[Federal Register: August 22, 2007 (Volume 72, Number 162)]
[Notices]
[Page 46996-47007]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22au07-97]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2006-1005; FRL-8149-5]
Pesticide Reregistration Performance Measures and Goals
AGENCY: Environmental Protection Agency (EPA).
[[Page 46997]]
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces EPA's progress in meeting its
performance measures and goals for pesticide reregistration during
fiscal year 2006. The Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) requires EPA to publish information about EPA's annual
achievements in this area. This notice discusses the integration of
tolerance reassessment with the reregistration process, and describes
the status of various regulatory activities associated with
reregistration and tolerance reassessment. The notice gives total
numbers of chemicals and products reregistered, tolerances reassessed,
Data Call-Ins issued, and products registered under the ``fast-track''
provisions of FIFRA. This notice also contains the schedule for
completion of activities for specific chemicals during fiscal years
2007 through 2008.
DATES: This notice is not subject to a formal comment period.
Nevertheless, EPA welcomes input from stakeholders and the general
public. Written comments, identified by the docket ID number [EPA-HQ-
OPP-2006-1005], should be received on or before October 22, 2007.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2006-1005, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov/.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is (703) 305-5805.
Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2006-1005. EPA's policy is that all comments received will be included
in the public docket without change and may be made available on-line
at http://www.regulations.gov/, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://www.regulations.gov
or e-mail. The http://www.regulations.gov website is an ``anonymous access''
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through
http://www.regulations.gov, your e-mail address will be captured automatically
and included as part of the comment that is placed in the public docket
and made available on the Internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses. For additional information about EPA's public docket, visit
the EPA Docket Center homepage athttp://www.epa.gov/epahome/docket.htm/.
Docket: All documents in the docket are listed in the index.
Although listed in the index, some information is not publicly
available, i.e., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, will be publicly available only in hard copy. Publicly
available docket materials are available either in the electronic
docket athttp://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. The hours
of operation of this Docket Facility are from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket telephone
number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Carol P. Stangel, Special Review and
Reregistration Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone: (703) 308-8007;
e-mail:stangel.carol@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
This action is directed to the public in general. Although this
action may be of particular interest to persons who are interested in
the progress and status of EPA's pesticide reregistration and tolerance
reassessment programs, the Agency has not attempted to describe all the
specific entities that may be affected by this action. If you have any
questions regarding the information in this notice, consult the person
listed under FOR FURTHER INFORMATION CONTACT.
B. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
EDOCKET, regulations.gov, or e-mail. Clearly mark the part or all of
the information that you claim to be CBI. For CBI information in a disk
or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM
as CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date, and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns, and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity, obscene language, or personal threats.
viii. Make sure to submit your comments by the comment period
deadline.
II. Background
EPA must establish and publish in the Federal Register its annual
performance measures and goals for pesticide
[[Page 46998]]
reregistration, tolerance reassessment, and expedited registration,
under section 4(l) of FIFRA, as amended by the Food Quality Protection
Act of 1996 (FQPA). Specifically, such measures and goals are to
include:
The status of reregistration.
The number of products reregistered, canceled, or amended.
The number and type of data requests or Data Call-In (DCI)
notices under section 3(c)(2)(B) issued to support product
reregistration by active ingredient.
Progress in reducing the number of unreviewed, required
reregistration studies.
The aggregate status of tolerances reassessed.
The number of applications for registration submitted
under subsection (k)(3) (which provides for expedited processing and
review of similar applications), that were approved or disapproved.
The future schedule for reregistrations in the current and
succeeding fiscal year.
The projected year of completion of the reregistrations
under section 4.
FIFRA, as amended in 1988, authorizes EPA to conduct a
comprehensive pesticide reregistration program--a complete review of
the human health and environmental effects of older pesticides
originally registered before November 1, 1984. Pesticides meeting
today's scientific and regulatory standards may be declared
``eligible'' for reregistration. To be eligible, an older pesticide
must have a substantially complete data base, and must not cause
unreasonable adverse effects to human health or the environment when
used according to Agency approved label directions and precautions.
In addition, all pesticides with food uses must meet the safety
standard of section 408 of the Federal Food, Drug, and Cosmetic Act
(FFDCA) 21 U.S.C. 346a, as amended by the Food Quality Protection Act
(FQPA) of 1996. Under FFDCA, EPA must make a determination that
pesticide residues remaining in or on food are ``safe''; that is,
``that there is reasonable certainty that no harm will result from
aggregate exposure to the pesticide chemical residue'' from dietary and
other sources. In determining allowable levels of pesticide residues in
food, EPA must perform a more comprehensive assessment of each
pesticide's risks, considering:
Aggregate exposure (from food, drinking water, and
residential uses).
Cumulative effects from all pesticides sharing a common
mechanism of toxicity.
Possible increased susceptibility of infants and children;
and
Possible endocrine or estrogenic effects.
