SIERRA CLUB\
\
February 6, 2008\
\
Docket No. APHIS-2007-0044\
DEPARTMENT OF AGRICULTURE\
Animal and Plant Health Inspection Service\
Regulatory Analysis and Development, PPD, APHIS\
Station 3A-03.8\
4700 River Road Unit 118\
Riverdale, MD 20737-1238\
Via electronic submission on APHIS web site\
\
Re: Comments on the scope of the issues and regulatory alternatives in
the proposed Environmental Impact Statement; Determination of Regulated
Status of Alfalfa Genetically Engineered for Tolerance to the Herbicide
Glyphosate\
\
Attention USDA-APHIS Docket No. APHIS-2007-0044:\
\
On behalf of the Sierra ClubÕs Genetic Engineering Committee and more
than 1.3 million members and supporters, comments are submitted on the
scoping of the proposed Environmental Impact Statement; Determination of
Regulated Status of Alfalfa Genetically Engineered for Tolerance to the
Herbicide Glyphosate.\
\
Specific scoping questions posed by the Sierra Club are listed under
several of the 18 scoping areas outlined by APHIS in the FR Notice as
#1-18 with a capital letter designating the APHIS questions presented in
the FR Notice. The Sierra Club\'s comments and questions are numbered
separately under the list of 18 scoping issues presented by APHIS. The
Sierra Club strongly supports the list of 18 proposed scoping issues but
recommend additional areas be investigated under those 18 categories.\
\
One of the most toxic chemicals associated with glyphosate use is
1,4-dioxane which apparently is present due to the fact that most
polyalkoxylated surfactants such as the polyoxyethylene alkylamine in
RoundUp are contaminated with 1,4-dioxane. However, APHIS has not
previously or seriously considered the presence of such highly toxic
impurities in glyphosate such as 1,4-dioxane in the Environmental
Assessment, but needs to do so in the EIS. An important public health
and environmental concern is whether Monsanto has ever submitted data to
APHIS on the concentrations of 1,4-dioxane impurities in its ingredients
list for the surfactants used in glyphosate commercial grades or any
glyphosate sold in the US. Any studies by Monsanto ignoring or excluding
health and environmental impact considerations of 1,4-dioxane as present
in glyphosate may be highly biased and should be regarded as
inappropriate science.\
\
1,4-Dioxane, often just called dioxane, is a clear, colorless
heterocyclic organic compound which is a liquid at room temperature and
pressure. It has the molecular formula C4H8O2 and a boiling point of
101°C. It is commonly used as an aprotic solvent. 1,4-Dioxane has a weak
smell similar to that of diethyl ether. There are also two other less
common isomeric compounds, 1,2-dioxane and 1,3-dioxane.\
\
1,4-Dioxane is classified as an ether, with each of its two oxygen atoms
forming an ether functional group. It is more polar than diethyl ether,
which also has four carbons, but only one ether functional group.
Diethyl ether is rather insoluble in water, but 1,4-dioxane is miscible
with water and is hygroscopic. Its higher polarity and slightly higher
molecular mass also gives it a substantially higher boiling point than
diethyl ether. When used as a solvent for a grignard reaction, Dioxane
favorably affects the formation of magnesium halide salts in the Schlenk
equilibrium.\
\
1,4-dioxane is a known eye and respiratory tract irritant. It is
suspected of causing damage to the central nervous system, liver and
kidneys. Accidental worker exposure to 1,4-dioxane has resulted in
several deaths. Dioxane is classified by the IARC as a Group 2B
carcinogen: possibly carcinogenic to humans due to the fact that it is a
known carcinogen in animals.\
\
Like many solvents, 1,4-dioxane forms contamination plumes in
groundwater when released to the environment. Groundwater supplies have
been adversely impacted in several areas. A health and environmental
concern is that 1,4-dioxane is highly soluble in groundwater, does not
readily bind to soils, and readily leaches to groundwater. It is also
resistant to naturally occurring biodegradation processes. Due to these
properties, a 1,4-dioxane plume is often much larger (and further
downgradient) than the associated solvent plume.\
\
Additional Sierra Club comments on the 18 proposed scoping items.\
\
(1) Alfalfa Management Practices:\
\
A. What are the particular management practices for organic alfalfa,
conventional alfalfa, and glyphosate-tolerant alfalfa?\
B. What are the procedures and associated costs of establishing,
growing, harvesting, and marketing (includes selling prices and premiums
for various quality standards) for each of the three types of alfalfa?\
C. What crop rotation regimes are used with each type of alfalfa?\
\
[Sierra Club Comments and Questions 1.D. - 1.J.:]{.underline}\
1.D. APHIS needs to survey a broad range of organic and conventional
alfalfa farmers in different states as to their management practices.
How many organic and conventional alfalfa farmers is APHIS going to
survey and who will conduct this survey?\
\
1.E. APHIS needs to network with organic and conventional alfalfa
farmers to develop its survey instrument to ensure that it is
representative of what these farmers are doing in their management
practices.\
\
1.F. APHIS needs to review and consider all of the public comments made
by organic and conventional alfalfa farmers during the initial comment
period before the deregulation of RR alfalfa was made since it appears
that APHIS ignored those farmer comments in its approval of deregulating
RR alfalfa.\
\
1.G. APHIS needs to assess how organic and conventional alfalfa farmers
might be affected in their management practices if they have neighbors
planting RR alfalfa. Is APHIS going to followup with organic and
conventional alfalfa farmers to see if they have changed their minds
since they filed public comments several years ago prior to deregulation
and post-deregulation?\
\
1.H. APHIS needs to interview RR alfalfa farmers to determine if they
informed their neighbors who are organic or conventional alfalfa farmers
that they were planting RR alfalfa. Is APHIS planning to conduct a
survey of RR alfalfa farmers to determine how many informed their
neighbors as a basic right-to-farm issue since organic and conventional
alfalfa farmers could well have their crops contaminated by RR genes?\
\
1.I. Is APHIS planning to hold any public pre-EIS field meetings with
organic and conventional alfalfa farmers to obtain their feedback?\
\
I.J. Are Monsanto or Forage Genetics scientists and staffs planning to
hold any public pre-EIS field meetings with organic and conventional
alfalfa farmers to obtain their feedback?\
\
(2) Alfalfa Seed Regional Production:\
\
A. What are the production levels of organic and conventional alfalfa
seed and hay by region, State, and county?\
B. Which regions of the country areas may be affected more than others
with the deregulation of glyphosate-tolerant alfalfa?\
C. What is the acreage of cultivated, volunteer, or feral alfalfa?\
D. What are the potential impacts on adjacent, nonagricultural lands
such as natural areas, forested lands, or along transportation routes
that may occur with the use of glyphosate-tolerant alfalfa?\
\
[Sierra Club Comments and Questions 2.E.:]{.underline}\
2.E. Is APHIS going to survey organic and conventional alfalfa farmers
to determine how many of them have already decided to abandon growing
organic or conventional alfalfa due to concerns over present or future
RR genetic contamination?\
\
(3) Glyphosate Impacts on Animal Health:\
\
A. What is the expected effect of glyphosate-tolerant alfalfa release on
animal production systems?\
\
[Sierra Club Comments and Questions 3.B. - 3.JJ.:]{.underline}\
A chief concern is that inadequate experimental and field studies have
been conducted in the past testing the toxicological effects of
glyphosate on the unborn animal fetus to determine if there are harmful
effects. If such harmful fetal effects were to be observed, the
widespread use of glyphosate might be questioned.\
\
3.B. Concerns need to be expressed about whether the toxicological
studies of glyphosate on animals have been adequate in thoroughly
evaluating all biological effects on the entire mammalian life cycle and
over multiple generations of a species. The toxicological studies of
glyphosate on animals need to be performed on all types of farm animals
that might be fed alfalfa or might be exposed to glyphosate residues
through direct or indirect exposure. Potential effects on wild animals
and food chains need to be thoroughly evaluated in addition.\
\
Please see abstracts of seven peer-reviewed scientific studies below
from PubMed, a service of the U.S. National Library of Medicine and the
National Institutes for Health.\
\
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Daruich, Zirulnik, and Gimenez (with the Catedra de Bioquimica
Molecular, Area Quimica Biologica, Facultad de Quimica, Bioquimica y
Farmacia, Universidad Nacional de San Luis, Argentina) studied the
effect of the herbicide glyphosate on enzymatic activity in pregnant
rats and their fetuses.\
\
They reported their findings in the March 2001 issue of Environmental
Research. According to these researchers, their \"results suggest that
maternal exposure to agrochemicals during pregnancy induces a variety of
functional abnormalities in the specific activity of the enzymes in the
studied organs of the pregnant rats and their fetuses.\"\
\
3.B.1. Environmental Research 2001 Mar;85(3):226-31.\
Effect of the herbicide glyphosate on enzymatic activity in pregnant
rats and their fetuses.\
Daruich J, Zirulnik F, Gimenez MS.\
\
Cátedra de Bioquímica Molecular, Area Química Biológica, Facultad de
Química, Bioquímica y Farmacia, Universidad Nacional de San Luis,
Argentina.\
\
To prevent health risk from environmental chemicals, particularly for
progeny, we have studied the effects of the herbicide glyphosate on
several enzymes of pregnant rats. Glyphosate is an organophosphorated
nonselective agrochemical widely used in many countries including
Argentina and acts after the sprout in a systemic way. We have studied
three cytosolic enzymes: isocitrate dehydrogenase-NADP dependent,
glucose-6-phosphate dehydrogenase, and malic dehydrogenase in liver,
heart, and brain of pregnant Wistar rats. The treatment was administered
during the 21 days of pregnancy, with 1 week as an acclimation period.
