[Code of Federal Regulations]
[Title 40, Volume 23]
[Revised as of July 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR158.150]

[Page 98-99]
 
                   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.

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    (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 
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.

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