As amended by FQPA, FFDCA required the reassessment of all existing
tolerances (pesticide residue limits in food) and tolerance exemptions
within 10 years, to ensure that they met the safety standard of the
law. EPA was directed to give priority to the review of those
pesticides that appeared to pose the greatest risk to public health,
and to reassess 33% of the 9,721 existing tolerances and exemptions
within 3 years (by August 3, 1999), 66% within 6 years (by August 3,
2002), and 100% in 10 years (by August 3, 2006).The Agency met the
first two statutory deadlines and substantially met the third,
completing over 99% of all required tolerance reassessment decisions by
August 3, 2006. These decisions represent significant enhancements in
public health and environmental protection. By successfully
implementing FQPA, EPA is ensuring that all pesticides used on food in
the United States meet the law's new, more stringent safety standard.
EPA's approach to tolerance reassessment under FFDCA is described fully
in the Agency's document, ``Raw and Processed Food Schedule for
Pesticide Tolerance Reassessment'' (62 FR 42020, August 4, 1997) (FRL-
5734-6). The Agency's accomplishments under FQPA during the past 10
years are discussed athttp://www.epa.gov/pesticides/regulating/laws/fqpa/fqpa_accomplishments.htm
.
The Pesticide Registration Improvement Act (PRIA) of 2003 became
effective on March 23, 2004. Among other things, PRIA directed EPA to
complete Reregistration Eligibility Decisions (REDs) for pesticides
with food uses/tolerances by August 3, 2006, and to complete all non-
food use pesticide REDs by October 3, 2008. The Agency completed 99% of
the REDs due by August 3, 2006, and plans to complete all remaining
REDs by October 3, 2008. EPA's schedule for meeting these deadlines is
available on the Agency's website athttp://www.epa.gov/pesticides/reregistration/decision_schedule.htm
.
III. FQPA and Program Accountability
One of the hallmarks of the FQPA amendments to the FFDCA is
enhanced accountability. Through this summary of performance measures
and goals for pesticide reregistration, tolerance reassessment, and
expedited registration, EPA describes progress made during the past
year in each of the program areas included in FIFRA section 4(l).
A. Status of Reregistration
During fiscal year (FY) 2006 (from October 1, 2005, through
September 30, 2006), EPA made significant progress in completing risk
assessments and risk management decisions for pesticide reregistration
(See Table 1).
The Agency's decisions are embodied in Reregistration Eligibility
Decision (RED) documents, Interim Reregistration Eligibility Decisions
(IREDs), and Reports on FQPA Tolerance Reassessment Progress and
(Interim) Risk Management Decisions (TREDs).
[[Page 46999]]
Table 1.--Reregistration/Risk Management Decisions Completed: In FY 2006
and FY 1991 through FY 2006
------------------------------------------------------------------------
Total, FY 1991 through FY
FY 2006 Decisions 2006
------------------------------------------------------------------------
59 FY 2006 REDs 330 REDs
(37 REDs + 22 OP IREDs became REDs).......
ADBAC.....................................
Aliphatic alkyl quarternaries (DDAC)......
Aliphatic solvents........................
Alkyl benzene sulfonates..................
Atrazine (2003 IRED became a RED, 4-6-06).
Cacodylic acid............................
Chlorine dioxide..........................
Copper and oxides.........................
Copper compounds II.......................
Copper salts..............................
Copper sulfate............................
Cypermethrin..............................
Dicamba...................................
Dichloran (DCNA)..........................
Imazapyr..................................
Inorganic chlorates (sodium chlorate).....
Inorganic sulfites........................
Iodine....................................
Malathion (OP RED)........................
MCPB......................................
Metaldehyde...............................
Methanearsonic acid, salts (DSMA, MSMA,
CAMA).
MGK-264...................................
Mineral bases, weak (sodium carbonate)....
PCNB......................................
Permethrin................................
2-Phenylphenol and salts..................
Phytophthora palmivora....................
Piperonyl butoxide........................
Propiconazole.............................
Propylene oxide...........................
Pyrethrins................................
Resmethrin................................
Salicylic acid............................
Simazine (triazine RED)...................
TCMTB.....................................
Triadimefon...............................
22 OP IREDs became REDs on 7-31-06
Acephate..................................
Azinphos-methyl...........................
Bensulide.................................
Chlorpyrifos..............................
Diazinon..................................
Dichlorvos or DDVP........................
Dicrotophos...............................
Dimethoate................................
Disulfoton................................
Ethoprop..................................
Methamidophos.............................
Methidathion..............................
Methyl Parathion..........................
Naled.....................................
Oxydemeton-methyl (ODM)...................
Phorate...................................
Phosmet...................................
Pirimiphos-methyl.........................
Profenofos................................
Propetamphos..............................
Terbufos..................................
Tribufos (DEF)............................
------------------------------------------------------------------------
4 IREDs 4 IREDs
Carbofuran (N-methyl carbamate)...........
Dichlorvos (DDVP) (OP IRED, became a RED
on 7-31-06).
Dimethoate (OP IRED, became a RED on 7-31-
06).
Formetanate HCl (N-methyl carbamate)......
------------------------------------------------------------------------
[[Page 47000]]
19 TREDs 95 TREDs
Acetochlor................................
Amitraz...................................
Azadirachitin.............................
Bitertanol................................
Boric acid group..........................
CP enolpyruvylshikimate-3-phosphate.......