The results suggest that maternal exposure to agrochemicals during
pregnancy induces a variety of functional abnormalities in the specific
activity of the enzymes in the studied organs of the pregnant rats and
their fetuses.\
\
Publication Types: \* Research Support, Non-U.S. Gov\'t\
\
PMID: 11237511 \[PubMed - indexed for MEDLINE\]\
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\
3.B.2. Reprod Toxicol. 2005 Mar-Apr;19(4):501-4.\
Effect of the herbicide glyphosate on liver lipoperoxidation in pregnant
rats and their fetuses.\
Beuret CJ, Zirulnik F, Giménez MS.\
\
Cátedra de Bioquímica Molecular, Area Química Biológica, Facultad de
Química, Bioquímica y Farmacia, Universidad Nacional de San Luis,
Chacabuco y Pedernera, 5700 San Luis, Argentina.\
\
Glyphosate is a post-emergence herbicide that acts on the synthesis of
amino acids and other endogenous metabolites in plants. It is commonly
used in agriculture, forestry, and nurseries for the control or
destruction of herbaceous plants. Metabolic processes during development
and pregnancy could be sensitive to changes induced by glyphosate such
as lipid peroxidation. The present study has investigated the effects
that 1% glyphosate oral exposure has on lipoperoxidation and antioxidant
enzyme systems in the maternal serum and liver of pregnant rats and
their term fetuses at 21 days of gestation. The results suggest that
excessive lipid peroxidation induced with glyphosate ingestion leads to
an overload of maternal and fetal antioxidant defense systems.\
\
PMID: 15749264 \[PubMed - indexed for MEDLINE\]\
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\
3.B.3. Toxicol Lett. 2003 Apr 30;142(1-2):45-52.\
The teratogenic potential of the herbicide glyphosate-Roundup in Wistar
rats.\
Dallegrave E, Mantese FD, Coelho RS, Pereira JD, Dalsenter PR, Langeloh
A.\
\
Department of Pharmacology, Instituto de Ciências Básicas da Saúde,
Universidade Federal do Rio Grande do Sul (UFRGS), Rua Sarmento Leite
500 sala 202, 90046-900 Porto Alegre, RS, Brazil.
elianed@vortex.ufrgs.br\
\
The aim of this study was to assess the teratogenicity of the herbicide
glyphosate-Roundup (as commercialized in Brazil) to Wistar rats. Dams
were treated orally with water or 500, 750 or 1000 mg/kg glyphosate from
day 6 to 15 of pregnancy. Cesarean sections were performed on day 21 of
pregnancy, and number of corpora lutea, implantation sites, living and
dead fetuses, and resorptions were recorded. Weight and gender of the
fetuses were determined, and fetuses were examined for external
malformations and skeletal alterations. The organs of the dams were
removed and weighed. Results showed a 50%, mortality rate for dams
treated with 1000 mg/kg glyphosate. Skeletal alterations were observed
in 15.4, 33.1, 42.0 and 57.3% of fetuses from the control, 500, 750 and
1000 mg/kg glyphosate groups, respectively. We may conclude that
glyphosate-Roundup is toxic to the dams and induces developmental
retardation of the fetal skeleton.\
\
PMID: 12765238 \[PubMed - indexed for MEDLINE\]\
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\
3.B.4. Arch Toxicol. 2007 Sep;81(9):665-73. Epub 2007 Jul 19.\
Pre- and postnatal toxicity of the commercial glyphosate formulation in
Wistar rats.\
Dallegrave E, Mantese FD, Oliveira RT, Andrade AJ, Dalsenter PR,
Langeloh A.\
\
Department of Pharmacology, Federal University of Rio Grande do Sul, Rua
Sarmento Leite 500 sala 202, 90046-900, Porto Alegre, RS, Brazil.
elianed@ufrgs.br\
\
Glyphosate is the active ingredient and polyoxyethyleneamine is the
surfactant present in the herbicide Roundup formulation commercialized
in Brazil. The aim of this study was to assess the reproductive effects
of glyphosate-Roundup on male and female offspring of Wistar rats
exposed during pregnancy and lactation. Dams were treated orally with
water or 50, 150 or 450 mg/kg glyphosate during pregnancy (21-23 days)
and lactation (21 days). These doses do not correspond to human exposure
levels. The results showed that glyphosate-Roundup did not induce
maternal toxicity but induced adverse reproductive effects on male
offspring rats: a decrease in sperm number per epididymis tail and in
daily sperm production during adulthood, an increase in the percentage
of abnormal sperms and a dose-related decrease in the serum testosterone
level at puberty, and signs of individual spermatid degeneration during
both periods. There was only a vaginal canal-opening delay in the
exposed female offspring. These findings suggest that in utero and
lactational exposure to glyphosate-Roundup may induce significant
adverse effects on the reproductive system of male Wistar rats at
puberty and during adulthood.\
\
PMID: 17634926 \[PubMed - indexed for MEDLINE\]\
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\
3.B.5. Environ Toxicol Chem. 2004 Aug;23(8):1928-38.Links\
Toxicity of glyphosate-based pesticides to four North American frog
species.\
Howe CM, Berrill M, Pauli BD, Helbing CC, Werry K, Veldhoen N.\
\
Department of Biology, Trent University, Peterborough, Ontario K9J 7B8,
Canada.\
\
Glyphosate-based herbicides are among the most widely used pesticides in
the world. We compared the acute toxicity of the glyphosate end-use
formulation Roundup Original to four North American amphibian species
(Rana clamitans, R. pipiens, R. sylvatica, and Bufo americanus) and the
toxicity of glyphosate technical, the polyethoxylated tallowamine
surfactant (POEA) commonly used in glyphosate-based herbicides, and five
newer glyphosate formulations to R. clamitans. For R. clamitans, acute
toxicity values in order of decreasing toxicity were POEA \> Roundup
Original \> Roundup Transorb \> Glyfos AU; no significant acute toxicity
was observed with glyphosate technical material or the glyphosate
formulations Roundup Biactive, Touchdown, or Glyfos BIO. Comparisons
between the four amphibian species showed that the toxicity of Roundup
Original varied with species and developmental stage. Rana pipiens
tadpoles chronically exposed to environmentally relevant concentrations
of POEA or glyphosate formulations containing POEA showed decreased
snout-vent length at metamorphosis and increased time to metamorphosis,
tail damage, and gonadal abnormalities. These effects may be caused, in
some part, by disruption of hormone signaling, because thyroid hormone
receptor beta mRNA transcript levels were elevated by exposure to
formulations containing glyphosate and POEA. Taken together, the data
suggest that surfactant composition must be considered in the evaluation
of toxicity of glyphosate-based herbicides.\
\
PMID: 15352482 \[PubMed - indexed for MEDLINE\]\
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\
3.B.6. Chemosphere. 2003 Aug;52(7):1189-97.\
Aquatic toxicity of glyphosate-based formulations: comparison between
different organisms and the effects of environmental factors.\
Tsui MT, Chu LM.\
\
Department of Biology, The Chinese University of Hong Kong, Shatin, New
Territories, Hong Kong, China.\
\
Glyphosate-based herbicides (e.g. Roundup) are extensively used in the
aquatic environment, but there is a paucity of data on the toxicity of
the formulated products and the influences by environmental factors. In
this study, the acute toxicity of technical-grade glyphosate acid,
isopropylamine (IPA) salt of glyphosate, Roundup and its surfactant
polyoxyethylene amine (POEA) to Microtox bacterium (Vibrio fischeri),
microalgae (Selenastrum capricornutum and Skeletonema costatum),
protozoa (Tetrahymena pyriformis and Euplotes vannus) and crustaceans
(Ceriodaphnia dubia and Acartia tonsa) was examined and the relative
toxicity contributions of POEA to Roundup were calculated. The effects
of four environmental factors (temperature, pH, suspended sediment and
algal food concentrations) on the acute toxicity of Roundup to C. dubia
were also examined. Generally, the toxicity order of the chemicals was:
POEA\>Roundup\>glyphosate acid\>IPA salt of glyphosate, while the
toxicity of glyphosate acid was mainly due to its high acidity. Microtox
bacterium and protozoa had similar sensitivities towards Roundup
toxicity (i.e. IC50 from 23.5 to 29.5 mg AE/l). In contrast, microalgae
and crustaceans were 4-5 folds more sensitive to Roundup toxicity than
bacteria and protozoa. Except photosynthetic microalgae, POEA accounted
for more than 86% of Roundup toxicity and the toxicity contribution of
POEA was shown to be species-dependent. Increase in pH (6-9) and
increase of suspended sediment concentration (0-200 mg/l) significantly
increased the toxicity of Roundup to C. dubia, but there were no
significant effects due to temperature change and food addition.\
\
PMID: 12821000 \[PubMed - indexed for MEDLINE\]\
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\
3.B.7. Toxicol Rev. 2004;23(3):159-67.\
Glyphosate poisoning.\
Bradberry SM, Proudfoot AT, Vale JA.\
\
National Poisons Information Service (Birmingham Centre) and West
Midlands Poisons Unit, City Hospital, Birmingham, UK.\
\
Glyphosate is used extensively as a non-selective herbicide by both
professional applicators and consumers and its use is likely to increase
further as it is one of the first herbicides against which crops have
been genetically modified to increase their tolerance. Commercial
glyphosate-based formulations most commonly range from concentrates
containing 41% or more glyphosate to 1% glyphosate formulations marketed
for domestic use. They generally consist of an aqueous mixture of the
isopropylamine (IPA) salt of glyphosate, a surfactant, and various minor
components including anti-foaming and colour agents, biocides and
inorganic ions to produce pH adjustment. The mechanisms of toxicity of
glyphosate formulations are complicated. Not only is glyphosate used as
five different salts but commercial formulations of it contain
surfactants, which vary in nature and concentration. As a result, human
poisoning with this herbicide is not with the active ingredient alone
but with complex and variable mixtures. Therefore, It is difficult to
separate the toxicity of glyphosate from that of the formulation as a
whole or to determine the contribution of surfactants to overall
toxicity. Experimental studies suggest that the toxicity of the
surfactant, polyoxyethyleneamine (POEA), is greater than the toxicity of
glyphosate alone and commercial formulations alone. There is
insufficient evidence to conclude that glyphosate preparations
containing POEA are more toxic than those containing alternative
surfactants. Although surfactants probably contribute to the acute
toxicity of glyphosate formulations, the weight of evidence is against
surfactants potentiating the toxicity of glyphosate.Accidental ingestion
of glyphosate formulations is generally associated with only mild,
transient, gastrointestinal features. Most reported cases have followed
the deliberate ingestion of the concentrated formulation of Roundup (The
use of trade names is for product identification purposes only and does
not imply endorsement.) (41% glyphosate as the IPA salt and 15% POEA).
There is a reasonable correlation between the amount ingested and the
likelihood of serious systemic sequelae or death. Advancing age is also
associated with a less favourable prognosis. Ingestion of \>85 mL of the
concentrated formulation is likely to cause significant toxicity in
adults. Gastrointestinal corrosive effects, with mouth, throat and
epigastric pain and dysphagia are common. Renal and hepatic impairment
are also frequent and usually reflect reduced organ perfusion.
