### ECONOMIC ANALYSIS

OF THE

AMENDMENT TO THE POLY MER EXEMPTION RULE

TO EXCLUDE CERTAIN PERF LUORINATED POLYMERS

— DOES NOT CONTAIN TSCA CBI —

Prepared by:

Wendy Hoffman Economic and Policy Analysis Branch Economics, Exposure and Technology Division

Office of Pollution Prevention and Toxics Office of Prevention, Pesticides and Toxic Substances

U.S. ENVIRONMENTAL PROTECTION AGENCY

1200 PENNSYLVANIA AVENUE, NW

WASHINGTON, D.C. 20460

October 30, 2009iiABSTRACT

This economic analysis estimates the cost of a final rule to amend the Polymer Exemption Rule. The Polymer Exemption Rule provides an exemption for certain polymers from the premanufacture notif ication (PMN) requirements under section 5 of the Toxic Substances Control Act (TSCA) and the implem enting regulations at 40 CFR part 720. This amendment excludes from eligibility under th e Polymer Exemption Rule those polymers containing as an integral part of their compos ition, except as impurities, certain perfluoroalkyl moieties consisting of a CF3- or longer chain length.

Under the final rule, any person who intends to manufacture (defined by statute to include import) any of these polymers not alre ady on the TSCA Inventory must complete the TSCA premanufacture review proc ess prior to commencing the manuf acture or import of such polymers. Alternatively, manufacturers or im porters may submit a request for a different exemption, such as the Low Volume Exempti on (LVE) or Low Environmental Release and Human Exposure Exemption (LoREX), for affect ed polymers that they reasonably believe may qualify for such exemptions. Those persons who are currently manufactur ing or importing such polymers, or who have previously manufactured or imported them but are not doing so now, in full compliance with the 1995 polymer exemp tion rule, may continue manufacturing or importing them until 24 months after pub lication of the final rule in the Federal Register . After that date, manufacture of these polymers will no longer be authorized under the polymer exemption rule, and continued manufacture or import must be authorized under a different section 5(h)(4) exemption or under a different se ction 5 authority, such as section 5(a)(1) or section 5(e).

EPA estimates that the net cost for completing and submitting a PMN as a result of this amendment will be $7,897 per chemical for chem icals that are currently being manufactured under the exemption. EPA estimates that compan ies that are not manuf acturing an affected polymer, but begin to manufacture these polymers in the future, may also incur costs associated with delays in commercialization of the new ch emical of $14,522 per chemical, for a total of $22,419 per chemical.

EPA estimates that a maximum of 252 PMNs for previously exempt chemicals could be submitted during the first two years af ter publication of the final rule. However, because EPA has no way of predicting accurately the actual timing of the submissions, in this analysis, EPA is averaging the 252 PM Ns over the two-year period and is assuming that 126 PMNs for previously exempt chemi cals will be submitted each of the first two years. In addition, EPA is expecting a ma ximum of 18 PMNs to be submitted to the Agency each year after public ation for new chemicals th at were not previously manufactured under the exemption, for a total of 144 PMNs during each of the first two years of the rule.

Using the estimated costs per chemical and the estimated anticipated number of PMNs, EPA estimates the potential PMN submi ssion costs of the rule to industry in the first two years of the rule to be $1.4 milli on, including delay costs for the new chemicals that were not previously manu factured under the exemption. In the third and subsequent

iiiyears of the rule, the annual estimated cost for manufacturers of affected chemicals is estimated to be $403,542.

Finally, the final rule clarifies that othe r TSCA section 5(h)(4) exemption requests may be submitted in lieu of PMNs. EPA estimates that the cost of preparing an LVE or a LoREX is equal to the cost of preparing a PMN. However, LVEs and LoREXs are not subject to the $2,500 user fee. Accordingly, if the Agency receives no LVE or LoREXs notices as a result of this clarification, th en Agency estimated costs are not affected by this clarification. However, if the Agency does receive any LVE or LoREX notices, then

estimated costs would be overstated because these notices would not be subject to the user fee. The Agency has never received a photographic film exemption request and does not expect to as a result of this final rule

As was the case prior to the promulgation of the Polymer Exemption Rule in 1995, the Agency recognizes that the submission of a PM N may lead to other re gulatory actions under TSCA; for example, consent orders issued unde r TSCA section 5(e). Any such actions are highly dependent on the circumstances surr ounding the individual PMN (e.g., available

information and scientific understa nding about the chemical and its risks at the time the PMN is being reviewed). Such potential actions and any co sts associated with them would not be a direct result of the amendments to the Polymer Ex emption Rule, but this economic analysis does

contain a brief discussion of th e Agency’s previous and ongoing re g ulatory activities with respect to potentially affected polymers.

ivTABLE OF CONTENTS Page

ABSTRACT....................................................................................................................... i

1.0 INTRODUCTION .................................................................................................1

2.0 INDUSTRY BURDEN AND COSTS............................................................. .....3 2.1 Potentially Affected Entities .........................................................................3 2.2 Estimated Burden and Costs for Submitting a Premanufacture Notice (PMN)................................................................................4 2.2.1 Estimated Burden and Costs for Submitting Other TCA Section 5(h)(4) Exemption Requests........................................................... .............6 2.3 Estimated Number of PMNs Anticipated .....................................................7

2.4 Total Estimated Annual Indus try Costs and Burdens ......................................8

3.0 AGENCY COSTS .................................................................................................9

4.0 POTENTIAL FOLLOW-ON ACTION S FOR AFFECTED POLYMERS.......10 4.1 Examples of Previous Follow-on Actions for Affected Polymers ..............10 4.2 Potential Follow-on Actions for Affected Polymers ...................................11

5.0 ADDITIONAL ANALYSES................................................................................13

5.1 Executive Order 12866.............................................................13

5.2 Re gulatory Flexibility Act (RFA) ...............................................................13 5.3 Unfunded Mandates Reform Act (UMRA) ................................................ 14 5.4 Paperwork Reduction Act (PRA) ................................................................14

5.5 Executive Order 13132 ................................................................................14

5.6 Executive Order 12898 ................................................................................15

5.7 Executive Order 13045 ................................................................................15

5.8 Executive Order 13175 ................................................................................15

5.9 Executive Order 13211 ................................................................................16 5.10 National Technology Tran sfer Advancement Act..............................16 5.11 Congressional Review Act.......................................................................... ..16

