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Environmental Assessment
Availability of Petition and Environmental Assessment for Determination of Nonregulated Status for Papaya Genetically Engineered for Resistance to the Papaya Ringspot Virus
The regulations in 7 CFR part 340, "Introduction of Organisms and Products Altered
or Produced Through Genetic Engineering Which Are Plant Pests or Which There Is
Reason To Believe Are Plant Pests," regulate, among other things, the introduction
(importation, interstate movement, or release into the environment) of organisms
and products altered or produced through genetic engineering that are plant pests
or that there is reason to believe are plant pests. Such genetically engineered
organisms and products are considered "regulated articles.".
The regulations in 340.6(a) provide that any person may submit a petition to
the Animal and Plant Health Inspection Service (APHIS) seeking a determination
that an article should not be regulated under 7 CFR part 340. Paragraphs (b) and
(c) of 340.6 describe the form that a petition for a determination of nonregulated
status must take and the information that must be included in the petition.
On December 2, 2004, APHIS received a petition seeking a determination of
nonregulated status (APHIS No. 04 337 01p) from the University of Florida,
Institute of Food and Agricultural Sciences (UFL IFAS) of Homestead, FL, for
papaya (Carica papaya L.)designated as transformation event X17-2, which has been
genetically engineered for resistance to the papaya ringspot virus (PRSV), stating
that papaya line X17 2 does not present a plant pest risk and, therefore, should
not be a regulated article under APHIS' regulations in 7 CFR part 340. UFL IFAS
responded to APHIS' subsequent requests for additional information and
clarification and submitted revisions to their petition on January 12, 2007, and
June 14, 2007. The petition is available for public review and comment.
Analysis
As described in the petition, papaya transformation event X17-2 has been
genetically engineered with a sequence from the PRSV. This sequence was derived
from the PRSV coat protein (cp)gene and introduced into X17-2 papaya along with
one plant-expressed selectable marker gene, nptII, via Agrobacterium-mediated
transformation. The marker gene is commonly used and enables researchers to select
those plant tissues that have been successfully transformed with the gene of
interest. The resistance to PRSV appears to be conferred through post
transcriptional gene silencing.
Transformation event X17-2 has been considered a regulated article under the
regulations in 7 CFR part 340 because it contains gene sequences from plant
pathogens. X17 2 papaya has been field tested in the United States since 1999
under notifications authorized by theU.S. Department of Agriculture (USDA).
APHIS has presented two alternatives in the draft environmental assessment
(EA)based on its analyses of data submitted by UFL IFAS, a review of other
scientific data, and field tests conducted under APHIS oversight. APHIS may:
(1)Take no action (X17-2 papaya remains a regulated article); or
(2) deregulate X17-2 papaya in whole (the preferred alternative).
In section 403 of the Plant Protection Act (7 U.S.C. 7701 et seq.), "plant pest"
is defined as any living stage of any of the following that can directly or
indirectly injure, cause damage to, or cause disease in any plant or plant
product: A protozoan, a nonhuman animal, a parasitic plant, a bacterium, a fungus,
a virus or viroid, an infectious agent or other pathogen, or any article similar
to or allied with any of the foregoing. APHIS views this definition broadly to
cover direct or indirect injury, disease, or damage not just to agricultural
crops, but also to other plant parts and plant products whether natural,
manufactured, or processed.
X17-2 papaya is subject to regulation by other
Federal agencies. Under the Coordinated Framework for the Regulation of
Biotechnology, the U.S. Environmental Protection Agency (EPA) is responsible for
the regulation of pesticides under the Federal Insecticide,Fungicide, and
Rodenticide Act(FIFRA), as amended (7 U.S.C. 136 et seq.). FIFRA requires that all
pesticides,including herbicides, be registered prior to distribution or sale,
unless exempt by EPA regulation. In order to be registered as a pesticide under
FIFRA, it must be demonstrated that when used with common practices, a pesticide
will not cause unreasonable adverse effects in the environment. Because the use of
Plant Incorporated Protectants (PIP), such as viral coat proteins, is considered
pesticidal, the University of Florida has submitted a registration package to EPA
for X17-2 papaya.
Under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended (21 U.S.C.301
et seq.), pesticides added to (or contained in) raw agricultural commodities
generally are considered to be unsafe unless a tolerance or exemption from
tolerance has been established. Residue tolerances for pesticides are established
by EPA under the FFDCA, and the U.S. Food and Drug Administration (FDA) enforces
the tolerances set by EPA. EPA has previously granted a tolerance exemption for
PRSV coat protein in papaya.
