55842 Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Notices
concerning a pesticide active ingredient, comments, identified by the docket ID electronic public docket and comment
‘‘the Administrator shall determine number [OPP–2005–0013], should be system, EPA Dockets. You may use EPA
whether pesticides containing such received on or before November 22, Dockets at http://www.epa.gov/edocket/
active ingredient are eligible for 2005. to submit or view public comments,
reregistration,’’ before calling in ADDRESSES: Comments may be access the index listing of the contents
product-specific data on individual end- submitted by mail, electronically, or in of the official public docket, and to
use products and either reregistering person. Please follow the detailed access those documents in the public
products or taking other ‘‘appropriate instructions for each method as docket that are available electronically.
regulatory action.’’ provided in Unit I. of the Once in the system, select ‘‘search,’’
Section 408(q) of the FFDCA, 21 SUPPLEMENTARY INFORMATION section of then key in the appropriate docket ID
U.S.C. 346a(q), requires EPA to review this notice. number.
tolerances and exemptions for pesticide Certain types of information will not
FOR FURTHER INFORMATION CONTACT:
residues in effect as of August 2, 1996, be placed in EPA Dockets. Information
Carol P. Stangel, Special Review and
to determine whether the tolerance or claimed as CBI and other information
Reregistration Division (7508C), Office
exemption meets the requirements of whose disclosure is restricted by statute,
of Pesticide Programs, Environmental
section 408(b)(2) or (c)(2) of FFDCA. which is not included in the official
Protection Agency, 1200 Pennsylvania
This review is to be completed by public docket, will not be available for
Ave., NW., Washington, DC 20460;
August 3, 2006. public viewing in EPA’s electronic
telephone: (703) 308–8007;
public docket. EPA’s policy is that
List of Subjects e-mail:stangel.carol@epa.gov.
copyrighted material will not be placed
SUPPLEMENTARY INFORMATION: in EPA’s electronic public docket but
Environmental protection, Pesticides
and pests. I. General Information will be available only in printed, paper
form in the official public docket. To the
Dated: September 14, 2005. A. Does this Action Apply to Me? extent feasible, publicly available
Debra Edwards,
This action is directed to the public docket materials will be made available
Director, Special Review and Reregistration in general. Although this action may be in EPA’s electronic public docket. When
Division, Office of Pesticide Programs. of particular interest to persons who are a document is selected from the index
[FR Doc. 05–18705 Filed 9–22–05; 8:45 am] interested in the progress and status of list in EPA Dockets, the system will
BILLING CODE 6560–50–S EPA’s pesticide reregistration and identify whether the document is
tolerance reassessment programs, the available for viewing in EPA’s electronic
Agency has not attempted to describe all public docket. Although, not all docket
ENVIRONMENTAL PROTECTION the specific entities that may be affected materials may be available
AGENCY by this action. If you have any questions electronically, you may still access any
[OPP–2005–0013; FRL–7696–1] regarding the information in this notice, of the publicly available docket
consult the person listed under FOR materials through the docket facility
Pesticide Reregistration Performance FURTHER INFORMATION CONTACT. identified in Unit I.B. EPA intends to
Measures and Goals work towards providing electronic
B. How Can I Get Copies of this
access to all of the publicly available
AGENCY: Environmental Protection
Document and Other Related
docket materials through EPA’s
Agency (EPA).
Information?
electronic public docket.
ACTION: Notice.
1. Docket. EPA has established an For public commenters, it is
official public docket for this action important to note that EPA’s policy is
SUMMARY: This notice announces EPA’s under docket ID number OPP–2005– that public comments, whether
progress in meeting its performance 0013. The official public docket consists submitted electronically or in paper,
measures and goals for pesticide of the documents specifically referenced will be made available for public
reregistration during fiscal year 2004. in this action, any public comments viewing in EPA’s electronic public
The Federal Insecticide, Fungicide, and received, and other information related docket as EPA receives them and
Rodenticide Act (FIFRA) requires EPA to this action. Although a part of the without change, unless the comment
to publish information about EPA’s official docket, the public docket does contains copyrighted material, CBI, or
annual achievements in this area. This not include Confidential Business other information whose disclosure is
notice discusses the integration of Information (CBI) or other information restricted by statute. When EPA
tolerance reassessment with the whose disclosure is restricted by statute. identifies a comment containing
reregistration process, and describes the The official public docket is the copyrighted material, EPA will provide
status of various regulatory activities collection of materials that is available a reference to that material in the
associated with reregistration and for public viewing at the Public version of the comment that is placed in
tolerance reassessment. The notice gives Information and Records Integrity EPA’s electronic public docket. The
total numbers of chemicals and Branch (PIRIB), Rm. 119, CrystalMall entire printed comment, including the
products reregistered, tolerances #2, 1801 S. Bell St., Arlington, VA. This copyrighted material, will be available
reassessed, Data Call-Ins issued, and docket facility is open from 8:30 a.m. to in the public docket.
products registered under the ‘‘fast- 4 p.m., Monday through Friday, Public comments submitted on
track’’ provisions of FIFRA. Finally, this excluding legal holidays. The docket computer disks that are mailed or
notice contains the schedule for telephone number is (703) 305–5805. delivered to the docket will be
completion of activities for specific 2. Electronic access. You may access transferred to EPA’s electronic public
chemicals during fiscal years 2005 this Federal Register document docket. Public comments that are
through 2008. electronically through the EPA internet mailed or delivered to the docket will be
DATES: This notice is not subject to a under the ‘‘Federal Register’’ listings at scanned and placed in EPA’s electronic
formal comment period. Nevertheless, http://www.epa.gov/fedrgstr/. public docket. Where practical, physical
EPA welcomes input from stakeholders An electronic version of the public objects will be photographed, and the
and the general public. Written docket is available through EPA’s photograph will be placed in EPA’s
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Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Notices 55843
electronic public docket along with a EPA’s e-mail system automatically please consult the person listed under
brief description written by the docket captures your e-mail address. E-mail FOR FURTHER INFORMATION CONTACT.
