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Supporting Statement for a Request for OMB Review under

The Paperwork Reduction Act

1 IDENTIFICATION OF THE INFORMATION COLLECTION

1(a) Title and Number of the Information Collection

Title: TSCA Section 8(a) Preliminary Assessment Information Rule (PAIR)

EPA ICR No.: 0586.13 OMB Control No.: 2070-0054

1(b) Short Characterization

On June 22, 1982, EPA promulgated the generic section 8(a) Preliminary Assessment 

Information Rule (PAIR) (40 CFR part 712; see Attachment B) under the Toxic Substances 

Control Act (TSCA) (15 U.S.C. 2607; see Attachment A). EPA uses PAIR to collect information 

to identify, assess, and manage human health and environmental risks from chemical substances, 

mixtures and categories. PAIR requires chemical manufacturers and importers to complete a 

standardized reporting form to help evaluate the potential for adverse human health and 

environmental effects caused by the manufacture or importation of identified chemical 

substances, mixtures or categories.

Chemicals identified by the existing chemical review program or any other EPA office or 

federal agency, for which a justifiable information need for production, use, or exposure-related 

data can be satisfied by the use of the PAIR, is a proper subject for a chemical-specific TSCA 

section 8(a) PAIR rulemaking. Many of the chemical substances, mixtures and categories listed 

in 40 CFR part 712 have been recommended by the Interagency Testing Committee (ITC) to 

EPA for test rule consideration. In most instances, such as in a preliminary risk determination, or 

in reaching a decision on whether testing of a chemical is necessary to satisfy an identified data 

need, the information that EPA receives from a PAIR report is sufficient to satisfy its 

information needs.

This information collection activity also covers certain specific chemical testing and 

reporting requirements under Subpart B of 40 CFR part 766 (see Attachment D) that are very

similar to the PAIR requirements. The Agency rarely receives submissions of the information 

required by 40 CFR 766. EPA received no more than five submissions over the course of the last 

OMB approval for this particular aspect of the information collection. However, collection of 

this information is covered under the PAIR ICR because the requirements are similar and 

because the Paperwork Reduction Act requires that recordkeeping and reporting activities 

contained in any regulation be approved by OMB even if they involve less than ten respondents 

or would otherwise not require approval (see 5 CFR 1320.3(c)(4)(i)).

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 according to the

schedules described in at 40 CFR 766.35. These chemical substances are subject to testing
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immediately upon manufacture, import or processing. Persons who manufacture or import a 

chemical substance listed under 40 CFR 766.25 must report results, using the Dioxin/Furan 

Report Form (EPA Form 7710-51; see Attachment E), of all existing test data that show that 

chemical substance has been tested for the presence of halogenated dibenzodioxins/halogenated 

dibenzofurans (HDDs/HDFs), as defined in the regulation, no later than 90 days after the person 

first manufactures or imports the chemical substance. Copies of EPA Form 7710-51 are available 

from the Office of Pollution Prevention and Toxics’ (OPPT) National Program Chemicals 

Division. 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 various provisions of 40 CFR 716, no 

later than 90 days after the person first manufactures or imports the chemical substance.

2 NEED FOR AND USE OF THE COLLECTION

2(a) Need/Authority for the Collection

Under TSCA, which covers the production, distribution, and disposal of commercial and 

industrial chemicals in the United States, EPA’s Office of Pollution Prevention and Toxics 

(OPPT) is charged with the responsibility for assuring that chemicals made available for sale and

use in the United States do not pose any unreasonable adverse risks to human health or to the 

environment. To carry out this mandate, EPA has broad authority to issue regulations designed to 

gather health/safety and exposure information on, require testing of, and control exposure to 

chemical substances and mixtures. Drugs, cosmetics, foods, food additives, pesticides, and 

nuclear materials are exempt from TSCA and are subject to control under other U.S. Government

statutes (e.g., foods, food additives, drugs and cosmetics are under the purview of the Federal 

Food, Drug, and Cosmetic Act (FFDCA)).

TSCA section 8(a) gives EPA the authority to promulgate rules under which manufacturers 

(which by statute includes importers) and processors of chemical substances must maintain 

records and/or report such data as EPA may reasonably require to carry out the TSCA mandates. 

Examples of information that can be required to be reported under TSCA section 8(a) include:

 chemical or mixture identity;

 categories of use;

 quantity manufactured or processed;

 by-product description;

 health and environmental effects information;

 number of individuals exposed; and

 method(s) of disposal

Section 8(a) regulations can be tailored to meet unique information needs (e.g., via 

chemical-specific rules, which are covered under EPA ICR #1198, OMB Control #2070-0067) or 

information can be obtained via the use of “model” or standardized reporting rules. One example 

of a model TSCA section 8(a) reporting rule is the “Preliminary Assessment Information Rule” 

or PAIR. Under PAIR, producers and importers of a listed chemical are required to report the 
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following site-specific information on EPA Form 7710-35 (described in more detail in section 4

of this Supporting Statement; also see Attachment C):

 Quantity of chemical produced and/or imported;

 Amount of chemical lost to the environment during production or importation;

 Quantity of enclosed, controlled and open releases of the chemical; and

 Per release, the number of workers exposed and the number of hours exposed.

Exemptions for such reporting are as follows:

 Production or importation for the sole purpose of research and development (R&D);

 Production or importation of less than 500 kilograms during the reporting period at 

single plant site;

 Companies whose total annual sales from all sites owned by the domestic or foreign 

parent company are below $30 million for the reporting period and who produced or 

imported less than 45,400 kilograms of the chemical; and

 Production or importation of the listed chemical solely as an impurity, a non-isolated

intermediate, and under certain circumstances as a by-product.

