[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: 40CFR158.150]



[Page 90-91]

 

                   TITLE 40--PROTECTION OF ENVIRONMENT

 

         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)

 

PART 158_DATA REQUIREMENTS FOR REGISTRATION--Table of Contents

 

              Subpart C_Product Chemistry Data Requirements

 

Sec.  158.150  General.



    Source: 53 FR 15993, May 4, 1988, unless otherwise noted.





    (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 Sec.  158.175 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



[[Page 91]]



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 

Sec.  158.155 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 Sec.  158.175).

    (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.