Ethephon..................................
Ethylene oxide (ETO) (RED in FY 2007).....
Inert ingredients of semichemical
dispensers.
Imazaquin.................................
Methyl bromide (commodity uses RED & TRED
in FY 2006; soil fumigant uses RED in FY
2007).
Neomycinphosphotransferase II.............
Oxytetracycline...........................
Propazine.................................
Rotenone (RED in FY 2007).................
Sodium Cyanide............................
Streptomycin..............................
Triadimenol...............................
Tridemorph................................
------------------------------------------------------------------------
1. REDs. Through the reregistration program, EPA is reviewing
current scientific data for older pesticides (those initially
registered before November 1984), reassessing their effects on human
health and the environment, and requiring risk mitigation measures as
necessary. Pesticides that have sufficient supporting data and whose
risks can be successfully mitigated may be declared ``eligible'' for
reregistration. EPA presents these pesticide findings in a RED
document.
i. Overall RED progress. EPA's overall progress at the end of FY
2006 in completing Reregistration Eligibility Decisions (REDs) for
groups of related pesticide active ingredients or cases is summarized
in Table 2.
Table 2.--Overall RED Progress, FY 1991 through FY 2006
------------------------------------------------------------------------
------------------------------------------------------------------------
REDs completed 330 (54%)
------------------------------------------------------------------------
Cases canceled 229 (37%)
------------------------------------------------------------------------
REDs to be completed 54 (9%)
------------------------------------------------------------------------
Total reregistration cases 613 (100%)
------------------------------------------------------------------------
ii. Profile of completed REDs. A profile of the REDs completed by
the end of FY 2006 is presented in Table 3.
Table 3.--Profile of 330 REDs Completed, FY 1991 through FY 2006
------------------------------------------------------------------------
------------------------------------------------------------------------
Pesticide active ingredients 527
------------------------------------------------------------------------
Pesticide products over 20,000
------------------------------------------------------------------------
iii. Risk reduction in REDs. Through the reregistration program,
EPA seeks to reduce risks associated with the use of older pesticides.
In developing REDs, EPA works with stakeholders including pesticide
registrants, growers and other pesticide users, and environmental and
public health interests groups, as well as the States, USDA, and other
Federal agencies and others to develop measures to effectively reduce
risks of concern. Almost every RED includes some measures or
modifications to reduce risks. The options for such risk reduction are
extensive and include voluntary cancellation of pesticide products or
deletion of uses; declaring certain uses ineligible or not yet eligible
(and then proceeding with follow-up action to cancel the uses or
require additional supporting data); restricting use of products to
certified applicators; limiting the amount or frequency of use;
improving use directions and precautions; adding more protective
clothing and equipment requirements; requiring special packaging or
engineering controls; requiring no-treatment buffer zones; employing
ground water, surface water, or other environmental and ecological
safeguards; and other measures.
2. Interim REDs or IREDs. EPA issues IREDs for pesticides that are
undergoing reregistration, require a reregistration eligibility
decision, and also must be included in a cumulative assessment under
FQPA because they are part of a group of pesticides that share a common
mechanism of toxicity. An IRED is issued for each individual pesticide
in the cumulative group when EPA completes the pesticide's risk
assessment and interim risk management decision. An IRED may include
measures to reduce risks from food, drinking water, residential,
occupational, and/or ecological exposure while the cumulative risk
assessment is pending. For example, EPA generally did not consider
individual organophosphate (OP) pesticide decisions made in advance of
the cumulative risk assessment to be completed REDs or tolerance
reassessments. Instead, the Agency issued IREDs for these chemicals.
EPA completed the risk assessments and reregistration eligibility
decisions for those OP pesticides with IREDs, once the Agency completed
the OP cumulative risk assessment on July 31, 2006.See http://www.epa.gov/pesticides/cumulative/
.
3. Tolerance reassessment ``TREDs.'' EPA issues Reports on FFDCA
Tolerance Reassessment Progress and [Interim] Risk Management
Decisions, known as TREDs, for pesticides that require tolerance
reassessment decisions under FFDCA, but do not require a reregistration
eligibility decision at present because:
The pesticide was first registered after November 1, 1984,
and is considered a ``new'' active ingredient, not subject to
reregistration;
[[Page 47001]]
EPA completed a RED for the pesticide before FQPA was
enacted; or
The pesticide is not registered for use in the U.S. but
tolerances are established that allow crops treated with the pesticide
to be imported from other countries.
As with IREDs, EPA does not complete risk assessment and risk
management for pesticides subject to TREDs that are part of a
cumulative group until cumulative risks have been considered for the
group.
During FY 2006, EPA completed 19 TREDs. By August 3, 2006, EPA also
completed tolerance assessment decisions for food use pesticide inert
ingredients that are exempted from the tolerance requirement. Almost
900 of the 9,721 tolerance reassessment decisions required by the
amended FFDCA were for such inert ingredient tolerance exemptions.
