(1) A food additive shall, with respect to
any particular use or intended use of such additives, be deemed
unsafe for the purpose of the application of clause (2)(c) of RCW 69.04.210, unless:
(a) It and its use or intended use conform to the terms of an
exemption granted, pursuant to a regulation under subsection (2)
hereof providing for the exemption from the requirements of this
section for any food additive, and any food bearing or containing
such additive, intended solely for investigational use by qualified
experts when in the director's opinion such exemption is consistent
with the public health; or
(b) There is in effect, and it and its use or intended use are
in conformity with a regulation issued or effective under
subsection (2) hereof prescribing the conditions under which such
additive may be safely used.
While such a regulation relating to a food additive is in
effect, a food shall not, by reason of bearing or containing such
an additive in accordance with the regulation, be considered
adulterated within the meaning of clause (1) of RCW 69.04.210.
(2) The regulations promulgated under section 409 of the
Federal Food, Drug and Cosmetic Act, as of July 1, 1975,
prescribing the conditions under which such food additive may be
safely used, are hereby adopted as the regulations applicable to
this chapter: PROVIDED, That the director is hereby authorized to
adopt by regulation any new or future amendments to the federal
regulations. The director is also authorized to issue regulations
in the absence of federal regulations and to prescribe the
conditions under which a food additive may be safely used and
exemptions where such food additive is to be used solely for
investigational purposes; either upon his own motion or upon the
petition of any interested party requesting that such a regulation
be established. It shall be incumbent upon such petitioner to
establish, by data submitted to the director, that a necessity
exists for such regulation and that the effect of such a regulation
will not be detrimental to the public health. If the data
furnished by the petitioner is not sufficient to allow the director
to determine whether such a regulation should be promulgated, the
director may require additional data to be submitted and failure to
comply with this request shall be sufficient grounds to deny the
request of the petitioner for the issuance of such a regulation.
(3) In adopting any new or amended regulations pursuant to
this section, the director shall give appropriate consideration,
among other relevant factors, to the following: (a) The purpose of
this chapter being to promote uniformity of state legislation with
the federal act; (b) the probable consumption of the additive and
of any substance formed in or on food because of the use of the
additive; (c) the cumulative effect of such additive in the diet of
man or animals, taking into account any chemically or
pharmacologically related substance or substances in such diet; and
(d) safety factors which in the opinion of experts qualified by
scientific training and experience to evaluate the safety of food
additives are generally recognized as appropriate for the use of
animal experimentation data.
[1975 1st ex.s. c 7 § 27; 1963 c 198 § 4.]
NOTES:
Purpose of section: See RCW 69.04.398.