Ian & Stuart's Australian Mac: Not for Sale/Another.not.for.sale (Australia).iso/Dr. Doyle/Cotton Environmental Ass

Text File | 1994-06-22 | 37KB | 789 lines

NBIAP BBS Note - (tm) = Trademark






         USDA/APHIS Petition P93-196-01 for Determination
           That BXN(tm) Cotton Poses No Plant Pest Risk


                      Environmental Assessment
                           February 1994








    Finding of No Significant Impact (FONSI) for Nonregulatory
                               Status
            of BXN(tm) Cotton, Calgene Petition P93-196-01



The Animal and Plant Health Inspection Service (APHIS) of
 the U.S. Department of Agriculture has conducted an
 environmental assessment in response to a petition (APHIS
 Number P93-196-01) received from Calgene, Inc., regarding
 the status of trademarked cotton lines, designated BXN(tm)
 cotton, under APHIS regulations at 7 CFR Part 340.  The
 plants have been engineered with a selectable genetic marker
 gene and a gene that confers tolerance to the herbicide
 bromoxynil.  Based upon the analysis documented in its
 environmental assessment, APHIS has reached a finding of no
 significant impact on the environment from its determination
 that cotton lines fitting the definition of BXN(tm) cotton that
 have been field tested prior to the submission of the
  petition will no longer be regulated articles.







 John H. Payne, Ph.D.
 Acting Director
 Biotechnology, Biologics, and Environmental Protection
 Animal and Plant Health Inspection Service
 U.S. Department of Agriculture
 Date:
  I.  Summary

The U.S. Department of Agriculture, Animal and Plant Health
 Inspection Service (APHIS) has prepared an environmental
 assessment in response to a petition (APHIS Number
 P93-196-01) from Calgene, Inc., regarding trademarked lines
 of cotton (Gossypium hirsutum) designated BXN(tm) cotton.
 Calgene seeks a determination from APHIS that BXN(tm) cotton
 does not present a plant pest risk and is therefore no
 longer a regulated article.  The significant modification to
 the BXN(tm) cotton plants relative to traditional cotton
 varieties is that BXN(tm) cotton has been modified to express
 one genetic marker gene and another gene that provides
  tolerance to herbicide bromoxynil.

APHIS regulations at 7 CFR Part 340, which were promulgated
 pursuant to authority granted by the Federal Plant Pest Act
 (FPPA), (7 U.S.C. 150aa-150jj) as amended, and the Plant
 Quarantine Act (PQA), (7 U.S.C. 151-164a, 166-167) as
 amended, regulate the introduction (importation, interstate
 movement, or release into the environment) of certain
 genetically engineered organisms and products.  An organism
 is not subject to the regulatory requirements of 7 Part 340
 when it is demonstrated not to present a plant pest risk.
 Section 340.6 of the regulations, entitled "Petition Process
 for Determination of Nonregulated Status," provides that a
 person may petition the agency to evaluate submitted data
 and determine that a particular regulated article does not
 present a plant pest risk and should no longer be regulated.
 If the agency determines that the regulated article does not
 present a risk of introduction or dissemination of a plant
 pest, the petition would be granted, thereby allowing for
 unregulated introduction of the article in question.
 Permits under those regulations will no longer be required
 from APHIS for field testing, importation, or interstate
 movement of that article or its progeny.  Normal agronomic
 practices with it, e.g., cultivation, propagation, movement,
 and cross-breeding could then be conducted without APHIS
  permit.

BXN(tm) cotton lines have previously been field tested under
 15 APHIS permits.  Permitted field tests took place at a
 total of 57 sites in 13 states.  Field tests were also
 conducted in Argentina, Bolivia, and South Africa in
 accordance with national regulatory requirements.
 Additional demonstration trials using BXN(tm) cotton were also
 performed under notification during the growing season just
 ended.  All field trials were performed essentially under
  conditions of reproductive confinement.

