G/SPS/N/USA/2503/Add.6  
 
16 November 2015  
(15-6048)  Page: 1/2  
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  NOTIFICATION 
Addendum 
The following communication, received on 16 November 2015, is being circulated at the request of 
the Delegation of the United States of America. 
 
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 Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; 
Final Rule 
To minimize the risk of serious adverse health consequences or death from consumption of contaminated produce, the Food and Drug Administration (FDA) is establishing science-based minimum standards for the safe growing, harvesti ng, packing, and holding of produce, meaning 
fruits and vegetables grown for human consumption. FDA is establishing these standards as part of 
our implementation of the FDA Food Safety and Modernization Act. These standards do not apply 
to produce that is rarely consumed raw, produce for personal or on-farm consumption, or produce 
that is not a raw agricultural commodity. In addition, produce that receives commercial processing 
that adequately reduces the presence of microorganisms of public health significance is eligible for exemption from the requirements of this rule. The rule sets forth procedures, processes, and practices that minimize the risk of serious adverse health consequences or death, including those 
reasonably necessary to prevent the introduction of known or reasonably foreseeable biological 
hazards into or onto produce and to provide reasonable assurances that the produce is not adulterated on account of such hazards. FDA expects the rule to reduce foodborne illness 
associated with the consumption of contaminated produce. 
The text of the final rule can be found on the US Federal Register website at: 
https://federalregister.gov/a/2015-28159 . 
To accompany this final rule, FDA has also made available for public review the Final 
Environmental Impact Statement (EIS) and Record of Decision (ROD) for the standards for the growing, harvesting, packing, and holding of pr oduce for human consumption. FDA prepared the 
Final EIS after taking into account public comment received on the corresponding Draft EIS and is 
publishing the ROD at the time of our decision. The Final EIS and ROD documents are available in 
Docket No. FDA-2014-N-2244. More information on these documents can be found on the US Federal Register website at: https://federalregister.gov/a/2015-28161 . 
http://members.wto.org/crnattachments/2015/SPS/USA/15_4582_00_e.pdf  
This addendum concerns a: 
[ ] Modification of final date for comments 
[X] Notification of adoption, publication or entry into force of regulation 
[ ] Modification of content and/or scope of  previously notified draft regulation 
[ ] Withdrawal of proposed regulation 
[ ] Change in proposed date of adoption, publication or date of entry into force 
[ ] Other:   G/SPS/N/USA/2503/Add.6 
 
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  Comment period: (If the addendum extends the scope of the previously notified 
measure in terms of products and/or potent ially affected Members, a new deadline for 
receipt of comments should be provided, norm ally of at least 60 calendar days. Under 
other circumstances, such as extension of or iginally 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) : Not applicable. This is a final rule. 
Agency or authority designated to handle co mments: [ ] National Notification Authority, 
[ ] National Enquiry Point. Address, fax nu mber and e-mail address (if available) of 
other body: 
For further information contact: Samir Assar, Center for Food Safety and Applied Nutrition 
(HFS-317), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 
240 402 1636 
Text(s) available from: [X] National Notificati on Authority, [ ] National Enquiry Point. 
Address, fax number and e-mail addre ss (if available) of other body: 
United States SPS National Notification Authority, USDA Foreign Agricultural Service, International 
Regulations and Standards Division (IRSD), Stop 1014, Washington D.C. 20250; Tel: +(1 202) 
720 1301; Fax: +(1 202) 720 0433; E-mail: us.spsenquirypoint@fas.usda.gov 
Text can also be found on the US Federal Register website at: https://federalregister.gov/a/2015-
28159 .  
 
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