CRE Homepage About The CRE Advisory Board Newsletter Search Links Representation Comments/Ideas
Reg Week Archives
Data Access
Data Quality
Regulation by Litigation
Regulation by Information
Regulation by Appropriation
Special Projects
CRE Watch List
Emerging Regulatory Issues
OMB Papers
Guest Column
Voluntary Standards Program
CRE Report Card
Public Docket Preparation
Interactive Public Docket
Electronic Regulatory Reform
Consumer Response Service
Site Search

Enter keyword(s) to search
  • Read CRE's Review of ACC's Comments
  • Read ACC's Comments to EPA.
  • Read Selected Quotes From ACC's Comments to EPA.
  • Read CRE comments on EPA's HPV Rulemaking.
    CRE Comments on EPA's HPV Rulemaking

    April 25, 2001

    Document Control Office (7407)
    Office of Pollution Prevention and Toxics (OPPT)
    Environmental Protection Agency 1200 Pennsylvania Ave., NW
    Washington, DC 20460

    Mr. Donald R. Arbuckle
    Deputy Administrator
    Office of Information and Regulatory Affairs
    Office of Management and Budget
    Eisenhower Exec. Offc. Bldg., Rm. 10201
    17th St. and Pennsylvania Ave., NW
    Washington, DC 20503

    Dear EPA OPPT and Mr. Arbuckle:

    Subject:    Docket control number OPPTS – 42213A; comments on Dec. 26, 2000 NPRM for collection and dissemination of new TSCA test data on 37 HPV chemicals; EPA failure to comply with Paperwork Reduction Act and request for OMB review pursuant to 5 CFR 1320.14(c) and issuance of a new NPRM

       The purpose of this letter is to provide CRE comments on the subject proposed rule (65 Fed. Reg. 81658 et seq) and to request that OMB disapprove the pending Information Collection Request (ICR) and require a new NPRM and 60-day public comment period. These comments are directed principally at deficiencies in the Paperwork Reduction Act (PRA) public notice and comment and the OMB review processes. Specifically:

    • The proposed rule contains "substantive or material modifications to a collection of information" requiring OMB approval. Yet the NPRM states that "[t]his action does not contain any new information collection activities requiring additional OMB approval." (At 81678, 2d col.)

    • In notifying the public of the new ICR, EPA has mischaracterized the ICR in earlier Federal Register notices as only a request for an extension, and not as a revision or modification of an existing ICR. In addition, the current NPRM does not notify the public that it is seeking OMB information collection authorization for three years beyond April 30, 2001.

    • EPA has not adequately justified a proposed new use of the collected data – Agency dissemination to the general public under a Right-To-Know program – under the data quality provisions of the PRA and OMB guidance in terms of practical utility and as necessary to perform one of the Agency’s statutory functions.

    • EPA has not complied with the Executive Order 12866 with respect to the requirements to assess the significance of the problem, as well as to evaluate alternatives to the proposed rule. Thus, OMB should direct to EPA to prepare a Regulatory Impact Analysis (RIA) that would fully assess the costs and benefits of the proposed rule including the costs and benefits of alternatives to the proposed regulatory action.

       Consequently, CRE is requesting OMB review, and disapproval of the information collection proposed in the NPRM, pursuant to 5 CFR 1320.5(g), which provides:

    Any person may request OMB to review any collection of information conducted by or for an agency to determine if, under this Act and this part, a person shall maintain, provide, or disclose the information to or for the Agency.

  •    As a result of the deficiencies in public notice of opportunity for comment, CRE is also requesting that OMB require a new NPRM with a 60-day comment period, followed by an Agency summary of comments received, before OMB decides whether to approve or disapprove the ICR reflected in the NPRM.  

    1. Substantive or Material Modifications to the Original Collection of Information Requires OMB Approval

       The ICR form (OMB Form 83-I) submitted by EPA on August 31, 2000 indicates only that it is a request for an extension of a currently approved collection, and does not contain a revision of a currently approved collection. This is misleading both to the public and to OMB.

      • The NPRM and ICR incorporate a totally new information collection initiative, referred to in the NPRM as the "HPV Initiative", which was established in 1998, long after the 1993 approval of the original ICR (65 Fed.Reg. at 81664, col.1). This initiative requires a new test battery (the OECD SIDS battery) on 37 new chemicals selected under the Agency’s "B Policy". This selection process had not been discussed in the original 1993 ICR for TSCA § 4(a) test rules and subjected to OMB scrutiny. Imposition of these new information collection activities will impact new respondents and greatly increase cumulative burdens (hours and costs) over previously approved levels. OMB’s instructions for its PRA ICR form (Form 83-I) state that an agency must indicate a request as a "revision" if it would include "a material change to the collection instrument, [or] instructions . . . ."

