Revocation of TSCA Section 4 Testing Requirements for Certain Chemical Substances, 18650-18654 [06-3491]

Download as PDF 18650 Federal Register / Vol. 71, No. 70 / Wednesday, April 12, 2006 / Rules and Regulations ZB1b) in/on the following commodities when present therein as a result of the application of emamectin to crops listed in the table in paragraph (a)(1) of this section: Commodity Parts per million Cattle, fat ........................ Cattle, liver ...................... Cattle, meat .................... Cattle, meat byproducts, except liver .................. Goat, fat .......................... Goat, liver ....................... Goat, meat ...................... Goat, meat byproducts, except liver .................. Horse, fat ........................ Horse, liver ..................... Horse, meat .................... Horse, meat byproducts, except liver .................. Milk ................................. Sheep, fat ....................... Sheep, liver ..................... Sheep, meat ................... Sheep, meat byproducts, except liver .................. 0.010 0.050 0.003 0.020 0.010 0.050 0.003 0.020 0.010 0.050 0.003 0.020 0.003 0.010 0.050 0.003 0.020 (b) Section 18 emergency exemptions. [Reserved] (c) Tolerances with regional registrations. [Reserved] (d) Indirect and inadvertant residues. [Reserved] [FR Doc. 06–3308 Filed 4–11–06; 8:45 am] BILLING CODE 6560–50–S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 799 [EPA–HQ–OPPT–2003–0006; FRL–7751–7] RIN 2070–AD42 Revocation of TSCA Section 4 Testing Requirements for Certain Chemical Substances Environmental Protection Agency (EPA). ACTION: Direct final rule. cprice-sewell on PROD1PC66 with RULES AGENCY: SUMMARY: EPA is taking direct final action to amend the final test rule, ‘‘In Vitro Dermal Absorption Rate Testing of Certain Chemicals of Interest to the Occupational Safety and Health Administration,’’ promulgated under section 4 of the Toxic Substances Control Act (TSCA). This amendment removes dimethyl sulfate (DMS) from the list of chemical substances regulated under the test rule and also removes the requirement that testing be conducted to determine a permeability constant (Kp) for methyl isoamyl ketone (MIAK) and dipropylene glycol methyl ether VerDate Aug<31>2005 15:11 Apr 11, 2006 Jkt 208001 (DPGME). However, the requirement to conduct testing to measure short-term dermal absorption rates remains for MIAK and DPGME. EPA is basing its decisions to take these actions on information it received since publication of the final rule. Also, upon the effective date of the revocation of the TSCA section 4 testing requirements for DMS, persons who export or intend to export DMS will no longer be subject to the TSCA section 12(b) export notification requirements to the extent that they were triggered by the testing requirements being revoked by this action. DATES: This direct final rule is effective June 12, 2006 without further notice, unless EPA receives adverse comment in writing, or a request to present comment orally, on or before May 12, 2006. If EPA receives adverse comment, or a written request for an opportunity to present oral comments, EPA will publish a timely withdrawal in the Federal Register informing the public that this direct final rule, or relevant portions of this direct final rule, will not take effect. If you write EPA to request an opportunity to present oral comments on or before May 12, 2006, EPA will hold a public meeting on this direct final rule in Washington, DC. The announcement of such a meeting would be published in the Federal Register. ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA–HQ–OPPT–2003–0006, by one of the following methods: • https://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, Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. Attention: Docket ID Number EPA–HQ–OPPT–2003–0006. 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– 2003–0006. 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 https:// www.regulations.gov, including any PO 00000 Frm 00062 Fmt 4700 Sfmt 4700 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 email. 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 https:// www.epa.gov/epahome/docket.htm. Docket: All documents in the docket are listed in the 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 at https:// www.regulations.gov or in hard copy at the OPPT Docket, EPA Docket Center (EPA/DC), EPA West, Rm. B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566–1744, and the telephone number for the OPPT Docket is (202) 566–0280. 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. E:\FR\FM\12APR1.SGM 12APR1 Federal Register / Vol. 71, No. 70 / Wednesday, April 12, 2006 / Rules and Regulations For technical information contact: John Schaeffer or Catherine Roman, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (202) 564–8173 or (202) 564– 8172; e-mail address: schaeffer.john@epa.gov or roman.catherine@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information cprice-sewell on PROD1PC66 with RULES A. Does this Action Apply to Me? This action is directed to the public in general, and may be of particular interest to those persons who manufacture (defined by statute to include import) or process DMS, DPGME, or MIAK. Also, persons that export or intend to export DMS may have an interest in this action, as, upon the effective date of the revocation of the TSCA section 4 testing requirements for DMS, persons who export or intend to export DMS will no longer be subject to the TSCA section 12(b) export notification requirements to the extent that they were triggered by the testing requirements being revoked by this action. Because other persons may also be interested, the Agency has not attempted to describe all the specific persons that may be affected by this action. If you have any questions regarding the applicability of this action to a particular person, consult the persons listed under FOR FURTHER INFORMATION CONTACT. B. What Should I Consider as I Prepare My Comments for EPA? 1. Submitting CBI. Do not submit CBI to EPA through regulations.gov or email. 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. Requesting an opportunity to present oral comments to the Agency. When you submit a request for an opportunity to present oral comments, this request must be in writing. If such a request is received on or before May VerDate Aug<31>2005 15:11 Apr 11, 2006 Jkt 208001 12, 2006, EPA will hold a public meeting on this direct final rule in Washington, DC. This written request must be submitted to the Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001. If such a request is received, EPA will announce the scheduling of the public meeting in a subsequent Federal Register document. If a public meeting is announced, and if you are interested in attending or presenting oral and/or written comments and data at the public meeting, you should follow the instructions provided in the subsequent Federal Register document announcing the public meeting. 