07-2104. Removal of Two Chemical Substances from Preliminary Assessment Information Reporting and Health and Safety Data Reporting Rules

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Direct final rule.

SUMMARY:

This direct final rule the removes chemical substances phosphorotrithious acid, tributyl ester, CAS No. 150-50-5, and phosphorodithioic acid, O,O-diethyl ester, sodium salt, CAS No. 3338-24-7, which were inadvertently added to the list of voluntary High Production Volume (HPV) Challenge Program orphan (unsponsored) chemical substances by EPA. As a result, these chemical substances were inadvertently added to two final rules: The Preliminary Assessment Information Reporting (PAIR) rule (Toxic Substances Control Act (TSCA) section 8(a)) and the Health and Safety Data Reporting rule (TSCA section 8(d)), both published in the Federal Register issue of August 16, 2006. With this removal action, persons who manufacture (including import) either of these two chemical substances are no longer subject to the reporting requirements imposed by these TSCA section 8(a) and 8(d) rules.

DATES:

This rule is effective on June 29, 2007 without further notice, unless EPA receives adverse comment on or before May 30, 2007.

ADDRESSES:

Submit your comments, identified by docket identification (ID) numbers EPA-HQ-OPPT-2005-0014 and EPA-HQ-OPPT-2005-0055, 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 Numbers EPA-HQ-OPPT-2005-0014 and EPA-HQ-OPPT-2005-0055. 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 [phone]. 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 numbers EPA-HQ-OPPT-2005-0014 and EPA-HQ-OPPT-2005-0055. EPA's policy is that all comments received will be included in the 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 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 index available in regulations.gov. To access the electronic docket, go to http://www.regulations.gov, select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov web site to view the docket index or access available documents. 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 [phone], and the telephone number for the OPPT Docket is [phone]. 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: [phone]; e-mail address: [e-mail].

For technical information contact: Joe Nash, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: [phone]; fax number: [phone]; e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by this action if you manufacture (defined by statute to include import) either of the two chemical substances listed in this direct final rule. Entities potentially affected by this action may include, but are not limited to:

• Chemical manufacturers (including importers), (NAICS codes 325, 32411), e.g., persons who manufacture (defined by statute to include import) one or more of the subject chemical substances.

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

B. How Can I Access Electronic Copies of this Document?

In addition to accessing an electronic copy of this Federal Register document through the electronic docket at http://www.regulations.gov, you may access this “Federal Register” document electronically through the EPA Internet under the “Federal Register” listings at http://www.epa.gov/​fedrgstr. Frequently updated electronic versions of 40 CFR parts 712 and 716 are available through the Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/​ecfr.

C. 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 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?

The chemical substances phosphorotrithious acid, tributyl ester, CAS No. 150-50-5, and phosphorodithioic acid, O,O-diethyl ester, sodium salt, CAS No. 3338-24-7, are being removed from the table in 40 CFR 712.30(e) of the TSCA section 8(a) PAIR rule published in the Federal Register of August 16, 2006 (Ref. 1), and the table in 40 CFR 716.120(d) of the TSCA section 8(d) Health and Safety Data Reporting rule published in the Federal Register of August 16, 2006 (Ref. 2). On August 16, 2006, EPA published a final PAIR rule under TSCA section 8(a) (40 CFR part 712), which requires manufacturers (including importers) of chemical substances in the category of voluntary HPV Challenge Program orphan (unsponsored) chemical substances on the ITC's TSCA section 4(e) Priority Testing List to submit a one-time report on general production/importation volume, end use, and exposure-related information to EPA. Also on August 16, 2006, EPA published a final Health and Safety Data Reporting rule under TSCA section 8(d) (40 CFR part 716), which requires manufacturers (including importers) of chemical substances in this category of voluntary HPV Challenge Program orphan (unsponsored) chemical substances to submit certain unpublished health and safety data to EPA. On September 15, 2006, EPA published a final rule (Ref. 3) that revised the effective date of the two rules published on August 16, 2006. The effect of this action is that persons who manufacture (including import) either of the two chemical substances are not subject to the reporting requirements imposed by the final TSCA section 8(a) and 8(d) rules published on August 16, 2006, and the rule published on September 15, 2006 (Ref. 3), that changed the effective date for these two rules.

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

EPA promulgated the PAIR rule under TSCA section 8(a) (15 U.S.C. 2607(a)), and it is codified at 40 CFR part 712. This model TSCA section 8(a) rule establishes standard reporting requirements for certain manufacturers (including importers) of the chemical substances listed in the rule at 40 CFR 712.30. The final rule published by EPA on August 16, 2006, amended the model TSCA section 8(a) rule by adding the ITC category of certain voluntary HPV Challenge Program orphan (unsponsored) chemical substances (Ref. 1).

