[Federal Register Volume 89, Number 27 (Thursday, February 8, 2024)]
[Notices]
[Pages 8675-8677]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-02587]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2023-0607; FRL-11686-01-OCSPP]


Pesticides; Flexible Packaging; Child Resistant Packaging 
Requirements; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Environmental Protection Agency (EPA) has determined that 
pesticide products marketed in flexible packaging (e.g., pouches) 20 
fluid ounces or less in size with labeling either directly recommending 
residential use or reasonably interpreted to permit residential use are 
subject to the Child Resistant Packaging (CRP) mitigation measures, 
regardless of acute toxicity requirements, based on the visual 
similarity of the packaging design to children's food products. As 
such, pesticide applicants and registrants must comply with CRP for 
this packaging type at the size limits specified when labeled for or 
reasonably interpreted to permit residential use and EPA will evaluate 
applications for new products or amendments to currently registered 
products submitted to EPA under the Federal Insecticide, Fungicide and 
Rodenticide Act (FIFRA), as amended by the Pesticide Registration 
Improvement Act of 2022 (referred to as ``PRIA 5''). Changes to 
packaging to implement CRP measures on existing products must be 
submitted as described in this document to allow for CRP data review. 
Additionally, the Agency is including recommended labeling mitigation 
for all flexible packaging, regardless of packaging size and intended 
use site.

DATES: If a registrant has a registered pesticide product in flexible 
packaging that is not compliant with this determination, the registrant 
must contact the appropriate EPA Product Manager by August 6, 2024.

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2023-0607, is available online at 
https://www.regulations.gov. Additional information about dockets 
generally, along with instructions for visiting the docket in-person is 
available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Charles Smith, Registration Division 
(7505M), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: 
(703) 305-7090; email address: <a href="/cdn-cgi/l/email-protection#42100604100c2d362b212731022732236c252d34"><span class="__cf_email__" data-cfemail="e4b6a0a2b6aa8b908d878197a4819485ca838b92">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Does this action apply to me?

    You may be potentially affected by this action if you currently 
market or propose to market a pesticide in flexible packaging (e.g., 
pouches). The following list of entities with North American Industrial 
Classification System (NAICS) codes is not intended to be exhaustive, 
but rather provides a guide to help readers determine whether this 
document applies to them. Potentially affected entities may include:
    <bullet> Crop production (NAICS code 111).
    <bullet> Animal production (NAICS code 112).
    <bullet> Food manufacturing (NAICS code 311).
    <bullet> Pesticide manufacturing (NAICS code 32532).

B. What is the Agency's authority for taking this action?

    EPA is taking this action pursuant to the Federal Insecticide, 
Fungicide and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq., as amended 
by the Pesticide Registration Improvement Act of 2022 (referred to as 
``PRIA 5''), Public Law 117-328, and the packaging requirements for 
pesticides and devices promulgated in 40 CFR part 157.

C. What action is the Agency taking?

    This document announces that EPA has determined pursuant to 40 CFR 
157.22(a)(6) and (b), that pesticide products marketed in flexible 
packaging (e.g., pouches) in 20 fluid ounces or less in size with 
labeling either directly recommending residential use or reasonably 
interpreted to permit residential use are subject to the Child 
Resistant Packaging (CRP) mitigation measures, regardless of acute 
toxicity requirements, based on the visual similarity of the packaging 
design to children's food products. As such, pesticide applicants and 
registrants must comply with CRP for this packaging type at the size 
limits specified when labeled for or reasonably interpreted to permit 
residential use and EPA will evaluate applications for new products or 
amendments to currently registered products submitted to EPA under 
IFRA, as amended by PRIA 5. Changes to packaging to implement CRP 
measures on existing products must be submitted as described in this 
document to allow for CRP data review. Additionally, the Agency is 
including recommended labeling mitigation for all flexible packaging, 
regardless of packaging size and intended use site.