REFERENCES..................................................................................................................17

APPENDIX A DERIVATION OF WAGE RATES......................................................... 19

LIST OF TABLES

Table 1 Industry Costs and Burden or Submitting a PMN..........................................5 Table 2 Net Industry Costs and Bu rden for Submitting a PMN..................................6 Table 3 Cost Estimates for Examples of Previous Testing Requested .......................11

Table A-1 Former and Current EPA and BLS Labor Categories................................19 Table A-2 Derivation of Loaded Wage Rates..............................................................21

v1.0 INTRODUCTION

This report presents the U.S. Environmen tal Protection Agency (EPA), Office of Pollution Prevention and Toxics’ (OPPT) analys is of the potential costs incurred as a result of amending the Polymer Exemption Rule. The Polymer Exemption Rule provides an exemption for certain polymers from the premanufacture notification (PMN) requirements under section 5 of the Toxic Substances Control Act (TSCA) and the implementing regulations at 40 CFR part 720. Th is final rule exclude s from eligibility under the Polymer Exemption Rule those polymers containing as an integral part of their composition, except as impurities, certain perfluoroalkyl moieties consisting of a CF3- or longer chain length. The exclusion includes poly mers that contain any one or more of the following: perfluoroalkyl sulfonates ( PFAS); perfluoroalkyl carboxylates (PFAC); fluorotelomers; or perfluoroalkyl moieties th at are covalently bound to either a carbon or sulfur atom where the carbon or sulfur atom is an integral part of the polymer molecule. This change to the current regulation is necessary because, based on available information, EPA can no longer conclude that these polymers “will not present an

unreasonable risk to human health or the en vironment,” under the terms of the Polymer Exemption Rule, which is the determinati on necessary to suppor t an exemption under TSCA section 5(h)(4).

In general, any person who intends to manufact ure (or import) any affected polymers that are not already on the TSCA Inventory must comp lete the TSCA premanufacture review process prior to commencing the manufacture or import of such polymers. Alternatively, manufacturers or importers may submit a request for a different section 5(h)(4) exemption, such as the Low Volume Exemption (LVE) or Low Environmental Release and Human Exposure Exemption (LoREX), for affected polymers that they reas onably believe may qualify for such exemptions.

The effective date of this final rule w ill be 30 days after its publication in the Federal Register, which is the minimum required by section 553(c ) of the Administrative Procedure Act. Accordingly, the TSCA section 5(a)(1)(A) requirement to submit a PMN (or alternate exemption request, if appropriate) for a new chemical subs tance applies to all affected polymers beginning 30 days after publication of the final rule in the Federal Register. However, EPA is providing an extended compliance date for those who, prior to the effective date of the final rule, had already initiated the manufacture or import of affected polymers in full compliance with the 1995 polymer exemption rule. Specifically, this rule allows manufacturers or importers of affected polymers who are in full compliance with the terms of the 1995 polymer exemption rule, to continue manufacturing or importing them until 24 months after publication of the final rule in

the Federal Register . After that date, manufacture of these polymers will no longer be authorized under the polymer ex emption rule, and continued ma nufacture or import must be authorized under a different section 5(h)(4) exem ption or under a differe nt section 5 authority, such as section 5(a)(1) or section 5(e).

The remainder of this analysis is or ganized as follows. Chapter 2 presents estimates of the industry cost s and burdens resulting from the amendment. Chapter 3 discusses estimated Agency costs and burdens for reviewing the PMNs anticipated as a result of this amendment. Chapter 4 presen ts a discussion of poten tial follow-on actions

2for companies submitting PMNs after the Polymer Exemption Rule is amended. Finally, Chapter 5 includes a review of additional analyses related to the potential impacts of this rulemaking, as required under various statutes and Executive Orders.

2.0 INDUSTRY BU RDEN AND COSTS

EPA has evaluated the industry costs that are expected to result from the amendment to exclude from eligibility under the Polymer Exemption Rule those polymers described in the final rule.

2.1 Potentially Affected Entities

Entities expected to be impacted by this final rule include:

• Chemical Manufacturers or Importe rs (North American Industrial Classification System (NAICS) code 325), e.g., Persons who manufacture (defined by statute to include import) one or more of the subject chemical

substances.

• Chemical Exporters (NAICS code 325), e.g., persons who export, or intend to export, one or more of the subject chemical substances.

This listing and the NAICS codes that are provided are not intended to be exhaustive, but rather provide a guide for en tities likely to be affected by this action. Other types of entities not listed also could be affected.

Within this universe, a company may be im pacted by this action if the company is currently manufacturing or importing polymers, or has previously done so, that contain as an integral part of their composition, except as impurities, certain perfluoroalkyl moieties consisting of a CF3- or longe r chain length (“affected polym ers”). A company may also be impacted by this action if the compa ny intends to manufacture or import these polymers in the future. As specified in the regulatory text (§ 723.250(d)(6)), this action includes polymers that contain any one or more of the following: PFAS; PFAC; fluorotelomers; or perfluoroalkyl moieties th at are covalently bound to either a carbon or sulfur atom where the carbon or sulfur atom is an integral part of the polymer molecule.

Persons who import or intend to import pol ymers that are covered by the final rule are subject to the TSCA section 13 (15 U.S. C. 2612) import certifi cation requirements, and to the regulations codified at 19 CFR 12.118 through 12.127 and 127.28. Those persons must certify that they are in comp liance with the PMN requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. Importers of formulated products that contain a polymer that is a subject of this final rule as a component (for example, for use as a wate r-proof coating for text iles or as a top antireflective coating (TARC) used to manuf acture integrated circuits) also may be potentially affected. A list of potential mono mers and reactants that could be used to

3manufacture polymers that are affected by this rulemaking may be found in the public docket for this rulemaking.

