[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: smoot.cameo@epa.gov.
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]]
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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: opp-docket@epa.gov. 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