This Supporting Statement addresses the information collection activities associated with 

PAIR, which establishes procedures for chemical manufacturers and processors to report 

production, use, and exposure-related information on listed chemical substances. Subpart A 

establishes requirements that apply to all reporting under PAIR, and Subpart B covers 

manufacturers’ and processors’ reporting. Processors are not required to report PAIR information 

under this information collection.

In addition, as described in the previous section, this Supporting Statement addresses 

information collection activities associated with the reporting and recordkeeping requirements

contained in 40 CFR 766.

2(b) Use/Users of the Data

EPA uses PAIR data to (1) monitor domestic manufacture and/or importation of chemical 

substances, mixtures and categories, (2) identify possible routes of human or environmental 

exposure, (3) support regulations designed to prevent possible adverse health effects and (4) 

support EPA programs. The information provided by PAIR is needed to complete assessments of 

chemicals of interest and to assist in the development of regulations to control hazardous 

chemicals.

All EPA program offices are potential users of the PAIR. The information helps EPA 

evaluate the potential for adverse human health or environmental effects caused by the 

manufacture and importation of the identified chemical substance, mixture or category. If EPA 

does not monitor these parameters, adverse human health or environmental effects may occur 

without EPA’s knowledge. Without this information, EPA would not be able to evaluate the need 

for additional testing or further regulatory action.
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Other federal agencies, which require data on the human health and environmental effects 

of a chemical, use PAIR information. States also have access to public portions of PAIR 

information. Public interest groups use information reported under the public portions of PAIR.

3 NON-DUPLICATION, CONSULTATION AND OTHER COLLECTION CRITERIA

3(a) Non-Duplication

PAIR reporting data assist EPA in identifying, evaluating and managing the human health 

and environmental effects of chemical substances, mixtures and categories.

EPA has developed procedures that must be met to ensure that the chemicals added to the

rule and the information requested on these chemicals does not duplicate other activities or 

impose a burden on industry that outweighs the need for the data. These procedures are for rule 

promulgation and implementation:

(1) A continuing evaluation of the information collection and management activities;

(2) The management of the collected information;

(3) A chemical nomination, screening and selection process; and

(4) Technical assistance for persons subject to the rule.

It is unlikely that the information to be reported is duplicative because (1) EPA estimates 

that each rule will generate only a few reports, (2) the information required by the PAIR is 

unique to the manufacturer or importer, and (3) efforts are made to ensure that the information 

requested is not currently in the possession of EPA or easily obtained by EPA from other public 

sources. The following databases and sources of information are checked:

 The Chemical Screening Branch’s Existing Chemical Assessment Tracking System 

(CECATS), a database containing information on TSCA section 8(e) and For Your 

Information (FYI) submissions and Chemical Hazard Information Profiles (CHIPs);

 The Toxic Substances Control Act Test Submissions (TSCATS) database, an online

index to the compiled, unpublished health and safety studies submitted to EPA;

 The Registry of Toxic Effects of Chemical Substances (RTECS), a file containing

chemical toxicity data;

 LEXIS/NEXUS, a data network with a wide range of fields including information

published in the Code of Federal Regulations (CFR) and BNA’s Environmental

Reporter and Chemical Regulation Reporter;

 The Toxicology Data Network (TOXNET), run by the National Library of Medicine; 

and

 The Toxic Substances Control Act section 8(b) inventory data (CICIS) and inventory

update data (CUS).

Similar searches are conducted for each list of chemical substances, mixtures or

categories added to the PAIR.
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Some chemicals in PAIR are referred to EPA by other federal agencies. These agencies 

conduct searches of their own databases for existing chemical information before they refer any 

chemical to EPA. Referrals are made to EPA only after a decision has been made that an 

agency’s existing chemical information is inadequate to meet its needs.

3(b) Public Notice Required Prior to ICR Submission to OMB

In proposing to renew this ICR, EPA provided a 60-day public notice and comment 

period that ended on August 18, 2015 (80 FR 35349, June 19, 2015). EPA received no comments 

during the comment period.

3(c) Consultations

Additionally, under 5 CFR 1320.8(d)(1), OMB requires agencies to consult with potential 

ICR respondents and data users about specific aspects of ICRs before submitting an ICR to OMB 

for review and approval. In accordance with this regulation, EPA submitted questions to nine 

parties via e-mail. The individuals contacted were:

Scott Jensen

American Chemistry Council

Scott_Jensen@AmericanChemistry.com

Jenny Gaines

Specialty Chemical Manufacturing Association

gainesj@socma.com

Dan Turner

E. I. du Pont de Nemours and Company

Daniel.A.Turner@dupont.com

Eric Wohlschlegel

American Petroleum Institute

wohlschlegele@api.org

Melissa Scanlan

Environmental Law Center, Vermont Law School

MSCANLAN@vermontlaw.edu

Stacy Cooks

Asthma & Allergy Foundation of America

stacy@aafa.org
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Sharyn Stein

Environmental Defense Fund

sstein@edf.org

Ken Cook

Environmental Working Group

ken@ewg.org

David Goldston

Natural Resources Defense Council

eheyd@nrdc.org

EPA received no responses to its solicitation for consultations. A copy of EPA’s 

consultation e-mail to the above nine potential respondents is included in Attachment H.

3(d) Effects of Less Frequent Collection

Under PAIR, persons are required to report only once for a chemical listed in the PAIR. 

However, if information received from the initial report indicates human health and 

environmental risks, then the Agency may require that additional information be submitted at 

some future date to monitor any changes pertaining to that chemical. As such, the reporting 

frequency for PAIR cannot be reduced without effectively suspending the information collection 

requirement.