APHIS has considered the information provided by Calgene in
 its petition as well as other scientific data and comments
 received from the public relating to the potential plant
 pest risk of BXN(tm) cotton. APHIS has made the determination
 that BXN(tm) cotton has no potential to pose a plant pest risk,
 and determined that BXN(tm) cotton lines that have been
 previously field tested under permit are no longer regulated
 articles.  Our documentation of that determination is
 attached as an appendix.  In reaching that determination, in
 accordance with regulations and guidelines implementing the
 National Environmental Policy Act of 1969 (42 U.S.C. 4321 et
 seq.; 40 CFR 1500-1508; 7 CFR Part 1b; 44 FR 50381-50384;
 and 44 FR 51272-51274), APHIS has evaluated the potential
 for significant impact to the human environment from its
  determination.  That analysis is presented herein.

An environmental assessment (EA) was prepared prior to
 granting each of the permits for a field trial using BXN(tm)
 cotton.  The 15 previous EA's discussing BXN(tm) cotton
 addressed issues pertinent to plant pest risk issues
 relative to the conduct of field trials under reproductive
 confinement.  The technical discussion of plant pest risk
 issues is reiterated and expanded in our determination in
 the appendix.  The analyses in the 15 previous EA's, though
 adequate to address most of the issues relating to the
 properties of BXN(tm) cotton, do not address several new issues
 that are of relevance to the growth of BXN(tm) cotton in the
 absence of such confinement.  The main new issues that are
  considered in this EA are:
     * Is there any potential for significant impact to the
      environment based on increased weediness of BXN(tm) cotton
       relative to traditionally bred cotton?

     * Will outcrossing of BXN(tm) cotton with any wild plant
      relatives result in any significant impact to the
       environment? and

     * Will the use of BXN(tm) cotton result in any significant
      impact on any unrelated (nontarget) organisms,
      including both beneficial organisms such as bees and
       earthworms as well as endangered species?

Based on its review, APHIS has concluded that:  (1) there is
 no reason to believe that BXN(tm) cotton should exhibit
 enhanced weediness relative to traditionally bred cotton,
 which is not considered to show particular weedy aggressive
 tendencies; (2) although outcrossing is likely to occur at
 some level between BXN(tm) cotton and other wild or cultivated
 cottons or cotton relatives, there is no reason to believe
 that outcrossing will either increase the weediness of other
 cotton populations or otherwise impact them differently from
 outcrossing with traditionally bred cottons; and (3) there
 is no reason to believe that BXN(tm) cotton will have any
  significant impact on any nontarget species.

This EA specifically addresses the potential for impacts to
 the human environment through the use in agriculture of BXN(tm)
 cotton.  It does not address the separate issue of the
 potential use of the herbicide bromoxynil (Buctril) in
 conjunction with BXN(tm) cotton.  The U.S. Environmental
 Protection Agency (EPA) has authority over the use in the
 environment of all pesticidal substances, including
 herbicides, under the Federal Insecticide, Fungicide, and
 Rodenticide Act (FIFRA); in particular, EPA has jurisdiction
 over registration of bromoxynil for use on cotton.  The
 potential issuance by EPA of a new label for use of the
 herbicide bromoxynil on BXN(tm) cotton and the determination
 by APHIS regarding the cotton itself are independent
 decisions, under consideration by different agencies, based
 on distinct regulations under unrelated legal authorities,
 in response to requests from two separate corporate
 entities.  We have considered the potential for impacts
 outside the boundaries of the United States in response to
 comments although APHIS' decision only goes to actions
  within the United States.

The APHIS review and analysis of Calgene's petition in this
 EA result in a finding of no significant impact (FONSI) to
 the human environment relative to the determination that
 BXN(tm) cotton lines that have been previously field tested
 under the regulations at 7 CFR Part 340 will no longer be
  regulated articles.  The FONSI accompanies this document.

 II.  Introduction

A petition was submitted to USDA/APHIS pursuant to
 regulations codified in 7 CFR Part 340 which are entitled
 "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."  The
 regulations govern the introduction (importation, interstate
 movement, or release into the environment) of certain
 genetically engineered organisms and products.  Under
 section 340.0 of the regulations, a person is required to
 obtain a permit prior to introducing a regulated article.
 Prior to issuing a permit, APHIS conducts an analysis of the
 potential impacts associated with the proposed introduction,
 and publishes an environmental assessment which documents
 the analysis in accordance with regulations and guidelines
 implementing the National Environmental Policy Act of 1969
 (42 U.S.C. 4321 et seq.; 40 CFR 1500-1508; 7 CFR Part 1b; 44
 FR 50381-50384; and 44 FR 51272-51274).  Certain field
 trials may be conducted according to the requirements of a
 notification option described under section 340.3.  (A
 Special Assessment relative to the introduction of regulated
 articles under notification was prepared by APHIS prior to
 promulgation of the notification option.  It is available
  upon request.)

