U.S. Environmental Protection Agency
Office of Pesticide Programs
Carbofuran Registration Review Status
December 2009
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Carbofuran Registration Review Status
December 2009
Case 0101
Approved by: ^ <-yt
Richard P. Keigwin, Jr.
Director
Pesticide Re-evaluation Division
Date;
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Carbofuran Registration Review Status
Introduction
I'hc Food Quality Protection Act of 1 9% mandated a registration review program.
Ail pesticides distributed or so'd in the United States (l.'.S.) general!) must be registered
by the Hnvironrnenial Protection Agency (FPA or the Agency), based on scientific data
showing that they will not cause unreasonable risks to human health or the environment
when used as directed on product labeling. The registration review program is intended to
make sure that, as the ability to assess risk evolves and as policies and practices change,
all registered pesticides continue to meet the statutory standard of no unreasonable
adverse effects to human health or the environment. Changes in science, public pol'e\.
and pesticide use practices will occur over time. Through, the registration review
program, the Agency periodically reevaluates pesticides to make sure that as change
occurs, products in the marketplace can be used safely. Information on this program is
provided at
fhe Agency is mplemcniing the registration review program pursuant to Section 3(g).
and will review each registered pesticide every 15 >ears to determine whether it
continues to meet the federal Insecticide. Fungicide, and Rodenticide Act (FlhRA)
standard for registration. The Agency will consider benefits information anc data as
required by F1FRA. The publij phase of registration review begins when the initial
docket is opened for each case. The docket is the Agency's opportunity to state what it
knows about th: pesticide and whal aJditional risk analyses and data it believes are
needed to make a registration review- decision. In the case of carbofuran. the Agency's
decision, finalized in the August 2006 Reregi.stration F.ligibilitv Decision {R -]D)
Document for carbofuran was .hat pesticide products containing the active ingredient
carbofuran were not eligible for Rcregi strati on. The regulator) process to implement that
decision by tolerance revocation and -egistration cancellation is ongoing, fhe Agency
will therefore not be opening a registiation review docket lor carbofuran. The Agency
expects growers to successfully transition to the available alternative pesticides or
cultural practices that pose fewer risks.
Status Update for Carbofuran
Final Decision and Tolerance Revocation:
This is the hnvironmental Protection Agency's status update for the registration
review" of carbc.furan. Carbofuran is an N-methyl carbamate pesticide that poses health
risks to humans and the environment.
In August 2006. after several public comment periods on the risk ass:ssmerts,
EPA announced that no uses of carbofuran were eligible for Reregistration. The
following timeline lists actions relating to carbofuran registrations after the RFD was
completed on 2006.
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• April-October 2007, Registrant submitted new data and infornniion on
carbofuran.
• January 2008. KFA published a draft Notice of Intent lo Cancel (MOIC)
and re\ised risk assessments and benefits analyses based on information
reeened during 2007; and requested review b\ the FIFRA Scientific
Advisory Panel (SAP) and the L'.S. Department of Agriculture (ICiDA),
as required b\ statute.
• -ebruarv 2008. FIFRA SAP meeting on draft NOIC. As part of the
process to cancel carbofuran registrations, the Agene} presented li e
rationale tor its decision, as well as reviews of new data submitted
throughout .2007.
• March 2008. 1 he SAP agreed with EPA's rationale. (Meeting Minutes of
the i I/• RA Scientific Advisory Panel Meeting Held February 5-8, 2008 on
the Agency '$ Proposed Action under F1FRA 6(b) Notice of Intent to
Cancel Carbofuran).
• March 2008. US DA commented on the benefits analyses 'that EPA should
consider pest resistance management, benefits on a local level effects on
consumers and iradc, lisks of alternative chemicals, emergency exemption
;ssues. crops other than corn and potatoes, and should conduct a crop-by-
crop benefits analysis.
• Juh" 22. 2008. ZPA responded to each of CSDA's concerns.
• Juh" 31. 2008. ~PA proposed to revoke all tolerances for carbofuran (73
,'R 44864).
• August 2008. EPA notified the World Trade Organization (W'EO) that the
.Agency had proposed to revoke all carbofuran tolerances.
• March 18. 2009. EPA's product cancellation order confirmed and
malized the registrant 's voluntary cancellation of some uses of carbofuran
(74 I-'R 1 15M ). Uses which have not been voluntary cancelled are: corn,
sunflower, pokvo. pumpkin, spinach grown for seed and pine seed ings.
• May 15. 2000. 1 lie Agency issued its final rule revoking all tolerances for
carboturan (74 -R 23('46) and addressing all public comments received on
the proposed rule.
• May 2009. EPA notif ed the WTO that the Agency had revoked all
carbofuran toieiances.
• October 30, 201*9. FIViC Corporation, the National Com Growers
Association, the Natio nil Sunllower Association, and the National Potato
Council, jointly filed objections to EPA's tolerance revocations and a
request for a hearing.
• No\ember 1 8. 1009. EPA denied all objections and hearing requests and
provided the rationale for each denial (74 FR 59608).
• No\ember 19. 1009. "he registrant filed a motion with the DC Circuit
Court ol Appea.s requesting a stay of (he Agency's decision and expedited
review' of the merils of the case,
• November 30, 2009. EPA tiled a brief responding to FMC"s motion.
• December 7, 2009. EMC responded to KPA's brief.
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The DC Circuit Court of Appeals is in the process of considering FMC's motion.
As a result of HPA tolerance revocation actions, after December 31. 2009. food crops
with residues of carbofuran will be considered adulterated, unless those food crops were
treated with carboiuran prior to December 31. 2009. Use of carbofuran on volun.arily
cancelled non-food crops according to label directions is allowed until stocks arc
depleted. I. se on the non-iood uses of pine seedlings and spinach grown fo; scco will be
subject to, any existing stocks provisions in the future cancellation order.
The final carbofuran Decision Document and supporting materials including all
correspondence, reports, and risk assessments arc available electronically at
www.reanlattons.gov in docket number EPA-HQ-OPP-2005-0162. The draft NOIC and
associated risk assessments. S VP charge questions, presentations by the Agency and the
public, SAP report and the Agencs's response can be found in the SAP docket m mher
hPA-11Q-OPP-2007-108 K.
Anticipated Actions
As many uses of carbofuran have already been voluntarily cancelled, and all tolerances
have been revoked, the Agency will be proceeding to finalize the draft Notice of r.tent to
( ancel o! January 2008 and cancel a I remaining carbofuran products and uses d,ie to
risks to applicators and wildlife.
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