As a result of the FQPA, food-contact surface sanitizing solutions
previously regulated by both EPA and the Food and Drug Administration
were transferred to EPA's sole jurisdiction. Consequently, the
approximately 107 ingredients that made up these sanitizer solutions in
21 CFR 178.1010 were transferred to 40 CFR 180.940. In addition to
reassessing the 9,721 tolerances and exemptions for food and feed
commodities, EPA also was required to reassess these sanitizer
tolerance exemptions by August 3, 2006. The Antimicrobials Division
(AD) in EPA's Office of Pesticide Programs is responsible for
reassessing exemptions from the requirement of a tolerance for the
food-contact surface sanitizing solutions requiring reassessment. AD
completed the reassessment of 120 tolerance exemptions in FY 2006,
resulting in a total of 174 tolerance exemptions reassessed for the
food-contact surface sanitizing solutions.
4. Goals for FY 2007 and future years. EPA's major pesticide
reregistration and tolerance reassessment goals for FY 2007 and future
years are as follows.
i. Complete individual pesticide risk management decisions. EPA's
goal in conducting the reregistration program is to complete 6
remaining Reregistration Eligibility Decisions (REDs) and Interim REDs
(IREDs) for pesticides with food uses and 19 REDs for pesticides with
no food uses during FY 2007. The Agency plans to complete the remaining
29 non-food use REDs in FY 2008. EPA's schedule for completing these
decisions appears near the end of this document, and also is available
on the Agency's website at http://www.epa.gov/pesticides/reregistration/decision_schedule.htm
.
ii. Complete tolerance reassessment decisions. EPA completed over
99% of all required tolerance reassessment decisions by August 3, 2006,
the 10-year anniversary of FQPA. EPA expects to complete the N-methyl
carbamate cumulative risk assessment and the Agency's final 84
tolerance reassessment decisions, thereby completing theFQPA tolerance
reassessment program.
iii. Evaluate cumulative risks. EPA completed cumulative risk
assessments for the organophosphate (OP), triazine, and
chloroacetanilide pesticides during FY 2006. Once EPA completes an
individual decision for aldicarb, the Agency will make a cumulative
risk finding for the N-methyl carbamate common mechanism group of
pesticides. No other groups are scheduled at present for cumulative
risk assessments. For further information, see EPA's Assessing
Pesticide Cumulative Risk web page,http//http://www.epa.gov/pesticides/cumulative/index.htm
.
B. Product Reregistration; Numbers of Products Reregistered, Canceled,
and Amended
At the end of the reregistration process, after EPA has issued a
RED and declared a pesticide reregistration case eligible for
reregistration, individual end-use products that contain pesticide
active ingredients included in the case still must be reregistered.
This concluding part of the reregistration process is called ``product
reregistration.''
In issuing a completed RED document, EPA sends registrants a Data
Call-In (DCI) notice requesting any product-specific data and specific
revised labeling needed to complete reregistration for each of the
individual pesticide products covered by the RED. Based on the results
of EPA's review of these data and labeling, products found to meet
FIFRA and FFDCA standards may be reregistered.
A variety of outcomes are possible for pesticide products
completing this final phase of the reregistration process. Ideally, in
response to the DCI notice accompanying the RED document, the pesticide
producer, or registrant, will submit the required product-specific data
and revised labeling, which EPA will review and find acceptable. At
that point, the Agency may reregister the pesticide product. If,
however, the product contains multiple active ingredients, the Agency
instead issues an amendment to the product's registration,
incorporating the labeling changes specified in the RED. A product with
multiple active ingredients may not be fully reregistered until the
last active ingredient in its formulation is eligible for
reregistration. In other situations, the Agency may temporarily suspend
a product's registration if the registrant has not submitted required
product-specific studies within the time frame specified. The Agency
may cancel a product's registration because the registrant did not pay
the required registration maintenance fee. Alternatively, the
registrant may request a voluntary cancellation of their end-use
product registration.
1. Product reregistration actions in FY 2006. EPA counts each of
the post-RED product outcomes described above as a product
reregistration action. A single pesticide product may be the subject of
several product reregistration actions within the same year. For
example, a product's registration initially may be amended, then the
product may be reregistered, and later the product may be voluntarily
canceled, all within the same year. During FY 2006, EPA completed the
product reregistration actions detailed in Table 4.
Table 4.--Product Reregistration Actions Completed during FY 2006
------------------------------------------------------------------------
------------------------------------------------------------------------
Product reregistration actions 169
------------------------------------------------------------------------
Product amendment actions 40
------------------------------------------------------------------------
Product cancellation actions 297
------------------------------------------------------------------------
Product suspension actions 0
------------------------------------------------------------------------
Total actions 506
------------------------------------------------------------------------
2. Status of the product reregistration universe. The status of the
universe of pesticide products subject to reregistration at the end of
FY 2006 is shown in Table 5 below. This overall status information is
not ``cumulative''--it is not derived from summing up a series of
annual actions. Adding annual actions would result in a larger overall
number since each individual product is subject to multipleactions--it
can be amended, reregistered, and/or canceled, over time. Instead, the
``big picture'' status information in Table 5 should be considered a
snapshot in time. As registrants and EPA make marketing and regulatory
decisions in the future, the status of individual products may change,
and numbers in this table are expected to fluctuate.