II. Background

    EPA has seen an increased interest from pesticide manufacturers in 
the use of flexible packaging (e.g., pouches) to store and distribute 
products, especially insecticides and herbicides that residential users 
can dilute and apply to their lawn and garden. These packages contain a 
concentrated form of pesticide product, without added water, which 
ready-to-use (RTU) products typically contain. By removing the water, 
pesticide packaging is smaller and

[[Page 8676]]

lighter, reducing plastic consumption and shipping costs.
    To date, EPA has not been made aware of incidents with children 
involving pesticides in flexible packaging, potentially due to the 
relatively new occurrence of such products on the market. However, due 
to multiple incidents involving children ingesting other toxic products 
that were sold in similar packaging resembling food products, as 
documented in public news sources, EPA has determined that there is 
potential for accidental injury or illness which CRP could reduce or 
prevent. The following is a list of case studies of this occurrence in 
other industries have been outlined:
    <bullet> Twelve elementary students in Alaska accidentally drank 
floor sealant in a product designed similar to milk containers (Ref. 
1).
    <bullet> A nine-year-old boy accidentally ingested a `flame color 
changing' agent sold in packaging with a similar design to children's 
candy (Ref. 2).
    <bullet> Numerous news stories have reported children ingesting 
cannabis-infused sweets marketed to look similar to candy products 
(Refs. 3 through 7).
    Action taken by the Agency to mitigate risks associated with 
flexible packaging has precedent from other Federal agencies. For 
example, the sale of edible products containing Delta-8 THC in 
packaging almost identical to children's food products prompted the 
Federal Trade Commission (FTC) and U.S. Food and Drug Administration 
(FDA) to send Cease and Desist letters to six companies (Ref. 4).
    With this determination, the Agency intends to prevent similar 
inadvertent exposure to residential use pesticide products. The Agency 
also reminds registrants that, pursuant to FIFRA section 6(a)(2) and 40 
CFR part 159, pesticide manufacturers are required to submit 
information regarding unreasonable adverse effects on the environment, 
including incidents affecting humans or other non-target organisms; 
such information must be submitted to EPA within 15 days after learning 
of any allegations involving human fatality and within 30 days after 
the end of each 30-day report accumulation for other human incidents.

III. EPA Determination Regarding Flexible Packaging

A. CRP Requirements for Pesticides

    EPA sets standards for pesticide containers and labeling in 40 CFR 
parts 156 and 165, including design, construction, and labeling 
requirements to ensure safe and uniform packaging. To ensure pesticides 
are packaged in a manner safe for use around children, 40 CFR part 157 
describes requirements for CRP on pesticide containers used in 
residential settings. CRP containers are 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 amount of time. Generally, pesticide products that 
meet the toxicity criteria in 40 CFR 157.22(a)(1) through (4) and are 
labeled for or reasonably interpreted to permit residential use as 
contemplated in 40 CFR 157.22(b), are required to be packaged in CRP, 
unless the products satisfy the exemptions of 40 CFR 157.24 (e.g., are 
restricted use products or are packaged in a large size).

B. CRP Test Guidelines

    Prior to a pesticide product being packaged and sold in CRP, the 
registrant must conduct, and submit to EPA for review and approval, CRP 
testing performed in accordance with the protocol specified at 16 CFR 
1700.20. Selected child testers must be between the ages of 42-51 
months. Children are presented an empty package for five minutes to 
test if they can open it. If after five minutes the child does not open 
the package, the test administrator will provide a physical 
demonstration without verbal instructions on how to open the package 
and then allow the child an additional five minutes to attempt to open 
the package. A test failure is defined as any a child who opens the 
special packaging or gains access to its contents.
    The sequential test is initially conducted using 50 children, and, 
depending on the results, it is determined whether the package is 
either child-resistant or not child-resistant or whether further 
testing is required. Further testing is required if the results are 
inconclusive and involves the use of one or more additional groups of 
50 children each, up to a maximum of 200 children. If, after conducting 
the two 5-minute tests, fewer than 5 failures occur with the first 50 
testers, then no further testing is required, and the package passes 
the Child Resistance Effectiveness test. If more than 6 or fewer than 
14 failures occur with the first 50 testers, then further testing is 
required by testing an additional 50 testers. If more than 15 failures 
occur with the first 50 testers, then no further testing is required, 
and the packages fails the Child Resistance Effectiveness test.

