Haw. Code R. § 4-71A-34 - Import of a microbial product under trade secret claim

(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.

(f) Products containing microorganisms under trade secret claim shall not be listed on the same permit application as products for which no trade secret claim is asserted.

Notes

Haw. Code R. § 4-71A-34

[Eff. 11/30/01] (Auth: HRS §§ 150A-9, 150A-6.3) (Imp: HRS § 150A-6.3)