion that only granular dosage forms pose an unacceptable risk. Of the 98 adverse events associated with all psyllium products recorded by FDA between 1966 to 2000 (Ref. 1), 3 deaths were associated with powder dosage forms compared to only 1 death associated with granular dosage forms, which the comment contended was not directly caused by the granular dosage form (Ref. 2). The comment stated that FDA emphasized the single fatality associated with psyllium laxatives in the granular dosage form, but ignored the fatalities associated with psyllium laxatives in nongranular dosage forms. The comment stated that the record of fatalities did not support FDA's conclusions concerning the risk from granular dosage forms containing psyllium. Rather, FDA should have requested safety records from manufacturers of nongranular dosage forms, similar to those requested from the distributor of a granular product. • FDA failed to consider the benefits of granular psyllium products. The comment contended that psyllium laxatives in granular dosage form are preferred by millions of consumers over powder and other forms, are the most widely used laxative drugs in the world, and have provided safe and effective relief for many years. The comment submitted an article (Ref. 3) that reported a clinical study comparing psyllium-containing products in granular and powder dosage forms in constipated subjects. In the study, the psyllium plus senna combination product in granular dosage form was significantly superior to the psyllium-only product in powder dosage form with respect to stool frequency, moisture content, and weight. • FDA should consider foreign safety data. The comment submitted listings of suspected foreign cases of dysphagia (difficulty in swallowing) associated with the use of its two psyllium laxative products in granular dosage form from 1980 to 2003 (Refs. 4 and 5). The comment reported three serious, and five nonserious, cases for the company's psyllium plus senna laxative in granular dosage form and six serious, and two nonserious, cases for the company's psyllium-only laxative in granular dosage form. None of these cases resulted in serious injury or death. (Response) FDA disagrees that its analysis overstated the risks of psyllium products in granular dosage form. While the number of adverse events reports of esophageal blockage associated with psyllium laxatives in granular dosage form is low relative to the number of doses taken, many of the reports describe serious medical consequences. Of the 78 reports of esophageal obstruction and choking-related events associated with psyllium laxatives in granular dosage form, 59 required hospitalization or medical intervention, including endoscopic procedures to remove blockages (68 FR 46133 at 46134). The manufacturer's claim that 1 death among 78 adverse events indicates the relative safety of the company's granular dosage form product ignores the fact that these 78 events represent most of the 98 total events of esophageal obstruction associated with all dosage forms containing psyllium reported between 1966 and 2000 (68 FR 46133 at 46134). Although the comment claims that 17 case reports of esophageal obstruction from 1989 to 2000 should not be considered a basis for increased safety concern, FDA believes that reports of 44 adverse events related to esophageal obstruction reported between January 1999 and May 2002 (68 FR 46133 at 46135) does provide this basis. In 1993, FDA required labeling for all products containing water-soluble gums, including psyllium, to include a warning of possible esophageal obstruction and directions to take adequate fluid. Many of these recent events occurred even though the users had complied with the label directions. Thus, FDA has concerns that the problem of esophageal obstruction cannot be addressed through labeling. In addition, these adverse events are probably significantly underreported. OTC drugs without approved applications were not subject to mandatory reporting requirements, prior to the enactment of the Dietary Supplement and Nonprescription Drug Consumer Protection Act (S. 3546), which was signed by the President on December 22, 2006, and voluntary submission of reports by health professionals normally account for only about 10 percent of all reports in FDA's spontaneous reporting system. Under S. 3546, which amends the Federal Food, Drug, and Cosmetic Act, manufacturers, packers, or distributors of certain nonprescription drugs must report serious adverse events to FDA. FDA acknowledges the occurrence of esophageal obstruction and choking-related events associated with psyllium laxatives in nongranular dosage forms. In 2000, FDA reviewed reports from its adverse event reporting system

(AERS)database and the medical literature for esophageal obstruction and choking-related events associated with psyllium laxatives in all dosage forms, not granular dosage forms alone (Ref. 6). This review found 98 total adverse events. Of the four deaths reported, only one death was related to a psyllium laxative in a granular dosage form, swallowed unchewed with liquid. However, significantly more esophageal obstruction and choking-related events (78 out of 98) were associated with the granular dosage form compared to the powder or wafer dosage form (68 FR 46133 at 46135), and these events frequently required medical intervention (59 out of 78). Only 13 out of the 98 choking-related and esophageal obstruction events were reported for a leading psyllium laxative in powder dosage form. Only 2 of these 13 events were confirmed cases of esophageal obstruction, where a mass blocking the esophagus was actually visualized. The two events involved subjects who, along with a psyllium laxative in powder dosage form, took an additional medicine (contrast medium tablets or a pain relief caplet), which was later found in the blocking mass. In comparison, most of the events associated with the psyllium laxatives in granular dosage form (59 out of 78) were confirmed cases of esophageal obstruction, requiring medical intervention to relieve the obstruction. None of the esophageal obstruction cases associated with psyllium laxatives in granular dosage form mentioned an additional medicine being taken as a complicating factor. FDA subsequently requested an update of adverse events associated with psyllium laxatives in granular dosage form from a major manufacturer of these products. This manufacturer reported 43 events of esophageal obstruction associated with the company's psyllium products in granular dosage form occurring between January 1999 and January 2001 (Ref. 7). In May 2002, FDA searched the AERS database for events of esophageal obstruction that had occurred since the previous search in October 2000, and found one additional event caused by this same psyllium product in granular dosage form (Ref. 8). These more recent events occurred despite labeling changes initiated by the manufacturer, as well as labeling required by FDA (§ 201.319). FDA concludes that this safety risk posed by psyllium laxatives in granular dosage form outweighs the benefits of these products. To support its claim that FDA failed to consider the benefits of psyllium laxatives in granular dosage form, the comment contended that granular dosage forms are preferred by consumers over powder and other forms. However, many other OTC laxative drug products are available that have the same purpose as psyllium products in granular dosage form but without the associated danger of esophageal obstruction. FDA finds that the study by Marlett et al. (Ref. 3) submitted by the comment does not contribute any new data to support the safety of psyllium laxative products in granular dosage form. The article reports the results of a placebo-controlled, single-blind study comparing the effectiveness of two psyllium-containing laxatives, a granular dosage form containing psyllium plus senna and a powder dosage form containing psyllium only. FDA believes that any results suggesting that the granular dosage form is more effective than the powder dosage form are confounded by the comparison of products with different active ingredients—psyllium plus senna combined versus psyllium only. FDA reviewed the study for information relating to product safety. Only a few nonserious adverse events are reported for either treatment group. The small number of subjects

(42)precludes any conclusions about the safety of either formulation in the general population. FDA concludes that the submitted foreign safety data (Refs. 4 and 5), a total of 16 events that occurred outside the United States since 1980, do not add any significant evidence to support the safety of psyllium laxatives in granular dosage form. The comment reported three serious and five nonserious cases of dysphagia and/or esophageal obstruction following use of the company's psyllium and senna combination product in granular dosage form. The comment also reported six serious and two nonserious events for its psyllium-only product in granular dosage form. According to the comment, none of these events resulted in death or serious injury, and all of the people recovered. The comment claims these products are leading laxatives in Europe and this small number of serious adverse events demonstrates their safety. FDA finds the data inadequate to make any conclusion on safety. Further, FDA believes the data collected within the United States provides sufficient basis for a safety concern, without the need for additional consideration of foreign safety data. III. FDA's Final Conclusions on OTC Laxative Products in Granular Dosage Form Containing Psyllium Ingredients FDA finds that OTC laxative drug products in granular dosage form containing psyllium present an unnecessary risk of esophageal obstruction and choking. These serious medical emergencies continue to occur despite previous measures taken to promote safe use of these products, including required warning and direction statements in § 201.319 for all OTC drug products containing water-soluble gums, hydrophilic gums, or hydrophilic mucilloids as active ingredients, including psyllium ingredients in granular dosage form. These statements instruct consumers to take adequate fluid and to avoid using the product if the person has previously experienced any difficulty in swallowing. FDA is reclassifying bulk laxatives in granular dosage form containing psyllium ingredients from Category I (monograph) to Category II (nonmonograph). FDA is adding granular dosage forms containing psyllium ingredients to § 310.545(a)(12)(i) (21 CFR 310.545(a)(12)(i)), which lists those active ingredients currently without adequate data to establish general recognition of safety and effectiveness as a bulk laxative. Concurrently, FDA is revising § 201.319 to specifically exclude laxative drug products in granular dosage form containing psyllium ingredients. FDA concludes that the warnings and directions statements required in § 201.319 are not adequate to provide for the safe and effective use of psyllium products in granular dosage form. This final rule applies to OTC psyllium laxative drug products in granular dosage form that include, but are not limited to, any granules that are:

(1)Swallowed dry prior to drinking liquid,

(2)dispersed, suspended, or partially dissolved in liquid prior to swallowing,

(3)chewed, partially chewed, or unchewed, and then washed down (or swallowed) with liquid, or

(4)sprinkled over food. Part of an August 5, 2003, proposed rule for OTC laxative drug products proposes to exclude psyllium ingredients when contained in granular dosage forms from the list of GRASE bulk-forming psyllium laxative active ingredients in § 334.10 (21 CFR 334.10). We will finalize this part of the proposed rule to exclude psyllium ingredients when we publish the final monograph for OTC laxative drug products. Accordingly, any OTC laxative drug product in granular dosage form that contains psyllium is considered not GRASE and misbranded under section 502 of the act (21 U.S.C. 352). This type of drug product is considered a new drug under section 201(p) of the act (21 U.S.C. 321(p)) for which an approved application under section 505 of the act (21 U.S.C. 355), and set forth in part 314 of the regulations (21 CFR part 314), is required for marketing. This final rule applies to any OTC psyllium-containing laxative drug product in granular dosage form that is initially introduced or initially delivered for introduction into interstate commerce after the effective date of this final rule. Further, any OTC drug product that was previously initially introduced or initially delivered for introduction into interstate commerce cannot then be repackaged or relabeled after the effective date of this final rule. IV. Analysis of Impacts In accordance with Executive Order 12866, FDA has previously analyzed the potential economic effects of this final rule (68 FR 46133 at 46136). As announced in the proposal, the agency has determined that the rule is not a significant regulatory action as defined by the Order. The agency has not received any new information or comments that would alter its previous determination. FDA has examined the impacts of this final rule under Executive Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this final rule is not a significant regulatory action under the Executive order. The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of the rule on small entities. Because of the limited number of products affected by this final rule, FDA does not believe that the final rule would have a significant economic impact on a substantial number of small entities. Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $122 million, using the most current

(2005)Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount. The purpose of this final rule is to establish conditions under which OTC bulk-forming laxatives in granular dosage form containing psyllium ingredients are not generally recognized as safe and effective. At the time this rule was proposed, FDA's drug listing system

(DLS)identified nine marketed OTC laxative drug products in granular dosage form containing psyllium ingredients, and FDA was aware of at least one other product not in its DLS. One manufacturer marketed three stock keeping units

(SKUs)(individual products, packages, and sizes) of the granular dosage form. This manufacturer has since reformulated its products and, therefore, will not incur any new costs under this final rule. Two manufacturers marketed two SKUs each, and one manufacturer marketed one SKU. This final rule will result in the reformulation or removal of probably less than 10 products. • Reformulation Costs Some manufacturers may elect not to reformulate (i.e., they may elect to discontinue marketing of the product). For those products that need reformulation, the cost can be significant. The cost to reformulate a product will vary greatly depending on the nature of the change in the formulation, the product, the process, and the size of the firm. A manufacturer may elect to change the dosage form of the psyllium product or to substitute other monograph ingredients. This would require the manufacturer to redo the validation (product, process, new supplier), conduct stability tests, change master production records in order to insure compliance with current good manufacturing practice, and, for some dosage forms, conduct palatability tests. (See section 501(a)(2)(B) of the act (21 U.S.C. 351(a)(2)(B) and 21 CFR parts 210 and 211.) FDA estimates the cost of reformulation to range from $100,000 to $500,000 per product. Therefore, if 10 products are reformulated, the midpoint of the cost estimate implies total costs of $3,000,000. However, FDA believes the total costs will be much smaller because not all manufacturers will elect to reformulate and some may choose to discontinue a product line if sales are too low to justify the added cost, and/or they also produce substitute products that do not require reformulation. Also, the major U.S. manufacturer of psyllium laxatives in granular dosage form has already reformulated its products and will not incur any new costs due to this final rule. Manufacturers may also elect to purchase reformulated products from another manufacturer and then be a distributor of that product. Competitive market forces and increased public awareness of a potential safety hazard of these bulk-forming psyllium laxatives in granular dosage form would most likely lead all manufacturers to move to alternative products over time. • Relabeling Costs Manufacturers of these products will also incur costs to relabel their products to reflect the new formulation. Estimates of relabeling costs vary greatly and range from $3,000 to $5,000 per SKU depending on whether the products are nationally branded or private label. FDA estimates that manufacturers with more than one affected SKU will likely discontinue one or more SKUs. If some SKUs are discontinued, FDA estimates that only approximately three SKUs will need to be relabeled as a result of reformulation. If these SKUs are relabeled, the total one-time cost of relabeling is about $9,000 (three SKUs x $3,000) to $15,000 (three SKUs x $5,000). This relabeling cost should not be a significant economic impact on a substantial number of small entities. Some manufacturers may choose to submit an NDA deviation for their psyllium product in accordance with 21 CFR 330.11. Overall, there may be fewer costs incurred by this process than by submission of a full NDA. Because these products must be manufactured in compliance with pharmaceutical current good manufacturing practices (21 CFR parts 210 and 211), all firms currently have the necessary skills and personnel to perform the tasks of reformulation, validation, and relabeling either in-house or by contractual arrangement. This rule will not require any new reporting and recordkeeping activities. No additional professional skills are needed. • Regulatory Alternatives Considered FDA considered but rejected the following alternatives:

(1)Leave these products in the monograph, and

(2)an exemption from coverage for small entities. FDA does not believe that these or other alternatives to this final rule would adequately provide for the safe use of these OTC drug products. Based on the foregoing, FDA does not believe that this final rule would have a significant economic impact on a substantial number of small entities. However, FDA recognizes the uncertainty of its estimates with respect to the number of affected small entities and products, as well as the economic impact of the rule on those small entities. Thus, this economic analysis, together with other relevant sections, serves as FDA's final regulatory flexibility analysis. V. Paperwork Reduction Act of 1995 FDA concludes that any relabeling required by this final rule is not subject to review by the Office of Management and Budget because it does not constitute a “collection of information” under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq.* ). Rather, the relabeling statements are in the TFM for OTC laxative drug products (50 FR 2124 and 51 FR 35136) and are a “public disclosure of information originally supplied by the Federal Government to the recipient for the purpose of disclosure to the public” (5 CFR 1320.3(c)(2)). VI. Environmental Impact FDA has determined under 21 CFR 25.31(a) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. VII. Federalism FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule will have a preemptive effect on State law. Section 4(a) of the Executive order requires agencies to “construe * * * a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State authority conflicts with the exercise of Federal authority under the Federal statute.” Section 751 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 379r) is an express preemption provision. Section 751(a) of the act (21 U.S.C. 379r(a)) provides that: * * * no State or political subdivision of a State may establish or continue in effect any requirement-- * * *

(1)that relates to the regulation of a drug that is not subject to the requirements of section 503(b)(1) or 503(f)(1)(A); and

(2)that is different from or in addition to, or that is otherwise not identical with, a requirement under this Act, the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 *et seq.* ), or the Fair Packaging and Labeling Act (15 U.S.C. 1451 *et seq.* ).* * * Currently, this provision operates to preempt States from imposing requirements related to the regulation of nonprescription drug products. (See Section 751(b) through

(e)of the act for the scope of the express preemption provision, the exemption procedures, and the exceptions to the provision.) This final rule will establish that OTC laxative drug products in granular dosage form containing bulk-forming psyllium ingredients are not GRASE and are misbranded. Although this final rule would have a preemptive effect, in that it would preclude States from promulgating requirements related to OTC laxative drug products in granular dosage form containing psyllium ingredients that are different from or in addition to, or not otherwise identical with the requirements in this final rule, this preemptive effect is consistent with what Congress set forth in section 751 of the act. Section 751(a) of the act displaces both State legislative requirements and State common law duties. We also note that even where the express preemption provision is not applicable, implied preemption may arise. See *Geier* v. *American Honda Co.* , 529 US 861 (2000). FDA believes that the preemptive effect of the final rule would be consistent with Executive Order 13132. Section 4(e) of the Executive order provides that “when an agency proposes to act through adjudication or rulemaking to preempt State law, the agency shall provide all affected State and local officials notice and an opportunity for appropriate participation in the proceedings.” FDA provided the States with an opportunity for appropriate participation in this rulemaking when it sought input from all stakeholders through publication of the proposed rule in the **Federal Register** of August 5, 2003 (68 FR 46133). FDA received no comments from any States on the proposed rulemaking. In addition, on February 13, 2007, FDA's Division of Federal and State Relations provided notice via fax and e-mail transmission to elected officials of State governments and their representatives of national organizations. The notice provided the States with further opportunity for input on the rule. It advised the States of the publication of the August 5, 2003, proposed rule and encouraged State and local governments to review the notice and to provide any comments to the docket (Docket No. 1978N-0036L) by a date 30 days from the date of the notice (i.e., by March 14, 2007), or to contact certain named individuals. FDA received no comments in response to this notice. The notice has been filed in Docket No. 1978N-0036L. In conclusion, FDA believes that it has complied with all of the applicable requirements under the Executive order and has determined that the preemptive effects of this rule are consistent with Executive Order 13132. VIII. References The following references are on display in the Division of Dockets Management (see ADDRESSES ), under Docket No. 1978N-0036L, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. 1. Adverse Event Reports from 1966 to 2000 for Psyllium Laxative Products (Perdiem, Metamucil, and Serutan) collected by FDA's Office of Compliance, in OTC vol. 090TFM6. 2. Comment No. C00206, Attachment 1. 3. Comment No. C00206, Attachment 3. 4. Comment No. C00206, Attachment 4. 5. Comment No. C00206, Attachment 5. 6. FDA, Office of Postmarketing Drug Risk Assessment (OPDRA)(Project ID

(PID)000607) regarding Psyllium Laxative Products Associated with Esophageal Obstruction and Choking, November 17, 2000, in OTC vol. 090TFM6. 7. Adverse Event Reports from January 1999 to January 2001 for Overnight Relief PERDIEM and Fiber Therapy PERDIEM collected by FDA's Office of Compliance in January 2001, in OTC vol. 090TFM6. 8. FDA, OPDRA Postmarketing Safety Review (PID D020201) regarding Senokot and Psyllium Laxative Products Associated with Esophageal Obstruction and Choking, May 15, 2002, in OTC vol. 090TFM6. List of Subjects 21 CFR Part 201 Drugs, Labeling, Reporting and recordkeeping requirements. 21 CFR Part 310 Administrative practice and procedure, Drugs, Labeling, Medical devices, Reporting and recordkeeping requirements. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 201 and 310 are amended as follows: PART 201—LABELING 1. The authority citation for 21 CFR part 201 continues to read as follows: Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 358, 360, 360b, 360gg-360ss, 371, 374, 379e; 42 U.S.C. 216, 241, 262, 264. 2. Section 201.319 is amended by revising paragraph

(a)to read as follows: § 201.319 Water-soluble gums, hydrophilic gums, and hydrophilic mucilloids (including, but not limited to agar, alginic acid, calcium polycarbophil, carboxymethylcellulose sodium, carrageenan, chondrus, glucomannan ((B-1,4 linked) polymannose acetate), guar gum, karaya gum, kelp, methylcellulose, plantago seed (psyllium), polycarbophil, tragacanth, and xanthan gum) as active ingredients; required warnings and directions.

