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?
If your product requires CRP you must:
- 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 five 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.
If you are submitting CRP data, this is typically done through PRIA code R340.
If you are citing CRP data or submitting only a robust certification, you may submit a new or revised CRP certification as a fast track amendment (see CRP certification guidance below).
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 criteria in 40 CFR § 157.22(a) and the product’s labeling either directly recommends residential use or reasonably can be interpreted to permit residential use [40 CFR § 157.22(b)].
- Exemptions are clearly described in 40 CFR§ 157.24.
- General exemptions may include:
- Products classified for restricted use; or
- Products packaged in large sizes.
- If the product is a solid product, regardless of pesticide type, a size of 50 pounds or greater.
- If the product is a liquid product intended for use in swimming pools, a size greater than 7.5 gallons by volume.
- If the product is a liquid product intended for any other pesticide use, a size of 5 gallons or greater by volume.
- If the product is packaged as an aerosol (measured by weight), regardless of pesticide type, a weight of 2 pounds or greater.
- The Agency may still require a product packaged in the size exceeding that listed above be listed in CRP, see 40 CFR§ 157.24 for more information.
- Exemptions requiring Agency approval:
- Exemption based upon lack of toxicity.
- Exemption based on technical factors.
- General exemptions may include:
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 which 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 and largest fill volume 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.
For 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
In what other situations can bridging be used to satisfy testing requirements?
SAUE testing can be “bridged down” from the max number of blisters or applicators in a strip (e.g., a strip of three connected applicators) to lower numbers of identical connected applicators (e.g. a strip of two or a single applicator). This is because it is assumed that opportunity for exposure and difficulty of opening are increased in a scenario where the senior is tasked with removing one blister from a strip and then following opening instructions for that blister.
Additionally, this bridging rationale can only be employed if the opening instructions for all counts are identical to those provided to the senior (with the exception of directions for separating one blister from the others).
Please note that child-resistant effectiveness testing may not be “bridged down” in the same way, but bridging a from a strip of three to a strip of four or more may be permitted on a case by case basis.
Any bridging rationale should be included in the CRP certification.
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.
If you are citing data your CRP package needs to be manufactured at the same establishment as the cited data.
What Should I be testing?
It is strongly advised that you contact EPA before running any tests to ensure all necessary tests will be done.
The entire package configuration needs to be tested, e.g. if the package is a cap and bottle, the exact cap and bottle combination that will be marketed needs to be tested.
Do not test empty packages— This does not allow for a failure according to the full definition set forth in 16CFR1700.20B: A test failure shall be any child who opens the special packaging or gains access to its contents (emphasis added).
In addition to not testing empty packages, the tested package should contain a placebo that reflects the formulation of the proposed product (liquid, granular, etc).
For SAUE testing, the directions provided to seniors CANNOT include bracketed statements (e.g. Cut with scissors to open [applicator][vial][tube]).
However, IF separate (successful) tests were done, AND the only difference in opening directions is one word (vial vs. applicator vs. tube, etc), the label can list the same directions but place in brackets the one word that is different.
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.
The certification must include the statement, “I certify that the packaging that will be used for this product meets the standards of 40 CFR 157.32”.
What information needs to be included in a certification statement?
CRP Certification
A child-resistant packaging (CRP) certification must comply with the requirements of 40 CFR 157.34. If a registrant changes their CRP (e.g. size, fill level, color, shape, packaging materials, etc.), additional CRP testing must be performed. Changes in CRP require the registrant to amend their registration, and submit a new CRP certification. In certain circumstances the Agency may request the registrant submit their CRP test data in addition to the CRP certification. When the Agency permits the registrant to submit the CRP certification without CRP test data it must be on company letterhead and contain the following information: a statement as to whether new CRP certification is a replacement or in addition to the current CRP certification; a summary of the information for each CRP test; and 40 CFR 157.34 information.
The actual CRP studies do not need to be submitted, but for each package configuration tested, the certification letter needs to include:
- The product name and EPA registration number.
- State whether CRP is voluntary or required for the product.
- Identify which package is associated with the CRP test data:
- A description of the package tested including a photograph of the package (including closure model and size, material specification, package color, Manufacturer, ASTM classification, size package tested with, and fill volumes).
- The name of the testing firm.
- If you are employing any bridging rationales to cover certain packaging configurations, please explain.
- For the SAUE (see checklist below for 16 CFR 1700.20 requirements):
- The directions on the package used for Senior Adult Use Effectiveness (SAUE) Testing along with any additional directions provided to the Seniors during SAUE Testing.
- The number of Seniors tested.
- Percent able to open the package after the initial 5 minutes.
- Percent able to open the package in the next one-minute trial.
- For the Child-Resistant Effectiveness (CRE)(see checklist below for 16 CFR 1700.20 requirements):
- The number of children tested.
- The number of failures.
- For unit dose packaging:
- Define the number of units that represent a child failure.
- The number of units a child receives at the beginning of the test.
- The CRP 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). - Please sign and date the certification and place on company letterhead (including the registrant name and address and the title and signature of company official).
What is required for 100% repack products?
Products that are 100% repacks of a product in CRP do not need to submit a CRP certification, but do need to certify that they are using the same package as the parent product. The parent product packaging should have an acceptable CRP certification. To certify to the 100% repack packaging, registrants should submit the following on company letterhead:
- Company name;
- Product name and registration number;
- Description of package (e.g. size, cap, material, blister pack, fill volume(s), manufacturer etc.);
- Name and registration number of product they are a 100% repack of;
- Statement certifying they are using the same package as Product X;
- Statement acknowledging that if they ever change formulation and/or packaging, CRP testing and a certification may be required; and
- Registrant’s signature and date.
What do I need to do if my product meets the requirements for CRP or I want to amend my current CRP?
The following should be submitted to EPA:
- New products or products newly fitting the criteria for CRP requirements – include the CRP certification and CRP data (if submitting) in their initial application package to the Agency.
- Revisions to CRP packaging – submission of CRP certification may be done as a fast-track amendment, submission of CRP data with CRP certification 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 are not required as part of your Agency submission, but if requested, must be provided to the Agency within 6 weeks.
Ensure that all testing information included in a certification or submitted to support a product really does support that product; do not include studies that do not support a product’s specific packaging on the data matrix or on the submitted certification.
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.
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 the Child Resistant Packaging Team at ChildResistantPackaging@epa.gov.
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.
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. Please note that the appearance of a CRP manufacturer on this list is based solely on the manufacturers’ request to be included and the manufacturers’ claims. The Agency has not reviewed the test data for packaging manufactured by these firms.
- 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 an error or omission is found 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: Child Resistant Packaging Team
Environmental Protection Agency
Office of Pesticide Programs (7505P)
Registration Division
1200 Pennsylvania Ave., N.W.
Washington, DC 20460
E-mail: ChildResistantPackaging@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 Web site. 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