Environmental Protection Agency (EPA).
Direct final rule.
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.
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.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2003-0006, by one of the following methods:
- 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, 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 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/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 http://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.Start Further Info
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.Start Printed 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: firstname.lastname@example.org or email@example.com.End Further Info End Preamble Start Supplemental 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.
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 Start Printed Page 18652were 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 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.
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: http://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 Start Printed Page 18653Nemours 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).Start List of Subjects
List of Subjects in 40 CFR Part 799End List of Subjects Start Signature
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:End Amendment Part Start Part Start Printed Page 18654
PART 799—AMENDEDEnd Part Start Amendment Part
1. The authority citation for part 799 continues to read as follows:End Amendment Part Start Amendment Part
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.End Amendment Part
(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]
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