2.2 Estimated Burden and Costs for Subm itting a Premanufacture Notice (PMN)

In the Regulatory Impact Analysis (RIA) (EPA 1994) prepared for amendments to the PMN regulations finalized in 1995, EPA re lied on industry estimates of the effort needed to collect and compile all data requi red for a PMN, to prepare the form, and to submit the form and data to EPA. These estimates, based on a 1991 survey conducted by the Chemical Manufacturers Association (now called the American Chemistry Council), indicate that the average effort required to prepare and submit a PMN is between 95 and 114 hours for reporting activities, plus two hours for recordkeeping, for a midpoint burden estimate of 107 hours. EPA expects that the burden and cost for submitting a PMN will decline when EPA’s proposed e-PM N rule, requiring electronic submission of all PMNs, is finalized (EPA, 2008b). However, because the final rule has not yet been published, the expected reduction in industry an d cost burden from the e-PMN rule is not reflected in this analysis.

The labor mix includes categories that EPA had been labeling as managerial, technical, and clerical (EPA, 2003) in previ ous economic analyses. In 2004, the Bureau of Labor Statistics (BLS) switched from the Occupational Classification System (OCS), to the Standard Occupational Classification System (SOC). Labor category titles have thus been changed here to reflect the switc h. However, the coverage of the old and new occupational groups is approximately the same . See Appendix A for the derivation of the
wage rates.

The cost for completion and submission of a PMN is estimated to be $5,769 (see Appendix A for derivation of wage rates). PMN submitters must also pay a standard $2,500 user fee, for a total cost of $8,269. See Table 1. Submitters of PMNs for new chemicals may also incur an estimated $24,094 in commercialization delay costs (BLS, 2007, and EPA, 2003), which assumes that the product is ready for sale on the market and the PMN review process caused the comp any to forego production and profits for the duration of the PMN review period. In cases where the company has taken the delay into account in its product planning schedule, no dela y costs may be incurred. However, for the purposes of this analysis, the delay cost is included.

EPA has estimated previously that chemicals using the polymer exemption could incur $6,462 in commercialization delay co sts (EPA 1994). Updating that figure for inflation using the Producer Price Index fo r Chemical Manufacturers results in an updated cost of $9,572 (BLS, 2007a). When th e polymer exemption delay cost, which will no longer be incurred under the rule, is subtracted from the PMN delay cost, the net delay cost is $14,522. This figure is less than the figure of $19,416 that appeared in the Economic Analysis for the proposed rule because the $19,416 had not been updated for inflation since 2003, and did not reflect the subtraction of $9,572 in commercialization delay costs that would no longer be incurre d as a result of ending the exemption for certain polymers. The Economic Analysis for the proposed rule, therefore, overestimated

4the cost of submitting a PMN for a new chem ical that is not already on the TSCA Inventory.

Table 1. Industry Costs and Burden for Submitting a PMN

Labor Category Average

Hours 1 Loaded Wage Rate 2 (2007 dollars) Total Labor Cost (loaded wage × hours)

Office and administrative support 14.0 $27.47 $384

Professional and related 75.0 $55.44 $4,158

Management, business,

and financial 18.0 $68.18 $1,227

Subtotal 107 $5,769

PMN User Fee $2,500

TOTAL $8,269

Figures may not equal totals due to rounding.

1 Hours range for each labor category is from the RIA for the PMN Am endments (EPA, 1994).

2 Loaded wage rates include fringe benefits and overhead. See Appendix A for derivation.

While the burden and cost for submitting a PMN are estimated to be 107 hours and $8,269 per chemical for the usual PMN cas e, the burden and cost for submitting a

PMN as a result of this final rule is es timated to be 101 hours and $7,897 per chemical.

The estimates for this final rule are lower than usual because the Agency has accounted for the elimination of the existing burden a nd costs related to th e recordkeeping and reporting requirements in the Polymer Exemption Rule, which are estimated to be six hours per chemical. This figure includes four hours for reporting, and two hours for recordkeeping (EPA, 2003). The net burde n is therefore 101 hours (107 - 6). The reduction of six hours was apportioned across the three labor categories in the same percentages as each category contributes to th e total burden hours, and results in the net cost and burden shown in Table 2. The net cost per PMN is therefore calculated as $7,897.

5Table 2. Net Industry Costs and Burden for Submitting a PMN under the Rule

Labor Category Average

Hours 1 Loaded Wage Rate 2 (2007 dollars) Total Labor Cost (loaded wage × hours)

Office and administrative
support 13.0 $27.47 $357

Professional and related 70.0 $55.44 $3,881

Management, business, and

financial 17.0 $68.18 $1,159

Subtotal 101 $5,397

PMN User Fee $2,500

TOTAL $7,897

Figures may not equal totals due to rounding.

1 Hours ranges for each labor cat egory are from the RI A for the PMN Amendments (EPA, 1994).

2 Loaded wage rates include fringe benefits and overhead. See Appendix A for derivation.

Including PMN preparation and submission costs, the user fee, and net commercialization delay costs, the total cost for a company to submit a new PMN under this amendment is estimated at $22,419 ($7,897 + $14,522) per chemical. Small

businesses with annual sales of less than $40 million are subject to a reduced PMN user fee of $100, so the total cost for a small business to submit a PMN for a new chemical is estimated to be $20,019 per chemical. Potentia l small business impacts are discussed in Chapter 5.1 of this EA. LVEs and LoREXs are not subject to any user fee, so to the

extent that small businesses submit either of these two types of notices, the impact of the

rule on small business also would be further reduced.

These net costs do not include the followi ng per chemical costs that would have

been incurred had a manufacturer of an aff ected polymer been allowed to continue to submit an exemption notification under the Polymer Exemption Rule (i.e., had this amendment to the Polymer Exemption Ru le not been fina lized): (1) $372 for recordkeeping and reporting costs, and (2) $9,572 commercialization delay cost.