Respiratory distress, impaired consciousness, pulmonary oedema,
infiltration on chest x-ray, shock, arrythmias, renal failure requiring
haemodialysis, metabolic acidosis and hyperkalaemia may supervene in
severe cases. Bradycardia and ventricular arrhythmias are often present
pre-terminally. Dermal exposure to ready-to-use glyphosate formulations
can cause irritation and photo-contact dermatitis has been reported
occasionally; these effects are probably due to the preservative Proxel
(benzisothiazolin-3-one). Severe skin burns are very rare. Inhalation is
a minor route of exposure but spray mist may cause oral or nasal
discomfort, an unpleasant taste in the mouth, tingling and throat
irritation. Eye exposure may lead to mild conjunctivitis, and
superficial corneal injury is possible if irrigation is delayed or
inadequate. Management is symptomatic and supportive, and skin
decontamination with soap and water after removal of contaminated
clothing should be undertaken in cases of dermal exposure.\
\
PMID: 15862083 \[PubMed - indexed for MEDLINE\]\
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\
3.C. Does glyphosate produce toxicological effects on reproductive
systems such as egg and sperm production or fertilization?\
\
3.D. What is the toxicological effect of glyphosate on the mammalian
fetus and at the different stages of fetal development?\
\
3.E. Have fetal deaths occurred to exposed mammalian fetus in utero
during or after exposures to glyphosate to either farm animals or
laboratory, experimental animals?\
\
3.F. Has Monsanto reported data showing that fetal deaths occurred to
glyphosate exposed mothers or has Monsanto claimed CBI for reports of
fetal deaths in previous studies?\
\
3.G. Has Monsanto or APHIS thoroughly investigated the possibility of
fetal deaths occurring to glyphosate exposed pregnant mothers, including
farm animals or laboratory, experimental animals?\
\
3.H. What glyphosate concentrations were used in the experimental or
laboratory studies exposing the fetus and at what stage of development
were they tested?\
3.I. Has Monsanto thoroughly investigated the possibility of low weight
births occurring to glyphosate exposed mothers?\
\
3.J. What is the toxicological effect of glyphosate over multiple
generations (at least four minimum) since pesticide exposure, for
instance, has been shown in published laboratory studies in
peer-reviewed science journals to produce reproductive impairments
through a series of generations after the initial exposure to a female
(great grandmother)?\
\
3.K. What is the toxicological effect of glyphosate on mammalian
hormonal systems over multiple generations (at least four minimum)
including male and female hormones, etc?\
\
3.L. How many peer-reviewed toxicology studies have been conducted using
glyphosate in the feeding trails on laboratory animals?\
\
A research concern exists over Monsanto\'s (and researchers paid by
Monsanto) corporate bias in its glyphosate studies since it has a
significant economic interest in showing APHIS and the public positive
results rather than negative data to support glyphosate use.\
\
3.M. Did Monsanto provide any glyphosate studies or glyphosate data to
APHIS that was shielded from the public under Confidential Business
Information?\
\
3.N. If Monsanto or external paid scientists submitted glyphosate
studies or glyphosate data to APHIS shielded from the public under
Confidential Business Information (CBI), how many studies were under CBI
and how much data, if any, was CBI?\
\
A public concern exists that APHIS possesses a governmental zeal
trumping science and consumer interests in supporting genetically
engineered crops such as Roundup Ready alfalfa despite serious questions
about Monsanto\'s own glyphosate studies and whether RR alfalfa is
needed at all.\
\
A significant concern is the inherent bias in Monsanto\'s research
studies that they are flawed by design and flawed by analysis. As a
result, questions arise over how much of Monsanto\'s glyphosate research
has actually been subjected to external peer-review and published in
journals.\
\
3.O. Has Monsanto submitted CBI information on glyphosate under the RR
alfalfa permit application that has not been subjected to external
peer-review and published in scientific journals?\
\
3.P. Did Monsanto submit non-peer-reviewed studies on glyphosate
conducted by Monsanto\'s own scientists or external scientists?\
\
3.Q. If Monsanto hired external scientists not directly working for the
company, how much were they paid to conduct research for Monsanto? A
public concern is that Monsanto\'s studies are not adequate to
demonstrate the short-term and long-term safety of using large amounts
of glyphosate on farm fields due to the contamination in the environment
and public health.\
\
3.R. How many peer-reviewed toxicology studies have been conducted by
independent scientists, who are not working for Monsanto and are not
paid by Monsanto, using glyphosate in the feeding trails on laboratory
animals?\
\
3.S. What types of differences have been observed in the peer-reviewed
toxicology studies conducted by independent scientists not associated
with Monsanto in any way versus Monsanto\'s own studies using glyphosate
in the feeding trails on laboratory animals?\
\
3.T. How many of the peer-reviewed toxicology studies performed using
glyphosate in the feeding trails were conducted on adult laboratory
animals?\
\
3.U. How many of the peer-reviewed toxicology studies performed using
glyphosate in the feeding trails were conducted on infant and young
laboratory animals?\
\
3.V. How many peer-reviewed toxicology studies were conducted by
independent scientists not associated with Monsanto using glyphosate in
the feeding trails on adult laboratory animals?\
\
3.W. What types of differences were observed in the peer-reviewed
toxicology studies conducted by independent scientists not associated
with Monsanto versus Monsanto\'s own studies using glyphosate in the
feeding trails on infant and young laboratory animals?\
\
3.X. How many peer-reviewed toxicology studies were conducted by
Monsanto using glyphosate in the feeding trails on pregnant laboratory
animals?\
\
3.Y. How many peer-reviewed toxicology studies were conducted by
independent scientists not associated with Monsanto in any way using
glyphosate in the feeding trails on pregnant laboratory animals?\
\
3.Z. What types of differences were observed in the peer-reviewed
toxicology studies conducted by independent scientists not associated
with Monsanto versus Monsanto\'s own studies using glyphosate in the
feeding trails on pregnant laboratory animals?\
\
3.AA. APHIS needs to ensure that legitimate external peer-review is
conducted of the scoping process so the EIS is good science and not as
inadequate as the Environmental Assessment was on RR Alfalfa. Is APHIS
going to utilize an external scientific auditing company with
independent scientists to verify that the scoping issues in the EIS are
comprehensive and encompassing of the science that needs to be
conducted?\
\
3.BB. Since the public does not trust APHIS, Monsanto and Forage
Genetics to conduct an honest scientific assessment of RR Alfalfa in the
EIS, it can not be stressed too much that there needs to be transparency
of all data sources used and peer-reviewed studies rather than hiding
behind CBI or opinions not based on good science.\
\
3.CC. Were the glyphosate concentrations that were used in the
experimental or laboratory studies exposing the fetus representative of
environmental glyphosate levels or representative of the RR alfalfa feed
concentrations?\
\
3.DD. If Monsanto has not conducted representative studies of typical
glyphosate concentrations ending up on RR alfalfa feed that is fed to
agricultural animals, will APHIS order Monsanto to conduct
representative studies or not?\
\
3.EE. If Monsanto has not performed representative feeding studies of
pregnant agricultural animals testing the typical glyphosate
concentrations ending up on RR alfalfa feed that is fed to agricultural
animals, will APHIS order Monsanto to conduct representative studies or
not?\
\
3.FF. What glyphosate concentrations have been measured in RR alfalfa
feed?\
\
3.GG. Why did Monsanto seek to increase the tolerance levels by several
fold of the allowable concentrations of glyphosate residues sprayed on
RR alfalfa and allowed to stay on the RR alfalfa at harvest?\
\
3.HH. Has Monsanto, Forage Genetics, or APHIS conducted any
peer-reviewed studies or unpublished feeding studies or other
experiments on the higher glyphosate tolerance levels allowed on RR
alfalfa?\
\
3.II. Will an independent scientific audit be conducted of Monsanto\'s
and Forage Genetics study designs of any additional gene flow
experiments on RR alfalfa to determine if there is bias in this
corporate research?\
\
3.JJ. Will an independent scientific audit be conducted of Monsanto\'s
and Forage Genetics applicable gene flow studies on RR alfalfa to
determine if there is bias in this corporate data and misinterpretation
of the data?\
\
(4) Glyphosate Impacts on Food and Feed:\
\
A. What are the potential impacts of glyphosate-tolerant alfalfa release
on food and feed?\
B. How does glyphosate tolerance affect food or feed value or
nutritional quality?\
C. Should the low level presence of glyphosate-tolerant alfalfa occur in
situations where it is unwanted, unintended, or unexpected, what impact
would this have on the ability of producers to market affected organic
or conventional alfalfa or livestock fed this material?\
D. What are the negative impacts, if any, on food or feed value or
quality from the use of glyphosate?\
\
[Sierra Club Comments and Questions 4.E. - 4.O.:]{.underline}\
4.E. What are the negative impacts on food or feed value or quality from
the use of glyphosate containing organic chemical impurities detectable
in batch quantities of herbicide produced such as formaldehyde,
N-Nitrosoglyphosate, and insolubles? These organic chemical impurities
and insolubles occur in the glyphosate manufacturing process and are not
100% removed during purification of the herbicide that is commercially
marketed.\
\
4.F. Does the presence of detectable or undetectable glyphosate residues
effect the taste of alfalfa when itÕs processed into food products?\
\
4.G. Does the presence of detectable or undetectable glyphosate residues
effect the nutritional quality of alfalfa when itÕs processed into food
products?\
\
4.H. ** **Another major public concern is the serious potential for
contamination of organic foods by RR alfalfa in the fields across the
U.S. The organic food sector is the fastest growing part of the food
industry growing at the rate of 20% a year while conventional food sales
are only growing 2%-3% a year, primarily because millions of consumers
want certified organically grown food items as being more nutritional to
eat, better tasting without toxic agricultural chemical residues, and
safer for families to consume with the lowest levels of harmful
pesticides-insecticides-herbicides-fungicides that may bioaccumulate in
mammalian systems. Consumers also realize that organic farmers are less
exposed to toxic chemicals than conventional farmers and this is a
benefit to organic farmers and their families; farm workers on organic
farms also have less toxic chemical exposures. American families and
consumers have grown deeply suspicious and alarmed at the poisoning of
the food supply and are willing to buy certified organic foods to
protect their health. The result is that organic food industry is
growing rapidly. A person has to be ignorant to believe that a
smorgasbord of toxic agricultural chemicals in the foods is safe to
consume.\
\
See report on \"A Statistical Picture of CaliforniaÕs Organic
Agriculture 1995-1998\" in California by UC Davis and UC Cooperative
Extension for Santa Cruz County agricultural economic specialists at:
http://www.sarep.ucdavis.edu/organic/Organic1995-98.pdf\
\
EXECUTIVE SUMMARY\
\"Annual statistical analyses of CaliforniaÕs organic agriculture
identify emerging trends in the organic sector. In addition, organic
agricultureÕs relative importance to the larger agricultural industry
can be quantified over time. This information is critical to
understanding new directions for agriculture as value-added crops and
niche markets gain importance in the state and the nation.\
\
Over 70 individual commodities representing every major commodity group
were produced and marketed as organic during the three years covered in
this report, 1995-96, 1996-97 and 1997-98. Sales rose an average of 18%
per year over this period reaching \$158 million in 1997-98. Produce
(vegetables, fruits and nuts) continues to dominate the organic farm
sector with over 90% of total sales. This is in striking contrast to
California agriculture as a whole, where produce makes up about half of
gross sales.\
\...\...\...\...\...\...\...\...\...\...\...\
\
INDUSTRY SIZE\
The number of registered organic farms increased from 1,427 to 1,533
(7%), during the three years of this analysis. The number of organically
farmed crop acres increased from 46,258 to 67,826 (47%), during the same
period. Total sales increased from \$113 million in the first year of
the study to \$158 million in the third, an increase of 40% (Table 1).