3. 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? Pursuant to section 4 of TSCA, EPA promulgated and published in the Federal Register a test rule on April 26, 2004 (OSHA dermal test rule) requiring that manufactures (including importers) and processors of 34 chemical substances of interest to the Occupational Safety and Health Administration (OSHA) conduct in vitro dermal absorption rate testing (Ref. 1). OSHA intends to use the data from these studies to evaluate the need to develop ‘‘skin designations’’ for these chemicals. Skin designations are used PO 00000 Frm 00063 Fmt 4700 Sfmt 4700 18651 by OSHA to alert industrial hygienists, employers, and workers to the potentially significant contribution of a particular chemical to an individual’s total workplace exposure to chemicals which can occur by the cutaneous route. Skin designations encourage employers to consider whether changes should be made to processes involving such chemical substances in order to reduce the potential for systemic toxicity from dermal absorption of these chemicals. EPA recently received dermal absorption data on 3 of the 34 chemical substances listed in the final rule. These data have persuaded EPA to fully withdraw the testing requirements set forth in the final rule for dimethyl sulfate (DMS; Chemical Abstracts Service Number (CAS No.): 77–78–1, Chemical Abstracts (CA) Index Name: Sulfuric acid, dimethyl ester), and to partially withdraw such requirements for methyl isoamyl ketone (MIAK; CAS No.: 110–12–3, CA Index Name: 2Hexanone, 5-methoxy-) and dipropylene glycol methyl ether (DPGME; CAS No.: 34590–94–8, CA Index Name: Propanol, 1(or 2)-(2-methoxymethylethoxy)-). On November 2, 2004, DuPont Chemical Solutions Enterprise (DCSE) submitted results of an exploratory skin absorption study entitled Dimethyl Sulfate: An In Vitro Assay for Assessment of Dermal Corrosivity Using Transcutaneous Electrical Impedance (Refs. 2 and 3). This study clearly showed that DMS is corrosive (Ref. 3). While the test rule requires that if a chemical ‘‘damages the skin when applied neat, it must be dissolved in water’’ (40 CFR 799.5115(h)(5)(vi)), DMS is also rapidly hydrolyzed in water, and would not be available as the test substance, even for the required short-term testing (Refs. 1, 2, and 4). These factors, considered together, render the in vitro dermal absorption testing of DMS which is required in the test rule technically infeasible (Ref. 5). Furthermore, EPA neither has, nor knows of, any test standard which could successfully obtain the dermal absorption testing data for DMS as described in the OSHA dermal test rule. Therefore, for the dermal absorption testing requirements for DMS, EPA can no longer meet the TSCA requirement under section 4(b)(1)(B) of TSCA regarding the inclusion of standards for development of test data. Therefore, EPA, in this direct final rule, is revoking the testing requirements for DMS by removing it from the list of chemical substances in 40 CFR 799.5115(j) for which in vitro dermal absorption rate testing is required (Ref. 1). EPA also received dermal absorption studies on MIAK and DPGME, which E:\FR\FM\12APR1.SGM 12APR1 18652 Federal Register / Vol. 71, No. 70 / Wednesday, April 12, 2006 / Rules and Regulations cprice-sewell on PROD1PC66 with RULES were conducted prior to issuance of the final test rule. On June 22, 2005, the Eastman Chemical Company submitted a study entitled Methyl Isoamyl Ketone: Measurement of the In Vitro Rate of Percutaneous Absorption through Human Skin (Refs. 6 and 7). The study determined an absorption rate for MIAK of 0.215 ± 0.15 milligrams/centimeter squared/hour (mg/cm2/h) yielding a Kp (permeability constant) of 0.000261 cm/ h (Ref. 7). On September 29, 2004, EPA received a request from the American Chemistry Council to review a recently published study by Venier, et al. (2004) on the dermal absorption of five glycol ethers, including DPGME (Ref. 8). This study determined an absorption rate for DPGME of 0.106 ± 0.038 mg/cm2/h yielding a Kp of 0.00011 cm/h (Ref. 9). EPA and OSHA have reviewed the studies submitted for MIAK and DPGME and have concluded that the studies are reliable and provide sufficient data for EPA to reasonably determine the Kp for these two chemical substances (Refs. 10, 11, and 12). Therefore, this direct final rule revokes the requirement to conduct testing to determine the Kp for MIAK and DPGME. However, the test data provided did not include a determination of short-term dermal absorption rates. Therefore, EPA is not revoking the short-term testing requirement for MIAK and DPGME. EPA has already granted an extension of the testing deadline for the short-term testing for these two substances to allow for the completion of this testing, which was suspended by the test sponsors pending review by EPA and OSHA of the submitted studies (Refs. 11 and 12). B. What is the Agency’s Authority for Taking this Action? The final rule requiring in vitro dermal absorption rate testing for DMS, DPGME, and MIAK (Ref. 1) was promulgated under section 4 of TSCA (15 U.S.C. 2603), which mandates that EPA require that manufacturers and/or processors of chemical substances and mixtures conduct testing if certain findings are made by EPA (see section 4(a) of TSCA). Section 4(b)(5) of TSCA authorizes EPA to amend or repeal test rules issued under section 4(a) of TSCA. One of the findings that EPA made in promulgating the OSHA dermal test rule was a determination that testing was necessary in order to determine both a Kp and short-term absorption rates for all of the chemicals included in the rule (see section 4(a)(1)(B)(iii) of TSCA; see also Ref. 1). In this direct final rule, EPA is withdrawing the testing required by the final test rule for DMS, and partially withdrawing the testing required for VerDate Aug<31>2005 15:11 Apr 11, 2006 Jkt 208001 DPGME and MIAK. The test rule requirements for DMS are being withdrawn because the extreme corrosiveness of DMS and its rapid rate of hydrolysis preclude obtaining a relevant rate of absorption, and thus make it infeasible to conduct in vitro dermal absorption rate testing for this chemical. The test requirement to determine a Kp for DPGME and MIAK is being withdrawn because EPA has concluded the data recently submitted to EPA on June 22, 2005, and September 29, 2004, are sufficient to determine this value for these chemicals for the purposes identified in the test rule. Therefore, EPA finds that testing to determine a Kp for DPGME and MIAK is no longer necessary. III. Economic Analysis In the economic analysis conducted for the final rule, the Agency estimated the total cost of the testing to be $1.16 million for all 34 chemicals, or $33,987 per chemical (Ref. 13). This total included an average $10,425 per chemical for the short-term dermal absorption rate testing, $16,765 for the