18 AAC 34.035. Permit requirements; application, renewal, and denial

(a) Except as provided in (f) of this section, a person may not conduct an activity described in 18 AAC 34.005(b) without a current annual permit issued under this chapter for that activity. An applicant shall apply for a permit to operate a processing facility using a form provided by the department. After a complete application is received, to the extent possible, the department will process the application and issue or deny the permit within 60 days. Except as provided in (e) of this section, the complete application must include

(1) the applicable permit fee required in 18 AAC 34.900; the department will not review an application until the fee is received;

(2) a list of ingredients to be used for seafood products that have two or more ingredients;

(3) a statement that the processor has

(A) conducted a hazard analysis as required by 21 C.F.R. 123.6 (Hazard Analysis and Hazard Analysis Critical Control Point (HACCP) plan), adopted by reference in 18 AAC 34.010, and, if hazards were identified, has a HACCP plan as required by 18 AAC 34.045; and

(B) a sanitation plan as required by 18 AAC 34.050 or, if the application is for a direct-market fishing vessel that is not required to have a HACCP plan because no hazards were identified under 18 AAC 34.045, a sanitation schedule as required under 18 AAC 34.525;

(4) for thermally processed product, a copy of

(A) the food canning establishment registration (FDA form 2541) and the food canning establishment process filing form (FDA form 2541a) submitted to the United States Food and Drug Administration (FDA); and

(B) the scheduled process as set out in 21 C.F.R. 113.83 (Establishing scheduled processes), adopted by reference in 18 AAC 34.010;

(5) for a mobile processing facility, a location selected from 18 AAC 34.930(i) for inspection purposes;

(6) a copy of the plans required by 18 AAC 34.060; and

(7) unless previously approved by the department, or the United States Environmental Protection Agency (EPA) if applicable, a plan for

(A) the facility's drinking water supply and treatment under 18 AAC 80;

(B) wastewater disposal for the facility under 18 AAC 72; and

(b) To ensure compliance with the labeling requirements of 18 AAC 34.110, the applicant may include a printer's proof or an actual label from the product for the department's review.

(c) After receiving a complete application, the department will reserve for the applicant and assign for the processor's use a permit number consisting of the state abbreviation "AK" followed by a number or combination of a number and an alphabetical letter.

(d) The permit to operate the facility

(1) must be prominently posted in public view in the facility; a copy of the permit may be used to comply with this paragraph;

(2) is not transferable; and

(3) expires on December 31 of the year in which it is issued.

(e) An applicant shall apply to renew a permit to operate a processing facility, using forms supplied by the department. An applicant for renewal need not resubmit the information provided under (a)(2) - (7) of this section if that information remains unchanged. At least every three years, the department will, applying its enforcement discretion, require the processor to submit the information required under (a)(2) - (7) of this section to assure compliance. A renewal application is not complete and the department will not review it until the department receives the renewal fee required in 18 AAC 34.900.

(f) The department will, in its discretion, grant provisional approval of a permit to operate a facility and will state in writing the reasons for and the terms of the provisional approval.

(g) If the department denies a permit to operate a facility, it will notify the applicant in writing as soon as practicable but, to the extent possible, no later than 60 days after the department receives a complete application. The notice of denial will include the reasons for denial. The applicant may, within 30 days after receiving notice of denial, request an adjudicatory hearing as set out in 18 AAC 15.200 - 18 AAC 15.910. Nothing in this subsection affects an applicant's rights under the Administrative Procedure Act (AS 44.62).

History: Eff. 12/18/97, Register 144; am/readopt 12/2/99, Register 152

Authority: AS 17.20.005

Editor's note: Effective 12/2/99, Register 152, the Department of Environmental Conservation readopted 18 AAC 34.035, to affirm the validity of that section following statutory amendments made in ch. 72, SLA 1998. The department also amended 18 AAC 34.035(a) (3)(b) and (d)(1). Chapter 72, SLA 1998 relocated department authority to adopt regulations in 18 AAC 34 from AS 03.05 to AS 17.20.

Information about how to review or obtain a copy of a requirement referred to in 18 AAC 34.035 and adopted by reference in 18 AAC 34.010 is set out in the editor's note to 18 AAC 34.010.

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