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Environmental Protection Agency Pt. 157

for pesticides (MSHA/NIOSH approval 

number prefix TC-23C), or a canister 

approved for pesticides (MSHA/NIOSH 

approval number prefix 14G). For all 

other exposures, wear a dust/mist filtering respirator (MSHA/NIOSH approval number prefix TC-21C).’’

(h) New respirator requirement established for pesticide handlers in this part—

(1) General requirement. If the table in 

paragraph (e) of this section indicates a 

respiratory protection device is required, and existing product labeling 

has no respiratory protection requirement, the registrant shall add a respiratory protection statement that 

specifies a: ‘‘dust/mist filtering respirator (MSHA/NIOSH approval number prefix TC-21C).’’

(2) Exception. The registrant shall 

specify a different type of respiratory 

protection device if information, such 

as vapor pressure value, is available to 

the registrant to indicate that the type 

of respiratory protection device required in paragraph (h)(1) of this section would not be adequately protective or might increase risks to the user 

unnecessarily.

(i) Additional personal protective equipment requirements for pesticide handlers.

In addition to the minimum personal 

protective equipment and work clothing requirements given in the table in 

paragraph (e) of this section, the labeling statement for any product in toxicity category I or II on the basis of 

dermal toxicity or skin irritation potential (or their surrogate as specified 

in paragraph (d)(2) of this section), 

shall include the following personal 

protective equipment instructions, additions, or substitutions as applicable: 

(1) If the product is not ready-to-use 

and there is no existing requirement 

for a chemical-resistant suit, the following statement shall be included: 

‘‘Mixers/Loaders: add a chemical-resistant apron.’’

(2) If the application of the product 

may result in overhead exposure to any 

handler (for example, applicator exposure during airblast spraying of orchards or flagger exposure during aerial application), the following statement shall be included: ‘‘Overhead Exposure: wear chemical-resistant headgear.’’

(3) If any type of equipment other 

than the product container may be 

used to mix, load, or apply the product, 

and there is no requirement for a 

chemical-resistant protective suit, the 

following statement shall be included: 

‘‘For Cleaning Equipment: add a chemical-resistant apron.’’

(j) Personal protective equipment for 

early-entry workers. This paragraph 

specifies minimum requirements for 

personal protective equipment (as defined in §170.240 of this chapter) and 

work clothing for early-entry workers. 

(1) For all pesticide products, add the 

statement: ‘‘For early entry to treated 

areas that is permitted under the 

Worker Protection Standard and that 

involves contact with anything that 

has been treated, such as plants, soil, 

or water, wear: (list the body protection, glove, footwear, protective 

eyewear, and protective headgear, if 

applicable, statements specified for applicators and other handlers, but omit 

any respiratory protection statement).’’

(2) If the body protection statement 

in the personal protective equipment 

requirement for handlers specifies a 

long-sleeved shirt and long pants, 

‘‘coveralls’’ must be specified in the 

statement of personal protective equipment for early-entry workers. 

(3) If there is no statement requiring 

gloves and no prohibition against 

gloves for applicators and other handlers under the heading HAZARDS TO 

HUMANS (AND DOMESTIC ANIMALS) 

in the labeling, add a requirement for 

‘‘waterproof gloves’’ in the statement 

of personal protective equipment for 

early-entry workers. 

[57 FR 38146, Aug. 21, 1992, as amended at 58 

FR 34203, June 23, 1993]

PART 157—PACKAGING REQUIREMENTS FOR PESTICIDES AND DEVICES

Subpart A [Reserved]

Subpart B—Child-Resistant Packaging

Sec.

157.20 General. 

157.21 Definitions. 

157.22 When required. 

157.24 Exemptions. 

157.27 Unit packaging. 

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§ 157.20 40 CFR Ch. I (7–1–03 Edition)

157.30 Voluntary use of child-resistant 

packaging.

157.32 Standards. 

157.34 Certification. 

157.36 Recordkeeping.

AUTHORITY: 7 U.S.C. 136w.

SOURCE: 51 FR 21286, June 11, 1986 and 51 

FR 36692, Oct. 15, 1986, unless otherwise 

noted.

Subpart A [Reserved]

Subpart B—Child-Resistant 

Packaging

§ 157.20 General. 