A genetically engineered organism is considered a regulated
 article if the donor organism, recipient organism, vector or
 vector agent used in engineering the organism belongs to one
 of the taxa listed in the regulation and is also a plant
 pest, or if there is reason to believe that it is a plant
 pest.  The transgenic cotton plants described in the Calgene
 petition have been considered regulated articles because
 noncoding DNA regulatory sequences and portions of the
  plasmid vector are derived from plant pathogens.

An organism is not subject to the regulatory requirements of
 7 Part 340 when it is demonstrated not to present a plant
 pest risk.  Section 340.6 of the regulations, entitled
  Petition Process for Determination of Nonregulated Status,
 provides that a person may petition the agency to evaluate
 submitted data and determine that a particular regulated
 article does not present a plant pest risk and should no
 longer be regulated.  Among other data requirements, section
  340.6 (c)(3) requires that a petitioner,

     "... Describe known and potential differences from the
      unmodified organism that would substantiate that the
      regulated article is unlikely to pose a greater plant
      pest risk than the unmodified organism from which it
      was derived, including but not limited to:  plant pest
      risk characteristics, disease and pest
      susceptibilities, expression of the gene product, new
      enzymes, or changes to plant metabolism, weediness of
      the regulated article, impact on the weediness of any
      other plant with which it can interbreed, agricultural
      or cultivation practices, effects of the regulated
      article on nontarget organisms, indirect plant pest
      effects on other agricultural products, transfer of
      genetic information to organisms with which it cannot
      interbreed, and any other information which the
      Director believes to be relevant to a determination.
      Any information known to the petitioner that a
      regulated article may pose a greater plant pest risk
      than the unmodified recipient organism shall also be
       included."

If the agency determines that the regulated article does not
 present a risk of introduction or dissemination of a plant
 pest, the petition would be granted, thereby allowing for
  unregulated introduction of the article in question.


 III.  Alternatives

APHIS has considered the following four alternatives with
  respect to Calgene's petition:

     (1) deny the petition, so that BXN(tm) cotton plants would
      continue to be regulated articles under 7 CFR Part 340;


     (2) approve the petition for all cotton lines fitting
      the definition of BXN(tm) cotton, regardless of whether
      they have been field tested or produced in the
       laboratory to date;

     (3) approve the petition for all cotton lines fitting
      the definition of BXN(tm) cotton that have been field
      tested prior to the submission of the subject petition;
       or

     (4) approve either alternative (2) or (3) with the
      additional stipulation that the determination applies
      to the use of BXN(tm) cotton within the continental United
       States.


 IV.  Scope

This EA is concerned with potential environmental impacts
 from the unrestricted introduction of BXN(tm) cotton.  The
 genetic material introduced into BXN(tm) cotton has been
 discussed in detail in EA's prepared for 15 prior field
 tests under APHIS permits 92-106-01, 92-105-01, 91-357-01,
 91-333-02, 91-329-04, 91-329-03, 91-329-02, 91-329-01,
 91-107-06, 91-035-07, 90-303-02, 90-297-01, 90-016-04,
 89-192-01, and 89-047-07.  Permitted field tests took place
 at a total of 57 sites in the following 13 states:  Alabama,
 Arizona, Arkansas, California, Georgia, Hawai'i, Louisiana,
 Mississippi, Missouri, North Carolina, South Carolina,
 Tennessee, and Texas.  Field tests were also conducted in
 Argentina, Bolivia, and South Africa in accordance with
 national regulatory requirements.  Additional demonstration
 trials using BXN(tm) cotton were also performed under
 notification during the growing season just ended.  All
 field trials were performed essentially under conditions of
 reproductive confinement.  Further discussions of the
 biology of cotton as well as of the genetic components used
 to construct BXN(tm) cotton are found in APHIS' Determination
 that BXN(tm) cotton has no potential to pose a plant pest risk.
 As this information is included in the appendix, it will not
  be described in detail in the body of this document.

