| (iii) In addition, to pass the financial test, a licensee
shall meet all the following requirements:
(I) the licensee's independent certified public accountant
shall have compared the data used by the licensee in the financial
test that is required to be derived from the independently audited
year-end financial statements, based on United States generally accepted
accounting practices, for the latest fiscal year, with the amounts
in the financial statement. In connection with that procedure, the
licensee shall inform the department within 90 days of any matters
coming to the attention of the auditor that cause the auditor to believe
that the data specified in the financial test should be adjusted and
that the licensee no longer passes the test; and
(II) after the initial financial test, the licensee
shall repeat passage of the test within 90 days after the close of
each succeeding fiscal year;
(III) if the licensee no longer meets the requirements
of subparagraph (A) of this paragraph, the licensee shall send notice
to the department of its intent to establish alternative financial
assurance as specified in the department's rules. The notice shall
be sent by certified mail, return receipt requested, within 90 days
after the end of the fiscal year for which the year-end financial
data show that the licensee no longer meets the financial test requirements.
The licensee shall provide alternate financial assurance within 120
days after the end of such fiscal year.
(C) Self-guarantee. The terms of a self-guarantee that
an applicant or licensee furnishes shall provide the following:
(i) The guarantee shall remain in force unless the
licensee sends notice of cancellation by certified mail, return receipt
requested, to the department. Cancellation may not occur unless an
alternative financial assurance mechanism is in place.
(ii) The licensee shall provide alternative financial
assurance as specified in the department's regulations within 90 days
following receipt by the department of a notice of cancellation of
the guarantee.
(iii) The guarantee and financial test provisions shall
remain in effect until the department has terminated the license or
until another financial assurance method acceptable to the department
has been put in effect by the licensee.
(iv) The applicant or licensee shall provide to the
department a written guarantee (a written commitment by a corporate
officer or officer of the institution) that states that the licensee
will fund and carry out the required decommissioning activities or,
upon issuance of an order by the department, the licensee will set
up and fund a trust in the amount of the current cost estimates for
decommissioning.
(v) If, at any time, the licensee's most recent bond
issuance ceases to be rated in any category of "A" or above by either
Standard and Poor's or Moody's, the licensee shall provide notice
in writing of the fact to the department within 20 days after publication
of the change by the rating service.
(7) Quantities of radioactive materials requiring consideration
of the need for an emergency plan for responding to a release. The
following table contains quantities of radioactive materials requiring
consideration of the need for an emergency plan for responding to
a release.
Attached Graphic
(8) Requirements for demonstrating financial qualifications.
(A) If an applicant or licensee is not required to
submit financial assurance in accordance with subsection (gg) of this
section, that applicant or licensee shall demonstrate financial qualification
by submitting attestation that the applicant or licensee is financially
qualified to conduct the activity requested for licensure, including
any required decontamination, decommissioning, reclamation, and disposal
before the department issues a license.
(B) If an applicant or licensee is required to submit
financial assurance in accordance with subsection (gg) of this section,
that applicant or licensee shall:
(i) submit one of the following:
(I) the bonding company report or equivalent (from
which information can be obtained to calculate a ratio in clause (ii)
of this subparagraph) that was used to obtain the financial assurance
instrument used to meet the financial assurance requirement specified
in subsection (gg) of this section. However, if the applicant or licensee
posted collateral to obtain the financial instrument used to meet
the requirement for financial assurance specified in subsection (gg)
of this section, the applicant or licensee shall demonstrate financial
qualification by one of the methods specified in subclause (II) or
(III) of this clause;
(II) Securities and Exchange Commission documentation
(from which information can be obtained to calculate a ratio as described
in clause (ii) of this subparagraph, if the applicant or licensee
is a publicly-held company); or
(III) a self-test (for example, an annual audit report
certifying a company's assets and liabilities and resulting ratio
as described in clause (ii) of this subparagraph or, in the case of
a new company, a business plan specifying expected expenses versus
capitalization and anticipated revenues); and
(ii) declare its Standard Industry Classification (SIC)
code. Several companies publish lists, on an annual basis, of acceptable
assets-to liabilities (assets divided by liabilities) ratio ranges
for each type of SIC code. If an applicant or licensee submits documentation
of its current assets and current liabilities or, in the case of a
new company, a business plan specifying expected expenses versus capitalization
and anticipated revenues, and the resulting ratio falls within an
acceptable range as published by generally recognized companies (for
example, Almanac of Business and Industrial Financial Ratios, Industry
NORM and Key Business Ratios, Dun & Bradstreet Industry publications,
and Manufacturing USA: Industry Analyses, Statistics, and Leading
Companies), the department will consider that applicant or licensee
financially qualified to conduct the requested or licensed activity.
(C) If the applicant or licensee is a state or local
government entity, a statement of such will suffice as demonstration
that the government entity is financially qualified to conduct the
requested or licensed activities.
(D) The department will consider other types of documentation
if that documentation provides an equivalent measure of assurance
of the applicant's or licensee's financial qualifications as found
in subparagraphs (A) and (B) of this paragraph.
(9) Category 1 and category 2 radioactive materials.
Licensees shall use Figure: 25 TAC §289.252(jj)(9) to determine
whether a quantity of radioactive material constitutes a Category
1 or Category 2 quantity of radioactive material.
Attached Graphic
(10) Broad scope license limits (for use in subsection
(h) of this section).
Attached Graphic
(kk) Requirements for the issuance of specific licenses
for a medical facility or educational institution to produce Positron
Emission Tomography (PET) radioactive drugs for noncommercial transfer
to licensees in its consortium.
(1) A license application will be approved if the department
determines that an application from a medical facility or educational
institution to produce PET radioactive drugs for noncommercial transfer
to licensees in its consortium authorized for medical use in accordance
with §289.256 of this title includes:
(A) a request for authorization for the production
of PET radionuclides or evidence of an existing license issued in
accordance with this section, the NRC, or another agreement states
requirements for a PET radionuclide production facility within its
consortium from which it receives PET radionuclides;
(B) evidence that the applicant is qualified to produce
radioactive drugs for medical use by meeting one of the criteria in
subsection (r)(1)(A) of this section;
(C) identification of individual(s) authorized to prepare
the PET radioactive drugs if the applicant is a pharmacy, and documentation
that each individual meets the requirements of an authorized nuclear
pharmacist as specified in subsection (r)(3)(B) of this section; and
(D) information identified in subsection (r)(1)(B)
of this section on the PET drugs to be noncommercially transferred
to members of its consortium.
(2) Authorization in accordance with paragraph (1)
of this subsection to produce PET radioactive drugs for noncommercial
transfer to medical use licensees in its consortium does not relieve
the licensee from complying with applicable FDA, other federal, and
state requirements governing radioactive drugs.
(3) Each licensee authorized in accordance with paragraph
(1) of this subsection to produce PET radioactive drugs for noncommercial
transfer to medical use licensees in its consortium shall:
Cont'd... |
