Federal Register / Vol. 89, No. 27 / Thursday, February 8, 2024 / Notices 8675 

be applied per year is up to ∼1.83g/week 

or 95g/year. 

This notice does not constitute a 

decision by EPA on the application 

itself. The regulations governing FIFRA 

section 18 require publication of a 

notice of receipt of an application for a 

specific exemption proposing a new use 

of a microbial pesticide (i.e., an active 

ingredient) which has not been 

registered by EPA. The notice provides 

an opportunity for public comment on 

the application. 

The Agency will review and consider 

all comments received during the 

comment period in determining 

whether to issue the specific exemption 

requested by the Hawaii Department of 

Agriculture. 

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

Dated: February 1, 2024. 

Charles Smith, 

Director, Registration Division, Office of 

Pesticide Programs. 

[FR Doc. 2024–02586 Filed 2–7–24; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–OPP–2023–0074; FRL–11590–01– 

OCSPP] 

Cancellation Order for Certain 

Pesticide Registrations and 

Amendments to Terminate Uses 

Correction 

In notice document 2023–28547, 

beginning on page 89448 in the issue of 

Wednesday, December 27, 2023, make 

the following correction: 

On page 89449, in the first column, 

beginning on the 13th line beneath the 

‘‘Section IV. Cancellation Order’’ the 

text ‘‘[INSERT DATE OF PUBLICATION 

IN THE Federal Register]’’ should read 

‘‘December 27, 2023’’. 

[FR Doc. C1–2023–28547 Filed 2–7–24; 8:45 am] 

BILLING CODE 0099–10–D 

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: RDFR

Notices@epa.gov. 

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: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• 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 


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8676 Federal Register / Vol. 89, No. 27 / Thursday, February 8, 2024 / Notices 

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: 

• Twelve elementary students in 

Alaska accidentally drank floor sealant 

in a product designed similar to milk 

containers (Ref. 1). 

• 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). 

• Numerous news stories have 

reported children ingesting cannabisinfused 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 childresistant 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: 


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Federal Register / Vol. 89, No. 27 / Thursday, February 8, 2024 / Notices 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: 

• No child-attractant packaging colors

(e.g., neon colors, bright colors, more 

than three colors). Packaging should be 

primarily in black, white, or grey. 

• 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. 

• 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: 

• ‘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.’ 

• 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-checmicalcandy/. 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/pressreleases/2023/07/ftc-sends-cease-desistletters-fda-companies-selling-edibleproducts-containing-delta-8-thc. 

Accessed on 9/25/2023. 

5. Kaur, H. and D. Shepherd. 2020. Two

Children Hospitalized After Eating THCinfused 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-girlscouts-now-pepsi-why-big-brands-hatemarijuana/?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/mushroomschocolate-psilocybin-psychedelicschildren. 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 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–OAR–2011–0742; FRL—11599– 

01–OAR] 

Information Collection Request; 

Comment Request; Air Pollution 

Regulations for Outer Continental 

Shelf (OCS) Activities 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: The Environmental Protection 

Agency (EPA) is planning to submit an 

information collection request (ICR), 

‘‘Air Pollution Regulations for Outer 

Continental Shelf (OCS) Activities’’ 

(EPA ICR No. 1601.10, OMB Control No. 

2060–0249), to the Office of 

Management and Budget (OMB) for 

review and approval in accordance with 

the Paperwork Reduction Act (PRA). 

Before doing so, the EPA is soliciting 

public comments on specific aspects of 

the proposed information collection as 

described below. This is a proposed 

renewal of the ICR, which is currently 

approved through May 31, 2024. An 

Agency may not conduct or sponsor, 

and a person is not required to respond 

to, a collection of information unless it 

displays a currently valid OMB control 

number. 

DATES: Comments must be submitted on 

or before April 8, 2024. 

ADDRESSES: Submit your comments, 

referencing Docket ID No. EPA–HQ– 

OAR–2011–0724, online using 

www.regulations.gov (our preferred 

method), by email to a-and-r-docket@

epa.gov, or by mail to: EPA Docket 

Center, Environmental Protection 

Agency, Mail Code 28221T, 1200 

Pennsylvania Ave. NW, Washington, DC 

20460. 

EPA’s policy is that all comments 

received will be included in the public 


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