staff. addresses that are automatically
E. What Should I Consider as I Prepare
captured by EPA’s e-mail system are
C. How and to Whom Do I Submit My Comments for EPA?
included as part of the comment that is
Comments? You may find the following
placed in the official public docket, and
You may submit comments made available in EPA’s electronic suggestions helpful for preparing your
electronically, by mail, or through hand public docket. comments:
delivery/courier. To ensure proper iii. Disk or CD ROM. You may submit 1. Explain your views as clearly as
receipt by EPA, identify the appropriate comments on a disk or CD ROM that possible.
docket ID number in the subject line on you mail to the mailing address 2. Describe any assumptions that you
the first page of your comment. If you identified in Unit I.C.2. These electronic used.
wish to submit CBI or information that submissions will be accepted in 3. Provide any technical information
is otherwise protected by statute, please WordPerfect or ASCII file format. Avoid and/or data you used that support your
follow the instructions in Unit I.D. Do the use of special characters and any views.
not use EPA Dockets or e-mail to submit form of encryption. 4. If you estimate potential burden or
CBI or information protected by statute. 2. By mail. Send your comments to: costs, explain how you arrived at your
1. Electronically. If you submit an estimate.
Public Information and Records
electronic comment as prescribed in this 5. Provide specific examples to
Integrity Branch (PIRIB) (7502C), Office
unit, EPA recommends that you include illustrate your concerns.
your name, mailing address, and an of Pesticide Programs (OPP),
6. Offer alternatives.
e-mail address or other contact Environmental Protection Agency, 1200
7. Make sure to submit your
information in the body of your Pennsylvania Ave., NW., Washington,
comments by the comment period
comment. Also include this contact DC 20460–0001, Attention: Docket ID
deadline identified.
information on the outside of any disk Number OPP– 2005–0013.
8. To ensure proper receipt by EPA,
or CD ROM you submit, and in any 3. By hand delivery or courier. Deliver identify the appropriate docket ID
cover letter accompanying the disk or your comments to: Public Information number in the subject line on the first
CD ROM. This ensures that you can be and Records Integrity Branch (PIRIB), page of your response. It would also be
identified as the submitter of the Office of Pesticide Programs (OPP), helpful if you provided the name, date,
comment, and allows EPA to contact Environmental Protection Agency, Rm. and Federal Register citation related to
you in case EPA cannot read your 119, Crystal Mall#2, 1801 S. Bell St., your comments.
comment due to technical difficulties or Arlington, VA, Attention: Docket ID
needs further information on the Number OPP–2005–0013. Such II. Background
substance of your comment. EPA’s deliveries are only accepted during the EPA must establish and publish in the
policy is that EPA will not edit your docket’s normal hours of operation as Federal Register its annual performance
comment, and any identifying or contact identified in Unit I.B.1. measures and goals for pesticide
information provided in the body of a D. How Should I Submit CBI To the reregistration, tolerance reassessment,
comment will be included as part of the Agency? and expedited registration, under
comment that is placed in the official section 4(l) of FIFRA, as amended by the
public docket, and made available in Do not submit information that you Food Quality Protection Act of 1996
EPA’s electronic public docket. If EPA consider to be CBI electronically (FQPA). Specifically, such measures
cannot read your comment due to through EPA’s electronic public docket and goals are to include:
technical difficulties and cannot contact or by e-mail. You may claim • The status of reregistration.
you for clarification, EPA may not be information that you submit to EPA as • The number of products
able to consider your comment. CBI by marking any part or all of that reregistered, canceled, or amended.
i. EPA Dockets. Your use of EPA’s information as CBI (if you submit CBI • The number and type of data
electronic public docket to submit on disk or CD ROM, mark the outside requests or Data Call-In (DCI) notices
comments to EPA electronically is of the disk or CD ROM as CBI and then under section 3(c)(2)(B) issued to
EPA’s preferred method for receiving identify electronically within the disk or support product reregistration by active
comments. Go directly to EPA Dockets CD ROM the specific information that is ingredient.
at http://www.epa.gov/edocket, and CBI). Information so marked will not be • Progress in reducing the number of
follow the online instructions for disclosed except in accordance with unreviewed, required reregistration
submitting comments. Once in the procedures set forth in 40 CFR part 2. studies.
system, select ‘‘search,’’ and then key in In addition to one complete version of • The aggregate status of tolerances
docket ID number OPP–2005–0013. The the comment that includes any reassessed.
system is an ‘‘anonymous access’’ information claimed as CBI, a copy of • The number of applications for
system, which means EPA will not the comment that does not contain the registration submitted under subsection
know your identity, e-mail address, or information claimed as CBI must be (k)(3), expedited processing and review
other contact information unless you submitted for inclusion in the public of similar applications, that were
provide it in the body of your comment. docket and EPA’s electronic public approved or disapproved.
ii. E-mail. Comments may be sent by docket. If you submit the copy that does • The future schedule for
e-mail to opp-docket@epa.gov, not contain CBI on disk or CD ROM, reregistrations in the current and
Attention: Docket ID Number OPP– mark the outside of the disk or CD ROM succeeding fiscal year.