Table 5.--Status of the Universe of Products Subject to Product
Reregistration, for FY 2006 (as of September 30, 2006)
------------------------------------------------------------------------
------------------------------------------------------------------------
Products reregistered 2,063
------------------------------------------------------------------------
Products amended 554
------------------------------------------------------------------------
[[Page 47002]]
Products canceled 4,672
------------------------------------------------------------------------
Products sent for suspension 30
------------------------------------------------------------------------
Total products with actions completed 7,319
------------------------------------------------------------------------
Products with actions pending 12,932
------------------------------------------------------------------------
Total products in product reregistration 20,251
universe
------------------------------------------------------------------------
The universe of 20,251 products in product reregistration at the
end of FY 2006 represented an increase of 8,638 products from the FY
2005 universe of 11,613 products. The increase consists of 8,613
products associated with FY 2006 REDs, IREDs, and TREDs, and 25
products that were added as a result of DCI activities and processing
for several previously issued REDs and IREDs.
At the end of FY 2006, 12,932 products had product reregistration
decisions pending. Some pending products await science reviews, label
reviews, or reregistration decisions by EPA. Others are not yet ready
for product reregistration actions, but they are associated with more
recently completed REDs. Their product-specific data are not yet due to
be submitted to or reviewed by the Agency. EPA's goal is to complete
545 product reregistration actions during fiscal year 2007.
C. Number and Type of DCIs to Support Product Reregistration by Active
Ingredient
1. DCIs for REDs and IREDs. The number and type of Data Call-In
requests or DCIs that EPA is preparing to issue under FIFRA section
3(c)(2)(B) to support product reregistration for pesticide active
ingredients included in FY 2006 REDs and IREDs are shown in Table 6.
Table 6.--DCIs Issued to Support Product Reregistration for FY 2006 REDs and IREDs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Product Number of Acute
Case Name Case No. Number of Products Chemistry Studies Toxicology Studies Number of Efficacy
Covered by the RED1 Required2 Required3 Studies Required
--------------------------------------------------------------------------------------------------------------------------------------------------------
ADBAC 0350 1,047 PDCI has not been Antimicrobial RED - PDCI has not been
completed yet Acute toxicity completed yet
batching not
completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Aliphatic Alkyl Quarternaries 3003 382 PDCI has not been Antimicrobial RED - PDCI has not been
(DDAC) completed yet Acute toxicity completed yet
batching not
completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Aliphatic Solvents 3004 158 31 Acute toxicity PDCI has not been
batching not completed yet
completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Alkylbenzene Sulfonates 4006 20 0 Antimicrobial RED - 5
Acute toxicity
batching not
completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cacodylic Acid 2080 36 31 See footnote 4 below 0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chlorine Dioxide 4023 95 PDCI has not been Antimicrobial RED - PDCI has not been
completed yet Acute toxicity completed yet
batching not
completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Copper Compounds II 0649 173 31 Needs batching 0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Copper and Oxides 4025 237 PDCI has not been Acute toxicity PDCI has not been
completed yet batching not completed yet
completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Copper Salts 4026 38 31 Acute toxicity 0
batching not
completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Copper Sulfate 0636 127 31 Acute toxicity 0
batching not
completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cypermethrin 2130 69 31 Acute toxicity PDCI has not been
batching not completed yet
completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 47003]]
Dicamba 0065 448 31 Acute toxicity 0
batching not
completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dichloran (DCNA) 0113 25 31 54 (1 batch/8 not 0
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dichlorvos (DDVP) 0310 100 31 258 (20 batches/23 PDCI has not been
not batched) completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dimethoate 0088 54 31 96 (7 batches/9 not 0
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Formetantate HCL (IRED) 0091 6 31 36 (6 products not 0
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Imazapyr 3078 19 31 Acute toxicity 0
batching not
completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Inorganic Chlorates (Sodium 4049 58 31 156 (9 batches/17 not PDCI has not been
Chlorate) batched) completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Inorganic Sulfites 4056 9 31 Acute toxicity 1
batching not
completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Iodine and Iodophor Complexes 3080 67 0 126 (12 batches/9 not 9
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Malathion 0248 153 31 Acute toxicity PDCI has not been
batching not completed yet
completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
MCPB and Salts 2365 5 31 24 (1 batch/3 not 0
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Metaldehyde 0576 52 31 102 (7 batches/10 not 0
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Methanearsonic acid, salts (Organic 2395 129 See footnote 4 below See footnote 4 below See footnote 4 below
Arsenicals) (MSMA/DSMA/CAMA)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Methyl Bromide (RED/TRED) 0335 14 31 Not Applicable 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
MGK 264 2430 653 31 Acute toxicity PDCI has not been
batching not completed yet
completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Mineral Bases, Weak (Sodium 4066 4 PDCI has not been Antimicrobial RED - PDCI has not been
Carbonate) completed yet Acute toxicity completed yet
batching not
completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
2-Phenylphenol and Salts 2575 118 PDCI has not been 450 (22 batches/53 PDCI has not been
(Orthophenyl Phenol) completed yet not batched) completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
PCNB 0128 82 31 270 (14 batches/31 0
not batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 47004]]
Permethrin 2510 957 31 Acute toxicity PDCI has not been
batching not completed yet
completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Piperonyl Butoxide (PBO) 2525 1,451 31 Acute toxicity PDCI has not been
batching not completed yet
completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Propiconazole 3125 172 31 264 (14 batches/30 0
not batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Propylene Oxide (PPO) 2560 3 31 18 (3 not batched) 0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pyrethrins 2580 1,286 31 Acute toxicity PDCI has not been
batching not completed yet
completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Resmethrin 0421 232 31 Acute toxicity PDCI has not been
batching not completed yet
completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Simazine 0070 44 31 84 (8 batches/6 not 0
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
TCMTB 2625 27 PDCI has not been Antimicrobial RED - PDCI has not been
completed yet Acute toxicity completed yet
batching not
completed yet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Triadimefon 2700 56 31 102 (7 batches/10 not 0
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total No. of Products --- 8,606 --- --- ---
--------------------------------------------------------------------------------------------------------------------------------------------------------
1The 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.