Growth of both organic crop acreage and gross sales was attributable to
many new growers entering the organic program and continuing growers
expanding acreage to meet increasing consumer demand.\
\
The number of farmed acres increased by almost half even though the
number of growers increased only slightly because established growers
increased crop acreage and new growers entered the program with above
average farm size. Total organic acreage also grew at a faster rate than
gross sales. This is attributable to a relatively greater increase in\
field crop acreage compared to the increase in vegetable crop acreage
with average sales per acre for field crops being substantially lower
than for vegetable crops.\
\
The 40% increase in gross sales of organically grown non-livestock
commodities was much greater than the 2% increase in overall
non-livestock agricultural sales in California for 1995-98. Organic crop
acreage increased by almost half, despite no change in total California
crop acreage. Organic agriculture nevertheless represented only 0.6% of
total farmed acreage and 0.8% of total cash income from marketing of
crops in California by 1997-98, excluding livestock. Organic produce
(vegetable, fruit, and nut crops) was slightly more prominent, with 1%
of statewide produce sales. It should be noted that gross sales for
organic products are thought to be artificially low in this analysis
because of limitations of the data.\"\
**\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\***\
\
4.I. What is the negative impact to consumers whose preference is to
purchase organic alfalfa sprouts and organic alfalfa food products
because they seek more certified organic nutritional foods in their diet
and seek to avoid eating genetically engineered alfalfa products and
will have to avoid all alfalfa products in the future if they become
contaminated with RR GE alfalfa ingredients and no organic alfalfa is
available?\
\
4.J. What is the negative impact on consumers seeking certified organic
meat with cattle fed organic alfalfa and the alfalfa becomes
contaminated?\
\
Reports are that this food sector is growing dramatically as noted in
the organic news at this Archived Organic News web page:
http://www.organicfooddirectory.com.au/news_item.php?id=186&headline=Meat%20dominates%20the%20global%20organic%20food%20market\
\
Meat dominates the global organic food market\
\
12 Jul 2006\
\"Organic meat has experienced approximately 51 percent growth in sales
in the past year, making it the leader in the organic sector short
news.\
\
Condiments and dairy products stood at second and third position with 25
percent and 24 percent respectively. Organic pork has led the organic
meat market in terms of growth. In its recently published market
research report ÒW Organic Foods and Beverages Report ( 2006 )Ó RNCOS
has included the following statistics: × European Union led the world in
global pork export during the year 2005, followed by USA, China, Brazil,
Mexico and Canada. × During 2005, Japan was the largest consumer market
for pork followed by Russia, Mexico, Korea, USA and Hong Kong. × USA was
the biggest producer of broiler in 2005 followed by China & Brazil. As
per experts at RNCOS, ÓOrganic meat ( pork, beef, broilers ) is taking
over the world organic foods marketÓ. ÒGrowing at an average CAGR of
3.0%, beef trade will reach 8.6Mn Metric tons towards by 2015. At the
same time, beef production shall reach 61.9Mn Metric tons growing at an
average rate of 1.7%Ó, further added experts. This report is of
paramount importance for both investors and businesses, as it: × Gives a
complete overview of world organic foods and beverages market. × Focuses
on the current market trends. × Includes discussion about the challenges
and opportunities before the industry. × Lists the profiles of key
players in the organic foods industry across the globe. × Provides a
discussion about the various factors influencing the industry. × Looks
in to the future prospect of the industry.\"\
\*\*\*\
\
One example, besides popular organic alfalfa sprouts, of another organic
alfalfa food products that are popular consumer items are foods called
\"greens\" or \"super foods\" which are marketed as dietary supplements.
Numerous companies are marketing \"greens\" and many contain organic
alfalfa ingredients in them as a basic food item. Greens or super foods
containing certified organic alfalfa nutritional ingredients would be
threatened if organic alfalfa crops were contaminated by RR alfalfa.
Conventional alfalfa food items would also be similarly threatened if
they were contaminated by RR GE alfalfa.\
\
According to a Google search in early January 2008 of \"greens\"
(36,000,000 hits) which includes many diverse items and then searching
within those \"greens\" using \"alfalfa\" shows 199,000 hits), it
reveals that dozens to potentially hundreds of new and existing
nutritional food supplement companies such as Nature Rich are marketing
\"green\" with \"alfalfa\" ingredients; the term \"Organic\" had 694,000
hits on Google in the search within mode after \"greens\" and
\"alfalfa\".\
\
**Organic Essential Greens uses organic alfalfa in their Greens:**\
http://www.melrosehealth.com.au/products/index.php?main_page=product_info&products_id=95\
\
**Earth in Common uses organic alfalfa in their Super Greens:**\
http://www.earthincommon.com/grainfields-super-greens-capsules-p-111.html\
\
**Diamond Organics uses organic alfalfa in their sprouts:**\
http://www.diamondorganics.com/text_alfalfa_sprouts\
\
**Greens+ uses alfalfa powder in their superfood:**\
http://www.greensplus.com/index.php/cPath/34_36\
\
Google search showing part of two pages of results among the 694,000:\
\
http://www.google.com/search?hl=en&client=firefox-a&channel=s&rls=org.mozilla%3Aen-US%3Aofficial&hs=7NR&q=greens+alfalfa&as_q=organic&btnG=Search%C2%A0within%C2%A0results\
\
Product search results for \"greens alfalfa organic\"\
\
**ORGANIC ALFALFA** \$6.92 - TheBetterHealthStore.com\
**Organic Alfalfa \...** \$1.85 - The Green Chronicle\
**Alfalfa Seeds \... \$40.98 - Organic Kingdom**\
See greens alfalfa organic results available through Google Checkout\
\
**Alfalfa Organic Sprouting Seed**\
Sunflower Green Sprouting Seed · Wheat Sprouting Seed \... **Organic
Alfalfa \... **\
www.wheatgrasskits.com/sprouting/alfalfa_sprout_seed.htm - 24k\
\
Alfalfa Sprouting Seed - High Germination Rate - Perfect for Edible
Seeds, Gardening, \...\
**Alfalfa Organic Sprouting Seeds** from The Sprout House Wheat Grass
\...\
**Alfalfa Organic Sprouting Seeds, organic alfalfa sprouting seeds **are
a beautiful wheat colored seed that produces a bright green sprout,
**organic alfalfa .**..\
www.sprouthouse.com/Alfalfa_Organic_Sprouting_Seeds_p/alfalfa.htm\
\
**Alfalfa Organic Sprouting Seeds** .:. Infinite Health Resources\
**Alfalfa Organic Sprouting Seeds** **Alfalfa Organic Sprouts **Organic
Sprout \... Good sprouting technique doesn\'t take a \"green thumb\" ,
just paying attention to \...\
www.infinitehealthresources.com/Store/Products/Item/-274/1/2951.html -
52k\
\
**CERTIFIED ORGANIC **STEVIA and **ALFALFA **- SUEDE HILLS ORGANIC
FARMS\
Our main crops are organic green leaf stevia, the natural, no calorie
sweetener, and organic alfalfa, a whole complete greens food, for
people\'s overall and \...\
www.steviasweetsuccess.com/ - 4k\
\
**Bulk Organic Green **- vegetable - fruit powders @ Pure Health
Systems\
**Bulk Organic Green,** vegetable, fruit powders, green foods, whole
foods, natural supplements, chlorella, green kamut, **alfalfa juice,**
barley juice, \...\
www.purehealthsystems.com/green-foods.html\
\
**Organic Alfalfa Powder **- Compare Prices, Reviews and Buy at NexTag
\...\
related:alfalfa powder,organic whey protein powder,organic protein
powder,organic green powder,organic spirulina powder,organic milk
powder,organic cocoa \...\
www.nextag.com/organic-alfalfa-powder/search-html\
\
**Organic Pharmacy **\>\> PRODUCTS\
Welcome to the Organic Pharmacy. My name is Timothy Collins, \...
**Alfalfa** is a green superfood that is rich in vitamins, minerals and
chlorophyll. \...\
organicpharmacy.org/products/Alfalfa/SKU:2622NOW\
\
**Bodybuilding.com** - Biochem 100% Greens & Whey - Mixes Instantly
\...\
Proprietary Organic Greens Blend Providing: 1000mg. **Organic Alfalfa
Leaf Juice Powder**, \*\*. Organic Barley Grass Juice, \*\*. Orgnic Sun
Chlorella (Chlorella \...\
www.bodybuilding.com/store/bioc/green.html - 38k\
\
Delicious Living - for the **organic, green and healthy lifestyle**\
**Alfalfa**, also known as lucerne, is a member of the pea family and is
native to \... **Alfalfa sprouts **have become a popular food. **Alfalfa
herbal **supplements \...\
healthnotes.deliciouslivingmag.com/healthnotes.cfm?lang=EN&org=nh&ContentID=2035004\
\
Consumers, such as those whose preference is organic foods, are gravely
concerned that the fast-growing multi-million dollar a year organic
alfalfa nutritional and sprout business will be threatened by RR
glyphosate contamination of certified organic alfalfa crops. If
certified organic alfalfa nutritional food items are contaminated, what
will be the economic impacts to the organic food sector and to consumers
who want the certified organic alfalfa nutritional food items?\
\
4.K. What is the negative economic impact to retailers and wholesalers
if they lose sales of organic alfalfa sprouts and other organic alfalfa
food products because the organic alfalfa food items are contaminated
with RR GE alfalfa ingredients and little or no organic alfalfa is
available?\
\
4.L. What is the negative economic impact to retailers and wholesalers
if they lose sales of organic alfalfa sprouts and organic alfalfa food
products because consumers are concerned about the threat of
contamination by RR GE alfalfa ingredients?\
\
4.M. What is the negative economic impact to organic and conventional
alfalfa growers if they lose sales of organic (and conventional) alfalfa
sprouts and organic alfalfa food products because the organic (and
conventional) alfalfa items are contaminated with RR GE alfalfa
ingredients and no organic alfalfa is available?\
\
4.N. What is the negative economic impact to organic and conventional
alfalfa growers if they lose sales of organic (and conventional) alfalfa
sprouts and organic alfalfa food products because organic food retailer
and wholesalers refuse to buy these food items due to their concerns
about the threat of contamination by RR GE alfalfa ingredients?\
\
4.O. What is the negative economic impact to organic and conventional
alfalfa growers if they lose sales of organic (and conventional) alfalfa
sprouts and organic alfalfa food products because consumers refuse to
buy these food items due to their concerns about the threat of
contamination by RR GE alfalfa ingredients?\
\
**\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\***\
Page 1\
Overview of California ORganic Agriculture\
by William Douglas \[Organic Alfalfa Grower, Oakdale, CA\]\
http://ucanr.org/alf_symp/2001/01-053.pdf\
\
ABSTRACT\
California organic alfalfa production can be economically feasible.
Production in a monoculture is possible but organic alfalfa can also be
very beneficial in a crop rotation, soil enhancement program. Many
producers find compost the most beneficial soil amendment and harvest
hay early for pest control. Producers find the certification process
difficult but once familiar with it, attainable. Consumer demand of
organic products has stimulated rapid growth of the organic industry
over the past ten years. This has been reflected in the doubling of
sales revenues over multiple years for organic feed and dairy products.\
\
INTRODUCTION\
The purpose of this paper is to overview the production of organic
alfalfa in California. Cultural practices, cost, marketing,
certification, and a brief summary of the organic feed and dairy
industry will be discussed.\
\
Production of organic hay deals with the same issues as conventional hay
yet uses a different set of tools to solve problems. Organic producers
have the same fertilization, disease and pest concerns as conventional
producers, yet must deal with the issues differently, which often
requires non-traditional thinking.\
\
The cost of producing organic alfalfa differs dramatically from the cost
of conventional production because high priced commercial fertilizers
and chemicals are not used. Yield and quality can be effected by this,
but are offset by premiums of ten to twenty percent.\
\
Certification of organic alfalfa is a time consuming process. Records
are required, rules are to be followed and integrity must be maintained.
