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Biopharm
Rule summary
The proposed rule established a system for a coordinated joint review of any federal permit applications for growing biopharmaceutical crops in Oregon. The intent is not to duplicate the federal permit review process, rather to allow the state to provide input on Oregon specific issues and requirements. The applicant would be billed $100/ hour, up to $10,000, for state services related to permit review and oversight of the biopharmaceutical crop production.


Biopharm rule text
Effective 2/4/2010
Biopharmaceutical Crops
603-052-1236


(1) As authorized by ORS 561.738 & 561.740 a system is established for joint federal-state oversight of biopharmaceutical crops in Oregon.

(2) Memoranda of understanding (MOU’s).  
(a) ORS 561.740 authorizes the Director of Agriculture and an appointee of the Director of Human Services to enter into a MOU or other state-federal cooperative agreement designed to increase state input to the federal biopharmaceutical crop permitting system on issues and requirements of specific interest to the State.  These rules clarify the procedures for carrying out the provisions of ORS 561.740.
 
(b) ODA and DHS will enter into a separate MOU or other cooperative agreement to clarify how they will interact during the joint review of a biopharmaceutical crop permits and oversight of biopharmaceutical crop production.

(3) Federal Regulations
Federal permit regulations related to genetically engineered crops are contained in 7 CFR, Part 340.  As part of the permit process (7 CFR, Part 340.4 (14)(c)), USDA submits the application and initial review (minus confidential business information (CBI)) to the department of agriculture of the State of destination.  

ORS 561.740 (2)(a) authorizes certain Oregon state officials from the departments of Agriculture and Human Services to receive CBI and keep it confidential if the application is for a biopharmaceutical crop.

(4) ODA/DHS Review of Federal Biopharmaceutical Crop Permit
The intent of ODA/DHS review is not to duplicate the efforts of USDA, rather to allow ODA/DHS to provide input on Oregon-specific issues and requirements.  ODA/DHS officials may not disclose CBI revealed to them as part of this process.

(5) Public Input
(a) ODA will maintain a list of interested parties requesting notification in the event the State receives a biopharmaceutical crop permit application.  Notification to interested parties will be done via email.  Only non-CBI will be shared with interested parties and other members of the public.
(b) If ten or more people or an association with ten or more members requests a public information meeting, ODA will conduct such a meeting pursuant to ORS 192.610 to 192.710 in the county of the proposed biopharmaceutical planting to answer questions and gather input. Notice of the meeting will be via email and will include the list of interested parties and the OSU County Extension office in the county of the proposed planting so that local growers can be invited.  The meeting notice will also be posted on ODA’s website as will addresses for sending comments via postal mail or email.  All input received by the end of the public information meeting will be supplied to the ODA and DHS officials reviewing the application for their consideration.
(c) The period for public comment will be 30 days or as long as possible if the State receives the application with less than 30 days before any USDA-imposed deadlines related to maximum review periods outlined in 7 CFR, Part 340.4 (14)(c).

(6) State Response
(a) After thorough review, ODA, in consultation with DHS, will jointly issue a letter to USDA with signatures of designated officials from both agencies.  If either agency has concerns, those concerns will be expressed in the joint letter.  The letter will recommend approval, approval with additional safeguards, or denial of the biopharmaceutical crop permit application.

(7) Monitoring
(a) In coordination with USDA, and to the extent resources are available, ODA/DHS officials will participate in inspecting and monitoring of biopharmaceutical crops and take action if it is determined that there is evidence an existing or proposed biopharmaceutical crop is likely to endanger human health, the environment, Oregon agriculture, horticulture, or forest production.  
(b) The costs of any required remedial action, which may include crop destruction, are the responsibility of the permit applicant.

(8) State Fees
The applicant will be billed at a maximum rate of $100/hour for state services related to the authorization and oversight of biopharmaceutical crop production, including but not limited to permit application review, site inspections, monitoring, administration and enforcement.  Invoices will be sent quarterly by the ODA.  DHS will receive its share of payments received via interagency transfer.  Total fees charged under this paragraph may not exceed $10,000 for each federal permit and the resulting production.
 


Questions on biopharm or permit process
Questions on biopharm and the permit review process contact Dan Hilburn at the Oregon Department of Agriculture by phone at 503-986-4663 or email dhilburn@oda.state.or.us.