2This column shows the number of product chemistry studies that are required for each product covered by the RED.
3In 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. Factors considered in the
sorting process include each product's active and inert ingredients (e.g., identity, percent composition, and biological activity), 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.)
4Ineligible for reregistration; public comments under consideration. Depending on the Agency's formal response to the public comments, PDCIs may or may
not be required for these chemicals.
2. DCIs for TREDs. There are cases in which product-specific DCIs
may be required for TREDs, particularly if the Agency believes that
adequate product chemistry or acute toxicity data are not currently on
file to support the reregistration of the products associated with the
TREDs. The Agency is requiring product-specific DCIs for the following
TRED:
Table 7.--DCIs Issued to Support Product Reregistration for FY 2006 TRED
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Product Number of Acute
Case Name Case No. Number of Products Chemistry Studies Toxicology Studies Number of Efficacy
Covered by the TRED1 Required2 Required3 Studies Required
--------------------------------------------------------------------------------------------------------------------------------------------------------
Triadimenol NA 7 31 42 (7 products not 0
batched)
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 47005]]
Total No. of Products --- 7 --- --- ---
--------------------------------------------------------------------------------------------------------------------------------------------------------
1The 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.
2This column shows the number of product chemistry studies that are required for each product covered by the RED.
3In 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. Factors considered in the
sorting process include each product's active and inert ingredients (e.g., identity, percent composition, and biological activity), 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.)
D. Progress in Reducing the Number of Unreviewed, Required
Reregistration Studies
EPA has made progress in reviewing scientific studies submitted by
pesticide registrants in support of pesticides undergoing
reregistration (See Table 8). The percent of studies reviewed by EPA
remained constant in FY 2006.
Table 8.--Review Status of Studies Submitted for Pesticide Reregistration, End of FY 2006
----------------------------------------------------------------------------------------------------------------
Pesticide Reregistration List, per Studies Reviewed +
FIFRA Section 4(c)(2) Extraneous1 Studies Awaiting Review Total Studies Received
----------------------------------------------------------------------------------------------------------------
List A 11,262 + 588 = 11,850 1,788 (13%) 13,638
(87%)
----------------------------------------------------------------------------------------------------------------
List B 6,585 + 1,041 = 7,626 1,748 (19%) 9,374
(81%)
----------------------------------------------------------------------------------------------------------------
List C 2,097 + 334 = 2,431 463 (16%) 2,894
(84%)
----------------------------------------------------------------------------------------------------------------
List D 1,266 + 133 = 1,399 228 (14%) 1,627
(86%)
----------------------------------------------------------------------------------------------------------------
Total Lists A - D 21,210 + 2,096 = 23,306 4,227 (15.35%) 27,533 (100%)
(84.65%)
----------------------------------------------------------------------------------------------------------------
1Extraneous studies is a term used to classify those studies that are not needed because the guideline or data
requirement has been satisfied by other studies or has changed.
E. Aggregate Status of Tolerances Reassessed
During FY 2006, EPA completed 1,820 tolerance reassessments and
ended the fiscal year with a total of 9,637 tolerance reassessment
decisions to date, addressing over 99% of the 9,721 tolerances that
require reassessment (See Table 9).
EPA reassessed over 33% of all food tolerances by August 3, 1999,
and completed over 66% of all required tolerance reassessment decisions
by August 3, 2002, meeting two important statutory deadlines
established by the FQPA. EPA's general schedule for tolerance
reassessment (62 FR 42020, August 4, 1997) identified three groups of
pesticides to be reviewed; this grouping continues to reflect the
Agency's overall scheduling priorities. In completing tolerance
reassessment, EPA continues to give priority to pesticides in Group 1,
the Agency's highest priority group for reassessment.
1. Aggregate accomplishments through reregistration and other
programs. EPA is accomplishing tolerance reassessment through the
registration and reregistration programs; by revoking tolerances for
pesticides that have been canceled (many as a result of
reregistration); by reevaluating pesticides with pre-FQPA REDs, and
through other decisions not directly related to registration or
reregistration, described further below. EPA is using the Tolerance
Reassessment Tracking System (TORTS) to compile this updated
information and report on the status of tolerance reassessment (See
Table 9).
