Electronic Code of Federal Regulations:

Source: 53 FR 15993, May 4, 1988, unless otherwise noted. Redesignated and amended at 72 FR 60253–60255, Oct. 24, 2007.

§ 161.150 General.

(a) Applicability. This subpart describes the product chemistry data that are required to support the registration of each pesticide product. The information specified in this subpart must be submitted with each application for new or amended registration or for reregistration, if it has not been submitted previously or if the previously submitted information is not complete and accurate. References in this subpart to the “applicant” include the registrant if the information is required for a registered product.

(b) Purpose —(1) Product composition. (i) Data on product composition are needed to support the conclusions expressed in the statement of formula. These data include information on the starting materials, production or formulating process, possible formation of impurities, results of preliminary analysis of product samples, a description of analytical methods to identify and quantify ingredients and validation data for such methods. In addition, an applicant is required to certify the limits for ingredients of his product.

(ii) Product composition data are compared to the composition of materials used in required testing under subpart D of this part. This comparison indicates which components of a pesticide product have been evaluated by a particular study, and might lead to a conclusion that another study is needed. Based on conclusions concerning the product's composition and its toxic properties, appropriate use restrictions, labeling requirements, or special packaging requirements may be imposed.

(iii) Product composition data, including certified limits of components, are used to determine whether a product is “identical or substantially similar” to another product or “differs only in ways that do not significantly increase the risk of unreasonable adverse effects on the environment” (FIFRA sec. 3(c)(7)(A)). In nearly every case, this determination involves a comparison of the composition of an applicant's product with that of currently registered products.

(2) Certified limits. Certified limits required by §161.175 are used in two ways. First, the Agency considers the certified limits in making the registration determination required by sections 3(c)(5), 3(c)(7) and 3(d) of the Act and making other regulatory decisions required by the Act. Second, the Agency may collect commercial samples of the registered products and analyze them for the active ingredient(s), inert ingredients, or impurities determined by the Agency to be toxicologically significant. If, upon analysis the composition of such a sample is found to differ from that certified, the results may be used by the Agency in regulatory actions under FIFRA sec. 12(a)(1)(C) and other pertinent sections.

(3) Nominal concentration. The nominal concentration required by §161.155 is the amount of active ingredient that is most likely to be present in the product when produced. Unlike the certified limits, which are the outer limits of the range of the product's ingredients and thus are present only in a small proportion of the products, the nominal concentration is the amount that typically is expected to result from the applicant's production or formulating process. The nominal concentration together with production process information is used to gauge the acceptability of the certified limits presented by the applicant. The nominal concentration is used by the Agency as the basis for enforceable certified limits if the applicant has chosen not to specify certified limits of his own (thereby agreeing to abide by the standard limits in §161.175).

(4) Physical and chemical characteristics. (i) Data on the physical and chemical characteristics of pesticide active ingredients and products are used to confirm or provide supportive information on their identity. Such data are also used in reviewing the production or formulating process used to produce the pesticide or product. For example, data that indicate significant changes in production or formulation might indicate the need for additional information on product composition.

(ii) Certain information (e.g., color, odor, physical state) is needed for the Agency to respond to emergency requests for identification of unlabeled pesticides involved in accidents or spills. Physicians, hospitals, and poison control centers also request this information to aid in their identification of materials implicated in poisoning episodes.

(iii) Certain physical and chemical data are used directly in the hazard assessment. These include stability, oxidizing and reducing action, flammability, explodability, storage stability, corrosion, and dielectric breakdown voltage. For example, a study of the corrosion characteristics of a pesticide is needed to evaluate effects of the product formulation on its container. If the pesticide is highly corrosive, measures can be taken to ensure that lids, liners, seams or container sides will not be damaged and cause the contents to leak during storage, transport, handling, or use. The storage stability study provides data on change (or lack of change) in product composition over time. If certain ingredients decompose, other new chemicals are formed whose toxicity and other characteristics must be considered.

(iv) Certain data are needed as basic or supportive evidence in initiating or evaluating other studies. For example, the octanol/water partition coefficient is used as one of the criteria to determine whether certain fish and wildlife toxicity or accumulation studies must be conducted. Vapor pressure data are needed, among other things, to determine suitable reentry intervals and other label cautions pertaining to worker protection. Data on viscosity and miscibility provide necessary information to support acceptable labeling for tank mix and spray applications.

