Notice2024-02587
Pesticides; Flexible Packaging; Child Resistant Packaging Requirements; Notice of Availability
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Published
February 8, 2024
Issuing agencies
Environmental Protection Agency
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 27 (Thursday, February 8, 2024)</title>
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[Federal Register Volume 89, Number 27 (Thursday, February 8, 2024)]
[Notices]
[Pages 8675-8677]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-02587]
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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.
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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
<a href="https://www.regulations.gov">https://www.regulations.gov</a>. Additional information about dockets
generally, along with instructions for visiting the docket in-person is
available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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. <a href="https://www.cnn.com/2022/06/16/us/alaska-students-floor-sealant-milk/index.html">https://www.cnn.com/2022/06/16/us/alaska-students-floor-sealant-milk/index.html</a>. Accessed on September 25, 2023.
2. WRAL Staff. 2023. Boy, 9, Hospitalized After Mistaking Chemical
For Candy. WAGM TV. January 11, 2023. <a href="https://www.wagmtv.com/2023/01/11/boy-9-hospitalized-after-mistaking-checmical-candy/">https://www.wagmtv.com/2023/01/11/boy-9-hospitalized-after-mistaking-checmical-candy/</a>. 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. <a href="https://www.ncbi.nlm.nih.gov/search/research-news/15335/?utm_source=gquery&utm_medium=referral&utm_campaign=gquery-home">https://www.ncbi.nlm.nih.gov/search/research-news/15335/?utm_source=gquery&utm_medium=referral&utm_campaign=gquery-home</a>.
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. <a href="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">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</a>. 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. <a href="https://www.cnn.com/2020/04/06/us/children-thc-candy-food-bank-trnd/index.html">https://www.cnn.com/2020/04/06/us/children-thc-candy-food-bank-trnd/index.html</a>. Accessed on September
25, 2023.
6. Roberts, C. 2022. First The Girl Scouts, Now Pepsi: Why Big
Brands Hate Marijuana. Forbes. April 30, 2022. <a href="https://www.forbes.com/sites/chrisroberts/2022/04/30/first-the-girl-scouts-now-pepsi-why-big-brands-hate-marijuana/?sh=5e7a10735108">https://www.forbes.com/sites/chrisroberts/2022/04/30/first-the-girl-scouts-now-pepsi-why-big-brands-hate-marijuana/?sh=5e7a10735108</a>. 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. <a href="https://www.theguardian.com/society/2023/jun/12/mushrooms-chocolate-psilocybin-psychedelics-children">https://www.theguardian.com/society/2023/jun/12/mushrooms-chocolate-psilocybin-psychedelics-children</a>.
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
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