[Code of Federal Regulations]

[Title 40, Volume 23]

[Revised as of July 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 40CFR152.6]



[Page 9-10]

 

                   TITLE 40--PROTECTION OF ENVIRONMENT

 

         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)

 

PART 152_PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES--Table of 

Contents

 

                      Subpart A_General Provisions

 

Sec.  152.6  Substances excluded from regulation by FIFRA.



    Products and substances listed in this section are excluded from 

FIFRA regulation if they meet the specified conditions or criteria.

    (a) Liquid chemical sterilants. A liquid chemical sterilant product 

is not a pesticide under section 2(u) of FIFRA if it meets all of the 

following criteria. Excluded products are regulated by the Food and Drug 

Administration (FDA). Products excluded are those meeting all of the 

following criteria:

    (1) Composition. The product must be in liquid form as sold or 

distributed. Pressurized gases or products in dry or semi-solid form are 

not excluded by this provision. Ethylene oxide products are not liquid 

products and are not excluded by this provision.

    (2) Claims. The product must bear a sterilant claim, or a sterilant 

plus subordinate level disinfection claim. Products that bear 

antimicrobial claims solely at a level less than ``sterilant'' are not 

excluded and are jointly regulated by EPA and FDA. ``Sterilant'' is 

defined in Sec.  156.441 of this chapter.

    (3) Use site. (i) The product must be intended and labeled only for 

use on ``critical or semi-critical devices.'' A ``critical device'' is 

any device which is introduced directly into the human body, either into 

or in contact with the bloodstream or normally sterile areas of the 

body. A semi-critical device is any device which contacts intact mucous 

membranes but which does not ordinarily penetrate the blood barrier or 

otherwise enter normally sterile areas of the body.

    (ii) Liquid chemical sterilants that bear claims solely for use on 

non-critical medical devices are jointly regulated by EPA and FDA.

    (iii) Liquid chemical sterilants that bear claims solely for use on 

sites that are not medical devices, such as veterinary equipment, are 

not excluded and are regulated solely by EPA.

    (b) Nitrogen stabilizers. A nitrogen stabilizer is excluded from 

regulation under FIFRA if it is a substance (or mixture of substances), 

meeting all of the following criteria:

    (1) The substance prevents or hinders the process of nitrification, 

denitrification, ammonia volatilization, or urease production through 

action affecting soil bacteria and is distributed and sold solely for 

those purposes and no other pesticidal purposes. For purposes of this 

section, living organisms are not considered to be substances, and the 

actions of living organisms are not relevant to whether a substance is 

deemed to be a nitrogen stabilizer.

    (2) The substance was in ``commercial agronomic use'' in the United 

States before January 1, 1992. EPA considers a substance to be in 

commercial agronomic use if it is available for sale or distribution to 

users for direct agronomic benefit, as opposed to limited research, 

experimental or demonstration use.

    (3) The substance was not registered under FIFRA before January 1, 

1992.

    (4) Since January 1, 1992, the distributor or seller has made no 

claim that the product prevents or hinders the process of nitrification, 

denitrification, ammonia volatilization or urease production. EPA 

considers any of the following claims (or their equivalents) to be a 

claim that the product prevents or hinders nitrification, 

denitrification, ammonia volatilization or urease production:

    (i) Improves crop utilization of applied nitrogen.

    (ii) Reduces leaching of applied nitrogen or reduces groundwater 

nitrogen contamination.

    (iii) Prevents nitrogen loss.

    (iv) Prolongs availability of nitrogen.

    (v) Increases nitrogen uptake, availability, usage, or efficiency.

    (5) A product will be considered to have met the criterion of 

paragraph (b)(4) of this section that no nitrogen stabilization claim 

has been made if:

    (i) The nitrogen stabilization claim, in whatever terms expressed, 

is made solely in compliance with a State requirement to include the 

claim in materials required to be submitted to a State legislative or 

regulatory authority, or in the labeling or other literature 

accompanying the product; and

    (ii) The State requirement to include the claim was in effect both 

before the



[[Page 10]]



product bearing the claim was introduced into commercial agronomic use, 

and before the effective date of this rule.

    (6) A product that meets all of the criteria of this paragraph with 

respect to one State is not thereby excluded from FIFRA regulation if 

distributed and sold in another State whose nitrogen stabilization 

statement requirement does not meet the requirements of paragraph 

(b)(5)(ii) of this section.

    (c) Human drugs. Fungi, bacteria, viruses or other microorganisms in 

or on living man are not ``pests'' as defined in section 2(t) of FIFRA. 

Products intended and labeled for use against such organisms are human 

drugs subject to regulation by the FDA under the FFDCA.

    (d) Animal drugs. (1) Fungi, viruses, bacteria or other 

microorganisms on or in living animals are not ``pests'' under section 

2(t) of FIFRA. Products intended for use against such organisms are 

``animal drugs'' regulated by the FDA under the FFDCA.

    (2) A ``new animal drug'' as defined in section 201(w) of the FFDCA, 

or an animal drug that FDA has determined is not a ``new animal drug'' 

is not a pesticide under section 2(u) of FIFRA. Animal drugs are 

regulated by the FDA under the FFDCA.

    (e) Animal feeds. An animal feed containing a new animal drug is not 

a pesticide under section 2(u) of FIFRA. An animal feed containing a new 

animal drug is subject to regulation by the FDA under the FFDCA.

    (f) Vitamin hormone products. A product consisting of a mixture of 

plant hormones, plant nutrients, inoculants, or soil amendments is not a 

``plant regulator'' under section 2(v) of FIFRA, provided it meets the 

following criteria:

    (1) The product, in the undiluted package concentration at which it 

is distributed or sold, meets the criteria of Sec.  156.62 of this 

chapter for Toxicity Category III or IV; and

    (2) The product is not intended for use on food crop sites, and is 

labeled accordingly.

    (g) Products intended to aid the growth of desirable plants. A 

product of any of the following types, intended only to aid the growth 

of desirable plants, is not a ``plant regulator'' under section 2(v) of 

FIFRA, and therefore is not a pesticide:

    (1) A plant nutrient product, consisting of one or more 

macronutrients or micronutrient trace elements necessary to normal 

growth of plants and in a form readily usable by plants.

    (2) A plant inoculant product consisting of microorganisms to be 

applied to the plant or soil for the purpose of enhancing the 

availability or uptake of plant nutrients through the root system.

    (3) A soil amendment product containing a substance or substances 

intended for the purpose of improving soil characteristics favorable for 

plant growth.



[66 FR 64763, Dec. 14, 2001]