(a)Reports in the medical literature and data accumulated by the Food and Drug Administration indicate that esophageal obstruction and asphyxiation have been associated with the ingestion of water-soluble gums, hydrophilic gums, and hydrophilic mucilloids including, but not limited to, agar, alginic acid, calcium polycarbophil, carboxymethylcellulose sodium, carrageenan, chondrus, glucomannan ((B-1,4 linked) polymannose acetate), guar gum, karaya gum, kelp, methylcellulose, plantago seed (psyllium), polycarbophil, tragacanth, and xanthan gum. Esophageal obstruction and asphyxiation due to orally-administered drug products containing water-soluble gums, hydrophilic gums, and hydrophilic mucilloids as active ingredients are significant health risks when these products are taken without adequate fluid or when they are used by individuals with esophageal narrowing or dysfunction, or with difficulty in swallowing. Additional labeling is needed for the safe and effective use of any OTC drug product for human use containing a water-soluble gum, hydrophilic gum, or hydrophilic mucilloid as an active ingredient when marketed in a dry or incompletely hydrated form to include, but not limited to, the following dosage forms: Capsules, granules, powders, tablets, and wafers. Granular dosage forms containing psyllium are not generally recognized as safe and effective as OTC laxatives (see § 310.545(a)(12)(i)(B) of this chapter) and may not be marketed without an approved new drug application because the warnings and directions in paragraph

(b)of this section have been found inadequate for these products. PART 310—NEW DRUGS 1. The authority citation for 21 CFR part 310 continues to read as follows: Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360b-360f, 360j, 361(a), 371, 374, 375, 379e; 42 U.S.C. 216, 241, 242(a), 262, 263b-263n. 2. Section 310.545 is amended by redesignating paragraph (a)(12)(i) as paragraph (a)(12)(i)(A), by adding paragraph (a)(12)(i)(B), by revising paragraph

(d)introductory text and paragraph (d)(1), and by adding paragraph (d)(38) to read as follows: § 310.545 Drug products containing active ingredients offered over-the-counter

(OTC)for certain uses.

(a)* * *

(12)* * * (i)(B) *Bulk laxatives* — *Approved as of* March 29, 2007. Granular dosage forms containing psyllium (hemicellulose), psyllium hydrophilic mucilloid, psyllium seed, psyllium seed (blond), psyllium seed husks, plantago husks, or plantago seed including, but not limited to, any granules that are: ( *1* ) Swallowed dry prior to drinking liquid, ( *2* ) Dispersed, suspended, or partially dissolved in liquid prior to swallowing, ( *3* ) Chewed, partially chewed, or unchewed, and then washed down (or swallowed) with liquid, or ( *4* ) Sprinkled over food.

(d)Any OTC drug product that is not in compliance with this section is subject to regulatory action if initially introduced or initially delivered for introduction into interstate commerce after the dates specified in paragraphs (d)(1) through (d)(38) of this section.

(1)May 7, 1991, for products subject to paragraphs (a)(1) through (a)(2)(i), (a)(3)(i), (a)(4)(i), (a)(6)(i)(A), (a)(6)(ii)(A), (a)(7) (except as covered by paragraph (d)(3) of this section), (a)(8)(i), (a)(10)(i) through (a)(10)(iii), (a)(12)(i)(A), (a)(12)(ii) through (a)(12)(iv)(A), (a)(14) through (a)(15)(i), (a)(16) through (a)(18)(i)(A), (a)(18)(ii) (except as covered by paragraph (d)(22) of this section), (a)(18)(iii), (a)(18)(iv), (a)(18)(v)(A), and (a)(18)(vi)(A) of this section.

(38)October 1, 2007, for products subject to paragraph (a)(12)(i)(B) of this section. Dated: March 20, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-5740 Filed 3-28-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 [TD 9318] RIN 1545-BE57 Guidance Regarding the Simplified Service Cost Method and the Simplified Production Method AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Final regulations and removal of temporary regulations. SUMMARY: This document contains final regulations relating to the capitalization of costs under the simplified service cost method and the simplified production method provided by the Income Tax Regulations. For taxpayers that use the simplified service cost method or the simplified production method, the regulations clarify when self-constructed assets are produced on a routine and repetitive basis in the ordinary course of their businesses. DATES: *Effective Date:* These regulations are effective on March 29, 2007. *Applicability Date:* For dates of applicability, see §§ 1.263A-1(l) and 1.263A-2(f). FOR FURTHER INFORMATION CONTACT: Steven J. Gee or Donna M. Crawford,

(202)622-4970 (not a toll-free number). SUPPLEMENTARY INFORMATION: Background This document contains amendments to 26 CFR part 1. On August 2, 2005, the IRS and Treasury Department published in the **Federal Register** a notice of proposed rulemaking (REG-121584-05; 70 FR 44535) by cross reference to temporary regulations (TD 9217; 70 FR 44467) (collectively, the 2005 regulations) under section 263A of the Internal Revenue Code (Code). These regulations provide that self-constructed tangible personal property is considered produced on a routine and repetitive basis in the ordinary course of a taxpayer's trade or business for purposes of the simplified service cost method or the simplified production method when units of tangible personal property are mass-produced, that is, numerous substantially identical assets are manufactured within a taxable year using standardized designs and assembly line techniques, and the applicable recovery period of such assets under section 168(c) is not longer than 3 years. The IRS and Treasury Department issued Rev. Proc. 2006-11 (2006-3 IRB 309), see § 601.601(d)(2)(ii)( *b* ), which provides procedures by which a taxpayer changing its method of accounting to comply with § 1.263A-1T or § 1.263A-2T (issued under TD 9217) for its first taxable year ending on or after August 2, 2005, may request the consent of the Commissioner utilizing either the administrative procedures for requesting the advance consent of the Commissioner (for further guidance, for example, see Rev. Proc. 97-27 (1997-1 CB 680), as modified and amplified by Rev. Proc. 2002-19 (2002-1 CB 696), as amplified and clarified by Rev. Proc. 2002-54 (2002-2 CB 432), and § 601.601(d)(2)(ii)( *b* )), or the administrative procedures for obtaining the automatic consent of the Commissioner (for further guidance, for example, see Rev. Proc. 2002-9 (2002-1 CB 327), as modified and clarified by Announcement 2002-17 (2002-1 CB 561), modified and amplified by Rev. Proc. 2002-19 (2002-1 CB 696), and amplified, clarified, and modified by Rev. Proc. 2002-54 (2002-2 CB 432), and § 601.601(d)(2)(ii)( *b* )). These final regulations have been revised to be consistent with the procedures provided in Rev. Proc. 2006-11. One written comment was received in response to the 2005 regulations. No requests to speak at a public hearing were received, and no hearing was held. After consideration of the comment, the proposed regulations under section 263A are adopted by this Treasury decision. Summary of Comments A commentator expressed the belief that the categories of property, as described in Notice 88-86 (1988-2 CB 401), see § 601.601(d)(2)(ii)( *b* ), eligible for the simplified service cost method and the simplified production method represent a reasonable balance between technical accuracy and simplification. The commentator opposed the requirements in the 2005 regulations that, to qualify for the category of property “produced on a routine and repetitive basis,” the property must be mass-produced using standardized designs and assembly line techniques, and have an applicable recovery period of not longer than 3 years. The commentator argued that, with respect to electric utility companies, there is no sound tax policy to support limiting the application of the methods based on the manner in which self-constructed assets are produced or the number of years over which the self-constructed assets are depreciated. The commentator further stated that the preamble to the 2005 regulations did not explain why there may be a distortion of income from the use of the simplified methods, and why such a distortion justified distinctions based on the method of manufacturing and the recovery lives of property. The simplified methods are less accurate and less precise than a facts and circumstances method and, thus, may capitalize more or less costs than a facts and circumstances method. Therefore, the simplified methods may cause distortions when compared to a more accurate facts and circumstances method. The amount of distortion may not be very large for assets that are mass produced, because the underlying assumption of the simplified methods that costs are incurred ratably across all the assets may be appropriate. Additionally, any distortion caused by the lack of precision quickly reverses if the assets to which the methods may be applied typically have a high turnover rate, that is, a short recovery period. Inventory production frequently meets one or both of these two criteria. The IRS and Treasury Department provided the simplified methods for inventory because the reduction in the burdens of complying with the uniform capitalization rules generally outweighed the possible distortion within the simplified methods. Under temporary regulations published in the **Federal Register** on March 30, 1987 (TD 8131, 1987-1 CB 98, [52 FR 10052]) (1987 regulations), the simplified methods were available only to inventory and non-inventory property held by a taxpayer primarily for sale to customers in the ordinary course of the taxpayer's trade or business. The preamble to the 1987 regulations stated that the methods were “designed to alleviate the administrative burdens of complying with [section 263A] where mass production of assets occurs on a repetitive and routine basis, with a typically high ‘turnover’ rate for the produced assets.” The preamble to the 1987 regulations stated that the simplified methods could not be utilized with respect to self-constructed assets because the simplified methods were not appropriate for use “in accounting for casual or occasional production of property.” In response to comments suggesting that the categories of property eligible for the simplified service cost method and the simplified production method be expanded to include other categories of property with similar characteristics, Notice 88-86 expanded the availability of the methods, in relevant part, to “property constructed by a taxpayer for use in its trade or business if, in the ordinary course of its production activities, the taxpayer produces such property on a routine and repetitive basis (that is, the taxpayer produces numerous items of such property within a taxable year).” The final regulations published in the **Federal Register** on August 9, 1993 (TD 8482, 1993-2 CB 77, [58 FR 42198]) included the new category from Notice 88-86. The addition of certain self-constructed assets was merely intended to add another category of property with characteristics similar to inventory (mass produced or high turnover) and was not an indication that the application of the simplified methods to the production, whether or not casual or occasional, of all self-produced assets was considered appropriate. The IRS and Treasury Department continue to believe that to prevent distortion when applied to self-constructed property, the simplified service cost method and simplified production method should be limited to property that is mass produced and has a typically high “turnover” rate. Accordingly, the final regulations do not incorporate the commentator's suggestions. The regulations clarify, however, that property with a typically high “turnover” rate includes materials and supplies that are used and consumed within three years of being produced. The IRS and Treasury Department recognize that the application of the uniform capitalization requirements to self-constructed property can be burdensome, particularly to small taxpayers. The IRS and Treasury Department will consider proposing simplified methods for self-constructed property for small taxpayers in future guidance under section 263A. Additionally, a commentator indicated that for taxpayers that have both property that is eligible for the simplified methods and property that is ineligible for the simplified methods, the regulations do not provide specific procedures to determine how to allocate service costs and other indirect costs between the eligible property and the ineligible property. The IRS and Treasury Department agree that service costs and other indirect costs must be allocated to ineligible property as well as eligible property. However, prescribing specific procedures and methods for these allocations is beyond the scope of these regulations. The IRS and Treasury Department may address this issue in future guidance. Special Analyses It has been determined that this Treasury decision is not a significant regulatory action as defined in Executive Order 12866. Therefore, a regulatory assessment is not required. It also has been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to these regulations, and because the regulations do not impose a collection of information on small entities, the Regulatory Flexibility Act (5 U.S.C. chapter 6) does not apply. Pursuant to section 7805(f) of the Code, the notice of proposed rulemaking that preceded these regulations was submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on its impact on small business. Drafting Information The principal author of these regulations is Scott Rabinowitz of the Office of Associate Chief Counsel (Income Tax and Accounting). However, other personnel from the IRS and Treasury Department participated in their development. List of Subjects in 26 CFR Part 1 Income taxes, Reporting and recordkeeping requirements. Adoption of Amendments to the Regulations Accordingly, 26 CFR part 1 is amended as follows: PART 1—INCOME TAXES **Paragraph 1.** The authority citation for part 1 continues to read in part as follows: Authority: 26 U.S.C. 7805 * * * **Par. 2.** Section 1.263A-1 is amended by revising paragraphs (h)(2)(i)(D),

(k)and

(l)to read as follows: § 1.263A-1 Uniform capitalization of costs.

(h)* * *

(2)* * *

(i)* * *

(D)*Self-constructed tangible personal property produced on a routine and repetitive basis—(1) In general.* Self-constructed tangible personal property produced by the taxpayer on a routine and repetitive basis in the ordinary course of the taxpayer's trade or business. Self-constructed tangible personal property is produced by the taxpayer on a routine and repetitive basis in the ordinary course of the taxpayer's trade or business when units of tangible personal property (as defined in § 1.263A-10(c)) are mass-produced, that is, numerous substantially identical assets are manufactured within a taxable year using standardized designs and assembly line techniques, and either the applicable recovery period of the property determined under section 168(c) is not longer than 3 years or the property is a material or supply that will be used and consumed within 3 years of being produced. For purposes of this paragraph (h)(2)(i)(D), the applicable recovery period of the assets will be determined at the end of the taxable year in which the assets are placed in service for purposes of § 1.46-3(d). Subsequent changes to the applicable recovery period after the assets are placed in service will not affect the determination of whether the assets are produced on a routine and repetitive basis for purposes of this paragraph (h)(2)(i)(D). *(2) Examples.* The following examples illustrate this paragraph (h)(2)(i)(D): Example 1. Y is a manufacturer of automobiles. During the taxable year Y produces numerous substantially identical dies and molds using standardized designs and assembly line techniques. The dies and molds have a 3-year applicable recovery period for purposes of section 168(c). Y uses the dies and molds to produce or process particular automobile components and does not hold them for sale. The dies and molds are produced on a routine and repetitive basis in the ordinary course of Y's business for purposes of this paragraph because the dies and molds are both mass-produced and have a recovery period of not longer than 3 years. Example 2. Z is an electric utility that regularly manufactures and installs identical poles that are used in transmitting and distributing electricity. The poles have a 20-year applicable recovery period for purposes of section 168(c). The poles are not produced on a routine and repetitive basis in the ordinary course of Z's business for purposes of this paragraph because the poles have an applicable recovery period that is longer than 3 years.

(k)*Change in method of accounting* —(1) *In general.* A change in a taxpayer's treatment of mixed service costs to comply with paragraph (h)(2)(i)(D) of this section is a change in method of accounting to which the provisions of sections 446 and 481 and the regulations under those sections apply. See § 1.263A-7. For a taxpayer's first taxable year ending on or after August 2, 2005, the taxpayer is granted the consent of the Commissioner to change its method of accounting to comply with paragraph (h)(2)(i)(D) of this section, provided the taxpayer follows the administrative procedures, as modified by paragraphs (k)(2) through

(4)of this section, issued under § 1.446-1(e)(3)(ii) for obtaining the Commissioner's automatic consent to a change in accounting method (for further guidance, for example, see Rev. Proc. 2002-9 (2002-1 CB 327), as modified and clarified by Announcement 2002-17 (2002-1 CB 561), modified and amplified by Rev. Proc. 2002-19 (2002-1 CB 696), and amplified, clarified, and modified by Rev. Proc. 2002-54 (2002-2 CB 432), and § 601.601(d)(2)(ii)( *b* ) of this chapter). For purposes of Form 3115, “Application for Change in Accounting Method,” the designated number for the automatic accounting method change authorized by this paragraph

(k)is “95.” If Form 3115 is revised or renumbered, any reference in this section to that form is treated as a reference to the revised or renumbered form. Alternatively, notwithstanding the provisions of any administrative procedures that preclude a taxpayer from requesting the advance consent of the Commissioner to change a method of accounting that is required to be made pursuant to a published automatic change procedure, for its first taxable year ending on or after August 2, 2005, a taxpayer may request the advance consent of the Commissioner to change its method of accounting to comply with paragraph (h)(2)(i)(D) of this section, provided the taxpayer follows the administrative procedures, as modified by paragraphs (k)(2) through

(5)of this section, for obtaining the advance consent of the Commissioner (for further guidance, for example, see Rev. Proc. 97-27 (1997-1 CB 680), as modified and amplified by Rev. Proc. 2002-19 (2002-1 CB 696), as amplified and clarified by Rev. Proc. 2002-54 (2002-2 CB 432), and § 601.601(d)(2)(ii)( *b* ) of this chapter). For the taxpayer's second and subsequent taxable years ending on or after August 2, 2005, requests to secure the consent of the Commissioner must be made under the administrative procedures, as modified by paragraphs (k)(3) and

(4)of this section, for obtaining the Commissioner's advance consent to a change in accounting method.

(2)*Scope limitations.* Any limitations on obtaining the automatic consent or advance consent of the Commissioner do not apply to a taxpayer seeking to change its method of accounting to comply with paragraph (h)(2)(i)(D) of this section for its first taxable year ending on or after August 2, 2005.

(3)*Audit protection.* A taxpayer that changes its method of accounting in accordance with this paragraph

(k)to comply with paragraph (h)(2)(i)(D) of this section does not receive audit protection if its method of accounting for mixed service costs is an issue under consideration at the time the application is filed with the national office.