There are minor differences in the description of cotton
 varieties tested under the cited permits and the
 description, in Calgene's petition, of BXN(tm) cotton, based
 on new information provided by Calgene concerning the
 genetic composition of BXN(tm) cotton transformants.
 Additional sequences, derived from the region outside the
 T-DNA borders in the vectors used for the genetic
 transformation of cotton, may be present in some BXN(tm) cotton
 lines.  Although some of these sequences may be derived from
 plant pathogens, none of them is involved in the causation
 of disease and none will be expressed in BXN(tm) cotton.  These
  sequences are discussed more fully in the appendix.

Effects associated with the potential uses of the herbicide
 bromoxynil in conjunction with BXN(tm) cotton are outside the
 scope of APHIS' analysis.  APHIS' determination does not
 constitute authorization to use bromoxynil on BXN(tm) cotton.
 Rather, EPA has the responsibility for ensuring that any
 uses of herbicide will not cause unreasonable adverse
 effects on the environment within the context of FIFRA.
 Approval by EPA of a particular label condition for a
 pesticide is granted when, under the specified conditions of
 use, it will not generally cause such effects.  EPA
 considers both human health and safety as well as nontarget
 effects of both the herbicide and its breakdown products in
 making a decision on registration of an herbicide.  The
 potential issuance by EPA of a new label for use of the
 herbicide bromoxynil on BXN(tm) cotton and the determination
 by APHIS regarding the cotton itself are separate decisions,
 under consideration by different agencies based on distinct
 regulations under unrelated legal authorities in response to
  requests from two separate corporate entities.

APHIS has also considered potential effects of the
 cultivation of BXN(tm) cotton outside the United States.  A
 general consideration of this topic indicates to us that
 there are no necessary impacts on cotton diversity
 occasioned by this determination to allow the cultivation,
 without permit, of BXN(tm) cotton in the United States.  Even
 if BXN(tm) cotton were to be cultivated in agricultural regions
 around centers of cotton diversity, it seems extremely
 unlikely that BXN(tm) cotton would have any effect on wild
 progenitors of cultivated cotton.  The herbicide bromoxynil
 is generally used only in agricultural contexts rather than
 on uncultivated land, and there is no reason to believe that
 the bromoxynil resistance trait would impart any selective
 advantage to a recipient plant in the absence of bromoxynil
 application.  In any event, there is already considerable
 cultivation of nontransgenic cotton around most centers of
 cotton diversity.  The major threat to many relatives of
 cotton appears to be habitat destruction (Fryxell, 1979).
 Therefore, this topic will not be discussed in any greater
 detail.  We would, however, note these additional facts:
 (1) crop plants and seeds exported from the United States,
 whether transgenic or nontransgenic varieties, are still
 subject to the phytosanitary restrictions of the importing
 nation; (2) APHIS has no jurisdiction over agricultural
 practices in foreign nations and our action does not
 constitute approval for field testing or commercialization
 of this cotton in any other nation; (3) foreign laws
 restricting or regulating field testing and/or commerce with
 transgenic cotton are unaffected by our action; and (4)
 APHIS has no jurisdiction over approval for the use of
 bromoxynil on cotton plants in foreign nations.  Scenarios
 in which an impact of BXN(tm) cotton on wild cotton varieties
 is envisioned depend, at a minimum, on a biologically
 unlikely scenario coupled with a failure of regulatory
  oversight in a foreign nation.


 V.  Potential Environmental Impacts

Potential impacts to be addressed in this EA are those that
 pertain to the use of BXN(tm) cotton in the absence of
  confinement.

Potential impacts based on increased weediness of BXN(tm)
  cotton relative to traditionally bred cotton

Almost all definitions of weediness stress as core
 attributes the undesirable nature of weeds from the point of
 view of humans; from this core, individual definitions
 differ in approach and emphasis (Baker, 1965; de Wet and
 Harlan, 1975; Muenscher, 1980).  In further analysis of
 weediness, Baker (1965) listed 12 common weed attributes,
 almost all pertaining to sexual and asexual reproduction,
 which can be used as an imperfect guide to the likelihood
 that a plant will behave as a weed.  Keeler (1989) and
 Tiedje et al. (1989) have adapted and analyzed Baker's list
 to develop admittedly imperfect guides to the weediness
 potential of transgenic plants; both authors emphasize the
 importance of looking at the parent plant and the nature of
  the specific genetic changes.

