Document ID: EPA-HQ-OPP-2005-0162-0474
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-01-09T05:00Z

December 29, 2007

Docket ID No. EPA-HQ-OPP-2007-0935

Federal Register (FR): September 26, 2007 (Volume 72, Number 18)

Att: 	Neil Anderson, Docket manager

	Jude Andreasen, Chemical manager

Natural Resources Defense Council

and American Bird Conservancy

Amended Petition to Revoke Import Tolerances of Carbofuran

On November 26, 2007, the Natural Resources Defense Council (NRDC)
petitioned the U.S. Environmental Protection Agency (EPA) to, among
other things, revoke all tolerances of carbofuran.   NRDC and the
American Bird Conservancy (ABC) submit this amended petition to provide
more detailed facts to support NRDC’s original petition and
incorporate the original petition herein.

Background

A U.S. tolerance is the maximum residue level of a pesticide permitted
in or on food or feed grown in the U.S. or imported into the U.S. from
other countries. Food may not be lawfully sold in the U.S. or imported
into the U.S. from other countries if the food contains detectable
pesticide residues above the level permitted by a tolerance, or if the
food contains residues at any level if no tolerance or tolerance
exemption has been established.

Section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA)
authorizes EPA to establish, modify, or maintain tolerances or tolerance
exemptions for pesticide residues in or on food. 21 U.S.C. § 346a.  Any
food with pesticide residues not covered by a tolerance or tolerance
exemption and any food with residues in excess of the tolerance may be
subject to regulatory action, including seizure, by the U.S. government.
Pesticide tolerances and exemptions are enforced by the U.S. Food and
Drug Administration (FDA) for most foods, the U.S. Department of
Agriculture (USDA) for meat, poultry, and some egg products, and the
individual states. 

Retaining the carbofuran import tolerances will result in
carbofuran-contaminated food products in the U.S.

Foreign-grown crops that are treated with carbofuran are very likely to
result in carbofuran-contaminated crops being imported to the U.S. 
Given EPA’s proper determination that carbofuran contamination of food
in the U.S. is not safe, EPA must accordingly cancel all import
tolerances for carbofuran.

Carbofuran contamination of food is not safe

Under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), 7
U.S.C. §§ 121 et. seq, no pesticide may be sold in the U.S. without
being properly registered.  Only pesticides that EPA finds will not
create either any “unreasonable risk to man or the environment, taking
into account the economic, social, and environmental costs and benefits
of the use of any pesticide” or “a human dietary risk from residues
that result from a use of a pesticide in or on any food inconsistent
with the standard under section 408” of the FFDCA may be registered. 
Id. § 136(bb).  During the process of reregistration, EPA reanalyzed
previously registered pesticides, including carbofuran, to determine
whether they still met the FIFRA and the FFDCA health standards.  Id. §
136a-1.

In July 2006, EPA issued its proposed decision to cancel all domestic
uses of the toxic pesticide carbofuran, based on its extensive findings
that the pesticide does not meet the FIFRA and FFDCA health standards. 
(Revised N-Methyl Carbamate Cumulative Risk Assessment at 24, available
at <http://www.epa.gov/oppsrrd1/REDs/nmc_revised_cra.pdf>.)  However,
EPA did, inexplicably, choose to retain four import tolerances for
coffee, bananas, sugarcane, and rice.  While we applauded the decision
to cancel carbofuran domestic uses, we petitioned EPA to also revoke all
import tolerances.  By continuing to allow the import tolerances, EPA is
allowing food and products that are contaminated with carbofuran to
enter the U.S. without triggering any type of action. Since FDA, and not
EPA, checks imports for such violations, only by updating the list of
tolerances to reflect risk management decisions correctly can EPA ensure
that appropriate action be taken to keep America’s food supply safe. 