2.2.1 Estimated Burden and Costs for Submitting Other TSCA section 5(h)(4) Exemption s Requests

EPA has clarified in the final rule that the Agency is al lowing other section 5(h)(4) exemption requests, such as Low Volume Exemptions (LVE) and Low Release and Exposure (LoREX) exemptions, and photogr aphic film exemptions, to be submitted

in lieu of a PMN. EPA estimates that the co st of preparing an LVE or a LoREX is equal

6to the cost of preparing a PMN. However, LVEs and LoREXs are not subject to the $2,500 user fee. Accordingly, if the Agency receives no LVE or LoREXs notices as a result of this clarification, then Agency estimated costs are not affected by this clarification. However, if the Agency does receive any LVE or LoREX notices, then

estimated costs would be overstated because these notices would not be subject to the user fee. The Agency has never received a photographic film exemption request and does not expect to as a result of this final rule

It is possible that EPA may deny a re quest for a different section 5(h)(4) exemption. In that case, the manufacturer may choose to submit a PMN for the affected polymer. See, e.g., 40 CFR § 723.50(h). The additional costs of preparing and submitting the PMN in such “double submissions” are not estimated in this Economic Analysis. EPA is not able to track polyme rs that came in under the polymer exemption

but which could have come in under a diffe rent exemption. EPA does not receive enough

information in notifications submitted under the polymer exemption rule to make any reasonable judgments in that respect. Moreover, EPA doe s not regularly track “double submissions,” whether they pertain to affect ed polymers or other chemical substances. Thus, EPA cannot reasonably estimate the num ber of affected polymers for which double submissions might be necessary as a result of this rule. However, in 2007 and 2008 there were an average of 20 denials or withdrawal s of LVE or LOREX submissions per fiscal year, for all chemical substances (EPA, 2009a).

Based on the 20 withdrawals or denials averaged in 2007 and 2008 for all chemical substances, the Agency does not anticipate a significant number of “double submissions” for affected polymers as a result of this rule, and therefore, does not expect the costs to be significant

. In addition, the cost of the PMN submission, after the denial of a request for a different section 5(h)(4) ex emption, would not be a direct cost of this rule, but rather, of an independent EP A action (denial of the LVE/LoREX or photographic film exemption request). The direct cost of this rule is only the cost of submitting a single PMN or a single alternative section 5(h)(4) exemption request for each affected polymer.

2.3 Estimated Number of PMNs Anticipated

EPA searched for polymers in various databases, including the Science and Technology Network (STN) database maintained by the Chemical Abstracts Service of the American Chemical Society, which holds the public inventory fo r TSCA chemicals; the TSCA New Chemicals database, which in cludes the public STN database and the nonpublic Confidential Inventory; and other so urces to obtain information on the number of polymers that could be affected by the rule. Based on these searches, EPA has estimated that this rule will affect approxima tely three to six percent of the average 292 polymers reported annually since the polym er exemption took effect for chemicals affected by this rule (EPA, 2008a). EPA used the high end of six percent to estimate that 18 polymers per year may be affected by th is rule, and therefore, a maximum of 18 additional PMNs could be anticipated each ye ar under the final rule. While EPA believes

7that this is an overestimate based on CBI and non-CBI data, it is using this figure to

ensure that the estimated burdens and costs are not underestimated.

Applying the same number of 18 chemicals per year to the 14 years the Polymer Exemption Rule has been in effect (1996 th rough 2009) for the polymers covered by this rule, EPA estimates that it could receive a maximum of 252 PMNs for previously exempt polymers (18 chemicals x 14 years) under this rule. The final rule allows those persons who are currently manufacturing or importing such polymers, or who have previously manufactured or imported them but are not doing so now, in full compliance with the 1995 polymer exemption rule, to continue manufacturing or importing them until 24

months after the effective date of the fina l rule. Current manufacturers and importers may submit PMNs as soon as the final rule is in effect. In light of comments EPA received on the proposed rule that one year was not sufficient time for companies to prepare, submit, and complete the PMN revi ew process, EPA expects to receive the majority of PMNs for previously exempt chemicals during the second year of the proposed rule. However, because EPA has no way of predicting accurately the actual timing of the submissions, in this analysis, EPA is averaging the 252 expected PMNs for previously exempt chemical s over the two-year period a nd is assuming that 126 PMNs for previously exempt chemicals will be submitted each of the first two years after publication of the final rule.

In addition, EPA estimates that a maximu m 18 PMNs for new chemicals could be submitted each year after publicati on of the final rule. Therefor e, in each of the first two years, EPA is expecting a total of 144 PMNs to be submitted; 126 PMNs for previously exempt chemicals and 18 PMNs for new chemicals.

2.4 Total Estimated Annual Industry Costs and Burdens

Companies that are currently manufactu ring an affected polymer, or have previously done so in compliance with the 1995 polymer exemption, are estimated to incur a total cost of $7,897 per chemical under the final rule . Companies that are not manufacturing an affected polymer, but be gin to manufacture su ch polymers in the future, are estimated to incur a total cost of $22,419 per chemical.

Based on the estimated per chemical cost s and the estimated number of PMNs anticipated, EPA estimates the potential first and second year costs for manufacturers and importers to be $1,398,564, or $1.4 million pe r year, including $995,022 for previously exempt chemicals (126 chemicals x $7,897 per chemical) + $403,542 (18 new chemicals x $22,419). This will decrease to an estimated annual cost of $403,542 in the third year and beyond for the maximum of 18 PMNs that EPA believes could be submitted annually by manufacturers and importers of new chemicals that are no longer eligible for the exemption.

The industry burden associated with submitting a PMN as a result of this amendment is estimated to be a total of 101 hours per PMN submission. Based on the assumption of a total of 144 PMNs in each of the first two years afte r publication of the

8final rule (126 PMNs for previously exempt chemicals and 18 PMNs for new chemicals), EPA estimates that the industry burden w ill be 14,544 hours per year (144 PMNs x 101 hours per submission). This will decrease to an estimated annual burden of 1,818 hours in the third year and beyond for the maximum of 18 PMNs that EPA believes could be submitted annually by manufacturers and importe rs of new chemicals that are no longer eligible for the exemption.

3.0 AGENCY COSTS

EPA will incur costs associated with the st aff time needed to review each PMN. Costs to the Agency include: 1) initial re view of PMN substances, after which the majority of cases are dropped from furthe r regulatory review, and 2) comprehensive reviews on a minority of chemicals. Under a comprehensive review, the Agency conducts a more thorough evaluation of the potentia l risks associated with manufacturing, processing, use and disposal of the PMN s ubstance, including, if necessary, taking regulatory action under TSCA s ections 5(e) or 5(f).

