Child-Resistant Packaging for Pesticides
To protect children from poisonings around the home, the law requires that certain household pesticides be in child-resistant packaging (Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) section 25 (c)(3)). EPA's pesticide regulations for Child-Resistant Packaging (CRP) are located at 40 CFR 157 subpart B.
Does Your Pesticide Product Require Child-Resistant Packaging?
If a pesticide product triggers the CRP toxicity criteria and is used in a residential setting, then it is subject to CRP. A pesticide product triggers the CRP toxicity criteria when, based upon testing with an appropriate test species, it meets anyone of the following:
- Acute oral LD50 of 1.5 g/kg or less.
- Acute dermal LD50 of 2000 mg/kg or less.
- Acute inhalation LC50 of 2 mg/ liter or less.
- Is corrosive to the eye (causes irreversible destruction of ocular tissue) or causes corneal involvement or irritation persisting for 21 days or more.
- 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.
- 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.
What is Necessary if Your Product Requires CRP?
- Certify to CRP as stated in 40 CFR 157.34 and PR Notice 96-2 (see CRP certification guidance below)
- Comply with the CRP standards as stated in 40 CFR 157.32 – Effectiveness Standard - CRP tested by the protocol in 16 CFR 1700.20 shall meet the effectiveness specifications in 16 CFR 1700.15(b)
- Compatibility Standard; Durability Standard Recordkeeping per 40 CFR 157.36
Questions and Answers about Implementing Child Resistant Packaging:
What is CRP?
CRP is defined in 40 CFR 157.21(b) as 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.
Can CRP be used voluntarily?
Yes, per 40 CFR 157.30, but all the requirements for CRP must be met.
What happens if I want to change the CRP?
-
an application to amend the product registration; and
-
a new CRP certification.
What CRP does EPA require for unit dose packaging?
The CRP generally may be either the outer retail package or the individual unit package. However, prefilled, nonrefillable insecticide bait stations not designed or intended to be opened or activated in a manner that exposes the contents to human contact must be in CRP rather than the outer package (PR 97-9).
What does “opened” in the Senior Adult Use Effectiveness (SAUE) mean to EPA?
EPA will consider a package successfully “opened” in SAUE testing only if the contents of the package can be removed in a condition suitable for their intended use, and the process of opening and removing the contents would not result in significant exposure to the pesticide.
When does my product require CRP?
- When it meets the toxicity criterion in 40 CFR § 157.22(a) and the product’s labeling either directly recommends residential use or reasonable can be interpreted to permit residential use [40 CFR § 157.22(b)].
- Exemptions are clearly described in 40 CFR§ 157.24
What is required for unit-dose packaging?
- For the purposes of CRP testing, a child failure is opening or access to a toxic or harmful amount or more than 8 units, whichever number is lower, based on an 11.4kg child. Testing that demonstrates safety below a toxic or harmful dose is required.
- We are planning on putting various fill volumes inside identical CRP packaging. Can I bracket test?
- To align regulatory practices with CPSC, EPA is accepting bracket testing to satisfy testing requirements for unit-dose packaging which houses various fill volumes. The smallest, largest, and a middle quantity for each container size must be tested.
- Bracketed tests do not need to come in under PRIA, but the certification statement must differentiate which fill volumes were tested and which were waived due to bracket testing.
- Example:
|
Fill Volume |
Container Size |
Child Testing Required? |
SAUE Testing Required? |
|---|---|---|---|
|
0.25 |
S |
Y |
Y |
|
0.50 |
S |
Bridging could be used to satisfy these fill volumes |
Bridging could be used to satisfy these fill volumes |
|
1.0 |
S |
||
|
1.5 |
S |
||
|
2.0 |
S |
Y |
Y |
|
2.0 |
L |
Y |
Y |
|
2.5 |
L |
Bridging could be used to satisfy these fill volumes |
Bridging could be used to satisfy these fill volumes |
|
3.0 |
L |
||
|
4.0 |
L |
||
|
5.0 |
L |
Y |
Y |
Note: Additional testing may be required at EPA discretion
- Can I use existing data to support different packaging?
- EPA will entertain data bridging proposals beyond the bracket testing on a case by case basis.
- These must be submitted to the Agency under PRIA Code R272 which include data summary sheets for all supporting CRP and SAUE studies.
When is a CRP Certification Appropriate?
- A certification statement must be submitted with each application for new registration, if applicable. If EPA determines that a currently registered product is required to be packaged in CRP, a certification must be submitted within 6 months after the Agency notifies the registrant of the requirement.
What information needs to be included in a certification statement?
- The product name and EPA registration number
- A description of the package tested
- Whether CRP for this product voluntary or required
- For each package: Testing information for the child-resistant effectiveness
- Number of children tested
- Number of children opening/accessing contents in full 10 minutes
- For each package: Testing information for senior adult use effectiveness:
- Number of adults tested
- Number of adults unable to access package contents
- Include the certification statement (I certify that the packaging used for this product meets the standards of 40 CFR 157.32 including the revised standards in 16 CFR 1700.15(b) when tested by the revised testing procedures in 16 CFR 1700.20 as published in 60 FR 37710 (July 21, 1995)) and your signature
What do I need to submit to the Agency?
- New products or products newly fitting the criterion for CRP requirements – include the CRP certification in their initial application package to the Agency.
- Revisions to CRP packaging – submission of CRP certification may be submitted as a fast-track amendment, submission of CRP data must be submitted as a PRIA R340.
- Bridging rationales – PRIA R272 code for products within the Registration Division and A385 or A540 for products within Antimicrobials Division.