§ 161.153 Definitions.

(a) Active ingredient means any substance (or group of structurally similar substances, if specified by the Agency) that will prevent, destroy, repel or mitigate any pest, or that functions as a plant regulator, desiccant, or defoliant within the meaning of FIFRA sec. 2(a).

(1) Includes directions for use of the product (as distributed or sold, or after combination by the user with other substances) for controlling pests or defoliating, desiccating or regulating growth of plants, and

(2) Does not state that the product may be used to manufacture or formulate other pesticide products.

(1) The process of mixing, blending, or dilution of one or more active ingredients with one or more other active or inert ingredients, without an intended chemical reaction, to obtain a manufacturing use product or an end use product, or

(d) Impurity means any substance (or group of structurally similar substances if specified by the Agency) in a pesticide product other than an active ingredient or an inert ingredient, including unreacted starting materials, side reaction products, contaminants, and degradation products.

(2) Any impurity which forms in the pesticide product through reactions between the active ingredient and any other component of the product or packaging of the product.

(f) Inert ingredient means any substance (or group of structurally similar substances if designated by the Agency), other than an active ingredient, which is intentionally included in a pesticide product.

(1) Contains any active ingredient derived from a source that is not an EPA-registered product; or

(2) Contains any active ingredient that was produced or acquired in a manner that does not permit its inspection by the Agency under FIFRA sec. 9(a) prior to its use in the process.

(h) Manufacturing use product means any pesticide product other than an end use product. A product may consist of the technical grade of active ingredient only, or may contain inert ingredients, such as stabilizers or solvents.

(i) Nominal concentration means the amount of an ingredient which is expected to be present in a typical sample of a pesticide product at the time the product is produced, expressed as a percentage by weight.

(j) Starting material means a substance used to synthesize or purify a technical grade of active ingredient (or the practical equivalent of the technical grade ingredient if the technical grade cannot be isolated) by chemical reaction.

(k) Technical grade of active ingredient means a material containing an active ingredient:

(1) Which contains no inert ingredient, other than one used for purification of the active ingredient; and

(2) Which is produced on a commercial or pilot-plant production scale (whether or not it is ever held for sale).

§ 161.155 Product composition.

Information on the composition of the pesticide product must be furnished. The information required by paragraphs (a), (b) and (f) of this section must be provided for each product. In addition, if the product is produced by an integrated system, the information on impurities required by paragraphs (c) and (d) must be provided.

(a) Active ingredient. The following information is required for each active ingredient in the product:

(1) If the source of any active ingredient in the product is an EPA-registered product:

(i) The chemical and common name (if any) of the active ingredient, as listed on the source product.

(ii) The nominal concentration of the active ingredient in the product, based upon the nominal concentration of active ingredient in the source product.

(iii) Upper and lower certified limits of the active ingredient in the product, in accordance with §161.175.

(2) If the source of any active ingredient in the product is not an EPA-registered product:

(i) The chemical name according to Chemical Abstracts Society nomenclature, the CAS Registry Number, and any common names.

(ii) The molecular, structural, and empirical formulae, and the molecular weight or weight range.

(b) Inert ingredients. The following information is required for each inert ingredient (if any) in the product:

(1) The chemical name of the ingredient according to Chemical Abstracts Society nomenclature, the CAS Registry Number, and any common names (if known). If the chemical identity or chemical composition of an ingredient is not known to the applicant because it is proprietary or trade secret information, the applicant must ensure that the supplier or producer of the ingredient submits to the Agency (or has on file with the Agency) information on the identity or chemical composition of the ingredient. Generally, it is not required that an applicant know the identity of each ingredient in a mixture that he uses in his product. However, in certain circumstances, the Agency may require that the applicant know the identity of a specific ingredient in such a mixture. If the Agency requires specific knowledge of an ingredient, it will notify the applicant in writing.

(c) Impurities of toxicological significance associated with the active ingredient. For each impurity associated with the active ingredient that is determined to be toxicologically significant, the following information is required:

(d) Other impurities associated with the active ingredient. For each other impurity associated with an active ingredient that was found to be present in any sample at a level equal to or greater than 0.1 percent by weight of the technical grade active ingredient, the following information is required:

(f) Ingredients that cannot be characterized. If the identity of any ingredient or impurity cannot be specified as a discrete chemical substance (such as mixtures that cannot be characterized or isomer mixtures), the applicant must provide sufficient information to enable EPA to identify its source and qualitative composition.