The average Agency cost per PMN was calculated by multiplying the Agency’s 64 labor hours for each PMN (EPA 1994) by the Agency labor cost per hour for a fully loaded GS-13, Step 5 employee in the Washington, D.C. area in 2007. Extramural costs for contractor support are also included in the Agency cost calculation. EPA expects that the cost to the Agency to process and revi ew PMNs will decline when EPA’s proposed ePMN rule, requiring electronic submission of all PMNs, is finalized (EPA, 2008b). However, the expected reduction in cost is not reflected in these estimates.

Agency wage rate data used to calculate labor costs were taken from the U.S. Office of Personnel Management (OPM) salary table for a GS-13, step 5 employee in the Washington, D.C. area (OPM, 2007). A loading factor of 1.6 to reflect fringe benefits and overhead was applied to the base salary of $89,985 to arrive at th e 2007 loaded salary of $143,976. The final loaded hourly wage of $69.22 was calculated by dividing the loaded salary by the 2,080 hours associated with a full-time employee (EPA 2003).

Agency unit costs for review of full PM Ns are estimated to average $5,550 per notice, including $4,430 in Agency labor costs and $1,120 in extramural costs for contractor support ((EPA, 2003) updated to 2007, and (BLS, 2007a)). Based on the assumption that EPA will receive PMNs for a maximum of 144 chemicals in each of the first two years after publication of the fi nal rule, the annual Agency cost of the amendment is estimated to be $799,200 (126 PMNs x $5,550 per submission), or $800,000 for the first two years. This will de crease to an estimated annual cost of $99,900 in the third year and beyond for the maximum of 18 PMNs that EPA believes could be submitted annually by manufacturers and importers of new chemicals that are no longer eligible for the exemption.

94.0 POTENTIAL FOLLOW-ON ACTIONS FOR AFFECTED POLYMERS

In addition, as was the case prior to th e promulgation of the Polymer Exemption Rule in 1995, the Agency recognizes that th e submission of a PMN may lead to other regulatory actions under TSCA, for example, consent orders issued under TSCA section 5(e). Any such actions are highly depe ndent on the circumstances surrounding the individual PMN (e.g., available informati on and scientific understanding about the

chemical and its risks at the time the PMN is being reviewed). Such potential actions and any costs associated with them would not be a direct result of the amendments to the Polymer Exemption Rule. Nevertheless, EP A is providing a brie f discussion of the Agency’s previous and ongoing regulatory activ ities with respect to potentially affected polymers.

4.1 Examples of Previous Follow-on Actions for Affected Polymers

Prior to promulgation of the Polymer Exemption Rule amendment in 1995, which exempted fluorinated chemicals that met the cr iteria described in that amendment to the Polymer Exemption Rule from the PMN re view process, manufacturers of those fluorinated chemicals were required to submit a PMN prior to manufacturing or importing those chemicals. As a result of the Agency’s PMN review, the Agency might have sought additional inform ation or taken other regulat ory actions under TSCA. For example, EPA may have requested under TS CA section 5(e) that those manufacturers

submit additional test data a bout the polymer, either up-front , or when the manufacture of

the chemical was in excess of certain quantities. By elim inating the polymer exemption for these fluorinated chemicals, this final ru le returns those chemicals to their pre-1995 status of being subject to the PMN review process. In addi tion to the costs and burden of submitting a PMN discussed in Chapter 2 of this analysis, chemical manufacturers potentially are also subject to costs from other regulatory activities that could be

undertaken under TSCA that are distinct from the costs of submitting a PMN.

During the past 13 years, a number of manufacturers have voluntarily submitted PMNs for their fluorinated chemicals despite their eligibility for the polymer exemption. Since 2000, when the Agency first identified co ncerns about fluorinat ed chemicals, the Agency has requested additional test data under TSCA section 5(e) on fewer than 80 fluorochemicals that met the polymer exempti on criteria but for which companies chose to submit PMNs. Because the follow-on actions are highly dependent on the circumstances surrounding the individual PMN (e.g., available information and scientific understanding about the chemical and its risks at the time the PMN is being reviewed), the Agency cannot predict future follow-on ac tions for individual fluorinated chemicals, including requests for specific test data. While prior experience with PMNs for these fluorinated chemicals shows the type of additiona l test data that has been requested in the past, PMNs submitted in the future for such chemicals might involve different requests for additional information to reflect the Agency’s evolving understanding of these

substances.

Typically, in the past, the Agency has request ed test data from the following studies:

10subacute oral toxicity (28 days); subchronic inhalation toxicity test ing in very limited situations

based on a commercial or consumer use that would involve spray application and where the Agency has special concerns for subchronic i nhalation toxicity based on animal testing and Structural Activity Relationship (SAR); and the th ree-test aquatic panel in some cases where the chemical was expected to persist. In addi tion, the Agency has generally requested that companies use high temperature incineration (900 ○ C) for disposal, rather than other disposal methods such as landfilling.

The Agency can request that th e test data be provided be fore the manufacture of the chemical begins, or by setting a particular producti on volume trigger. In the trigger case, testing may be triggered as the production volume reaches levels where the Agency has calculated that

the cost of the test would be recove red by profits earned by the chemical.

Table 3 presents EPA’s ranges of estimated co sts to conduct these examples of tests that previously have been requested. No data are available on the cost per pound or per ton for

incineration.

Table 3. Testing Costs for Examples of Prev ious Tests Requested for Polymer Exemption

Chemical s

Test 1 Estimate Range

Subacute Oral Toxicity (28 Days) (OECD 407) 2 $35,000 to $59,000

Subchronic 90-Day Inhalation T oxicity in Rodents (OTS 799.9346) $197,000 to $474,000

Three Test Aquatic Panel (D aphnid Acute Toxicity, OPPT 850.1010; Fish Acute Toxicity; OPPT 850.1075; Algal Toxicity Tiers I and II, OPPT 850.5400) $21,000 to $46,000

1 These tests are examples of the types of tests that woul d have provided the test data requested in the past, and the related guidelines identified above were used to identify an estimated range for potential costs. The tests and related guidelines provided above do not necessarily represent actual tests or guidelines identified in any consent orders or testing agreements.

