G/SPS/N/USA/2156/Add.10  
 
9 December  2021 
(21-9225) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  
NOTIFICATION  
Addendum  
The following communication, received on 9 December 2021, is being circulated at the request of 
the Delegation of  the United States of America . 
 
_______________  
 
 
Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption 
Relating to Agricultural Water; Notice of Proposed Rulemaking  
The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend the agricultural 
water provisions of the produce safety regulation that covered farms have found complex and 
challenging to implement. This proposal would replace the microbial  criteria and testing requirements 
for pre -harvest agricultural water for covered produce (other than sprouts) with provisions for 
systems -based agricultural water assessments that are designed to be more feasible to implement 
across the wide variety of ag ricultural water systems, uses, and practices, while also being adaptable 
to future advancements in agricultural water quality science and achieving improved public health 
protections. Additionally, we are proposing to require expedited mitigation for haza rds related to 
certain activities associated with adjacent and nearby lands, in light of findings from several recent 
produce outbreak investigations. These proposed revisions to the produce safety regulation, if 
finalized, would more comprehensively addre ss a known route of microbial contamination that can 
lead to preventable foodborne illness that is a significant public health problem.  
https://members.wto.org /crnattachments/2021/SPS/USA/21_7665_00_e.pdf  
This addendum concerns a:  
[ ] Modification of final date for comments  
[ ] Notification of adoption, publication or entry into force of regulation  
[X] Modification of content and/or scope of previously notif ied draft regulation  
[ ] Withdrawal of proposed regulation  
[ ] Change in proposed date of adoption, publication or date of entry into force  
[ ] Other:  
Comment period: (If the addendum extends the scope of the previously notified measure 
in terms of products and/or potentially affected Members, a new deadline for receipt of 
comments should be provided, normally of at least 60 calendar days. Under other 
circumstances, such as extension of originally announced final date for comments, the 
comment period  provided in the addendum may vary.)  
[ ] Sixty days from the date of circulation of the addendum to the notification and/or 
(dd/mm/yy) : 5 April 2022 . You may submit comments as follows. Please note that 
late, untimely filed comments will not be considered . Electronic comments must be 
submitted on or before 5 April 2022. The https://www.regulations.gov  electronic filing 
system will accept comments until 11:59 p.m. Eastern Time on 5 April 2022. 
Comments received by  mail/hand delivery/courier (for written/paper submissions) G/SPS/N/USA/2156/Add.10  
 
- 2 - 
 
  will be considered timely if they are postmarked or the delivery service acceptance 
receipt is on or before that date.  
Agency or authority designated to handle comments: [  ] National Notification  Authority, 
[ ] National Enquiry Point. Address, fax number and e -mail address (if available) of other 
body:  
Submit electronic comments in the following way:  
− Federal eRulemaking Portal: https://www.regulations. gov. Follow the instructions for submitting 
comments. Comments submitted electronically, including attachments, to 
https://www.regulations.gov  will be posted to the docket unchanged. Because your comment will 
be made public, you are solely responsible for ensuring that your comment does not include any 
confidential information that you or a third party may not wish to be posted, such as medical 
information, your or anyone else's Social Security number, or confiden tial business information, 
such as a manufacturing process. Please note that if you include your name, contact information, 
or other information that identifies you in the body of your comments, that information will be 
posted on https://www.regulations.gov . 
− If you want to submit a comment with confidential information that you do not wish to be made 
available to the public, submit the comment as a written/paper submission and in the manner 
detailed (see "Written/Paper Submissions" and "Instructions") . 
Text(s) available from: [  ] National Notification Authority, [  ] National Enquiry Point. 
Address, fax number and e -mail address (if available) of other body:  
Text can also be found in the Federal Register,  Vol. 86, No. 231, page  69120 or on the Internet at: 
https://www.govinfo.gov/content/pkg/FR -2021-12-06/pdf/2021 -26127.pdf . 
 
__________