Kp testing, and an additional 25% ($6,797) in administrative costs. This direct final rule would have the effect of reducing the total testing cost by an estimated $75,899, or approximately 7%, by eliminating the Kp testing for three chemicals and the short-term dermal absorption rate testing for one chemical. In addition, the 25% administrative cost would be eliminated for those tests. The new total cost of the testing is estimated to be $1.08 million (i.e., $1.16 million minus $75,899). The annualized cost per chemical calculated in the economic analysis, based on a 15–year amortization period and a 7% discount rate, was $3,732. For DPGME and MIAK, which will no longer be required to undergo the Kp testing, the annualized cost is estimated to be reduced to $2,301 as a result of the direct final rule. IV. Export Notification Upon the effective date of the revocation of the TSCA section 4 testing requirements for DMS, persons who export or intend to export DMS will no longer be subject to the TSCA section 12(b) export notification requirements to the extent that they were triggered by the testing requirements being revoked by this action. For all of the other chemicals, including MIAK and DPGME, listed as subject to the requirements of the OSHA dermal test rule (Ref. 1), the export notification requirements remain the same. PO 00000 Frm 00064 Fmt 4700 Sfmt 4700 V. Direct Final Rule Procedures EPA is publishing this direct final rule without prior proposal because the Agency views this as a noncontroversial amendment and anticipates no adverse comment as this action simply revokes testing for which EPA already has adequate data or for which such testing is not feasible. This direct final rule is effective June 12, 2006 without further notice, unless EPA receives adverse comment or a written request for an opportunity to present oral comments on or before May 12, 2006. If EPA receives adverse comment or a request for an opportunity to present oral comments on one or more distinct amendments, paragraphs, or sections of this direcct final rule, the Agency will publish a timely withdrawal in the Federal Register indicating which provisions will become effective and which provisions are being withdrawn due to adverse comment. Any distinct amendment, paragraph, or section of this direct final rule for which the Agency does not receive adverse comment or a request for an opportunity to present oral comments will become effective June 12, 2006, notwithstanding any adverse comment or request on any other distinct amendment, paragraph, or section of this direct final rule. For any distinct amendment, paragraph, or section of this direct final rule that is withdrawn due to adverse comment or a request for an opportunity to present oral comments, EPA will publish a notice of proposed rulemaking in a future edition of the Federal Register. The Agency will address the comment or request for an opportunity to present oral comments on any such distinct amendment, paragraph, or section as part of that notice of proposed rulemaking. VI. References 1. EPA. Final Test Rule for In Vitro Dermal Absorption Rate Testing of Certain Chemicals of Interest to the Occupational Safety and Health Administration. Federal Register (69 FR 22402, April 26, 2004) (FRL–7312–2). Available on-line at: https:// www.epa.gov/fedrgstr/EPA-TOX/2004/ April/Day-26/t9409.htm. 2. DCSE. Letter from Robert W. Freerksen, PhD to EPA Re: In Vitro Dermal Absorption Test rule (69 FR 22402 (4/26/04; OPPT–2003–0006)) 40 CFR 799.5115 Dimethyl Sulfate (CAS No.77–78–1) Request for Modification of Test Standard. November 2, 2004. 3. Fasano, W.J. Dimethyl Sulfate: An In Vitro Assay for Assessment of Dermal Corrosivity Using Transcutaneous Electrical Impedance. E.I. du Pont de E:\FR\FM\12APR1.SGM 12APR1 cprice-sewell on PROD1PC66 with RULES Federal Register / Vol. 71, No. 70 / Wednesday, April 12, 2006 / Rules and Regulations Nemours and Company. Haskell Laboratory for Health and Environmental Sciences. October 15, 2004. 4. EPA. E-mail from Andrew Mamantov, PhD to Greg Schweer Re: Hydrolysis rate for Dimethyl Sulfate. March 9, 2005. 5. EPA. Note from Leonard Keifer to Greg Schweer Re: Technical Feasibility of Performing an In Vitro Dermal Absorption Study with Dimethyl Sulfate. March 10, 2005. 6. Eastman Chemical Company. Letter from Marc G. Schurger to Catherine Roman Re: In vitro dermal absorption testing on methyl isoamyl ketone (CAS No. 110–12–3) under TSCA Section 4 Test Rule (OPPT–2003–0006). June 22, 2004. 7. Hill, T.S. and Taylor, L. Methyl isoamyl ketone: measurement of the in vitro rate of percutaneous absorption through human skin. Final Report: Toxicological Sciences Laboratory, Health and Environment Laboratories, Eastman Kodak Company. January 29, 2001. 8. ACC. Communication (e-mail) from Susan Lewis to Catherine Roman. Directing EPA’s attention to a recent publication (2004) on dermal absorption of dipropylene glycol methyl ether (DPGME). September 29, 2004. 9. Venier, M., Adami, G., Larese, F., and Renzi, N. Percutaneous absorption of 5 glycol ethers through human skin in vitro. Toxicology In Vitro 18:665–671. 2004. 10. OSHA, Department of Labor. Letter from William G. Perry, CIH to Catherine Roman dated January 26, 2005. 11. EPA. Letter from Charles M. Auer to Marc G. Shurger Re: USEPA and OSHA review of the dermal absorption rate study sponsored by the Eastman Chemical Company and conducted by Toxicological Sciences Laboratory. May 26, 2005. (OPPT–2003–0006–0270). 12. EPA. Letter from Charles M. Auer to Susan Anderson Lewis, Ph.D. Re: USEPA review of a recently published dermal absorption rate study on dipropylene glycol methyl ether. May 26, 2005. (OPPT–2003–0006–0272). 13. EPA. Economic Impact Analysis and Small Entity Impact Analysis for the TSCA Section 4(a) Test Rule for 34 Chemicals Targeted for In Vitro Dermal Absorption Rate Testing. Prepared by OPPT/Economics, Exposure, and Technology Division (EETD)/Economic and Policy Analysis Branch (EPAB). Washington, DC. February 3, 2004. VerDate Aug<31>2005 15:11 Apr 11, 2006 Jkt 208001 VII. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review This direct final rule implements changes to 40 CFR 799.5115 resulting in a burden and cost reduction. Since this direct final rule does not impose any new requirements, it is not subject to review by the Office of Management and Budget (OMB) under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). B. Paperwork Reduction Act This direct final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. C. Regulatory Flexibility Act Because this direct final rule eliminates reporting requirements, the Agency certifies pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), that this revocation of certain requirements under section 4 of TSCA will not have a significant economic impact on a substantial number of small entities. D. Unfunded Mandates Reform Act This action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104–4). E. Executive Order 13132: Federalism This direct final rule has no federalism implications, because it will not have substantial direct effects 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). F. Executive Order 13175: Consultation and Coordination with Indian Tribal Governments This direct final rule has no tribal implications because it will not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, nor on the distribution of power and responsibilities between the Federal Government and Indian tribes as specified in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). PO 00000 Frm 00065 Fmt 4700 Sfmt 4700 18653 G. 