3(e) General Guidelines

This collection does not exceed any of the Paperwork Reduction Act guidelines at 5 CFR 

1320.6. Note that when this information collection was approved by OMB in October 2001, 

OMB established the following terms of clearance:

“The Agency shall ensure that the approximate annual burden estimates for each PAIR

rule are provided in the preamble to each rule. Upon renewal of this ICR, the Agency

shall provide a list of the chemicals covered by the final PAIR rules issued by EPA over

the next three years.”

Accordingly, in the preamble to each PAIR rule, EPA provides an annual burden estimate 

for the rule. The list of chemicals in those final PAIR rules, along with the burden estimate 

provided for those rules, is generally found in this supporting statement. However, this 

supporting statement contains no such information because no PAIR rules were issued over the 

last three years.

3(f) Confidentiality

Submitters may designate information reported under PAIR and subpart B of 40 CFR 766 

as confidential business information (CBI). EPA has implemented procedures to protect any 

confidential, trade secret or proprietary information from disclosure. These procedures comply 

with EPA’s confidentiality regulations at 40 CFR part 2, subpart B, and TSCA section 10.
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3(g) Sensitive Questions

This information collection does not include questions of a sensitive nature.

4 THE RESPONDENTS AND THE INFORMATION REQUESTED

4(a) Respondent NAICS Codes

PAIR’s respondents are manufacturers and importers of chemical substances, mixtures or 

categories. Respondents affected by this collection are included primarily in the following 

NAICS codes:

3251 Basic Chemical Manufacturing

3252 Resin, Synthetic Rubber, and Artificial Synthetic Fibers and Filaments

Manufacturing

3255 Paint, Coating, and Adhesive Manufacturing

3253 Pesticide, Fertilizer, and Other Agricultural Chemical Manufacturing

3259 Other Chemical Product and Preparation Manufacturing

32411 Petroleum Refineries

4(b) Information Requested

(i) Data Items

PAIR requires manufacturers or importers of the listed chemical substances, mixtures or 

categories to report to EPA information such as the substances’ chemical identification, quantity

produced or imported, chemical processes, employee exposure, environmental releases, uses and 

products. Respondents are only required to report information that is known or reasonably 

ascertainable by them. As described in the previous section, extensive files searches are not 

required. The PAIR reporting requirements are included in the PAIR form (EPA Form 7710-35)

and instructions.

(ii) Respondent Activities

A representative respondent would engage in the following activities:

 Conduct an initial review of the rule to determine if their company must report;

 Familiarize themselves with the PAIR reporting form;

 Complete the PAIR reporting form;

 Provide trade name notification;

 Indicate CBI status if so desired; and

 Keep a copy for recordkeeping requirements.

The PAIR generally requires one-time reporting and establishes the reporting period for 

the listed chemical substances, mixtures or categories. Typically, the reporting period is 30 days 
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from the effective date of the PAIR rule. Effective dates of PAIR rules are typically 30 days after 

publication of the rule in the Federal Register. In other words, the reporting period is typically

60 days from the publication of a final PAIR rule in the Federal Register. Therefore, a reporting 

schedule is not required.

5 THE INFORMATION COLLECTED - AGENCY ACTIVITIES, COLLECTION 

METHODOLOGY AND INFORMATION MANAGEMENT

5(a) Agency Activities

The activities routinely conducted by EPA related to the rule development, processing, 

analysis and storage of the information collected under a PAIR rule are as follows:

 Chemical nomination, review and selection;

 Rule development;

 Evaluation of the rule (including impact assessments);

 Industry/public assistance;

 Compliance monitoring; and

 Processing of data received for listed chemicals (includes receipt, dissemination, 

evaluation, etc.).

5(b) Collection Methodology and Management

The PAIR requires respondents to submit TSCA section 8(a) notices to the Information 

Management Division, Office of Pollution Prevention and Toxics (OPPT), using EPA Form 

7710-35. Information collected under PAIR is logged in and assigned a document control 

number (DCN), distributed to appropriate EPA personnel for further processing, review, 

analysis, etc. The information is maintained by EPA’s Information Management Division.

At the time OMB last approved this information collection, OMB included the following 

Terms of Clearance for EPA to address in the current renewal:

“In accordance with 5 CFR 1320, this information collection has been approved 

for 3 years. The agency is reminded to review older forms and update where 

applicable.”

EPA has reviewed EPA Form 7710-35 and has updated the form as necessary.

5(c) Small Entity Flexibility

In accordance with TSCA section 8(a)(1)(B), PAIR contains a small business exemption. 

A manufacturer or importer is considered a small business if (1) the firm’s total annual sales 

when combined with those of its parent company (if any) are less than $30 million for the 

reporting period and (2) its total production and/or importation of the chemical substances, 
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mixture or category, for the reporting period, does not exceed 100,000 pounds (45,000 

kilograms) at an individual site owned and controlled by the firm.

The small manufacturer/importer exemptions apply to PAIR, regardless of which office 

or agency nominates a chemical. In some instances, the EPA Administrator can remove these 

exemptions on a chemical-specific basis, provided notice and comment rulemaking is utilized. 

EPA expects that those offices that have a critical need for reporting from small businesses 

usually exempt from PAIR reporting will use other mechanisms to gather the data. EPA does not 

expect to issue a PAIR rule during the next 3 years that would impact such small businesses.

5(d) Collection Schedule

Information collection under PAIR occurs after publication of a Federal Register notice 

establishing the reporting period for the listed chemical substances, mixtures or categories. 

Respondents are asked to respond once, within 30 days of the effective date of the final PAIR 

rule (which is usually 30 days after publication of the rule in the Federal Register). The Agency

has no plans to publish the data collected by PAIR, although non-CBI information may be made 

available to the public upon request.

