[Federal Register Volume 61, Number 156 (Monday, August 12, 1996)]
[Proposed Rules]
[Pages 41764-41766]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-20459]


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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 153 and 159

[OPP-60010E; FRL-5388-1]
RIN 2070-AB50


Reporting Requirements for Risk/Benefit Information; Reopening of 
Comment Period to Request Comments on Burden Estimates

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposal; reopening of comment period.

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SUMMARY: Under section 6(a)(2) of the Federal Insecticide, Fungicide, 
and Rodenticide Act (FIFRA), pesticide registrants are required to 
submit to the Agency information that they acquire which may be 
relevant to the balancing of the risks and benefits of their pesticide 
product(s). On September 24, 1992 (57 FR 44290), EPA issued a proposed 
rule which defined the specifics of this reporting requirement. After 
evaluating the comments received in response to that proposal, as well 
as several discussions with stakeholders, the Agency is now working to 
issue a final rule which clearly defines the reporting obligations of 
registrants under FIFRA section 6(a)(2). Before issuing this final 
rule, however, the Agency is reopening the rulemaking record to allow 
interested individuals to comment on the burdens that would be imposed 
by the rule in its current draft final form. In addition, the Agency is 
seeking comments on the revised burden estimates presented in the 
Information Collection Request (ICR) related to the draft final rule. 
Although an ICR was prepared and made available as part of the proposed 
rule, and the comments received on that ICR have been considered in 
developing the final draft rule and ICR, the Agency has recently 
received several letters expressing concern about preliminary burden 
estimates which were prematurely made publicly available. In order to 
provide another opportunity for the regulated community to provide new 
comments or information related to the burden and cost estimates, the 
Agency has decided to reopen the rulemaking record for the narrow 
purpose of soliciting additional comment on the sole issue of the costs 
or burdens associated with the proposed rule and the draft final rule. 
After consideration of any comments received, the Agency will submit 
the revised ICR package to the Office of Management and Budget (OMB) 
for review and approval under the Paperwork Reduction Act (44 U.S.C. 
3501 et seq.). EPA is soliciting comments on the specific aspects of 
the collection described below. This ICR, entitled: Submission of 
Unreasonable Adverse Effects Information Under FIFRA Section 6(a)(2) 
[EPA ICR No. 1204.04; OMB No. 2070-0039], will replace the existing ICR 
once EPA issues the final rule.

DATES: Comments must be submitted on or before September 11, 1996.

ADDRESSES: Submit written comments identified by the docket control 
number OPP-60010E and EPA ICR No. 1204.04 by mail to: Public Response 
Section, Field Operations Division (7506C), Office of Pesticide 
Programs, Environmental Protection Agency, 401 M St., SW., Washington, 
DC 20460. In person, bring comments directly to the OPP docket which is 
located in Rm. 1132 of Crystal Mall #2, 1921 Jefferson Davis Highway, 
Arlington, VA.
    Comments and data may also be submitted electronically by sending 
electronic mail (e-mail) to: [email protected]. Electronic 
comments must be submitted as a ASCII file avoiding the use of special 
characters and any form or encryption. Comments and data will also be 
accepted on disks in WordPerfect 5.1 file format or ASCII file format. 
All comments and data in electronic form must be identified by the 
docket number ``OPP-60010E'' and EPA ICR No. 1204.04. No Confidential 
Business Information (CBI) should be submitted through e-mail. 
Electronic comments on this document may be filed online at many 
Federal Depository Libraries.

[[Page 41765]]

    Information submitted as a comment concerning this document may be 
claimed confidential by marking any part or all of that information as 
CBI. Information so marked will not be disclosed except in accordance 
with procedures set forth in 40 CFR part 2. A copy of the comment that 
does not contain CBI must be submitted for inclusion in the public 
record. Information not marked confidential may be disclosed publicly 
by EPA without prior notice. All comments will be available for public 
inspection in Rm. 1132 at the Virginia address given above from 8 a.m. 
to 4:30 p.m., Monday through Friday, excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: Jim Roelofs, Policy and Special 
Projects Staff, Office of Pesticide Programs, Environmental Protection 
Agency, Mail Code (7501C), 401 M St., SW., Washington, DC 20460, 
Telephone: (703) 308-2964, e-mail: [email protected].
    To obtain a copy of the material referenced in this notice (i.e., 
the Supporting Statement and attachments that make up ICR 1204.04), you 
may visit the OPP Public Response Section at the address provided 
above, using docket number OPP-60010E to obtain the information you 
need, or you can request a copy of the material by calling or e-mailing 
a request to Jim Roelofs.

SUPPLEMENTARY INFORMATION:
Electronic Availability: Electronic copies of the ICR and any 
accompanying material are available from the EPA Public Access gopher 
(gopher.epa.gov) at the Environmental Sub-Set entry for this document 
under ``Rules and Regulations.''