(4)*Section 481(a) adjustment.* A change in method of accounting to conform to paragraph (h)(2)(i)(D) of this section requires a section 481(a) adjustment. The section 481(a) adjustment period is two taxable years for a net positive adjustment for an accounting method change that is made to conform to paragraph (h)(2)(i)(D) of this section.

(5)*Time for requesting change.* Notwithstanding the provisions of § 1.446-1(e)(3)(i) and any contrary administrative procedure, a taxpayer may submit a request for advance consent to change its method of accounting to comply with paragraph (h)(2)(i)(D) of this section for its first taxable year ending on or after August 2, 2005, on or before the date that is 30 days after the end of the taxable year for which the change is requested.

(l)*Effective date.* Paragraphs (h)(2)(i)(D), (k), and

(l)of this section apply for taxable years ending on or after August 2, 2005. § 1.263A-1T [Removed] **Par. 3.** Section 1.263A-1T is removed. **Par. 4.** Section 1.263A-2 is amended by revising paragraphs (b)(2)(i)(D),

(e)and

(f)to read as follows: § 1.263A-2 Rules relating to property produced by the taxpayer.

(b)* * *

(2)* * *

(i)* * *

(D)*Self-constructed tangible personal property produced on a routine and repetitive basis—(1) In general.* Self-constructed tangible personal property produced by the taxpayer on a routine and repetitive basis in the ordinary course of the taxpayer's trade or business. Self-constructed tangible personal property is produced by the taxpayer on a routine and repetitive basis in the ordinary course of the taxpayer's trade or business when units of tangible personal property (as defined in § 1.263A-10(c)) are mass-produced, that is, numerous substantially identical assets are manufactured within a taxable year using standardized designs and assembly line techniques, and either the applicable recovery period of the property determined under section 168(c) is not longer than 3 years or the property is a material or supply that will be used and consumed within 3 years of being produced. For purposes of this paragraph (b)(2)(i)(D), the applicable recovery period of the assets will be determined at the end of the taxable year in which the assets are placed in service for purposes of § 1.46-3(d). Subsequent changes to the applicable recovery period after the assets are placed in service will not affect the determination of whether the assets are produced on a routine and repetitive basis for purposes of this paragraph (b)(2)(i)(D). *(2) Examples.* The following examples illustrate this paragraph (b)(2)(i)(D): Example 1. Y is a manufacturer of automobiles. During the taxable year Y produces numerous substantially identical dies and molds using standardized designs and assembly line techniques. The dies and molds have a 3-year applicable recovery period for purposes of section 168(c). Y uses the dies and molds to produce or process particular automobile components and does not hold them for sale. The dies and molds are produced on a routine and repetitive basis in the ordinary course of Y's business for purposes of this paragraph because the dies and molds are both mass-produced and have a recovery period of not longer than 3 years. Example 2. Z is an electric utility that regularly manufactures and installs identical poles that are used in transmitting and distributing electricity. The poles have a 20-year applicable recovery period for purposes of section 168(c). The poles are not produced on a routine and repetitive basis in the ordinary course of Z's business for purposes of this paragraph because the poles have an applicable recovery period that is longer than 3 years.

(e)*Change in method of accounting* —(1) *In general.* A change in a taxpayer's treatment of additional section 263A costs to comply with paragraph (b)(2)(i)(D) of this section is a change in method of accounting to which the provisions of sections 446 and 481 and the regulations under those sections apply. See § 1.263A-7. For a taxpayer's first taxable year ending on or after August 2, 2005, the taxpayer is granted the consent of the Commissioner to change its method of accounting to comply with paragraph (b)(2)(i)(D) of this section, provided the taxpayer follows the administrative procedures, as modified by paragraphs (e)(2) through

(e)is “95.” If Form 3115 is revised or renumbered, any reference in this section to that form is treated as a reference to the revised or renumbered form. Alternatively, notwithstanding the provisions of any administrative procedures that preclude a taxpayer from requesting the advance consent of the Commissioner to change a method of accounting that is required to be made pursuant to a published automatic change procedure, for its first taxable year ending on or after August 2, 2005, a taxpayer may request the advance consent of the Commissioner to change its method of accounting to comply with paragraph (b)(2)(i)(D) of this section, provided the taxpayer follows the administrative procedures, as modified by paragraphs (e)(2) through

(4)of this section, for obtaining the Commissioner's advance consent to a change in accounting method.

(2)*Scope limitations.* Any limitations on obtaining the automatic consent or advance consent of the Commissioner do not apply to a taxpayer seeking to change its method of accounting to comply with paragraph (b)(2)(i)(D) of this section for its first taxable year ending on or after August 2, 2005.

(3)*Audit protection.* A taxpayer that changes its method of accounting in accordance with this paragraph

(e)to comply with paragraph (b)(2)(i)(D) of this section does not receive audit protection if its method of accounting for additional section 263A costs is an issue under consideration at the time the application is filed with the national office.

(4)*Section 481(a) adjustment.* A change in method of accounting to conform to paragraph (b)(2)(i)(D) of this section requires a section 481(a) adjustment. The section 481(a) adjustment period is two taxable years for a net positive adjustment for an accounting method change that is made to conform to paragraph (b)(2)(i)(D) of this section.

(5)*Time for requesting change.* Notwithstanding the provisions of § 1.446-1(e)(3)(i) and any contrary administrative procedure, a taxpayer may submit a request for advance consent to change its method of accounting to comply with paragraph (b)(2)(i)D) of this section for its first taxable year ending on or after August 2, 2005, on or before the date that is 30 days after the end of the taxable year for which the change is requested.

(f)*Effective date.* Paragraphs (b)(2)(i)(D), (e), and

(f)of this section apply for taxable years ending on or after August 2, 2005. § 1.263A-2T [Removed] **Par. 5.** Section 1.263A-2T is removed. Kevin M. Brown, Deputy Commissioner for Services and Enforcement. Approved: March 20, 2007. Eric Solomon, Assistant Secretary of the Treasury (Tax Policy). [FR Doc. E7-5732 Filed 3-28-07; 8:45 am] BILLING CODE 4830-01-P DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 [TD 9313] RIN 1545-BG29 Corporate Reorganizations; Additional Guidance on Distributions Under Sections 368(a)(1)(D) and 354(b)(1)(B); Correction AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Correcting amendment. SUMMARY: This document contains correction to temporary regulations (TD 9313) that were published in the **Federal Register** on Thursday, March 1, 2007 (72 FR 9262) providing guidance regarding the qualification of certain transactions as reorganizations described in section 368(a)(1)(D) where no stock and/or securities of the acquiring corporation are issued and distributed in the transaction. DATES: This amendment is effective March 29, 2007. FOR FURTHER INFORMATION CONTACT: Bruce A. Decker at

(202)622-7550 (not a toll-free number). SUPPLEMENTARY INFORMATION: Background The temporary regulations that are the subjects of this correction are under section 368 of the Internal Revenue Code. Need for Correction As published, temporary regulations (TD 9313) contain an error that may prove to be misleading and is in need of clarification. List of Subjects in 26 CFR Part 1 Income taxes, Reporting and recordkeeping requirements. Correction of Publication Accordingly, 26 CFR part 1 is corrected by making the following amendments: PART 1—INCOME TAXES **Paragraph 1.** The authority citation for part 1 continues to read, in part, as follows: Authority: 26 U.S.C. 7805 * * * **Par. 2.** Section 1.368-2T is amended by revising paragraph (l)(2)(iv) to read as follows: § 1.368-2T Definition of terms (temporary).

(l)* * *

(2)* * *

(iv)*Exception.* This paragraph (l)(2) of this section does not apply to a transaction otherwise described in § 1.358-6(b)(2) or section 368(a)(1)(G) by reason of section 368(a)(2)(D). LaNita Van Dyke, Chief, Publications and Regulations Branch, Legal Processing Division, Associate Chief Counsel, (Procedure and Administration). [FR Doc. E7-5603 Filed 3-28-07; 8:45 am] BILLING CODE 4830-01-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R05-OAR-2006-0774; FRL-8284-5] Approval and Promulgation of Air Quality Implementation Plans; Indiana AGENCY: Environmental Protection Agency (EPA). ACTION: Direct final rule. SUMMARY: The EPA is approving revisions to Indiana's State Implementation Plan

(SIP)submitted on August 25, 2006, revising its existing emission reporting rule to be consistent with the emission statement program requirements for stationary sources in the Clean Air Act (CAA). The rationale for approval and other information are provided in this rulemaking action. DATES: This direct final rule will be effective May 29, 2007, unless EPA receives adverse comments by April 30, 2007. If adverse comments are received, EPA will publish a timely withdrawal of the direct final rule in the **Federal Register** informing the public that the rule will not take effect. ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-OAR-2006-0774, by one of the following methods: 1. www.regulations.gov: Follow the on-line instructions for submitting comments. 2. E-mail: *mooney.john@epa.gov* . 3. Fax:

(312)886-5824. 4. Mail: John M. Mooney, Chief, Criteria Pollutant Section, Air Programs Branch (AR-18J), U.S. Environmental Protection Agency, 77 West Jackson Boulevard, Chicago, Illinois 60604. 5. Hand Delivery: John M. Mooney, Chief, Criteria Pollutant Section, Air Programs Branch (AR-18J), U.S. Environmental Protection Agency, 77 West Jackson Boulevard, Chicago, Illinois 60604. Such deliveries are only accepted during the Regional Office normal hours of operation, and special arrangements should be made for deliveries of boxed information. The Regional Office official hours of business are Monday through Friday, 8:30 a.m. to 4:30 p.m. excluding Federal holidays. *Instructions:* Direct your comments to Docket ID No. EPA-R05-OAR-2006-0774. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information

(CBI)or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through www.regulations.gov or e-mail. The www.regulations.gov Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through www.regulations.gov your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. 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. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. For additional instructions on submitting comments, go to Section I of the SUPPLEMENTARY INFORMATION section of this document. *Docket:* All documents in the docket are listed in the www.regulations.gov index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically in www.regulations.gov or in hard copy at the Environmental Protection Agency, Region 5, Air and Radiation Division, 77 West Jackson Boulevard, Chicago, Illinois 60604. This facility is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. We recommend that you telephone Charles Hatten, Environmental Engineer, at

(312)886-6031 before visiting the Region 5 office. FOR FURTHER INFORMATION CONTACT: Charles Hatten, Environmental Engineer, Criteria Pollutant Section, Air Programs Branch (AR-18J), Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604,

(312)886-6031, *Hatten.Charles@epa.gov* . SUPPLEMENTARY INFORMATION: Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA. This supplementary information section is arranged as follows: I. General Information II. What Is Required by the Clean Air Act and How Does It Apply to Indiana? III. What Change Is Indiana Requesting? IV. What Action Is EPA Taking? V. Statutory and Executive Order Reviews I. General Information This rulemaking applies to stationary sources located in ozone nonattainment areas. It requires sources to submit emission statement data to the Indiana Department of Environmental Management

(IDEM)on an annual basis. This collected emission data can help the IDEM develop a complete and accurate emission inventory for air quality planning purposes at the State, and also meet EPA emission reporting requirements. II. What Is Required by the Clean Air Act and How Does It Apply to Indiana? Emission Statements (Annual Reporting) Section 182(a)(3)(B) of the CAA requires each state to submit revisions to its State implementation plan

(SIP)to require that the owner or operator of each stationary source of oxides of nitrogen (NO X ) and volatile organic compounds

(VOCs)in nonattainment areas prepare and submit emission statements each year showing actual emissions of those pollutants. This requirement applies to all ozone nonattainment areas covered under subpart 2 of part D of Title I of the CAA, regardless of classification (marginal, moderate, etc.) In such nonattainment areas, facilities which emit VOC or NO X (on a plant-wide basis) in amounts of 25 tons per year or more into the ambient air must submit an emission statement to the State. On June 10, 2002 (67 FR 39602), EPA amended the list of pollutants to be reported on emission statements, adding particulate matter with an aerodynamic diameter less than or equal to 2.5 micrometers (PM 2.5) and ammonia (NH3). On April 30, 2004, EPA published its Phase 1 rule to implement the 8-hour ozone National Ambient Air Quality Standard (NAAQS) (69 FR 23951). On this same date, EPA set forth nonattainment and attainment designations for the 8-hour ozone NAAQS (69 FR 23858). EPA has determined that the emission statement program requirements previously applicable for the 1-hour ozone NAAQS apply in the same manner for the 8-hour NAAQS. See May 3, 2006, memorandum from Thomas C. Curran, Director, Air Quality Assessment Division, to Regional Air Division Directors, entitled “Emission Statement Requirement Under 8-hour Ozone NAAQS implementation.” Thus, the requirement for emission statements under section 182(a)(3)(B) applies to newly-designated subpart 2 ozone nonattainment areas. Also, those areas designated nonattainment for ozone under the 1-hour ozone NAAQS and then designated nonattainment under the 8-hour ozone NAAQS, regardless of classification under subpart 2 of part D of Title I of the Act, remain subject to the emission statement requirement of section 182(a)(3)(B). Indiana's Current SIP On June 10, 1994, EPA approved rule 2-6 of Title 326 of the Indiana Administrative Code (IAC), as meeting the emission statement program requirements of section 182(a)(3)(B) of the CAA. See 59 FR 29956. Subsequently, EPA redesignated a number of counties subject to the emission statement program to attainment for the 1-hour ozone standard. See, e.g., 59 FR 5439 (Indianapolis) and 62 FR 64725 (Evansville). On October 29, 2004, EPA approved a revision to rule 2-6 to reflect these changes. 69 FR 63069. As a result, the emission statement program requirements applied to stationary sources in Lake and Porter counties. On April 30, 2004, EPA designated Lake, Porter, and LaPorte Counties as nonattainment for the 8-hour ozone standard. 69 FR 23858. III. What Change Is Indiana Requesting? Indiana is requesting that EPA approve the revisions to the existing emission reporting rule, 326 IAC 2-6, to be consistent with the emission statement program requirements for stationary sources in section 182(a)(3)(B) of the CAA. Since, under the existing Federally approved SIP for Indiana, the emission statement program requirements for the 1-hour ozone NAAQS apply in the same manner as for the 8-hour NAAQS, the emission statement program requirements will remain applicable to stationary sources in Lake and Porter counties. The requirement for emission statements under section 182(a)(3)(B) will also apply to LaPorte County, the only newly designated nonattainment area in Indiana under subpart 2 of the 8-hour ozone NAAQS. Indiana is also requesting that EPA approve the addition of particulate matter with an aerodynamic diameter less than or equal to 2.5 micrometers (PM 2.5) and ammonia

(NH3)to the list of pollutants to be reported on the emission statement. IV. What Action Is EPA Taking? EPA has determined that the Indiana program contains the necessary applicability, compliance and reporting provisions necessary to meet the requirements for an emission statement program for all ozone nonattainment areas for the 8-hour ozone standard under subpart 2 of the CAA. The revision to Indiana's revised emission statement program will now include stationary sources in LaPorte County. Therefore, EPA is approving the revisions to the emission reporting requirements of 326 IAC 2-6 to satisfy the Federal requirements for an emission statement program as part of the SIP. EPA is also approving Indiana's request to include PM 2.5 and NH3 to the list of pollutants to be reported in emission statements. We are publishing this action without prior proposal because we view this as a noncontroversial amendment and anticipate no adverse comments. However, in the proposed rules section of this **Federal Register** publication, we are publishing a separate document that will serve as the proposal to approve the state plan if relevant adverse written comments are filed. This rule will be effective May 29, 2007 without further notice unless we receive relevant adverse written comments by April 30, 2007. If we receive such comments, we will withdraw this action before the effective date by publishing a subsequent document that will withdraw the final action. All public comments received will then be addressed in a subsequent final rule based on the proposed action. The EPA will not institute a second comment period. Any parties interested in commenting on this action should do so at this time. If we do not receive any comments, this action will be effective May 29, 2007. V. Statutory and Executive Order Reviews Executive Order 12866: Regulatory Planning and Review Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and, therefore, is not subject to review by the Office of Management and Budget. Executive Order 13211: Actions That Significantly Affect Energy Supply, Distribution, or Use Because it is not a “significant regulatory action” under Executive Order 12866 or a “significant energy action,” this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). Regulatory Flexibility Act This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 *et seq.* ). Unfunded Mandates Reform Act Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Order 13175: Consultation and Coordination With Indian Tribal Governments This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (59 FR 22951, November 9, 2000). Executive Order 13132: Federalism This action also does not have Federalism implications because it does not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. Executive Order 13045: Protection of Children From Environmental Health and Safety Risks This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant. National Technology Transfer Advancement Act In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the state to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. Paperwork Reduction Act This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq.* ). Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq.* , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the **Federal Register** . A major rule cannot take effect until 60 days after it is published in the **Federal Register** . This action is not a “major rule” as defined by 5 U.S.C. section 804(2). Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by May 29, 2007. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).) List of Subjects in 40 CFR Part 52 Environmental protection, Air pollution control, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements, and Volatile organic compounds. Dated: February 27, 2007. Steve Rothblatt, Acting Regional Administrator, Region 5. For the reasons stated in the preamble, part 52, chapter I, of title 40 of the Code of Federal Regulations is amended as follows: PART 52—[AMENDED] 1. The authority citation for part 52 continues to read as follows: Authority: 42 U.S.C. 7401 et seq. Subpart P—Indiana 2. Section 52.770 is amended by removing and reserving paragraphs (c)(91) and (c)(166), and adding paragraph (c)(178) to read as follows: § 52.770 Identification of plan.

(c)* * *

(178)On August 25, 2006, Indiana submitted final adopted revisions to its emission reporting requirement rules as a revision to the Indiana State Implementation Plan.

