[Federal Register Volume 64, Number 110 (Wednesday, June 9, 1999)]
[Notices]
[Pages 30988-30991]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-14363]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-00590; FRL-6070-2]


Maximum Residue Limit Petitions for Pesticides on Food/Feed and 
New Inert Ingredients; Renewal of Pesticide Information Collection 
Activities and Request for Comments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44 
U.S.C. 3501 et seq.), this notice announces that the EPA is seeking 
public comment on the following Information Collection Request (ICR): 
``Maximum Residue Limit Petitions for Pesticides on Food/Feed and New 
Inert Ingredients,'' (EPA ICR No. 0597.07, OMB No. 2070-0024). This ICR 
involves a collection activity that is currently approved. The ICR 
describes the nature of the information collection activity and its 
expected burden and costs. Before submitting this ICR to the Office of 
Management and Budget (OMB) for review and approval under the PRA, EPA 
is soliciting comments on specific aspects of the collection.

DATES: Written comments must be received on or before August 9, 1999.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit III. of the ``SUPPLEMENTARY INFORMATION'' section of 
this notice.

FOR FURTHER INFORMATION CONTACT: Cameo Smoot, Office of Pesticide 
Programs, Mail Code 7506C, Environmental Protection Agency, 401 M St., 
SW., Washington, DC 20460, telephone: 703-305-5454, fax: 703-305-5884, 
e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Does this Notice Apply to Me?

    You may be potentially affected by this notice if you have 
submitted a petition for a Maximum Residue Limit (MRL) or an exemption 
to the requirement for a MRL for an active or inert ingredient used in 
pesticides. By law, to protect the public health from unsafe pesticide 
residues, EPA is authorized to set MRLs on the nature and level of 
residues permitted to remain on food or feed (see sections 408(a)(1)(A) 
and (a)(1)(B) and section 408(b)(1) of the Federal Food, Drug and 
Cosmetic Act (FFDCA)). This ICR covers all requests for MRLs, or 
exemptions from the requirement of a MRL and the type of data that is 
required to be submitted.
    Potentially affected categories and entities may include, but are 
not limited to the following:


[[Page 30989]]



----------------------------------------------------------------------------------------------------------------
                                                                                       Examples of Potentially
              Category                     NAICS Code               SIC Codes             Affected Entities
----------------------------------------------------------------------------------------------------------------
Pesticide and other agricultural     325320                  286--Industrial         Pesticide manufacturing
 chemical manufacturing                                       organic chemicals       companies, pesticide
                                                                                      registrants, Interregional
                                                                                      Research Project No. 4 (IR-
                                                                                      4) petitioners, and third
                                                                                      party registrants
                                                             287--Agricultural
                                                              chemicals
----------------------------------------------------------------------------------------------------------------

    This table is not intended to be exhaustive, but rather provides a 
guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this table could also be 
affected. You or your business are affected by this action if you have 
a conditional pesticide registration with the Agency. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the technical person listed in the ``FOR FURTHER 
INFORMATION CONTACT'' section.

II. How Can I Get Additional Information or Copies of this Document 
or Other Support Documents?

A. Electronic Availability

    Electronic copies of this document and the ICR are available from 
the EPA Home Page at the Federal Register - Environmental Documents 
entry for this document under ``Laws and Regulations'' (http://
www.epa.gov/fedrgstr/). You can easily follow the menu to find this 
Federal Register notice using the publication date or the Federal 
Register citation for this notice. Although a copy of the ICR is posted 
with the Federal Register notice, you can also access a copy of the ICR 
by going directly to http://www.epa.gov/icr/. You can then easily 
follow the menu to locate this ICR by the EPA ICR number, the OMB 
control number, or the title of the ICR.

B. Fax-on-Demand

    Using a faxphone call 202-401-0527 and select item 6071 for a copy 
of the ICR.