This subpart prescribes requirements 

for child-resistant packaging of pesticide products and devices. The requirements are established under the 

authority of FIFRA section 25(a)(1), 

which authorizes the Administrator to 

issue regulations to carry out the purposes of the Act, and FIFRA section 

25(c)(3), which authorizes the Administrator to establish standards with respect to the package, container or 

wrapping in which a pesticide or device 

is enclosed in order to protect children 

and adults from serious injury or illness resulting from accidental ingestion or contact with pesticides or devices regulated under the Act.

§ 157.21 Definitions. 

Terms used in this subpart shall have 

the following meanings: 

(a) Appropriate, when used with respect to child-resistant packaging, 

means that the packaging is chemically compatible with the pesticide 

contained therein. 

(b) Child-resistant packaging means

packaging that is designed and constructed to be significantly difficult for 

children under 5 years of age to open or 

obtain a toxic or harmful amount of 

the substance contained therein within 

a reasonable time, and that is not difficult for normal adults to use 

properly.

(c) Package or packaging means the 

immediate container or wrapping, including any attached closure(s), in 

which the pesticide is contained for 

distribution, sale, consumption, use or 

storage. The term does not include any 

shipping or bulk container used for 

transporting or delivering the pesticide 

unless it is the only such package. 

(d) Practicable, when used with respect to child-resistant packaging, 

means that the packaging can be mass 

produced and can be used in assembly 

line production. 

(e) Residential use means use of a pesticide or device: 

(1) Directly on humans or pets; 

(2) In, on, or around any structure, 

vehicle, article, surface or area associated with the household, including but 

not limited to areas such as non-agricultural outbuildings, non-commercial 

greenhouses, pleasure boats and recreational vehicles; or 

(3) In or around any preschool or day 

care facility. 

(f) Technically feasible, when applied 

to child-resistant packaging, means 

that the technology exists to produce 

the child-resistant packaging for a particular pesticide. 

(g) Unit packaging means a package 

that is labeled with directions to use 

the entire contents of the package in a 

single application.

§ 157.22 When required. 

Unless exempted under §157.24, a pesticide product must be distributed and 

sold in child-resistant packaging complying with §157.32 if it meets both of 

the following criteria: 

(a) Toxicity criterion. Based upon testing with an appropriate test species, 

the product meets any of the following 

toxicity criteria: 

(1) The pesticide has an acute oral 

LD50 of 1.5 g/kg or less; 

(2) The pesticide has an acute dermal 

LD50 of 2000 mg/kg or less; 

(3) The pesticide has an acute inhalation LC50 of 2 mg/liter or less; 

(4) The pesticide is corrosive to the 

eye (causes irreversible destruction of 

ocular tissue) or causes corneal involvement or irritation persisting for 

21 days or more; 

(5) The pesticide is corrosive to the 

skin (causes tissue destruction into the 

dermis and/or scarring) or causes severe skin irritation (severe erythema 

or edema) at 72 hours; or 

(6) The pesticide or device has such 

characteristics that, based upon human 

toxicological data, use history, accident data or such other evidence as is 

75

Environmental Protection Agency § 157.24

available, the Agency determines there 

is serious hazard of accidental injury 

or illness which child-resistant packaging could reduce; and 

(b) Use criterion. The product’s labeling either directly recommends residential use or reasonably can be interpreted to permit residential use.

§ 157.24 Exemptions. 

(a) General exemptions. The Agency 

hereby exempts from the requirement 

for child-resistant packaging the following classes of products: 

(1) Products classified for restricted use.

(i) A product restricted to use by or 

under the supervision of a certified applicator is not required to be distributed and sold in child-resistant packaging.

(ii) Notwithstanding the exemption 

in paragraph (a)(1)(i) of this section, 

the Agency may require the use of 

child-resistant packaging for a product 

classified for restricted use by or under 

the direct supervision of a certified applicator if the Agency determines that 

the product poses a risk of serious accidental injury or illness which child-resistant packaging could reduce. If the 

Agency makes such a determination, it 

will notify the registrant in writing 

and provide a short statement of the 

basis of its determination. The registrant will then have 30 days to request a hearing on the Agency’s determination. Thereafter the Agency will 

decide whether to require the product 

to be distributed only in child-resistant 

packaging and will notify the registrant of its decision. 

