1 **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.: 0586.1 3**  **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 p art 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 b y 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 p art 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 und er Subpart B of 40 CFR part 766 (see Attachment D ) that are very similar to the PAIR requirement s. The Agency rarely receives submissions of the information required b y 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 i nformation 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 b y OMB even if they involve less than ten res pondents 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 testing2

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 F orm (EPA Form 7710

- 51 ; see Attachment E ), of all existing test data that show that chemical substance has been tested for the presence of halogenate d dibenzodioxins/halogenated dibenzofurans (HDDs/HDFs), as defined in the regulation, no later than 90 day s 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) Nation al 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 day s 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 testin g 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, dr ugs 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 b y statute includes importers) and processors of chemical substanc es 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 s ection 8(a) include:

 chemical or mixture identity ;  categories of use;
 qu antity

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 I CR #1198 , OMB Control #2070

- 0067) or information can be obtained via the use of “model” or standardized reporting rule s. One example of a model TSCA s ection 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 the3

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 processo rs’ 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 identi fied 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 tes ting or further regulatory action.4

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 inf ormation 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 unlikel y 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 currentl y in the possession of EPA or easil y obtained by EPA from other public sources. The following databases and sources of info rmation are checked:

 The Chemical Screening Branch’s Existing Chemical Assessment Tracking Sy stem (CECATS), a database containing information on TSCA section 8(e) and For Your In formation (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;
 LEX IS /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 Nati onal 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.5

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 I CR, EPA provided a 60

- day public notice and comment period that ended on August 18 , 2015 ( 80 FR 35349 , June 1 9, 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 befo re 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.org6

Shary n 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 onl y 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 subm itted at some future date to monitor any changes pertaining to that chemical. As such, the reporting frequency for PAIR cannot be reduced without effectivel y 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 b y 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 I CR, the Agency shall provide a list of the chemicals covered b y the final PAIR rules issued by EPA over the next three years.” A ccordingl y, in the preamble to each PAIR rule, EPA provide s 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 generall y found in this supporting statement. However, this supporting statement contains no such information because no PAIR rules were iss ued over the last three ye ars. **3(f) Confidentiality**  Submitters may

designate information reported under PAIR and s ubpart 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 compl y with EPA’s confidentiality regulations at 40 CFR p art 2, s ubpart B, and TSCA s ection 10.7

**3(g) Sensitive Questions**  This information collection does not include questions of a sensitive nature.

**4 THE RESPONDENTS AND THE INFORMATION**  **REQUES TED**  **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 primaril y in the following NAI CS codes: 3251 Basic Chemical Manufacturing 3252 Resin, Sy

nthetic Rubber, and Artificial Sy nthetic Fibers and Filaments M anufacturing 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. Respondent s are only required to report information that is known or reasonabl y ascertainable b y 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 cop y for recordkeeping requirements. The PAIR generally

requires one

- time reporting and establishes the reporting period for the listed chemical substances, mixtures or categories. Ty picall y, the reporting period is 30 day s8

from the effective date of the PAIR rule. Effective dates of PAIR rules are ty pically 30 days after publication of the rule in the Federal Register . In other words, the reporting peri od is ty pically 60 day s 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 routinel y conducted b y EPA related to the rule development, processing, anal ys is 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 In formation 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, anal ys is, 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,9

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**  In formation 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 day s of the effective date of the final PAIR rule (which is usuall y 30 days after publication of the rule in the Federal Register). The Agency has no plans to publish the data collected b y PAIR, although non

- CBIinformation 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 201 5 through 201 7 . 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 7 92 (see Attachment F ) . Since the GLPS represent basic standard practices used by laboratories, any burden and costs related to the GLPS are full y 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 phys ical 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 I CR 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 readil y available to the firm as it is generated and maintained as part of their normal business practices. In fact, the10

regulations specifically

s tate 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 av erage 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 analy sis 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 emplo yee training and costs associated with collecting and storing records or of file maintenance that enable a company to comply with a range of other f

ederal and state environmental, health and safety regulations or accounting requirements that rely on this type of information. The 8(a) PAIR requests are issued infrequentl y and based on conversations with respondents, this effort is similar to other efforts they perform which require familiarity with EPA, state and other f ederal agency requests for chemical information and does not involve additional familiarization or training to compl y with information requested under this I CR. 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 I CR accordingl y. Upon renewal, EPA will reassess its burden estimate based on the next three