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 under Executive Order 12866, and it does not address environmental health or safety risks disproportionately affecting children. H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use This direct final 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. I. National Technology Transfer Advancement Act Because 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. VIII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 et seq., 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 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. This rule is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 799 Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements. Dated: April 3, 2006. Susan B. Hazen, Acting Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances. Therefore, 40 CFR chapter I is amended as follows: I E:\FR\FM\12APR1.SGM 12APR1 18654 Federal Register / Vol. 71, No. 70 / Wednesday, April 12, 2006 / Rules and Regulations PART 799—AMENDED 1. The authority citation for part 799 continues to read as follows: I Authority: 15 U.S.C. 2603, 2611, 2625. 2. Amend §799.5115 by revising the first sentence of paragraph (h)(5)(vii)(A) in § 799.5115 to read as follows and by removing the entry ‘‘CAS No. 77–78–1 Dimethyl sulfate’’ in Table 2 of paragraph (j) in § 799.5115. I § 799.5115 Chemical testing requirements for certain chemicals of interest to the Occupational Safety and Health Administration. * * * * * (h) * * * (5) * * * (vii) * * * (A) Kp. A Kp must be determined for each test chemical, except for methyl isoamyl ketone (MIAK; CAS No.: 110– 12–3, Chemical Abstracts (CA) Index Name: 2-Hexanone, 5-methoxy-) and dipropylene glycol methyl ether (DPGME; CAS No.: 34590–94–8, CA Index Name: Propanol, 1(or 2)-(2methoxymethylethoxy)-). * * * * * * * * [FR Doc. 06–3491 Filed 4–11–06; 8:45 am] BILLING CODE 6560–50–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Parts 412 and 413 [CMS–1531–IFC] RIN 0938–AO35 Medicare Program; Medicare Graduate Medical Education Affiliation Provisions for Teaching Hospitals in Certain Emergency Situations Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Interim final rule with comment period. cprice-sewell on PROD1PC66 with RULES AGENCY: SUMMARY: This interim final rule with comment period will modify the current Graduate Medical Education (GME) regulations as they apply to Medicare GME affiliations to provide for greater flexibility during times of disaster. Specifically, this rule will implement the emergency Medicare GME affiliated group provisions that will address issues that may be faced by certain teaching hospitals in the event that residents who would otherwise have trained at a hospital in an emergency area (as that term is defined in section VerDate Aug<31>2005 15:11 Apr 11, 2006 Jkt 208001 1135(g) of the Social Security Act (the Act)) are relocated to alternate training sites. DATES: This interim final rule is effective as of August 29, 2005. Comment date: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on June 12, 2006. ADDRESSES: In commenting, please refer to file code CMS–1531–IFC. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission. You may submit comments in one of four ways (no duplicates, please): 1. Electronically. You may submit electronic comments on specific issues in this regulation to https:// www.cms.hhs.gov/eRulemaking. Click on the link ‘‘Submit electronic comments on CMS regulations with an open comment period.’’ (Attachments should be in Microsoft Word, WordPerfect, or Excel; however, we prefer Microsoft Word.) 2. By regular mail. You may mail written comments (one original and two copies) to the following address only: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS–1531– IFC, P.O. Box 8011, Baltimore, MD 21244–8011. Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. By express or overnight mail. You may send written comments (one original and two copies) to the following address only: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS–1531– IFC, Mail Stop C4–26–05, 7500 Security Boulevard, Baltimore, MD 21244–1850. 4. By hand or courier. If you prefer, you may deliver (by hand or courier) your written comments (one original and two copies) before the close of the comment period to one of the following addresses. If you intend to deliver your comments to the Baltimore address, please call telephone number (410) 786– 9994 in advance to schedule your arrival with one of our staff members. Room 445–G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201; or 7500 Security Boulevard, Baltimore, MD 21244–1850. (Because access to the interior of the HHH Building is not readily available to persons without Federal Government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main PO 00000 Frm 00066 Fmt 4700 Sfmt 4700 lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.) Comments mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period. Submission of comments on paperwork requirements. You may submit comments on this document’s paperwork requirements by mailing your comments to the addresses provided at the end of the ‘‘Collection of Information Requirements’’ section in this document. For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section. FOR FURTHER INFORMATION CONTACT: Elizabeth Truong, (410) 786–6005. Renate Rockwell, (410) 786–4645. SUPPLEMENTARY INFORMATION: Submitting Comments: We welcome comments from the public on all issues set forth in this rule to assist us in fully considering issues and developing policies. You can assist us by referencing the file code CMS–1531–IFC and the specific ‘‘issue identifier’’ that precedes the section on which you choose to comment. Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received: https://www.cms.hhs.gov/ eRulemaking. Click on the link ‘‘Electronic Comments on CMS Regulations’’ on that Web site to view public comments. Comments received timely will be also available for public inspection as they are received, generally beginning approximately three weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1–800–743–3951. I. Background [If you choose to comment on issues in this section, please include the caption ‘‘BACKGROUND’’ at the beginning of your comments.] E:\FR\FM\12APR1.SGM 12APR1