Taking care of all these things is possible but requires a strong
commitment from the producer.\
\
The organic feed and dairy industries are servicing a niche market for
organic milk and milk products. This ÒnicheÓ market nets 500 million
dollars in annual sales at only one and a half percent of total milk and
milk product sales. Growth in organic feed and dairies in California
over the past ten years has been remarkable.\
\
Page 2\
\
PROCEDURES\
A list of several questions were assembled and distributed to a number
of organic alfalfa growers. The growers surveyed were a network of
producers that local organic dairymen knew of. Production questions
ranged from new planting and seedbed preparations to pest control and
fertilization needs. Cost, marketing, and premiums were also addressed,
as well as what type of quality organic dairymen expected. Producers
were asked about the advantages and disadvantages of producing organic
hay, and what transition problems or obstacles they faced at start-up.
Additionally, organic growers were asked what other crops they produce
and how those crops fit in with their operation.\
\
RESULTS\
A person has to really want to make organic production work to be
successful at it. Producers expressed that they were all willing to try
different methods to make organic production work. For example, they
established new plantings by pre-irrigating, turning weed sprouts under
and then planting, and rotating crops with others that were conducive to
a weed free bed (i.e. sweet potatoes). Producers also stressed the
importance of soil fertility and timing of the first irrigation to
establish a strong stand from the beginning, crowding out weeds early.
Weed control in an established stand was accomplished by mowing borders,
flaming, timely harvest and separation of less desirable hay from higher
quality areas. Many practices reflect what conventional producers do in
lean times.\
\
Both pest and weed control rely on proper soil fertility to prevent
invasion. Growers tried to establish strong, vigorous, stress free
plants, through proper soil fertility and moisture, to crowd out weeds
and deter invasion by pests. Dust control, beneficial insects,
repellants (garlic, pepper, fish etc.), and close monitoring were also
pest control tools growers used. They also had the option to harvest
early. Location of their fields was also crucial. It was important that
their fields were isolated from other fields or at least not next to
poorly managed fields. Pest management programs that strive to reduce
pesticides are also a helpful resource and widely available on the
Internet.\
\
Organic fertilizers are becoming more available as the size of farms
increase and demand intensifies. Fertilizer must be approved by
certifying agents and may be quite costly. Most producers seem to rely
on properly composted material that adds proper nutrients and humus to
the soil.\
\
Most producers felt that they could receive a ten to fifteen percent
premium for their organic hay. Buyers of organic hay in general were not
as critical because organic hay is less available. Dairy producers were
the most numerous buyers. Racehorse, organic beef and lamb producers
were also buyers. Some producers actually started producing organically
before a market was established because they felt so strongly about
organic production.\
\
Other producers found the market prior to production because they were
attracted to the niche and meeting the needs of that market. The
elimination of costly chemicals seems to be the economic advantage in
organic hay production.\
\
Major obstacles for growers in producing organically are not only
adjusting to the physical changes from the way they previously farmed,
but also mentally thinking about farming in an entirely different way.
One of the biggest obstacles organic farmers face is the certification\
\
Page 3\
\
process. They have to deal with a ton of paper work, figure out what
materials they can use, and prepare for inspection of their farms and
processing units (balers must be cleaned before used on organic fields).
They have learned that they can no longer farm the way their neighbors
do and that they are watched carefully by critical eyes. Additionally
there are no silver bullets in organic farming. The system relies on
building soil fertility, and problems take seasons rather than weeks to
alleviate. Organic growers truly have to be good and patient Òstewards
of the landÓ.\
\
CONCLUSION\
Organic farming became one of the fastest growing segments of U.S.
agriculture during the 1990Õs. Acres of certified organic hay and silage
grew 51 percent during this period. Although becoming very popular and
demand increasing substantially many conventional growers remain
skeptical. Organic hay producer in California in general started
producing because they believed in a more natural, sustainable way of
farming and then made it work economically. To only farm organically for
economic reasons would make it very difficult because there are many
hurdles to overcome. On a large scale, organic hay should be grown in
climates that have less insect pressure (i.e. northern California,
Nevada). In regions of high conventional acreage, organic alfalfa would
work well in a crop rotation with other high-income organic products.\
**\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\***\
\
http://lists.eco-farm.org/pipermail/ge_news/2007-August/000013.html\
\
\[GE_News\] Reader disputes Roundup Ready alfalfa claims\
\
Reader disputes Roundup Ready alfalfa claims\
The Prairie Star, August 4 2007\
http://www.theprairiestar.com/articles/2007/08/04/ag_news/opinion/opinion02.txt\
\
To the editor:\
\
On June 22, Mike Waters of Growers for Biotechnology wrote about a March
2007 court decision that banned future sales and planting of Roundup
Ready alfalfa, a genetically engineered variety initially commercialized
in June 2005.\
\
In his piece, Waters deplores the judge\'s ruling, and credits the
\"organic activists and environmental extremist groups\" and their \"all
organic, no biotech crop agenda\" for the ruling. Yet, a landmark
lawsuit such as this (a court has never before vacated a USDA decision
to approve a genetically engineered crop) deserves a deeper examination.
The nature of alfalfa and its significance to the organic industry
points toward a reality different than the one Waters paints.\
\
The organic food industry was worth \$17 billion in 2006, and continues
to grow by about 20 percent each year (compared to the conventional food
industry\'s rate of 2 to 3 percent). Organic alfalfa is an essential
component to this growth. The total number of certified organic
livestock, especially beef cattle and dairy cows, increased by a
startling 572 percent between 1997 and 2003. And several events show
this demand is growing. For example, the U.S. has experienced a chronic
shortage of organic milk, and California now imports some of its organic
feed to meet the state\'s demands. Implicit in the demand for more
organic meat and dairy products is the need for more organic feed,
especially alfalfa.\
\
Because alfalfa is an open-pollinated crop, markets for alfalfa seed and
hay that shun, or reject outright, genetically engineered material in
seeds and feed (such as certified organic and some export markets) risk
acquiring the Roundup Ready trait through gene flow. The USDA National
Organic Program does not allow the use of agricultural biotechnology in
certified organic farming systems, so cross-pollination of Roundup Ready
alfalfa with organic crops could increase production costs, reduce
profits, or even eliminate markets for organic alfalfa producers.\
\
Unfortunately, no law or regulation requires farmers who plant Roundup
Ready alfalfa for hay to implement practices that prevent
cross-pollination with neighbors\' crops. And farmers can\'t control the
weather; meaning, they can\'t always avoid hay stands going to bloom,
from producing viable pollen. Instead, the burden of protecting alfalfa
plants and sensitive markets from transgenic traits, such as planting
buffer areas, is completely transferred to the producer of non-Roundup
Ready alfalfa.\
\
As for Roundup Ready alfalfa seed production, segregation distances
proved ineffective even before the judge made his decision. In December
2006, just over a year after Roundup Ready alfalfa was commercialized,
the Idaho Alfalfa and Seed Clover Association reported that Roundup
Ready alfalfa traits were found in conventional alfalfa seed in Montana,
Wyoming, and Idaho, including foundation seed, which contained enough
transgenic material to deem it useless as seed stock.\
\
This foundation seed was two miles from the nearest Roundup Ready field.
At the time of these tests, segregation distances were set at 900 feet.
Also in 2006, The Colorado State University Extension tested feral
alfalfa plants at 23 sites in Mesa County along roadsides, abandoned
fields, and edges of active hay fields within two miles of Roundup Ready
alfalfa seed fields. Transgenic gene flow was found at 83 percent of the
collection sites. Complete segregation of Roundup Ready and conventional
(including organic) alfalfa varieties is simply unlikely.\
\
Although only a small percentage of U.S. alfalfa is exported, Pacific
Northwest growers export a much higher percentage of their crop, and
stand to lose a \$480 million market. Roundup Ready alfalfa\'s
introduction depicts a notable difference between an export country\'s
government approval of a genetically engineered crop and export
customers\' approval. Even after Japan\'s government approved Roundup
Ready alfalfa for import, Japanese customers continued to show
resistance to the transgenic variety. Some U.S. export companies relayed
that Japanese customers (Japan accounts for 75 percent of the alfalfa
export market) were demanding documents that verified alfalfa shipments
as free of transgenic traits.\
\
Both the organic and biotechnology industries are rapidly growing, quite
literally, side-by-side. Although biotechnology firms claim there is a
successful ÒcoexistenceÓ between conventional and genetically engineered
crops, farmers have been dealing with unwanted transgenic material (be
it through gene flow or human error) in their crops for a decade, with
little recourse for damages.\
\
A recent example is last year\'s finding of an unapproved genetically
engineered long-grain rice variety in the food supply. Though only
approved for field trials and not human consumption, the rice strain
found its way into the commercial rice supply in all five of the
Southern states where long-grain rice is grown. Shockingly, this
discovery was made five years after the manufacturer stopped growing the
variety in experimental plots. A lawsuit was filed against the
manufacturer on behalf of 400 rice producers, and export losses were
estimated at \$150 million.\
\
The lawsuit that found USDA\'s approval of Roundup Ready alfalfa illegal
leveled the playing field, and said that a crop variety can\'t be grown
at the expense of significantly impacting another.\
\
In other words, if transgenic gene flow affects organic farmers\'
ability to grow organic alfalfa free of transgenic traits, then the
impacts must seriously be considered.\
\
Furthermore, the case was filed shortly after USDA\'s own Inspector
General released a report citing numerous problems with USDA\'s
oversight of genetically engineered crops, stating that current
regulations and policies do not go far enough to ensure the safe
introduction of genetically engineered crops. Performing a full
Environmental Impact Statement (EIS), as was ordered by the court, seems
the least the agency can do.\
\
Kristina Hubbard\
Missoula, Mont.\
**\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\***\
\
APHIS needs assess the economic impacts of organic alfalfa production
such as the following report from California.\
\
http://72.14.205.104/search?q=cache:ABZIFpgCTPgJ:coststudies.ucdavis.edu/files/alfalfaorg2007.pdf+%22Organic+Alfalfa%22+growth&hl=en&ct=clnk&cd=12&gl=us&client=firefox-a\
\
2007\
UNIVERSITY OF CALIFORNIA - COOPERATIVE EXTENSION\
SAMPLE COSTS TO ESTABLISH AND PRODUCE ORGANIC ALFALFA HAY\