EPA promulgated the model Health and Safety Data Reporting rule under TSCA section 8(d) (15 U.S.C. 2607(d)), and it is codified at 40 CFR part 716. The TSCA section 8(d) model rule requires past, current, and prospective manufacturers, importers, and (if specified by EPA in a particular notice or rule under TSCA section 8(d)) processors of listed chemical substances to submit to EPA copies and lists of unpublished health and safety studies on the listed chemical substances that they manufacture, import, or (if specified by EPA in a particular notice or rule under TSCA section 8(d)) process. The final rule published by EPA on August 16, 2006, amended the model TSCA section 8(d) rule by adding the ITC category of certain voluntary HPV Challenge Program orphan (unsponsored) chemical substances (Ref. 2).

C. Why is EPA Using a Direct Final Rule?

EPA is publishing this direct final rule without a prior proposed rule because we view this as a non-controversial action and anticipate no adverse comment. If EPA receives adverse comment, we will publish a timely withdrawal in the Federal Register informing the public that the direct final rule will not take effect. Any parties interested in commenting must do so on or before May 30, 2007.

D. Why are These Two Chemical Substances Being Removed?

The chemical substances phosphorotrithious acid, tributyl ester, CAS No. 150-50-5, and phosphorodithioic acid, O,O-diethyl ester, sodium salt, CAS No. 3338-24-7, were inadvertently added by EPA to the list of HPV orphan orphan (unsponsored) chemical substances. This list was the source of the category of “Voluntary HPV Challenge Program orphan (unsponsored) chemicals” that was the subject of the TSCA section 8(a) PAIR rule and TSCA section 8(d) Health and Safety Data Reporting rule published in the Federal Register of August 16, 2006 (Refs. 1 and 2). These two chemicals were originally sponsored in the HPV Challenge Program by Bayer CropScience on March 15, 1999 (Ref. 4). Subsequently, in a letter dated December 29, 2003, Bayer CropScience requested that EPA “designate the two chemicals as ‘no longer HPV’ on the HPV Challenge Program Chemical List” because Bayer CropScience considered the chemicals to be “non-isolated intermediates” (Ref. 5). In a letter dated December 3, 2004, EPA responded that, based on a review of the information submitted by Bayer CropScience, EPA had determined that the two substances were “isolated intermediates” and, consequently, did not meet the ‘no longer HPV’ criteria and that “they will remain in the HPV Challenge Program and should continue to be reported” (Ref. 6). In a letter dated December 15, 2005, Bayer CropScience clarified the status of the two chemicals (Ref. 7). In that letter, Bayer “recommit[ed] to sponsoring” both chemicals in the HPV Challenge Program and proposed to include the two chemicals into two categories. This record demonstrates that Bayer CropScience did not withdraw its commitment to sponsor these two chemicals in the HPV Challenge Program. Consequently, EPA is removing these two chemicals from the table in 40 CFR 712.30(e) of the TSCA section 8(a) PAIR rule published in the Federal Register of August 16, 2006 (Ref. 1), and the table in 40 CFR 716.120(d) of the TSCA section 8(d) Health and Safety Data Reporting rule published in the Federal Register of August 16, 2006 (Ref. 2).

This action does not preclude the future listing of these two chemical substances under the TSCA section 8(a) PAIR rule or the TSCA section 8(d) Health and Safety Data Reporting rule should the information be reasonably required.

III. Economic Analysis

In the economic analysis conducted for the final TSCA section 8(a) PAIR rule, the Agency estimated the total reporting cost to industry to be $644,000 for all 243 chemical substances, or approximately $2,650 per chemical substance (Ref. 1). The Agency is estimated to incur an additional $248,000 or $1,021 per chemical substance to provide public support for the TSCA section 8(a) PAIR rule and to process the data (Ref. 1). The total cost of the TSCA section 8(a) rule, per chemical substance, is estimated to be approximately $3,671. This direct final rule removes two chemical substances from the TSCA section 8(a) PAIR rule. Therefore, costs are estimated to be reduced by $7,342 (two chemical substances x $3,671 per chemical substance).

Furthermore, this direct final rule will also remove two chemical substances from the TSCA section 8(d) Health and Safety Data Reporting rule. The economic analysis conducted for the TSCA section 8(d) Health and Safety Data Reporting rule estimates that the total cost to industry is $110,000 and to the Agency is $79,000, or $453 and $325 per chemical substance, respectively, for a total of $778 per chemical substance (Ref. 2). Because this direct final rule removes two chemical substances from the TSCA section 8(d) Health and Safety Data Reporting rule, the costs of the TSCA section 8(d) Health and Safety Data Reporting rule are estimated to be reduced by $1,556 (two chemical substances x $778).

Therefore, the removal of two chemical substances from the TSCA section 8(a) and TSCA section 8(d) rules is estimated to result in a total reduction in costs of $8,898.