Agencies

[Federal Register Volume 71, Number 70 (Wednesday, April 12, 2006)]
[Rules and Regulations]
[Pages 18650-18654]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-3491]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 799

[EPA-HQ-OPPT-2003-0006; FRL-7751-7]
RIN 2070-AD42


Revocation of TSCA Section 4 Testing Requirements for Certain 
Chemical Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

-----------------------------------------------------------------------

SUMMARY: EPA is taking direct final action to amend the final test 
rule, ``In Vitro Dermal Absorption Rate Testing of Certain Chemicals of 
Interest to the Occupational Safety and Health Administration,'' 
promulgated under section 4 of the Toxic Substances Control Act (TSCA). 
This amendment removes dimethyl sulfate (DMS) from the list of chemical 
substances regulated under the test rule and also removes the 
requirement that testing be conducted to determine a permeability 
constant (Kp) for methyl isoamyl ketone (MIAK) and dipropylene glycol 
methyl ether (DPGME). However, the requirement to conduct testing to 
measure short-term dermal absorption rates remains for MIAK and DPGME. 
EPA is basing its decisions to take these actions on information it 
received since publication of the final rule. Also, upon the effective 
date of the revocation of the TSCA section 4 testing requirements for 
DMS, persons who export or intend to export DMS will no longer be 
subject to the TSCA section 12(b) export notification requirements to 
the extent that they were triggered by the testing requirements being 
revoked by this action.

DATES: This direct final rule is effective June 12, 2006 without 
further notice, unless EPA receives adverse comment in writing, or a 
request to present comment orally, on or before May 12, 2006. If EPA 
receives adverse comment, or a written request for an opportunity to 
present oral comments, EPA will publish a timely withdrawal in the 
Federal Register informing the public that this direct final rule, or 
relevant portions of this direct final rule, will not take effect. If 
you write EPA to request an opportunity to present oral comments on or 
before May 12, 2006, EPA will hold a public meeting on this direct 
final rule in Washington, DC. The announcement of such a meeting would 
be published in the Federal Register.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2003-0006, by one of the following methods:
     https://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, Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. Attention: 
Docket ID Number EPA-HQ-OPPT-2003-0006. 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-
2003-0006. 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 https://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 https://www.epa.gov/epahome/docket.htm.
    Docket: All documents in the docket are listed in the 
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 
at https://www.regulations.gov or in hard copy at the OPPT Docket, EPA 
Docket Center (EPA/DC), EPA West, Rm. B102, 1301 Constitution Ave., 
NW., Washington, DC. The EPA Docket Public Reading Room is open from 
8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Public Reading Room is (202) 
566-1744, and the telephone number for the OPPT Docket is (202) 566-
0280.

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.

[[Page 18651]]

    For technical information contact: John Schaeffer or Catherine 
Roman, Chemical Control Division (7405M), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: 
(202) 564-8173 or (202) 564-8172; e-mail address: 
schaeffer.john@epa.gov or roman.catherine@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general, and may be of 
particular interest to those persons who manufacture (defined by 
statute to include import) or process DMS, DPGME, or MIAK. Also, 
persons that export or intend to export DMS may have an interest in 
this action, as, upon the effective date of the revocation of the TSCA 
section 4 testing requirements for DMS, persons who export or intend to 
export DMS will no longer be subject to the TSCA section 12(b) export 
notification requirements to the extent that they were triggered by the 
testing requirements being revoked by this action. Because other 
persons may also be interested, the Agency has not attempted to 
describe all the specific persons that may be affected by this action. 
If you have any questions regarding the applicability of this action to 
a particular person, consult the persons listed under FOR FURTHER 
INFORMATION CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit CBI 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. Requesting an opportunity to present oral comments to the 
Agency. When you submit a request for an opportunity to present oral 
comments, this request must be in writing. If such a request is 
received on or before May 12, 2006, EPA will hold a public meeting on 
this direct final rule in Washington, DC. This written request must be 
submitted to the Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001. If such a request is 
received, EPA will announce the scheduling of the public meeting in a 
subsequent Federal Register document. If a public meeting is announced, 
and if you are interested in attending or presenting oral and/or 
written comments and data at the public meeting, you should follow the 
instructions provided in the subsequent Federal Register document 
announcing the public meeting.
    3. 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?