Imported bananas represent a particularly high risk food product 

In its “Guidance on Pesticide Import Tolerances and Residue Data for
Imported Food,” EPA provided an example of the conditions upon which
it may determine that further data is needed to establish an import
tolerance. See 65 Fed. Reg. 35069 (June 1, 2000).  It is interesting
that the Guidance uses bananas as an example, since bananas are one of
the carbofuran import tolerances that EPA has now failed to cancel. The
Guidance says: 

The vast majority of bananas consumed in the U.S. are imported. Bananas
are imported from Central and South America, and cultural practices for
bananas grown in the U.S. differ from those in Latin America. Existing
residue data consist of five U.S. field trials in Hawaii and Puerto
Rico. Bananas represent a relatively high percentage of the U.S. diet,
especially for children. To assess the safety of the tolerance, EPA
would likely require submission of additional residue data based on the
pesticide’s use in major banana exporting countries for the following
reasons: Most of what is consumed in the U.S. is imported and EPA has no
data on such foreign uses; cultural practices in other countries appear
to differ from those in the U.S.; and bananas represent a relatively
high percentage of the diet of a potentially sensitive subpopulation
(children). The tolerance petitioner would not necessarily have to
conduct new trials; however, since there may be existing, reliable
residue data that supported a Codex submission or an MRL approved by
another regulatory body. 

Id. at 35073.

Approximately 99.8% of all bananas available in the U.S. are imported.
The highest consumption level for any population sub-group is 0.96% of
the diet for infants. 

Id. at 35080.

This discussion by EPA underscores the fact that EPA recognizes that
imported bananas represent a particularly high risk food product:
imports contribute the most of the bananas in this country, bananas are
eaten in high quantities by children, and bananas are imported from
countries that have demonstrated lax health and safety enforcement for
pesticide use, including Ecuador, Costa Rica, Columbia, Honduras,
Guatemala, and Mexico.  

Bananas are routinely contaminated with pesticide residues

According to an analysis by Consumers Union of the USDA Pesticide Data
Program (PDP) data of dietary consumption of foods with pesticide
residues, bananas imported into the U.S. are routinely contaminated with
pesticides. Although the analysis does not provide data specific to
carbofuran residues, it does provide evidence of frequent pesticide
contamination of bananas.  

For bananas from Colombia, 70.4% had thiabendazole residues and 4% had
imazalil residues (1994). 

For  bananas from Costa Rica, 70.1% had thiabendazole residues and 4.4%
had imazalil residues (1994)

For bananas from Guatemala, 67.4% had thiabendazole residues, 4.3% had
imazalil residues, and 2.2% had diphenylamine residues (1995). 

For bananas from Honduras, 42.6% had thiabendazole residues and 4.3% had
imazalil residues (1995). 

For bananas from Panama, 95.7% had thiabendazole residues and 39.1% had
imazalil residues (1994). 

Because the EPA data only provide the mean (average) residue, rather
than actual residues found, it is difficult to determine the extent to
which the tolerances were routinely exceeded.  However, the data do
underscore the fact that the use of pesticides on these crops outside
the U.S. will result in routine contamination of imported bananas with
pesticide residue inside the U.S.  Imported coffee, which enters the
U.S. from many of the same countries that bananas do like Brazil,
Colombia, and Mexico, very likely suffers similar routine contamination
with pesticide residues.  

Carbofuran is a common residue on imported foods

A similar determination can be made that carbofuran use on crops in
other countries will result in carbofuran contamination of those food
products entering the U.S. based on carbofuran residues that have been
found on other crops. For example, according to the EPA data, carbofuran
residues have been detected on grapes from Chile and from Mexico.  
These residue detections highlight the fact that the use of carbofuran
on food products results in contamination of food by carbofuran at
detectable levels. 

Continuing to allow carbofuran import tolerances will expose the U.S.
food supply to carbofuran-treated imported foods that are not safe

In conclusion, the data available on imported food crops contaminated
with pesticides, including data on contaminated bananas and carbofuran
contamination of other food crops, highlight the high potential for
carbofuran contamination of those food crops which EPA allows import
tolerances.  EPA has determined that carbofuran contamination of food in
the U.S. is not safe, and yet the use of carbofuran on foreign-grown
crops that will likely result in contamination of those food when
imported into the U.S. is inexplicably allowed to continue.  Because the
U.S. food supply of carbofuran-treated imported foods (bananas, coffee,
sugarcane, rice) will not be safe, EPA must cancel all import tolerances
for carbofuran.