(i)*Incorporation by reference.* Indiana Administrative Code Title 326: Air Pollution Control Board, Article 2: Permit Review Rules, Rule 6 Emission Reporting, Section 1: Applicability, Section 3: Compliance schedule, and Section 4: Requirements. Approved by the Attorney General June 29, 2006. Approved by the Governor July 13, 2006. Filed with the Publisher July 14, 2006. Published on the Indiana Register Web site August 9, 2006, Document Identification Number (DIN):20060809-IR-326050078FRA. Effective August 13, 2006. [FR Doc. E7-5655 Filed 3-28-07; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 80 [FRL-8293-1] Regulation of Fuels and Fuel Additives: Extension of the Reformulated Gasoline Program to the East St. Louis, IL Ozone Nonattainment Area AGENCY: Environmental Protection Agency (EPA). ACTION: Withdrawal of direct final rule. SUMMARY: EPA published a direct final rule on December 27, 2006, to extend the reformulated gasoline program to the Illinois portion of the St. Louis Illinois-Missouri ozone nonattainment area effective as of May 1, 2007. However, we received an adverse comment during the 30 day comment period and are now withdrawing that direct final rule. DATES: As of March 29, 2007, EPA withdraws the direct final rule published at 71 FR 77615, on December 27, 2006. FOR FURTHER INFORMATION CONTACT: Kurt Gustafson at

(202)343-9219. SUPPLEMENTARY INFORMATION: Because EPA received adverse comment, we are withdrawing the direct final rule for “Regulation of Fuels and Fuel Additives: Extension of the Reformulated Gasoline Program to the East St. Louis, Illinois Ozone Nonattainment Area.” We published the direct final rule on December 27, 2006 (71 FR 77615), that would have approved the State of Illinois's request to opt-in to the Federal Reformulated Gasoline Program effective as of May 1, 2007. That action would have amended our regulations to make the Illinois portion of the St. Louis, Illinois-Missouri ozone nonattainment area a covered area and prohibit the sale of conventional gasoline. We stated in that **Federal Register** document that if we received adverse comment by January 26, 2007, we would publish a timely notice of withdrawal in the **Federal Register** . We subsequently received an adverse comment. We will address the comment in a subsequent final action based on the parallel proposal also published on December 27, 2006 (71 FR 77690). As stated in the parallel proposal, we will not institute a second comment period on this action. Dated: March 22, 2007. Stephen L. Johnson, Administrator. PART 80—REGULATION OF FUELS AND FUEL ADDITIVES § 80.70 [Amended]. Accordingly, the amendment to 40 CFR 80.70 which was published in the **Federal Register** on December 27, 2006 (71 FR 77615) is withdrawn as of March 29, 2007. [FR Doc. E7-5808 Filed 3-28-07; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 721 [EPA-HQ-OPPT-2003-0063; FRL-7699-5] RIN 2070-AB27 Significant New Use Rules on Certain Chemical Substances and Notification on Certain Substances for Which Significant New Use Rules are Not Being Issued AGENCY: Environmental Protection Agency (EPA). ACTION: Direct final rule. SUMMARY: EPA is promulgating significant new use rules (SNURs) under section 5(a)(2) of the Toxic Substances Control Act

(TSCA)for 65 chemical substances which were the subject of premanufacture notices (PMNs). Thirteen of these chemical substances are subject to TSCA section 5(e) consent orders issued by EPA. This action requires persons who intend to manufacture, import, or process any of these 65 chemical substances for an activity that is designated as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. The required notification will provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. This direct final rule also provides notification on two substances for which EPA has decided not to issue significant new use rules at this time. DATES: The effective date of this rule is May 29, 2007 without further notice, unless EPA receives adverse or critical comments, or notice of intent to submit adverse or critical comments before April 30, 2007. This rule shall be promulgated for purposes of judicial review at 1 p.m. (e.s.t.) on April 12, 2007. If EPA receives adverse or critical comments, or notice of intent to submit adverse or critical comments, on one or more of these SNURs before April 30, 2007, EPA will withdraw the relevant sections of this direct final rule before its effective date. EPA will then issue a proposed SNUR for the chemical substance(s) on which adverse or critical comments were received, providing a 30-day period for public comment. ADDRESSES: Submit your comments, identified by docket identification

(ID)number EPA-HQ-OPPT-2003-0063, by one of the following methods: • *Federal eRulemaking Portal: http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • *Hand Delivery* : OPPT Document Control Office (DCO), EPA East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. Attention: Docket ID number EPA-HQ-OPPT-2003-0063. The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the DCO is

(202)564-8930. Such deliveries are only accepted during the DCO's normal hours of operation, and special arrangements should be made for deliveries of boxed information. *Instructions* : Direct your comments to docket ID number EPA-HQ-OPPT-2003-0063. EPA's policy is that all comments received will be included in the public docket without change and may be made available on-line at *http://www.regulations.gov* , including any personal information provided, unless the comment includes information claimed to be Confidential Business Information

(CBI)or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or e-mail. The regulations.gov website is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD ROM you submit. 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. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. For additional information about EPA's public docket visit the EPA Docket Center homepage at *http://www.epa.gov/epahome/dockets.htm.* *Docket* : All documents in the docket are listed in the docket's index available at *http://www.regulations.gov* . Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available electronically at *http://www.regulations.gov* , or, if only available in hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding Federal holidays. The telephone number of the EPA/DC Public Reading Room is

(202)566-1744, and the telephone number for the OPPT Docket is

(202)566-0280. Docket visitors are required to show photographic identification, pass through a metal detector, and sign the EPA visitor log. All visitor bags are processed through an X-ray machine and subject to search. Visitors will be provided an EPA/DC badge that must be visible at all times in the building and returned upon departure. FOR FURTHER INFORMATION CONTACT: *For general information contact* : Colby Lintner, Regulatory Coordinator, Environmental Assistance Division (7408M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:

(202)554-1404; e-mail address: *TSCA-Hotline@epa.gov.* *For technical information contact* : Karen Chu, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:

(202)564-8773; e-mail address: *chu.karen@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you manufacture, import, process, or use the chemical substances contained in this rule. Potentially affected entities may include, but are not limited to: • Manufacturers, importers, or processors of one or more subject chemical substances (NAICS codes 325 and 324110), e.g., Chemical manufacturing and petroleum refineries. 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. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in 40 CFR 721.5. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under FOR FURTHER INFORMATION CONTACT . This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Persons who import any chemical substance governed by a final SNUR are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements and the corresponding regulations at 19 CFR 12.118 through 12.127 and 19 CFR 127.28. Those persons must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA, including any SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export a chemical substance that is the subject of this rule on or after April 30, 2007 are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see 40 CFR 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D. B. What Should I Consider as I Prepare My Comments for EPA? 1. *Submitting CBI* . Do not submit this information to EPA through regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. 2. *Tips for preparing your comments* . When submitting comments, remember to: i. Identify the document by docket ID number and other identifying information (subject heading, **Federal Register** date, and page number). ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations

(CFR)part or section number. iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes. iv. Describe any assumptions and provide any technical information and/or data that you used. v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced. vi. Provide specific examples to illustrate your concerns and suggest alternatives. vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats. viii. Make sure to submit your comments by the comment period deadline identified. II. Background A. What Action is the Agency Taking? EPA is promulgating these SNURs using direct final procedures. These SNURs will require persons to notify EPA at least 90 days before commencing the manufacture, import, or processing of a chemical substance for any activity designated by these SNURs as a significant new use. Additional rationale and background to this rule are more fully set out in the preamble to EPA's first direct final SNUR published in the **Federal Register** of April 24, 1990 (55 FR 17376). Consult that preamble for further information on the objectives, rationale, and procedures for SNURs and on the basis for significant new use designations, including provisions for developing test data. B. What is the Agency's Authority for Taking this Action? Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors, including those listed in TSCA section 5(a)(2). Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B) requires persons to submit a significant new use notice

(SNUN)to EPA at least 90 days before they manufacture, import, or process the chemical substance for that use. The mechanism for reporting under this requirement is established under 40 CFR part 721.5. C. Applicability of General Provisions General provisions for SNURs appear under 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the final rule. Provisions relating to user fees appear at 40 CFR part 700. According to 40 CFR 721.1(c), persons subject to these SNURs must comply with the same notice requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these requirements include the information submission requirements of TSCA section 5(b) and 5(d)(1), the exemptions authorized by TSCA section 5 (h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA may take regulatory action under TSCA section 5(e), 5(f), 6, or 7 to control the activities on which it has received the SNUN. If EPA does not take action, the Agency is required under TSCA section 5(g) to explain in the **Federal Register** its reasons for not taking action. Persons who export or intend to export a chemical substance identified in a proposed or final SNUR are subject to the export notification provisions of TSCA section 12(b). The regulations that interpret TSCA section 12(b) appear at 40 CFR part 707, subpart D. Persons who import a chemical substance identified in a final SNUR are subject to the TSCA section 13 import certification requirements, codified at 19 CFR 12.118 through 12.127 and 19 CFR 127.28. Such persons must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA, including any SNUR requirements. The EPA policy on import certification appears at 40 CFR part 707, subpart B. III. Substances Subject to this Rule EPA is establishing significant new use and recordkeeping requirements for 65 chemical substances under 40 CFR part 721, subpart E. In this unit, EPA provides the following information for each chemical substance: • PMN number. • Chemical name (generic name if the specific name is claimed as CBI). • CAS number (if assigned for non-confidential chemical identities). • Basis for the section 5(e) consent order, or, for non-5(e) SNURs, the basis for the SNUR. • Toxicity concerns. • Tests recommended by EPA to provide sufficient information to evaluate the chemical substance (see Unit VI. for more information). • CFR citation assigned in the regulatory text section of this rule. The specific activities designated as significant new uses are listed in the regulatory text section of 40 CFR part 721, subpart E. Certain new uses, including production limits and other uses designated in the rule are claimed as CBI. The procedure for obtaining confidential information is set out in Unit VII. This rule includes SNURs on 13 PMN substances that are subject to “risk-based” consent orders under TSCA section 5(e)(1)(A)(ii)(I) wherein EPA determined that activities associated with the PMN substances may present unreasonable risk to health or the environment. The consent orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The so-called “5(e) SNURs” on these substances are promulgated pursuant to 40 CFR 721.160, and are based on and consistent with the provisions in the underlying consent orders. The SNURs designate as a “significant new use” the absence of the protective measures required in the consent order. Where EPA determined that the PMN substance may present an unreasonable risk of injury to human health via inhalation exposure, the underlying section 5(e) consent order usually requires, among other things, that potentially exposed employees must wear specified respirators unless actual measurements of the workplace air show that air-borne concentrations of the PMN substance are below a New Chemical Exposure Limit

(NCEL)that is established by EPA to provide adequate protection to human health. In addition to the actual NCEL concentration, the comprehensive NCELs provisions in section 5(e) consent orders, which are modeled after Occupational Safety and Health Administration

(OSHA)Permissible Exposure Limits

(PELs)provisions, include requirements addressing performance criteria for sampling and analytical methods, periodic monitoring, respiratory protection, and recordkeeping. However, no comparable NCELs provisions currently exist in 40 CFR part 721, subpart B for SNURs. Therefore, for these cases, the individual SNURs in subpart E state that persons subject to the SNUR who wish to pursue NCELs as an alternative to the § 721.63 respirator requirements may request to do so under 40 CFR 721.30. Persons whose § 721.30 requests to use the NCELs approach are approved by EPA will receive NCELs provisions comparable to those contained in the corresponding section 5(e) consent order for the same chemical substance for SNURs. This rule also includes SNURs on 52 PMN substances that are not subject to consent orders under TSCA section 5(e). In these cases, EPA did not find that the use scenario described in the PMN triggered the determinations set forth under section 5(e) of TSCA. EPA, however, does believe that certain changes from the use scenario described in the PMN could result in increased exposures, thereby constituting a “significant new use.” These so called “Non-5(e) SNURs” are promulgated pursuant to 40 CFR 721.170. EPA has determined that every activity designated as a “significant new use” in all non-5(e) SNURs issued under 40 CFR 721.170 satisfies the two requirements stipulated in § 721.170(c)(2), i.e., these significant new use activities, “(i) are different from those described in the premanufacture notice for the substance, including any amendments, deletions, and additions of activities to the premanufacture notice, and

(ii)may be accompanied by changes in exposure or release levels that are significant in relation to the health or environmental concerns identified” for the PMN substance. **PMN Number P-97-415** *Chemical name:* 2-Thiazolidinone. *CAS number:* 2682-49-7. *Effective date of section 5(e) consent order:* April 20, 2000. *Basis for section 5(e) consent order:* The PMN states that the substance will be used as an intermediate. The order was issued under section 5(e)(1)(A)(i) and (ii)(I) of TSCA based on a finding that this substance may present an unreasonable risk of injury to health and the environment. To protect against this risk, the consent order requires worker protection and hazard communication and restricts disposal, water releases, and aggregate manufacture/importation volume of the PMN substance. It also prohibits use of the PMN substance other than as an intermediate and prohibits domestic manufacturing, processing, or use of the PMN substance as a powder. The SNUR designates as a ‘significant new use’ the absence of these protective measures. *Toxicity concern:* EPA has identified health concerns for high acute toxicity and signs of neurotoxic effects based on test data for the PMN substance. EPA also has concerns for chronic effects and systemic, developmental, and maternal toxicity based on test data on a structurally similar substance. The NCEL is 0.7 mg/m 3 as an 8-hour time-weighted average. EPA is concerned that toxicity to aquatic organisms may occur at concentrations as low as 300 parts per billion

(ppb)of the PMN substance in surface waters based on test data on a structurally similar substance. *Recommended testing:* EPA has determined that the following test would help characterize the human health effects of the PMN substance: A combined repeated dose toxicity with the reproductive/developmental toxicity screening test (oral route) (OPPTS 870.3650 test guideline) with a neurotoxicity functional observational battery (National Technical Information Service

(NTIS)PB 91-154617) and a histopathologic examination extended to include the blood, liver, kidney, brain, and spinal cord on the PMN substance to help characterize neurotoxic, systemic, reproductive, and developmental effects. The PMN submitter has agreed not to exceed the production volume limit without performing this test. In addition, EPA has determined that a porous pot test (OPPTS 835.3220 test guideline), a fish acute toxicity test (OPPTS 850.1075 test guideline (public draft)), a daphnid acute toxicity test (OPPTS 850.1010 test guideline (public draft)), and an algal toxicity test (OPPTS 850.5400 test guideline (public draft)) would help characterize the environmental effects of the PMN substance. *CFR citation:* 40 CFR 721.10002. **PMN Numbers P-98-625/626/627/628/629** and **P-00-614/617** *Chemical name:* Manganese heterocyclic tetraamine complex (generic). *CAS number:* Not available. *Basis for action:* The PMNs state that the generic (non-confidential) use of the substances will be in commercial research and development. EPA has identified health concerns for chronic organ effects based on data on a structurally similar substance. Since significant worker exposure is unlikely at the production volume identified in the PMNs, EPA has not determined that the proposed manufacture, processing, or use of the substances may present an unreasonable risk. EPA has determined, however, that a manufacture or importation volume greater than 10,000 kilograms/year of any one of the PMN substances may result in serious chronic effects. Based on this information, each of the PMN substances meet the concern criteria at § 721.170(b)(3)(ii). *Recommended testing:* EPA has determined that the results of a 90-day oral toxicity study (OPPTS 870.3100 test guideline) would help characterize the human health effects of the PMN substances. *CFR citation:* 40 CFR 721.10003. **PMN Number P-98-1181** *Chemical name:* 2-Butenoic acid, 4,4′-[(dibutylstannylene)bis(oxy)]bis[4-oxo-, (2Z,2′Z)-, di-C 8-10 -isoalkyl esters, C 9 -rich. *CAS number:* 247041-56-1. *Basis for action:* The PMN states that the substance will be used as a polyvinyl chloride stabilizer. EPA has identified concerns for corrosion to skin, eyes, and mucuous membranes, neurotoxicity, blood toxicity, liver toxicity, immunosupression, reproductive toxicity, and adrenal effects based on analogy to organotins. As described in the PMN, significant worker exposure is unlikely. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that uses of the substance in a solid form, involving an application method that generates a vapor, mist, or aerosol, or where there is potential dermal exposure without the use of impervious gloves, may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii). *Recommended testing:* EPA has determined that the results of a 90-day oral toxicity study (OPPTS 870.3100 test guideline) and a neurotoxicity screening test (OPPTS 870.6200 test guideline) would help characterize the human health effects of the PMN substance. *CFR citation:* 40 CFR 721.10004. **PMN Number P-98-1182** *Chemical name:* 2-Butenoic acid, 4,4′-[(dibutylstannylene)bis(oxy)]bis[4-oxo-, (2Z,2′Z)-, di-C 9-11 -isoalkyl esters, C 10 -rich. *CAS number:* Not available. *Basis for action:* The PMN states that the substance will be used as a polyvinyl chloride stabilizer. EPA has identified concerns for corrosion to skin, eyes, and mucuous membranes, neurotoxicity, blood toxicity, liver toxicity, immunosupression, reproductive toxicity, and adrenal effects based on analogy to organotins. As described in the PMN, significant worker exposure is unlikely. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that uses of the substance in a solid form, involving an application method that generates a vapor, mist, or aerosol, or where there is potential dermal exposure without the use of impervious gloves, may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii). *Recommended testing:* EPA has determined that the results of a 90-day oral toxicity study (OPPTS 870.3100 test guideline) and a neurotoxicity screening test (OPPTS 870.6200 test guideline) would help characterize the human health effects of the PMN substance. *CFR citation:* 40 CFR 721.10005. **PMN Number P-99-511** *Chemical name:* Mixed metal oxide (generic). *CAS number:* Not available. *Basis for action:* The PMN states that the substance will be used as an additive for coatings. Based on data for a similar substance, EPA has identified concerns for cancer, immunotoxicity, and lung toxicity. As described in the PMN, significant inhalation exposure is unlikely. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that a manufacture/importation volume greater than 60,000 kilograms/year of the PMN substance may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170 (b)(1)(i)(C) and (b)(3)(ii). *Recommended testing:* EPA has determined that a bacterial reverse mutation test (OPPTS 870.5100 test guideline) and a mammalian erythrocyte micronucleus test (intraperitoneal route) (OPPTS 870.5395 test guideline) with special attention to histopathology of the lung tissues and organs of the immune systems (spleen, thymus, bone marrow) would help characterize the human health effects of the PMN substance. If the results of the recommended tests indicate that the PMN substance has carcinogenic potential, a carcinogenicity study (OPPTS 870.4200 test guideline) would help further characterize the health effects. *CFR citation:* 40 CFR 721.10006. **PMN Number P-00-11** *Chemical name:* Alcohols, C 12-14 - secondary, ethoxylated propoxylated. *CAS number:* 103331-86-8. *Basis for action:* The PMN states that the generic (non-confidential) use of the substance will be as a household cleaning agent additive. Based on analogy to nonionic surfactants, EPA is concerned that toxicity to aquatic organisms may occur at concentrations above 50 ppb in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations above 50 ppb. Thus, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in surface water concentrations above 50 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii). *Recommended testing:* EPA has determined that a fish acute toxicity test (OPPTS 850.1075 test guideline (public draft)), a daphnid acute toxicity test (OPPTS 850.1010 test guideline (public draft)), and an algal toxicity test (OPPTS 850.5400 test guideline (public draft)) would help characterize the environmental effects of the PMN substance. *CFR citation:* 40 CFR 721.10007. **PMN Numbers P-00-1121/1122/1123/1124/1125/1126** *Chemical names:* (P-00-1121) Manganese strontium oxide (MnSrO 3 ); (P-00-1122) Manganese yttrium oxide (MnYO 3 ); (P-00-1123) Barium manganese oxide (BaMnO 3 ); (P-00-1124) Barium calcium manganese strontium oxide; (P-00-1125) Manganate (MnO 2 1 - ), calcium (2:1); and (P-00-1126) Manganese yttrium oxide (Mn 2 YO 5 ). *CAS numbers:* (P-00-1121) 12163-45-0, (P-00-1122) 12032-75-6, (P-00-1123) 12230-80-7, (P-00-1124) 359427-90-0, (P-00-1125) 12049-47-7, and (P-00-1126) 12438-71-0. *Effective date of section 5(e) consent order:* March 23, 2001. *Basis for section 5(e) consent order:* The PMNs state that the generic (non-confidential) use of the substances will be as pigments. The order was issued under section 5(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding that these substances may present an unreasonable risk of injury to human health and the environment. To protect against this risk, the consent order requires hazard communication and restricts aggregate manufacture/importation volume, particle size and water releases of the PMN substances. The SNUR designates as a ‘significant new use’ the absence of these protective measures. *Toxicity concern:* EPA has health concerns for neurotoxicity and mutagenicity for the PMN substances based on exposure to manganese; concerns for lung toxicity, fibrosis, and possible cancer of the lungs due to potential exposure to the particulate form of the substances; and concern for lung effects through lung overload if respirable particles are inhaled. Based on test data on structurally similar substances, EPA is concerned that toxicity to aquatic organisms for each of these PMN substances may occur at concentrations as low as 100 ppb in surface waters. Further, the Agency has determined that the PMN substances may be persistant, bioaccumulative, and toxic based on physical/chemical properties of the substances, consistent with the New Chemical Program's Persistant, Bioaccumulative, and Toxic

