Post by ruth on Oct 9, 2005 14:04:02 GMT -5
Dear Concerned Citizen:
Thank you for writing to the Secretary of the U.S. Department of Agriculture (USDA)
concerning genetically engineered plants that produce pharmaceutical and industrial
substances.
We at USDA share your concern for American agriculture and the environment, and
our officials actively work to safeguard these resources. We believe that our current
regulations are more than adequate to ensure the safe introduction of genetically
engineered organisms. Nevertheless, we also recognize that the science of biotechnology
is always changing. The Biotechnology Regulatory Services (BRS) program of USDA's
Animal and Plant Health Inspection Service (APHIS) strives to ensure that the most
current scientific data is used when evaluating each application to grow genetically
engineered organisms.
We agree that crops cannot be used for the production of pharmaceutical and industrial
substances without the use of stringent measures designed to protect our food system
from contamination. We believe that these crops are not and should not be treated
as nonregulated commodity crops in the United States given current technology and
agricultural practices. APHIS follows a comprehensive risk assessment and management
program for pharmaceutical and industrial crop production. This program has become
the basis for the permit requirements associated with pharmaceutical and industrial
crop field plantings as well as the inspection regimen for those crops. The inspection
regimen includes a minimum of five inspections at critical points in the field operations
during the growing season. Additional requirements for field testing these crops
include a 50-foot fallow zone around the field test and the use of dedicated equipment
for planting and harvesting. Isolation distances from other sexually compatible
crops are even more stringent; for example, openly pollinated corn requires 1 mile
of separation.
In addition, crops intended for food or feed use cannot be planted at the test site
during the following growing season without a variance granted by BRS' Deputy Administrator.
Training programs must be implemented to ensure that personnel follow permit conditions
exactly. To verify adherence to permit conditions, BRS inspectors review the records
of those entities executing pharmaceutical and industrial crop field tests. Failure
to meet APHIS' permit and notification requirements can lead to substantial fines.
In the last 15 years, APHIS has overseen more than 10,000 permits and notifications
for the field testing of genetically engineered crops. APHIS officials have found
no evidence of harm to the environment or the food supply as a result of this testing,
and we remain confident that current regulations are adequately ensuring the safe
introduction of genetically engineered organisms. As science and technology advances,
we will continue to safeguard American agriculture by updating the regulations to
ensure that biotechnology poses no risk to our Nation's plants and agriculture.
As part of this commitment, we announced plans on January 22, 2004, to update the
biotechnology regulations. APHIS subsequently published in the Federal Register
a notice of intent to prepare an environmental impact statement (EIS) regarding
the importation, interstate movement, and environmental release of certain genetically
engineered organisms.
The EIS will provide the first critical steps in the comprehensive update and strengthening
of our biotechnology regulatory framework. As part of that work, BRS officials
are reviewing all of the program's biotechnology regulations, including a thorough
and systematic examination of the issues concerning the confinement of pharmaceutical
and industrial crops. We feel that our approach to developing the EIS demonstrates
our ongoing commitment to transparency in our regulatory process. Once USDA publishes
the EIS in the Federal Register, the public will have an opportunity to provide
comments during a formal comment period. In addition, we assure you that any future
rulemaking based on the EIS would also be open to public comment.
If you would like to learn more about BRS' efforts in promoting the safe development
of genetically engineered crops, you may wish to visit BRS' Web site. The address
is www.aphis.usda.gov/brs. In addition, for more information about the efforts
of other Federal entities with respect to biotechnology, the environment, and food
safety, please visit usbiotechreg.nbii.gov/.
Sincerely,
Cindy Smith
Deputy Administrator
Biotechnology Regulatory Services
Animal and Plant Health Inspection Service
Thank you for writing to the Secretary of the U.S. Department of Agriculture (USDA)
concerning genetically engineered plants that produce pharmaceutical and industrial
substances.
We at USDA share your concern for American agriculture and the environment, and
our officials actively work to safeguard these resources. We believe that our current
regulations are more than adequate to ensure the safe introduction of genetically
engineered organisms. Nevertheless, we also recognize that the science of biotechnology
is always changing. The Biotechnology Regulatory Services (BRS) program of USDA's
Animal and Plant Health Inspection Service (APHIS) strives to ensure that the most
current scientific data is used when evaluating each application to grow genetically
engineered organisms.
We agree that crops cannot be used for the production of pharmaceutical and industrial
substances without the use of stringent measures designed to protect our food system
from contamination. We believe that these crops are not and should not be treated
as nonregulated commodity crops in the United States given current technology and
agricultural practices. APHIS follows a comprehensive risk assessment and management
program for pharmaceutical and industrial crop production. This program has become
the basis for the permit requirements associated with pharmaceutical and industrial
crop field plantings as well as the inspection regimen for those crops. The inspection
regimen includes a minimum of five inspections at critical points in the field operations
during the growing season. Additional requirements for field testing these crops
include a 50-foot fallow zone around the field test and the use of dedicated equipment
for planting and harvesting. Isolation distances from other sexually compatible
crops are even more stringent; for example, openly pollinated corn requires 1 mile
of separation.
In addition, crops intended for food or feed use cannot be planted at the test site
during the following growing season without a variance granted by BRS' Deputy Administrator.
Training programs must be implemented to ensure that personnel follow permit conditions
exactly. To verify adherence to permit conditions, BRS inspectors review the records
of those entities executing pharmaceutical and industrial crop field tests. Failure
to meet APHIS' permit and notification requirements can lead to substantial fines.
In the last 15 years, APHIS has overseen more than 10,000 permits and notifications
for the field testing of genetically engineered crops. APHIS officials have found
no evidence of harm to the environment or the food supply as a result of this testing,
and we remain confident that current regulations are adequately ensuring the safe
introduction of genetically engineered organisms. As science and technology advances,
we will continue to safeguard American agriculture by updating the regulations to
ensure that biotechnology poses no risk to our Nation's plants and agriculture.
As part of this commitment, we announced plans on January 22, 2004, to update the
biotechnology regulations. APHIS subsequently published in the Federal Register
a notice of intent to prepare an environmental impact statement (EIS) regarding
the importation, interstate movement, and environmental release of certain genetically
engineered organisms.
The EIS will provide the first critical steps in the comprehensive update and strengthening
of our biotechnology regulatory framework. As part of that work, BRS officials
are reviewing all of the program's biotechnology regulations, including a thorough
and systematic examination of the issues concerning the confinement of pharmaceutical
and industrial crops. We feel that our approach to developing the EIS demonstrates
our ongoing commitment to transparency in our regulatory process. Once USDA publishes
the EIS in the Federal Register, the public will have an opportunity to provide
comments during a formal comment period. In addition, we assure you that any future
rulemaking based on the EIS would also be open to public comment.
If you would like to learn more about BRS' efforts in promoting the safe development
of genetically engineered crops, you may wish to visit BRS' Web site. The address
is www.aphis.usda.gov/brs. In addition, for more information about the efforts
of other Federal entities with respect to biotechnology, the environment, and food
safety, please visit usbiotechreg.nbii.gov/.
Sincerely,
Cindy Smith
Deputy Administrator
Biotechnology Regulatory Services
Animal and Plant Health Inspection Service