G/SPS/N/USA/703/Add.4  
 
8 April 2014  
(14-2212)  Page: 1/2  
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  NOTIFICATION 
Addendum 
The following communication, received on 8 April 2014, is being circulated at the request of the 
Delegation of the United States of America. 
 
_______________ 
 
 Establishment, Maintenance, and Availability of  Records: Amendment to Record Availability 
Requirements 
The Food and Drug Administration (FDA) is issuing a final regulation that adopts, without change, 
the interim final rule (IFR) entitled "Establishment, Maintenance, and Availability of Records: Amendment to Record Availability Requirements". This final rule affirms the IFR's change to FDA's 
records access as required by the FDA Food Safety  Modernization Act (FSMA). Prior to the passage 
of FSMA, the Federal Food, Drug, and Cosmetic Ac t (the FD&C Act) provided the Secretary (by 
delegation FDA) with access to records relating to food that FDA reasonably believes to be 
adulterated and presents a threat of serious adverse health consequences or death to humans or 
animals. The FSMA amendment expands FDA's fo rmer records access authority beyond records 
relating to the specific suspect article of food to include records relating to any other article of food 
that FDA reasonably believes is likely to be affected in a similar manner. In addition, the FSMA 
amendment permits FDA to access records relating to articles of food for which FDA believes that 
there is a reasonable probability that the use of or exposure to the article of food, and any other 
article of food that FDA reasonably believes is like ly to be affected in a similar manner, will cause 
serious adverse health consequences or death to humans or animals. This final rule does not make 
any changes to the regulatory requirements esta blished by the IFR. The final regulation also 
responds to comments submitted in response to the request for comments in the IFR. 
http://members.wto.org/crnattachments/2014/sps/USA/14_1875_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:   
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) : This final rule is effective 4 April 2014. G/SPS/N/USA/703/Add.4 
 
- 2 - 
 
  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: William A. Correll, Jr., Office of Compliance, Center for Food 
Safety and Applied Nutrition (HFS-607), Food an d Drug Administration, 5100 Paint Branch Pkwy., 
College Park, MD 20740, 240 402 1611. 
Text 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 available from the US Federal Register, Vol. 79, No. 65, Page 18799 or at 
http://www.gpo.gov/fdsys/pkg/FR- 2014-04-04/pdf/ 2014-07550.pdf . 
 
__________