    Pursuant to section 4 of TSCA, EPA promulgated and published in the 
Federal Register a test rule on April 26, 2004 (OSHA dermal test rule) 
requiring that manufactures (including importers) and processors of 34 
chemical substances of interest to the Occupational Safety and Health 
Administration (OSHA) conduct in vitro dermal absorption rate testing 
(Ref. 1). OSHA intends to use the data from these studies to evaluate 
the need to develop ``skin designations'' for these chemicals. Skin 
designations are used by OSHA to alert industrial hygienists, 
employers, and workers to the potentially significant contribution of a 
particular chemical to an individual's total workplace exposure to 
chemicals which can occur by the cutaneous route. Skin designations 
encourage employers to consider whether changes should be made to 
processes involving such chemical substances in order to reduce the 
potential for systemic toxicity from dermal absorption of these 
chemicals.
    EPA recently received dermal absorption data on 3 of the 34 
chemical substances listed in the final rule. These data have persuaded 
EPA to fully withdraw the testing requirements set forth in the final 
rule for dimethyl sulfate (DMS; Chemical Abstracts Service Number (CAS 
No.): 77-78-1, Chemical Abstracts (CA) Index Name: Sulfuric acid, 
dimethyl ester), and to partially withdraw such requirements for methyl 
isoamyl ketone (MIAK; CAS No.: 110-12-3, CA Index Name: 2-Hexanone, 5-
methoxy-) and dipropylene glycol methyl ether (DPGME; CAS No.: 34590-
94-8, CA Index Name: Propanol, 1(or 2)-(2-methoxymethylethoxy)-).
    On November 2, 2004, DuPont Chemical Solutions Enterprise (DCSE) 
submitted results of an exploratory skin absorption study entitled 
Dimethyl Sulfate: An In Vitro Assay for Assessment of Dermal 
Corrosivity Using Transcutaneous Electrical Impedance (Refs. 2 and 3). 
This study clearly showed that DMS is corrosive (Ref. 3). While the 
test rule requires that if a chemical ``damages the skin when applied 
neat, it must be dissolved in water'' (40 CFR 799.5115(h)(5)(vi)), DMS 
is also rapidly hydrolyzed in water, and would not be available as the 
test substance, even for the required short-term testing (Refs. 1, 2, 
and 4). These factors, considered together, render the in vitro dermal 
absorption testing of DMS which is required in the test rule 
technically infeasible (Ref. 5). Furthermore, EPA neither has, nor 
knows of, any test standard which could successfully obtain the dermal 
absorption testing data for DMS as described in the OSHA dermal test 
rule. Therefore, for the dermal absorption testing requirements for 
DMS, EPA can no longer meet the TSCA requirement under section 
4(b)(1)(B) of TSCA regarding the inclusion of standards for development 
of test data. Therefore, EPA, in this direct final rule, is revoking 
the testing requirements for DMS by removing it from the list of 
chemical substances in 40 CFR 799.5115(j) for which in vitro dermal 
absorption rate testing is required (Ref. 1).
    EPA also received dermal absorption studies on MIAK and DPGME, 
which

[[Page 18652]]

were conducted prior to issuance of the final test rule. On June 22, 
2005, the Eastman Chemical Company submitted a study entitled Methyl 
Isoamyl Ketone: Measurement of the In Vitro Rate of Percutaneous 
Absorption through Human Skin (Refs. 6 and 7). The study determined an 
absorption rate for MIAK of 0.215  0.15 milligrams/
centimeter squared/hour (mg/cm\2\/h) yielding a Kp (permeability 
constant) of 0.000261 cm/h (Ref. 7). On September 29, 2004, EPA 
received a request from the American Chemistry Council to review a 
recently published study by Venier, et al. (2004) on the dermal 
absorption of five glycol ethers, including DPGME (Ref. 8). This study 
determined an absorption rate for DPGME of 0.106  0.038 mg/
cm\2\/h yielding a Kp of 0.00011 cm/h (Ref. 9).
    EPA and OSHA have reviewed the studies submitted for MIAK and DPGME 
and have concluded that the studies are reliable and provide sufficient 
data for EPA to reasonably determine the Kp for these two chemical 
substances (Refs. 10, 11, and 12). Therefore, this direct final rule 
revokes the requirement to conduct testing to determine the Kp for MIAK 
and DPGME. However, the test data provided did not include a 
determination of short-term dermal absorption rates. Therefore, EPA is 
not revoking the short-term testing requirement for MIAK and DPGME. EPA 
has already granted an extension of the testing deadline for the short-
term testing for these two substances to allow for the completion of 
this testing, which was suspended by the test sponsors pending review 
by EPA and OSHA of the submitted studies (Refs. 11 and 12).

