Hawaii Administrative Rules › Title 4 - DEPARTMENT OF AGRICULTURE › Subtitle 6 - DEPARTMENT OF AGRICULTURE › Chapter 71A - PLANT AND NON-DOMESTIC ANIMAL QUARANTINE MICROORGANISM IMPORT RULES › Subchapter 4 - INTRODUCTION OF MICROBIAL PRODUCTS › Section 4-71A-34 - Import of a microbial product under trade secret claim

Current through June, 2024
(a) Import of a microbial product containing
				  a microorganism for which species identification is claimed by the product's
				  manufacturer or shipper to be trade secret shall be subject to special handling
				  to assure confidentiality of the species identification of the microorganism,
				  provided that the manufacturer or shipper and importer comply with branch
				  procedures for notification and accommodation of a trade secret
				  claim.
(b) Notwithstanding the
				  assertion of a trade secret claim as described in subsection (a), the
				  manufacturer or shipper shall disclose to the chief the scientific name or
				  species identification of each microorganism contained in the microbial product
				  requested for import, after which the asserted trade secret data will only be
				  reviewed as necessary by certain persons in the branch's permit and
				  registration review process. To maintain confidentiality, the asserted trade
				  secret data will appear in coded form in written materials at any public
				  meetings at which the import request is considered or in any disclosure of
				  public records.
(c) It is the
				  responsibility of the applicant or permittee to defend a trade secret claim if
				  challenged and prove trade secret status. The department will treat a properly
				  asserted trade secret claim as such and maintain confidentiality for the
				  asserted trade secret data to the extent permitted by law or unless required to
				  disclose the information pursuant to chapter
				  92F, HRS. If upon challenge, the
				  state Office of Information Practices or a court determines that the scientific
				  name or species identification of a microorganism contained in a microbial
				  product is not a trade secret, subject to the outcome of any appeal, the
				  department will disclose the data.
(d) A microbial product under trade secret
				  claim is subject to the import requirements for microbial products described in
				  this subject.
(e) Both a local
				  importer as applicant and a manufacturer or shipper as co-applicant shall
				  complete and sign an application for import under trade secret claim as
				  provided herein and on branch forms. A trade secret claim under this section
				  will be processed as follows:
(1) The
				  manufacture or shipper shall notify the chief in writing of a trade secret
				  claim asserted as to species identification of one or more microorganisms
				  contained in a microbial product and shall provide the product name and the
				  name and address of the local importer;
(2) Upon notification, the chief shall send
				  to the manufacturer or shipper a permit application for import under trade
				  secret claim;
(3) The manufacture
				  or shipper shall list on the application the scientific name of each
				  microorganism contained in the product, identifying which microorganisms are
				  asserted to be trade secret protected, and shall complete and sign the
				  application;
(4) Prior to
				  submitting the completed application to the branch for special handling, the
				  manufacturer or shipper shall send to the importer a copy of the same
				  application, first deleting species identification for those microorganisms in
				  the product asserted to be trade secret protected; and
(5) The importer shall complete, sign and
				  submit the trade secret data redacted application to the department.