§ 161.160 Description of materials used to produce the product.

The following information must be submitted on the materials used to produce the product:

(a) Products not produced by an integrated system. (1) For each active ingredient that is derived from an EPA-registered product:

(i) Each brand name, trade name, or other commercial designation of the ingredient.

(ii) All information that the applicant knows (or that is reasonably available to him) concerning the composition (and, if requested by the Agency, chemical and physical properties) of the ingredient, including a copy of technical specifications, data sheets, or other documents describing the ingredient.

(iii) If requested by the Agency, the name and address of the producer of the ingredient or, if that information is not known to the applicant, the name and address of the supplier of the ingredient.

(b) Products produced by an integrated system. (1) The information required by paragraph (a)(1) of this section concerning each active ingredient that is derived from an EPA-registered product (if any).

(2) The following information concerning each active ingredient that is not derived from an EPA-registered product:

(i) The name and address of the producer of the ingredient (if different from the applicant).

(ii) Information on each starting material used to produce the active ingredient, as follows:

(A) Each brand name, trade name, or other commercial designation of the starting material.

(B) The name and address of the person who produces the starting material or, if that information is not known to the applicant, the name and address of each person who supplies the starting material.

(C) All information that the applicant knows (or that is reasonably available to him) concerning the composition (and if requested by the Agency, chemical or physical properties) of the starting material, including a copy of all technical specifications, data sheets, or other documents describing it.

(3) The information required by paragraph (a)(2) of this section concerning each inert ingredient.

(c) Additional information. On a case-by-case basis, the Agency may require additional information on substances used in the production of the product.

§ 161.162 Description of productionprocess.

If the product is produced by an integrated system, the applicant must submit information on the production (reaction) processes used to produce the active ingredients in the product. The applicant must also submit information on the formulation process, in accordance with §161.165.

(a) Information must be submitted for the current production process for each active ingredient that is not derived from an EPA-registered product. If the production process is not continuous (a single reaction process from starting materials to active ingredient), but is accomplished in stages or by different producers, the information must be provided for each such production process.

(b) The following information must be provided for each process resulting in a separately isolated substance:

(1) the name and address of the producer who uses the process, if not the same as the applicant.

(2) A general characterization of the process (e.g., whether it is a batch or continuous process).

(3) A flow chart of the chemical equations of each intended reaction occurring at each step of the process, the necessary reaction conditions, and the duration of each step and of the entire process.

(4) The identity of the materials used to produce the product, their relative amounts, and the order in which they are added.

(5) A description of the equipment used that may influence the composition of the substance produced.

(6) A description of the conditions (e.g., temperature, pressure, pH, humidity) that are controlled during each step of the process to affect the composition of the substance produced, and the limits that are maintained.

(7) A description of any purification procedures (including procedures to recover or recycle starting materials, intermediates or the substance produced).

(8) A description of the procedures used to assure consistent composition of the substance produced, e.g., calibration of equipment, sampling regimens, analytical methods, and other quality control methods.

§ 161.165 Description of formulation process.

The applicant must provide information on the formulation process of the product (unless the product consists solely of a technical grade of active ingredient), as required by the following sections:

§ 161.167 Discussion of formation of impurities.

The applicant must provide a discussion of the impurities that may be present in the product, and why they may be present. The discussion should be based on established chemical theory and on what the applicant knows about the starting materials, technical grade of active ingredient, inert ingredients, and production or formulation process. If the applicant has reason to believe that an impurity that EPA would consider toxicologically significant may be present, the discussion must include an expanded discussion of the possible formation of the impurity and the amounts at which it might be present. The impurities which must be discussed are the following, as applicable:

(a) Technical grade active ingredients and products produced by an integrated system. (1) Each impurity associated with the active ingredient which was found to be present in any analysis of the product conducted by or for the applicant.

(2) Each other impurity which the applicant has reason to believe may be present in his product at any time before use at a level equal to or greater than 0.1 percent (1000 ppm) by weight of the technical grade of the active ingredient, based on what he knows about the following:

(i) The composition (or composition range) of each starting material used to produce his product.

(ii) The impurities which he knows are present (or believes are likely to be present) in the starting materials, and the known or presumed level (or range of levels) of those impurities.