(PBT)Category (64 FR 60194, November 4, 1999) (FRL-6097-7). Because of the potential PBT nature of the PMN substances, bioaccumulation and the potential for eventual exposure to humans and wildlife could result from exposure to concentrations below 100 ppb. Therefore, to adequately mitigate this concern, EPA has decided to limit surface water concentrations resulting from manufacturing, processing, or use to 1 ppb or less for each of the PMN substances. *Recommended testing:* EPA has determined that a fish bioconcentration factor

(BCF)test (OPPTS 850.1730 test guideline (public draft)) would help characterize the environmental effects of the substances. The PMN submitter has agreed not to exceed the production volume limit without performing the fish BCF test on P-00-1122 or P-00-1126. EPA has determined that a 90-day inhalation toxicity study in rats with a 60-day holding period with special attention to the histopathology of the lungs (OPPTS 870.3465 test guideline) would help characterize the human health effects of the PMN substances. Based on the results of the 90-day study, a 2-year inhalation carcinogenicity test (OPPTS 870.4200 test guideline) may be warranted. *CFR citations:* 40 CFR 721.10008 (P-00-1121); 40 CFR 721.10009 (P-00-1122); 40 CFR 721.10010 (P-00-1123); 40 CFR 721.10011 (P-00-1124); 40 CFR 721.10012 (P-00-1125); and 40 CFR 721.10013 (P-00-1126). **PMN Number P-01-109** *Chemical name:* Halogenated naphthalic anhydride (generic). *CAS number:* Not available. *Basis for action:* The PMN states that the substance will be used as a dye intermediate. Based on toxicity data on structurally similar chemicals, EPA expects toxicity to aquatic organisms to occur at concentrations as low as 20 ppb of the PMN substance in surface waters. As described in the PMN, the substance is not released to surface waters. Therefore, EPA has not determined that the proposed processing or use of the substance may present an unreasonable risk. EPA has determined, however, that releases to surface waters may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii). *Recommended testing:* EPA has determined that the results of the following testing would help characterize the PMN substance: An algal toxicity test (OPPTS 850.5400 test guideline (public draft)), a daphnid acute toxicity test (OPPTS 850.1010 test guideline (public draft)), and a fish acute toxicity test (OPPTS 850.1075 test guideline (public draft)). *CFR citation:* 40 CFR 721.10014. **PMN Number P-01-110** *Chemical name:* Halogenated benzimidazole (generic). *CAS number:* Not available. *Basis for action:* The PMN states that the substance will be used as a dye intermediate. Based on Structure Activity Relationships

(SAR)analysis, EPA expects toxicity to aquatic organisms to occur at concentrations as low as 1 ppb of the PMN substance in surface waters. In addition, EPA has identified environmental concerns because the PMN substance may be persistent, bioaccumulative, and toxic based on physical/chemical properties of the PMN substance, consistent with the New Chemical Program's PBT Category (64 FR 60194, November 4, 1999). As described in the PMN, the substance is not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in release of the PMN substance to surface waters may cause significant adverse environmental effects, since the PMN substance has been characterized by EPA as a PBT. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii). *Recommended testing:* EPA has determined that the results of the following tiered testing would help characterize the PMN substance: Tier 1 - Melting point/melting range test (OPPTS 830.7200 test guideline) and an octanol water partition coefficient/K ow test (OPPTS 830.7550 test guideline); Tier 2 - Activated sludge sorption isotherm (OPPTS 835.1110 test guideline) or modified coagulation-flocculation jar test of water (D2034-80); Tier 3 - An algal toxicity test (OPPTS 850.5400 test guideline (public draft)), a daphnid acute toxicity test (OPPTS 850.1010 test guideline (public draft)) and a fish acute toxicity test (OPPTS 850.1075 test guideline (public draft)); Tier 4 - tiered testing as described in the New Chemicals Program's PBT Category (excluding the octanol water partition coefficient/K ow test already recommended in Tier 1). *CFR citation:* 40 CFR 721.10015. **PMN Number P-01-111** *Chemical name:* Dibenzimidazothianaphthalene (generic). *CAS number:* Not available. *Basis for action:* The PMN states that the substance will be used as a fluorescent dye. Based on toxicity data on structurally similar chemicals, EPA expects chronic toxicity to aquatic organisms to occur at concentrations as low as 1 ppb of the PMN substance in surface waters. As described in the PMN, the substance is not released to surface waters. Therefore, EPA has not determined that the proposed processing or use of the substance may present an unreasonable risk. EPA has determined, however, that releases to surface waters may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii). *Recommended testing:* EPA has determined that the results of the following tiered testing would help characterize the PMN substance: Tier 1 - Activated sludge sorption isotherm test (OPPTS 835.1110 test guideline) or modified coagulation-flocculation jar test of water (D2034-80); Tier 2 - An algal toxicity test (OPPTS 850.5400 test guideline (public draft)), a daphnid acute toxicity test (OPPTS 850.1010 test guideline (public draft)), and a fish acute toxicity test (OPPTS 850.1075 test guideline (public draft)); and Tier 3 - A daphnid chronic toxicity test (OPPTS 850.1300 test guideline (public draft)) and a fish early-life stage toxicity test (OPPTS 850.1400 test guideline (public draft)). *CFR citation:* 40 CFR 721.10016. **PMN Numbers P-01-257/258/259 and P-01-261** *Chemical name:* Amine terminated bisphenol A diglycidyl ether polymer (generic). *CAS number:* Not available. *Basis for action:* The PMNs state that the substances will be used as epoxy resin curing agents. Based on analogy to structurally similar polycationic polymers, EPA is concerned that toxicity to aquatic organisms may occur at concentrations as low as 40 ppb in surface waters. As described in the PMNs, the substances are not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substances may present an unreasonable risk. EPA has determined, however, that other uses of the substances resulting in release to surface waters may cause significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(4)(ii). *Recommended testing:* EPA has determined that an algal toxicity test (OPPTS 850.5400 test guideline (public draft)), a daphnid acute toxicity test (OPPTS 850.1010 test guideline (public draft)), a fish acute toxicity test (OPPTS 850.1075 test guideline (public draft)), and a fish acute toxicity test mitigated by humic acid (OPPTS 850.1085 test guideline (public draft)) would help characterize the environmental effects of the PMN substances. *CFR citation:* 40 CFR 721.10017. **PMN Number P-01-442** *Chemical name:* Calcium hydroxide oxide silicate (Ca 6

(OH)2 O 2 (Si 2 O 5 ) 3 ). *CAS number:* 13169-90-9. *Basis for action:* The PMN states that the substance will be used as a filler to reinforce resins, an additive for resins, and a filter medium. Based on test data on this chemical and structurally similar compounds, EPA has identified human health concerns for cancer and toxicity to the respiratory tract, lungs, respiratory system, and liver to workers exposed via inhalation. As described in the PMN, significant worker exposure is unlikely. Therefore, EPA has not determined that the proposed import, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that domestic manufacture, uses other than as described in the PMN, or processing or use as a powder resulting in significant worker inhalation exposure may cause significant adverse human health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170 (b)(1)(i)(C), (b)(3)(i), and (b)(3)(ii). *Recommended testing:* EPA has determined that a 90-day inhalation toxicity study (OPPTS 870.3465 test guideline) would help characterize the human health effects of the PMN substance. *CFR citation:* 40 CFR 721.10018. **PMN Number P-01-563** *Chemical name:* Benzoic acid, 2-chloro-5-nitro-, 1,1-dimethyl-2-oxo-2-(2-propenyloxy) ethyl ester. *CAS number:* 174489-76-0. *Basis for action:* The PMN states that the substance will be used as a chemical intermediate. Based on submitted test data and on structural analogy to esters, EPA is concerned that toxicity to aquatic organisms may occur at concentrations as low as 3 ppb of the PMN substance in surface waters. As described in the PMN, the substance is not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in release to surface waters may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170 (b)(4)(i) and (b)(4)(ii). *Recommended testing:* EPA has determined that a fish acute toxicity test (OPPTS 850.1075 test guideline (public draft)), a daphnid acute toxicity test (OPPTS 850.1010 test guideline (public draft)), an algal toxicity test (OPPTS 850.5400 test guideline (public draft)), and an aerobic aquatic biodegradation test with an analytical methodology to identify the isononyl phenol degradation product (OPPTS 835.3100 test guideline) would help characterize the environmental effects of the PMN substance. *CFR citation:* 40 CFR 721.10019. **PMN Number P-01-564** *Chemical name:* Benzoic acid, 5-amino-2-chloro-, 1,1-dimethyl-2-oxo-2-(2-propenyloxy) ethyl ester. *CAS number:* 174489-43-1. *Basis for action:* The PMN states that the substance will be used as a chemical intermediate. Based on structural analogy to anilines, EPA is concerned that toxicity to aquatic organisms may occur at concentrations as low as 1 ppb of the PMN substance in surface waters. As described in the PMN, the substance is not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in release to surface waters may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii). *Recommended testing:* EPA has determined that a fish acute toxicity test (OPPTS 850.1075 test guideline (public draft)), a daphnid acute toxicity test (OPPTS 850.1010 test guideline (public draft)), an algal toxicity test (OPPTS 850.5400 test guideline (public draft)), and an aerobic aquatic biodegradation test with an analytical methodology to identify the isononyl phenol degradation product (OPPTS 835.3100 test guideline) would help characterize the environmental effects of the PMN substance. *CFR citation:* 40 CFR 721.10020. **PMN Number P-01-764** *Chemical name:* Magnesium potassium titanium oxide. *CAS number:* 39290-90-9. *Effective date of section 5(e) consent order:* July 29, 2002. *Basis for section 5(e) consent order:* The PMN states that the generic (non-confidential) use of the substance will be as a physical characteristics modifier for industrial use in certain solid composite articles. The order was issued under section 5(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding that this substance may present an unreasonable risk of injury to human health. To protect against this risk, the consent order requires worker protection and hazard communication and restricts the aggregate manufacture/importation volume of the PMN substance. The SNUR designates as a ‘significant new use’ the absence of these protective measures. *Toxicity concern:* Based on test data on titanium dioxide, EPA has health concerns for lung toxicity, including lung overload and oncogenicity, with inhalation exposure. The NCEL is 5 mg/m 3 as an 8-hour time-weighted average. *Recommended testing:* EPA has determined that the results of a 90-day inhalation toxicity study with a 60-day holding period (OPPTS 870.3465 test guideline) and possibly a 2-year carcinogenicity study (OPPTS 870.4200 test guideline) would help characterize the human health effects of the PMN substance. The consent order contains two production volume limits. The PMN submitter agreed not to exceed the first production volume limit without performing the 90-day inhalation toxicity study and not to exceed the second production volume limit without performing the 2-year carcinogenicity study if warranted based on the results of the first study. *CFR citation:* 40 CFR 721.10021. **PMN Numbers P-01-769/770/771/772** *Chemical names:* (P-01-769) Benzenamine, *N* -phenyl-, ar-(C 9 -rich C 8-10 -branched alkyl) derivs; (P-01-770) Benzenamine, *N* -phenyl-, ar, ar′-(C 9 -rich C 8-10 -branched alkyl) derivs; (P-01-771) 10H-Phenothiazine, ar-(C 9 -rich C 8-10 -branched alkyl) derivs; and (P-01-772) 10H-Phenothiazine, ar, ar′-(C 9 -rich C 8-10 -branched alkyl) derivs. *CAS numbers:* (P-01-769) 333955-69-4, (P-01-770) 333955-70-7, (P-01-771) 333955-79-6, and (P-01-772) 333955-80-9. *Basis for action:* The PMNs state that the substances will be used as antioxidants for lubricating oils. EPA has identified human health and environmental concerns because the PMN substances may be persistent, bioaccumulative, and toxic, based on submitted test data and physical/chemical properties of the PMN substances, consistent with the New Chemical Program's PBT Category (64 FR 60194, November 4, 1999). As described in the PMNs, significant worker exposure is unlikely and the substances are not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the PMN substances may present an unreasonable risk. EPA has determined, however, that use of the PMN substances other than as described in the PMNs resulting in release to water may cause serious chronic human health effects and significant environmental effects, since the PMN substances have been characterized by EPA as a PBT. Based on this information, the PMN substances meet the concern criteria at § 721.170 (b)(3)(i), (b)(4)(ii), and (b)(4)(iii). *Recommended testing:* EPA has determined that the results of testing Tiers 2 and 3 as described in the New Chemicals Program's PBT Category would help characterize the PBT attributes of the PMN substances. *CFR citations:* 40 CFR 721.10022 (P-01-769); 40 CFR 721.10023 (P-01-770); 40 CFR 721.10024 (P-01-771); and 40 CFR 721.10025 (P-01-772). **PMN Number P-01-856** *Chemical name:* Cashew, nutshell liq., ethoxylated. *CAS number:* 350820-95-0. *Effective date of section 5(e) consent order:* July 5, 2002. *Basis for section 5(e) consent order:* The PMN states that the substance will be used as a pigment dispersant. The order was issued under section 5(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding that this substance may present an unreasonable risk of injury to the environment. To protect against this risk, the consent order restricts molecular weight and composition of the PMN substance. The SNUR designates as a ‘significant new use’ the absence of these protective measures. *Toxicity concern:* Based on test data on structurally similar nonionic surfactants, particularly alkyl ethoxylate, EPA has concerns that the environmental toxicity of the PMN substance varies depending on the average number of moles of the ethoxy. As the number of moles of ethoxy decreases, the aquatic toxicity of the substance increases. For this PMN substance, the average number of moles may vary. When the average number of moles of the ethoxy group is 80, EPA expects toxicity to aquatic organisms to occur at concentrations as low as 1,000 ppb. *Recommended testing:* The Agency has determined that the results of a fish acute toxicity test (OPPTS 850.1075 test guideline (public draft)), a daphnid acute toxicity test (OPPTS 850.1010 test guideline (public draft)), and an algal toxicity test (OPPTS 850.5400 test guideline (public draft)) would help characterize possible environmental effects of the substance. The tests should be conducted on the PMN substance with less than 55 moles of the ethoxy group or with an average molecular weight less than 2,700 daltons. *CFR citation:* 40 CFR 721.10026. **PMN Number P-01-862** *Chemical name:* Ethoxylated alkylsulfate, substituted alkylamine salt (generic). *CAS number:* Not available. *Basis for action:* The PMN states that the generic (non-confidential) use of the substance will be as a processing aid. Based on analogy to cationic surfactants and similar substances, EPA is concerned that chronic toxicity to aquatic organisms may occur at concentrations as low as 4 ppb of the PMN substance in surface waters. As described in the PMN, the substance is not released to surface waters in significant quantities. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in significant release to surface waters may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii). *Recommended testing:* EPA has determined that a fish early-life stage toxicity test (OPPTS 850.1400 test guideline (public draft)), a daphnid chronic toxicity test (OPPTS 850.1300 test guideline (public draft)), and a ready biodegradability test (OPPTS 835.3110 test guideline) would help characterize the chronic environmental effects and the fate in the environment of the PMN substance. After this testing is completed, if the results of the testing and projected environmental risk warrant it, a porous pot test (OPPTS 835.3220 test guideline) or modified semi-continuous activated sludge