2005–0013. In contrast to EPA’s clearly that it does not contain CBI. • The projected year of completion
electronic public docket, EPA’s e-mail Information not marked as CBI will be of the reregistrations under section 4.
system is not an ‘‘anonymous access’’ included in the public docket and EPA’s FIFRA, as amended in 1988,
system. If you send an e-mail comment electronic public docket without prior authorizes EPA to conduct a
directly to the docket without going notice. If you have any questions about comprehensive pesticide reregistration
through EPA’s electronic public docket, CBI or the procedures for claiming CBI, program--a complete review of the
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55844 Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Notices
human health and environmental effects • Cumulative effects from all became effective on March 23, 2004.
of older pesticides originally registered pesticides sharing a common Among other things, PRIA directs EPA
before November 1, 1984. Pesticides mechanism of toxicity. to complete Reregistration Eligibility
meeting today’s scientific and regulatory • Possible increased susceptibility of Decisions (REDs) for pesticides with
standards may be declared ‘‘eligible’’ for infants and children; and food uses/tolerances by August 3, 2006,
reregistration. To be eligible, an older • Possible endocrine or estrogenic and to complete all non-food use
pesticide must have a substantially effects. pesticide REDs by October 3, 2008.
complete data base, and must not cause As amended by FQPA, FFDCA EPA’s schedule for meeting these
unreasonable adverse effects to human requires the reassessment of all existing deadlines are available on the Agency’s
health or the environment when used tolerances (pesticide residue limits in website atwww.epa.gov/pesticides/
according to Agency approved label food) and tolerance exemptions within reregistration/candidates.htm.
directions and precautions. 10 years, to ensure that they meet the
In addition, all pesticides with food safety standard of the law. EPA was III. FQPA and Program Accountability
uses must meet the safety standard of directed to give priority to the review of
those pesticides that appear to pose the One of the hallmarks of the FQPA
section 408 of the Federal Food, Drug,
greatest risk to public health, and to amendments to the FFDCA is enhanced
and Cosmetic Act (FFDCA) 21 U.S.C.
346a, as amended by the Food Quality reassess 33% of the 9,721 existing accountability. Through this summary
Protection Act (FQPA) of 1996. Under tolerances and exemptions within 3 of performance measures and goals for
FFDCA, EPA must make a years (by August 3, 1999), 66% within pesticide reregistration, tolerance
determination that pesticide residues 6 years (by August 3, 2002), and 100% reassessment, and expedited
remaining in or on food are ‘‘safe’’; that in 10 years (by August 3, 2006).The registration, EPA describes progress
is, ‘‘that there is reasonable certainty Agency met the first two statutory made during the past year in each of the
that no harm will result from aggregate deadlines and is on schedule to meet program areas included in FIFRA
exposure to the pesticide chemical the third. EPA’s approach to tolerance section 4(l).
residue’’ from dietary and other sources. reassessment under FFDCA is described A. Status of Reregistration
In determining allowable levels of fully in the Agency’s document, ‘‘Raw
pesticide residues in food, EPA must and Processed Food Schedule for During fiscal year (FY) 2004 (from
perform a more comprehensive Pesticide Tolerance Reassessment’’ (62 October 1, 2003, through September 30,
assessment of each pesticide’s risks, FR 42020, August 4, 1997) (FRL–5734– 2004), EPA made significant progress in
considering: 6). completing risk assessments and risk
• Aggregate exposure (from food, The Pesticide Registration management decisions for pesticide
drinking water, and residential uses). Improvement Act (PRIA) of 2003 reregistration (See Table 1).
TABLE 1.—REREGISTRATION/RISK MANAGEMENT DECISIONS COMPLETED: IN FY 2004 AND FY 1991 THROUGH FY 2004
FY 2004 Decisions Total, FY 1991 through FY 2004
17 REDs 244 REDs
Benfluralin
Carboxin
Cycloate
Dihalodialkylhydantoins
Ethoxyquin
MCPA
Methoxychlor (Voluntary Cancellation)
Naphthalene Acetic Acid
Naptalam
Oleic Acid Sulfonates
Phenol and Salts
PHMB or Poly(hexamethylenebiguanide)
Pine Oil
Propylene Glycol and Dipropylene Glycol
Sabadilla Alkaloids
Thiram
Zinc Pyrithione (Omadine Salts)
0 IREDs 23 IREDs
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Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Notices 55845
TABLE 1.—REREGISTRATION/RISK MANAGEMENT DECISIONS COMPLETED: IN FY 2004 AND FY 1991 THROUGH FY
2004—Continued
FY 2004 Decisions Total, FY 1991 through FY 2004
18 TREDs 63 TREDs
Bacillus thuringiensis var. Kurstaki (delta endotoxin)
Bacillus thuringiensis var. San Diego
Carbon dioxide
Chlorimuron ethyl
DCPA (Dacthal)
Desmedipham
Dimethenamid
Flumetsulam
Fluridone
Limonene
Nitrogen
Oil of Lemon
Oil of Menthol
Oil of Orange
Oryzalin
Thifensulfuron-methyl
Tribenuron methyl
Trifluralin
The Agency’s decisions are embodied TABLE 3.—PROFILE OF 244 REDS improving use directions and
in Reregistration Eligibility Decision COMPLETED, FY 1991 THROUGH FY precautions; adding more protective
(RED) documents, Interim Reregistration 2004 clothing and equipment requirements;
Eligibility Decisions (IREDs), and requiring special packaging or
Reports on FQPA Tolerance Pesticide active ingredients 357 engineering controls; requiring no-
Reassessment Progress and [Interim] treatment buffer zones; employing
Risk Management Decisions (TREDs). Pesticide products about ground water, surface water, or other
10,400 environmental and ecological
1. REDs. Through the reregistration
safeguards; and other measures.
program, EPA is reviewing current REDs with food uses 128 2. Interim REDs or IREDs. EPA issues
scientific data for older pesticides (those IREDs for pesticides that are undergoing
initially registered before November Post-FQPA REDs 103
reregistration, require a reregistration
1984), reassessing their effects on eligibility decision, and also must be
human health and the environment, and Post-FQPA REDs with food 75
uses* included in a cumulative assessment
requiring risk mitigation measures as under FQPA because they are part of a
necessary. Pesticides that have *EPA is revisiting tolerances associated with group of pesticides that share a common
sufficient supporting data and whose the 53 food use REDs that were completed
before FQPA was enacted to ensure that they mechanism of toxicity. An IRED is
risks can be successfully mitigated may meet the safety standard of the new law, as issued for each individual pesticide in
be declared ‘‘eligible’’ for reregistration. set forth in the Agency’s August 4, 1997, the cumulative group when EPA
EPA presents these pesticide findings in Schedule for Pesticide Tolerance completes the pesticide’s risk
a RED document. Reassessment.