C. CRP for Flexible Packaging

    Packaging for products with a toxicity below the threshold 
specified in 40 CFR 157.22(a)(1) through (4) would not ordinarily 
trigger the requirement for CRP. However, EPA has determined under 40 
CFR 157.22(a)(6) that pesticide products in flexible packaging 
resembling child food containers have characteristics that present a 
serious hazard of accidental injury or illness which CRP could reduce. 
As most children's food pouches are between 3 and 5 fluid ounces, the 
Agency believes that CRP measures on pesticide products 20 fluid ounces 
or less would provide a sufficient margin of protection to avoid 
children mistaking pesticidal flexible packaging for food pouches. 
While these products are relatively new to the market, flexible 
packaging containing pesticides are generally 1 to 54 fluid ounces. 
Flexible packaging that is larger than 20 fluid ounces are much larger 
than traditional children's food pouches and are unlikely to be 
mistaken by adults or children as food. This notice conveys that EPA 
has determined that, pursuant to 40 CFR 157.22(a)(6) and (b), pesticide 
products marketed in flexible packaging (e.g., pouches) 20 fluid ounces 
or less in size with labeling either directly recommending residential 
use or reasonably interpreted to permit residential use are subject to 
CRP mitigation measures under 40 CFR part 157, regardless of acute 
toxicity requirements, based on the visual similarity of the packaging 
design to children's food products.
    This document further conveys to applicants and registrants that 
CRP is necessary for this packaging type at the size limits specified 
when labeled for or reasonably interpreted to permit residential use 
and will be evaluated for applications for new products or for 
amendment of currently registered products submitted under FIFRA 
section 33, i.e., PRIA 5. Changes to packaging to implement CRP 
measures on existing products must be submitted as a PRIA R340/341, 
A572, or B680/681, not as a fast-track non-PRIA amendment, to allow for 
CRP data review.
    Changes in the shape, color, or composition of packaging and 
changes in labeling statements due to modification of package size and 
type may be done by notification only if all criteria in PRN 98-10 
section II.E. are met. Due to the Agency's determination, products 
marketed in flexible packaging do not meet the following criteria in 
PRN 98-10 section II.E and may not modify the package size and type via 
notification:


[[Page 8677]]


``. . . 3. Either before or after the proposed change, the product 
is neither subject to child resistant packaging (CRP), nor has the 
registrant voluntarily used CRP; [. . .]
    6. The package size is not reduced to the point that the net 
contents of the package is smaller than the dosage required by 
directions for use or that a reduced package size will require CRP;
    7. The package size or other characteristics is not changed in a 
way which violates EPA mandated restrictions imposed on a product 
(e.g., size limitations may be imposed on a product to limit its use 
to homeowners only).''

D. Additional Recommendations for Flexible Packaging and Labeling

    In addition to determining that CRP requirements are necessary for 
pesticidal flexible packaging products 20 ounces or less in size with 
labeling either directly recommending residential use or reasonably 
interpreted to permit residential use, the following additional 
mitigation measures are recommended for all pesticide products sold in 
flexible packaging, regardless of size or intended use site:
    <bullet> No child-attractant packaging colors (e.g., neon colors, 
bright colors, more than three colors). Packaging should be primarily 
in black, white, or grey.
    <bullet> Flexible packaging (e.g., pouches) should be packaged by 
the manufacturer within an outer box containing the full product label 
for sale to the consumer.
    <bullet> All product packaging (e.g., outer box and flexible 
packaging) should contain a graphic or icon stating, `Not A Food 
Product.'
    The following statements should be included in the Directions for 
Use section of the label:
    <bullet> `Store pouches in closed product box and away from 
children and food.'
    For pouches 20 fluid ounces or less: `Each pouch is for one-time 
use only. Do not store any opened pouches. Empty the entire contents of 
the pouch into the container. Once empty, discard the empty pouch 
immediately into a secure trash receptacle that cannot be accessed by 
children.'
    <bullet> For pouches greater than 20 fluid ounces: `Once empty, 
discard the empty pouch immediately into a secure trash receptacle that 
cannot be accessed by children.'

