01-18653. Preliminary Assessment Information Reporting; Addition of Certain Chemicals

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

This final rule addresses the recommendations of the 47^th Toxic Substances Control Act (TSCA) Interagency Testing Committee (ITC) Report by adding 37 indium chemicals and 4 chemicals discussed in the 46^th ITC Report (pentachlorothiophenol; tetrachloropyrocatechol; p-toluidine, 5-chloro-.alpha.,.alpha.,.alpha.-trifluoro-2-nitro-N-phenyl-; and benzoic acid, 3-[2-chloro-4-(trifluoromethyl)phenoxy]-, 2-ethoxy-1-methyl-2-oxoethyl ester) to the TSCA section 8(a) Preliminary Assessment Information Reporting (PAIR) rule. The ITC recommendations are given priority consideration by EPA in promulgating TSCA section 4 test rules. This PAIR rule will require manufacturers (including importers) of the 41 substances identified in this document to report certain production, importation, use, and exposure-related information to EPA.

DATES:

This rule is effective on August 27, 2001.

Any person who believes that section 8(a) reporting required by this rule is not warranted, should promptly submit to EPA on or before August 9, 2001, detailed reasons for that belief.-

See Unit V. of the SUPPLEMENTARY INFORMATION concerning the submission date for those manufacturers required to submit PAIR Forms.

ADDRESSES:

Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPPTS-82056 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

For general information contact: Barbara Cunningham, Acting Director, Environmental Assistance Division, Office of Pollution Prevention and Toxics (7401), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: [phone]; e-mail address: [e-mail]. -

For technical information contact: Paul Campanella, Chemical Control Division (7405), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 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 affected by this action if you manufacture (defined by statute to include import) any of the chemical substances that are listed in the regulatory text of this document. Entities potentially affected by this action may include, but are not limited to:

Category	SIC codes	NAICS codes	Examples of potentially affected entities
Chemical manufacturers (including importers)	28, 2911	325, 32411	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 Standard Industrial Classification (SIC) codes and the North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not 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 Get Additional Information or Copies of this Document or Other Documents? -

1. Electronically. You may obtain electronic copies of this document and other documents from the EPA Internet Home Page at http://www.epa.gov/​. On the Home Page select “Law and Regulations,” “Regulations and Proposed Rules,” and then look up the entry for this document under “Federal Register—Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/​fedrgstr/​. -

2. In person. The Agency has established an official record for this action under docket control number OPPTS-82056. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the TSCA Nonconfidential Information Center, North East Mall Rm. B-607, Waterside Mall, 401 M St., SW., Washington, DC. The Center is open from noon to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Center is [phone].

C. How and to Whom Do I Submit Comments?-

Other than formal requests for removal of a chemical listed in this PAIR rule (see Unit VI.), which must be submitted to EPA on or before August 9, 2001, you may submit comments on this action at any time. Comments, as well as formal requests for removal of chemical substances, can be submitted through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPPTS-82056 in the subject line on the first page of your response. -

1. By mail. Submit your comments to: Document Control Office (7407), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.-

2. In person or by courier. Deliver your comments to: OPPT Document Control Office (DCO) in East Tower Rm. G-099, Waterside Mall, 401 M St., SW., Washington, DC. 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]. -

3. Electronically. You may submit your comments electronically by e-mail to: [e-mail], or mail your computer disk to the address identified above. Do not submit any information electronically that you consider to be CBI. Electronic comments must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. Comments and data will also be accepted on standard disks in WordPerfect 6.1/8.1 or ASCII file format. All comments in electronic form must be identified by docket control number OPPTS-82056. Electronic comments may also be filed online at many Federal Depository Libraries

D. How Should I Handle CBI That I Want to Submit to the Agency?-

Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any 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 version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the technical person listed under FOR FURTHER INFORMATION CONTACT.

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

You may find the following suggestions helpful for preparing your comments:-

1. Explain your views as clearly as possible.-

2. Describe any assumptions that you used.-

3. Provide copies of any technical information and/or data you used that support your views.-

4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide.-

5. Provide specific examples to illustrate your concerns.-

6. Offer alternatives for improvement.-

7. To ensure proper receipt by EPA, be sure to identify the docket control number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

II. What Action is EPA Taking? -

In this document, EPA is issuing a final TSCA section 8(a) PAIR rule for 41 chemicals recommended for testing in the 47^th ITC Report to the EPA Administrator published in the Federal Register of April 3, 2001 (66 FR 17768) (FRL-6763-6).