C. In Person or By Phone

    If you have any questions or need additional information about this 
notice or the ICR referenced, please contact the person identified in 
the ``FOR FURTHER INFORMATION CONTACT'' section.
    In addition, the official record for this notice, including the 
public version, has been established under docket control number OPP-
00590, (including comments and data submitted electronically as 
described below). A public version of this record, including printed, 
paper versions of any electronic comments, which does not include any 
information claimed as Confidential Business Information (CBI), is 
available for inspection in the Office of Pesticide Programs (OPP) 
Public Docket, Rm. 119, CM #2, 1921 Jefferson Davis Highway, Arlington, 
VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The OPP Public Docket telephone number is 703-305-5805.

III. How Can I Respond to this Notice?

A. How and to Whom Do I Submit the Comments?

    You may submit comments through the mail, in person, or 
electronically. Be sure to identify the appropriate docket control 
number, OPP-00590, in your correspondence.
    1. By mail. Submit written comments to: OPP Public Docket, Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460.
    2. In person or by courier. Deliver written comments to: OPP Public 
Docket, Public Information and Records Integrity Branch, Rm. 119, CM 
#2, 1921 Jefferson Davis Highway, Arlington, VA, Telephone: 703-305-
5805.
    3. Electronically. Submit your comments and/or data electronically 
by e-mail to: [email protected]. Please note that you should not 
submit any information electronically that you consider to be CBI. 
Electronic comments must be submitted as an ASCII file avoiding the use 
of special characters and any form of encryption. Comments and data 
will also be accepted on standard computer disks in WordPerfect 5.1/6.1 
or ASCII file format. All comments and data in electronic form must be 
identified by the docket control number OPP-00590. Electronic comments 
on this notice may also be filed online at many Federal Depository 
Libraries.

B. How Should I Handle CBI Information that I Want to Submit to the 
Agency?

    You may claim information that you submit in response to this 
notice as CBI 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 also be submitted for inclusion in the public 
record. Information not marked confidential will be included in the 
public docket by EPA without prior notice. If you have any questions 
about CBI or the procedures for claiming CBI, please consult with the 
technical person listed in the ``FOR FURTHER INFORMATION CONTACT'' 
section.

C. What Information is EPA Particularly Interested in?

    Pursuant to section 3506(c)(2)(A) of PRA, EPA specifically solicits 
comments and information to enable it to:
    1. Evaluate whether the proposed collections of information are 
necessary for the proper performance of the functions of the Agency, 
including whether the information will have practical utility.
    2. Evaluate the accuracy of the Agency's estimates of the burdens 
of the proposed collections of information.
    3. Enhance the quality, utility, and clarity of the information to 
be collected.
    4. Minimize the burden of the collections of information on those 
who are to respond, including through the use of appropriate automated 
or electronic collection technologies or other forms of information 
technology, e.g., permitting electronic submission of responses.

D. What Should I Consider When I Prepare My Comments for EPA?

    We invite you to provide your views on the estimates provided, new 
approaches we haven't considered, the potential impacts of the various 
options (including possible unintended consequences), and any data or 
information that you would like the Agency to consider during the 
development of the final action. You may find the following suggestions 
helpful for preparing your comments:
     Explain your views as clearly as possible.
     Describe any assumptions that you used.
     Provide solid technical information and/or data to support 
your views.
     If you estimate potential burden or costs, explain how you 
arrived at the estimate.

[[Page 30990]]

     Provide specific examples to illustrate your concerns.
     Offer alternative ways to improve the collection activity.
     Make sure to submit your comments by the deadline in this 
notice.
     At the beginning of your comments (e.g., as part of the 
``Subject'' heading), be sure to properly identify the document you are 
commenting on. You can do this by providing the docket control number 
assigned to the notice, along with the EPA and OMB ICR numbers.