assessment and interim risk
i. Overall RED progress. EPA’s overall iii. Risk reduction in REDs. Through management decision. An IRED may
progress at the end of FY 2004 in the reregistration program, EPA seeks to include measures to reduce food,
completing Reregistration Eligibility reduce risks associated with the use of drinking water, residential,
Decisions (REDs) for groups of related older pesticides. In developing REDs, occupational, and/or ecological risks, to
pesticide active ingredients or cases is EPA works with stakeholders including gain the benefit of these changes before
summarized in Table 2. pesticide registrants, growers and other the final RED can be issued following
pesticide users, and environmental and the Agency’s consideration of
TABLE 2.—OVERALL RED PROGRESS, public health interests, as well as the cumulative risks. For example, EPA
FY 1991 THROUGH FY 2004 States, USDA, and other Federal generally has not considered individual
agencies and others to develop measures organophosphate (OP) pesticide
REDs completed 244 (40%)
to effectively reduce risks of concern. decisions to be completed REDs or
Almost every RED includes some tolerance reassessments. Instead, the
Cases canceled 231 (38%) measures or modifications to reduce Agency is issuing IREDs for these
risks. The options for such risk chemicals at this time. EPA will
REDs to be completed 137 (22%) reduction are extensive and include complete the risk assessments and
voluntary cancellation of pesticide reregistration eligibility decisions for OP
Total reregistration cases 612 products or deletion of uses; declaring pesticides with IREDs, once the Agency
(100%) certain uses ineligible or not yet eligible completes a cumulative assessment of
(and then proceeding with follow-up the OPs.
ii. Profile of completed REDs. A action to cancel the uses or require 3. Tolerance reassessment ‘‘TREDs.’’
profile of the 244 REDs completed by additional supporting data); restricting EPA issues Reports on FFDCA
the end of FY 2004 is presented in Table use of products to certified applicators; Tolerance Reassessment Progress and
3. limiting the amount or frequency of use; [Interim] Risk Management Decisions,
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55846 Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Notices
known as TREDs, for pesticides that 4. Goals for FY 2005 and future years. In issuing a completed RED
require tolerance reassessment decisions EPA’s major pesticide reregistration and document, EPA sends registrants a Data
under FFDCA, but do not require a tolerance reassessment goals for FY Call-In (DCI) notice requesting any
reregistration eligibility decision at 2005 and future years are as follows. product-specific data and specific
present because: i. Complete individual pesticide risk revised labeling needed to complete
• The pesticide was first registered management decisions. EPA’s goal in reregistration for each of the individual
after November 1, 1984, and is conducting the reregistration and pesticide products covered by the RED.
considered a ‘‘new’’ active ingredient, tolerance reassessment program is to Based on the results of EPA’s review of
not subject to reregistration; complete 30–40 Reregistration these data and labeling, products found
• EPA completed a RED for the Eligibility Decisions (REDs) and Interim to meet FIFRA and FFDCA standards
pesticide before FQPA was enacted; or REDs each year during fiscal years 2005 may be reregistered.
• The pesticide is not registered for and 2006, for pesticides with associated A variety of outcomes are possible for
use in the U.S. but tolerances are tolerances, and to complete a total of 40 pesticide products completing this final
established that allow crops treated with REDs in FY 2007 and in FY 2008 for phase of the reregistration process.
the pesticide to be imported from other pesticides with no food uses or Ideally, in response to the DCI notice
countries. tolerances. This will satisfy PRIA accompanying the RED document, the
As with IREDs, EPA will not complete pesticide producer, or registrant, will
requirements and support the Agency’s
risk assessment and risk management submit the required product-specific
tolerance reassessment goal. EPA’s
for pesticides subject to TREDs that are data and revised labeling, which EPA
schedule for completing these decisions
part of a cumulative group until will review and find acceptable. At that
cumulative risks have been considered appears near the end of this document,
and also is available on the Agency’s point, the Agency may reregister the
for the group. pesticide product. If, however, the
During FY 2004, in addition to website at http://www.epa.gov/
pesticides/reregistration/ product contains multiple active
completing 18 TREDs, EPA also ingredients, the Agency instead issues
completed 27 tolerance assessment candidates.htm.
ii. Complete 100% of tolerance an amendment to the product’s
decisions for pesticide inert ingredients registration, incorporating the labeling
that are exempted from the tolerance reassessment decisions. EPA is
continuing to reassess tolerances within changes specified in the RED; a product
requirement. Almost 900 of the 9,721 with multiple active ingredients may
tolerance reassessment decisions time frames set forth in FFDCA as
amended by FQPA, giving priority to not be fully reregistered until the last
required by the amended FFDCA are for active ingredient in its formulation is
such inert ingredient tolerance those food use pesticides that appear to
pose the greatest risk. Integration of the eligible for reregistration. In other
exemptions. EPA has reassessed 404 of situations, the Agency may temporarily
these inert ingredient tolerance reregistration and tolerance
reassessment programs has added suspend a product’s registration if the
exemptions to date, and plans to registrant has not submitted required
complete the reassessment of all the complexity to the reregistration process
for food use pesticides. The Agency product-specific studies within the time
inert ingredient tolerance exemptions by
successfully reached its first two frame specified. The Agency may cancel
August 2006.
tolerance reassessment milestones by a product’s registration because the
As a result of the Food Quality
Protection Act of 1996, food-contact completing over 33% of all tolerance registrant did not pay the required
surface sanitizers previously regulated reassessment decisions by August 3, registration maintenance fee.
by both EPA and the Food and Drug 1999, and over 66% by August 3, 2002. Alternatively, the registrant may request
Administration were transferred to EPA plans to meet the final FQPA a voluntary cancellation of their end-use
EPA’s sole jurisdiction. Consequently, tolerance reassessment goal: To product registration.