(iii) The intended reactions and side reactions which may occur in the production of the product, and the relative amounts of byproduct impurities produced by such reactions.

(iv) The possible degradation of the ingredients in the product after its production but prior to its use.

(vi) The possible migration of components of packaging materials into the pesticide.

(vii) The possible carryover of contaminants from use of production equipment previously used to produce other products or substances.

(viii) The process control, purification and quality control measures used to produce the product.

(b) Products not produced by an integrated system. Each impurity associated with the active ingredient which the applicant has reason to believe may be present in the product at any time before use at a level equal to or greater than 0.1 percent (1000 ppm) by weight of the product based on what he knows about the following:

(1) The possible carryover of impurities present in any registered product which serves as the source of any of the product's active ingredients. The identity and level of impurities in the registered source need not be discussed or quantified unless known to the formulator.

(2) The possible carryover of impurities present in the inert ingredients in the product.

(3) Possible reactions occurring during the formulation of the product between any of its active ingredients, between the active ingredients and inert ingredients, or between the active ingredients and the production equipment.

(4) Post-production reactions between any of the product's active ingredients and any other component of the product or its packaging.

(6) Possible contaminants resulting from earlier use of equipment to produce other products.

(c) Expanded discussion. On a case-by-case basis, the Agency may require an expanded discussion of information of impurities:

§ 161.170 Preliminary analysis.

(a) If the product is produced by an integrated system, the applicant must provide a preliminary analysis of each technical grade of active ingredient contained in the product to identify all impurities present at 0.1 percent or greater of the TGAI. The preliminary analysis should be conducted at the point in the production process after which no further chemical reactions designed to produce or purify the substance are intended.

(b) Based on the preliminary analysis, a statement of the composition of the technical grade of active ingredient must be provided. If the technical grade of active ingredient cannot be isolated, a statement of the composition of the practical equivalent of the technical grade of active ingredient must be submitted.

§ 161.175 Certified limits.

The applicant must propose certified limits for the ingredients in the product. Certified limits become legally binding limits upon approval of the application. Certified limits will apply to the product from the date of production to date of use, unless the product label bears a statement prohibiting use after a certain date, in which case the certified limits will apply only until that date.

(a) Ingredients for which certified limits are required. Certified limits are required on the following ingredients of a pesticide product:

(3) If the product is a technical grade of active ingredient or is produced by an integrated system, an upper limit for each impurity of toxicological significance associated with the active ingredient and found to be present in any sample of the product.

(4) On a case-by-case basis, certified limits for other ingredients or impurities as specified by EPA.

(b) EPA determination of certified limits for active and inert ingredients. (1) Unless the applicant proposes different limits as provided in paragraph (c) of this section, the upper and lower certified limits for active and inert ingredients will be determined by EPA. EPA will calculate the certified limits on the basis of the nominal concentration of the ingredient in the product, according to the table in paragraph (b)(2) of this section.

(c) Applicant proposed limits. (1) The applicant may propose a certified limit for an active or inert ingredient that differs from the standard certified limit calculated according to paragraph (b)(2) of this section.

(2) If certified limits are required for impurities, the applicant must propose a certified limit. The standard certified limits may not be used for such substances.

(i) Be based on a consideration of the variability of the concentration of the ingredient in the product when good manufacturing practices and normal quality control procedures are used.

(ii) Allow for all sources of variability likely to be encountered in the production process.

(iii) Take into account the stability of the ingredient in the product and the possible formation of impurities between production and sale of distribution.

(4) The applicant may include an explanation of the basis of his proposed certified limits, including how the certified limits were arrived at (e.g., sample analysis, quantitative estimate based on production process), and its accuracy and precision. This will be particularly useful if the range of the certified limit for an active or inert ingredient is greater than the standard certified limits.

(d) Special cases. If the Agency finds unacceptable any certified limit (either standard or applicant-proposed), the Agency will inform the applicant of its determination and will provide supporting reasons. EPA may also recommend alternative limits to the applicant. The Agency may require, on a case-by-case basis, any or all of the following:

(3) A narrower range between the upper and lower certified limits than that proposed.