6 ESTIMATING THE BURDEN AND COST OF THE COLLECTION

6(a) Estimating Respondent Burden

This section presents the Agency’s estimates of the burden associated with the reporting 

and recordkeeping requirements under the TSCA section 8(a) PAIR. The total annual industry

burden for both reporting and recordkeeping is estimated to be 31.5 hours. These estimates are 

based on the level of PAIR reporting activity expected during the ICR period of FY 2015

through 2017. In conducting any study that will be submitted to EPA under TSCA, the 

respondent must comply with the Good Laboratory Practice Standards (GLPS) at 40 CFR part 

792 (see Attachment F). Since the GLPS represent basic standard practices used by laboratories, 

any burden and costs related to the GLPS are fully captured in the cost and burden estimates 

provided below.

The PAIR report is submitted on EPA Form 7710-35, which is two pages long (available 

on the Internet at http://www.epa.gov/opptintr/chemtest/pubs/pairform.pdf). The first page asks 

the respondent to provide basic identifying information, such as the identity of the chemical 

(CAS number), the physical location of the plant and mailing address of the responding entity. 

The second page requires the respondent to provide general information on the quantities of the 

chemical used and number of workers exposed and some additional information on the 

categories of products (e.g., industrial and consumer) associated with manufacture or processing 

of the reported substance.

Much of the information requested under this ICR is routinely collected by manufacturers 

and processors for the maintenance and upkeep of health and safety information but has not 

previously been made available to the Agency. This information should be readily available to 

the firm as it is generated and maintained as part of their normal business practices. In fact, the 
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regulations specifically state that the respondent is not required to conduct an exhaustive search 

of their files (see 40 CFR 712.7). The EPA has reviewed the average per-report burden estimate 

in light of the Agency’s experience and feedback received from actual submitters. Our average 

estimate of 31.5 hours per response is consistent with that information.

The methodology used to develop these cost estimates follows principles that have been 

used in previous ICRs. The methodology and calculations used in this analysis assume the 

employee responsible for filling out the form has a reasonable level of familiarity with the 

company and knowledge of the operation at the site. The analysis deals with the marginal costs 

of complying with this specific request and not the total costs to the company of initial employee 

training and costs associated with collecting and storing records or of file maintenance that 

enable a company to comply with a range of other federal and state environmental, health and 

safety regulations or accounting requirements that rely on this type of information. The 8(a) 

PAIR requests are issued infrequently and based on conversations with respondents, this effort is 

similar to other efforts they perform which require familiarity with EPA, state and other federal

agency requests for chemical information and does not involve additional familiarization or 

training to comply with information requested under this ICR.

The Agency is not asserting an exact measurement of the burden and costs that all

potential respondents will incur while complying with this information collection activity. The 

Agency’s burden and cost estimates are based on averages. Some respondents may require more 

time to respond the information collection than the Agency’s estimated average of 31.5 hours per 

report; however, the Agency believes some respondents will be able to complete their response 

activities in less time. The Agency also intends to continue to provide rule-specific estimates of 

burden and costs, presenting them in the preamble to the PAIR rule. Should the Agency

determine in that context that this average estimate is insufficient, it will adjust the ICR 

accordingly. Upon renewal, EPA will reassess its burden estimate based on the next three-year 

approval period and make adjustments as appropriate.

Based on information provided by EPA’s Information Management Division (IMD), an 

average of 14.8 sites submitted a total of 33 reports per year (an average of 2.23 reports per site 

per year) during the period of FY 2006 through FY 2010. The rate at which new PAIR rule 

chemicals are added is sporadic and not entirely predictable; between FY 2011 and FY 2014, 

EPA received no PAIR submissions. In general, the analysis uses data and methodological 

assumptions from previous economic analyses of PAIR rules, other government data sources, 

and assumptions as described. A detailed description of the methodology used to derive the 

estimates follows.

Number of Sites and Reports per Site

The burden hour estimates in this analysis are based on an estimate of the level of PAIR 

reporting activity during the next three-year ICR approval period (FY 2015 to FY 2017). This, in 

turn, is related to the number of expected PAIR chemical reports and reporting sites. During

fiscal years 2011 to 2014, EPA received no PAIR submissions. Furthermore, EPA has no new 

PAIR rulemakings planned for the next three years. Some PAIR reports submitted during a given 

fiscal year may be for chemicals added to the PAIR during previous years. For the purposes of 
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this analysis, EPA assumes an annual average of 1 site (respondent) submitting 1 report (form), 

for an average of 1 report per respondent.

Chemicals are added to the PAIR (via Federal Register notices) based on Interagency

Testing Committee reports as published in the Federal Register. The number of chemicals added 

to the PAIR recently is not used in estimating burden but are provided as background (Source: 40 

CFR 712.30).

Error! Reference source not found. presents the historic submission statistics for 

section 8(a) PAIR reporting.

Table 1: Historic Numbers of Sites Reporting and PAIR 

Reports Submitted

Fiscal Year Sites Reporting

2006 3

2007 68

2008 1

2009 0

2010 2

2011 0

2012 0

2013 0

2014 0

Totals 74

Unit Burden Estimates

To estimate the burden and costs to industry respondents, several reporting activities (or 

burden factors) are analyzed. These burden items include: form familiarization; report

preparation; trade name notification; CBI substantiation; recordkeeping; CDX registration; and 

report submission. Each of these activities requires the skills of various labor categories. The 

section below details each separate activity and presents the estimated labor hours required by

each task, by labor category (clerical, technical and managerial).