The parent plant in this petition, G. hirsutum, does not
 show any appreciable weedy characteristics.  The genus also
 seems to be devoid of any such characteristics; although
 some New World cottons show tendencies to weediness
 (Fryxell, 1979; Haselwood et al., 1983), the genus shows no
 particular weedy aggressive tendencies.  The standard texts
 and list of weeds give no indication that cotton is clearly
 regarded as a weed anywhere (Holm et al., 1979; Muenscher,
 1980; Reed, 1970; Weed Science Society of America, 1989).
 Any reports that cottons behave as a weed are rare and
  anecdotal, and vague as to the nature of the problem.

The relevant introduced trait, bromoxynil tolerance, is
 unlikely to increase weediness of this cotton.  Bromoxynil
 would not be applied on BXN(tm) cotton for the purpose of
 controlling the cotton itself, but rather for controlling
 unrelated weeds in the field.  To increase weediness of the
 cotton plant there would have to be selection pressure on
 BXN(tm) cotton (Tiedje et al., 1989; Office of Technology
 Assessment, 1988) associated with bromoxynil use on it.
 Because bromoxynil will not affect the survival of BXN(tm)
 cotton and because G. hirsutum is not itself weedy, this
 type of selection pressure does not now and is unlikely ever
 to exist. Even if such bromoxynil-resistant weedy plants did
 exist, bromoxynil treatment would not be the control method
 of choice; many other methods of control would be readily
  available.

A review of other new traits, besides bromoxynil resistance,
 that may be present in the transgenic plant shows no
 likelihood to increase weediness potential.  None of these
 traits is in any way related to characteristics associated
  with weediness.

No other variation seen in BXN(tm) lines is indicative of
 increased weediness.  Calgene's data from greenhouse studies
 show a variation in germination rates among transgenic seed
 lines but no evidence of specific changes in the rate from
 parent to transgenic plant.  Calgene's burial study shows no
 obvious increase in volunteer plants from buried seeds.  In
 addition, Calgene's field reports show no obvious increase
 in volunteers from seed, regrowth from stubble, or increase
 in seed dormancy.  Calgene does report on lint
 characteristics which may suggest a decrease in seed size.
 If such a decrease does indeed exist, APHIS believes that no
 competitive advantage affecting weediness would be conferred
 on the transgenic plants by this change.  Calgene has
 correctly argued, APHIS believes, that a relationship
 between seed size and increase in weediness potential should
 only apply in small-seeded crops, in which seed dispersal is
 affected by factors like wind, and not in large-seeded crops
  like cotton.


Potential impacts from pollen escape and outcrossing of BXN(tm)
  cotton with wild relatives

None of the relatives of cotton found in the United States
 (G. barbadense, G. thurberi, and G. tomentosum) shows any
  definite weedy tendencies.

Successful sexual transmission of genetic material via
 pollen is possible only to certain cotton relatives.  In the
 United States, the compatible species are G. hirsutum (wild
 or under cultivation), G. barbadense (cultivated Pima
  cotton), and G. tomentosum.

BXN(tm) cotton is chromosomally compatible with wild G.
 hirsutum.  However, according to Dr. Paul Fryxell of Texas
 A&M University (personal communication), a leading authority
 on the systematics and distribution of Gossypieae, wild
 cottons are found only in southern Florida (virtually
 exclusively in the Florida Keys), whereas cultivated cottons
 are found in northernmost portions of the State.  Other wild
 G. hirsutum found around the Gulf of Mexico is to be found
 along the Mexican coast, largely along the Yucatan, and
 populations do not extend as far north as the Texas border.
 G. hirsutum has also been grown in several U.S. Territories
 and Possessions, and may even to a greater or lesser degree
 be spontaneous or naturalized in places such as the Northern
 Mariana Islands, Puerto Rico, and the Virgin Islands.
 However, there are no peculiarities of cotton in these areas
 that would require unique review.  Even if the
 nonagricultural land containing any wild cotton populations
 were near sites of commercial cotton production, there would
 be no significant impacts, APHIS believes, because:  (1) any
 potential effects of the trait would not alter the weediness
  of the wild cotton; and (2)



wild cotton populations have not been actively protected,
 but have in fact been, in some locations such as Florida,
 subject in the past to Federal eradication campaigns,
 because they can serve as potential hosts for the boll
  weevil, Anthonomus grandis Boh.