Table 9.--Tolerance Reassessments Completed Post-FQPA by Fiscal Year, through FY 2006*
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total,
Tolerances Reassessed Through... Late FY FY 1997 FY 1998 FY 1999 FY 2000 FY 2001 FY 2002 FY 2003 FY 2004 FY 2005 FY 2006 End of
96 FY 2006
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reregistration/REDs 25 339 277 359 44 46 231 79 87 413 1,037 2,937
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 47006]]
Tolerance Reassessments/TREDs 0 0 0 0 0 0 776 14 119 69 306 1,284
--------------------------------------------------------------------------------------------------------------------------------------------------------
Registration 0 224 308 340 55 216 200 0 71 0 1 1,415
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tolerance revocations 3 0 812 513 22 35 545 0 172 75 185 2,362
--------------------------------------------------------------------------------------------------------------------------------------------------------
Other decisions including inerts 0 1 0 233 0 0 905 26 18 165 291 1,639
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total tolerances reassessed 28 564 1,397 1,445 121 297 2,657 119 467 722 1,820 9.637
--------------------------------------------------------------------------------------------------------------------------------------------------------
*Includes corrected counts for some previous years.
i. Reregistration/REDs. EPA is using the reregistration program to
accomplish much of tolerance reassessment. For each of the tolerance
reassessment decisions made through REDs since enactment of the FQPA,
the Agency has made the finding as to whether there is a reasonable
certainty of no harm, as required by FFDCA. Many tolerances reassessed
through reregistration remain the same while others may be raised,
lowered, or revoked.
ii. Tolerance reassessments/TREDs. Tolerances initially evaluated
through REDs that were completed before FQPA was enacted in August 1996
now are being reassessed to ensure that they meet the new FFDCA safety
standard. EPA issues these post-RED tolerance reassessment decisions as
TREDs. The Agency also issues TREDs summarizing tolerance reassessment
decisions for some developing REDs, for new pesticide active
ingredients not subject to reregistration, and for pesticides with
import tolerances only. Tolerance reassessments for the OPs, triazines,
and chloroacetanilides (groups with completed cumulative risk
assessments) and for pesticides that are not part of a cumulative group
may be counted at present and are included in the FY 2006
accomplishments.Tolerance reassessments for pesticides that are part of
the N-methyl carbamate cumulative group are not included in the
Agency's lists of accomplishments. The reassessment of these 84
tolerances will be completed after EPA completes a cumulative risk
evaluation for the group in FY 2007.
iii. Registration. Like older pesticides, all new pesticide
registrations must meet the safety standard of FFDCA. Many of the
registration applications EPA receives are for new uses of pesticides
already registered for other uses. To reach a decision on a proposed
new food use of an already registered pesticide, EPA must reassess the
aggregate risk of the the existing tolerances, as well as the proposed
new tolerances, to make sure there is reasonable certainty that no harm
will result to the public from aggregate exposure from all uses.
iv. Tolerance revocations. Revoked tolerances represent uses of
many different pesticide active ingredients that have been canceled in
the past. Some pesticides were canceled due to the Agency's risk
concerns. Others were canceled voluntarily by their manufacturers,
based on lack of support for reregistration. Tolerance revocations are
important even if there are no domestic uses of a pesticide because
residues in or on imported commodities treated with the chemical could
still present dietary risks that may exceed the FFDCA ``reasonable
certainty of no harm'' standard, either individually or cumulatively
with other substances that share a common mechanism of toxicity.
v. Other reassessment decisions. In addition to the types of
reassessment actions described above, a total of 1,639 additional
tolerance reassessment decisions have been made. Some have been made
for inert ingredient tolerance exemptions through actions not directly
related to registration or reregistration.
2. Accomplishments for priority pesticides. During FY 2006, EPA
completed tolerance reassessment decisions for many high priority
pesticides in review, including OPs, carbamates, and carcinogens (See
Table 10).
Table 10.--Tolerance Reassessments Completed for Priority Pesticides
------------------------------------------------------------------------
Tolerances to be Reassessed by End
Pesticide Class Reassessed of FY 2006
------------------------------------------------------------------------
Carbamates 545 461 (84.6%)
------------------------------------------------------------------------
Carcinogens 2,008 2,008 (100%)
------------------------------------------------------------------------
Inert ingredient tolerance 844 844 (100%)
exemptions
------------------------------------------------------------------------
Organochlorines 253 253 (100%)
------------------------------------------------------------------------
Organophosphates (OPs) 1,691 1,691 (100%)
------------------------------------------------------------------------
Other 4,380 4,380 (100%)
------------------------------------------------------------------------
Total 9,721 9,637 (99.1%)
------------------------------------------------------------------------
[[Page 47007]]
3. Tolerance reassessment and the organophosphates. EPA developed
an approach for assessing cumulative risk for the OP pesticides as a
group, as required by FFDCA, and applied this methodology in conducting
an OP cumulative risk assessment. The Agency issued preliminary and
revised OP cumulative risk assessment documents in December 2001 and
June 2002, and completed an OP Cumulative Risk Assessment; 2006 Update
in August 2006, available on EPA's website athttp://www.epa.gov/pesticides/cumulative
.
