TSCA Section 8(a) Preliminary Assessment Information Rule (PAIR) (Renewal)

Forms and Documents

Document Name	Status
Form 7710-51 TSCA Section 8(a) Preliminary Assessment Information Rule (PAIR) Form and Instruction	Modified
0586ss14_Attachment F_CFR-2011_40CFRpart792.pdf Supplementary Document	2019-04-23
0586ss14_Attachment E_Screenshot of CBI Qs.DOCX Supplementary Document	2019-04-23
7710-51 dioxin furan form revised 1-14-20.docx Supplementary Document	2020-01-14
0586ss14_Attachment C_CFR-2011-title40-vol31-part766.pdf Supplementary Document	2019-04-23
0586ss14_Attachment B_USCODE-2012-title15-chap53-subchapI-sec2607.pdf Supplementary Document	2019-04-23
0586ss14_Attachment A_CFR-2012-title40-vol32-part712.pdf Supplementary Document	2019-04-23
0586ss14.docx Supporting Statement A	2019-04-23

IC Document Collections

IC ID	Document Title	Status
24903	TSCA Section 8(a) Preliminary Assessment Information Rule (PAIR) Form and Instruction	Modified

ICR Details

OMB Control No: 2070-0054	ICR Reference No: 201904-2070-005
Status: Active	Previous ICR Reference No: 201603-2070-001
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 0586.14
Title: TSCA Section 8(a) Preliminary Assessment Information Rule (PAIR) (Renewal)
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 01/16/2020
	Date Received in OIRA: 04/29/2019
Terms of Clearance: The agency is reminded to to cite the mandatory nature of the collection as required under 5 CFR 1320.8(b)(3)(iv).

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2023	36 Months From Approved	01/31/2020
Responses	1	0	1
Time Burden (Hours)	33	0	32
Cost Burden (Dollars)	0	0	0

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Abstract: EPA promulgated the generic Preliminary Assessment Information Rule (PAIR) (40 CFR part 712) under section 8(a) of the Toxic Substances Control Act (TSCA). The Frank R. Lautenberg Chemical Safety for the 21st Century Act amending TSCA was enacted on June 22, 2016; however, the authority for a TSCA section 8(a) PAIR rule was not modified. EPA uses PAIR, using the Manufacturer’s Report Preliminary Assessment Information Form, to collect information to help identify, assess, and manage human health and environmental risks from chemical substances, mixtures and categories. PAIR requires chemical manufacturers and importers to complete and submit standardized information about production, use, or exposure-related data to help evaluate the potential for human health and environmental risks caused by the manufacture or importation of identified chemical substances, mixtures or categories. EPA or other federal agencies can identify chemicals for a TSCA section 8(a) PAIR expediated rulemaking that have a justifiable need for production, use, or exposure-related data. This ICR also covers certain specific chemical testing and reporting requirements under Subpart B of 40 CFR part 766 that are very similar to the PAIR requirements. The Agency rarely receives submissions of the information required by 40 CFR 766. The dibenzo-para-dioxin/dibenzofuran regulations at 40 CFR part 766 require that any person who manufactures, imports, or processes a chemical substance listed at 40 CFR 766.25 test that chemical substance and submit appropriate information to EPA. Persons who commence manufacture, import, or processing of a chemical substance listed at 40 CFR 766.25, must submit a letter of intent to test or an exemption application within 60-days of starting any of those activities. Each person who is manufacturing or processing a chemical listed in 40 CFR 766.25, must submit a protocol for testing. Persons who manufacture or import a chemical substance listed under 40 CFR 766.25 must report positive test results, using the Dioxin/Furan Report Form, of all existing test data that show that chemical substance has been tested for the presence of halogenated dibenzodioxins/halogenated dibenzofurans (HDDs/HDFs), as well as any health and safety studies for the chemical substance, as defined in the regulation, no later than 90 days after the date of submission of the positive test result. Additionally, any manufacturer or importer of a chemical substance listed in 40 CFR 766.25 in possession of unpublished health and safety studies on HDDs/HDFs is required to submit copies of such studies to EPA, in accordance with provisions of 40 CFR 716, no later than 90 days after the person first manufactures or imports the chemical substance.

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Authorizing Statute(s): US Code: 15 USC 2607 Name of Law: Toxic Substances Control Act
  

Citations for New Statutory Requirements: PL: Pub.L. 114 - 182 322 Name of Law: Frank R. Lautenberg Chemical Safety for the 21st Century Act

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 44045	08/29/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 18026	04/29/2019
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
TSCA Section 8(a) Preliminary Assessment Information Rule (PAIR)	7710-35, 7710-51	Dioxin/Furans Report ,   Manufacturer's Report Preliminary Assessment Inform

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	1	1	0	0	0	0
Annual Time Burden (Hours)	33	32	1	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This request reflects a slight increase in the estimated annual burden of 1 hour (from 32 hours to 33 hours) from that currently in the OMB inventory. In the previous ICR update, EPA assumed 4 hours of managerial time per report related to the submitters decision whether to make a CBI claim; whereas this update estimates a total of 5.345 hours per report. EPA continues to attribute burden to CBI substantiation while also estimating an increased burden due to the additional CBI substantiation requirements from the 2016 amendments to TSCA.

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Annual Cost to Federal Government: $169,915

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 04/29/2019

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