\
CALIFORNIA ­ 2007\
\
Prepared by:\
Rachael F. Long - UC Cooperative Extension Farm Advisor, Yolo, Solano &
Sacramento Counties\
Steve B. Orloff - UC Cooperative Extension Farm Advisor, Siskiyou
County\
Roland D. Meyer - UC Cooperative Extension Soils Specialist Emeritus,
Department of Land, Air, and Water Resources, UC Davis.\
Karen M. Klonsky - UC Cooperative Extension Economist, Department of
Agriculture and Resource Economics, UC Davis\
Pete Livingston - UC Cooperative Extension Staff Research Associate,
Department of Agriculture and Resource Economics, UC Davis\
**\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\***\
\
(5) Weediness Traits:\
\
A, What differences are there in weediness traits of conventional
alfalfa versus glyphosate-tolerant alfalfa under managed crop production
systems as well as in unmanaged ecosystems?\
B. Are weediness traits evolving in conventional alfalfa versus
glyphosate-tolerant alfalfa?\
\
[Sierra Club Comments and Questions 5.C. - 5.D.:]{.underline}\
5.C. Are weediness traits evolving in organic alfalfa versus
glyphosate-tolerant alfalfa?\
\
5.D. Are there differences in weediness traits between organic and
conventional alfalfa since conventional crops do involve some pesticide
use?\
\
(6) Weed Occurrance:\
\
A. What is the occurrence of common and serious weeds found in organic
alfalfa systems, in conventional alfalfa systems, and in
glyphosate-tolerant alfalfa systems?\
B. What are the current impacts of weeds, herbicide-tolerant weeds, weed
management practices, and unmet weed management needs for organic and
conventional alfalfa cultivation?\
C. How may the weed impacts change with the use of glyphosate-tolerant
alfalfa?\
D. Concerns exist over weed impact changes as more and more glyphosate
is being used in agriculture. More and more plant species are developing
resistance to glyphosate use.\
\
(7) Weed Control Practices:\
\
A. What are the particular management practices for controlling weeds in
organic alfalfa systems, in conventional alfalfa systems, and in
glyphosate-tolerant alfalfa systems?\
B. What are the potential changes in crop rotation practices and weed
management practices for control of volunteer alfalfa or
herbicide-tolerant weeds in rotational crops that may occur with the use
of glyphosate-tolerant alfalfa?\
C. What are the potential effects on alfalfa stand termination and
renovation practices that may occur with the use of glyphosate-tolerant
alfalfa?\
D. What is the potential weediness of glyphosate-tolerant alfalfa?\
\
(8) Cumulative Impacts of Glyphosate-Resistant Weeds:\
\
A. What is the potential cumulative impact of glyphosate resistant
weeds, especially with the increase in acreage of glyphosate-tolerant
crops?\
B. Are there glyphosate resistant weeds and what is their prevalence in
crops and in non-crop ecosystems?\
C. Will the release of glyphosate-tolerant alfalfa cause an increase in
glyphosate resistant weeds in alfalfa and in other crops?\
D. Which weeds are the most likely to gain glyphosate resistance with
the use of glyphosate-tolerant alfalfa?\
E. What are the alternatives for management of glyphosate-tolerant or\
other herbicide-tolerant weeds in glyphosate-tolerant alfalfa stands or\
in subsequent crops?\
F. What are the potential changes that may occur in glyphosate-tolerant
alfalfa as to susceptibility or tolerance to other herbicides?\
\
(9) Herbicide-Tolerant Herbicide Weed Mitigation:\
\
A. What are current or prospective herbicide-tolerant weed mitigation
options, including those addressed by the Environmental Protection
Agency-approved label for glyphosate herbicides?\
\
(10) Gene Flow:\
\
A. What is the potential for gene flow in all combinations between seed
fields, hay fields, and feral plants?\
B. To what extent will deregulation of glyphosate-tolerant alfalfa
impact hybridization between cultivated and feral alfalfa, alfalfa\'s
introgression or\
establishment outside of cultivated lands, and alfalfa\'s persistence
in\
situations where it is unwanted, unintended, or unexpected?\
C. What are the risks associated with feral glyphosate-tolerant alfalfa
plants?\
D. How will the removal of glyphosate-tolerant alfalfa in situations
where it is unwanted, unintended, or unexpectedly results in adverse
impacts?\
E. In such situations, how will glyphosate-tolerant alfalfa be
controlled or\
managed differently from other unwanted, unintended, or unexpected\
alfalfa?\
F. To what extent can organic or conventional alfalfa farmers prevent
their crops from being commingled with unwanted, unintended, or\
unexpected glyphosate-tolerant alfalfa?\
\
[Sierra Club Comments and Questions 10.G. - 10.N.:]{.underline}\
10.G. What are the range of economic costs to organic or conventional
alfalfa seed growers of having to conduct annual DNA tests of their
alfalfa seeds for the presence of RR gene contamination?\
\
10.H. What are range of economic costs to organic or conventional
alfalfa farmers/growers of having to conduct annual DNA tests of their
alfalfa seeds and alfalfa crops for the presence of RR gene
contamination?\
\
10.I. What extent of alfalfa seed and alfalfa crop DNA testing will be
needed to be performed each year by organic and conventional alfalfa
farmers to sample their alfalfa seeds and alfalfa crops for the presence
of RR gene contamination?\
\
10.J. What is the range of economic costs passed on to consumers who
consume products derived from organic or conventional alfalfa if the
farmers have to conduct annual DNA tests of their alfalfa seeds and
alfalfa crops for the presence of RR gene contamination?\
\
10.K. What is the range of economic costs to organic or conventional
food retail and wholesale companies of having to conduct annual DNA
tests of their alfalfa seeds and alfalfa crops for the presence of RR
gene contamination?\
\
10.L. What is the range of economic costs to organic or conventional
alfalfa farmers if they had to label their RR contaminated alfalfa seeds
and alfalfa crops when the presence of RR gene contamination is
detectable?\
\
10.M. What are the economic costs to food retailers or wholesalers if
they had to label their RR contaminated alfalfa seed products and
alfalfa food items when the presence of RR gene contamination is
detectable?\
\
10.N. What would be the costs borne by a company such as Monsanto to pay
for RR testing if their RR alfalfa crop contaminates neighboring non-RR
alfalfa crops?\
\
(11) Economic & Social Impacts of RR Alfalfa on Organic/Conventional
Farmers:\
\
A. What are the potential economic and social impacts of
glyphosate-tolerant alfalfa release on organic and conventional alfalfa
farmers?\
B. What are the potential impacts of the presence of glyphosate-\
tolerant alfalfa caused by pollen movement or seed admixtures?\
C. What are the economic issues associated with using alfalfa seed or
hay commingled with glyphosate-tolerant alfalfa?\
D. What are the particular economics of growing seed or hay of\
organic alfalfa, conventional alfalfa, or glyphosate-tolerant alfalfa?\
E. What are the potential changes in the economics of growing and\
marketing organic and conventional alfalfa that may occur with the use\
of glyphosate-tolerant alfalfa?\
F. What are the potential changes in production levels of other crops
that may occur with the use of glyphosate-tolerant alfalfa (i.e., will
the release of glyphosate-tolerant alfalfa result in more or fewer acres
of corn, wheat, other forage crops, etc.)?\
G. What are the potential changes in growing practices, management
practices, and crop rotational practices in the production of alfalfa
hay or seed for planting or sprouting purposes that may occur with the
use of glyphosate-tolerant alfalfa?\
H. What are the potential changes in the choice of seeds available for
organic and conventional alfalfa farmers that may occur with the use of
glyphosate-tolerant alfalfa?\
\
(12) A serious concern exists over RR alfalfa trade impacts on export
markets:\
\
A. What are the potential impacts of the deregulation of
glyphosate-tolerant alfalfa on U.S. trade?\
B. If the presence of glyphosate-tolerant alfalfa should occur in
organic or conventional alfalfa where it is unwanted, unintended, or
unexpected, what are the expected impacts on trade with countries that
normally import alfalfa seed or hay?\
C. What are the expected impacts on trade with countries that do not
normally import alfalfa?\
D. Is there an expected impact on trade in other commodities?\
\
[Sierra Club Comments and Questions 12.E. :]{.underline}\
12.E. APHIS needs to conduct a thorough economic review of the RR
alfalfa trade impacts on export markets. Will APHIS avoid relying too
extensively on economic data provided by Monsanto and Forage Genetics
due to their vested interests in RR alfalfa?\
\
(13) Cumulative impacts of increasing glyphosate use raise growing
public health and environmental concerns about the growing threats of
widespread glyphosate contamination:\
\
A. What is the potential cumulative impact of increased glyphosate usage
with the release of glyphosate-tolerant crops?\
B. Have changes in glyphosate usage (including its known chemical
impurities such as 1,4-dioxane and others) impacted soil quality, water
quality, air quality, weed populations, crop rotations, soil
microorganisms, diseases, insects, soil fertility, food or feed quality,
crop acreages, and crop yields?\
C. Does the level of glyphosate tolerance within glyphosate-tolerant
alfalfa plants have a major impact on the amount of glyphosate applied
on the glyphosate-tolerant alfalfa crop on a routine basis?\
D. Glyphosate contamination (including its known chemical impurities
such as 1,4-dioxane and others) is a serious public health and
environmental concern in agricultural areas where glyphosate is being
used. Glyphosate contamination raises many questions that APHIS needs to
comprehensively address in the EIS. These are additional questions.\
\
[Sierra Club Comments and Questions 13.D. - 13.AA.:]{.underline}\
13.D. Are there data gaps in ground and surface water monitoring
programs to adequately assess the impacts of glyphosate residues
(including its known chemical impurities such as 1,4-dioxane and others)
in the water as contamination?\
\
13.E. How should these data gaps be addressed in ground and surface
water monitoring programs to better assess the impacts of glyphosate
residues in water, including monitoring and testing for its known
chemical impurities such as 1,4-dioxane and others?\
\
13.F. How many states with glyphosate in agricultural use routinely
conduct water testing that includes testing for the herbicide glyphosate
and all known glyphosate residues present or have a potential to be
present in the ground and surface water, including its known chemical
impurities such as 1,4-dioxane and others?\
\
13.G. How frequently is glyphosate contamination and all known
impurities like 1,4-dioxane detected in the ground and surface water
monitoring programs in the U.S.?\
\
13.H. How many drinking water alerts been issued by states or
municipalities due to glyphosate contamination and glyphosate-related
contaminants in the ground and surface water conduct testing?\
\
13.I. How many public or private drinking water wells in the U.S. have
been contaminated by glyphosate contamination?\
\
13.J. How many public or private drinking water wells in the U.S. have
had to be permanently closed down due to glyphosate contamination?\
\
13.K. Has Monsanto cooperated with local, state or federal agencies in
cleaning up drinking water wells contaminated by glyphosate
contamination?\
\
13.L. What remediation steps were taken to cleanup drinking water wells
in the U.S. contaminated by glyphosate contamination?\
\
13.M. What is the economic cost of remediation steps that were taken to
cleanup drinking water wells in the U.S. contaminated by glyphosate
contamination?\
\
13.N. How much will the economic costs increase of remediating drinking
water wells in the U.S. that may become contaminated by glyphosate
contamination?\
\
13.O. Will Monsanto pay any portion of the economic cost of remediation
that may have to be made to cleanup drinking water wells in the U.S.
