[Title 40 CFR 157]
[Code of Federal Regulations (annual edition) - July 1, 1996 Edition]
[Title 40 - PROTECTION OF ENVIRONMENT]
[Chapter I - ENVIRONMENTAL PROTECTION AGENCY--(Continued)]
[Subchapter E - PESTICIDE PROGRAMS]
[Part 157 - PACKAGING REQUIREMENTS FOR PESTICIDES AND DEVICES]
[From the U.S. Government Publishing Office]
40
PROTECTION OF ENVIRONMENT
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1996-07-01
1996-07-01
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PACKAGING REQUIREMENTS FOR PESTICIDES AND DEVICES
157
PART 157
PROTECTION OF ENVIRONMENT
ENVIRONMENTAL PROTECTION AGENCY--(Continued)
PESTICIDE PROGRAMS
PART 157--PACKAGING REQUIREMENTS FOR PESTICIDES AND DEVICES--Table of Contents
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.
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
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
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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 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)
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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, 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.
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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.
(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
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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.
(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).
(Approved by the Office of Management and Budget under control number
2070-0052)