Attachment B- 40 CFR 157

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
157.21
157.22
157.24
157.27

General.
Definitions.
When required.
Exemptions.
Unit packaging.

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§ 157.20

40 CFR Ch. I (7–1–03 Edition)

157.30 Voluntary use
packaging.
157.32 Standards.
157.34 Certification.
157.36 Recordkeeping.

of

child-resistant

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.

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

§ 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

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

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Environmental Protection Agency

§ 157.24
less 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,

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), regard-

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§ 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.

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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

ing, 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.

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 copy-

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Pt. 158

40 CFR Ch. I (7–1–03 Edition)
158.190 Physical and chemical characteristics.

(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).

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.

[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.

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

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.

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