IV. References

The dockets for this direct final rule are the dockets established for the TSCA section 8(a) PAIR rule (docket ID number EPA-HQ-OPPT-2005-0014) (Ref. 1) and the TSCA section 8(d) Health and Safety Data Reporting rule (docket ID number EPA-HQ-OPPT-2005-0055) (Ref. 2). These dockets are available for review as specified in ADDRESSES. The following is a listing of the materials referenced in this document that have been placed in the dockets:

1. EPA. Preliminary Assessment Information Reporting; Addition of Certain Chemicals. Federal Register (71 FR 47122, August 16, 2006) (FRL-7764-9). Available on-line at: http://www.epa.gov/​fedrgstr.

2. EPA. Health and Safety Data Reporting; Addition of Certain Chemicals. Federal Register (71 FR 47130, August 16, 2006) (FRL-7764-7). Available on-line at: http://www.epa.gov/​fedrgstr.

3. EPA. Preliminary Assessment Information Reporting Rule and Health and Safety Data Reporting Rule; Revision of Effective Dates. Federal Register (71 FR 54434, September 15, 2006) (FRL-8094-8). Available on-line at: http://www.epa.gov/​fedrgstr.

4. Bayer Corporation. Letter from Ron Fuchs (Bayer Corporation) to Carol Browner (EPA) RE: Sponsorship of chemicals in the HPV Challenge Program. March 15, 1999.

5. Bayer Corporation. Letter from Janet M. Mostowy (Bayer Corporation) to Michael Leavitt (EPA) RE: Request to designate chemicals as ‘no longer HPV.’ December 29, 2003.

6. EPA. Letter from Diane Sheridan (EPA/OPPT) to Janet M. Mostowy (Bayer Corporation) RE: EPA response to December 29, 2003 letter from Bayer Corporation. December 3, 2004.

7. Bayer CropScience. Letter from George S. Goodridge to Oscar Hernandez (EPA/OPPT) RE: Clarification of status of chemicals appearing on EPA’s 9/16/05 orphan list. December 15, 2005.

V. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

The Office of Management and Budget (OMB) has exempted actions under TSCA sections 8(a) and 8(d) related to the PAIR and Health and Safety Data Reporting rules from the requirements of Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). In addition, this direct final rule does not impose any new requirements and will result in a burden and cost reduction; therefore, it is not subject to OMB review under the Executive order.

B. Paperwork Reduction Act

The information collection requirements contained in TSCA sections 8(a) PAIR and 8(d) Health and Safety Data Reporting rules have already been approved by OMB under the provisions of the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., and OMB control numbers 2070-0054 (EPA ICR No. 0586) and 2070-0004 (EPA ICR No. 0575). The collection activities in this direct final rule are captured by the existing approval and do not require additional review and/or approval by OMB.

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 action will not have a significant adverse economic impact on a substantial number of small entities.

D. Unfunded Mandates Reform Act

Pursuant to Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, EPA has determined that this direct final rule does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and tribal governments, in the aggregate, or the private sector in any 1 year. In addition, EPA has determined that this direct final rule will not significantly or uniquely affect small governments. Accordingly, the direct final rule is not subject to the requirements of UMRA sections 202, 203, 204, or 205.

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 (59 FR 22951, November 6, 2000).

G. Executive Order 13045: Protection of Children from Environmental Health Risks and Safety Risks

Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23,1997), does not apply to this direct final rule because this is not an economically significant regulatory action as defined under Executive Order 12866, and it does not concern an environmental health or safety risk that may have a disproportionate effect on children.

H. Executive Order 13211: Actions that Significantly Affect Energy Supply, Distribution, or Use

This rule is not subject to Executive Order 13211, entitled Actions 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 and 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.

J. Executive Order 12898: Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations

This action does not involve special considerations of environmental justice-related issues pursuant to Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

VI. 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 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. This rule is not a major rule as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Parts 712 and 716

• Environmental protection
• Chemicals
• Hazardous substances
• Health and safety
• Reporting and recordkeeping requirements

Dated: April 23, 2007.

Charles M. Auer,

Director, Office of Pollution Prevention and Toxics.

Therefore, 40 CFR chapter I is amended as follows:

PART 712—[AMENDED]

1. The authority citation for part 712 continues to read as follows:

Authority: 15 U.S.C. 2607(a).

§ 712.30

[Amended]

2. In § 712.30, in the table under the heading “Voluntary HPV Challenge Program orphan (unsponsored) chemicals” in paragraph (e), remove the entries CAS No. 150-50-5, Phosphorotrithious acid, tributyl ester and CAS No. 3338-24-7, Phosphorodithioic acid, O,O-diethyl ester, sodium salt.

PART 716--[AMENDED]

3. The authority citation for part 716 continues to read as follows:

Authority: 15 U.S.C. 2607(d).

§ 716.120

[Amended]

4. In § 716.120, in the table under the heading “Voluntary HPV Challenge Program orphan (unsponsored) chemicals in paragraph (d), remove the entries Phosphorotrithious acid, tributyl ester, CAS No. 150-50-5 and Phosphorodithioic acid, O,O-diethyl ester, sodium salt, CAS No. 3338-24-7.