1. Product reregistration actions in FY
the approximately 107 ingredients that complete 100% of all required tolerance
2004. EPA counts each of the post-RED
made up these sanitizer solutions in 21 reassessment decisions by August 3,
product outcomes described above as a
CFR 178.1010 were transferred to 40 2006.
product reregistration action. A single
CFR part 180, subpart D. In addition to iii. Evaluate cumulative risks. Once pesticide product may be the subject of
reassessing the 9,721 tolerances and EPA completes individual risk several product reregistration actions
exemptions for food and feed assessments for the OPs, carbamates and within the same year. For example, a
commodities, EPA also must reassess others, the Agency will make product’s registration initially may be
these sanitizer tolerance exemptions by cumulative risk findings for each of amended, then the product may be
August 3, 2006. The Antimicrobials these common mechanism groups of reregistered, and later the product may
Division (AD) in EPA’s Office of pesticides. For further information, see be voluntarily canceled, all within the
Pesticide Programs is responsible for EPA’s cumulative risk website, http:// same year. During FY 2004, EPA
reassessing exemptions from the www.epa.gov/pesticides/cumulative/. completed the product reregistration
requirement of a tolerance for the food-
B. Product Reregistration; Numbers of actions detailed in Table 4.
contact surface sanitizing solutions
Products Reregistered, Canceled, and
requiring reassessment. AD is
Amended TABLE 4.—PRODUCT REREGISTRATION
reassessing 60 of the 107 exemptions,
either as free-standing decisions or At the end of the reregistration ACTIONS COMPLETED DURING FY 2004
through REDs. During FY 2004, AD process, after EPA has issued a RED and
Product reregistration actions 78
completed tolerance exemption declared a pesticide reregistration case
reassessments for 14 of these 60 food- eligible for reregistration, individual Product amendment actions 35
contact surface sanitizing solution end-use products that contain pesticide
ingredients. EPA is reassessing tolerance active ingredients included in the case Product cancellation actions 14
exemptions for the other food-contact still must be reregistered. This
surface sanitizing solutions through concluding part of the reregistration Product suspension actions 0
other REDs and inert exemption process is called ‘‘product Total actions 127
decisions. reregistration.’’
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Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Notices 55847
2. Status of the product reregistration TABLE 5.—STATUS OF THE UNIVERSE processing for several previously issued
universe. The status of the universe of OF PRODUCTS SUBJECT TO PROD- REDs and IREDs.
pesticide products subject to UCT REREGISTRATION, FOR FY 2004 At the end of FY 2004, 4,143 products
reregistration at the end of FY 2004 is (AS OF SEPTEMBER 30, 2004) had product reregistration decisions
shown in Table 5 below. This overall pending. Some pending products await
status information is not ‘‘cumulative’’- Products reregistered 1,770 science reviews, label reviews, or
-it is not derived from summing up a reregistration decisions by EPA. Others
series of annual actions. Adding annual Products amended 427 are not yet ready for product
actions would result in a larger overall reregistration actions; they are
Products canceled 4,033
number since each individual product is associated with more recently
subject to multipleactions--it can be Products sent for suspension 30 completed REDs, and their product-
amended, reregistered, and/or canceled, specific data are not yet due to be
over time. Instead, the ‘‘big picture’’ Total products with actions 6,260 submitted to or reviewed by the Agency.
completed EPA’s goal is to complete 450 product
status information in Table 5 should be
considered a snapshot in time. As reregistration actions during fiscal year
Products with actions pending 4,143
registrants and EPA make marketing and 2005.
regulatory decisions in the future, the Total products in product re- 10,403 C. Number and Type of DCIs to Support
status of individual products may registration universe Product Reregistration by Active
change, and numbers in this table are Ingredient
expected to fluctuate. The universe of 10,403 products in
product reregistration at the end of FY 1. DCIs for REDs. The number and
2004 represented an increase of 747 type of Data Call-In requests or DCIs that
products from the FY 2003 universe of EPA is preparing to issue under FIFRA
9,656 products. The increase consists of section 3(c)(2)(B) to support product
713 products associated with FY 2004 reregistration for pesticide active
REDs, and 34 products that were added ingredients included in FY 2004 REDs
as a result of DCI activities and are shown in Table 6.
TABLE 6.—DCIS PREPARED TO SUPPORT PRODUCT REREGISTRATION FOR FY 2004 REDS
Number of Prod Number of Product Number of Acute Number of Efficacy
Case Name Case Number ucts Covered by Chemistry Studies Toxicology Studies Studies Required
the RED1 Required2 Required3
Benfluralin 2030 119 31 138 (15 batches/ 0
8 products not
batched)
Carboxin 0012 44 31 186 (2 batches/ 0
29 products
not batched)
Cycloate 2125 9 31 6 (1 Batch) 0
Dihalodialkyldantoins 3955 106 34 Antimicrobial 2
RED - Acute
toxicity batch
ing not com
pleted yet.
Ethoxyquin 0003 4 31 18 (No batch) 0
MCPA 0017 170 31 Acute toxicity 0
batching not
completed yet
Methoxychlor (Voluntary 0249 2 NA NA NA
Cancellation)
Napthalene acetic acid (NAA) 0379 46 31 Acute toxicity 0
batching not
completed yet.
Naptalam 0183 1 31 6 (No Batch) 0
Oleic acid sulfonates 4069 1 34 6 (No Batch) 1
Phenol and salts 4074 6 34 Antimicrobial 5
RED - Acute
toxicity batch
ing not com
pleted yet.