Revoking import tolerances protects both the U.S. population and the
international community through PIC reporting requirements

Generally, pesticide manufacturers prefer to voluntarily cancel high
risk products, or voluntarily withdraw high risks uses, rather than have
EPA issue a ban on those products. This practice highlights a separate,
but equally important, reason to revoke tolerances for pesticides that
are voluntarily withdrawn or cancelled. When a ban is issued, Prior
Informed Consent (PIC) listing is triggered, according to the Rotterdam
Convention which entered into force in early 2004. The Convention
creates legally binding obligations for the implementation of the Prior
Informed Consent (PIC) procedure for pesticides that have been banned or
severely restricted for health or environmental reasons. PIC
requirements include labelling and obligations to inform other parties
of a national ban or restrictions. At this time, there are 24 pesticides
subject to PIC procedures.  

To avoid PIC listing, that is, to avoid alerting the international
community of an unacceptably high risk pesticide, manufacturers will
instead issue a quiet voluntary withdrawal, thereby leaving open
international markets and trade options. We find this practice morally
reprehensible as it results in the transfer of high risk chemicals to
the developing countries, where environmental, occupational, and public
health protections are generally far weaker than the protections in the
U.S. Such countries often rely on the U.S. risk evaluations and risk
management decisions as guides and goals in managing their own chemical
risks. The U.S. can best serve the international community, and best
protect U.S. imports, by making public its risk assessments and risk
management determinations, including tolerance revocations.

Failing to revoke import tolerances leads to unacceptable ecological
risks

EPA has consistently identified that carbofuran use raises many
environmental concerns and acted on that information.  In 1992, EPA
cancelled the granular formulation with a prolonged phase-out period and
in 2002 it also cancelled all liquid formulations because of
unacceptably high risks.  The 2006 carbofuran Interim Reregistration
Eligibility Determination (IRED) concluded that, “based on the
assessment of ecological and human health risks associated with
carbofuran uses, the Agency has determined that all uses of carbofuran
are ineligible for reregistration.” The same IRED also concluded that,
“carbofuran is very highly toxic to birds on an acute basis, and
highly toxic on a sub-acute basis. A chronic effect level could not be
established due to the fact that all concentrations tested caused
mortality in the test subjects.”  And, “carbofuran is very highly
toxic to freshwater and estuarine/marine fish on an acute basis.” 

The continuing foreign use of pesticides cancelled in the U.S. presents
an unacceptable risk to North American migratory birds wintering in
Central and South American countries.  Billions of U.S. migratory birds
over-winter in countries that currently have registrations for
carbofuran, including the major countries listed for importation of
coffee, bananas, sugarcane and rice.  In fact, carbofuran use on rice
was the first major crop use documented to kill birds in significant
numbers, and the major reason for cancellation of the granular
formulation in 1992.  Maintaining a U.S. import tolerance for carbofuran
allows Central and South American countries to continue using any
formulation of this pesticide on crops for which the U.S. has already
determined there are unacceptable risks for protected U.S. migratory
birds.  EPA must protect U.S. migratory birds on their wintering grounds
as well as in the U.S. by cancelling tolerances for these crops.  Doing
so will encourage the use of legal, safer pesticides and non-chemical
practices by foreign growers, at least for those crops that are imported
into the U.S.

The ABC “Birds in Agricultural Areas” database contains data from 60
peer reviewed publications documenting the use of U.S. rice fields by
183 species of birds.  Thirty-seven of these species are on the
ABC-Audubon “Watch List” of vulnerable species, and many are species
that migrate to Latin America during the winter season.  Agricultural
use of carbofuran in Latin America occurs during the rice growing
season, which coincides with the seasonal migration pattern of U.S.
birds in these countries.

Rice is a very important crop for many shorebirds, waders, waterfowl and
some grassland birds; bananas and coffee (especially shade coffee) are
also very important winter habitats for many neotropical migrant
songbirds.  The use of carbofuran in these crops will continue to pose
unreasonable risks for U.S. and many additional bird species.  