I. Request for Comments

    The Agency is reopening the rulemaking record today in order to 
solicit additional comment on the sole issue of the costs or burdens 
associated with the proposed rule and the latest draft of the final 
rule [a copy of which is attached as an appendix to the ICR]. In this 
regard, the Agency notes that it is not soliciting comments on the 
perceived value to the Agency of the information identified in the 
proposed rule and draft final rule, nor is it soliciting comments on 
the legality of either rule. The Agency received a number of such 
comments during the original rulemaking comment period, and does not 
believe the changes from the proposal to the draft final rule raise any 
new issues related to the legality of the rule or the utility of the 
information which would warrant a reopening of the comment period for 
those issues. If any person wishes to submit comments on an issue other 
than the costs of the rule to registrants, that person may file a 
petition to reopen the rulemaking record and should include in such 
petition an explanation of why the requested reopening could lead to 
significant material changes in the rule and why the comments to be 
submitted during the reopening could not have been submitted earlier.
    In terms of comments on costs and burden estimates, the Agency is 
interested in detailed comments identifying how the proposed and draft 
final rules would affect the costs (and any other burdens) imposed upon 
registrants by their reporting obligations under section 6(a)(2). The 
Agency is particularly interested in comments addressing the issues set 
forth below, although interested persons are invited to submit any 
comments related to cost or burden they believe are material to this 
reporting rulemaking. Comments that provide detail on how registrants 
are currently complying or would have to comply with reporting 
requirements together with an accompanying identification and 
explanation of the costs (and/or other burdens) associated with each 
facet of compliance would be particularly helpful.
    (1) The nature of the training (and the costs associated with it) 
that registrants would be obligated to undertake under the terms of the 
proposed or draft final rule; how that training differs from the 
training (and the costs associated with it) that registrants are 
currently required to undertake in order to comply with the existing 
reporting requirements under section 6(a)(2); and whether and how any 
particular change in the proposed or draft final rule would affect the 
nature of the training or the costs associated with it.
    (2) The costs and burdens associated with reporting incidents under 
current reporting requirements; any changes in those costs and burdens 
associated with reporting pursuant to the provisions of the proposed 
rule; and any changes in those costs and burdens associated with 
reporting pursuant to the draft final rule. The Agency would be 
particularly interested in comments on how the threshold for reporting 
incidents, the summarization of incidents, and/or the proposal to 
require the reporting of all incidents (rather than series of 
incidents) affect the costs and burdens that would have to be borne by 
registrants in complying with these reporting requirements, as compared 
to current practices.
    (3) The costs and burdens associated with reporting efficacy 
failure studies and information concerning pesticide resistance.

II. The Information Collection Request

    EPA is seeking comments on the following Information Collection 
Request (ICR), which will revise an ICR currently approved by OMB:
    ICR numbers: EPA ICR No. 1204.04; OMB No. 2070-0039.
    Expiration: OMB approval of the current ICR expires on November 30, 
1996.
    Title: Submission of Unreasonable Adverse Effects Information Under 
FIFRA Section 6(a)(2).
    Affected entities: This collection applies to all pesticide 
registrants. The Standard Industrial Codes assigned to the businesses 
required to submit a response under this collection activity are 286 
and 287.
    Abstract: This information collection stems from a non-
discretionary statutory requirement. Section 6(a)(2) of the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA) requires pesticide 
registrants to submit information to the Agency that they acquire which 
may be relevant to the balancing of the risks and benefits of a 
pesticide product. In CSMA and NACA v. EPA 484 F. Supp. 513 (1980), the 
District Court of the District of Columbia agreed with EPA that FIFRA 
section 6(a)(2) covers all information relevant to EPA's determination 
of whether a pesticide may cause unreasonable adverse effects. The 
Court agreed that submissible information includes the same type of 
information as that provided by a registrant as part of an application 
for registration. The Court specifically rejected the argument that the 
responsibility for determining what constitutes an unreasonable adverse 
effect shifts to industry once EPA has granted a registration.
    As such, the statute requires the registrant to submit any factual 
information that it acquires regarding adverse effects associated with 
its pesticidal products, and it is up to the Agency to determine 
whether or not that factual information constitutes an unreasonable 
adverse effect. In order to limit the amount of less meaningful 
information that might be submitted to the Agency, EPA has limited the 
scope of factual information that the registrant must submit. The draft 
final rule would serve to limit this scope even further by providing a 
more detailed description of the reporting obligations of registrants 
under FIFRA section 6(a)(2).
    As further defined by the final rule implementing the FIFRA section 
6(a)(2) requirements, registrants are required to report on: (1) 
Studies showing new or