      • The ICR and NPRM propose a new use of the data collected: active Agency dissemination of the screening level hazard data to the general public and particular interested groups under the Agency’s ChemRTK program, which was not announced until April 1998, long after the original 1993 OMB approval (65 Fed.Reg. at 81660, 3d col.). Such use of the data was not described in the original ICR. OMB’s instructions for its PRA request form (Form 83-I) state that an agency must indicate a PRA submission to be a "revision" if the request includes "a material change to the...use to which the information is to be put." EPA has not done so.

      • The burden estimates for the ICR have been increased dramatically. The estimated number of responses has risen from 278 to 76,450, burden hours have risen from 17,299 to 1,182,574, and costs from approximately $5.6 million to $51 million annually (EPA ICR #1139.06). Burden estimates are integral to ICRs and the ICR submission form (Form 83-I) requires that changes in burden estimates from those currently approved be shown clearly on the form. The OMB instructions for the form require an explanation for any changes, and there is even a separate "Change Worksheet" (OMB Form 83-C) for reporting and explaining such changes.

    1. EPA was Deficient in Announcing Opportunity for Public Comment on the Proposed ICR

    2.    In characterizing the ICR submission form as only a request for an extension and in making similar representations in the 1999 and 2000 Federal Register notices announcing the ICR submission and opportunity for public comment,1 the Agency has misled members of the public who might otherwise have commented on the revisions actually being proposed. The PRA states explicitly that an agency must publish notice of submission of a proposed revision to a collection of information and invite comments. 44 U.S.C. § 3507. EPA did not comply with that statutory directive, and therefore must provide notice of a new comment period that explains that it is applying for OMB approval of a revised collection of information and describe in the notice all of the proposed revisions that are subject to OMB approval.2

         In connection with this point, in a section of the NPRM pertaining to OMB regulatory review (rather than OMB PRA clearance), EPA explains that OMB has designated the proposed rule as a "significant regulatory action" under E.O. 12866 because it "may raise novel legal or policy issues", yet the notice never indicates those significant issues so that the public can comment on them (At 81676, 2d col.). EPA must strive for transparency and present these legal and policy issues and allow the public to provide comment.  

    3. Data Quality: EPA Failed to Justify Use of the Acquired Data for Dissemination to the Public

       Under the Data Quality Act, the PRA and OMB guidance in Circular A-130,3 agency disseminations of data such as that proposed here must, like the collection of the data, satisfy the requirements of "practical utility" and be necessary for the performance of the agency’s statutory functions. Neither of these issues have been addressed by EPA, and it is unlikely that the requirements can be satisfied. The NPRM characterizes the test data to be collected and then disseminated under its HPV program as mere screening level "hazard" data that can be used to set priorities for assessing risk and considering regulatory measures. Since it is very unlikely that many members of the public are aware of the important distinction between hazard and risk, dissemination of "screening level" hazard data that are not equivalent to human exposure, will generally lack practical utility and will be likely to be misleading and counter-productive. We understand that the Agency intends to devote only minimal resources (approximately $100,000 over three years) to managing and evaluating the data. It is unclear as to the practical benefit the Agency places as it has not allocated appropriate resources to this task.  

    1. OMB Should Direct EPA to Perform an RIA as Set Forth in Section 6(a)(3)(C) of Executive Order 12866

    The EPA HPV Initiative, including both mandatory and voluntary components, will impose an economic burden exceeding $100 million per year.

    1. EPA Intends to Test Approximately 3,000 Chemicals Under the HPV Initiative

       The testing that would be required by the NPRM is part of a much larger HPV testing program, which includes both voluntary and mandatory testing components. EPA's Federal Register notice requesting comments on the Agency's ICR notes, when discussing the substantial increase in burden hours requested under the ICR, "This increase reflects the addition of a proposed High Production Volume (HPV) test rule that will review 3,000 chemicals over a 3 year period, or 1000 chemicals annually..."4

    1. The Annual Cost of the EPA HPV Initiative Will Exceed $100 Million.

       EPA's Economic Analysis of December 5, 2000 analyzes the costs associated with the testing of 49 specific chemicals. Based on the Least Cost Scenario data in Appendix C of the Analysis, the average industry compliance cost is $267,876 per chemical.

       EPA estimates the number of HPV chemicals range from 2,800 to 3,000. EPA's NPRM cites a 1998 EPA study, "Chemical Hazard Data Availability Study" which evaluated data on 2,863 HPV chemicals. EPA believes that data are available on 7% (or about 200) of these chemicals. Therefore, there are at least 2,663 HPV chemicals that will eventually be tested under the HPV initiative. The cost of testing these 2,663 chemicals would be over $700 million with an annual cost of over $237 million.

       EPA, in its 12/26/01 Federal Register Notice on the Challenge Program, states that the Agency has received full or provisional commitments to test 2,155 chemicals. Thus, there are at least 508 chemicals to be tested by rule. Thus, the cost of testing related to the TSCA testing rules would be over $136 million.

