[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: opp-docket@epamail.epa.gov. 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: roelofs.jim@epamail.epa.gov.
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