III. What is a PAIR Rule? -

EPA promulgated the PAIR rule in 40 CFR part 712 under section 8(a) of TSCA (15 U.S.C. 2607(a)). This model section 8(a) rule establishes standard reporting requirements for manufacturers (including importers) of the chemicals listed in the rule at § 712.30. These entities are required to submit a one-time report on general production/importation volume, end use, and exposure-related information using the PAIR Form entitled Manufacturer's Report—Preliminary Assessment Information (EPA Form No. 7710-35). EPA uses this model section 8(a) rule to quickly gather current information on chemicals. -

This model rule provides for the automatic addition of ITC Priority Testing List chemicals. Whenever EPA announces the receipt of an ITC Report, EPA may, at the same time and without providing notice and an opportunity for public comment, amend the model information-gathering rule by adding the recommended (or designated) chemicals. The amendment adding these chemicals to the PAIR rule is effective August 27, 2001.

IV. What Chemicals are to be Added ? -

In the 47^th ITC Report to EPA, the ITC recommended 41 chemicals. These chemicals are being added to the TSCA section 8(a) PAIR reporting rule. -

The regulatory text of this rule lists the 41 chemicals that are being added to the PAIR rule as a result of this document.

V. Who Must Report Under this PAIR Rule?

All persons who manufactured (defined by statute to include import) the 41 chemicals identified in the regulatory text of this document during their latest complete corporate fiscal year must submit a PAIR Form for each site at which they manufactured or imported a named substance. A separate form must be completed for each substance and submitted to the Agency as specified in § 712.28 no later than October 24, 2001. Persons who have previously and voluntarily submitted a PAIR Form to the ITC or EPA may be able to submit a copy of the original report to EPA or to notify EPA by letter of their desire to have this voluntary submission accepted in lieu of a current data submission. See § 712.30(a)(3).

Details of the PAIR reporting requirements, including the basis for exemptions, are provided in 40 CFR part 712. Copies of the Form are available from the Environmental Assistance Division at the address listed under FOR FURTHER INFORMATION CONTACT. Copies of the PAIR Form are also available electronically from the Chemical Testing and Information Gathering Home Page on the Internet at http://www.epa.gov/​opptintr/​chemtest/​.

VI. How is a Chemical Substance Removed From the PAIR Rule? -

Any person who believes that section 8(a) reporting required by this rule is not warranted, should promptly submit to EPA on or before August 9, 2001, detailed reasons for that belief. EPA, in its discretion, may remove the substance from this rule (see § 712.30(c)). When withdrawing a chemical from the PAIR rule, EPA will publish a final rule amending the PAIR rule in the Federal Register.

VII. Public Record -

The following documents constitute the public record for this rule under docket control number OPPTS-82056. -

1. This final rule. -

2. The Economic Analysis for this rule (March 7, 2001). -

3. The 46th ITC Report (65 FR 75551, December 1, 2000) (FRL-6594-7)).-

4. The 47th ITC Report (66 FR 17768, April 3, 2001) (FRL-6763-6)).

VIII. Why is this Action Being Issued as a Final Rule? -

EPA is publishing this action as a final rule without prior notice and an opportunity to comment because the Agency believes that providing notice and an opportunity to comment is unnecessary. As discussed in Unit III., whenever EPA announces the receipt of an ITC report, EPA may, at the same time and without providing notice and opportunity for public comment, amend the model information-gathering rule by adding the recommended (or designated) chemicals. EPA finds, therefore, that there is “good cause” under section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5 U.S.C. 553 (b)(3)(B)) to make these amendments without prior notice and comment.

IX. Economic Analysis -

The economic analysis for the addition of the 41 chemicals to the TSCA section 8(a) PAIR rule is entitled Economic Analysis for the Addition of 41 Chemicals Recommended for Testing in the 47^th Report of the TSCA Interagency Testing Committee to EPA's Preliminary Assessment Information Reporting (PAIR) Rule (March 7, 2001) (Economic Analysis). -

Only 3 of the 41 chemicals were located in EPA's 1998 or 1994 Chemical Update System (CUS) utilizing the ITC-supplied CAS numbers. Because the threshold for reporting to CUS under the Inventory Update Rule is 10,000 lbs., and the threshold for PAIR reporting is 500 kilograms (kg) (1,100 lbs.), EPA assumed that one manufacturer at one site exists per chemical to account for the possibility that there may be manufacturers producing PAIR-reportable amounts that were not captured by CUS. EPA has no way of ascertaining the validity of this assumption, a fact which highlights the need for PAIR reporting on these chemicals.-

Given the assumptions in this unit, the costs and burden associated with this rule are estimated in the Economic Analysis to be the following:

  Reporting Costs (dollars)

41 reports estimated at $2,219.42 per report = $90,996.17

Total Cost = $90,996.17

Mean cost per site/firm = $90,996.17/41 sites = $2,219.42/site

  Reporting Burden (hours)

Rule familiarization: 7 hours/site x 41 sites = 287 hours

Reporting: 21.42 hours/report x 41 reports = 878.1 hours

Total burden hours = 1,165.1 hours

Average burden per site/firm = 1,165.1 hours/41 sites = 28.4 hours/site

  EPA Costs (dollars)-

The annual costs to the Federal Government will be approximately 0.1035 Full Time Equivalents (FTEs) (or 215.25 hours annually). At an estimated $85,050 per FTE, the total 0.1035 FTEs ($8,802.68), plus $8,635.01 for data processing, will cost EPA $17,437.69.