2 No equivalent OPPT Guideline was identified for this test.

4.2 Potential Follow-on Action s for Affected Polymers

EPA’s knowledge and understanding about fluorinated chemicals are continuing to evolve. Based on the Agency’s developi ng understanding of how these chemicals behave in the environment, including their persistence and potential to bioaccumulate, and incoming health effects data, the informa tion the Agency may need when reviewing a PMN is also changing. For example, in some cases, such as incineration testing, based on: 1) data submitted to the New Chemicals program and other background data and information the Agency has obtained, 2) da ta the Agency will be receiving from incineration testing agreements with industry, an d 3) where it is warranted because of the type of chemical that has been submitted, the Agency has no longer been asking for

11additional incineration testi ng data that would identif y degradation products and impurities, especially the presence of com ponents that can lead to the formation of perfluoroalkyl acids after burning.

In other cases, concerns related to the e nvironmental fate and transport of these chemicals have arisen. Based on data submitted to the Agency showing that telomer

alcohol can breakdown to form PFOA, concern has been raised that the larger polymer

molecule can breakdown to form telomer alc ohol, which could then breakdown to form PFOA. As a result, EPA currently is interested in data that addresses questions such as

the rate at which the new fluorinated chemical s degrade, the identity of the degradation products, and what the fluorinated chemicals are specifically composed of, including any impurities. To address these concerns, the Agency has begun to request test data from

environmental fate studies such as OPPT 835.5045, Modified SCAS Test for Insoluble and Volatile Chemicals; OECD 303A, Si mulation Test Aerobic Sewage Treatment (Activated Sludge Units); OECD 307, Aerobi c and Anaerobic Transformations in Soil; OECD 308, Aerobic and Anaerobic Transformati ons in Aquatic Sediment Systems; and, OECD 311, Anaerobic Biodegradability of Or ganic Compounds in Digested Sludge.

EPA is working in a number of ways to avoid requesting unnecessary or duplicative testing of new fluorinated chem icals. Wherever possible in the New Chemicals Program, the Agency is sequenci ng testing and grouping together chemicals

with similar structures or chemicals that are expected to behave similarly in the environment to take full advantage of the da ta that are coming in. EPA also evaluates data submitted by companies from studies done voluntarily or for other regulatory authorities. In addition, TSCA section 8(e) requires companies to submit to EPA any

adverse effects data that is or becomes av ailable about the chemicals. EPA is also studying relevant test data that are being generated abroad, and where possible, using those studies to inform its requests for testing in the New Chemicals Program.

The Agency is adjusting its approach to new fluorinated chemicals based on new information that is continually coming into the Agency. Any follow-on actions are based on the individual chemical and the Agency’s knowledge at the time the PMN is undergoing review by the Agency. Therefore, it is very difficult to predict with accuracy what specific follow-on actions (e.g., othe r information, test data, or exposure protections), if any, the Agency may take when reviewing PMNs for new fluorinated

chemicals submitted in the future.

5.0 ADDITIONAL ANALYSES

This chapter presents the additional anal yses required under various statutes and

Executive Orders.

125.1 Executive Order 12866

Under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993), this action is a “significant regulatory action” under section 3(f) of the Executive Order because it may raise nov el legal or policy issues arising out of legal mandates, the President’s priorities, or the principles set forth in the Executive Order. Accordingly, EPA submitted this action to the Office of Management and Budget (OMB) for review under Executive Order 12866 and any changes made in response to

OMB recommendations have been documented in the docket for this action.

5.2 Regulatory Flexibility Act (RFA)

The Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq ) generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Ad ministrative Procedure Act or any other statute unless the agency certi fies that the rule will not have a significant economic impact on a substantial number of small entitie s. Small entities include small businesses, small organizations, and small governmental jurisdictions.

For purposes of assessing the impacts of this rule on small entities, small entity is defined as: (1) a small business as defined by the Small Business Administration’s (SBA) regulations at 13 CFR 121.201 based on the ap plicable NAICS code for the business sector impacted; (2) a small governmental ju risdiction that is a government of a city, county, town, school district or special district with a popul ation of less than 50,000; and (3) a small organization that is any not-for-profit enterpri se which is independently owned and operated and is not dominant in its field.

The regulated community does not include any small governmental jurisdictions or small not-for-profit organizations. For small businesses, the Agency assessed the impacts on small chemical manufacturers in NAICS codes 325 and 324110. The SBA size standards for sectors under NAICS 325 range from 500 to 1,000 employees or fewer

in order to be classified as small. Th e size standard for NAICS code 324110, Petroleum Refineries, is 1,500 employees.

Based on estimates of the number of PMNs expected to be submitted as a result of this rule, EPA expects that 12 or fewer bus inesses would be aff ected per year (EPA, 2009). Five companies that manufacture the majo rity of the volume of chemicals that are affected by these amendments to the Polymer Exemption Rule belong to either or both the Fluoropolymer Manufacturers Group, and the Telomer Research Program. These two groups, which have no other members beyond the five companies

, have negotiated enforceable consent agreements and other voluntary testing arrangements with the Agency for testing specific chemicals that ar e affected by the Polymer Exemption Rule. The two groups have told the Agency that their member companies manufacture the majority of the volume of chemicals that are affected by the rule (OPPT-2003-0012-0013 and -0016). None of these five companies m eet the definition of small under the Small Business Administration employee size criteria. The remaining volume of chemicals that

13could be affected by the rule is low enough so that even if a small company were to be affected, a significant number of businesses would not be affected. Small businesses are
also entitled to a reduced user fee of $100 for submitting a PMN, rather than the $2,500 user fee, which further reduces any impacts of the rule.

5.3 Unfunded Mandates Reform Act (UMRA)

This action contains no Federal mandates under the provisions of Title II of the Unfunded Mandates Reform Act of 1995 (UMR A), 2 U.S.C. 1531-1538 for State, local, or tribal governments or the private sector

. Based on EPA's experience with past PMNs, State, local, and tribal governments have not been affected by this reporting requirement, and EPA does not have any reas on to believe that any State, local, or tribal government will be affected by this rulemaking. As such, EPA has determined that this regulatory action does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small government s subject to the requi rements of sections

202 or 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).