Pursuant to Executive Order 13186 §3(e)(9), EPA must 

identify where unintentional take reasonably attributable to agency
actions is having, or is likely to have, a measurable negative effect on
migratory bird populations, focusing first on species of concern,
priority habitats, and key risk factors. With respect to those actions
so identified, the agency shall develop and use principles, standards,
and practices that will lessen the amount of unintentional take,
developing any such conservation efforts in cooperation with the [US
Fish and Wildlife] Service.  

Setting an import tolerance for carbofuran constitutes an agency action
that is likely to have a measurable negative effect on species of
concern as well as other protected species under the Migratory Bird
Treaty Act.  16 U.S.C. §§ 703-711.  Additionally, since the EPA has
already determined in the carbofuran IRED that carbofuran poses an
unreasonable risk to protected bird species, the Agency must cancel the
import tolerances for rice, bananas, coffee and sugarcane.

Conclusion

As explained above, EPA should cancel all the remaining import
tolerances for carbofuran.  EPA has already determined that the presence
of carbofuran residue on food products is unsafe and properly canceled
all uses and revoked all domestic tolerances.  To remain consistent with
that determination, EPA must therefore also revoke all import tolerances
to ensure complete protection of the U.S. food supply from carbofuran
contamination.  Furthermore, EPA’s revocation of the import tolerances
will also signal to the international community that carbofuran is too
toxic of a pesticide to be used on any human food product.  Therefore,
EPA should cancel all import tolerances for carbofuran.

Respectfully,

Jennifer Sass, Ph.D., Natural Resources Defense Council

Mae Wu, Esq., Natural Resources Defense Council

Michael Fry, Ph.D. American Bird Conservancy

 Petition to Cancel Carbaryl and Propoxur for Pet Collar Uses; Petition
to Revoke All Tolerances of Carbofuran; and Comments on EPA's revised
cumulative risk assessment for the N-methyl carbamate pesticides Nov.
26, 2007, EPA-HQ-OPP-2007-0935-0027 and -0027.1

 http://www.epa.gov/pesticides/factsheets/naftaqa.htm#2

 Id.

 Petition to Cancel Carbaryl and Propoxur for Pet Collar Uses; Petition
to Revoke All Tolerances of Carbofuran; and Comments on EPA's revised
cumulative risk assessment for the N-methyl carbamate pesticides Nov.
26, 2007, EPA-HQ-OPP-2007-0935

 Sass R. Agricultural "killing fields": the poisoning of Costa Rican
banana workers. Int J Health Serv. 2000;30(3):491-514.

 Table 5. Shares of Total Toxicity Index Values Contributed by
Individual Pesticides Detected on Each Food by Origin and Year,
Pesticide Data Program 1994-1998. Available at
http://www.ecologic-ipm.com/PDP/Table5_1998.pdf

 Table 5. Shares of Total Toxicity Index Values Contributed by
Individual Pesticides Detected on Each Food by Origin and Year,
Pesticide Data Program 1994-1998. Available at
http://www.ecologic-ipm.com/PDP/Table5_1998.pdf

 Rotterdam Convention http://www.pic.int/home.php?type=t&id=5&sid=16

 See Annex III of the  Rotterdam Convention for a list of chemicals
currently subject to the PIC procedure
http://www.pic.int/home.php?type=t&id=29

 Carbofuran IRED (2006).   HYPERLINK
"http://www.epa.gov/pesticides/reregistration/REDs/carbofuran_ired.pdf" 
http://www.epa.gov/pesticides/reregistration/REDs/carbofuran_ired.pdf 

Carbofuran IRED facts.
http://www.epa.gov/oppsrrd1/REDs/factsheets/carbofuran_ired_fs.htm

 Carbofuran IRED facts.
http://www.epa.gov/oppsrrd1/REDs/factsheets/carbofuran_ired_fs.htm

 Carbofuran IRED facts.
http://www.epa.gov/oppsrrd1/REDs/factsheets/carbofuran_ired_fs.htm

 http://www.abcbirds.org/abcprograms/policy/pesticides/biaa/biaa_form2.c
fm

 http://web1.audubon.org/science/species/watchlist/browsewatchlist.php

 PAGE   

 PAGE   1 

EPA-HQ-OPP-2007-0935

Supplemental information for NRDC petition to cancel import tolerances
for carbofuran