ICR Attachment B - 40 CFR 157

Attachment B

[Code of Federal Regulations]

[Title 40, Volume 21]

[Revised as of July 1, 2003]

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

[CITE: 40CFR157.20]

[Page 74]

TITLE 40--PROTECTION OF ENVIRONMENT

CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)

PART 157--PACKAGING REQUIREMENTS FOR PESTICIDES AND DEVICES--Table of

Contents

Subpart B--Child-Resistant Packaging

Sec. 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.

Sec. 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.

Sec. 157.22 When required.

Unless exempted under Sec. 157.24, a pesticide product must be

distributed and sold in child-resistant packaging complying with

Sec. 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

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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.

Sec. 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 Sec. 157.22(a) are not indicative

of the hazards to man. If granted,

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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.

Sec. 157.27 Unit packaging.

Pesticide products distributed or sold as an aggregate of one or

more unit packages and meeting the criteria of Sec. 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.

Sec. 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 Sec. 157.32. The

registrant must certify to this effect in accordance with Sec. 157.34,

and must retain the records required by Sec. 157.36.

Sec. 157.32 Standards.

(a) Effectiveness standard. The child-resistant 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 child-resistant 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.

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(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.

Sec. 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 Sec. 157.32.

(2) Certification must be submitted with each application for new

registration, if applicable. If the Agency determines, in accordance

with Sec. 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 Sec. 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.

Sec. 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 Sec. 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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(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 Sec. 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]