B. What is the Agency's Authority for Taking this Action?

    The final rule requiring in vitro dermal absorption rate testing 
for DMS, DPGME, and MIAK (Ref. 1) was promulgated under section 4 of 
TSCA (15 U.S.C. 2603), which mandates that EPA require that 
manufacturers and/or processors of chemical substances and mixtures 
conduct testing if certain findings are made by EPA (see section 4(a) 
of TSCA). Section 4(b)(5) of TSCA authorizes EPA to amend or repeal 
test rules issued under section 4(a) of TSCA. One of the findings that 
EPA made in promulgating the OSHA dermal test rule was a determination 
that testing was necessary in order to determine both a Kp and short-
term absorption rates for all of the chemicals included in the rule 
(see section 4(a)(1)(B)(iii) of TSCA; see also Ref. 1).
    In this direct final rule, EPA is withdrawing the testing required 
by the final test rule for DMS, and partially withdrawing the testing 
required for DPGME and MIAK. The test rule requirements for DMS are 
being withdrawn because the extreme corrosiveness of DMS and its rapid 
rate of hydrolysis preclude obtaining a relevant rate of absorption, 
and thus make it infeasible to conduct in vitro dermal absorption rate 
testing for this chemical. The test requirement to determine a Kp for 
DPGME and MIAK is being withdrawn because EPA has concluded the data 
recently submitted to EPA on June 22, 2005, and September 29, 2004, are 
sufficient to determine this value for these chemicals for the purposes 
identified in the test rule. Therefore, EPA finds that testing to 
determine a Kp for DPGME and MIAK is no longer necessary.

III. Economic Analysis

    In the economic analysis conducted for the final rule, the Agency 
estimated the total cost of the testing to be $1.16 million for all 34 
chemicals, or $33,987 per chemical (Ref. 13). This total included an 
average $10,425 per chemical for the short-term dermal absorption rate 
testing, $16,765 for the Kp testing, and an additional 25% ($6,797) in 
administrative costs. This direct final rule would have the effect of 
reducing the total testing cost by an estimated $75,899, or 
approximately 7%, by eliminating the Kp testing for three chemicals and 
the short-term dermal absorption rate testing for one chemical. In 
addition, the 25% administrative cost would be eliminated for those 
tests. The new total cost of the testing is estimated to be $1.08 
million (i.e., $1.16 million minus $75,899). The annualized cost per 
chemical calculated in the economic analysis, based on a 15-year 
amortization period and a 7% discount rate, was $3,732. For DPGME and 
MIAK, which will no longer be required to undergo the Kp testing, the 
annualized cost is estimated to be reduced to $2,301 as a result of the 
direct final rule.

IV. Export Notification

    Upon the effective date of the revocation of the TSCA section 4 
testing requirements for DMS, persons who export or intend to export 
DMS will no longer be subject to the TSCA section 12(b) export 
notification requirements to the extent that they were triggered by the 
testing requirements being revoked by this action. For all of the other 
chemicals, including MIAK and DPGME, listed as subject to the 
requirements of the OSHA dermal test rule (Ref. 1), the export 
notification requirements remain the same.

V. Direct Final Rule Procedures

    EPA is publishing this direct final rule without prior proposal 
because the Agency views this as a noncontroversial amendment and 
anticipates no adverse comment as this action simply revokes testing 
for which EPA already has adequate data or for which such testing is 
not feasible. This direct final rule is effective June 12, 2006 without 
further notice, unless EPA receives adverse comment or a written 
request for an opportunity to present oral comments on or before May 
12, 2006. If EPA receives adverse comment or a request for an 
opportunity to present oral comments on one or more distinct 
amendments, paragraphs, or sections of this direcct final rule, the 
Agency will publish a timely withdrawal in the Federal Register 
indicating which provisions will become effective and which provisions 
are being withdrawn due to adverse comment. Any distinct amendment, 
paragraph, or section of this direct final rule for which the Agency 
does not receive adverse comment or a request for an opportunity to 
present oral comments will become effective June 12, 2006, 
notwithstanding any adverse comment or request on any other distinct 
amendment, paragraph, or section of this direct final rule. For any 
distinct amendment, paragraph, or section of this direct final rule 
that is withdrawn due to adverse comment or a request for an 
opportunity to present oral comments, EPA will publish a notice of 
proposed rulemaking in a future edition of the Federal Register. The 
Agency will address the comment or request for an opportunity to 
present oral comments on any such distinct amendment, paragraph, or 
section as part of that notice of proposed rulemaking.

VI. References

    1. EPA. Final Test Rule for In Vitro Dermal Absorption Rate Testing 
of Certain Chemicals of Interest to the Occupational Safety and Health 
Administration. Federal Register (69 FR 22402, April 26, 2004) (FRL-
7312-2). Available on-line at: https://www.epa.gov/fedrgstr/EPA-TOX/
2004/April/Day-26/t9409.htm.
    2. DCSE. Letter from Robert W. Freerksen, PhD to EPA Re: In Vitro 
Dermal Absorption Test rule (69 FR 22402 (4/26/04; OPPT-2003-0006)) 40 
CFR 799.5115 Dimethyl Sulfate (CAS No.77-78-1) Request for Modification 
of Test Standard. November 2, 2004.
    3. Fasano, W.J. Dimethyl Sulfate: An In Vitro Assay for Assessment 
of Dermal Corrosivity Using Transcutaneous Electrical Impedance. E.I. 
du Pont de

[[Page 18653]]