- year approval period and make adjustment s 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. 2 3 reports per site per year) during the period of FY 200 6 through FY 20 10

. The rate at which new PAIR rule chemicals are added is sporadic and not entirel y predictable ; between FY 2011 and FY 2014, EPA received no PAIR submissions. In general, the anal ys is uses data and methodological assumptions from previous economic anal ys es o f 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 analy sis are based on an estimate of the level of PAIR reporting activity during the next three

- year ICR approval period (FY 201 5 to FY 201 7 ). This, in turn, is related to the number of expected PAIR chemical reports and reporting sites. During fiscal years 20 11 to 201 4 , 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 year s . F or the purposes of11

this analy sis , 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 recentl y 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 s ection 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 anal yzed. 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, b y 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 re duction of the clerical burden assoc iated with report submis sion. 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 Premanufac ture Notification Electronic Reporting Rule (EPA, 2009) and the electronic submission of TSCA 8(b) Chemic al12

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 anal ys is 1 , 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 I CR 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 anal ys is 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 previousl y, the respondents are not expected to conduct an exhaustive search of their files. Respondents are only required to report what is known or reasonabl y ascertainable to them (see 40 CFR 712.7). The relativ e 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 14.7 5 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).13

information about the downstream processors is submitted to EPA. Firms may cho o se 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 I CR 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 I CR 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, 3 the 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 anal ys is 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**  **C lerical**  **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

- CBIcopy of the submission (i.e., a sanitized version must also be subm itted). 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 I CR, the 1986 alternative CAIR4 CBI substantiation burden estimates have been used in this analy sis with substantial downward adjustments to account for the less rigorous substantiation requirements in PAIR reporting rules. CBI claims for a P AIR 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 Ra wie, 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 onl y 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, 198 6 (prepared for EPA by Kearney/Centaur).14

result, burden estimates used in CAIR have been reduced b y one - half in both labor categories to 0.5 hours of clerical time and 4 hours of managerial time per report. For this I CR, the clerical burden is removed as a result of electronic submissions, for a total burden of 4 hour s per substation. **Table 5**  : **Per -**  **Substantiation Burden for CBI Substantiation Activity**  **Clerical Technical**  **Managerial Total**  CBI Substantiation 0.00 0.00 4.00 4. 0 0 Based on an analy sis of CBI claims for reporting to the TSCA Inventory (discussed in the 1986 CAIR economic analy sis), onl y 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 b y 1 , in tur n, provides the per

- site burden for CBI substantiations of 3. 00 hours. Recordkeeping Pursuant to TSCA s ection 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 I CR also generall y covers the burden associated with maintaining records as required under the GLPS. These record s are used for compliance monitoring and enforcement purposes. EPA estimates that the recordkeeping burden associated with this I CR 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 k ept, 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**  **Clerica l**  **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) s ys tem. 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 Electronic15

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 analy sis 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 b y 78 FR 72818 ( December 4, 2013 ), which required electronic submission

. EPA estimates that the per

- report submission will require 0. 0 5 hours of clerical time and 0.5 hours of managerial time for a total of 0.55 hour s . 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 electronicall y . 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 hour s , 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 Site**  **s 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 ye ar to respond to PAIR rules during the period of FY 201 5 through FY 201 7 , 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 I CR. Labor costs in this report have been updated using the most recentl y available, revised wage rates and information on benefits cos ts. These wage rates are taken from the Bureau of Labor Statistics (BLS) Employer Costs for Employee Compensation Supplemental Tables, December 201 4 (released on March 11 , 201 5 ), with the information extracted from Table 2, Private industry workers in manu facturing 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 BL S 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 hourl y benefit costs taken from those sources have been used to calculate the labor cost to respondents, as shown below. The hourl y 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 analy sis 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 Anal ys is Branch, June 10, 2002. This approach, which is now standard practice in this office, produces wage and cost esti mates that are somewhat lower than the data and methods used in the most recent previous 8(a) PAIR I CR renewal anal ys is. Table 10 presents 2014 $ hourly industry

wages.17

**Table 10**  **: Industry**  **Hourly Labor Costs ( 201**  **4 $)**  **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 1.6 7 **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. 3 0 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. 3 0 . 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