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55848 Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Notices
TABLE 6.—DCIS PREPARED TO SUPPORT PRODUCT REREGISTRATION FOR FY 2004 REDS—Continued
Number of Prod Number of Product Number of Acute Number of Efficacy
Case Name Case Number ucts Covered by Chemistry Studies Toxicology Studies Studies Required
the RED1 Required2 Required3
PHMB 3122 17 34 42 (3 batches/4 4
products not
batched)
Pine oils 3113 89 34 Antimicrobial 4
RED - Acute
toxicity batch
ing not com
pleted yet.
Propylene/Dipropylene glycol 3126 14 34 Antimicrobial 5
RED - Acute
toxicity batch
ing not com
pleted yet.
Sabadilla alkaloids 3128 1 31 6 ( No Batch) 0
Thiram 0122 66 31 Acute toxicity 0
batching not
completed yet.
Zinc pyrithione 2480 18 34 84 (3 batches/11 0
products not
batched)
Total No. of Products 713
1 The number of registered products containing a pesticide active ingredient can change over time. The product total that appears in the RED
document (counted when the RED is signed) may be different than the number of products that EPA is tracking for product reregistration
(counted later, when the RED is issued). This table reflects the final number of products associated with each RED, as they are being tracked
for product reregistration.
2 This column shows the number of product chemistry studies that are required for each product covered by the RED.
3 In an effort to reduce the time, resources, and number of animals needed to fulfill acute toxicity data requirements, EPA ‘‘batches’’ products
that can be considered similar from an acute toxicity standpoint. For example, one batch could contain five products. In this instance, if six
acute toxicology studies usually were required per product, only six studies (rather than 30 studies) would be required for the entire batch. Fac
tors considered in the sorting process include each product’s active and inert ingredients (e.g., identity, percent composition, and biological ac
tivity), type of formulation (e.g., emulsifiable concentrate, aerosol, wettable powder, granular), and labeling (e.g., signal word, use classification,
precautionary labeling). The Agency does not describe batched products as ‘‘substantially similar,’’ because all products within a batch may not
be considered chemically similar or have identical use patterns.(Note: FIFRA section 24(c) or Special Local Need (SLN) registrations are not
included in the acute toxicity batchings because they are supported by a valid parent product (section 3) registration.)
2. DCIs for IREDs. EPA completed no reregistration decisions; they are subject by pesticide registrants in support of
IREDs during FY 2004. to tolerance reassessment only. pesticides undergoing reregistration
3. DCIs not needed for TREDs. The (See Table 7). The percent of studies
Agency does not issue product-specific D. Progress in Reducing the Number of
Unreviewed, Required Reregistration reviewed by EPA remained constant in
data requests or DCIs for pesticides FY 2004.
included in tolerance reassessment Studies
decisions or TREDs because, at present, EPA has made making progress in
these pesticides do not require product reviewing scientific studies submitted
TABLE 7.—REVIEW STATUS OF STUDIES SUBMITTED FOR PESTICIDE REREGISTRATION, END OF FY 2004
Pesticide Reregistration List, per Studies Reviewed + Extraneous 1 Studies Awaiting Review Total Studies Received
FIFRA Section 4(c)(2)
List A 11,220 + 583 = 11,803 (87%) 1,786 (13%) 13,589
List B 6,520 + 1,032 = 7,552 (81%) 1,748 (19%) 9,300
List C 2,087 + 334 = 2,421 (84%) 464 (16%) 2,885
List D 1,233 + 133 = 1,366 (86%) 229 (14%) 1,595
Total Lists A - D 21,060 + 2,082 = 23,142 4,227 (15.4%) 27,369 (100%)
(84.6%)
1 Extraneous studies is a term used to classify those studies that are not needed because the guideline or data requirement has been satis
fied by other studies or has changed.
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Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Notices 55849
E. Aggregate Status of Tolerances statutory deadlines established by the tolerance reassessment through the
Reassessed FQPA. EPA’s general schedule for registration and reregistration programs;
tolerance reassessment (62 FR 42020, by revoking tolerances for pesticides
During FY 2004, EPA completed 467 August 4, 1997) identified three groups that have been canceled (many as a
tolerance reassessments and ended the of pesticides to be reviewed; this result of reregistration); by reevaluating
fiscal year with a total of 7,093 tolerance grouping continues to reflect the pesticides with pre-FQPA REDs, and
reassessment decisions to date, Agency’s overall scheduling priorities. through other decisions not directly
addressing 73% of the 9,721 tolerances In completing tolerance reassessment, related to registration or reregistration,
that require reassessment (See Table 8). EPA continues to give priority to described further below. EPA is using
EPA reassessed over 33% of all food pesticides in Group 1, the Agency’s the Tolerance Reassessment Tracking
tolerances by August 3, 1999, and highest priority group for reassessment. System (TORTS) to compile this
completed over 66% of all required 1. Aggregate accomplishments updated information and report on the
tolerance reassessment decisions by through reregistration and other status of tolerance reassessment (See
August 3, 2002, meeting two important programs. EPA is accomplishing Table 8).
TABLE 8.—TOLERANCE REASSESSMENTS COMPLETED POST-FQPA BY FISCAL YEAR, THROUGH FY 2004*
During Total,
Tolerances Reas During During During During During During During During
Late FY End of
sessed Through... FY 1997 FY 1998 FY 1999 FY 2000 FY 2001 FY 2002 FY 2003 FY 2004
96 FY 2004
Reregistration/
REDs 25 339 277 359 44 46 231 79 87 1,487
Tolerance Reas
sessments/
TREDs 0 0 0 0 0 0 776 14 119 909
Registration 0 224 308 340 55 216 200 0 71 1,414
Tolerance revoca
tions 3 0 810 513 22 35 545 0 172 2,100
Other decisions 0 1 0 233 0 0 905 26 18 1,183
Total tolerances
reassessed 28 564 1,395 1,445 121 297 2,657 119 467 7,093
* Includes corrected counts for some previous years.