Gossypium thurberi, the wild relative found in Arizona, is
 not compatible with pollen from G. hirsutum, so that BXN(tm)
 cotton can have no effect on this species.  Movement to G.
 hirsutum and G. barbadense is possible if suitable insect
 pollinators are present, and if there is a short distance
 from transgenic plants to recipient plants.  Any physical
 barriers, intermediate pollinator-attractive plants, and
 other temporal or biological impediments would reduce the
  potential for pollen movement.

Movement of genetic material to G. tomentosum is more
 speculative.  The wild species is chromosomally compatible
 with G. hirsutum, but there is uncertainty about the
 possibility for pollination.  The flowers of G. tomentosum
 seem to be pollinated by moths, not bees, and they are
 reportedly receptive at night, not in the day.  Both these
 factors greatly lessen the possibility of cross-pollination.
 There have been reports based on morphological suggestions
 (Stephens, 1964; Fryxell, 1979) that G. tomentosum may be
 losing its genetic identity from hybridization with
 cultivated cottons by unknown means.  However, the most
 recent data, from DeJoode and Wendel (1992), indicate that
 despite the morphological suggestion of such hybrid
 populations, biochemical (allozyme) studies show no evidence
 of any such changes.  Major factors influencing the survival
 of G. tomentosum are construction and urbanization, i.e.,
 habitat destruction (Fryxell, 1979).  APHIS believes that it
 is these factors, rather than gene movement from cultivated
 cottons, that are of real significance to this species.
 Cotton lines bred by traditional means, which should be no
 more or less likely to interbreed with G. tomentosum than
 BXN(tm) cotton, are not considered to pose a threat to the wild
 cotton and are not subject to particular State or Federal
 regulation on this basis.  Neither the weediness nor the
 survival of G. tomentosum will be affected by the
 cultivation of BXN(tm) cotton, based on the facts that: the
 transgenic variety poses no increased weediness itself; the
 two species are unlikely to successfully cross in nature;
 and the added traits will confer no selective advantage in
  the wild species habitat.

In contrast to the situation with G. tomentosum, gene
 movement from G. hirsutum to G. barbadense is widespread in
 advanced cultivated stocks.  However, it is conspicuously
 low or absent in material derived from natural crosses such
 as that from Central America or the Caribbean where G.
 hirsutum and G. barbadense grow together.  The absence of
 natural introgression may be caused by any one of several
 isolating mechanisms of pollination, fertilization, ecology,
 gene incompatibility, or chromosome incompatibility (Percy
 and Wendel, 1990).  Movement of gene material from BXN(tm)
 cotton to cultivated or occasional noncultivated G.
 barbadense would therefore not likely occur at a high level.
 Any movement of genetic material from BXN(tm) cottons into G.
  barbadense is



likely to be the result of intentional breeding practice
 rather than accidental crossing.  Even if such movement did
 occur, it would not offer the progeny any clear selective
 advantage over the parents in the absence of sustained
  bromoxynil use.

Should a movement of genetic material take place to these
 receptive plants and bromoxynil resistance be transferred,
 no competitive advantage would be conferred, because
 bromoxynil is not used with these plants when they are found
 in nonagricultural areas.  In agricultural areas, such
 plants would be controlled by normal agronomic practices.
 Therefore, the presence of an occasional bromoxynil-tolerant
 relative of BXN(tm) cotton should pose no significant impact
  to the environment.


Potential impact on nontarget organisms, including
  beneficial organisms such as bees and earthworms

There is no reason to believe that deleterious effects or
 significant impacts on nontarget organisms, including
 beneficial organisms, would result from the cultivation of
 BXN(tm) cotton.  The novel proteins that will be expressed in
 BXN(tm) cotton are not known to have any toxic properties.  The
 lack of known toxicity for these proteins and the low levels
 of expression in plant tissue suggest no potential for
 deleterious effects on beneficial organisms such as bees and
 earthworms.  The narrow range of substances that can act as
 substrates for these two enzymes suggests that it is
 unlikely that they would act on any endogenous substance in
 any organism that might eat BXN(tm) cotton in the field to
 produce novel compounds toxic to it.  APHIS has not
 identified any other potential mechanisms for deleterious
 effects on beneficial organisms.  In addition, there is no
 reason to believe that the presence of BXN(tm) cotton would
 have any effect on any other threatened or endangered
  species in the United States.