.18 **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 ye ar. As a result , total industry cost for complying with PAIR rules is estimated to be $ 2,388 per ye ar during the period of FY 201 5 through FY 201 7

. **6(c) Estimating Agency Burden and Cost**  The FY 201 4 cost to EPA of a full

- time equivalent employee (FTE), Grade 12, Step 1 in the Baltimore

- Washington pay area is $ 75,6 2 1 (U.S. Office of Personnel Management Internet site at http://www.opm.gov). One FTE is equivalent to 2,080 hours per year. The full y loaded FTE cost is $ 120,994 . The annual costs per FTE are derived b y multiplying the annual pay rate by 1.6 (the benefits multiplication factor). The multiplication factor used i s recommended in EPA’s Office of Policy , Planning, and Evaluation’s Instructions for Preparing Information Collection Requests (I CRs), (June 1, 1992). Data processing costs have been updated from 20 10 to average 201 4 dollars using the GDP implicit price d eflator from the Bureau of Economic Analy sis (BEA). The BEA GDP price index series with a base of 200 9 = 100 has the 20 10 index at 101.949 and the 201 4 index at 108.647 so the adjustment factor from 200 6 to 2010 is 1.0657 ( 108.647 / 101.949 = 1. 0 657 ). Data processing costs for the 20 10 PAIR ICR update were estimated to be approximately $265.61 per report. Adjusting this number to 201 4 with the GDP implicit price deflator yi elds an adjusted data processing cost of $ 283.06 per report (i.e., $ 265.61 x 1

. 0 66 = $283.06 ). This analy sis assumes that an annual average of 1 report will be submitted over the three

ye ar 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 I CR update estimated that about 3.75 hours , or 0.002 FTE, of data processing/s ys tem 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 I CR update and from the previous 8(a) PAIR I CR renewal anal ys es, for all activities except for the recalculation of the burden associated with industry /public assistanc e and data processing/s ys tem support personnel time

. **Table 12**  **: Government Burden Summary** 

**Activity Annual Burden**  Chemical nomination, review, and selection 0.25 Rule development 0.9 0 Evaluation of rule 0.05 Industry /public assistance 0.0007 Compliance monitoring 0.1 0 Data processing and s ys tem support personnel 0.002 **Total FTE**  **1.3**20

It is estimat ed that the annual cost to the f ederal g overnment will be $ 2 83 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 f ederal government to $ 157,8 80 annually (i.e., $ 2 83 + $ 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 (**  **2 01**  **4 $)**  Total FTEs 1. 3 Loaded Cost per FTE $ 120 , 994 Government Labor Cost $ 1 57,597 Government Data Processing Cost $ 283 **Total Annual Government Cost $**  **157,8 80**  **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 9 16 hours (from 948 hours to 3 1 hours) from that currently in the OMB inventory . This change reflect s both adjustment changes from a decrease in the assumed number of PAIR reports filed annuall y and program changes resulting from mandatory electronic submissions of PAIR reports. In recent ye ars (FY 2011

– 2014), EPA has received no PAIR submissions and , for the purposes of this anal ys is , EPA assumes an annual rate of one submission per year. In the last I CR , EPA estimated an average of 33 reports from 14.8 submitters based on fiscal 200 6

- 20 10 data. **Table 14**  **: Annual Burden Hour Change**  Starting Burden 947.9 Adjustment Changes Change due to S ubmission D ecreases - 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

- 0 054 , 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 display s 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 I CR under Docket ID No. EPA

- HQ

OPPT

- 201 5

- 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 , e xcluding legal holiday s. 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

- 201 5

- 0236 and OMB Control No. 2070

- 0054 , to (1) EPA online using www.regulations.gov (our preferred method), or b y 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 b y m ail 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 t**  **he 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 F orm 7710

- 35) and i nstructions.

Available electronicall y 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 electronicall y 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