(e) Certification statement. The applicant must certify the accuracy of the information presented, and that the certified limits of the ingredients will be maintained. The following statement, signed by the authorized representative of the company, is acceptable:

I hereby certify that, for purposes of FIFRA sec. 12(a)(1)(C), the description of the composition of [ product name ], EPA Reg. No. [ insert registration number ], refers to the composition set forth on the Statement of Formula and supporting materials. This description includes the representations that: (1) no ingredient will be present in the product in an amount greater than the upper certified limit or in an amount less than the lower certified limit (if required) specified for that ingredient in a currently approved Statement of Formula (or as calculated by the Agency); and (2) if the Agency requires that the source of supply of an ingredient be specified, that all quantities of such ingredient will be obtained from the source specified in the Statement of Formula.

§ 161.180 Enforcement analytical method.

An analytical method suitable for enforcement purposes must be provided for each active ingredient in the product and for each other ingredient or impurity that is determined to be toxicologically significant.

§ 161.190 Physical and chemical characteristics.

(a) Table. Sections 161.100 through 161.102 describe how to use this table to determine the physical and chemical characteristics data requirements and the substance to be tested.

Kind of data required	(b) Notes	All general use patterns (requirements are the same for every use pattern)	Test substance		Guidelines reference No.
Kind of data required	(b) Notes		Data to support MP	Data to support EP	Guidelines reference No.
Color		[R]	MP and TGAI	EP* and TGAI	63–2
Physical state		[R]	MP and TGAI	EP* and TGAI	63–3
Odor		[R]	MP and TGAI	EP* and TGAI	63–4
Melting point	(¹)	[R]	TGAI	TGAI	63–5
Boiling point	(²)	[R]	TGAI	TGAI	63–6
Density, bulk density, or specific gravity		[R]	MP and TGAI	EP* and TGAI	63–7
Solubility		[R]	TGAI or PAI	TGAI or PAI	63–8
Vapor pressure		[R]	TGAI or PAI	TGAI or PAI	63–9
Dissociation constant		[R]	TGAI or PAI	TGAI or PAI	63–10
Octanol/water partition coefficient	(³)	[CR]	PAI	PAI	63–11
pH	(⁴)	[CR]	MP and TGAI	EP* and TGAI	63–12
Stability		[R]	TGAI	TGAI	63–13
Oxidizing or reducing action	(⁵)	[CR]
Flammability	(⁶)	[CR]	MP	EP*	63–15
Explodability	(⁷)	[R]	MP	EP*	63–16
Storage stability		[R]	MP	EP*	63–17
Viscosity	(⁸)	[CR]	MP	EP*	63–18
Miscibility	(⁹)	[CR]	MP	EP*	63–19
Corrosion characteristics		[R]	MP	EP*	63–20
Dielectric breakdown voltage	(¹⁰)	[CR]		EP*	63–21
Other requirements: Submittal of samples	(¹¹)	[CR]	MP, TGAI, PAI	EP*, TGAI, PAI	64–1

Key: R = Required; CR = Conditionally Required; [ ] = Brackets ( i.e. , [R],[CR]) indicate data requirements that apply when an experimental use permit is being sought; MP = Manufacturing Use Product, EP* = End Use Product; asterisk indicates those registrants that end-use applicants ( i.e. , formulators) need not satisfy, if their active ingredient(s) is (are) purchased from a registered source; TGAI = Technical Grade of the Active Ingredient; PAI = Pure Active Ingredient.

(b) Notes. The following notes are referenced in column two of the table contained in paragraph (a) of this section.

(¹)Required if technical chemical is a solid at room temperature.

(²)Required if technical chemical is a liquid at room temparature.

(³)Required if technical chemical is organic and non-polar.

(⁴)Required if test substance is dispersible with water.

(⁵)Required if product contains an oxidizing or reducing agent.

(⁶)Required if product contains combustible liquids.

(⁷)Required if product is potentially explosive.

(⁸)Required if product is a liquid.

(⁹)Required if product is a emulsifiable liquid and is to be diluted with petroleum solvents.

(¹⁰)Required if end-use product is a liquid and is to be used around electrical equipment.

(¹¹)Basic manufacturers are required to provide the Agency with a sample of each TGAI used to formulate a product produced by an integrated system when the new TGAI is first used as a formulating ingredient in products registered under FIFRA. A sample of the active ingredient (PAI) suitable for use as an analytical standard is also required at this time. Samples of end use products produced by an integrated system must be submitted on a case-by-case basis.

Subpart C—Product Chemistry Data Requirements