 VI.  Consideration of Alternatives

Based on the information Calgene has provided regarding the
 properties of the BXN(tm) cotton lines it has developed and
 other information from other sources, APHIS has identified
 no significant impact to the environment from issuance of a
 determination that BXN(tm) cotton poses no potential for plant
 pest risk that would justify denying Calgene's petition.
  Accordingly, alternative (1) is rejected.

Calgene has provided data that substantiates that the
 properties of cotton lines that fit the definition of BXN(tm)
 cotton and that have been developed to date, exhibit a level
 of variability consistent with that of traditional cotton
 varieties.  It is expected that the progeny of these cotton
 lines will exhibit similar levels of variability.  It is not
 unlikely that similar properties will be exhibited by new
 cotton lines that may be developed in the future that fit
 the definition of BXN(tm) cotton.  However, APHIS believes that
 it is prudent to require information to corroborate that new
 cotton lines do not exhibit unexpected properties.  (As
 experience with such organisms increases, such verification
 may cease to be essential in the future.)  Accordingly,
  alternative (2) is rejected.

APHIS has identified no factors that would suggest any
 likelihood of impacts to the environment of the United
 States but outside the continental United States.  While
 isolated environments, such as are found in Hawai'i or in
 territories or possessions of the United States, have
 fragile ecologies that have frequently been damaged through
 human intervention, APHIS has determined that BXN(tm) cotton
 will have impacts no different from traditional cotton
 varieties that are not subject to petition requirements
 under 7 CFR Part 340 before they enter agriculture.
 Accordingly, alternative (4) is rejected and alternative (3)
  is adopted.
  VII.  Summary

In accordance with the requirements of NEPA, APHIS has
 considered the potential for significant impact on the
 environment of a proposed action, i.e, reaching the
 determination that lines of BXN(tm) cotton, that have been
 field tested under permit prior to submission of petition
 P93-196-01 to APHIS, have no potential to pose a plant pest
 risk and should no longer be considered regulated articles
 under the regulations at 7 CFR Part 340.  After careful
 analysis of the available information, APHIS concludes that
 its proposed action should present no significant impact on
 the environment.  This conclusion is based on factors
 discussed herein or in the determination included in the
  appendix, as well as the following factors:

1.  A gene that confers tolerance to the herbicide
 bromoxynil and a marker gene that confers resistance to the
 antibiotic kanamycin have been inserted into a cotton
 chromosome in cotton lines denoted BXN(tm) cotton.  In nature,
 chromosomal genetic material from plants can only be
 transferred to another sexually compatible flowering plant
 by cross-pollination.  The sexually compatible species in
 the United States are Gossypium hirsutum (i.e., other
 cultivated cotton or wild cotton), G. tomentosum, and G.
  barbadense.

2.  Neither the gene that confers tolerance to the herbicide
 bromoxynil nor the gene that confers kanamycin resistance,
 nor the gene product of either gene, nor their associated
 regulatory sequences, confers on BXN(tm) cotton any plant pest
  characteristic.

3.  In nature, the gene that confers tolerance to the
 herbicide bromoxynil will not provide the BXN(tm) cotton plants
 with any measurable selective advantage over nontransformed
 cotton plants in their ability to disseminate or to become
 established in the environment.  There is no reason to
 believe that BXN(tm) cotton exhibits any increased weediness
  relative to that of traditional varieties.

4.  There is no reason to believe that the use of BXN(tm)
 cotton in agriculture will lead to an increase in weediness
  in any plant with which it can successfully interbreed.

5.  There is no reason to believe that the use of BXN(tm)
 cotton in agriculture will have a significant impact on any
 beneficial organisms in the environment, or on any
  threatened or endangered species.
  VIII.  Literature Cited

Baker, H. G.  1965.  Characteristics and Modes of Origin of
 Weeds.  In:  Baker, H. G., Stebbins, G. L., eds.  The
 Genetics of Colonizing Species.  pp. 147-172.  Academic
  Press, New York and London.