All burden estimates are taken from the Economic Impact and Small Business Definition 

Analysis for the Final TSCA Section 8(a) Preliminary Assessment Information Rule, Final 

Report (EPA, 1981), previous TSCA Section 8(a) PAIR ICRs updates, and the Economic 

Analysis for the Electronic Reporting under the Toxic Substances Control Act (TSCA) Final Rule

(EPA, 2012), unless otherwise noted. The 2012 EA estimates the burden associated with 

electronic PAIR submissions, including the burden associated with CDX registration, the 

reduction in recordkeeping burden, and the reduction of the clerical burden associated with 

report submission. However, for this ICR, in addition to the changes made in the 2012 EA, EPA

removed the clerical burden associated with all other PAIR submission activities. This change 

was made to be consistent with the burden estimates provided for the electronic reporting of 

TSCA Section 5 Notices in The Economic Analysis of the Premanufacture Notification 

Electronic Reporting Rule (EPA, 2009) and the electronic submission of TSCA 8(b) Chemical
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Data Reporting (CDR) submissions in the Economic Analysis for the Final Inventory Update 

Reporting (IUR) Modifications Rule (EPA, 2011).

Form Familiarization

In the 1981 PAIR economic analysis1, it was estimated that form familiarization would 

require 3 hours of effort from managerial personnel and 4 hours from technical personnel for a 

total of 7 hours per site. The estimate includes efforts for rule familiarization and to determine if 

reporting is required. Because EPA only expects one report from one site in the next ICR cycle, 

the per-report burden is estimated to be 7 hours.

Table 2: Per-Report Burden Hours for Form Familiarization

Activity Clerical Technical Managerial Total

Form Familiarization 0.00 4.00 3.00 7.00

Report Preparation

The 1981 PAIR economic analysis estimated that direct reporting activities would require 

a total of 16 hours of effort per report. This consists of the burden related to the completion of 

the PAIR form. As indicated previously, the respondents are not expected to conduct an 

exhaustive search of their files. Respondents are only required to report what is known or 

reasonably ascertainable to them (see 40 CFR 712.7). The relative distribution of reporting 

burden between managerial, technical and clerical personnel was developed for the 1992 PAIR 

ICR update. For this ICR update EPA removed the 1.25 hours of clerical time to adjust for 

electronic reporting submissions, for a total burden estimate of 14.75 hours.

Table 3: Per-Report Burden Hours for Report Preparation

Activity Clerical Technical Managerial Total

Reporting 0 9.25 5.5 14.75

Given that each site produces an average of 1 report, the per-site burden for report 

preparation is 1 x 14.75 hours, or 14.75 hours.

Trade Name Notification

Some companies may report their customers’ uses as “unknown” for more than twenty

percent of their volume. These companies must list under Item 10 of the PAIR reporting form the 

market (trade) name(s) under which they distribute the chemical. This reporting is referred to as 

trade name notification.2

All commercial manufacturing, importing and processing sites that distribute any of the 

chemicals subjected to a PAIR reporting rule under a trade name must take steps to ensure that 

 

1

Economic Impact and Small Business Definition Analysis for the Final TSCA Section 8(a) Preliminary 

Assessment Information Rule, Final Report, prepared for the EPA by ICF, Inc., Washington, D.C., 1981.

2

40 CFR 712.28 (July 1, 1993).
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information about the downstream processors is submitted to EPA. Firms may choose among 

several options to meet trade name notification requirements, including:

1) Submit trade name data to EPA for listing in the Federal Register;

2) Notify all customers of the need to report; or

3) Complete the reporting requirements for each customer.

This ICR assumes that companies will adopt the least-costly reporting alternative of 

providing a trade name list to EPA for inclusion in the Federal Register. However, trade name 

notification is not relevant if processor reporting is not required.

Furthermore, this ICR also assumes that all manufacturers and importers will incur trade

name notification costs, but does not address processors due to the lack of data on processor 

reporting. In the 1994 EPA PAIR ICR,3the unit burden of trade name notification was given as 

3.2 hours (i.e., 2.2 hours managerial and 1.0 hours clerical), for this analysis the 1.0 hours of 

clerical burden is removed to adjust for electronic submissions, for a total burden of 2.2 hours 

per report.

Table 4: Per-Report Burden Hours for Trade Name Notification

Activity Clerical Technical Managerial Total

Trade Name Notification 0.00 0.00 2.20 2.20

Given that each site produces an average of 1 report, the trade name notification per-site 

burden for trade name notification is 1 x 2.2 hours, or 2.2 hours.

CBI Substantiation

A company may make claims of confidentiality for any data element contained in its 

submission. For each CBI (confidential business information) claim, generic information must be 

supplied for a non-CBI copy of the submission (i.e., a sanitized version must also be submitted). 

It is assumed that most of the time required for CBI substantiation involves managerial staff 

discussion of whether or not to make a CBI claim. Furthermore, it is assumed that all firms will 

review their submissions for CBI content. As used in the previous PAIR ICR, the 1986 

alternative CAIR4 CBI substantiation burden estimates have been used in this analysis with 

substantial downward adjustments to account for the less rigorous substantiation requirements in

PAIR reporting rules. CBI claims for a PAIR report can be made by simply checking the

appropriate boxes on the PAIR reporting form. It is assumed that most of the time required for 

PAIR CBI substantiation involves staff discussion of whether or not to make a CBI claim. As a 

 

3

Burden Hour and Cost Estimates for PAIR Section 8(a) Reporting (1994 Update), internal U.S. EPA memorandum 

from Carol Rawie, Economics, Exposure, and Technology Division to Karen Boswell, Chemical Testing and 

Information Branch, May 16, 1994.