IV. What Information Collection Activity or ICR Does this Notice 
Apply to?

    EPA is seeking comments on the following ICR:
    Title: Maximum Residue Limit Petitions for Pesticides on Food/Feed 
and New Inert Ingredients.
    ICR numbers: EPA ICR No. 0597.07, OMB No. 2070-0024.
    ICR status: This ICR is currently scheduled to expire on June 30, 
1999. An Agency may not conduct or sponsor, and a person is not 
required to respond to a collection of information that is subject to 
approval under the PRA, unless it displays a currently valid OMB 
control number. The OMB control numbers for EPA's information 
collections appear on the collection instruments or instructions, in 
the Federal Register notices for related rulemakings and ICR notices, 
and, if the collection is contained in a regulation, in a table of OMB 
approval numbers in 40 CFR part 9.
    Abstract: To protect the public health from unsafe pesticide 
residues, the EPA is authorized to set MRLs on the nature and level of 
residues permitted to remain on food or feed (see sections 408(a)(1)(A) 
and (a)(1)(B) and section 408(b)(1) of the FFDCA). The use of 
pesticides to increase crop production often results in pesticide 
residues in or on the crop. While EPA is authorized to set pesticide 
MRLs, the Food and Drug Administration (FDA) is responsible for their 
enforcement. Food or feed commodities found to contain pesticide 
residues in excess of established MRLs are considered adulterated and 
are subject to seizure.
    This ICR covers all requests for MRLs, or exemptions from the 
requirement of a MRL, for both active and inert ingredients in 
pesticides. The type of data that is required to be submitted is 
dependent on the type of MRL that is sought. There are five types of 
MRL petitions that may be submitted and EPA may request the submission 
of data and/or other relevant information to assist it in its review 
and in setting the appropriate MRLS. The five types are as follows:
    1. Temporary MRL (or an exemption from the requirement for a 
temporary MRL) to permit sale of commodities containing residues 
resulting from authorized experimental use of an unregistered 
pesticide. In the absence of such a MRL or exemption, all such 
commodities must be destroyed. Because exposure is limited by the 
nature of the experimental use, the range of data required to support a 
temporary MRL is generally less than for a permanent MRL.
    2. Permanent MRL (or an exemption from the requirement for a 
permanent MRL) for residues which would result from a pesticide use 
registered under the Federal Insecticide, Fungicide, and Rodenticide 
Act (FIFRA).
    3. Permanent MRL (or an exemption from the requirement for a 
permanent MRL) petitioned by third parties for residues resulting from 
registered uses, usually on minor crops for which the pesticide 
registrant is unwilling to seek a MRL. When minor crops are involved, 
the range of data requirements is adjusted to be commensurate with the 
extent of pesticide use.
    4. MRLs for other ingredients in pesticides, such as solvents, 
baits, dust carriers, fillers, wetting or spreading agents, 
propellants, emulsifiers, etc.
    5. MRLs for residues on commodities which are not grown in the 
United States, and therefore for which there is no U.S. registrant 
(i.e., import MRLs).
    When necessary, EPA will also establish an MRL as part of the 
Agency's review of a state application for an emergency exemption for 
pesticides under section 18 of FIFRA. However, this information 
collection does not cover state submitted MRL data pursuant to section 
18 activities since EPA collects relevant state MRL data under the ICR 
entitled ``Application and Summary for an Emergency Exemption for 
Pesticides'' (OMB No. 2070-0032).
    It is EPA's responsibility to ensure that the maximum residue 
levels likely to be found in or on food/feed are safe for human 
consumption through a careful review and evaluation of residue 
chemistry and toxicology data. In addition, it must ensure that 
adequate enforcement of the MRL can be achieved through the testing of 
submitted analytical methods. Once the data are deemed adequate to 
support the findings, EPA will establish the MRL or grant an exemption 
from the requirement of a MRL.
    On August 3, 1996, the Food Quality Protection Act (FQPA) was 
signed into law. Effective upon signature, the new statute 
significantly amended the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA) and the Federal Food, Drug and Cosmetic Act. 
The new amendment establishes a strong health based safety standard for 
setting MRLs for pesticides in food. The FQPA requires that MRLs be set 
at a level to ensure that there be ``a reasonable certainty that no 
harm will result from aggregate exposure.'' Among other things, FQPA 
requires EPA to consider a number of new factors when setting such MRLs 
or registering pesticide products, including: (1) Special protection 
for infants and children; (2) aggregate of exposure and risk from foods 
and other known sources, such as drinking water and household pesticide 
use; and (3) consideration of common mechanisms of toxicity (some 
chemicals have different molecular structures but cause deleterious 
effects in the same manner).
    Since FQPA passed, EPA is applying this tough, new standard to all 
MRLs for newly-registered chemicals and food uses. In addition, FQPA 
has set a schedule for reassessing all 10,000 existing MRLs under this 
new standard by 2006. The new law did not provide for a phase-in period 
for many of the new requirements which had not previously been a part 
of EPA's risk assessment process. EPA has not changed the informational 
requirements of this ICR from the previous ICR. But while EPA does not 
require registrants to submit any additional information under this 
ICR, the new FQPA provisions requires EPA to consider additional 
information in order to make the necessary regulatory decisions. 
Therefore, petitioners, who submitted data to the Agency prior to 
passage of FQPA, are encouraged to supplement their original 
submissions with additional information. Respondents submitting new 
petitions may want to submit supplemental information to the Agency 
even without a requirement to do so. To allow for the most efficient 
processing and review of MRL petitions, the Agency has provided a 
description of the types of information that EPA considers helpful in 
the Appendices to Pesticide Registration (PR) Notice No. 97-1.
    PR 97-1 applies to most applicants with registration applications, 
non-crop-destruct experimental use permit applications, and MRL or MRL 
exemption petitions pending within the Agency. It also applies to most 
future applicants seeking new or amended pesticide registrations and 
all actions involving synthetic chemicals, antimicrobial, biochemical 
and microbial pesticides. However, the notice does not apply to 
applicants

