CRE Comments to OMB on The ICR For Chemical Testing Under TSCA

September 7, 2001

Dr. John D. Graham
Administrator
Office of Information and Regulatory Affairs
Office of Management and Budget
Eisenhower Exec. Offc. Bldg., Rm. 10201
17^th St. and Pennsylvania Ave., NW
Washington, DC 20503

Subject: The ICR For Chemical Testing Under TSCA

Dear Dr. Graham:

I am writing with respect to a pending ICR (#1139.06; OMB Control No. 2070-0033) submitted by EPA which is presently before OMB for review. The subject of the ICR is the testing of chemicals pursuant to the Toxic Substances Control Act (TSCA) which authorizes EPA to mandate chemical testing.

Program History

• OMB approved an EPA ICR (#1139.04) in August of 1993 to cover chemical testing information collected by the Agency pursuant to TSCA

• The ICR was again approved three years later, September 1996 (#1139.05).

• The proposed ICR (#1139.06) is presently before OMB for review.

• The proposed ICR represents a major increase in reporting requirements, an increase of some 1.1 million hours, an expansion of more than 1,400% over the currently approved ICR.

Program Components

Conclusions

1. EPA has proposed a dramatic increase in the TSCA Testing Program burden, primarily as a result of the Voluntary HPV Challenge Program. The increase reverses a pattern of decreases in TSCA testing burden over the last decade.

2. As a result of new TSCA testing initiatives, the pending ICR would cover two distinct types of programs: voluntary testing programs; and mandatory/enforceable testing programs.

3. The pending ICR is contrary to law because EPA has proposed adding a new reporting requirement, i.e. the new mandatory HPV testing program proposed by EPA in a late December 2000 NPRM, under the current control number without:

1. Giving the public the opportunity to comment on an ICR dealing with the new mandatory HPV testing program; and

2. Identifying the reporting burden associated with the new mandatory HPV program, including the burden associated with providing the exposure data that EPA states they will use in assessing potential risks.

Recommendations:

1. Control No. 2070-0033. The existing OMB Control Number 2070-0033 should restricted to collecting toxicology data from only voluntary TSCA programs.

2. New ICR for Mandatory TSCA Programs. EPA should develop a new ICR for toxicology data collected from mandatory TSCA testing programs.

3. New ICR for Exposure Data. EPA should develop a new ICR for exposure data from mandatory and voluntary TSCA testing programs.

4. Synchronize Mandatory Testing ICR and the HPV Test Rule(s). No final action should be taken on the proposed mandatory HPV test rule (65 Fed. Reg. 81658, December 26, 2000) until an ICR specific to mandatory testing programs has been published for public comment.
   
   

CRE's conclusions are documented in greater detail in the attached enclosure. EPA's estimate of the cost of the proposed ICR over the three year time period of the studies is in excess of $1 billion. This issue clearly warrants OMB's immediate attention.

 

Sincerely, Jim J. Tozzi Member, CRE Advisory Board

Click to make comment.

Attachment:

EPA ICR 1139.06:
Mandatory and Voluntary TSCA Testing Programs

The purpose of this document is to:

• Review burden trends and prior OMB actions regarding EPA's TSCA ICR;

• Describe the burdens associated with each Mandatory and Voluntary TSCA testing program for which EPA has provided a burden estimate;

• Analyze key issues pertinent to Mandatory and Voluntary TSCA testing programs; and

• Provide recommendations to OMB.

I.  Prior OMB Action on EPA TSCA ICRs; OMB Control No. 2070-0033

• EPA submitted ICR 1139.06 to OMB as an extension of a currently approved information collection. The following table describes OMB actions on EPA TSCA ICRs during the past decade along with the change in annual burden compared with the previous request.

Change in Burden: TSCA ICRs

• EPA explains that the substantially higher burdens requested in ICR 1139.06 were due to a program change resulting from the initiation of Voluntary testing programs. EPA stated, "This increase, and the corresponding increase in the costs, are the result of a program change. Specifically, the Agency has initiated two major new VTAs, the voluntary HPV Challenge Program and the voluntary children's health testing program."

II.  Voluntary and Mandatory Testing Program Burdens

• EPA estimates that the TSCA testing programs in the proposed ICR would result in an annual reporting and recordkeeping burden on industry of almost 1.2 million hours.

• The TSCA-related reporting and recordkeeping burden does not include EPA's estimate of an additional burden of almost 325,000 hours per year in non-reporting administrative tasks such as organizing testing programs and obtaining and reviewing laboratory bids.

• The following table displays the reporting and recordkeeping burden hours for TSCA testing programs for which EPA identified a burden. Non-reporting administrative burdens are not included in the chart below. All data was derived from ICR 1139.06.

• It should be noted that the "Test Rules" discussed in the ICR are distinct from the proposed HPV rule¹. The Test Rules are a continuation of an existing EPA program and involve different laboratory tests with different costs and different reporting requirements than the proposed HPV rule.