Nemours and Company. Haskell Laboratory for Health and Environmental 
Sciences. October 15, 2004.
    4. EPA. E-mail from Andrew Mamantov, PhD to Greg Schweer Re: 
Hydrolysis rate for Dimethyl Sulfate. March 9, 2005.
    5. EPA. Note from Leonard Keifer to Greg Schweer Re: Technical 
Feasibility of Performing an In Vitro Dermal Absorption Study with 
Dimethyl Sulfate. March 10, 2005.
    6. Eastman Chemical Company. Letter from Marc G. Schurger to 
Catherine Roman Re: In vitro dermal absorption testing on methyl 
isoamyl ketone (CAS No. 110-12-3) under TSCA Section 4 Test Rule (OPPT-
2003-0006). June 22, 2004.
    7. Hill, T.S. and Taylor, L. Methyl isoamyl ketone: measurement of 
the in vitro rate of percutaneous absorption through human skin. Final 
Report: Toxicological Sciences Laboratory, Health and Environment 
Laboratories, Eastman Kodak Company. January 29, 2001.
    8. ACC. Communication (e-mail) from Susan Lewis to Catherine Roman. 
Directing EPA's attention to a recent publication (2004) on dermal 
absorption of dipropylene glycol methyl ether (DPGME). September 29, 
2004.
    9. Venier, M., Adami, G., Larese, F., and Renzi, N. Percutaneous 
absorption of 5 glycol ethers through human skin in vitro. Toxicology 
In Vitro 18:665-671. 2004.
    10. OSHA, Department of Labor. Letter from William G. Perry, CIH to 
Catherine Roman dated January 26, 2005.
    11. EPA. Letter from Charles M. Auer to Marc G. Shurger Re: USEPA 
and OSHA review of the dermal absorption rate study sponsored by the 
Eastman Chemical Company and conducted by Toxicological Sciences 
Laboratory. May 26, 2005. (OPPT-2003-0006-0270).
    12. EPA. Letter from Charles M. Auer to Susan Anderson Lewis, Ph.D. 
Re: USEPA review of a recently published dermal absorption rate study 
on dipropylene glycol methyl ether. May 26, 2005. (OPPT-2003-0006-
0272).
    13. EPA. Economic Impact Analysis and Small Entity Impact Analysis 
for the TSCA Section 4(a) Test Rule for 34 Chemicals Targeted for In 
Vitro Dermal Absorption Rate Testing. Prepared by OPPT/Economics, 
Exposure, and Technology Division (EETD)/Economic and Policy Analysis 
Branch (EPAB). Washington, DC. February 3, 2004.

VII. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

    This direct final rule implements changes to 40 CFR 799.5115 
resulting in a burden and cost reduction. Since this direct final rule 
does not impose any new requirements, it is not subject to review by 
the Office of Management and Budget (OMB) under Executive Order 12866, 
entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993).

B. Paperwork Reduction Act

    This direct final rule does not contain any information collections 
subject to OMB approval under the Paperwork Reduction Act (PRA), 44 
U.S.C. 3501 et seq.

C. Regulatory Flexibility Act

    Because this direct final rule eliminates reporting requirements, 
the Agency certifies pursuant to section 605(b) of the Regulatory 
Flexibility Act (RFA) (5 U.S.C. 601 et seq.), that this revocation of 
certain requirements under section 4 of TSCA will not have a 
significant economic impact on a substantial number of small entities.

D. Unfunded Mandates Reform Act

    This action does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Public Law 104-4).

E. Executive Order 13132: Federalism

    This direct final rule has no federalism implications, because it 
will not have substantial direct effects 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).

F. Executive Order 13175: Consultation and Coordination with Indian 
Tribal Governments

    This direct final rule has no tribal implications because it will 
not have substantial direct effects on one or more Indian tribes, on 
the relationship between the Federal Government and Indian tribes, nor 
on the distribution of power and responsibilities between the Federal 
Government and Indian tribes as specified in Executive Order 13175, 
entitled Consultation and Coordination with Indian Tribal Governments 
(65 FR 67249, November 6, 2000).

G. 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 under Executive Order 12866, 
and it does not address environmental health or safety risks 
disproportionately affecting children.

H. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use

    This direct final 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.

I. National Technology Transfer Advancement Act

    Because 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.

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., 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 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. This rule is not a 
``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 799

    Environmental protection, Chemicals, Hazardous substances, 
Reporting and recordkeeping requirements.


    Dated: April 3, 2006.
Susan B. Hazen,
Acting Assistant Administrator, Office of Prevention, Pesticides and 
Toxic Substances.

0
Therefore, 40 CFR chapter I is amended as follows:

[[Page 18654]]

PART 799--AMENDED

0
1. The authority citation for part 799 continues to read as follows:

    Authority: 15 U.S.C. 2603, 2611, 2625.


0
2. Amend Sec. 799.5115 by revising the first sentence of paragraph 
(h)(5)(vii)(A) in Sec.  799.5115 to read as follows and by removing the 
entry ``CAS No. 77-78-1 Dimethyl sulfate'' in Table 2 of paragraph (j) 
in Sec.  799.5115.


Sec.  799.5115  Chemical testing requirements for certain chemicals of 
interest to the Occupational Safety and Health Administration.

* * * * *
    (h) * * *
    (5) * * *
    (vii) * * *
    (A) Kp. A Kp must be determined for each test chemical, except for 
methyl isoamyl ketone (MIAK; CAS No.: 110-12-3, Chemical Abstracts (CA) 
Index Name: 2-Hexanone, 5-methoxy-) and dipropylene glycol methyl ether 
(DPGME; CAS No.: 34590-94-8, CA Index Name: Propanol, 1(or 2)-(2-
methoxymethylethoxy)-). * * *
* * * * *
[FR Doc. 06-3491 Filed 4-11-06; 8:45 am]
BILLING CODE 6560-50-S
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