[[Page 41766]]

more severe toxicological responses than previously reported of any 
type in any strain of test organism; (2) epidemiological or exposure 
studies of human population groups; (3) studies or incidents tending to 
show lack of efficacy of certain pesticide products with public-health 
related uses; (4) incidents involving toxic or adverse effects to non-
target organisms; (5) information on excess residues on food or feed, 
or residues in surface water, ground water, or drinking water; (6) 
information on metabolites, degradates, contaminants or impurities 
which may be of toxicological concern; (7) information showing that a 
product fails to perform as claimed or that pests have developed 
resistance to the product; and (8) other information which may be 
relevant to risk/benefit determinations of any type.
    Respondents must (1) Read the final rule or instructions, (2) plan 
activities to ensure required information is identified and submitted, 
(3) process, compile, and review information for accuracy and 
appropriateness, (4) complete written instruments to effectuate a 
submission, and (5) submit the information to EPA. In addition, as a 
part of the initial implementation for the final rule, the registrant 
must conduct a ``screening'' or ``initial review'' of their existing 
records. The purpose of this initial exercise is to identify specific 
information that is within the registrant's possession which has not 
already been submitted to EPA, but which meets the criteria under the 
final rule for submission under FIFRA section 6(a)(2).
    Since section 6(a)(2) requires the submission of certain 
information when it is acquired by a registrant, any information 
meeting the criteria for submission under section 6(a)(2) which happens 
to be in the possession of the registrant upon the effective date of 
the final rule, and which has not already been submitted to EPA, would 
need to be submitted to EPA immediately. The Agency recognizes that 
some of this information may be out dated and has, therefore, limited 
the type of information that should be apart of this initial 
``screening.''
    Under FIFRA section 6(a)(2), as implemented by the final rule, 
pesticide registrants have absolutely no obligation to create or seek 
out this information. Such activities may be conducted by the 
registrant in support of pesticide registration under FIFRA section 3, 
or reregistration under section 4 (which are approved by OMB under 
separate ICR approvals), or in the normal course of business, such as 
following up on consumer complaints to gather more information. 
Regardless of how the information comes into the possession of the 
registrant, once the registrant acquires information subject to 
submission under section 6(a)(2), as defined by the final rule, the 
registrant must submit it to EPA.
    Burden statement: EPA estimates that the first year burdens 
associated with becoming familiar with the changes to the requirements 
total 38,265 burden hours, with an average of 17.39 burden hours per 
registrant (38,265  2,200). Calculated by taking an estimated 
total annual burden of 660 hours for registrants to determine who needs 
to know the new requirements (0.3 hour per registrant x 2,200 
registrants) and an estimated total of 37,605 hours for registrants to 
learn the new requirements (2.5 hours x 15,042 people expected to need 
instructions).
    Another initial first year burden is related to the requirements in 
40 CFR 159.159, which requires registrants to check their files for 
certain reportable information that they may already have but have not 
sent in earlier, either because it was not required or because of an 
error. The burden associated with this ``audit'' depends upon whether 
the Registrant has such reportable information (which is actually a 
subset of that information which is reportable) and then whether or not 
he or she prepares an inventory of the information he or she has, or 
simply submits copies of the information. In any case, the Agency 
estimates that this initial audit is likely to result in an estimated 
average burden of 5 hours for each registrant to review its records, 2 
hours for submissions to be prepared, and 0.5 hour for the actual 
submissions, for a total estimated first year burden of 7.5 hours per 
registrant, with a total first year burden of 16,500 hours (7.5 x 2,200 
registrants).
    After the initial implementation of these amended requirements, EPA 
estimates that the total annual burden for registrants to determine who 
needs to know the requirements will decrease to 440 hours (0.2 hour per 
registrant x 2,200 registrants) and the estimated total for reading the 
instructions will decrease to 22,563 hours (1.5 hour per person x 
15,042 people), for a total estimated annual burden of 23,003 hours 
associated with annual rule familiarization, with an average burden of 
10.46 hours per registrant (23,003  2,200 registrants).
    EPA has eliminated any recordkeeping requirements associated with 
the submittal of section 6(a)(2) information and any burdens associated 
with maintaining registration related data or information covered by 
another ICR. However, a registrant may be required to keep information 
related to a partial submission, so that when information completing 
the submittal is sent to EPA the registrant provides an appropriate 
cross reference to the original submission. EPA estimates that this 
need to cross reference a partial submission may occur a total of 10 or 
15 times each year, with an estimated annual burden of 0.5 hour per 
occurrence, for a total annual burden of 7.5 hours overall, or an 
average burden of 0.0034 hour per registrant (7.5  2,200).
    In order to determine an estimated per registrant burden, as 
requested by OMB, EPA has estimated that each registrant is likely to 
submit an average number of 4.07 submissions each year (annual 
submissions expected (8,960)  total number of registrants 
(2,200)). At a total annual burden of 6.4 hours per submission, the 
annual total burden per registrant for submissions could be 26.05 
hours. This burden must be added to the other burdens related to this 
rulemaking to bring the total annual per registrant burden associated 
with the rule to 36.3534 hours for the first year (26.05 for 
submissions + 10.3 for initial burdens + .0034 for follow-up), and 
27.7534 hours for subsequent years (26.05 for submissions + 1.7 for 
training + .0034 for follow-up).
    As for the total estimated burdens for the ICR, EPA estimates the 
first year total burden is 74,996.48 hours, which is expected to 
decrease in subsequent years to an annual estimated burden of 43,234.48 
hours.

List of Subjects in Part 153 and 159

    Environmental protection, Information collection requests, 
Pesticides and pests, Reporting and recordkeeping requirements.

    Date: August 1, 1996.
Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.
[FR Doc. 96-20459 Filed 8-9-96; 8:45 am]
BILLING CODE 6560-50-F