• EPA's estimate of the annual cost of the TSCA testing programs included in the ICR, including laboratory costs, and reporting and non-reporting administrative costs, is over $339 million.

• EPA's estimate of costs does not include any estimate of the costs associated with providing exposure data that will be used to evaluate the toxicology data. EPA's Federal Register notice for the Voluntary Children's Chemical Evaluation Program (VCCEP) states that the Agency will "develop a new ICR to cover the submission of exposure and risk information" for the VCCEP.

• EPA has not indicated that they need paperwork clearance to collect exposure data associated with the HPV test rule(s) even through the HPV NPRM states that the toxicology data will be combined with exposure and use data to evaluate potential health and environmental risks.

• The cost to industry of providing the toxicology data requested by EPA in the ICR, during the three year period of the Request, is over $1 billion.

• The following table presents EPA's estimates of the total laboratory and administrative costs of each TSCA testing program for which a burden estimate was provided.

EPA Cost Estimate of Voluntary and Mandatory TSCA Testing Programs

IV.  Action Item Before OMB

• OMB needs to decide whether to

  • Approve the ICR as presented; or

  • Request EPA submit a separate ICR for Mandatory testing programs, including the proposed HPV test rule, while utilizing the proposed ICR only for toxicology data from Voluntary test programs.

V.Issues Affecting OMB's Decision

Mandatory/Enforceable TSCA Testing Programs: HPV Rulemaking(s)

• EPA has stated that ICR 1139.06 does not include any burden related to the HPV rulemaking. The ICR states, "the burden associated with the High Production Volume Test Rules(s) have not been included in this ICR renewal request.²" EPA made the above assertion in response to public comments from the Chemical Manufacturers Association on the draft ICR asking for information on, among other issues, the scope of the ICR.

• EPA, in the NPRM for the initial Mandatory HPV test rule, stated that no additional OMB review and approval was required for the proposed rule's information collection activities.

• Instead of issuing an ICR for the initial proposed HPV rule, or including the burden associated with proposed rule in the subject ICR, EPA stated that a burden estimate for HPV test rule(s) will be developed and ICR 1139.06 will be amended when the HPV rule is finalized.³

• EPA's approach to the information collection requirements contained in the proposed HPV rulemaking does not allow any opportunity for public comment on the proposed rule's information collection burden and, thus, violates the Paperwork Reduction Act.

Voluntary TSCA Testing Programs: Voluntary HPV Challenge Program

• The annual reporting and recordkeeping burden associated with just the voluntary Challenge Program is more than 13-fold the currently approved reporting and recordkeeping burdens for OMB Control Number 2070-0033.

• The sharp increase in burden associated with voluntary programs does not include the burden associated with affected parties developing and submitting exposure data to the Agency.

Voluntary TSCA Program: Voluntary Children's Chemical Evaluation Program

• The Voluntary Children's Chemical Evaluation Program (VCCEP) is the leading edge of large and expensive testing program.

• The Federal Register notice for the VCCEP⁴ describes the request for sponsorship of the 23 chemicals⁵ to be tested as, "the first tier of a pilot of this Program."

• The VCCEP Federal Register notice also indicates that submission of exposure data will be a component of each Tier of the VCCEP and that a new ICR will be developed for collection of VCCEP exposure and risk data.

• EPA has not yet published for public comment an ICR describing the burden associated with providing the exposure and risk data for this program, even though the program is underway.

VI.Recommendations

1.Control No. 2070-0033. The existing OMB Control Number 2070-0033 should restricted to collecting toxicology data from only voluntary TSCA programs. Restricting the current control number to voluntary TSCA testing initiatives will not affect EPA's major testing initiatives.

2.New ICR for Mandatory TSCA Programs. EPA should develop a new ICR for toxicology data collected from mandatory TSCA testing programs. The public must be provided with the opportunity to comment on the estimated burden associated with the mandatory HPV test rule(s).

3.New ICR for Exposure Data. EPA should develop a new ICR for exposure data from mandatory and voluntary TSCA testing programs. EPA has recognized the need for - but not published for public comment - an exposure data ICR with respect to the voluntary children's chemical evaluation program.

4.Synchronize Mandatory Testing ICR and the HPV Test Rule(s). No final action should be taken on the proposed mandatory HPV test rule (65 Fed. Reg. 81658, December 26, 2000) until an ICR specific to mandatory testing programs has been published for public comment. Failure to synchronize HPV test rule(s) with the ICR would result in the public facing a regulatory compliance deadline without having the associated paperwork control number.

Endnotes:

1. "Testing of Certain High Production Volume Chemicals; Data Collection and Development on High Production Volume (HPV) Chemicals; Proposed Rule and Notice," 65 Fed. Reg. 81657.

2. ICR 1139.06, Attachment 6.

3. Ibid.

4. 65 Fed Reg. 81700

5. The ICR states that 22 chemicals are part of the initial program.