§ 158.2240 Nontarget organisms.

(a) General. Subpart B of this part and § 158.2201 describe how to use the table in paragraph (c) of this section to determine the terrestrial and aquatic nontarget organisms data requirements for a particular antimicrobial pesticide product. Notes that apply to an individual test, including specific conditions, qualifications, or exceptions are listed in paragraph (d) of this section.

(1) Terrestrial and aquatic nontarget organism data are required to support the registration of most end-use and manufacturing-use antimicrobial products.

(2) Data are generally not required to support end-use products of a gas, highly volatile liquid, highly reactive solid, or a highly corrosive material.

(3) Data on transformation/degradation products or leachate residues of the parent compound are also required to support registration, if the transformation/degradation/degradation products or leachate residues meet one of the following criteria:

(i) More toxic, persistent, or bioaccumulative than the parent;

(ii) Have been shown to cause adverse effects in mammalian or aquatic reproductive studies; or

(iii) The moiety of concern (i.e., functional group in the parent chemical molecule that imparts adverse effects) remains intact.

(4) If an antimicrobial may be applied to a field crop, horticultural crop, or turf, then the data requirements in § 158.630 apply.

(5) For the purpose of determining data requirements, the all other use patterns category includes the following use patterns:

(i) Agricultural premises and equipment.

(ii) Food-handling/storage establishments, premises, and equipment.

(iii) Commercial, institutional and industrial premises and equipment.

(iv) Residential and public access premises.

(v) Medical premises and equipment.

(vi) Human drinking water systems.

(vii) Materials preservatives.

(viii) Swimming pools.

(b) Key. MP = Manufacturing use product; EP = End-use product; R = Required; CR = Conditionally required; NR = Not required; TGAI = Technical grade of the active ingredient; TEP = Typical end-use product; PAIRA = Pure active ingredient radiolabeled; a.i. = active ingredient.

(c) Antimicrobial nontarget organism data requirements table. The following table shows the data requirements for nontarget organisms. The test notes appear in paragraph (d) of this section.

Table—Antimicrobial Nontarget Organism Data Requirements