(2) Products packaged in large sizes. (i)

Except as provided by paragraph 

(a)(2)(ii) of this section, a product is 

not required to be in child-resistant 

packaging if distributed and sold in the 

following sizes: 

(A) If the product is a solid product, 

regardless of pesticide type, a size of 50 

pounds or greater; 

(B) If the product is a liquid product 

intended for use in swimming pools, a 

size greater than 7.5 gallons by volume; 

(C) If the product is a liquid product 

intended for any other pesticide use, a 

size of 5 gallons or greater by volume; 

(D) If the product is packaged as an 

aerosol (measured by weight), regardless of pesticide type, a weight of 2 

pounds or greater. 

(ii) The Agency may require that a 

product packaged in a size exceeding 

that listed in paragraphs (a)(2)(i) (A) 

through (D) of this section be distributed and sold only in child-resistant 

packaging if the Agency determines 

that the product is, or is intended to 

be, distributed or sold to homeowners 

or other members of the general public. 

If the Agency makes such a determination, it will notify the registrant in 

writing and provide a short statement 

of the basis of its determination. The 

registrant will then have 30 days to request a hearing on the Agency’s determination. Thereafter the Agency will 

decide whether to require the product 

to be distributed only in child-resistant 

packaging and will notify the registrant of its decision. 

(b) Exemptions requiring Agency approval. The Agency may, in accordance 

with paragraphs (b) (1) through (3) of 

this section, grant an exemption from 

the requirements of this subpart. An 

exemption may be withdrawn in accordance with paragraph (b)(4) of this 

section.

(1) Requesting an exemption. A request 

for an exemption must be submitted to 

the Agency, and must be accompanied 

by two copies of the following information:

(i) The name, address, and telephone 

number of the requester; 

(ii) The name and registration number (or file symbol) of the product(s) 

for which the exemption is requested; 

(iii) A description of the package and 

the size(s) for which the exemption is 

requested; and 

(iv) Documentation supporting the 

request for exemption, including the 

length of time for which the exemption 

is requested. 

(2) Exemption based upon lack of toxicity. The Agency may grant an exemption from the requirements of this subpart if the registrant or applicant demonstrates to the Agency’s satisfaction 

that the hazards indicated by the toxicity criteria in §157.22(a) are not indicative of the hazards to man. If granted, 

76

§ 157.27 40 CFR Ch. I (7–1–03 Edition)

an exemption shall apply to other products of substantially similar composition. A notice will be issued in the FEDERAL REGISTER stating the nature of 

and reasons for the exemption. 

(3) Exemption based upon technical factors. The Agency may grant an exemption from the requirements of this subpart based upon technical considerations. If granted, the exemption will 

be for a specified length of time, and 

will apply to other products of substantially similar composition and intended uses. A notice of the granting of 

an exemption will be issued in the FEDERAL REGISTER. In considering whether 

to grant an exemption, the Agency will 

consider, among other things, the following:

(i) Whether the toxicity of the product is such that it should not be allowed to be distributed or sold except 

in child-resistant packaging. 

(ii) Whether child-resistant packaging is technically feasible, practicable, or appropriate. An exemption 

may be granted if the Agency determines that any one of these criteria 

has not been met. 

(iii) Whether the composition or use 

pattern of the product necessitates a 

particular form of packaging for proper 

use.

(iv) Whether child-resistant packaging that is technically feasible, practicable, and appropriate is available for 

the product or can reasonably be made 

available to the registrant in sufficient 

quantities to meet his packaging 

needs. This determination does not include a consideration of whether the 

packaging would be adaptable to a registrant’s existing package type or 

packaging equipment. 

(v) Whether the registrant has made 

a timely and good faith effort to obtain 

child-resistant packaging for the product.

(vi) If child-resistant packaging 

which is technically feasible, practicable, and appropriate is not yet 

available, when such packaging is likely to be available. 

(4) An exemption may be withdrawn 

by the Agency at any time if the lack 

of child-resistant packaging results in 

serious illnesses or injuries to children. 

If the Agency determines that an exemption should be withdrawn, it will 

notify the registrant, stating the basis 

for its determination. The registrant 

will then have 30 days to request a 

hearing on the Agency’s determination. Thereafter the Agency will decide 

whether to withdraw the exemption, 

and will notify the registrant of its decision.

§ 157.27 Unit packaging. 

