(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 required 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. For a person who wishes to conduct an activity described in 18
AAC
34.005(b) within a permitted
processor's
facility, that person shall apply
for a permit to operate using the current year's annual 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 or a
direct-market land-based facility 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 and 18 AAC
34.740;
(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;
(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
(C) solid waste
disposal for the facility under 18 AAC 60; and
(8) for an applicant who wishes to conduct an
activity described in 18 AAC
34.005(b) within a permitted
processor's
facility, a
written statement of consent from the permitted processor authorizing the
applicant to utilize the
facility and the agreed upon times or locations that
each operator will conduct processing activities.
(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 the current year's annual form supplied
by the
department. An applicant for renewal need not resubmit the information
provided under (a)(2) - (8) 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) - (8) 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, not later than 60 days after the
department receives a complete application. In the notice of denial the
department will include the reasons for denial. Not later than 30 days after
receiving notice of denial, the applicant may request an adjudicatory hearing
under AS 44.62 (Administrative Procedure Act) by submitting a request to the
commissioner. Upon receipt of a timely request for an adjudicatory hearing, the
commissioner will refer the matter to the office of administrative hearings (AS
44.64.010) for a hearing and recommended decision under 2 AAC
64.100 - 2 AAC
64.990 to the commissioner or to the commissioner's designee if the designee is a
person other than the person who issued the contested decision.