APHIS Notification Procedures
Information needed to receive transgenic seeds from the Maize COOP:
Note: All of the construct information about RescueMu is included in the sample notification letter (below), so you will only need to cut and paste that information. For other transgenic stocks in our collection (e.g., from the Chromatin Functional Genomics Consortium), please request the construct information for each stock.
For requests from outside the USA:
The requester must inquire about any regulatory
requirements from their government, and let us know if we need to do
anything
special.
For requests from within the USA:
In order to receive the shipment, you are required
to send a movement notification letter (see below for a sample) to
APHIS.
From outside Illinois, this is called 'interstate movement'; from
within
Illinois this is called 'intrastate movement'.
In order to grow these stocks under field, greenhouse or laboratory conditions, you will also need to submit a release notification. Movement and release notifications can be sent simultaneously, in the same letter. After review by APHIS and your state's officials, the notification will be acknowledged. See: http://www.aphis.usda.gov/biotechnology/brs_main.shtml for further information.
Note: a notification for movement should be acknowledged within 10 days of receipt by APHIS; and for release, within 30 days of receipt. After these periods, acknowledgement is 'supposidly' considered accepted de facto.
If you would like to keep your name and address confidential in the public release version of the notification, please ask APHIS personnel how to have this 'Personally Identifying Information (PII)' withheld from the public record.
A notification letter may be submitted by mail and/or by FAX. However, since the signature on a notification letter submitted by FAX is not legally binding, it is required that confirmative copies with legally valid (original) signatures be submitted by mail (preferably by an overnight delivery system that guarantees and tracks deliveries). Alternatively, notifications can now be sent through APHIS's ePermits system.
Suggestion: It seems to be better if PIs rather than students/staff send the notification to APHIS.
There are also requirements for how you should
keep
these seeds-- see http://www.aphis.usda.gov/biotechnology/
and http://www.access.gpo.gov/nara/cfr/waisidx_05/7cfr340_05.html
[Container requirements for regulated articles]. Regulations also
specify
that you must prevent any mixing of transgenic stocks with non
transgenic
ones and prevent any accidental escape of seeds or plants from your
storage
facility.
APHIS notification example for receiving RescueMu stocks from the Maize COOP:Sample Notification: (on your letterhead; see: http://www.aphis.usda.gov/biotechnology/notifications.shtml)Please modify this sample to suit your individual needs.
Permits Branch
Biotechnology Permits
Biotechnology, Biologics and Environmental Protection
4700 River Road
Riverdale, MD 20737-1228
Re: Notice of Environmental Release and Interstate Transfer
1. Reference Number: [leave blank; APHIS will assign]
2. Applicant Reference Number: [assign number for your internal purposes and to track progress of the acknowledgement]
3. Applicant/Responsible Party:
[Your
organization
here
your name here]
4. Duration of Introduction:
Release:
[Start Date - End Date] (County, State) *Note:
Release duration can be up to 5 years, max.
Interstate Movement: [Start Date - End Date] *Note: Movement duration can only be up to 1 year, max.
5. Recipient: Corn, Zea mays L.
6. Regulated Article:
Designation
of transformed line : MuRep R3
category : MG
phenotype(s) : red spots upon transposon excision
------------------------------------------------------------------------------------------------------------
construct 1 : pMuRep2
genotype:
promoter : 35S 5’ from cauliflower mosaic virus (CaMV)
gene(s):
Mu1 transposon from Zea mays
inserted with pUC-derived plasmid,
maize Lc cDNA from Zea mays,
short 200bp nodPQ subclone from Rhizobium meliloti
(as a marker)
terminator : rbcS 3’ end of rbcS-E9 gene from Pisum sativum
------------------------------------------------------------------------------------------------------------
construct 2: pMuRep3
genotype:
promoter : 35S 5’ from cauliflower mosaic virus (CaMV)
gene(s)
:
Mu1 transposon from Zea mays
inserted with pUC-derived plasmid,
maize Lc cDNA from Zea mays,
short 400bp nodPQ subclone from Rhizobium meliloti
(as a marker)
terminator : rbcS 3’ end of rbcS-E9 gene from Pisum sativum
------------------------------------------------------------------------------------------------------------
selectable marker : pAHC20
genotype:
promoter : ubiquitin promoter from Zea mays
enhancer: ubiquitin 1 intron from Zea mays
gene : phosphinothricin acetyltransferase (bar) from Streptomyces hygroscopicus
terminator : nos 3’ from Agrobacterium tumefaciens T-DNA
------------------------------------------------------------------------------------------------------------
7. Mode of Transformation: microprojectile bombardment
8. Introduction:
Release:
NUMBER OF STATES AND SITES: [your state] (1)
*[your county]
[amount, e.g., number of acres]
Interstate Transfer:
ORIGIN: IL DESTINATION: [your state (Your County)]
1) FROM: Champaign County, IL, as <1 lb of corn seed
TO: [Your organization, your county, your state]
9. Certification: I certify that the regulated article will be introduced in accordance with the eligibility criteria and the performance standards set forth in 7 CFR 340.3. The above information is true to the best of our knowledge. If there are any changes, we will contact APHIS.
Signature ____________________________ Date: [Date]
[ Name ], [ title]
[organization]