Pesticide products distributed or sold 

as an aggregate of one or more unit 

packages and meeting the criteria of 

§157.22 must be distributed or sold in 

child-resistant packaging either for 

each unit package or for the outer retail container which contains the unit 

packages. Child-resistant packaging is 

not required for both the outer package 

and the unit packages unless the Agency determines, on a case-by-case basis, 

that it is necessary for risk reduction.

§ 157.30 Voluntary use of child-resistant packaging. 

A registrant whose product is not required to be in child-resistant packaging may distribute or sell his pesticide product in child-resistant packaging. If he does so, that packaging 

must meet the standards for child-resistant packaging stated in §157.32. The 

registrant must certify to this effect in 

accordance with §157.34, and must retain the records required by §157.36.

§ 157.32 Standards. 

(a) Effectiveness standard. The childresistant packaging, when tested by 

the protocol specified in 16 CFR 1700.20, 

shall meet the effectiveness specifications in 16 CFR 1700.15(b). 

(b) Compatibility standard. The childresistant packaging must continue to 

meet the effectiveness specifications of 

paragraph (a) of this section when in 

actual use as a pesticide container. 

This requirement may be satisfied by 

appropriate scientific evaluation of the 

compatibility of the substance with the 

child-resistant packaging to determine 

that the chemical and physical characteristics of the pesticide will not compromise or interfere with the proper 

functioning of the child-resistant packaging and that the packaging will not 

be detrimental to the integrity of the 

product during storage and use. 

77

Environmental Protection Agency § 157.36

(c) Durability standard. The child-resistant packaging must continue to 

meet the effectiveness and compatibility standards of paragraphs (a) and 

(b) of this section for the reasonably 

expected lifetime of the package, taking into account the number of times 

the package is customarily opened and 

closed. This requirement may be satisfied by appropriate technical evaluation based on physical wear and stress 

factors of packaging, the force required 

for activation, and other relevant factors.

§ 157.34 Certification. 

(a) General. (1) The registrant of a 

pesticide product required to be in 

child-resistant packaging shall certify 

to the Agency that the package meets 

the standards of §157.32. 

(2) Certification must be submitted 

with each application for new registration, if applicable. If the Agency 

determines, in accordance with 

§157.24(a)(1)(ii), (2)(ii), or (b)(4), that a 

currently registered product is required to be packaged in child-resistant packaging, a certification must be 

submitted within 6 months after the 

Agency finally notifies the registrant 

of the requirement. 

(b) Contents of certification. The certification must contain the following 

information:

(1) The name and EPA registration 

number of the product to which the 

certification applies, the registrant’s 

name and address, the date, and the 

name, title and signature of the company official making the certification. 

(2) A statement that the packaging 

that is being used for the product will 

meet the standards of §157.32. The 

statement, ‘‘I certify that the packaging that will be used for this product 

meets the standards of 40 CFR 157.32,’’ 

will suffice for this purpose.

§ 157.36 Recordkeeping. 

For as long as the registration of a 

pesticide product required to be in 

child-resistant packaging is in effect, 

the registrant must retain the records 

listed in this section. The registrant 

must, upon request by the Agency, 

make them available to Agency representatives for inspection and copying, or must submit them to the Agency.

(a) A description of the package, including a description of: 

(1) The container and its dimensions 

and composition. 

(2) The closure or child-resistant 

mechanism, including the name of its 

manufacturer and the manufacturer’s 

designation for the closure or the physical working of the child-resistant 

packaging mechanism. 

(b) A copy of the certification statement required by §157.34. 

(c) One of the following types of 

records verifying that each package for 

the product is child-resistant: 

(1) Test data on the package based on 

the Consumer Product Safety Commission protocol in 16 CFR 1700.20. 

(2) Test data, not conforming to the 

protocol in 16 CFR 1700.20, or a set of 

measurements on the package, together with an explanation as to why 

such data or measurements demonstrate that the package is child-resistant.

(3) Test data, whether or not conforming to the protocol in 16 CFR 

1700.20, on a different package, together 

with an explanation of why such data 

demonstrate that the package being 

used is child-resistant. 