5.4 Paperwork Reduction Act (PRA)

According to the Paperwork Reduction Act (PRA), 44 USC 3501 et seq. , an agency may not conduct or sponsor, and a pe rson is not required to respond, to a collection of information that requires Office of Management and Budget (OMB) approval under the PRA, unless it has been approved by OMB and displays a valid OMB

control number. The information collection requirements related to the submission of PMNs are already approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq . That Information Collection Request (ICR) document has been assigned EPA ICR number 0574 and OMB control number 2070-0012. This rule does not impose any new requirements that require additional OMB approval. The existing paperwork burden is discussed in Section 2 of this EA.

5.5 Executive Order 13132

Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999), requires EPA to develop an accountable proces s to ensure “meaningful and timely input by State and local officials in the development of regulatory policies th at have federalism implications.” “Policies that have federali sm implications” is defined in the Executive Order to include regulations that have “subs tantial direct effects on the States, on the relationship between the nati onal government and the States, or on the distribution of power and responsibilities among the va rious levels of government.”

EPA has determined that this final ru le does not have federalism implications

because it will not have substantial direct effects on the states, on the relationship between the national governmen t and the states, or on the distribution of power and responsibilities among the various levels of government, as specified in the Order,

14because this rule simply amends the Polymer Exemption Rule (40 CFR 723.250) by removing the exemption from the premanufacture notification (PMN) requirements of TSCA that had previously existed for manuf acturers of certain polymers; manufacturers of such polymers must now submit premanufact ure notifications or alternate exemption requests, if appropriate, to EPA for review . Thus, Executive Order 13132 does not apply

to this rule.

5.6 Executive Order 12898

Executive Order (EO) 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629 (Feb. 16, 1994)), establishes federal executive policy on environmental just ice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and a dverse human health or environmental effects of their programs, policies, and activ ities on minority populations an d low-income populations in

the United States.

EPA has determined that this final rule will not have disproportionately high and

adverse human health or environmental eff ects on minority or low-income populations

because it increases the level of environmen tal protection for all affected populations without having any disproportionately high a nd adverse human health or environmental effects on any population, including a ny minority or low-income population

. This rule amends the Polymer Exemption Rule (40 CFR 723.250) by removing the exemption from the premanufacture notification (PMN) requi rements of TSCA that had previously existed for manufacturers of certain polymer s; manufacturers of such polymers must now submit premanufacture notificati ons or alternate exemption re quests, if appropriate, to

EPA for review.

5.7 Executive Order 13045

EPA interprets Executive Order 13045, entitled Protection of Children from

Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), as applying only to those regulatory actions th at concern health or safety ri sks, such that the analysis required under section 5-501 of Executive Orde r 13045 has the potential to influence the regulation. This action is not subject to Executive Order 13045 because it does not

establish an environmental standard intende d to mitigate health or safety risks.

5.8. Executive Order 13175

As required by Executive Order 13175, entitled Consultation and Coordination

with Indian Tribal Governments (65 FR 67249, November 9, 2000), EPA has determined that this final rule does not have tribal imp lications because it will not have any affect on tribal governments, on the relationship betw een the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in th e Order. Thus, Executive Order 13175

15does not apply to this rule.

5.9. Executive Order 13211

This action is not a “significant energy action” as defined in Executive Order 13211, entitled Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355 (May 22, 2001)) because it is not likely to have a significant adverse effect on the supply, distri bution, or use of energy. Further, we have concluded that this rule is not likely to ha ve any adverse energy effects because this rule simply amends the Polymer Exemption Rule (40 CFR 723.250) by removing the exemption from the premanufacture notificati on (PMN) requirements of TSCA that had previously existed for manufacturers of certain polymers; manufacturers of such polymers must now submit premanufacture notifi cations or alternate exemption requests, if appropriate, to EPA for review.

5.10 National Technology Transfer Advancement Act

Section 12(d) of the Na tional Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law No. 104-113, 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulat ory activities unless to do so would be inconsistent with applicable law or impr actical. Voluntary c onsensus standards are technical standards (e.g., mate rials specifications, test met hods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. NTTAA directs EPA to provide Congr ess, through OMB, explanations when the Agency decides not to use available and a pplicable voluntary consensus standards.

This action does not involved technical standards. Therefore, EPA did not consider the use of any voluntary consensus standards.

5.11 Congressional Review Act

The Congressional Review Act, 5 U.S.C. 801 et seq ., generally provides that before a rule may take effect, the agency pr omulgating the rule must submit a rule report to each House of the Congress and the Comptroller General of the United States. EPA will submit a report containing this rule a nd other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller Ge neral of the United States prior to publication of the rule in the Federal Register . This rule is not a “major rule” as defined by 5 U.S.C. 804(2).

16REFERENCES

BLS, 2006. U.S. Bureau of Labor Statistics , Employer Costs for Employee Compensation: Changes to NAICS and SOC, Table 2. ECEC Occupational Comparability between SOC and OCS. Downloaded January 2007 from http://www.bls.gov/ncs/ect/sp/ecsm0003.htm

.

BLS, 2007

. Employer Costs for Employee Compensation Supplementary Tables, September 2007. Supplementary Table 2. http://www.bls.gov/ncs/ect/sp/ecsuptc4.pdf

.

BLS, 2007a. Producer Price Index for the Ch emical Manufacturing Industry. Series Id PCU325, updated through Septembe r 2007. Downloaded May 2008 from http://data.bls.gov/PDQ/se rvlet/SurveyOutputServlet.

EPA, 1994. Regulatory Impact Analysis of Amen dments to Regulations for TSCA Section 5 Premanufacture Notifications. Washingt on, DC: EPA/OPPT/EETD/RIB. September 9,

1994.

EPA, 2001. Memo from Dr. Gregory Fritz to Mary Begley re: Polymer Exemption Rule Amendment. Washington, D.C.: EPA/ OPPT/EETD. November 21, 2001.

EPA, 2002. Cody Rice. Wage Rates for Economic Analysis of the Toxics Release Inventory Program. Washington, DC: U.S.EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch, June 10, 2002.

EPA, 2002a. Office of Pollution Prevention and T oxics, Economic and Policy Analysis Branch. Revised Economic Analysis for the Ame nded Inventory Update Rule: Final Report. Washington, DC. August 2002.

EPA, 2003. EPA ICR No. 0574.12, OMB Cont rol No. 2070-0012. Washington, D.C.: EPA/OPPT. August 2003.