(SCAS)test (OPPTS 835.3210 test guideline) would further characterize the environmental fate of this substance. *CFR citation:* 40 CFR 721.10027. **PMN Numbers P-01-901 and P-01-902** *Chemical name:* Disubstituted benzene metal salt (generic). *CAS number:* Not available. *Basis for action:* The PMNs state that the generic (non-confidential) use of the substances will be as a polymer additive. Based on test data and analogy to phenols and hydroquinones/quinones, EPA has concerns for dermal corrosivity, acute toxicity, kidney and liver effects, mutagenicity, carcinogenicity, neurotoxicity, developmental toxicity, depigmentation of skin, thyroid effects, and sensitization. Also, based on analogy to phenols and hydroquinones/quinones, EPA is concerned that toxicity to aquatic organisms may occur at concentrations as low as 1 ppb in surface waters. As described in the PMNs, significant worker exposure is not expected as workers wear impervious personal protective equipment and significant environmental exposure is not expected as the substances are not released to surface waters in significant quantities. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substances may present an unreasonable risk. EPA has determined, however, that use of the substances without workers wearing impervious gloves or uses other than as described in the PMNs could result in serious health effects or significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at § 721.170 (b)(1)(i)(C), (b)(3)(i), (b)(3)(ii), and (b)(4)(ii). *Recommended testing:* EPA has determined that an algal toxicity test (OPPTS 850.5400 test guideline (public draft)), a daphnid acute toxicity test (OPPTS 850.1010 test guideline (public draft)), and a fish acute toxicity test (OPPTS 850.1075 test guideline (public draft)) would help characterize the environmental effects of the PMN substances. EPA has also determined that a 90-day inhalation toxicity study with a 60-day holding period (OPPTS 870.3465 test guideline) would help characterize the human health effects. *CFR citation:* 40 CFR 721.10028. **PMN Number P-01-918** *Chemical name:* Isocyanate compound, modified with methoxysilane (generic). *CAS number:* Not available. *Effective date of section 5(e) consent order:* May 30, 2002. *Basis for section 5(e) consent order:* The PMN states that the generic (non-confidential) use of the substance will be as a sealant. The order was issued under section 5(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding that this substance may present an unreasonable risk of injury to human health. To protect against this risk, the consent order requires worker protection and hazard communication and restricts the aggregate manufacture/importation volume of the PMN substance. The SNUR designates as a ‘significant new use’ the absence of these protective measures. *Toxicity concern:* Based on test data on diisocyanates, the Agency has concern for dermal and respiratory sensitization and pulmonary toxicity. The NCEL is 0.05 mg/m 3 or 0.005 ppm as an 8-hour time-weighted average. *Recommended testing:* EPA has determined that the results of a skin sensitization study (OPPTS 870.2600 test guideline) and a 90-day inhalation toxicity study (OPPTS 870.3465 test guideline) would help characterize the human health effects of the substance. *CFR citation:* 40 CFR 721.10029. **PMN Number P-01-919** *Chemical name:* Pyrimido[5,4-g]pteridine-2,4,6,8-tetramine, 4-methylbenzenesulfonate, base-hydrolyzed. *CAS number:* 346709-25-9. *Basis for action:* The PMN states that the substance will be used as a pigment for thermoplastic polymers. Based on analogy to structurally similar *N* -heterocyclic chemicals, EPA has concerns for potential developmental toxicity from exposure to the PMN material. Significant worker exposure is unlikely when the substance is used as described in the PMN. In addition, based on test data on the PMN substance, EPA is concerned that chronic toxicity to aquatic organisms may occur at concentrations as low as 10 ppb in surface waters. As described in the PMN, the substance is not released to surface waters in significant quantities. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that domestic manufacture of the substance may cause serious health effects and significant environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170 (b)(3)(ii) and (b)(4)(i). *Recommended testing:* EPA has determined that a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OPPTS 870.3650 test guideline), a daphnid chronic toxicity test (OPPTS 850.1300 test guideline (public draft)), and a fish early-life stage toxicity test (OPPTS 850.1400 test guideline (public draft)) would help characterize the human health and environmental effects of the substance. *CFR citation:* 40 CFR 721.10030. **PMN Number P-02-214** *Chemical name:* Lithium potassium titanium oxide. *CAS number:* 39318-30-4. *Effective date of section 5(e) consent order:* June 17, 2002. *Basis for section 5(e) consent order:* The PMN states that the generic (non-confidential) use of the substance will be as a physical characteristics modifier for industrial use in certain solid composite articles. The order was issued under section 5(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding that this substance may present an unreasonable risk of injury to human health. To protect against this risk, the consent order requires worker protection and hazard communication and restricts the aggregate manufacture/importation volume of the PMN substance. The SNUR designates as a ‘significant new use’ the absence of these protective measures. *Toxicity concern:* Based on test data on titanium dioxide, the Agency has concerns for lung toxicity (including oncogenicity) if the PMN substance is inhaled. The NCEL is 5 mg/m 3 as an 8-hour time-weighted average. *Recommended testing:* EPA has determined that the results of a 90-day inhalation toxicity study with a 60-day holding period (OPPTS 870.3465 test guideline) and possibly a 2-year carcinogenicity study (OPPTS 870.4200 test guideline) would help characterize the human health effects of the PMN substance. The consent order contains two production volume limits. The PMN submitter agreed not to exceed the first production volume limit without performing the 90-day inhalation toxicity study and not to exceed the second production volume limit without performing the 2-year carcinogenicity study if warranted based on the results of the first study. *CFR citation:* 40 CFR 721.10031. **PMN Number P-02-269** *Chemical name:* Acrylic acid, polymer with substituted acrylamides (generic). *CAS number:* Not available. *Effective date of section 5(e) consent order:* October 22, 2002. *Basis for section 5(e) consent order:* The PMN states that the generic (non-confidential) use of the substance will be as a thermo-sensitive water absorbing/desorbing polymer to soil. The order was issued under section 5(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding that this substance may present an unreasonable risk of injury to human health. To protect against this risk, the consent order restricts the particle size of the PMN substance. The SNUR designates as a ‘significant new use’ the absence of this protective measure. *Toxicity concern:* Based on test data on swellable high molecular weight polymers (see 60 FR 16319-16320, March 29, 1995) (FRl-4921-9), the Agency has concerns for lung toxicity and oncogenicity if the PMN substance is inhaled. *Recommended testing:* The Agency has determined that a 90-day inhalation toxicity study (OPPTS 870.3465 test guideline) and a carcinogenicity study (OPPTS 870.4200 test guideline) would help characterize possible human health effects of the substance. *CFR citation:* 40 CFR 721.10032. **PMN Number P-02-322** *Chemical name:* Zinc, [ethanedioato(2-)-. kappa. O 1 , . kappa. O 2 ]-. *CAS number:* 547-68-2. *Basis for action:* The PMN states that the generic (non-confidential) use of the substance will be as an intermediate. Based on analogy to similar zinc compounds, EPA is concerned that toxicity to aquatic organisms may occur at concentrations above 1 ppb in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations above 1 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the PMN substance may cause significant adverse effects. EPA has determined, however, that other uses of the PMN substance resulting in surface water concentrations above 1 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii). *Recommended testing:* EPA has determined that the results of an algal toxicity test (OPPTS 850.5400 test guideline (public draft)), a fish early-life stage toxicity test (OPPTS 850.1400 test guideline (public draft)), and a daphnid chronic toxicity test (OPPTS 850.1300 test guideline (public draft)) would help characterize the environmental effects of the PMN substance. *CFR citation:* 40 CFR 721.10033. **PMN Number P-02-359** *Chemical name:* Substituted pyridine coupled with diazotized substituted nitrobenzonitrile, diazotized substituted benzenamine and substituted pyridinecarbonitrile (generic). *CAS number:* Not available. *Basis for action:* The PMN states that the generic (non-confidential) use of the substance will be as a textile dye. Based on structural analogy to neutral organics, EPA is concerned that chronic toxicity to aquatic organisms may occur at concentrations above 1 ppb of the PMN substance in surface waters. As described in the PMN, the substance is not released to surface waters in significant quantities. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in release to surface waters in concentrations above 1 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii). *Recommended testing:* EPA has determined that a fish early-life toxicity test (OPPTS 850.1400 test guideline (public draft)), a daphnid chronic toxicity test (OPPTS 850.1300 test guideline (public draft)), and an algal toxicity test (OPPTS 850.5400 test guideline (public draft)) would help characterize the environmental effects of the PMN substance. *CFR citation:* 40 CFR 721.10034. **PMN Number P-02-382** *Chemical name:* Alkylbenzene sulfonate (generic). *CAS number:* Not available. *Effective date of section 5(e) consent order:* December 17, 2002. *Basis for section 5(e) consent order:* The PMN states that the generic (non-confidential) use of the substance will be as a petroleum lubricant additive. The order was issued under section 5(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding that this substance may present an unreasonable risk of injury to the environment. To protect against this risk, the consent order restricts the formulation of the PMN substance. The SNUR designates as a ‘significant new use’ the absence of this protective measure. In addition, the order was issued under section 5(e)(1)(A)(ii)(II) of TSCA based on a finding that this substance will be produced in substantial quantities and may reasonably be anticipated to enter the environment in substantial quantities. *Toxicity concern:* Based on analogy to structurally similar anionic surfactants, EPA expects toxicity to aquatic organisms to occur at concentrations as low as 500 ppb in surface waters. However, when the PMN substance is manufactured, processed, and used in mineral oil as described in the PMN, EPA does not expect releases of this PMN substance to pose a risk to the environment. The oil diluent serves to minimize dispersion and bioavailability of the PMN substance in surface waters. EPA has determined that other uses of the substance when not diluted in mineral oil may result in significant release to surface waters and may cause significant adverse environmental effects. *Recommended testing:* EPA has determined that an algal toxicity test (OPPTS 850.5400 test guideline (public draft)), a daphnid acute toxicity test (OPPTS 850.1010 test guideline (public draft)), and a fish acute toxicity test (OPPTS 850.1075 test guideline (public draft)) would help characterize the environmental effects of the PMN substance when not used in mineral oil. *CFR citation:* 40 CFR 721.10035. **PMN Number P-02-406** *Chemical name:* Acetaldehyde based polymer (generic). *CAS number:* Not available. *Basis for action:* The PMN states that the generic (non-confidential) use of the substance will be as a corrosion inhibitor. EPA has identified health and environmental concerns for this substance. EPA has identified health concerns for carcinogenicity and dermal sensitization based on analogy to structurally similar chemicals. Based on structural analogy to aldehydes, EPA is concerned that toxicity to aquatic organisms may occur at concentrations as low as 1 ppb of the PMN substance in surface waters. In addition, the PMN substance may be persistent, bioaccumulative, and potentially toxic based on physical/chemical properties of the PMN substance as described in the New Chemical Program's PBT Category (64 FR 60194, November 4, 1999). As described in the PMN, significant worker exposure is unlikely and the substance is not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the PMN substance may present an unreasonable risk. EPA has determined, however, that other domestic manufacturing or other uses that result in predictable or purposeful releases to surface water could result in exposures which may cause serious chronic human health effects and significant environmental effects since the substance has been characterized by EPA as a PBT. Based on this information, the PMN substance meets the concern criteria at § 721.170 (b)(1)(i)(C), (b)(3)(ii), and (b)(4)(ii). *Recommended testing:* EPA has determined that the results of the tiered testing as described in the New Chemicals Program's PBT Category would help characterize the PBT attributes of the PMN substance. *CFR citation:* 40 CFR 721.10036. **PMN Number P-02-423** *Chemical name:* Complex halogenated salt of tris(ethylated aminocarbocyclic)methane (generic). *CAS number:* Not available. *Basis for action:* The PMN states that the substance will be used as a colorant for inks. Based on structurally similar compounds, EPA has identified human health concerns for carcinogenicity, mutagenicity, reproductive effects, and developmental effects from inhalation exposure to the PMN substance. In addition, based on structurally similar compounds, EPA expects toxicity to aquatic organisms at surface water concentrations above 1 ppb. As described in the PMN, significant worker and environmental exposure are unlikely. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in surface water concentrations above 1 ppb or any processing or use beyond the site of manufacture or import could result in worker and environmental exposures which may cause carcinogenic and serious chronic effects in humans and significant environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170 (b)(1)(i)(C), (b)(3)(ii), and (b)(4)(ii). *Recommended testing:* EPA has determined that a prenatal developmental toxicity study by the oral route (OPPTS 870.3700 test guideline), a reproductive and fertility effects study (OPPTS 870.3800 test guideline), a *Salmonella typhimurium* reverse mutation assay (40 CFR 798.5265), and a mammalian erythrocyte micronucleus study by the intraperitoneal route (OPPTS 870.5395 test guideline) would help characterize the human health effects of the PMN substance. Positive results in the mutagencity studies would trigger a carcinogenicity study (OPPTS 870.4200 test guideline). In addition, EPA has determined that a fish acute toxicity test (OPPTS 850.1075 test guideline (public draft)), a daphnid acute toxicity test (OPPTS 850.1010 test guideline (public draft)), and an algal toxicity test (OPPTS 850.5400 test guideline (public draft)) would help characterize the environmental effects of the PMN substance. *CFR citation:* 40 CFR 721.10037. **PMN Number P-02-434** *Chemical name:* Trimellitic anhydride, polymer with substituted glycol, alkyl phenols and ethoxylated nonylphenol (generic). *CAS number:* Not available. *Basis for action:* The PMN states that the substance will be used as curing resin for industrial can coatings. Based on structural analogy to esters, EPA is concerned that toxicity to aquatic organisms may occur at concentrations as low as 1 ppb of the PMN substance in surface waters. As described in the PMN, the substance is not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in release to surface waters may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii). *Recommended testing:* EPA has determined that an aerobic biodegradation test with an analytical methodology to identify the branched-nonyl phenol degradation product (OPPTS 835.3100 test guideline) would help characterize the environmental effects of the PMN substance. *CFR citation:* 40 CFR 721.10038. **PMN Number P-02-514** *Chemical name:* Diethoxybenzenamine derivative, diazotized, coupled with aminonaphthalenesulfonic acid derivative, ammonium salt (generic). *CAS number:* Not available. *Basis for action:* The PMN states that the generic (non-confidential) use of the substance will be as a dyestuff in printing ink. Based on structural analogy, EPA has identified concerns for carcinogenicity, mutagenicity, and developmental toxicity for the substituted beta-naphthylamine azo reduction product, blood and developmental toxicity for the aniline-acid-based azo reduction product, and carcinogenicity, developmental, liver toxicity and sensitization for the para-phenylenediamine-based azo reduction product. There is concern for chronic effects based on the submitted 28-day subchronic study with a No Observed Adverse Effect Level (NOAEL) of 15 mg/kg. As described in the PMN, worker inhalation exposures are not expected. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that domestic manufacture or processing or use of the substance as a solid may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170 (b)(1)(i)(C), (b)(3)(i), (b)(3)(ii), and (b)(3)(iii). *Recommended testing:* EPA has determined that a prenatal developmental toxicity study by the oral route in two species (40 CFR 799.9370), an Ames assay with the Prival modification with a concurrent positive control (OPPTS 870.5100 test guideline), and a 90-day inhalation toxicity study in rats (OPPTS 870.3465 test guideline) would help characterize the human health effects of the PMN substance. *CFR citation:* 40 CFR 721.10039. **PMN Number P-02-522** *Chemical name:* Substituted acridine naphtha substituted benzamide (generic). *CAS number:* Not available. *Basis for action:* The PMN states that the generic (non-confidential) use of the substance will be in exhaust dyeing of polyester fibers. Based on analogy to neutral organics, EPA is concerned that toxicity to aquatic organisms may occur at concentrations above 2 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations above 2 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in release to surface waters in concentrations above 2 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii). *Recommended testing:* EPA has determined that the results of an algal toxicity test (OPPTS 850.5400 test guideline (public draft)), a fish chronic toxicity test (OPPTS 850.1400 test guideline (public draft)), and a daphnid chronic toxicity test (OPPTS 850.1300 test guideline (public draft)) would help characterize the environmental effects of the PMN substance. *CFR citation:* 40 CFR 721.10040. **PMN Number P-02-530** *Chemical name:* 1-Butanone, 2-(dimethylamino)-2-[(4-methylphenyl)methyl]-1-[4-(4-morpholinyl)phenyl]-. *CAS number:* 119344-86-4. *Basis for action:* The PMN states that the substance will be used as a photo initiator for coatings and inks. Based on structural analogy to aliphatic amines, EPA is concerned that toxicity to aquatic organisms may occur at concentrations as low as 2 ppb of the PMN substance in surface waters. As described in the PMN, the substance is not released to surface waters in significant quantities. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that domestic manufacture of the PMN substance may result in significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii). *Recommended testing:* EPA has determined that a fish acute toxicity test (OPPTS 850.1075 test guideline (public draft)), a daphnid acute toxicity test (OPPTS 850.1010 test guideline (public draft)), and an algal toxicity test (OPPTS 850.5400 test guideline (public draft)) would help characterize the environmental effects of the PMN substance. *CFR citation:* 40 CFR 721.10041. **PMN Number P-02-585** *Chemical name:* 2-Propanol, 1-[bis(2-hydroxyethyl)amino]-. *CAS number:* 6712-98-7. *Basis for action:* The PMN states that the generic (non-confidential) use of the substance will be as a grinding aid and intermediate. EPA has identified health concerns for lung sensitization and carcinogenicity based on analogy to triethanolamine. There is concern for developmental toxicity, eye irritation, liver toxicity, kidney toxicity, and blood toxicity based on submitted test data. As described in the PMN, significant inhalation exposure is unlikely. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance other than as described in the PMN may result in significant human exposure. Based on this information, the PMN substance meets the concern criteria at § 721.170 (b)(1)(i)(C), (b)(3)(i), and (b)(3)(ii). *Recommended testing:* EPA has determined that a prenatal developmental toxicity study by the oral route in rats (OPPTS 870.3700 test guideline) would help characterize the human health effects of the PMN substance. *CFR citation:* 40 CFR 721.10042. **PMN Number P-02-697** *Chemical name:* Dineopentyl-4-substituted phthalate (generic). *CAS number:* Not available. *Basis for action:* The PMN states that the generic (non-confidential) use of the substance will be as a catalyst component. EPA has identified health and environmental concerns because the PMN substance may be persistent, bioaccumulative, and toxic based on physical/chemical properties of the PMN substance as described in the New Chemical Program's PBT Category (64 FR 60194, November 4, 1999). EPA has identified health concerns for developmental toxicity based on analogy to other phthalates and concerns for liver, kidney, and neurotoxicity based on analogy to haloaromatic compounds. As described in the PMN, significant worker exposure is unlikely and the substance is not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the PMN substance may present an unreasonable risk. EPA has determined, however, that other uses of the PMN substance which may result in predictable or purposeful release of the PMN substance into waters of the United States or any use of the PMN substance other than as described in the PMN could result in exposures which may cause serious chronic human health effects and significant environmental effects since the PMN substance has been characterized by EPA as a PBT. Based on this information, the PMN substance meets the concern criteria at § 721.170 (b)(3)(ii) and (b)(4)(ii). *Recommended testing:* EPA has determined that the results of the tiered testing as described in the New Chemicals Program's PBT Category would help characterize the PBT attributes of the PMN substance. *CFR citation:* 40 CFR 721.10043. **PMN Number P-02-698** *Chemical name:* Metal oxide, modified with alkyl and vinyl terminated polysiloxanes (generic). *CAS number:* Not available. *Basis for action:* The PMN states that the substance will be used as an adhesive. EPA has identified health concerns for lung toxicity based on analogy to poorly soluble respirable particulates. As described in the PMN, significant worker exposure is unlikely. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that manufacturing, processing, or use of the substance as a powder could result in exposures which may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii). *Recommended testing:* EPA has determined that a 90-day inhalation toxicity study in rodents with a 60-day holding period (OPPTS 870.3465 test guideline) would help characterize the human health effects of the PMN substance. *CFR citation:* 40 CFR 721.10044. **PMN Number P-02-737** *Chemical name:* Diazotized substituted heteromonocycle coupled with naphthalene sulfonic acid derivative, nickel complex, alkaline salt (generic). *CAS number:* Not available. *Basis for action:* The PMN states that the generic (non-confidential) use of the substance will be as a colorant for coating compositions. EPA has identified concerns for carcinogenicity, pulmonary sensitization, immunotoxicity, developmental toxicity, and neurotoxicity from analogous compounds, and carcinogenicity, mutagenicity, and developmental toxicity for the azo reduction products. As described in the PMN, worker inhalation exposure is not expected. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that domestic manufacture or processing or use of the substance as a solid may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170 (b)(1)(i)(C), (b)(1)(i)(D), (b)(3)(ii), and (b)(3)(iii). *Recommended testing:* EPA has determined that a 90-day oral toxicity test in rodents (OPPTS 870.3100 test guideline), a bacterial reverse mutation test with Prival modification (OPPTS 870.5100 test guideline), and an unscheduled DNA synthesis test in rat hepatocytes (OPPTS 870.5550 test guideline) would help characterize the human health effects of the PMN substance. If warranted by the results of any of the three above studies, a carcinogenicity test (OPPTS 870.4200 test guideline) is recommended. *CFR citation:* 40 CFR 721.10045. **PMN Number P-02-747** *Chemical name:* Polyaromatic amine phosphate (generic). *CAS number:* Not available. *Basis for action:* The PMN states that the substance will be used as a film additive. Based on structural analogy to soluble nonionic dyes and inorganic phosphates, EPA is concerned that toxicity to aquatic organisms may occur at concentrations as low as 10 ppb of the PMN substance in surface waters. As described in the PMN, the substance is not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in release to surface waters may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii). *Recommended testing:* EPA has determined that a fish acute toxicity test (OPPTS 850.1075 test guideline (public draft)), a daphnid acute toxicity test (OPPTS 850.1010 test guideline (public draft)), and an algal toxicity test (OPPTS 850.5400 test guideline (public draft)) would help characterize the environmental effects of the PMN substance. *CFR citation:* 40 CFR 721.10046. **PMN Number P-02-766** *Chemical name:* Polyphosphoric acids, compds. with piperazine. *CAS number:* 383905-85-9. *Basis for action:* The PMN states that the generic (non-confidential) use of the substance will be as a flame retardant. Based on analogy to aliphatic amines and inorganic phosphates, EPA is concerned that toxicity to aquatic organisms may occur at concentrations as low as 10 ppb of the PMN substance in surface waters. As described in the PMN, the substance is not released to surface waters in significant quantities. Therefore, EPA has not determined that the proposed manufacturing or use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance other than as described in the PMN could result in exposures which may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii). *Recommended testing:* EPA has determined that an algal toxicity test (OPPTS 850.5400 test guideline (public draft)), a daphnid acute toxicity test (OPPTS 850.1010 test guideline (public draft)), and a fish acute toxicity test (OPPTS 850.1075 test guideline (public draft)) would help characterize the environmental effects of the PMN substance. *CFR citation:* 40 CFR 721.10047. **PMN Number P-02-869** *Chemical name:* Substituted anthraquinone (generic). *CAS number:* Not available. *Basis for action:* The PMN states that the substance will be used as a site limited intermediate. Based on structural analogy to phenols, EPA is concerned that chronic toxicity to aquatic organisms may occur at concentrations above 1 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations above 1 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that a manufacture/importation volume greater than 4,500 kilograms/year may result in significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii). *Recommended testing:* EPA has determined that a fish early life stage test (OPPTS 850.1400 test guideline (public draft)), a daphnid chronic toxicity test (OPPTS 850.1300 test guideline (public draft)), and an algal toxicity test (OPPTS 850.5400 test guideline (public draft)) would help characterize the environmental effects of the PMN substance. *CFR citation:* 40 CFR 721.10048. **PMN Number P-02-912** *Chemical name:* Phenol, 4,4′-cyclohexylidenebis[2-methyl-. *CAS number:* 2362-14-3. *Basis for action:* The PMN states that the substance will be used as a raw material. Based on structural analogy to phenols, EPA is concerned that chronic toxicity to aquatic organisms may occur at concentrations as low as 1 ppb of the PMN substance in surface waters. As described in the PMN, the substance is not released to surface water. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any release of the PMN substance to surface water may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii). *Recommended testing:* EPA has determined that a fish early-life stage toxicity test (OPPTS 850.1400 test guideline (public draft)) and a daphnid chronic toxicity test (OPPTS 850.1300 test guideline (public draft)) would help characterize the environmental effects of the PMN substance. *CFR citation:* 40 CFR 721.10049. **PMN Number P-02-929** *Chemical name:* Disubstituted- *N* ′- hydroxy-benzenecarboximidamide (generic). *CAS number:* Not available. *Basis for action:* The PMN states that the substance will be used as an intermediate. EPA has concerns for chronic toxicity to blood, kidney, and liver based on a submitted 28-day study. As described in the PMN, significant worker exposure is unlikely. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA determined, however, that use of the substance other than as an intermediate may result in exposures which may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(i). *Recommended testing:* EPA has determined that a 90-day oral toxicity study in rodents by the gavage route (OPPTS 870.3100 test guideline) would help characterize the human health effects of the PMN substance. *CFR citation:* 40 CFR 721.10050. **PMN Number P-02-961** *Chemical name:* Spiro naphthoxazine (generic) . *CAS number:* Not available. *Basis for action:* The PMN states that the generic (non-confidential) use of the substance will be as a colorant. Based on structural analogy to neutral organic chemicals, EPA expects chronic toxicity to aquatic organisms at concentrations as low as 1 ppb of the PMN substance in surface waters. As described in the PMN, the substance is not released to surface waters in significant quantities. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that domestic manufacture of the substance could result in exposures which may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii). *Recommended testing:* EPA has determined that a fish early-life stage toxicity test (OPPTS 850.1400 test guideline (public draft)) and a daphnid chronic toxicity test (OPPTS 850.1300 test guideline (public draft)) would help characterize the environmental effects of the PMN substance. *CFR citation:* 40 CFR 721.10051. **PMN Number P-02-1088** *Chemical name:* Aminoalkyl substituted alkylphenol (generic). *CAS number:* Not available. *Basis for action:* The PMN states that the generic (non-confidential) use of the substance will be in a destructive use. Based on structural analogy to phenols and aliphatic amines, EPA is concerned that toxicity to aquatic organisms may occur at concentrations as low as 1 ppb of the PMN substance in surface waters. As described in the PMN, the substance is not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing or use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance other than as described in the PMN could result in exposures which may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii). *Recommended testing:* EPA has determined that an algal toxicity test (OPPTS 850.5400 test guideline (public draft)), a daphnid acute toxicity test (OPPTS 850.1010 test guideline (public draft)), and a fish acute toxicity test (OPPTS 850.1075 test guideline (public draft)) would help characterize the environmental effects of the PMN substance. *CFR citation:* 40 CFR 721.10052. **PMN Number P-03-41** *Chemical name:* Alkyl silane methacrylate (generic). *CAS number:* Not available. *Basis for action:* The PMN states that the generic (non-confidential) use of the substance will be as a chemical intermediate. Based on structural analogy to methacrylates and esters, EPA is concerned that toxicity to aquatic organisms may occur at concentrations as low as 3 ppb of the PMN substance in surface waters. As described in the PMN, the substance is not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in release to surface waters may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii). *Recommended testing:* EPA has determined that the results of a fish acute toxicity test (OPPTS 850.1075 test guideline (public draft)), a daphnid acute toxicity test (OPPTS 850.1010 test guideline (public draft)), and an algal toxicity test (OPPTS 850.5400 test guideline (public draft)) would help characterize the environmental effects of the PMN substance. *CFR citation:* 40 CFR 721.10053. **PMN Number P-03-43** *Chemical name:* Phenol, polymer with formaldehyde, 3-[(2-aminocyclohexyl)amino]-2-hydroxypropyl ethers. *CAS number:* 452082-53-0. *Basis for action:* The PMN states that the generic (non-confidential) use of the substance will be as a resin component. Based on structural analogy to polycationic polymers, EPA is concerned that toxicity to aquatic organisms may occur at concentrations as low as 20 ppb of the PMN substance in surface waters. As described in the PMN, the substance is not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in release to surface waters may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii). *Recommended testing:* EPA has determined that an algal toxicity test (OPPTS 850.5400 test guideline (public draft)), a daphnid acute toxicity test (OPPTS 850.1010 test guideline (public draft)), a fish acute toxicity test (OPPTS 850.1075 test guideline (public draft)), and a fish acute toxicity test mitigated by humic acid (OPPTS 850.1085 test guideline (public draft)) would help characterize the environmental effects of the PMN substance. *CFR citation:* 40 CFR 721.10054. **PMN Number P-03-46** *Chemical name:* 1-Propanaminium, 3-amino- *N* -(carboxymethyl)- *N* , *N* -dimethyl-, *N* -soya acyl derivs., inner salts. *CAS number:* 136504-87-5. *Basis for action:* The PMN states that the generic (non-confidential) use of the substance will be as an oilfield foamer. EPA has identified health concerns for developmental toxicity, neurotoxicity, irritation and corrosion to skin and eyes, and lung effects based on analogy to similar quaternary compounds. As described in the PMN, significant inhalation exposure is unlikely. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance other than as described in the PMN may result in significant human exposure. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii). *Recommended testing:* EPA has determined that a prenatal developmental toxicity study by the oral route in rats or rabbits (OPPTS 870.3700 test guideline) and a repeated dose 28-day oral toxicity study in rats (OPPTS 870.3050 test guideline) would help characterize the human health effects of the PMN substance. *CFR citation:* 40 CFR 721.10055. **PMN Number P-03-47** *Chemical name:* Benzenemethanaminium, *N* -(3-aminopropyl)- *N* , *N* -dimethyl-, *N* -soya acyl derivs., chlorides. *CAS number:* 90194-13-1. *Basis for action:* The PMN states that the generic (non-confidential) use of substance will be as an oilfield corrosion inhibitor. EPA has identified health concerns for developmental toxicity, neurotoxicity, lung effects, irritation to the lungs and mucous membranes, and severe eye irritation based on analogy to similar quaternary compounds. As described in the PMN, significant inhalation exposure is unlikely. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance other than as described in the PMN may result in significant human exposure. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii). *Recommended testing:* EPA has determined that a prenatal developmental toxicity study by the oral route in rats or rabbits (OPPTS 870.3700 test guideline) and a repeated dose 28-day oral toxicity study in rats (OPPTS 870.3050 test guideline) would help characterize the human health effects of the PMN substance. *CFR citation:* 40 CFR 721.10056. IV. Objectives and Rationale for this Rule A. Rationale During review of the PMNs submitted for the chemical substances that are subject to these SNURs, EPA concluded that for 13 of the 65 chemical substances, regulation was warranted under section 5(e) of TSCA, pending the development of information sufficient to make reasoned evaluations of the health or environmental effects of the chemical substances. The basis for such findings is outlined in Unit III. Based on these findings, TSCA section 5(e) consent orders requiring the use of appropriate exposure controls were negotiated with the PMN submitters; the SNUR provisions for these chemical substances listed in this document are consistent with the provisions of the TSCA section 5(e) consent orders. In the other 52 cases for which the proposed uses are not regulated under a TSCA section 5(e) consent order, EPA determined that one or more of the criteria of concern established at 40 CFR 721.170 were met, as discussed in Unit III. B. Objectives EPA is issuing these SNURs for specific chemical substances which have undergone premanufacture review because the Agency wants to achieve the following objectives with regard to the significant new uses designated in this rule: 1. EPA will receive notice of any person's intent to manufacture, import, or process a listed chemical substance for the described significant new use before that activity begins. 2. EPA will have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing, importing, or processing a listed chemical substance for the described significant new use. 3. EPA will be able to regulate prospective manufacturers, importers, or processors of a listed chemical substance before the described significant new use of the chemical substance occurs, provided that regulation is warranted pursuant to TSCA sections 5(e), 5(f), 6 or 7. 4. EPA will ensure that all manufacturers, importers, and processors of the same chemical substance that is subject to a TSCA section 5(e) consent order are subject to similar requirements. Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the TSCA Inventory. Manufacturers, importers, and processors are responsible for ensuring that a new chemical substance subject to a final SNUR is listed on the TSCA Inventory. V. Direct Final Procedures EPA is issuing these SNURs as a direct final rule, as described in 40 CFR 721.160(c)(3) and 721.170(d)(4). In accordance with 40 CFR 721.160(c)(3)(ii) and 721.170(d)(4)(i), this rule will be effective May 29, 2007, unless EPA receives a written notice by April 30, 2007 of adverse or critical comments, or notice of intent to submit adverse or critical comments, on EPA's action. If EPA receives such a notice, EPA will publish a document to withdraw the direct final SNUR for the specific chemical substance to which the adverse or critical comments apply. EPA will then propose a SNUR for the specific chemical substance providing a 30-day comment period. This action establishes SNURs for a number of chemical substances. Any person who submits adverse or critical comments or notice of intent to submit adverse or critical comments, must identify the chemical substance and the new use to which it applies. EPA will not withdraw a SNUR for a chemical substance not identified in a notice. VI. Test Data and Other Information EPA recognizes that TSCA section 5 does not require developing any particular test data before submission of a SNUN. Persons are required only to submit test data in their possession or control and to describe any other data known to or reasonably ascertainable by them. However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. In cases where EPA issued a TSCA section 5(e) consent order that requires or recommends certain testing, Unit III. lists those tests. Unit III. also lists recommended testing for non-5(e) SNURs. Descriptions of recommended tests are provided for informational purposes. EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol selection. Many test guidelines are now available on the Internet at *http://www.epa.gov/opptsfrs/home/guidelin.htm* . In the TSCA section 5(e) consent orders for several of the chemical substances regulated under this rule, EPA has established production limits in view of the lack of data on the potential health and environmental risks that may be posed by the significant new uses or increased exposure to the chemical substances. These production limits cannot be exceeded unless the PMN submitter first submits the results of toxicity tests that would permit a reasoned evaluation of the potential risks posed by these chemical substances. Under recent consent orders, each PMN submitter is required to submit each study at least 14 weeks (earlier consent orders required submissions at least 12 weeks) before reaching the specified production limit. Listings of the tests specified in the TSCA section 5(e) consent orders are included in Unit III. The SNURs contain the same production volume limits as the consent orders. Exceeding these production limits is defined as a significant new use. Persons who intend to exceed the production limit must notify the Agency by submitting a SNUN at least 90 days in advance. The recommended tests may not be the only means of addressing the potential risks of the chemical substance. However, SNUNs submitted for significant new uses without any test data may increase the likelihood that EPA will take action under TSCA section 5(e), particularly if satisfactory test results have not been obtained from a prior submitter. EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to conduct the appropriate tests. SNUN submitters should be aware that EPA will be better able to evaluate SNUNs which provide detailed information on the following: 1. Human exposure and environmental release that may result from the significant new use of the chemical substances. 2. Potential benefits of the chemical substances. 3. Information on risks posed by the chemical substances compared to risks posed by potential substitutes. VII. Procedural Determinations EPA is establishing through this rule certain significant new uses which have been claimed as CBI subject to Agency confidentiality regulations at 40 CFR part 2. EPA is required to keep this information confidential to protect the CBI of the original PMN submitter. EPA promulgated a procedure to deal with the situation where a specific significant new use is CBI. This procedure appears in 40 CFR 721.1725(b)(1) and is similar to that in § 721.11 for situations where the chemical identity of the chemical substance subject to a SNUR is CBI. This procedure is cross-referenced in each of the SNURs that include specific significant new uses that are CBI. A manufacturer or importer may request EPA to determine whether a proposed use would be a significant new use under this rule. Under the procedure in § 721.1725(b)(1), a manufacturer or importer must show that it has a *bona fide* intent to manufacture or import the chemical substance and must identify the specific use for which it intends to manufacture or import the chemical substance. If EPA concludes that the person has shown a *bona fide* intent to manufacture or import the chemical substance, EPA will tell the person whether the use identified in the *bona fide* submission would be a significant new use under the rule. Since most of the chemical identities of the chemical substances subject to these SNURs are also CBI, manufacturers and processors can combine the *bona fide* submission under the procedure in § 721.1725(b)(1) with that under § 721.11 into a single step. If a manufacturer or importer is told that the production volume identified in the *bona fide* submission would not be a significant new use, i.e., it is below the level that would be a significant new use, that person can manufacture or import the chemical substance as long as the aggregate amount does not exceed that identified in the *bona fide* submission to EPA. If the person later intends to exceed that volume, a new *bona fide* submission would be necessary to determine whether that higher volume would be a significant new use. EPA is considering whether to adopt a special procedure for use when CBI production volume is designated as a significant new use. Under such a procedure, a person showing a *bona fide* intent to manufacture or import the chemical substance, under the procedure described in § 721.11, would automatically be informed of the production volume that would be a significant new use. Thus, the person would not have to make multiple *bona fide* submissions to EPA for the same chemical substance to remain in compliance with the SNUR, as could be the case under the procedures in § 721.1725(b)(1). VIII. Applicability of Rule to Uses Occurring Before Effective Date of the Final Rule To establish a significant “new” use, EPA must determine that the use is not ongoing. The chemical substances subject to this rule have recently undergone premanufacture review. TSCA section 5(e) consent orders have been issued for 13 chemical substances and notice submitters are prohibited by the TSCA section 5(e) consent orders from undertaking activities which EPA is designating as significant new uses. In cases where EPA has not received a notice of commencement

