Child-resistant Packaging. We all know what that is: It’s the package that the five-year-old can get into, but the fifty-year-old cannot. With respect to regulatory compliance, the term has a distinct definition,
at least in terms of pesticides.
Section 25(c)(3) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) authorizes the Environmental Protection Agency to establish standards for packaging pesticides in order to protect children and adults from serious illness or injury. The EPA specifically issues standards for child-resistant packaging (CRP) in 40 CFR 157.
How EPA Defines Child-resistant Packaging (CRP)
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.” [40 CFR 157.21]
Which Pesticides Need CRP?
A pesticide must be distributed in child-resistant packaging if it meets two criteria:
- Use Criterion – the product is either directly recommended for, or could be reasonably interpreted as intended for, residential use.
- Toxicity Criterion –
- Has an acute oral LD50 of ≤ 1.5 mg/kg
- Has an acute dermal LD50 of ≤ 2000 mg/kg
- Has an acute inhalation LC50 of ≤ 2 mg/L
- Is corrosive to the eye (irreversible ocular tissue destruction) or causes corneal involvement or irritation persisting for ≥ 21 days
- Is corrosive to the skin (tissue destruction into the dermis and/or scarring) or causes severe erythema or edema at 72 hours
- Has such characteristics that, based upon human toxicology data or other such evidence, the EPA determines there is a serious hazard that child-resistant packaging could reduce
Standards for Pesticide Manufacturers
The manufacturer of the pesticide must meet the following standards, per 40 CFR 157.32:
- Effectiveness – tested to per the Consumer Product Safety Commission’s (CPSC) standards at 16 CFR 1700.20 to meet specifications at 16 CFR 1700.15(b)
- Compatibility – the child-resistant packaging must be compatible with the pesticide being placed in it, determined through appropriate scientific evaluation
- Durability – continue to meet the effectiveness and compatibility standards for the reasonably expected lifetime of the package, taking the customary number of openings and closures for that type of package into account
As part of registering a pesticide for use in the United States, the manufacturer must submit a certification to the EPA that the package meets the child-resistant packaging standards. The certification must include:
- The name and EPA registration number of the product
- The manufacturer’s name and address
- The date of submission of the certification
- The name, title, and signature of the company official making the certification
- A statement that the product meets the standards at 40 CFR 157.32
Recordkeeping for Manufacturers
For as long as the registration of a pesticide required to be in child-resistant packaging is in effect, the manufacturer must retain detailed documentation about the package, the testing of the child-resistant portion of same, the certification, and compatibility and durability data. The manufacturer must also be prepared to share such documents with the EPA when requested [40 CFR 157.36]
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