EPA completed IREDs and REDs for the three remaining individual OP
pesticides (DDVP, dimethoate, and malathion) in FY 2006.With the
mitigation measures identified for the individual OP pesticides in the
pertinent IREDs completed during the past several years, EPA determined
that the cumulative risks associated with the OPs do not exceed the
FFDCA safety standard. The individual OP pesticides are indeed eligible
for reregistration provided that they met the interim reregistration
eligibility criteria of the pertinent IREDs.
F. Applications for Registration Requiring Expedited Processing;
Numbers Approved and Disapproved
By law, EPA must expedite its processing of certain types of
applications for pesticide product registration, i.e., applications for
end use products that would be identical or substantially similar to a
currently registered product; amendments to current product
registrations that do not require review of scientific data; and
products for public health pesticide uses. During FY 2006, EPA
considered and approved the numbers of applications for registration
requiring expedited processing (also known as ``fast track''
applications) shown in Table 11.
Table 11.--Fast Track Applications Approved in FY 2006
------------------------------------------------------------------------
------------------------------------------------------------------------
Me-too product registrations/Fast track 308
------------------------------------------------------------------------
Amendments/Fast track 3,332
------------------------------------------------------------------------
Total applications processed by fast track 3,640
means
------------------------------------------------------------------------
For those applications not approved, the Agency generally notifies
the registrant of any deficiencies in the application that need to be
corrected or addressed before the application can be approved.
Applications may have been withdrawn after discussions with the Agency,
but none were formally ``disapproved'' during FY 2006.
On a financial accounting basis, EPA devoted 26.8 full-time
equivalents (FTEs) in FY 2006 to reviewing and processing applications
for fast track me-too product registrations and label amendments. The
Agency spent approximately $3.35 million in FY 2006 in direct costs
(i.e., time on task, not including administrative expenses, computer
systems, management overhead, and other indirect costs) on expedited
processing and reviews.
G. Future Schedule for Reregistrations
EPA plans to complete the remaining 7 REDs for pesticides with food
uses in FY 2007, as well as 18 of the remaining non-food use REDs. The
remaining REDs for pesticides that have no food uses or tolerances will
be completed by October 3, 2008. The Agency's schedule for completing
these decisions is as follows. This schedule also is available on EPA's
website athttp://www.epa.gov/pesticides/reregistration/decision_schedule.htm
.
1. RED and IRED Schedule for FY 2007. List 1 contains pesticides
scheduled for Reregistration Eligibility Decisions (REDs) and Interim
REDs (IREDs) in FY 2007.
List 1.--FY 2007 RED and IRED Schedule
2,4 DP
Aldicarb (N-methyl carbamate IRED and RED)
Aliphatic alcohols
Aliphatic esters
Alkyl trimethylenediamines
Allethrin stereoisomers
4-Aminopyridine
Antimycin A
Benzoic acid
Bioban-p-1487
Bromonitrostyrene
Chlorflurenol
Dikegulac sodium
Ethylene oxide (ETO) (TRED completed in FY 2006)
Glutaraldehyde
MCPP
Mefluidide
Naphthenate salts
Octhilinone
Rotenone (TRED completed in FY 2006)
Trimethoxysilyl quats
The following N-methyl carbamate IREDs will become REDs when EPA
completes the cumulative risk assessment for this common mechanism
group.
Carbaryl
Carbofuran
Formetanate HCl
Oxamyl
List 2.--FY 2008 REDs Schedule
Acrolein
Amical 48
Busan 77
Chloropicrin
Chromated arsenicals (CCA)
Coal tar/creosote
Dazomet
Flumetralin
Formaldehyde
Grotan
Inorganic thiosulfates (ammonium and calcium thiosulfate)
Methyl bromide (soil fumigant uses RED; commodity uses TRED & RED
completed FY 2006)
Methyldithiocarbamate salts (metam sodium/metam potassium)
MITC
Naphthalene
Nicotine
Organic esters of phosphoric acid
p-Dichlorobenzene
Pentachlorophenol
Polypropylene glycol
Prometon
Siduron
Sodium fluoride
Sulfometuron methyl
Sumithrin
TBT-containing compounds
Tetramethrin
Triforine
Triclosan (Ingasan)
H. Projected Year of Completion of Reregistrations
EPA expects to complete seven remaining reregistration eligibility
decisions for N-methyl carbamate pesticides and others with food uses
in FY 2007, and to complete decisions for the remaining 47 pesticides
with no food uses or tolerances during FY 2007 and FY 2008 (by October
3, 2008).Product reregistration, which takes place only after the
reregistration eligibility decisions have been completed for the active
ingredients, will not likely be completed before 2012.
List of Subjects
Environmental protection, Pesticides and pests.
Dated: August 15, 2007.
James B. Gulliford,
Assistant Administrator, Office of Prevention, Pesticides and Toxic
Substances.
[FR Doc. E7-16560 Filed 8-21-07; 8:45 am]
BILLING CODE 6560-50-S