(NOC)and the chemical substance has not been added to the TSCA Inventory, no other person may commence such activities without first submitting a PMN. For chemical substances for which an NOC has not been submitted at this time, EPA has concluded that the uses are not ongoing. However, EPA recognizes in cases when chemical substances identified in this SNUR are added to the TSCA Inventory prior to the effective date of the rule, the chemical substances may be manufactured, imported, or processed by other persons for a significant new use as defined in this rule before the effective date of the rule. However, 35 of the 65 chemical substances contained in this rule have CBI chemical identities, and since EPA has received a limited number of post-PMN *bona fide* submissions (per 40 CFR 720.25 and 721.11), the Agency believes that it is highly unlikely that any of the significant new uses described in the following regulatory text are ongoing. EPA solicits comments on whether any of the uses described as significant new uses are ongoing. As discussed in the **Federal Register** of April 24, 1990 (55 FR 17376), EPA has decided that the intent of section 5(a)(1)(B) of TSCA is best served by designating a use as a significant new use as of the date of publication of this direct final rule rather than as of the effective date of the rule. If uses begun after publication were considered ongoing rather than new, it would be difficult for EPA to establish SNUR notice requirements because a person could defeat the SNUR by initiating the significant new use before the rule became final, and then argue that the use was ongoing as of the effective date of the final rule. Thus, persons who begin commercial manufacture, import, or processing of the chemical substances regulated through this SNUR will have to cease any such activity before the effective date of this rule. To resume their activities, these persons would have to comply with all applicable SNUR notice requirements and wait until the notice review period, including all extensions, expires. EPA has promulgated provisions to allow persons to comply with this SNUR before the effective date. If a person were to meet the conditions of advance compliance under § 721.45(h), the person would be considered to have met the requirements of the final SNUR for those activities. IX. SNUN Submissions EPA recommends that submitters consult with the Agency prior to submitting a SNUN to discuss what data may be useful in evaluating a significant new use. Discussions with the Agency prior to submission can afford submitters ample time to conduct any tests that might be helpful in evaluating risks posed by the substance. According to 40 CFR 721.1(c), persons submitting a SNUN must comply with the same notice requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in 40 CFR 720.50. SNUNs must be mailed to the Environmental Protection Agency, OPPT Document Control Office (7407M), 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. Information must be submitted in the form and manner set forth in EPA Form No. 7710-25. This form is available from the Environmental Assistance Division (7408M), 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001 (see 40 CFR 721.25 and 720.40). Forms and information are also available electronically at *http://www.epa.gov/opptintr/newchems/pubs/pmnforms.htm* . X. Notification on Substances for Which Significant New Use Rules are Not Being Issued As required in 40 CFR 721.160(a)(2), EPA is providing notification on the following two chemical substances that are subject to final TSCA section 5(e) consent orders but for which EPA has decided not to issue significant new use rules at this time. EPA is not publishing SNURs for PMNs P-02-193 and P-03-394 because they are subject to exposure-based consent orders. EPA's exposure-based policies for new chemical substances are based on TSCA section 5(e)(1)(A)(ii)(II) and are described on the New Chemicals website at *http://www.epa.gov/oppt/newchems/pubs/expbased.htm* . Exposure-based consent orders are based on two findings: 1) Insufficient information available on the health and environmental effects of the PMN substance, and 2) expected substantial production volume and significant or substantial human exposure and/or release to the environment. Exposure-based consent orders prohibit the submitter from exceeding a specific, aggregate production or import volume unless the submitter has conducted the fate, aquatic toxicity, and/or health effects testing specified in the order and submitted the results to EPA. The production or import volume limit is usually set so that it will occur within a few years. Therefore, instead of publishing and often revoking exposure-based SNURs within a short timespan, EPA generally defers publication of SNURs on substances subject to exposure-based consent orders until the test data are received. In many cases, data received through an exposure-based consent order confirm the Agency's prediction of low or no risk, so no further regulatory action is warranted. XI. Economic Analysis EPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers, importers, and processors of the chemical substances subject to this rule. EPA's complete economic analysis is available in the public docket. XII. Statutory and Executive Order Reviews 1. Executive Order 12866: Regulatory Planning and Review Under Executive Order 12866, entitled *Regulatory Planning and Review* (58 FR 51735, October 4, 1993), the Office of Management and Budget