4

The alternative Comprehensive Assessment Information Rule (CAIR) estimate was developed to account for 

CAIR-listed chemicals for which respondents were required to answer only a limited number of questions. A 

discussion of the alternative CAIR burden and cost estimates is found in Section 6.6 (pp. 67- 69) of the Estimated 

Cost of the Final Comprehensive Assessment Information Rule, Final Report, U.S. EPA/OPPT/EETD, June 1, 1986 

(prepared for EPA by Kearney/Centaur).
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result, burden estimates used in CAIR have been reduced by one-half in both labor categories to 

0.5 hours of clerical time and 4 hours of managerial time per report. For this ICR, the clerical 

burden is removed as a result of electronic submissions, for a total burden of 4 hours per 

substation.

Table 5: Per-Substantiation Burden for CBI Substantiation

Activity Clerical Technical Managerial Total

CBI Substantiation 0.00 0.00 4.00 4.00

Based on an analysis of CBI claims for reporting to the TSCA Inventory (discussed in the 

1986 CAIR economic analysis), only 75 percent of reports are expected to make CBI claims. The 

burden distributed across all reports is 4.0 hours x 0.75, or 3.00 hours. Multiplying the adjusted 

report burden and cost by 1, in turn, provides the per-site burden for CBI substantiations of 3.00

hours.

Recordkeeping

Pursuant to TSCA section 8(a), the manufacturer/importer or processors of the chemical 

substances identified under PAIR must also maintain records of the information submitted to 

EPA. In addition, since manufacturer/importer or processors that submit data to EPA must 

comply with the GLPS in 40 CFR 792, this ICR also generally covers the burden associated with 

maintaining records as required under the GLPS. These records are used for compliance 

monitoring and enforcement purposes.

EPA estimates that the recordkeeping burden associated with this ICR involves about half 

an hour of time for both the clerical and the technical labor category, based on the Economic 

Analysis for the Electronic Reporting under the Toxic Substances Control Act (TSCA) Final Rule

(EPA, 2012). This burden estimate represents the time necessary for the individuals to identify

the information, determine the appropriate location for the record to be kept, and placing the 

record in such a location. The per-report recordkeeping burden is therefore estimated to be 1.00

hour.

Table 6: Per-Report Burden Estimates for Recordkeeping

Activity Clerical Technical Managerial Total

Recordkeeping 0.5 0.5 0 1.00

The per-site burden for recordkeeping is 1 report x 1.0 hours, or 1 hours.

CDX Registration

As part of EPA’s electronic reporting requirements, submitters of PAIR reports are 

required to register and submit information electronically with EPA’s Central Data Exchange 

(CDX) system. EPA estimates that companies registering with CDX for the first time would 

incur a one-time burden to complete CDX registration activities, obtain a CDX electronic 

signature, and familiarize themselves with electronic reporting requirements. The total burden 

associated with CDX registration is taken from the Economic Analysis for the Electronic 
15

Reporting under the Toxic Substances Control Act (TSCA) Final Rule (EPA, 2012) and is 

estimated to be 3.48 hours per company, including 0.91 hours for CDX Registration, 1.75 hours 

for completing electronic signature agreements, and 0.82 hours for rule familiarization.

Table 7: Per-Site Burden Estimates for One Time CDX Registration

Activity Clerical Technical Managerial Total

CDX Registration 0.00 0.73 0.18 0.91

CDX Electronic Signature 0.00 1.00 0.75 1.75

Rule Familiarization 0.00 0.27 0.55 0.82

Total 0.00 2.00 1.48 3.48

For the purposes of this analysis EPA assumes that the one site submitting PAIR data will 

register with CDX, for a total per-site burden of 3.48 hours.

Report Submission

Report submission consists of the preparation, review and electronic submission of a 

report (EPA Form No. 7710-35) in accordance with 40 CFR Part 712, Subpart B, as amended by 

78 FR 72818 (December 4, 2013), which required electronic submission.

EPA estimates that the per-report submission will require 0.05 hours of clerical time and 

0.5 hours of managerial time for a total of 0.55 hours. The clerical burden is taken from the 

Economic Analysis for the Electronic Reporting under the Toxic Substances Control Act (TSCA) 

Final Rule (EPA, 2012) and includes time to prepare and submit a report electronically. The 

managerial time assumes an involvement in the preparation of the transmittal letter and review of 

the report package before it is submitted to EPA.

Table 8: Per-Report Burden Estimates for Report Submission

Activity Clerical Technical Managerial Total

Report Submission 0.05 0.00 0.5 0.55

Given that each site produces an average of one (1) report, the per-site burden for report 

submission is 1 x 0.55 hours, or 0.55 hours.

Total Industry Burden Estimates

Table 9 presents the compilation of the annual burden hour estimates for respondents.
16

Table 9: Estimated Annual Burden Hours (assuming 1 report per site and a total of 1 

report per year)

Burden Item Hours Per 

Report

Total Number 

of Reports per 

Site

Hours Per 

Site

Total 

Number 

of Sites

Total 

Annual 

Hours

Form Familiarization 7.00 1 7.00 1.00 7.00

Reporting 14.75 1 14.75 1.00 14.75

Trade Name 

Notification 2.20 1 2.20 1.00 2.20

CBI Substantiation 3.00 1 3.00 1.00 3.00

Recordkeeping 0.50 1 0.50 1.00 0.50

CDX Registration - - 3.48 1.00 3.48

Report Submission 0.55 1 0.55 1.00 0.55

Totals 28.00 31.48 31.48

In summary, an average of one (1) respondent per year would be required to spend an

estimated total of 31.48 hours each year to respond to PAIR rules during the period of FY 2015

through FY 2017, resulting in an average burden of 31.48 hours per response.

