The Biological Products Industry Alliance (BPIA) has filed comments with the USDA’s Animal and Plant Health Inspection Service (APHIS) Plant Protection and Quarantine program regarding proposed amendments to Section 330 Regulations. Read the comments here.
APHIS has been very responsive to BPIA over the last few years. They heard BPIA members’ concerns and desire to be in compliance. Yet, it was hard to know the rules fully, given the lack of information on the APHIS website.
The proposed amendments confirm what APHIS has already been doing. The amendments include many good additions, especially a list of pests exempt from standard permit requirements, along with a petition process to add other pests to this list in the future.
The amendments would eliminate the need for a General Permit for importing EPA-registered microbial pesticides manufactured outside the U.S. During discussions, BPIA highlighted this as a big issue, especially since an import permit could only be shipped to a single address, and it duplicated EPA’s Notice of Arrival form for all pesticide imports. Now APHIS has developed a memorandum of understanding with EPA to eliminate this extra process.
BPIA’s comments focus mostly on 1) requesting more clarity for certain aspects (e.g., evidence); 2) leaving some aspects (e.g., similarity) without clear definition since flexibility is needed; 3) requesting more details about their risk assessment process; and 4) clarifying the boundaries of ‘A Letter of No Jurisdiction’ and ‘A Letter of No Permit Required’. BPIA also offers a few more organisms to add to the Exempt List.
Thanks to the BPIA Regulatory Committee’s USDA Subcommittee for taking the lead with these important comments.