contaminated by glyphosate contamination?\
\
13.P. How much has Monsanto paid to date in cleanup costs for cleanup
drinking water wells in the U.S. contaminated by glyphosate
contamination?\
\
13.Q. If Monsanto has not paid any of the glyphosate contaminated
drinking water cleanup costs in the U.S. for past contamination, where
will the cleanup costs come from?\
\
13.R. Has the U.S. Environmental Protection Agency paid for any of the
glyphosate contaminated drinking water cleanup costs in the U.S. for
past contamination?\
\
13.S. Has Monsanto been sued by private individuals or governmental
entities for allegations of glyphosate contamination in drinking water?\
\
13.T. Have any farmers been sued by private individuals or governmental
entities for allegations of glyphosate contamination in drinking water?\
\
13.U. What is the cost of providing clean drinking water for residents
who have had their drinking water contaminated by glyphosate?\
\
13.V. How will the costs increase in providing clean drinking water for
residents who have had their drinking water contaminated by glyphosate?\
\
13.W. Has Monsanto developed or funded a filtration process for
remediating glyphosate from contaminated water?\
\
13.X. How much would it cost for a family for one year with contaminated
drinking water to filter 100% of their water adequately to remove
glyphosate residues?\
\
13.Y. How much would it cost for a family for ten years with
contaminated drinking water to filter 100% of their water adequately to
remove glyphosate residues?\
\
13.Z. Will the U.S. government pay for any costs for a family for ten
years with contaminated drinking water to filter 100% of their water
adequately to remove glyphosate residues?\
\
13.AA. Will state or local governments pay for any costs for a family
for ten years with contaminated drinking water to filter 100% of their
water adequately to remove glyphosate residues?\
\
(14) Cumulative impacts of increasing glyphosate use raise growing
environmental concerns for impacts on threatened/endangered species.\
\
A. What are the potential impacts of the release of glyphosate-tolerant
alfalfa on threatened or endangered species and designated critical
habita[t]{.underline}?\
B. What are the potential effects of glyphosate-tolerant alfalfa use on
listed threatened or endangered species, species proposed for listing,
designated critical habitat, or habitat proposed for designation?\
C. What are the potential effects of glyphosate use on listed threatened
or endangered species, species proposed for listing, designated critical
habitat, or habitat proposed for designation; including glyphosate used
on glyphosate-tolerant alfalfa?\
\
[Sierra Club Comments and Questions 14.D. - 14.E.:]{.underline}\
14.D. What studies have been conducted that confirm the biological
effects of glyphosate residues on endangered or threatened species?\
\
14.E. What range of organic chemical impurities and inorganic chemical
impurities from the manufacturing process are detectable in glyphosate
that may cause or contribute to negative impacts on threatened or
endangered species?\
\
Known impurities in glyphosate according to an FAO report: Formaldehyde,
N-Nitrosoglyphosate, and insolubles.\
\
http://www.fao.org/ag/agp/agpp/pesticid/Specs/docs/Pdf/new/glypho01.pdf\
\
FAO SPECIFICATIONS AND EVALUATIONS\
FOR PLANT PROTECTION PRODUCTS\
.3 RELEVANT IMPURITIES\
\
.3.1 Formaldehyde (Note 2)\
Maximum 1.3 g/kg of the glyphosate acid content found under .2.2.\
\
.3.2 N-Nitrosoglyphosate (Note 2)\
Maximum 1 mg/kg\
\
.3.3 Insolubles in 1 M NaOH (MT 71)\
Maximum: 0.2 g/kg\
\
(15) What are the potential health and safety risks to field workers or
other workers that would come into contact with glyphosate-tolerant
alfalfa?\
\
Increasing use of glyphosate herbicide in agriculture raises potential
health impacts of glyphosate on workers and their families and
especially children and the unborn fetus. APHIS needs to comprehensively
review and consider all possible biological effects of glyphosate
exposure. Although glyphosate is among the ÒnewÓ generation of
pesticides with lower toxicity and less persistence, recent research has
raised the possibility that exposure to glyphosate can increase the risk
for developing non-HodgkinÕs lymphoma. APHIS needs to conduct a
comprehensive literature review of medical and related studies
investigating links between glyphosate and non-HodgkinÕs lymphoma.\
\
A. What are the potential health and safety risks to field workers or
other workers that would come into contact with glyphosate-tolerant
alfalfa?\
\
[Sierra Club Comments and Questions 15.B. - 15.I.:]{.underline}\
15.B. What are the potential health and safety risks to the families,
children and the unborn fetus\'s of field workers and any other farm
workers that would come into contact with glyphosate-tolerant alfalfa
and any glyphosate residues?\
\
15.C. Does glyphosate exposure increase the risk of non-HodgkinÕs
lymphoma since more and more medical studies are suggesting an increased
risk between glyphosate exposure and non-Hodgkin\'s lymphoma
occurrance?\
\
See one study by two eminent oncologists, Lennart Hardell, M.D., PhD.
Department of Oncology, Orebro Medical Centre, Orebro, Sweden and
Miikael Eriksson, M.D., PhD, Department of Oncology, University
Hospital, Lund, Sweden, \'A Case-Control Study of Non-Hodgkin Lymphoma
and Exposure to Pesticides\', Cancer, March 15, 1999/ Volume 85/ Number
6. The findings are based on a population-based case-control study
conducted in Sweden between 1987 - 1990. The necessary data was
ascertained by a series of comprehensive questionnaires and follow-up
telephone interviews. Dr. Hardell and Dr. Eriksson found that \'exposure
to herbicides and fungicides resulted in significantly increased risks
for NHL\'.\
\
In the study published in the 15 March 1999 Journal of American Cancer
Society, the researchers also maintain that exposure to glyphosate
\'yielded increased risks for NHL.\' They stress that with the rapidly
increasing use of glyphosate since the time the study was carried out,
\'glyphosate deserves further epidemiologic studies.\'\
\
Glyphosate, commonly known as Roundup, is the world\'s most widely used
herbicide. It is estimated that for 1998, over a 112,000 tons of
glyphosate was used world-wide. It indiscriminately kills off a wide
variety of weeds after application and is primarily used to control
annual and perennial plants.\
\
71% of genetically engineered crops planted in 1998 are designed to be
resistant to herbicides such as glyphosate, marketed by Monsanto as
Roundup. Companies developing herbicide resistant crops are also
increasing their production capacity for the herbicides such as
glyphosate, and also requesting permits for higher residues of these
chemicals in genetically engineered food. For example, Monsanto has
already received permits for a threefold increase in herbicide residues
on genetically engineered soybeans in Europe and the U.S., up from 6
parts per million (PPM) to 20 PPM.\
\
15.D. Does glyphosate contain organic chemical impurities or other
impurities such as 1,4-dioxane that may cause or contribute to health
effects on field workers and other workers that would come into contact
with glyphosate-tolerant alfalfa or any glyphosate residues in the soil,
water, air or on farm equipment or any other items?\
\
15.E. What is the minimum detectability limit in parts per billion or
parts per trillion that is performed on glyphosate to test batches for
the presence of organic or inorganic chemical impurities including
1,4-dioxane?\
\
15.F. How many samples are collected from each glyphosate production
batch to test for the presence of organic or inorganic chemical
impurities including 1,4-dioxane?\
\
15.G. What is the quantity of the samples collected from each glyphosate
production batch to test for the presence of organic or inorganic
chemical impurities such as 1,4-dioxane?\
\
15.H. What analytical chemical methods are utilized to test each
glyphosate production batch for the presence of organic or inorganic
chemical impurities including 1,4-dioxane?\
\
15.I. What purification and separation technologies are used to attempt
to remove organic chemical impurities or other impurities from
glyphosate production batches including 1,4-dioxane?\
\
15.J. What is the efficiency of the purification and separation
technologies that are used to attempt to remove organic chemical
impurities or other impurities from glyphosate production batches
including 1,4-dioxane?\
\
Known impurities in glyphosate according to an FAO report may include
additional chemicals: Formaldehyde, N-Nitrosoglyphosate, and
insolubles.\
\
http://www.fao.org/ag/agp/agpp/pesticid/Specs/docs/Pdf/new/glypho01.pdf\
\
FAO SPECIFICATIONS AND EVALUATIONS\
FOR PLANT PROTECTION PRODUCTS\
.3 RELEVANT IMPURITIES\
\
.3.1 Formaldehyde (Note 2)\
Maximum 1.3 g/kg of the glyphosate acid content found under .2.2.\
\
.3.2 N-Nitrosoglyphosate (Note 2)\
Maximum 1 mg/kg\
\
.3.3 Insolubles in 1 M NaOH (MT 71)\
Maximum: 0.2 g/kg\
\
15.K. Roundup Ready herbicide contains the following ingredients that
need to be considered in the EIS. Will APHIS investigate and review all
of this information in the EIS that glyphosate contains detectable
concentrations of 1,4-dioxane evidently as impurities in the
Polyoxyethylene alkylamine inert ingredients?\
\
In a letter forwarded to Northwest Coalition for Alternatives to
Pesticides, Monsanto identified RoundUp\'s ingredients as:\
\
1. Isopropylamine salt of glyphosate (active ingredient)\
2. Water\
3. The ethoxylated tallowamine surfactant\
4. Related organic acids of glyphosate\
5. Excess isopropylamine\
\
According to the US Environmental Protection Agency in a letter dated
April 30, 1999, in response to a Freedom of Information Request, the
following inert ingredients are in RoundUp Super Concentrate Weed &
Grass Killer:\
\
1. Polyoxyethylene alkylamine (CAS #61791-2) and impurities like
1,4-dioxane\
2. Water (CAS #7732-18-5)\
3. FD&C Blue No. 1 (CAS #3844-45-9)\
\
David H. Monroe, an Industrial and Environmental Toxicologist, stated in
an October 16, 1989 letter to the National Campaign Against the Misuse
of Pesticides (NCAMP) that most polyalkoxylated surfactants such as the
polyoxyethylene alkylamine in RoundUp are contaminated with 1,4-dioxane.