DeJoode, D. R., Wendel, F. F.  1992.  Genetic Diversity and
 Origin of the Hawaiian Island Cotton, Gossypium tomentosum.
  American Journal of Botany.  79:1311-1319.

de Wet, J. M. J., Harlan, J. R.  1975.  Weeds and
 Domesticates: Evolution in the Man-Made Habitat.  Economic
  Botany.  29:99-107.

Fryxell, P. A.  1979.  The Natural History of the Cotton
 Tribe (Malvaceae, Tribe Gossypieae).  Texas A&M University
  Press.  College Station and London.  245 pp.

Haselwood, E., Motten, B., Hirano, R.  1983.  Handbook of
 Hawaiian Weeds.  University of Hawaii Press, Honolulu. 491
  pp.

Holm, L., Pancho, J. V., Herbarger, J. P., Plucknett, D. L.
 1979.  A Geographical Atlas of World Weeds.  John Wiley and
  Sons, New York.  391 pp.

Keeler, K.  1989.  Can genetically engineered crops become
  weeds?  Bio/Technology 7:1134-1139.

Muenscher, W. C.  1980.  Weeds.  Second Edition.  Cornell
  University Press, Ithaca and London.  586 pp.

Office of Technology Assessment, United States Congress.
 1988.  New Developments in Biotechnology 3.  Field-Testing
 Engineered Organisms:  Genetic and Ecological Issues.  U.S.
  Government Printing Office, Washington, DC.  150 pp.

Percy, R. G., Wendel, J. F.  1990.  Allozyme evidence for
 the origin and diversification of Gossypium barbadense L.
  Theoretical and Applied Genetics 79:529-542.

Reed, C. F.  1970.  Selected Weeds of the United States.
 Agriculture Handbook No. 366.  Agricultural Research
 Service, United States Department of Agriculture,
  Washington, D.C.  463 pp.

Stephens, S. G. 1964.  Native Hawaiian Cotton (Gossypium
  tomentosum Nutt.).  Pacific Science 18:385-398.

Tiedje, J. M., Colwell, R. K., Grossman, Y. L., Hodson, R.
 E., Lenski, R. E., Mack, R. N., Regal, P. J.  1989.  The
 Planned Introduction of Genetically Engineered Organisms:
 Ecological Considerations and Recommendations.  Ecology
  70:298-315.

Weed Science Society of America.  1989.  Composite List of
  Weeds.  WSSA.  Champaign, Illinois.
  IX.  Preparers and Reviewers


 Office of the Administrator
 Terry L. Medley, J.D., Acting Associate Administrator
 Animal and Plant Health Inspection Service


 Biotechnology, Biologics, and Environmental Protection
 John H. Payne, Ph.D., Acting Director


 Biotechnology Permits
 Arnold Foudin, Ph.D., Deputy Director
 Subhash Gupta, Ph.D., Staff Biotechnologist
 David S. Heron, Ph.D., Staff Biotechnologist
 Catherine Joyce, Ph.D., Staff Biotechnologist (Preparer)
 James Lackey, Ph.D., Biological Safety Officer (Preparer)
 Sivramiah Shantharam, Ph.D., Chief, Microorganisms Branch
 Sally L. Van Wert, Ph.D., Staff Biotechnologist
 James L. White, Ph.D., Chief, Plants Branch


 Biotechnology Coordination and Technical Assistance
 Michael A. Lidsky, J.D., LL.M., Deputy Director
 Shirley P. Ingebritsen, M.A., Program Analyst
 L. Val Giddings, Ph.D., Chief, Science Policy Coord. Branch
Michael Schechtman, Ph.D., Senior Microbiologist (Chief
  Preparer)
 Frank Y. Tang, Ph.D., J.D., Biotechnologist




 X.  Agency Contact

 Ms. Kay Peterson, Regulatory Assistant
 Biotechnology, Biologics, and Environmental Protection
 USDA, APHIS
 6505 Belcrest Road
 Hyattsville, MD  20782
 Phone: [phone]
 Fax: [phone]