EPA, 2008a. Email communication from Anna Coutlakis to Geraldine Hilton. February 29, 2008.

EPA, 2008b. TSCA Section 5 Premanufacture and Significant New Use Notification Electronic Reporting; Revi sions to Notification Regulations; Proposed rule. Federal Register (73 FR 78261-78276), December 22, 2008) (FRL-8395-8).

EPA, 2009. Email communication from Greg Fr itz to Geraldine Hilton. March 27, 2009.

EPA, 2009a. Email communication from Anna Coutlakis to Geraldine Hilton. April 9,

2009.

OPM, 2007. U.S. Office of Personnel Manage ment. Salary Table 2007-DCB (Washington – Baltimore-Northern Virginia, DC-MD-VA-WV-PA). 2007.

17OPPT-2003-0012-0013. APFO Users. Letter of Intent (LOI) for the APFO Users to Stephen L. Johnson, EPA. March 14, 2003.

OPPT-2003-0012-0016. Telomer Research Program. Letter of Intent (LOI) for the Telomer Research Program to Stephen L. Johnson, EPA. March 14, 2003.

Weinstein, 2004. Harriet G. Weinstein and Mark A. Loewenstein, U.S. Bureau of Labor

Statistics. C omparing Current and Former Industry and Occupation ECEC Series. Originally posted August 25, 2004 at http://www.bls.gov/opub/cw c/print/cm20040823ar01p1.htm

.

18APPENDIX A

DERIVATION OF WAGE RATES

This appendix describes the derivation of the fully loaded labor rates and inflation factors used in calculating costs of labor , materials, and other inputs. Costs for this report are for yearend.

A.1 Derivation of Loaded Wage Rates

Unit labor costs are calculat ed by adding fringe benefits and overhead to the wage or salary to derive a fully loaded labo r cost. The basic method is described in Wage Rates for Economic Analysis of th e Toxics Release Inventory Program ( EPA, 2002 ). The resulting loaded labor rates ar e given in Table A-2. Costs are calculated for the labor categories of Managerial, Professional/ Technical, and Clerical.

In March 2004, the Bureau of Labor St atistics (BLS) began using the North American Industry Classification System (NAICS) codes instead of the Standard Industrial Classification (SIC ) System, and the Standard Occupational Classification (SOC) system instead of the Occupational Cl assification System (OCS). The following

table shows the crosswal k between old and new occupational titles.

Table A-1. Former and Current EPA and BLS Labor Categories

Source: Employer Costs for Employee Compensation: Changes to NAICS and SOC, Table 2 . ECEC Occupational Comparability between SOC and OCS (BLS, 2006) and Weinstein, 2004. EPA Reports Labor Category BLS Old Title (OCS) BLS New Title (SOC)

Managerial Executive, administrative, and managerial Management, business,

and financial

Professional/Technical Professional specialty and

technical Professional and related

Clerical Administrative support, including clerical Office and administrative
support

A.2. Derivation of Labor Rates for Man agerial, Technical and Clerical Labor

Wages and fringe benefits for the Ma nagement, business, and financial; Professional and related; and, Office and ad ministrative support la bor categories were taken from the Bureau of Labor Statistics (BLS) Employer Costs for Employee Compensation (ECEC) data, for September 2007, for manufacturing industries. 1

1 BLS Employer Costs for Employee Compensation, Supplementary Table 2. September 2007. http://www.bls.gov/ncs/ect/sp/ecsuptc4.pdf

. Past economic analyses used ECEC data for “A ll Goods Producing” sectors (manufact uring, mining, and construction). However, the manufacturing sector data seems more relevant because the rule mainly affects the chemical industry.

1920 The cost of fringe benefits such as paid leave and insurance, specific to each labor category, are taken from the same BLS series. An additional loading factor of 17 percent is applied to wages to account for overhead. This approach is used for consistency with

Office of Pollution Prevention and Toxics ec onomic analyses for two major rulemakings: Wage Rates for Economic Analyses of the Toxics Release Inventory Program (EPA, 2002), and the Revised Economic Analysis for the Amended Inventory Update Rule: Final Report (EPA, 2002a ). This overhead loading factor is added to the benefits loading factor, and the total is then applied to the base wage to derive the fully loaded wage. For example, the September 2007 fully loaded wage for technical labor is $33.25 + $16.54 + ($33.25 x .17) = $55.44. Fully load wages for managerial and clerical labor were calculated in a similar manner, as shown in Table A-2.Table A-2 Derivation of Loaded Wage RatesEPA LaborCategoryData SourcesDateWageFringeBenefitOverhead %of wage1Fringe +OverheadLoaded Wages2ManagerialBLS Employer Costs for EmployeeCompensation. All workers in manufacturing;Management, business, and financial.Sept.2007$41.40$19.7417%$26.78$68.18TechnicalBLS Employer Costs for EmployeeCompensation. All workers in manufacturing;Professional and related.Sept.2007$33.25$16.5417%$22.19$55.44ClericalBLS Employer Costs for EmployeeCompensation. All workers in manufacturing;Office and administrative support.Sept.2007$16.40$8.2817%$11.07$27.47EPA staff FTEAnnual Federal staff cost: OPM WashingtonBaltimore-Northern Virginia, DC-MD-PA-VAWV area, GS-13 Step 5 pay rates, with 60%overhead.3Jan. 2007$89,985(annual)--60%1.60$143,976 (annual)1An overhead rate of 17% was used based on assumptions inWage Rates for Economic Analyses ofthe Toxics Release Inventory Program(EPA, 2002), and theRevised EconomicAnalysis for the Amended Inventory Update Rule: Final Report(EPA, 2002a).2Wages and fringe benefits are from BLS websitehttp://www.bls.gov/ncs/ect/sp/ecsuptc4.pdf.3The Federal salary is the unloaded Federal GS-13 Step 5 salary ($89,985) for 2007, from the Office ofPersonnel Management salary table forWashington-Baltimore-Northern Virginia(OPM, 2007). The 60% fringes-and-overhead rate is from an EPA guide, Instructions for Preparing Information Collection Requests (ICRs)(OPPE, 1992, page 30, footnote 9).21