X. Regulatory Assessment Requirements

A. Executive Order 12866 -

The Office of Management and Budget (OMB) has exempted actions under TSCA section 8(a) related to the PAIR rule from the requirements of Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993).

B. Executive Order 12898 -

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).

C. Executive Order 13045 -

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 final rule, because it is not “economically significant” as defined under Executive Order 12866, and does not concern an environmental health or safety risk that may have a disproportionate effect on children. This rule requires the reporting of production, importation, use, and exposure-related information to EPA by manufacturers (including importers) of certain chemicals recommended in the 47^th ITC Report.

D. Regulatory Flexibility Act -

Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq., the Agency hereby certifies that this rule will not have a significant impact on a substantial number of small entities. The factual basis for the Agency's determination is presented in the small entity analysis prepared as a part of the Economic Analysis for this rule, and is briefly summarized here. Three of the six firms identified as manufacturers of chemicals affected by this rule met the Small Business Administration definition of a small business, (i.e., having less than 1,000 employees when combined with any corporate parents). Based on the Agency's analysis, the maximum potential impact of this action on an individual firm is estimated to be less than $2,219, regardless of the firm's size. To determine the potential significance of the estimated impact of this action on the small firms, the Agency compared the estimated maximum potential cost with the estimated annual sales revenue for these firms. Based on currently available financial information for these firms, EPA has determined that this action will not result in a significant impact on any of these firms. Information relating to this EPA determination is included in the docket for this rule (OPPTS-82056). Any comments regarding the economic impacts that this action imposes on small entities may be submitted to the Agency at any time after July 26, 2001 using the methods discussed in Unit I.C.

E. Paperwork Reduction Act-

Pursuant to the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), an Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information that is subject to approval under the PRA unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations, after appearing in the preamble of the final rule, are listed in 40 CFR part 9, and included on the related collection instrument. The information collection activities related to this action have already been approved by OMB, under OMB control number 2070-0054 (EPA ICR No. 586) for PAIR reporting. This action does not impose any burdens requiring additional OMB approval. The public reporting burden for this collection of information is estimated to be 1,165 hours. Of that total, an estimated 287 hours are spent in an initial review of the rule, and the remaining 878 hours are associated with actual reporting activities (Economic Analysis). Because this rule does not contain any new information collection activities, additional review and approval of these activities by OMB under the PRA is not necessary.

F. Unfunded Mandates Reform Act and Executive Orders 13084 and 13132 -

Pursuant to Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, EPA has determined that this 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 rule will not significantly or uniquely affect small governments. Accordingly, the rule is not subject to the requirements of UMRA sections 202, 203, 204, or 205. -

This rule does not have tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This does not significantly or uniquely affect the communities of Indian trial governments, nor does it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of section 3(b) of Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments (63 FR 27655, May 19, 1998), do not apply to this rule. Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000), which took effect on January 6, 2001, revokes Executive Order 13084 as of that date. EPA developed this rulemaking, however, during the period when Executive Order 13084 was in effect; thus, EPA addressed tribal considerations under Executive Order 13084. For the same reasons stated for Executive Order 13084, the requirements of Executive Order 13175 do not apply to this rule either. Nor will this action have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999).

G. National Technology Transfer and Advancement Act -

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to 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). Section 12(d) of NTTAA directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards. EPA invites public comment on the Agency's determination that this regulatory action does not require the consideration of voluntary consensus standards.

H. Executive Order 12988 -

In issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct, as required by section 3 of Executive Order 12988, entitled Civil Justice Reform (61 FR 4729, February 7, 1996).

I. Executive Order 12630 -

EPA has complied with Executive Order 12630, entitled Governmental Actions and Interference with Constitutionally Protected Property Rights (53 FR 8859, March 15, 1988), by examining the takings implications of this rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the Executive Order.

J. Executive Order 13211-

This rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001), because this action is not expected to affect energy supply, distribution, or use.-

XI. Submission to Congress and the Comptroller General -

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. Section 808 allows the issuing agency to make a good cause finding that notice and public procedure is impracticable, unnecessary or contrary to the public interest. This determination must be supported by a brief statement. 5 U.S.C. 808(2). EPA has made such a good cause finding for this final rule, and established an effective date of August 27, 2001. Pursuant to 5 U.S.C. 808(2), this determination is supported by the brief statement in Unit VIII. EPA will submit a report containing this final rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This is not a “major rule” as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 712 -

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

Dated: July 10, 2001.