[[Page 30991]]

seeking fast track ``me-too'' registrations or amendments not involving 
new uses. There are no forms associated with this information 
collection.

V. What are EPA's Burden and Cost Estimates for this ICR?

    Under the PRA, ``burden'' means the total time, effort, or 
financial resources expended by persons to generate, maintain, retain, 
or disclose or provide information to or for a Federal Agency. For this 
collection it includes the time needed to review instructions; develop, 
acquire, install, and utilize technology and systems for the purposes 
of collecting, validating, and verifying information, processing and 
maintaining information, and disclosing and providing information; 
adjust the existing ways to comply with any previously applicable 
instructions and requirements; train personnel to be able to respond to 
a collection of information; search data sources; complete and review 
the collection of information; and transmit or otherwise disclose the 
information.
    The ICR provides a detailed explanation of this estimate, which is 
only briefly summarized in this notice. The annual public burden for 
the MRL reporting information collection is estimated to average 1,442 
hours per response. The following is a summary of the estimates taken 
from the ICR:
    Respondents/affected entities: Pesticide registrants, pesticide 
companies, Interregional Research Project No. 4 (IR-4) petitioners, and 
third party registrants.
    Estimated total number of potential respondents: 150.
    Frequency of response: Once for each raw or processed commodity on 
which the pesticide is used.
    Estimated total/average number of responses for each respondent: 1.
    Estimated total annual burden hours: 216,300.
    Estimated total annual burden costs: $18,466,650.

VI. Are There Changes in the Estimates from the Last Approval?

    No. The annual registrant burden estimate for this information 
collection will remain at 1,442 hours per year with the number of 
respondents submitting MRL petitions remaining at 150 annually. Changes 
to the ICR reflect the cost increase for labor rates only. The 
individual burden per product for PRA reporting has remained constant 
at 455 hours.

VII. What is the Next Step in the Process for this ICR?

    EPA will consider the comments received and amend the ICR as 
appropriate. The final ICR package will then be submitted to OMB for 
review and approval pursuant to 5 CFR 1320.12. EPA will issue another 
Federal Register notice pursuant to 5 CFR 1320.5(a)(1)(iv) to announce 
the submission of the ICR to OMB and the opportunity to submit 
additional comments to OMB. If you have any questions about this ICR or 
the approval process, please contact the person listed in the ``FOR 
FURTHER INFORMATION CONTACT'' section.

List of Subjects

    Environmental protection, Information collection requests.

    Dated: May 19, 1999.

Susan H. Wayland,

Acting Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.

[FR Doc. 99-14363 Filed 6-8-99; 8:45 am]
BILLING CODE 6560-50-F