The FDA policy statement concerning regulation of products derived from new plant
varieties, including those genetically engineered, was published in the Federal
Register on May 29, 1992, and appears at 57 FR 22984 23005. Under this policy, FDA
ensures that human food and animal feed, including those derived from
bioengineered sources, are safe and wholesome.
The University of Florida has submitted a food and feed safety and nutritional
assessment summary to FDA for X17-2 papaya in 2007 that is currently under agency
review. A draft EA has been prepared to provide the APHIS decision maker with a
review and analysis of any potential environmental impacts associated with the
proposed determination of nonregulated status for X17-2 papaya.
The draft EA was prepared in accordance with:
(1) The National Environmental Policy Act of 1969(NEPA), as amended (42 U.S.C.
4321 et seq.),
(2) regulations of the Council on Environmental Quality for
implementing the procedural provisions of NEPA (40 CFR parts 1500 1508),
(3)
USDA regulations implementing NEPA (7 CFR part 1b), and
(4) APHIS' NEPA
Implementing Procedures (7 CFR part 372).In accordance with 340.6(d) of
the regulations, we are publishing this notice to inform the public that APHIS
will accept written comments regarding the petition for a determination of
nonregulated status from interested or affected persons for a period of 60 days
from the date of this notice. We are also soliciting written comments from
interested or affected persons on the draft EA prepared to examine any
environmental impacts of the proposed determination for the deregulation of the
subject papaya event.
The petition,the draft EA, and any comments received are available for public
review, and copies of the petitions and the draft EA are available as indicated
under ADDRESSES and FOR FURTHER INFORMATION CONTACT above. After the comment
period closes, APHIS will review all written comments received during the comment
period and any other relevant information. After reviewing and evaluating the
comments on the petition and the EA and other data and information, APHIS will
furnish a response to the petitioner, either approving or denying the petition.
APHIS will then publish a notice in the Federal Register announcing the regulatory
status of UFL IFAS PRSV-resistant papaya event X17-2 and the availability of
APHIS' written regulatory and environmental decision.
Authority: 7 U.S.C.
7701 7772 and 7781 7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3. Done in
Washington, DC, this 26th day of August 2008. Kevin Shea, Acting Administrator,
Animal and Plant Health Inspection Service. [FR Doc. E8 20289 Filed 8 29 08; 8:45
am]
Main Office: 660 Pennsylvania Ave., S.E., Suite 302, Washington, D.C.
• Phone: 202-547-9359 • Fax: 202-547-9429
California Office: 2601 Mission Street, Suite 803, San Francisco, CA 94110
• Phone: 415-826-2770 • Fax: 415-826-0507
Email: info@centerforfoodsafety.org • www.centerforfoodsafety.org
• www.foodsafetynow.org
Docket No. APHIS-2008-0054
Regulatory Analysis and Development, PPD, APHIS
Station 3A-03.8
4700 River Road Unit 118
Riverdale, MD 20737-1238
November 3, 2008
Re: Docket o. APHIS-2008-0054
University of Florida; Availability of Petition and Environmental Assessment for
Determination of Nonregulated Status for Papaya Genetically Engineered for
Resistance to the Papaya Ringspot Virus
Please find attached 7,873 comments opposing Docket No. APHIS-2008-0054
from Center for Food Safety True Food Network members.
The Center for Food Safety (CFS) is a national, non-profit, membership
organization founded in 1997 to protect human health and the environment by
curbing the use of harmful food production technologies and by promoting organic
and other forms of sustainable agriculture. CFS represents approximately 67,000
members. .
CFS and its members strongly oppose the deregulation of genetically engineered
papaya trees for the following reasons:
Genetic contamination is a serious and growing threat. Flowers and seeds in organic
and conventional papaya groves will become contaminated with GE papaya genes via
pollen transported by bees and other insects that travel many miles in search of
pollen. The result is that organic and conventional papaya growers will lose their
markets for non-GE papayas as DNA testing confirms the contamination, as it already
has with GE papayas in Hawaii. An organic tree might remain organic itself, but the
pollen, honey and seeds will be contaminated, and trees planted from the GE papaya
seeds will bear contaminated fruit.
The USDA's environmental assessment admits that the GE papaya readily hybridizes
within its species. Thus, there may be a significant potential for gene flow into
native perennial papaya varieties. GE papaya trees will be long lived, and capable
of contaminating orchards and native papaya tree populations for several decades.