i. Reregistration/REDs. EPA is using that are part of a cumulative group are are important even if there are no
the reregistration program to accomplish not included in the Agency’s lists of domestic uses of a pesticide because
much of tolerance reassessment. For accomplishments. These tolerances will residues in or on imported commodities
each of the tolerance reassessment be considered again and their treated with the chemical could still
decisions made through REDs since reassessment will be completed after present dietary risks that may exceed
enactment of the FQPA, the Agency has EPA completes a cumulative risk the FFDCA ‘‘reasonable certainty of no
made the finding as to whether there is evaluation for the group. harm’’ standard, either individually or
a reasonable certainty of no harm, as iii. Registration. Like older pesticides, cumulatively with other substances that
required by FFDCA. Many tolerances all new pesticide registrations must share a common mechanism of toxicity.
reassessed through reregistration remain meet the safety standard of FFDCA.
v. Other reassessment decisions. In
the same while others may be raised, Many of the registration applications
addition to the types of reassessment
lowered, or revoked. EPA receives are for new uses of
actions described above, a total of 1,182
ii. Tolerance reassessments/TREDs. pesticides already registered for other
additional tolerance reassessment
Tolerances initially evaluated through uses. To reach a decision on a proposed
decisions have been made, some for
REDs that were completed before FQPA new food use of an already registered
was enacted in August 1996 now are pesticide, EPA must reassess the inert ingredient tolerance exemptions,
being reassessed to ensure that they aggregate risk of the the existing through actions not directly related to
meet the new FFDCA safety standard. tolerances, as well as the proposed new registration or reregistration. A list of
EPA issues these post-RED tolerance tolerances, to make sure there is these other tolerance reassessment
reassessment decisions as TREDs. The reasonable certainty that no harm will decisions with their Federal Register
Agency also issues TREDs summarizing result to the public from aggregate citations is available in the docket for
tolerance reassessment decisions for exposure from all uses. this Federal Register notice. Other
some developing REDs, for new iv. Tolerance revocations. Revoked support documents are available in
pesticide active ingredients not subject tolerances represent uses of many docket ID number OPP–2002–0162.
to reregistration, and for pesticides with different pesticide active ingredients 2. Accomplishments for priority
import tolerances only. Tolerance that have been canceled in the past. pesticides. During FY 2004, EPA
reassessments for pesticides that are not Some pesticides were canceled due to completed tolerance reassessment
part of a cumulative group may be the Agency’s risk concerns. Others were decisions for many high priority
counted at present and are included in canceled voluntarily by their pesticides in review, including OPs,
the FY 2004 accomplishments. manufacturers, based on lack of support carbamates, organochlorines, and
Tolerance reassessments for pesticides for reregistration. Tolerance revocations carcinogens (See Table 9).
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55850 Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Notices
TABLE 9.—TOLERANCE REASSESSMENTS COMPLETED FOR PRIORITY PESTICIDES
Pesticide Class Tolerances to be Reassessed Reassessed by End of FY 2004
Carbamates 545 309 (56.7%)
Carcinogens 2,008 1,425 (70.97%)
High hazard inerts 5 5 (100%)
Organochlorines 253 253 (100%)
Organophosphates (OPs) 1,691 1,131 (66.88%)
Other 5,219 3,970 (76.07%)
Total 9,721 7,093 (72.97%)
3. Tolerance reassessment and the individual OP pesticides (DDVP, eligibility and tolerance reassessment
organophosphates. EPA developed an dimethoate, and malathion) in FY 2006. decisions for these pesticides.
approach for assessing cumulative risk Most of the reregistration and
tolerance reassessment decisions that F. Applications for Registration
for the OP pesticides as a group, as
EPA has made for the OP pesticides will Requiring Expedited Processing;
required by FFDCA, and applied this
not be considered complete until after Numbers Approved and Disapproved
methodology in conducting an OP
cumulative risk assessment. The Agency the Agency concludes its cumulative By law, EPA must expedite its
issued preliminary and revised OP evaluation of the OPs. The results of processing of certain types of
cumulative risk assessment documents individual OP assessments (IRED and applications for pesticide product
in December 2001 and June 2002, TRED documents) include significant registration, i.e., applications for end
available on EPA’s website at http:// risk mitigation measures, however, and use products that would be identical or
www.epa.gov/pesticides/cumulative. any resulting tolerance revocations are substantially similar to a currently
Through this assessment of the OP counted as completed tolerance registered product; amendments to
pesticides, EPA has evaluated several reassessments. In addition, some OP current product registrations that do not
hundred OP tolerances and found that tolerances that make at most a minimal require review of scientific data; and
most require no modification to meet or negligible contribution to the products for public health pesticide
the new FFDCA safety standard. The cumulative risk from OP pesticides were uses. During FY 2004, EPA considered
Agency’s regulatory actions on counted as reassessed during FY 2002. and approved the numbers of
individual OP pesticides during the past Once EPA completes a cumulative applications for registration requiring
few years have substantially reduced the evaluation of the OPs, the Agency will expedited processing (also known as
risks of these pesticides. EPA plans to reconsider individual OP IREDs and ‘‘fast track’’ applications) shown in
complete IREDs for the three remaining TREDs, and complete reregistration Table 10.
