Fuels and Fuel Additives: Health-Effects Research Requirements for Manufacturers (40 CFR part 79, subpart F) (Renewal)

Forms and Documents

Document Name	Status
1696ss10.docx Supporting Statement A	2019-09-25

IC Document Collections

IC ID	Document Title	Status
45799	Fuels and Fuel Additives: Health-Effects Research Requirements for Manufacturers (Tier 2/Alternative Tier 2/Tier 3 Health-Effects Testing)	Modified
24403	Fuels and Fuel Additives: Health-Effects Research Requirements for Manufacturers (Tier 1 Testing)	Modified

ICR Details

OMB Control No: 2060-0297	ICR Reference No: 201909-2060-015
Status: Received in OIRA	Previous ICR Reference No: 201608-2060-004
Agency/Subagency: EPA/OAR	Agency Tracking No: 1696.10
Title: Fuels and Fuel Additives: Health-Effects Research Requirements for Manufacturers (40 CFR part 79, subpart F) (Renewal)
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 09/30/2019

	Requested	Previously Approved
Expiration Date	36 Months From Approved	01/31/2021
Responses	2	2
Time Burden (Hours)	35,200	17,600
Cost Burden (Dollars)	597,000	597,000

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Abstract: In accordance with the regulations at 40 CFR 79, Subparts A, B, C, and D, Registration of Fuels and Fuel Additives, (including importers) of motor-vehicle gasoline, motor-vehicle diesel fuel, and additives for those fuels, are required to have these products registered by the EPA prior to their introduction into commerce. Registration involves providing a chemical description of the fuel or additive, and certain technical, marketing, and health-effects information. The development of health-effects data, as required by 40 CFR 79, Subpart F, is the subject of this ICR. The information collection requirements for Subparts A through D, and the supplemental notification requirements of Subpart F (including how the manufacturer will satisfy the health-effects data requirements) are covered by a separate ICR (EPS ICR Number 309.15, OMB Control Number 2060-0150). The health-effects data will be used to determine if there are any products which have evaporative or combustion emissions that may pose an unreasonable risk to public health, thus meriting further investigation and potential regulation. This information is required for specific groups of fuels and additives as defined in the regulations. For example, gasoline and gasoline additives which consist of only carbon, hydrogen, oxygen, nitrogen, and/or sulfur, and which involve a gasoline oxygen content of less than 1.5 weight percent, fall into a" baseline" group. Oxygenated additives, such as ethanol, when used in gasoline at an oxygen level of at least 1.5 weight percent, define separate "non-baseline" groups for each oxygenate. Additives which contain elements other than carbon, hydrogen, oxygen, nitrogen, and sulfur fall into separate "atypical" groups. There are similar grouping requirements for diesel fuel and diesel fuel additives.

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Authorizing Statute(s): None

Citations for New Statutory Requirements: None

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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:
	84 FR 23047	05/21/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 50826	09/26/2019
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Fuels and Fuel Additives: Health-Effects Research Requirements for Manufacturers (Tier 2/Alternative Tier 2/Tier 3 Health-Effects Testing)
Fuels and Fuel Additives: Health-Effects Research Requirements for Manufacturers (Tier 1 Testing)

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ICR Summary of Burden

	Total Request	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	2	2	0	0	0	0
Annual Time Burden (Hours)	35,200	17,600	0	0	17,600	0
Annual Cost Burden (Dollars)	597,000	597,000	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: There is an increase of 17,600 hours in the total estimated respondent burden compared with the ICR currently approved by OMB. This increase is based on input from an industry representative who stated that their actual literature review and Tier 2/Alternative Tier 2 costs were double the EPA estimate.

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Annual Cost to Federal Government: $93,600

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? No

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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: 09/30/2019

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