6(b) Estimating Respondent Costs

This section presents estimates of the cost expected to be incurred as a result of reporting 

under the TSCA section 8(a) PAIR. The total annual industry cost for both reporting and 

recordkeeping is estimated to be $2,078. This estimate is based on the cost of the burden estimate 

provided above, and includes other costs associated with this ICR.

Labor costs in this report have been updated using the most recently available, revised 

wage rates and information on benefits costs. These wage rates are taken from the Bureau of 

Labor Statistics (BLS) Employer Costs for Employee Compensation Supplemental Tables, 

December 2014 (released on March 11, 2015), with the information extracted from Table 2, 

Private industry workers in manufacturing industries, by occupational group. This table is 

available on-line at http://www.bls.gov/news.release/pdf/ecec.pdf in PDF format. The clerical 

wages are taken from the BLS data for “office and administrative support.” The technical wages 

are taken from the BLS data for “professional and related.” The managerial wages are taken from 

the BLS data for “management, business and financial.” Labor wage rates and hourly benefit 

costs taken from those sources have been used to calculate the labor cost to respondents, as

shown below. The hourly overhead is calculated as 17 percent of the base wage. This approach is 

used for consistency with Office of Pollution Prevention and Toxics economics practices, and is 

based on the analysis in Wage Rates for Economic Analyses of the Toxics Release Inventory 

Program, Cody Rice, U.S. EPA, Office of Pollution Prevention and Toxics, Economic and 

Policy Analysis Branch, June 10, 2002. This approach, which is now standard practice in this 

office, produces wage and cost estimates that are somewhat lower than the data and methods 

used in the most recent previous 8(a) PAIR ICR renewal analysis. Table 10 presents 2014$

hourly industry wages.
17

Table 10: Industry Hourly Labor Costs (2014$)

Wage Component Clerical Technical Managerial

Hourly Wage Rate $18.68 $42.19 $47.90

Benefit Costs $9.40 $22.86 $24.18

Fringe and Overhead Factor 1.67 1.71 1.67

Total Hourly Cost $31.26 $72.22 $80.22

These labor costs are multiplied by the estimated burden hours per activity and added to 

any non-labor costs to develop total unit costs per report (See Table 11). It is estimated that only

the CDX registration task will require expenditures other than labor.

Total non-burden costs per report are estimated to be $2.30 associated with mailing CDX 

electronic signature forms to EPA. With an annual estimate of 1 report expected, the total annual

non-burden cost for this ICR is $2.30. These non-burden hour costs are identified separately on 

the OMB Form 83-I pursuant to OMB guidance, but are included in the total costs here. Finally, 

unit costs per report are multiplied by the number of reports per site per year to arrive at unit 

costs per site (respondent costs), and are summarized in Table 11.
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Table 11: Reporting Costs by Labor Category and Reporting Activity

Cost Element Clerical Technical Managerial

Total 

Labor 

Costs

Other 

Direct 

Costs

Total 

Cost Per 

Report

Total 

Number of 

Reports

Total 

Cost Per 

Site

Total 

Number 

of Sites

Total 

Annual 

Industry 

Cost

Form 

Familiarization $31.26 0.00 $72.22 4.00 $80.22 3.00 $530 $0.00 $529.56 1 $529.56 1 $530 

Reporting $31.26 0.00 $72.22 9.25 $80.22 5.50 $1,109 $0.00 $1,109 1 $1,109 1 $1,109 

Trade Name 

Notification $31.26 0.00 $72.22 0.00 $80.22 2.20 $176 $0.00 $176 1 $176 1 $176 

CBI 

Substantiation $31.26 0.00 $72.22 0.00 $80.22 4.00 $321 $0.00 $321 1 $321 1 $321 

Recordkeeping $31.26 0.00 $72.22 0.50 $80.22 0.00 $36.11 $0.00 $36.11 1 $36.11 1 $36.11 

CDX 

Registration $31.26 0.00 $72.22 0.73 $80.22 1.48 $171 $2.30 $174 1 $174 1 $174 

Report 

Submission $31.26 0.05 $72.22 0.00 $80.22 0.50 $41.67 $0.00 $41.67 1 $41.67 1 $41.67 

TOTAL $2,385 $2.30 $2,388 1 $2,388 1 $2,388 
19

The average respondent is assumed to spend $2,388 per report, or $ 2,388 in total per 

respondent per year. As noted earlier, the Agency is estimating an average of 1 reporting sites 

and 1 reports per year. As a result, total industry cost for complying with PAIR rules is estimated 

to be $ 2,388 per year during the period of FY 2015 through FY 2017.

6(c) Estimating Agency Burden and Cost

The FY 2014 cost to EPA of a full-time equivalent employee (FTE), Grade 12, Step 1 in 

the Baltimore-Washington pay area is $75,621 (U.S. Office of Personnel Management Internet 

site at http://www.opm.gov). One FTE is equivalent to 2,080 hours per year. The fully loaded 

FTE cost is $120,994. The annual costs per FTE are derived by multiplying the annual pay rate 

by 1.6 (the benefits multiplication factor). The multiplication factor used is recommended in 

EPA’s Office of Policy, Planning, and Evaluation’s Instructions for Preparing Information 

Collection Requests (ICRs), (June 1, 1992).

Data processing costs have been updated from 2010 to average 2014 dollars using the

GDP implicit price deflator from the Bureau of Economic Analysis (BEA). The BEA GDP price 

index series with a base of 2009 = 100 has the 2010 index at 101.949 and the 2014 index at 

108.647 so the adjustment factor from 2006 to 2010 is 1.0657 (108.647 /101.949 = 1.0657). 