- Exemptions which require Agency approval – PRIA R340, including all the information from 40 CFR 157.24(b).
- Full data is not required as part of your Agency submission, but if requested, must be provided to the Agency within 6 weeks.
What records pertaining to CRP do I need to keep?
- Follow 40 CFR 157.36 recordkeeping requirements – “For as long as the registration of a pesticide product required to be in CRP 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 the Agency representatives for inspection and copying, or must submit them to the Agency.”
- Upon request, the registrant must submit a description of the package, certification statement, and test data.
- EPA will be performing product audits to ensure compliance with CRP recordkeeping.
Do I need to submit anything now?
We will be updating our records based on previously submitted data and certifications, but to expedite this process, please include a copy of the certification statement in your next Agency submission.
Submitting Data Electronically
CRP submissions may be made electronically through the new Pesticide Submission Portal (PSP) within EPA's Central Data Exchange (CDX) Network. Any questions not covered in PR Notice 97-9 should be addressed to Lisa Pahel (pahel.lisa@epa.gov) or by telephone at (703) 347-0459, fax (703) 308-9382.
Quick Reference Guide to Child-Resistant Packaging
This Quick Reference Guide to Child-Resistant Packaging is intended for use by pesticide registrants, product manufacturers, and others who are legally required to meet the EPA standards for child-resistant packaging of pesticide products. It describes various types of child-resistant packaging, along with their photographs, and how to obtain them. Please note that inclusion of a package on that site is no indication that it has been approved by the Agency for use.
Using the sortable table, Guide to CRP for Pesticides, you may search for a child-resistant package by one of the following topics. The table contains links to the child-resistant packaging descriptions and photographs in the fourth column.
- Package Type (e.g., aerosol overcap)
The Package Type column lists the various packages alphabetically by their package type. Once you have selected a particular package you can see view the package description and photographs in the fourth column. -
ASTM Type
The ASTM Type column lists the various packages by their ASTM classification of the package type (e.g., reclosable packaging – continuous thread closure). Once you have selected a particular package you can view the package description and photographs in the fourth column. If you are not familiar with the ASTM classification of CRP, use one of the other columns to locate the package.
The following ASTM Classifications are included in the guide:- ASTM Type I - Reclosable Packaging Continuous Thread Closure
- ASTM Type II - Reclosable Packaging Lug Finish Closure
- ASTM Type III - Reclosable Packaging Snap Closure
- ASTM Type IV - Unit Non-Reclosable Packaging Flexible (Strip/Pouch)
- ASTM Type V - Unit Non-Reclosable Packaging – Rigid
- ASTM Type VII Aerosol Packages
- ASTM Type VIII - Non-Reclosable Packaging Semi-Rigid (Blister)
- ASTM Type IX - Dispensers (Not Intended To Be Removed)
- ASTM Type X - Box Or Tray Package
- ASTM Type XI - Reclosable Packaging Flexible
- ASTM Type XIII - Reclosable Packaging Semi-Rigid (Blister)
- CRP Manufacturer
The CRP Manufacturer column lists the various packages alphabetically by their manufacturer. Once you have selected a particular package you can view the package description and photographs in the fourth column. - CRP Name
The CRP Name column provides links to the package descriptions and photographs of each type of CRP.
In addition to the CRP guidance table, three additional lists are provided:
- CRP Manufacturers - contact information for questions concerning specific child-resistant packaging
- CRP Testing Firms - contact information for package testing to ascertain if a package is child-resistant, and thus be included in the guide
- CRP Consultants - contact information for consultants with experience in child-resistant packaging
Disclaimers
The ASTM classifications are extracted, with permission, from D3475-14, Standard Classification of Child-Resistant Packages, copyrighted:
ASTM International
100 Barr Harbor Drive
West Conshohocken, PA 19428-2959
Copies of the complete standard may be purchased from ASTM International (telephone: 610-832-9585, fax: 610-832-9555, e-mail: service@astm.org, Web site: www.astm.org. Exit
Additions/Corrections
If you find an error or omission in the CRP guide, list of CRP consultants, list of CRP manufacturers or list of CRP testing firms, please notify EPA in writing.
- Describe the error, list what corrections are necessary, and state why.
- Note that, for inclusion in the CRP guide, two samples of the entire CRP along with the manufacturer's permission are required.
- Corrections and/or additions to the list of CRP consultants, the list of CRP manufacturers, the list of CRP testing firms, or the CRP guide must be verified with the company involved before any action is taken.
Address corrections for EPA to:
Attention: Lisa Pahel
Environmental Protection Agency
Office of Pesticide Programs (7505P)
Registration Division; Fungicide & Herbicide Branch
1200 Pennsylvania Ave., N.W.
Washington, DC 20460
Telephone: 703-347-0459
Fax: 703-308-9382
E-mail: pahel.lisa@epa.gov
Note: This guide is a joint undertaking of the U.S. Consumer Product Safety Commission (CPSC) and EPA. Non-pesticidal products requiring child-resistant packaging are under the jurisdiction of the CPSC. A version of this guide is also posted on CPSC's website. The CPSC maintains its own lists of CRP consultants, CRP manufacturers and CRP testing firms. Please address corrections to the CPSC list to:
Attention: Gregory K. Rea
Directorate for Laboratory Sciences
U.S. Consumer Product Safety Commission
National Product Testing and Evaluation Center
5 Research Place
Rockville, MD 20850
301-987-2258
Fax: 301-427-1956
Email:grea@cpsc.gov