(OMB)has determined that a proposed or final SNUR is not a “significant regulatory action” subject to review by OMB, because it does not meet the criteria in section 3(f) of the Executive order. 2. Paperwork Reduction Act According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 *et seq* ., an Agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under the PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the **Federal Register** , are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable. The information collection requirements related to this action have already been approved by OMB pursuant to the PRA under OMB control number 2070-0012 (EPA ICR No. 574). This action does not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average between 30 and 170 hours per response. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review, and submit the required SNUN. Send any comments about the accuracy of the burden estimate, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques, to the Director, Collection Strategies Division, Office of Environmental Information (2822T), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address. 3. Regulatory Flexibility Act Pursuant to section 605(b) of the Regulatory Flexibility Act

(RFA)(5 U.S.C. 601 *et seq* .), the Agency hereby certifies that promulgation of this SNUR will not have a significant adverse economic impact on a substantial number of small entities. The rationale supporting this conclusion is as follows. A SNUR applies to any person (including small or large entities) who intends to engage in any activity described in the rule as a “significant new use.” By definition of the word “new,” and based on all information currently available to EPA, it appears that no small or large entities presently engage in such activity. Since a SNUR only requires that any person who intends to engage in such activity in the future must first notify EPA by submitting a SNUN, no economic impact will even occur until someone decides to engage in those activities. Although some small entities may decide to conduct such activities in the future, EPA cannot presently determine how many, if any, there may be. However, EPA's experience to date is that, in response to the promulgation of over 1,000 SNURs, the Agency receives on average only 10 notices per year. Of those SNUNs submitted, none appear to be from small entities in response to any SNUR. In addition, the estimated reporting cost for submission of a SNUN (see Unit IX.), is minimal regardless of the size of the firm. Therefore, EPA believes that the potential economic impact of complying with this SNUR is not expected to be significant or adversely impact a substantial number of small entities. In a SNUR that published on June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency presented it's general determination that proposed and final SNURs are not expected to have a significant economic impact on a substantial number of small entities, which was provided to the Chief Counsel for Advocacy of the Small Business Administration. 4. Unfunded Mandates Reform Act Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reason to believe that any State, local, or Tribal government will be impacted by this rulemaking. As such, EPA has determined that this regulatory action does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any affect on small governments subject to the requirements of sections 202, 203, 204, or 205 of the Unfunded Mandates Reform Act of 1995

(UMRA)(Public Law 104-4). 5. Executive Order 13132: Federalism This action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999). 6. Executive Order 13175: Consultation and Coordination with Indian Tribal Governments This rule does not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This does not significantly or uniquely affect the communities of Indian Tribal governments, nor does it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000), do not apply to this rule. 7. Executive Order 13045: Protection of Children from Environmental Health Risks and Safety Risks This action is not subject to Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined by Executive Order 12866, and this action does not address environmental health or safety risks disproportionately affecting children. 8. Executive Order 13211: Actions that Significantly Affect Energy Supply, Distribution, or Use This rule is not subject to Executive Order 13211, entitled *Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use* (66 FR 28355, May 22, 2001), because this action is not expected to affect energy supply, distribution, or use. 9. National Technology Transfer Advancement Act In addition, since this action does not involve any technical standards, section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note), does not apply to this action. 10. Executive Order 12898: Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898, entitled *Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations* (59 FR 7629, February 16, 1994). 11. Executive Order 12630: Governmental Actions and Interference with Constitutionally Protected Property Rights (Takings) EPA has complied with Executive Order 12630, entitled *Governmental Actions and Interference with Constitutionally Protected Property Rights* (53 FR 8859, March 15, 1988), by examining the takings implications of this rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the Executive order. 12. Executive Order 12988: Civil Justice Reform In issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct, as required by section 3 of Executive Order 12988, entitled *Civil Justice Reform* (61 FR 4729, February 7, 1996). 13. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq* ., generally provides that before a final rule may take effect, the Agency promulgating the final rule must submit a final rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this final rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the **Federal Register** . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 721 Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements. Dated: March 22, 2007. Charles M. Auer, Director, Office of Pollution Prevention and Toxics. Therefore, 40 CFR part 721 is amended as follows: PART 721—[AMENDED] 1. The authority citation for part 721 continues to read as follows: Authority: 15 U.S.C. 2604, 2607, and 2625(c). 2. By adding new § 721.10002 to subpart E to read as follows: § 721.10002 2-Thiazolidinone.

(a)*Chemical substance and significant new uses subject to reporting* .

(1)The chemical substance identified as 2-thiazolidinone (PMN P-97-415; CAS No. 2682-49-7) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2)The significant new uses are:

(i)*Protection in the workplace* . Requirements as specified in § 721.63 (a)(1), (a)(3), (a)(4), (a)(6)(i), (b), and (c). The following National Institute for Occupational Safety and Health (NIOSH)-approved respirators with an assigned protection factor

(APF)of 10-25 meet the minimum requirements for § 721.63(a)(4): Air-purifying, tight-fitting respirator (either half- or full-face) equipped with N100 (if aerosols absent), R100, or P100 filters; powered air-purifying respirator equipped with a loose-fitting hood or helmet and High Efficiency Particulate Air

(HEPA)filters; powered air-purifying respirator equipped with a tight-fitting facepiece (either half- or full-face) and HEPA filters; and supplied-air respirator operated in pressure demand or continuous flow mode and equipped with a hood or helmet or tight-fitting facepiece (either half- or full-face). As an alternative to the respiratory requirements listed here, a manufacturer, importer, or processor may choose to follow the new chemical exposure limit

(NCEL)provisions listed in the TSCA section 5(e) consent order for this substance. The NCEL is 0.7 mg/m 3 as an 8-hour time-weighted average. Persons who wish to pursue NCELs as an alternative to the § 721.63 respirator requirements may request to do so under 40 CFR 721.30. Persons whose § 721.30 requests to use the NCELs approach are approved by EPA will receive NCELs provisions comparable to those contained in the corresponding section 5(e) consent order.

(ii)*Hazard communication program* . Requirements as specified in § 721.72 (a), (b), (c), (d),

(e)(concentration set at 1.0 percent), (f), (g)(1)(iii), (g)(1)(iv), (g)(1)(vi), (g)(1)(ix), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv) (use respiratory protection or maintain workplace airborne concentrations at or below an 8-hour time-weighted average of 0.7 mg/m 3 ), (g)(2)(v), (g)(3)(ii), (g)(4)(i), (g)(4)(ii), (g)(4)(iii), and (g)(5). The following statement shall appear on each label as specified in § 721.72(b) and the Material Safety Data Sheet

(MSDS)as specified in § 721.72(c). The substance may cause severe eye irritation. The substance may cause internal organ effects (blood, liver, and kidney). The substance may cause developmental/maternal effects. When handling this substance as a powder, use respiratory protection.

(iii)*Industrial, commercial, and consumer activities* . Requirements as specified in § 721.80 (g),

(p)(300,000 kilograms), (v)(1), (w)(1), and (x)(1).

(iv)*Disposal* . Requirements as specified in § 721.85 (a)(1), (a)(2), (a)(3), (b)(1), (b)(2), (b)(3), (c)(1), (c)(2), and (c)(3).

(v)*Release to water* . Requirements as specified in § 721.90 (a)(1), (b)(1), and (c)(1).

(b)*Specific requirements* . The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1)*Recordkeeping* . Recordkeeping requirements as specified in § 721.125 (a), (b), (c), (d), (e), (f), (g), (h), (i), (j), and

(k)are applicable to manufacturers, importers, and processors of this substance.

(2)*Limitations or revocation of certain notification requirements* . The provisions of § 721.185 apply to this section. 3. By adding new § 721.10003 to subpart E to read as follows: § 721.10003 Manganese heterocyclic tetraamine complex (generic).

(a)*Chemical substances and significant new uses subject to reporting* .

(1)The chemical substances identified generically as manganese heterocyclic tetraamine complex (PMNs P-98-625/626/627/628/629 and P-00-614/617) are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2)The significant new uses are:

(i)*Industrial, commercial, and consumer activities* . Requirements as specified in § 721.80(s) (10,000 kilograms per chemical substance).

(ii)[Reserved]

(b)*Specific requirements* . The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1)*Recordkeeping* . Recordkeeping requirements as specified in § 721.125 (a), (b), (c), and

(i)are applicable to manufacturers, importers, and processors of this substance.

(2)*Limitations or revocation of certain notification requirements* . The provisions of § 721.185 apply to this section. 4. By adding new § 721.10004 to subpart E to read as follows: § 721.10004 2-Butenoic acid, 4,4′-[(dibutylstannylene)bis(oxy)]bis[4-oxo-, (2Z,2′Z)-, di-C 8-10 -isoalkyl esters, C 9 -rich.

(a)*Chemical substance and significant new uses subject to reporting* .

(1)The chemical substance identified as 2-butenoic acid, 4,4′-[(dibutylstannylene)bis(oxy)]bis[4-oxo-, (2Z,2′Z)-, di-C 8-10 -isoalkyl esters, C 9 -rich (PMN P-98-1181; CAS No. 247041-56-1) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2)The significant new uses are:

(i)*Protection in the workplace* . Requirements as specified in § 721.63 (a)(1), (a)(2)(i), and (a)(3).

(ii)*Industrial, commercial, and consumer activities* . Requirements as specified in § 721.80 (v)(2), (w)(2), (x)(2), and (y)(1).

(b)*Specific requirements* . The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1)*Recordkeeping* . Recordkeeping requirements as specified in § 721.125 (a), (b), (c), (d), (e), and

(i)are applicable to manufacturers, importers, and processors of this substance.

(2)*Limitations or revocation of certain notification requirements* . The provisions of § 721.185 apply to this section. 5. By adding new § 721.10005 to subpart E to read as follows: § 721.10005 2-Butenoic acid, 4,4′-[(dibutylstannylene)bis(oxy)]bis [4-oxo-, (2Z,2′Z)-, di-C 9-11 -isoalkyl esters, C 10 -rich.

(a)*Chemical substance and significant new uses subject to reporting* .

(1)The chemical substance identified as 2-butenoic acid, 4 ,4′-[(dibutylstannylene)bis(oxy)]bis [4-oxo-, (2Z,2′Z)-, di-C 9-11 -isoalkyl esters, C 10 -rich (PMN P-98-1182) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2)The significant new uses are:

(i)*Protection in the workplace* . Requirements as specified in § 721.63 (a)(1), (a)(2)(i), and (a)(3).

(ii)*Industrial, commercial, and consumer activities* . Requirements as specified in § 721.80 (v)(2), (w)(2), (x)(2), and (y)(1).

(b)*Specific requirements* . The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1)*Recordkeeping* . Recordkeeping requirements as specified in § 721.125 (a), (b), (c), (d), (e), and

(i)are applicable to manufacturers, importers, and processors of this substance.

(2)*Limitations or revocation of certain notification requirements* . The provisions of § 721.185 apply to this section. 6. By adding new § 721.10006 to subpart E to read as follows: § 721.10006 Mixed metal oxide (generic).

(a)*Chemical substance and significant new uses subject to reporting* .

(1)The chemical substance identified generically as mixed metal oxide (PMN P-99-511) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2)The significant new uses are:

(i)*Industrial, commercial, and consumer activities* . Requirements as specified in § 721.80(s) (60,000 kilograms).

(ii)[Reserved]

(b)*Specific requirements* . The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1)*Recordkeeping* . Recordkeeping requirements as specified in § 721.125 (a), (b), (c), and

(i)are applicable to manufacturers, importers, and processors of this substance.

(2)*Limitations or revocation of certain notification requirements* . The provisions of § 721.185 apply to this section. 7. By adding new § 721.10007 to subpart E to read as follows: § 721.10007 Alcohols, C 12-14 - secondary, ethoxylated propoxylated.

(a)*Chemical substance and significant new uses subject to reporting* .

(1)The chemical substance identified as alcohols, C 12-14 - secondary, ethoxylated propoxylated (PMN P-00-11; CAS No. 103331-86-8) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2)The significant new uses are:

(i)*Release to water* . Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N = 50).

(ii)[Reserved]

(b)*Specific requirements* . The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1)*Recordkeeping* . Recordkeeping requirements as specified in § 721.125 (a), (b), (c), and

(k)are applicable to manufacturers, importers, and processors of this substance.

(2)*Limitations or revocation of certain notification requirements* . The provisions of § 721.185 apply to this section. 8. By adding new § 721.10008 to subpart E to read as follows: § 721.10008 Manganese strontium oxide (MnSrO 3 ).

(a)*Chemical substance and significant new uses subject to reporting* .

(1)The chemical substance identified as manganese strontium oxide (MnSrO 3 ) (PMN P-00-1121; CAS No. 12163-45-0) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2)The significant new uses are:

(i)*Hazard communication program* . Requirements as specified in § 721.72 (a), (b), (c), (d),

(e)(concentration set at 0.1 percent), (f), (g)(1)(i), (g)(1)(ii), (g)(1)(iii), (g)(1)(vii), (g)(1)(viii), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(v), (g)(3)(ii), (g)(4)(i), and (g)(5).

(ii)*Industrial, commercial, and consumer activities* . Requirements as specified in § 721.80

(k)(manufacture, processing, or use of the PMN substance if the particle size is less than 10 microns) and (q).

(iii)*Release to water* . Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N=1).

(b)*Specific requirements* . The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1)*Recordkeeping* . Recordkeeping requirements as specified in § 721.125 (a), (b), (c), (f), (g), (h), (i), and

(k)are applicable to manufacturers, importers, and processors of this substance.

(2)*Limitations or revocation of certain notification requirements* . The provisions of § 721.185 apply to this section.

(3)*Determining whether a specific use is subject to this section* . The provisions of § 721.1725(b)(1) apply to this section. 9. By adding new § 721.10009 to subpart E to read as follows: § 721.10009 Manganese yttrium oxide (MnYO 3 ).

(a)*Chemical substance and significant new uses subject to reporting* .

(1)The chemical substance identified as manganese yttrium oxide (MnYO 3 ) (PMN P-00-1122; CAS No. 12032-75-6) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.