       Although the annual costs associated with the proposed mandatory portion of the HPV Initiative would, as the program is currently described, be under $100 million, EPA should still conduct a complete Regulatory Impact Analysis because EPA may: 1) increase the number of chemicals to be tested by rule depending on the progress (or lack thereof) in the Challenge Program which could bring the testing costs to over $100 million/year; 2) add additional chemicals to the mandatory testing program beyond the list of 2,663; and 3) add additional tests to the testing regime for an unknown number of chemicals on the list.

       Clearly, given that OMB has already designated the rule as a "significant regulatory action" as well as the potential for an even larger mandatory testing program, OMB should direct EPA to conduct an RIA under Section 6(a)(3)(C) of Executive Order 12866.

    1. EPA Failed to Comply with Executive Order 12866 

         For regulations of this magnitude, Executive Order 12866 requires agencies to perform a detailed regulatory analysis. The analysis EPA performed fails to satisfy several critical analytical requirements. First, EPA begins from the false premise that a market failure justifying government intervention is presumed to have occurred in any instance where consumers, workers and other market actors lack perfect information about potential chemical risks.5 Information is always imperfect, so the absence of perfect information would justify regulatory intervention anywhere at any time for virtually any purpose.

       Second, even if a genuine market failure is presumed to exist, EPA provides no evaluation of its significance relative to other market failures generally, or even just those within its regulatory purview.6 Without such an evaluation, EPA’s analysis fails to "assess the significance of [the] problem" (see section 1(b)(1) of Executive Order 12866) or "consider ¼ the degree and nature of the risks posed by various substances or activities within its jurisdiction" (section 1(b)(4)). Such an analysis is essential for determining whether any observed market failure is significant.7

    Third, EPA’s analysis fails to evaluate any alternatives to the proposed rule. According to EPA, "[s]everal approaches for developing this information have been considered by EPA, one of which includes the current proposal." The agency acknowledges, however, that "[t]hese alternatives have not been evaluated quantitatively in the economic analysis."8 The failure to evaluate reasonable alternatives is a fatal flaw in any economic analysis, especially one whose effects are economically significant. Section 6(a)(3)(C)(i) of Executive Order 12866 clearly requires agencies to submit a detailed analysis of benefits anticipated from the regulatory action.

       Fourth, EPA’s analysis provides no credible mechanism by which the information this rule requires to be produced and disseminated could actually enhance the quality of decisionmaking.9 EPA relies on statistics about the numbers and types of persons who access similar data found in government databases, but such information is irrelevant to estimating social benefits. Access data do not reveal anything about incremental value, and some persons accessing these data may be "free riders" capturing an external benefit.


    • EPA Needs to Develop a Revised ICR. EPA must develop a revised ICR that reflects the substantive and material changes that the Agency proposes to make to the HPV testing program, including new uses of screening level hazard data.

    • EPA Must Demonstrate the Practical Utility of the Proposed Information Collection. EPA is required to demonstrate in the revised ICR that the information intended for dissemination has practical utility under the data quality provisions of the PRA and OMB guidance.

    • EPA Must Provide a 60 Day Public Comment Period on the Revised ICR. EPA is required by the PRA to provide the public with a 60 day comment period on the proposed revised information collection.

    • EPA is Required to Obtain OMB Approval of the Revised ICR. After the 60 day comment period and any subsequent revisions to the draft revised ICR, EPA must submit the revised ICR to OMB for approval. EPA must also to provide the public with a 30 day comment period at that time.

    • OMB Should Direct EPA to Conduct an Appropriate RIA and Comply with the Other Provisions of Executive Order 12866. Since the costs associated with the rule are large (over $100 million), could go substantially higher, and the Agency has not conducted the required assessment of benefits anticipated from the proposed rule, OMB should direct EPA to prepare an RIA as specified in Section 6(a)(3)(C) of Executive Order 12866.

    • EPA Must Issue a New Notice of Proposed Rulemaking. As EPA has not complied with key provisions of both the PRA and Executive Order 12866, EPA is obligated to provide the public with a new NPRM.

       Thank you for the opportunity to submit these comments. We trust that they will receive your careful consideration. 


    Jim J. Tozzi
    Member, CRE Advisory Board



    1 64 Fed.Reg. 40866-97, July 28, 1999; 65 Fed.Reg. 54864-65, Sept. 7, 2000. For example, the later of the two notices states that the ICR is "a renew an existing ICR currently scheduled to expire on August 31, 2000." At 52464.3d.col.

    2 The agency noted changes in burden estimates, but did not describe the new information proposed for collection or the new use proposed (dissemination as public right-to-know data).

    3 And see also the appendix to A-130 containing the "Analysis of Key Sections."

    64 Fed.Reg. at 40867

    EPA, Economic Analysis for the Proposed Section 4 Test Rule for HPV Chemicals, December 5, 2000 (referred to as the Economic Analysis) at 1-2 et-seq.


    Office of Management and Budget, Economic Analysis of Federal Regulations Under Executive Order 12866, Section I.A.

    Economic Analysis at 1-4.

    Economic Analysis at 5-1 et seq..