One GE papaya tree will be able to produce thousands of GE seeds and extensive
quantities of pollen, and will be capable of spreading fertile GE papaya seeds and
pollen into the environment for many years.
There are also serious and mounting concerns about a broad range of health effects
associated with consumption of GE crops, GE pollen, and GE-produced honey. For
example, consumers may suffer allergic reactions due to unexpected toxins in GE
foods. The GE papaya pollen may produce unintended effects such as allergic
reactions in sensitive individuals and the USDA has not properly evaluated the
potential for allergic reactions.
Finally, the deregulatory petition completely ignores potential effects on bees
and other pollinator species. Today honey bee colony collapse disorder known as
CCD is a serious and growing problem for apiaries and bee-pollinated crops
including in Florida where the GE papaya trees will be grown. Although unintended
effects are common in GE crops (and are part of regulatory human health
assessments), there is extremely little assessment of possible environmental
impacts from unintended effects. There are no studies that would allow us to
evaluate the potential hazards of GE tree pollen or GE papaya tree pollen for a
variety of insects, or for consumers of honey. We also do not know how animals and
insects that browse on papaya leaves might be affected.
Thank you for taking the comments of our members under consideration.
Kevin Zelig Golden
Staff Attorney
Center for Food Safety
.
Dr. Rachel Smolker, Ph.D. Global Justice Ecology Project Stop GE Trees Campaign PO Box 412 Hinesburg, Vermont 05461 November 3, 2008 Subject: Docket No. APHIS-2008-0054, Ring Spot Virus Resistant Papaya The University of Florida petition to deregulate the Ring Spot Virus Resistant Papaya is a threat to consumers and to growers of papaya. It also sets a dangerous precedent towards deregulation of other genetically engineered tree varieties, and is therefore a threat to native forests and tree species. Once this genetically engineered papaya is introduced, contamination of non-genetically engineered papaya will most certainly occur. The rapid and extensive contamination of native and non- genetically engineered papayas on Hawaii, following introduction of a similar GE variety, illustrates clearly that contamination is to be expected. It is simply not possible to contain the pollen and seed, and once contamination has occurred it is not possible to retract. Contamination risk is of utmost concern, and is the basis for strong public opposition to the commercial release of any genetically engineered tree variety, not just papaya, and regardless of whether it produces edible fruit. Patterns and mechanisms for reproduction of trees are simply not amenable to control with widespread wind, insect, animal and waterway dispersal of seeds and pollen. As the coordinating body for the Stop GE Trees Campaign, which engages participants from 137 organizations in 34 countries, we can confidently state that internationally as well as nationally, public opinion is strongly opposed to the commercial release of GE trees. We have worked extensively with the UN Convention on Biological Diversity toward adoption of an international ban on commercialization of GE trees in light of the contamination risks and unknown consequences for native trees and forests. Following long deliberations, the CBD ultimately failed to adopt the ban, acquiescing to pressure from industry lobbyists with vested interest in commercialization of GE trees (especially in Brazil, New Zealand and Canada). However, the ban was very clearly and overwhelming supported by all African delegates as well as all participating NGO and Indigenous Peoples Organizations, illustrating that public opinion, both national and international is widely opposed to GE trees. Additionally, the UN Food and Agriculture published a study on GE trees in December 2004 titled, "A Preliminary Review of Biotechnology in Forestry Including Genetic Modification" http://www.fao.org/docrep/008/ae574e/AE574E00.htm In this document, GE tree researchers were interviewed about their greatest concerns regarding the technology. Over half of researchers surveyed reported unintended contamination of non-target species as a major concern. A brief glance at the public comments already filed within this docket demonstrates, once again, strong public opposition. If APHIS makes the decision to deregulate the ring spot resistant papaya at this time, it can only be undertaken by means of blatant disregard for public opinion. The USDA APHIS processes are intended to protect consumers and plant and animal health. Given the risks of contamination, the numerous potential unknown (and unstudied) health consequences for human and animal consumers of GE papaya, and the precedent that this deregulation would set with respect to future GE tree deregulation, this petition must be denied. We urge you to protect growers and consumers and to avoid setting a precedent for further introduction of genetically engineered trees. Sincerely, Dr. Rachel Smolker, Ph.D. Global Justice Ecology Project Stop GE Trees Campaign (802) 482 2689 (office) (802) 482 2848 (home) (802) 735 7794 (mobile) rsmolker@globaljusticeecology.orgContact arthurtesla@yahoo.com Email Arthur Tesla
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