E. Next Steps

    These mitigation measures will be reflected in an updated version 
of the Label Review Manual to serve as guidance for registrants 
pursuing flexible packaging containers.
    As pesticides in flexible packaging is a relatively new occurrence, 
EPA does not believe that there are any registered pesticide products 
in flexible packaging without the CRP and mitigation language above. If 
a registrant has a registered pesticide product in flexible packaging 
that is not compliant with the determination as described in this 
document, the registrant must contact the appropriate EPA Product 
Manager by August 6, 2024.

IV. References

    The following is a listing of the documents that are specifically 
referenced in this document. The docket includes these documents and 
other information considered by EPA, including documents that are 
referenced within the documents that are included in the docket, even 
if the referenced document is not physically located in the docket. For 
assistance in locating these other documents, please consult the 
technical person listed under FOR FURTHER INFORMATION CONTACT.

1. Boyette, C. 2022. Alaska Schoolchildren Were Served Floor Sealant 
Instead Of Milk At A Child Care Program, School District Says. CNN. 
June 16, 2022. https://www.cnn.com/2022/06/16/us/alaska-students-floor-sealant-milk/index.html. Accessed on September 25, 2023.
2. WRAL Staff. 2023. Boy, 9, Hospitalized After Mistaking Chemical 
For Candy. WAGM TV. January 11, 2023. https://www.wagmtv.com/2023/01/11/boy-9-hospitalized-after-mistaking-checmical-candy/. Accessed 
on September 25, 2023.
3. Caron, C. 2022. More Young Kids Are Getting Sick From Cannabis 
Edibles. The New York Times. January 14, 2022. https://www.ncbi.nlm.nih.gov/search/research-news/15335/?utm_source=gquery&utm_medium=referral&utm_campaign=gquery-home. 
Accessed on September 25, 2023.
4. U.S. Federal Trade Commission (FTC) and U.S. Food and Drug 
Administration (FDA), 2023. FTC Sends Cease and Desist Letters with 
FDA To Companies Selling Edible Products Containing Delta-8 THC in 
Packaging Nearly Identical to Food Children Eat. Federal Trade 
Commission. July 5, 2023. https://www.ftc.gov/news-events/news/press-releases/2023/07/ftc-sends-cease-desist-letters-fda-companies-selling-edible-products-containing-delta-8-thc. Accessed on 9/25/
2023.
5. Kaur, H. and D. Shepherd. 2020. Two Children Hospitalized After 
Eating THC-infused Candy Accidentally Given Out By A Local Food 
Bank. CNN. April 7, 2020. https://www.cnn.com/2020/04/06/us/children-thc-candy-food-bank-trnd/index.html. Accessed on September 
25, 2023.
6. Roberts, C. 2022. First The Girl Scouts, Now Pepsi: Why Big 
Brands Hate Marijuana. Forbes. April 30, 2022. https://www.forbes.com/sites/chrisroberts/2022/04/30/first-the-girl-scouts-now-pepsi-why-big-brands-hate-marijuana/?sh=5e7a10735108. Accessed 
on September 25, 2023.
7. Semley, J. 2023. Cartoon Packaging And An `Inconsolable' High: 
When Magic Mushroom Chocolate Gets Into The Wrong Hands. The 
Guardian. June 12, 2023. https://www.theguardian.com/society/2023/jun/12/mushrooms-chocolate-psilocybin-psychedelics-children. 
Accessed on September 25, 2023.

    Authority: 7 U.S.C. 136 et seq.

    Dated: February 1, 2024.
Edward Messina,
Director, Office of Pesticide Programs.
[FR Doc. 2024-02587 Filed 2-7-24; 8:45 am]
BILLING CODE 6560-50-P


</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>