Data processing costs for the 2010 PAIR ICR update were estimated to be approximately

$265.61 per report. Adjusting this number to 2014 with the GDP implicit price deflator yields an 

adjusted data processing cost of $283.06 per report (i.e., $265.61 x 1.066 = $283.06).

This analysis assumes that an annual average of 1 report will be submitted over the threeyear period of the ICR. Personnel burden and costs associated with industry/public assistance 

and data processing activities have been adjusted based on that estimate. From the 1989 PAIR 

ICR update it has been derived that industry/public assistance required approximately 1.5 hours 

per report or 0.0007 FTE. Similarly, the 1989 PAIR ICR update estimated that about 3.75 hours, 

or 0.002 FTE, of data processing/system support personnel time would be required per report.

Table 12 summarizes the government’s activities in developing and administrating the 

PAIR. The required FTEs per activity are retained from the 1996 PAIR ICR update and from the 

previous 8(a) PAIR ICR renewal analyses, for all activities except for the recalculation of the 

burden associated with industry/public assistance and data processing/system support personnel 

time.

Table 12: Government Burden Summary

Activity Annual Burden

Chemical nomination, review, and selection 0.25

Rule development 0.90

Evaluation of rule 0.05

Industry/public assistance 0.0007

Compliance monitoring 0.10

Data processing and system support personnel 0.002

Total FTE 1.3
20

It is estimated that the annual cost to the federal government will be $283 in data 

processing costs plus 1.3 FTEs. At an estimated loaded annual salary of $120,994 per FTE, the 

total of 1.3 FTEs will cost EPA $157,597 in fully loaded labor cost (salaries, benefits, and 

overhead). This brings the total costs to the federal government to $157,880 annually (i.e., $283

+ $157,597).

Table 13 presents a summary of the costs to the federal government for this information

collection.

Table 13: Government Estimated Annual Burden and Cost Summary (2014$)

Total FTEs 1.3

Loaded Cost per FTE $120,994

Government Labor Cost $157,597

Government Data Processing Cost $283

Total Annual Government Cost $157,880

6(d) Bottom Line Burden Hours and Costs

Respondent Burden and Costs

Total respondent annual burden hours = 31.48 hours

Total respondent annual costs = $2,388

Agency Burden and Costs

Agency burden hours: 1.3 FTEs = 2,709.3 hours

Agency annual costs = $157,880

6(e) Reason for Change in Burden

This request reflects a decrease in the estimated annual burden of 916 hours (from 948

hours to 31 hours) from that currently in the OMB inventory. This change reflects both 

adjustment changes from a decrease in the assumed number of PAIR reports filed annually and 

program changes resulting from mandatory electronic submissions of PAIR reports. In recent 

years (FY 2011 – 2014), EPA has received no PAIR submissions and, for the purposes of this 

analysis, EPA assumes an annual rate of one submission per year. In the last ICR, EPA estimated 

an average of 33 reports from 14.8 submitters based on fiscal 2006-2010 data.

Table 14: Annual Burden Hour Change

Starting Burden 947.9

Adjustment Changes

Change due to Submission Decreases -914.23

Program Changes

Changes due to Electronic Submission Requirements -2.22

Total Change -916.45

Total Annual Burden 31.48
21

6(f) Burden Statement

The annual public burden for this collection of information, which is approved under 

OMB Control No. 2070-0054, is estimated to average 31.5 hours per response. Burden is defined 

in 5 CFR 1320.3(b). An agency may not conduct or sponsor, and a person is not required to 

respond to, a collection of information unless it displays a currently valid OMB control number. 

The OMB control numbers for EPA’s regulations in title 40 of the CFR, after appearing in the 

Federal Register, are listed in 40 CFR part 9 and included on the related collection instrument or 

form, if applicable.

The Agency has established a public docket for this ICR under Docket ID No. EPA-HQOPPT-2015-0236, which is available for online viewing at www.regulations.gov, or in person 

viewing at the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Ave., 

NW, Washington, DC. The EPA Docket Center 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 

Reading Room is (202) 566-1744, and the telephone number for the Pollution Prevention and 

Toxics Docket is (202) 566-0280. You may submit comments regarding the Agency’s need for 

this information, the accuracy of the provided burden estimates and any suggested methods for 

minimizing respondent burden, including the use of automated collection techniques.

Submit your comments, referencing Docket ID No. EPA-HQ-OPPT-2015-0236 and 

OMB Control No. 2070-0054, to (1) EPA online using www.regulations.gov (our preferred 

method), or by mail to: Document Control Office (DCO), Office of Pollution Prevention and 

Toxics (OPPT), Environmental Protection Agency, Mail Code: 7407T, 1200 Pennsylvania Ave., 

NW, Washington, D.C. 20460, and (2) OMB by mail to: Office of Information and Regulatory

Affairs, Office of Management and Budget (OMB), Attention: Desk Officer for EPA, 725 17th 

Street, NW, Washington, DC 20503.
22

Attachments to the Supporting Statement

Attachment A Section 8(a) of the Toxic Substances Control Act (15 U.S.C. 

2607a)

Attachment B Chemical Information Rules – 40 CFR 712

Attachment C PAIR Reporting Form (EPA Form 7710-35) and instructions. 

Available electronically at 

http://www.epa.gov/opptintr/chemtest/pubs/pairform.pdf

Attachment D Dibenzo-para-dioxins/dibenzofurans – 40 CFR 766

Attachment E Dioxin/Furan Report Form (EPA Form 7710-51) and instructions

Available electronically at

http://www.epa.gov/opptintr/chemtest/pubs/7710-51.pdf

Attachment F Good Laboratory Practice Standards – 40 CFR 792

Attachment G List of Chemicals Covered by Final PAIR Rules

Attachment H Copy of Consultations Message Sent by EPA to Potential Respondents