William H. Sanders III,

Director, Office of Pollution Prevention and Toxics.

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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).

-

2. In § 712.30, the table in paragraph (d) is amended by adding the chemicals: Pentachlorothiophenol; tetrachloropyrocatechol; p-toluidine, 5-chloro-.alpha.,.alpha.,.alpha.-trifluoro-2-nitro-N-phenyl-; and benzoic acid, 3-[2-chloro-4-(trifluoromethyl)phenoxy]-, 2-ethoxy-1-methyl-2-oxoethyl ester in ascending numeric CAS number order to read as follows:

§ 712.30

Chemical lists and reporting periods.

* * * * *

(d) * *  *

CAS No.	Substance	Effective date	Reporting date
*    *    *    *     *    *    *
133-49-3	Pentachlorothiophenol	8/27/01	10/24/01
*    *    *    *     *    *    *
1198-55-6	Tetrachloropyrocatechol	8/27/01	10/24/01
1806-24-2	p-toluidine, 5-chloro-.alpha.,.alpha.,.alpha.-trifluoro-2-nitro-N-phenyl-	8/27/01	10/24/01
*    *    *    *     *    *    *
88185-22-2	Benzoic acid, 3-[2-chloro-4-(trifluoromethyl)phenoxy]-, 2-ethoxy-1-methyl-2-oxoethyl ester	8/27/01	10/24/01

* * * * *

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3. In § 712.30, the table in paragraph (e) is amended by adding in alphabetical order the category “Indium Chemicals” containing 37 chemicals in ascending numeric CAS number order to read as follows:

§ 712.30

Chemical lists and reporting periods.

* * * * *

(e) * *  *

CAS No.	Substance	Effective date	Reporting date
*    *    *    *     *    *    *
Indium Chemicals:
923-34-2	Triethylindium	8/27/01	10/24/01
1303-11-3	Indium arsenide	8/27/01	10/24/01
1312-41-0	Indium antimonide	8/27/01	10/24/01
1312-43-2	Indium (III) oxide	8/27/01	10/24/01
1312-45-4	Indium (III) telluride	8/27/01	10/24/01
4194-69-8	Indium (III) citrate	8/27/01	10/24/01
7440-74-6	Indium	8/27/01	10/24/01
7783-52-0	Indium (III) fluoride	8/27/01	10/24/01
10025-82-8	Indium (III) chloride	8/27/01	10/24/01
12018-95-0	Copper indium diselenide	8/27/01	10/24/01
12030-14-7	Indium (II) sulfide	8/27/01	10/24/01
12030-24-9	Indium (III) sulfide	8/27/01	10/24/01
12056-07-4	Indium selenide	8/27/01	10/24/01
12672-70-7	Indium chloride	8/27/01	10/24/01
12672-71-8	Indium oxide	8/27/01	10/24/01
13464-82-9	Indium (III) sulfate	8/27/01	10/24/01
13465-09-3	Indium (III) bromide	8/27/01	10/24/01
13465-10-6	Indium (I) chloride	8/27/01	10/24/01
13510-35-5	Indium (III) iodide	8/27/01	10/24/01
13709-93-8	Indium (III) borate	8/27/01	10/24/01
13770-61-1	Indium (III) nitrate	8/27/01	10/24/01
13966-94-4	Indium (I) iodide	8/27/01	10/24/01
14166-78-0	Indium (III) fluoride	8/27/01	10/24/01
14280-53-6	Indium (I) bromide	8/27/01	10/24/01
14405-45-9	Indium tris(acetylacetonate)	8/27/01	10/24/01
20661-21-6	Indium (III) hydroxide	8/27/01	10/24/01
22398-80-7	Indium (I) phosphide	8/27/01	10/24/01
25114-58-3	Indium (III) acetate	8/27/01	10/24/01
25617-98-5	Indium nitride	8/27/01	10/24/01
27765-48-6	Indium (III) tetrafluoroborate	8/27/01	10/24/01
50926-11-9	Indium tin oxide	8/27/01	10/24/01
55326-87-9	Indium hydroxide	8/27/01	10/24/01
66027-93-8	Indium (III) sulfamate	8/27/01	10/24/01
66027-94-9	Hydroxybis(trifluoroacetato-O)indium	8/27/01	10/24/01
67816-06-2	Indium (III) 2-ethylhexanoate	8/27/01	10/24/01
68310-35-0	Indium (III) neodecanoate	8/27/01	10/24/01
71243-84-0	Indium tin oxide (In1.69 Sn0.1502 O2.85)	8/27/01	10/24/01
*    *    *    *     *    *