(4) Written evidence that verifies 

that testing on the package has been 

conducted according to the protocol in 

16 CFR 1700.20. Written evidence may 

be one of the following: 

(i) A letter or literature from the 

packaging supplier; 

(ii) A letter from the facility that 

conducted the testing; or 

(iii) A specification in the contract 

between the registrant or applicant 

and the packaging supplier; 

(5) When the container and closure 

are purchased separately by the registrant:

(i) Information of the kinds described 

in paragraphs (c) (1) through (4) of this 

section showing that the closure is 

child-resistant; and 

(ii) A written explanation of why the 

container is child-resistant; and 

(iii) Information showing that the 

closure and container are compatible 

with each other, and a written explanation of why the resulting package is 

child-resistant.

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Pt. 158 40 CFR Ch. I (7–1–03 Edition)

(6) A combination of the records listed in paragraphs (c) (1) through (5). 

(d) Records verifying that the package meets the compatibility and durability standards of §157.32(b) and (c). 

[51 FR 21286, June 11, 1986 and 51 FR 36692, 

Oct. 15, 1986, as amended at 65 FR 39304, June 

26, 2000]

PART 158—DATA REQUIREMENTS 

FOR REGISTRATION

Subpart A—General Provisions

Sec.

158.20 Overview. 

158.25 Applicability of data requirements. 

158.30 Timing of the imposition of data requirements.

158.32 Format of data submission. 

158.33 Procedures for claims of confidentiality of data. 

158.34 Flagging of studies for potential adverse effects. 

158.35 Flexibility of the data requirements. 

158.40 Consultation with the Agency. 

158.45 Waivers. 

158.50 Formulators’ exemption. 

158.55 Agricultural vs. non-agricultural pesticides.

158.60 Minor uses. 

158.65 Biochemical and microbial pesticides. 

158.70 Acceptable protocols. 

158.75 Requirements for additional data. 

158.80 Acceptability of data. 

158.85 Revision of data requirements and 

guidelines.

Subpart B—How To Use Data Tables

158.100 How to determine registration data 

requirements.

158.101 Required vs. conditionally required 

data.

158.102 Distinguishing between what data 

are required and what substance is to be 

tested.

158.108 Relationship of Pesticide Assessment Guidelines to data requirements.

Subpart C—Product Chemistry Data 

Requirements

158.150 General. 

158.153 Definitions. 

158.155 Product composition. 

158.160 Description of materials used to 

produce the product. 

158.162 Description of production process. 

158.165 Description of formulation process. 

158.167 Discussion of formation of impurities.

158.170 Preliminary analysis. 

158.175 Certified limits. 

158.180 Enforcement analytical method. 

158.190 Physical and chemical characteristics.

Subpart D—Data Requirement Tables

158.202 Purposes of the registration data requirements.

158.240 Residue chemistry data requirements.

158.290 Environmental fate data requirements.

158.340 Toxicology data requirements. 

158.390 Reentry protection data requirements.

158.440 Spray drift data requirements. 

158.490 Wildlife and aquatic organisms data 

requirements.

158.540 Plant protection data requirements. 

158.590 Nontarget insect data requirements. 

158.640 Product performance data requirements.

158.690 Biochemical pesticides data requirements.

158.740 Microbial pesticides—Product analysis data requirements.

APPENDIX A TO PART 158—DATA REQUIREMENTS FOR REGISTRATION: USE PATTERN

INDEX.

AUTHORITY: 7 U.S.C. 136–136y.

SOURCE: 49 FR 42881, Oct. 24, 1984, unless 

otherwise noted.

Subpart A—General Provisions

§ 158.20 Overview. 

(a) Legal authority. These requirements are promulgated under the authority of sections 3, 5, 12, and 25 of the 

Federal Insecticide, Fungicide and 

Rodenticide Act, as amended (FIFRA) 

(7 U.S.C. 136–136y). 

(b) Purposes of this part. (1) The primary purpose of this part is to specify 

the types and minimum amounts of 

data and information the Agency requires in order to make regulatory 

judgments about the risks and benefits 

of various kinds of pesticide products 

under the criteria set forth in FIFRA 

sections 3(c)(5) (C) and (D) and 3(c)(7). 

(2) This part also specifies the types 

and minimum amounts of data and information the Agency requires to decide whether to approve applications 

for experimental use permits under 

FIFRA section 5. 

(3) Finally, this part specifies the 

types and minimum amounts of data 

and information that an applicant for 

registration, amended registration, or 

reregistration must submit or cite in 

support of an application in order to