TABLE 10.—FAST TRACK APPLICATIONS APPROVED IN FY 2004
Me-too product registrations/Fast track 328
Amendments/Fast track 4,379
Total applications processed by fast track means 4,707
For those applications not approved, overhead, and other indirect costs) on 2 contain pesticides scheduled for
the Agency generally notifies the expedited processing and reviews. Reregistration Eligibility Decisions
registrant of any deficiencies in the (REDs), Interim REDs (IREDs), and
G. Future Schedule for Reregistrations
application that need to be corrected or Reports on FQPA Tolerance
addressed before the application can be EPA plans to complete tolerance Reassessment Progress and Risk
approved. Applications may have been reassessment by August 3, 2006, as Management Decisions (TREDs) in FY
withdrawn after discussions with the required by FFDCA, and also to 2005 and FY 2006. Although these lists
Agency, but none were formally complete reregistration eligibility may change due to the dynamic nature
‘‘disapproved’’ during FY 2004. decisions for pesticides with food uses of the review process, EPA is committed
On a financial accounting basis, EPA by that date. REDs for pesticides that to meeting the reregistration and
devoted over 32.7 full-time equivalents have no food uses or tolerances will be tolerance reassessment deadlines. Any
(FTEs) in FY 2004 to reviewing and completed by October 3, 2008. The pesticides for which decisions are not
processing applications for fast track Agency’s schedule for completing these completed during the current fiscal year
me-too product registrations and label decisions is as follows. This schedule will be rescheduled for decisions the
amendments. The Agency spent also is available on EPA’s website at following year.
approximately $3.6 million in FY 2004 http://www.epa.gov/pesticides/ List 1.—FY 2005 RED, IRED, and TRED
in direct costs (i.e., time on task, not reregistration/candidates.htm. Schedule
including administrative expenses, 1. RED, IRED, and TRED Schedules REDs
computer systems, management for FY 2005 and FY 2006. Lists 1 and 2,4-D
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Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Notices 55851
2,4-DB MCPB Chlorflurenol
Ametryn Metaldehyde Copper salts
4-t-Amylphenol Methanearsonic acid, salts (DSMA, Dazomet
Aquashade MSMA, CAMA) Dikegulac sodium
Aromatic solvents Methyl bromide Grotan
Azadioxabicyclo-octane Methyldithiocarbamate salts (Metam Irgasan
Benzisothiazoline-3-one sodium/metam potassium) MCPP
Chloroneb MGK-264 Octhilinone
Chlorsulfuron MITC List 4.—FY 2008 RED Schedule
Dimethipin Pentachlorophenol 4-Aminopyradine
Endothall Permethrin Busan 77
Ethofumesate 2-Phenylphenol and salts Flumetralin
Ferbam (Dimethyldithiocarbamate Mefluidide
Piperonyl butoxide
Naphthalene
salts; case has completed RED) Propiconazole Naphthalene salts
Fluometuron Propylene oxide Nicotine
Inorganic polysulfides Pyrethrins p-Dichlorobenzene
Inorganic sulfites Resmethrin Polypropylene glycol
Iodine Rotenone Prometon
Mancozeb Salicylic acid Siduron
Maneb Sethoxydim Sodium fluoride
Metiram TCMB Sodium/potassium
Napropamide Thiadiazuron dimethyldithiocarbamate salts (case has
Nitrapyrin Triadimefon completed RED)
PCNB IREDs Sulfometuron methyl
Phenmedipham Aldicarb
Sumithrin
Phytophtora palmivora Carbofuran
TBT-containing compounds
Pyrazon Dichlorvos (DDVP)
Tetramethrin
Trichloromelamine Dimethoate
Triforine
IREDs Formetanate
Trimethoxysilyl quats
None Malathion
Simazine
H. Projected Year of Completion of
TREDs
TREDs Reregistrations
Bromine
Cyhexatin
Acetochlor EPA generally is conducting
Fluazifop-p-butyl
Amitraz reregistration in conjunction with
Flumiclorac-pentyl
Ammonia tolerance reassessment, which FFDCA
Imazamethabenz methyl
Azadirachtin mandates be completed by August 2006.
Imazaquin
Benzaldehyde EPA plans to meet the statutory
Maleic hydrazide
Bitertanol deadline for completing tolerance
Methyl eugenol
Boric acid group reassessment, and in so doing, to
Nicosulfuron
Ethephon complete reregistration eligibility
Procymidone
Fomesafen decisions for pesticides with tolerances,
Putrescent whole egg solids
Oxytetracycline as required by PRIA. The Agency
Sulfuric acid monourea
Propazine (Interim TRED for triazine expects to complete remaining
List 2.—FY 2006 RED, IRED, and TRED pesticide) reregistration eligibility decisions for
Schedule Sodium cyanide pesticides with no food uses or
REDs Streptomycin tolerances during FY 2007 and FY 2008
ADBAC
Tetradifon (by October 3, 2008).
Aliphatic alkyl quarternaries
Triadimenol
Tridemorph List of Subjects
Aliphatic solvents
Alkylbenzene sulfonates
2. Post-2006 REDs. REDs for Environmental protection, Pesticides
Aromatic solvents
pesticides with no associated tolerances and pests.
Cacodylic acid
will be completed in FY 2007 and FY
Chlorine dioxide
2008, unless decisions for these Dated: September 15, 2005.
Chloropicrin
pesticides can be completed sooner. Susan B. Hazen,
Chromated arsenicals (CCA)
Lists 3 and 4 contain pesticides Acting Assistant Administrator, Office of
Coal tar/creosote
scheduled for REDs in FY 2007 and FY Prevention, Pesticides and Toxic Substances.
Copper and oxides
2008. [FR Doc. 05–18961 Filed 9–22–05; 8:45 am]
Copper compounds
List 3.—FY 2007 RED Schedule BILLING CODE 6560–50–S
Copper sulfate
2,4-DP
Cypermethrin
Acrolein
Dicamba
Aliphatic alcohols
ENVIRONMENTAL PROTECTION
Dichloran (DCNA)
Aliphatic esters
AGENCY
Dodine
Alkyl trimethylenediamine
[OPPT–2005–0048; FRL–7739–1]
Ethylene oxide
Allethrin stereoisomers
Fluvalinate
Amical 48
Certain New Chemicals; Receipt and
Formaldehyde
Antimycin A
Status Information
Glutaraldehyde
Benzoic acid
Imazapyr
Bioban-p-1487
AGENCY: Environmental Protection
Inorganic chlorates
Bromonitrostyrene
Agency (EPA).
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