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

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

mation 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

n,

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.

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.

et 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

e 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.

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.

inal 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

A 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

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

prod

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

n 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

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

r 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