HARRY HUGHES, Governor

1901

ESTABLISH BY INFORMATION THAT IS SUBMITTED TO THE SECRETARY
THAT THE RULE OR REGULATION IS NEEDED AND THAT THE EFFECT OF
THE RULE OR REGULATION WILL NOT HARM THE PUBLIC HEALTH.

(3) IF THE INFORMATION SUBMITTED BY THE
PETITIONER IS NOT SUFFICIENT TO ALLOW THE SECRETARY TO
DETERMINE WHETHER, UNDER THE STANDARDS SET FORTH IN
SUBSECTION (E) OF THIS SECTION, THE RULE OR REGULATION
SHOULD BE ADOPTED, THE SECRETARY MAY REQUIRE THAT ADDITIONAL
INFORMATION BE SUBMITTED. FAILURE BY THE PETITIONER TO
COMPLY WITH THE SECRETARY'S REQUEST IS A SUFFICIENT GROUND
TO DENY THE PETITION.

(E) FACTORS RELEVANT TO ADOPTING STATE RULES AND
REGULATIONS.

THE SECRETARY, IN DETERMINING WHETHER TO ADOPT A RULE
OR REGULATION UNDER THIS SECTION, SHALL CONSIDER:

(1)  THE NAME OF AND ALL PERTINENT INFORMATION
THAT CONCERNS THE SUBSTANCE OR ADDITIVE, INCLUDING, IF
AVAILABLE:

(I)  ITS CHEMICAL IDENTITY AND COMPOSITION;

(II)  THE CONDITIONS OF ITS PROPOSED USE,
INCLUDING DIRECTIONS, RECOMMENDATIONS, AND SUGGESTIONS;

(III)  SAMPLES OF THE PROPOSED LABELING FOR
THE SUBSTANCE OR ADDITIVE; AND

(IV)  ALL RELEVANT INFORMATION BEARING ON
THE PHYSICAL OR OTHER TECHNICAL EFFECT OF THE SUBSTANCE OR
ADDITIVE AND THE QUANTITY OF THE SUBSTANCE OR ADDITIVE THAT
IS REQUIRED TO PRODUCE THE EFFECT;

(2)  THE PROBABLE COMPOSITION OF ANY SUBSTANCE
THAT MAY BE FORMED IN OR ON A FOOD, DRUG, OR COSMETIC AS A
RESULT OF THE USE OF THE SUBSTANCE OR ADDITIVE;

(3)  THE PROBABLE AMOUNT OF THE SUBSTANCE OR
ADDITIVE THAT WOULD BE CONSUMED IN THE AVERAGE HUMAN DIET,
TAKING INTO ACCOUNT ANY CHEMICALLY OR PHARMACOLOGICALLY
RELATED SUBSTANCE IN THE DIET;

(4)  SAFETY FACTORS THAT, IN THE OPINION OF
EXPERTS QUALIFIED BY SCIENTIFIC TRAINING AND EXPERIENCE TO
EVALUATE THE SAFETY OF THE SUBSTANCE OR ADDITIVE FOR ITS
PROPOSED USE, ARE GENERALLY RECOGNIZED AS APPROPRIATE FOR
THE USE OF ANIMAL EXPERIMENTATION INFORMATION;

(5)  THE AVAILABILITY OF A PRACTICABLE METHOD OF
ANALYSIS FOR DETERMINING THE IDENTITY AND QUANTITY OF:

(I) THE SUBSTANCE OR THE ADDITIVE IN OR ON
AN ARTICLE;