A study done by Monroe on Vision, a glyphosate product by Monsanto,
revealed that it contained 1,4-dioxane at a level of 350 ppm.\
\
(Monroe D, 1989. Letter to NCAMP.)\
\
1,4-dioxane is carcinogenic, and is known to damage the liver, kidney,
brain and lungs.\
\
http://www.naturescountrystore.com/roundup/page2.html\
\
15.K. Research on RoundUp\'s toxicity raises many questions about its
increased use as well as its existing use. Will APHIS investigate and
review all of these studies in the EIS on RoundUp\'s toxicity?\
\
Ingestion of RoundUp has been shown to cause \"irritation of the oral
mucous membrane and gastrointestinal tract¦pulmonary dysfunction,
oliguria, metabolic acidosis, hypotension, leukocytosis and fever.\"\
\
Monsanto\'s own toxicologist, Rebecca Tominack, participated in this
study.\
\
(Tominack RL, Yang GY, Tsai WJ, Chung HM, Deng JF, 1991. Taiwan National
Poison Center survey of glyphosate-surfactant herbicide ingestions. J
Toxicol Clin Toxicol 1991; 29 (1): 91-109)\
\
Many people report experiencing severe digestive problems related to
irritation of their gastrointestinal tract after overexposure to
RoundUp, limiting the foods their bodies will tolerate to a very few
bland foods.\
\
This is believed to be related to the fact that in a 1983 study by
Heitanen, Linnainmaa and Vainio, RoundUp\'s main ingredient, glyphosate,
was shown to decrease the hepatic level level of cytochrome P-450,
monooxygenase activities, and the intestinal activity of aryl
hydrocarbon hydroxylase.\
\
The inhibition of erythrocyte glutathione conjugate transport by
polyethoxylated surfactants has also been reported in a 1993 letter to
FEBS from studies done by P. G. Board, part of the Molecular Genetics
Group, John Curtin School of Medical Research, Australian National
University, Canberra.\
\
Glutathione is a tripeptide which the body produces from the amino acids
cysteine, glutamic acid, and glycine. Glutathione is a powerful
antioxidant produced in the liver, where it detoxifies harmful compounds
so that they can be excreted through the bile. The glutathione released
from the liver directly into the bloodstream helps to maintain the
integrity of red blood cells and protect white blood cells. Glutathione
is also found in the lungs. In the intestinal tract, it is needed for
carbohydrate metabolism, and also appears to exert anti-aging effects,
aiding in the breakdown of oxidized fats that may contribute to
atherosclerosis. Glutathione\'s role in carbohydrate metabolism is
compromised by the effect of RoundUp\'s surfactant, POEA, on erythrocyte
glutathion conjugate transport.\
\
RoundUp causes damage to the liver that inhibits the liver\'s ability to
process toxic substances.\
\
Research subject animals injected with glyphosate evidenced a depressed
function of the liver. \"Glyphosate decreased the hepatic function of
cytochrome P-450 and monoxygnease activities and the intestinal activity
of aryl hydrocarbon hydrolase.\" (Heitanen et al, 1983). The P-450
enzyme system is one of the main body systems for detoxifying harmful
chemicals. When it becomes impaired by those same chemicals it is
supposed to be detoxifying, the effects of a given chemical on the body
increase dramatically.\
\
(Heitanen, et al., 1983. Effects of phenoxyherbicides and glyphosate on
the hepatic and intestinal biotransformation activities in the rat. Acta
Pharmacol Toxicol (Copenh) 1983 Aug; 53(2):103-12.)\
\
Testing of patients suffering RoundUp overexposure has indicated damage
to their P-450 enzyme system.\
\
Roundup produces significant increases in sister-chromatid exchanges
(SCE), albeit in higher concentrations over those used for other
pesticides. This suggests that it should be evaluated in other genetic
tests measuring mutations and chromosome aberrations, although few
studies of this nature have yet been done.\
\
A 1980 study by Vigfusson and Vyse noted sister-chromatid exchanges in
human lymphocytes in vitro. This lymphocyte disturbance correlates with
the swelling experienced by persons poisoned by RoundUp.\
\
(Vigfusson, N.V. and Vyse, E.R. (1980), \"The effect of the pesticides,
Dexon, Captan, and Roundup, on sister-chromatid exchanges in human
lymphocytes in vitro\". MUTATION RESEARCH, v.79 p.53-57.)\
\
William Meggs, M.D., Ph.D., School of Medicine, East Carolina
University:\
\
In patients who have been chemically injured, Meggs has noted
significant lymphatic hyperplasia, lymphatic tissue that is swollen and
engorged. He has also found significant cobblestoning in upper airway
passages. This represents chronic inflammation caused by lymphocytes
migrating out of the blood stream and seeping into the tissues. Meggs
has also noted thickening of the structure called the basement membrane,
the structure on which the lining of cells that lines the interior of
the nose sits. Meggs\' study also found a defect in the tight junctions
(the joining of cells together) and a proliferation of nerve fibers.\
\
\"Chemicals bind to receptors on nerve fibers and produce something
called neurogenic inflammation. These chemicals bind to these receptors
and cause the release of potent substances that produce inflammation in
tissue.\
\
When chemicals bind to nerve fibers, they can produce inflammation.
Inflammation, in turn, produces other changes in the tissue, and it
brings in these lymphocytes. We believe that inflammation causes these
barrier cells to open up and sometimes even come off the basement
membrane. Below the basement membrane is the nerve fibers, so we have a
process whereby a chemical exposure will damage the lining of the nose.\
\
What happens is people have a large chemical exposure, they breathe in
noxious chemicals, and this damages the epithelium. This huge exposure
is able to penetrate this barrier we have between the chemicals we
breathe in and these nerve cells beneath the lining layer that react to
chemicals by producing inflammation. The inflammation, in turn, produces
substances that cause further damage to the lining cell, and actually
produce the substances which cause the tight junctions between these
cells to open up. In some cases the cells actually come off and just
leave these bare nerves exposed. Once you have the bare nerves exposed,
low levels of chemicals that we all experience every day are enough to
produce inflammation which in turn keeps the epithelium damaged.\"\
\
RoundUp was found to cause significant DNA damage to erythrocytes (red
blood cells) in a study done in 1997 by Clements, Ralph and Petras.
RoundUp\'s surfactant, POEA, is known to cause haemolysis.\
\
(Clements C, Ralph S, Pertas M, 1997. Genotoxicity of select herbicides
in Rana catesbeiana tadpoles using the alkaline single-cell gel DNA
electrophoresis (comet) assay. Environ Mol Mutagen 1997;
29(3):277-288.)\
\
(Sawada Y, Nagai Y, Ueyama M, Yamamoto I, 1988. Probable toxicity of
surface-active agent in commercial herbicide containing glyphosate.
Lancet. 1988 Feb 6;1(8580):299.)\
\
In haemolysis, hemoglobin leaks from the red blood cells, leaving them
unable to transport sufficient supplies of oxygen to the body\'s
tissues.\
\
The chest pains, difficulty breathing, and impaired cognitive skills
reported by persons who have sustained RoundUp poisoning also point to
impairment of the blood\'s oxygen transport system, hemoglobin, as being
responsible for these symptoms. This impairment of the erythrocytes\'
ability to deliver adequate oxygen to both brain and body results in
impaired tissue perfusion and hypoxia.\
\
\"The brain is particularly vulnerable to hypoxia, and exposure to
toxins that interfere with the intake, transport and utilization of
oxygen provoke rapid and major neuronal damage. Compounds crossing the
blood-brain barrier may induce both general and extremely localized
neurotoxic effects.\"\
\
(Kyvik KR, Morn BE, 1995. Environmental poisons and the nervous system.
Tidsskr Nor Laegeforen 1995. June 10; 115(15):1834-8.)\
\
According to both the EPA and the World Health Organization in 1993 and
1994, glyphosate appears to mimic adrenaline. This would explain the
sleeping problems encountered by many persons exposed to RoundUp, as for
them, cortisol appears to no longer be properly regulated by their
bodies\' adrenal glands.\
\
(US EPA, 1993. EPA Reregistration Eligibility Document, Glyphosate,
Office of Prevention, Pesticides and Toxic Substances, Washington, D.C.,
September 1993.)\
\
(IPCS, 1994. Environmental health criteria 159: Glyphosate.
International Programme of Chemical Safety, World Health Organization,
Geneva.)\
\
(16) Possible Mitigation of GlyphosateÕs Environmental Impacts: Can any
of the potential negative environmental impacts resulting from the
deregulation of glyphosate-tolerant alfalfa be reasonably mitigated and
what is the likelihood that mitigation measures will be successfully
implemented?\
\
A. The EIS will consider the stewardship measures outlined in the
Addendum to section VIII of the petition, as well as any other
mitigation measures APHIS considers applicable and viable. Such
measures, some of which may be outside the jurisdiction of APHIS, are
designed to reduce inadvertent gene flow of glyphosate-tolerant alfalfa
to negligible levels as well as to monitor and minimize the potential
development of glyphosate-tolerant weeds.\
\
[Sierra Club Comments and Questions 16.B. - 16.G.:]{.underline}\
16.B. At what gene flow level does APHIS consider the use of mitigation
measures such as stewardship practices as a failure due to increasing
levels of RR genetic contamination?\
\
16.C. APHIS previously downplayed the risks of RR genetic contamination
of organic and conventional alfalfa crops in the Environmental
Assessment which was loaded with unscientific opinions and a lack of
good science. Will APHIS conduct an honest scientific assessment of RR
genetic contamination since APHIS previously ignored, downplayed and
dismissed the problem posed by RR genetic contamination?\
\
16.D. Does APHIS have any funds for conducting its own gene flow field
studies on RR genetic contamination independent of Monsanto and Forage
Genetics?\
\
16.E. Is APHIS going to conduct any gene flow field studies of RR
genetic contamination using its own scientific staff?\
\
16.F. Monsanto and Forage Genetics also attempted to downplay the risks
of RR genetic contamination such that the gene flow experts\' documents
were highly biased toward approval of RR alfalfa. Will Monsanto, Forage
Genetics and their highly paid gene flow experts continue to present a
case of denial as to the serious potential of RR genetic contamination
due to gene flow?\
\
16.G. Will APHIS avoid relying on external gene flow scientists who have
been paid by Monsanto and Forage Genetics to avoid the appearance of
bias and unethical research motives?\
\
(17) Coexistence with Organic/Conventional Alfalfa:\
\
A. What are the impacts of the mitigation measures on coexistence with
organic and conventional alfalfa production and export markets?\
\
[Sierra Club Comments and Questions 17.B. - 17.D.:]{.underline}\
17.B. Can APHIS define what it means precisely by the term ÒCoexistenceÓ
of Organic/Conventional Alfalfa as to whether its a scientific term or
an APHIS policy position on genetic contamination?\
\
17.C. Has APHIS conducted a field study to survey Organic or
Conventional Alfalfa farmers as to their views of the meaning of
ÒCoexistenceÓ with RR alfalfa?\
\
17.D. What is the difference in the perceptions of ÒCoexistenceÓ between
Organic or Conventional Alfalfa farmers compared to RR alfalfa?\
\
(18) A. Are there any other potential direct, indirect or cumulative\
impacts from the release of glyphosate-tolerant alfalfa other than\
those mentioned above?\
\
[Sierra Club Comments and Questions 18.B. - 18.D.:]{.underline}\
18.B. Does glyphosate use in RR alfalfa fields have negative impacts on
bee populations and colonies considering the recent emerging phenomenon
called the Colony Collapse Disorder or CCD?\
\
18.C. What range of organic and inorganic chemical impurities are
detectable in glyphosate that may cause or contribute to negative
impacts on bee populations and colonies considering the recent emerging
phenomenon called the Colony Collapse Disorder or CCD?\
\
18.D. What range of organic and inorganic chemical impurities are
detectable in glyphosate that may cause or contribute to negative
impacts on insect or wildlife populations?\
\
Known impurities in glyphosate according to an FAO report: Formaldehyde,
N-Nitrosoglyphosate, and insolubles.\
\
http://www.fao.org/ag/agp/agpp/pesticid/Specs/docs/Pdf/new/glypho01.pdf\
\
FAO SPECIFICATIONS AND EVALUATIONS\
FOR PLANT PROTECTION PRODUCTS\
.3 RELEVANT IMPURITIES\
\
.3.1 Formaldehyde (Note 2)\
Maximum 1.3 g/kg of the glyphosate acid content found under .2.2.\
\
.3.2 N-Nitrosoglyphosate (Note 2)\
Maximum 1 mg/kg\
\
.3.3 Insolubles in 1 M NaOH (MT 71)\
Maximum: 0.2 g/kg\
\
\
Respectfully,\
\
Neil J. Carman, Ph.D.\
Sierra Club Genetic Engineering Committee\
1202 San Antonio Street\
Austin, Texas 78701\
Neil_Carman@greenbuilder.com