[Federal Register Volume 79, Number 13 (Tuesday, January 21, 2014)]
[Rules and Regulations]
[Pages 3301-3302]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-01071]



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Rules and Regulations
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Federal Register / Vol. 79, No. 13 / Tuesday, January 21, 2014 / 
Rules and Regulations

[[Page 3301]]



DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 205

[Document Number AMS-NOP-11-0073; NOP-11-14]


National Organic Program: Notice of Final Guidance on 
Certification Requirements for Handling Unpackaged Organic Products

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Notice of availability of final guidance.

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SUMMARY: The National Organic Program (NOP) is announcing the 
availability of a final guidance document intended for use by 
accredited certifying agents, certified operations and non-certified 
handlers of certified organic products. The guidance document is 
entitled: Certification Requirements for Handling Unpackaged Organic 
Products (NOP 5031). This guidance document is intended to inform the 
public of NOP's current thinking on this topic.

DATES: The final guidance document announced by this notice is 
effective on January 22, 2014.

FOR FURTHER INFORMATION CONTACT: Melissa Bailey, Ph.D., Director, 
Standards Division, National Organic Program, USDA-AMS-NOP, 1400 
Independence Ave. SW., Room 2646-So., Ag Stop 0268, Washington, DC 
20250, Email: Melissa.bailey@ams.usda.gov; Telephone: (202) 720-3252; 
Fax: (202) 205-7808.

SUPPLEMENTARY INFORMATION:

I. Background

    On February 3, 2012, the National Organic Program (NOP) published 
in the Federal Register a notice of availability with request for 
public comment on a draft guidance document addressing the 
certification requirements for handlers of unpackaged products (76 FR 
5415). The NOP selected the topic for the draft guidance in response to 
a recommendation issued by the National Organic Standards Board (NOSB) 
in October 2010. On October 28, 2010, the NOSB finalized a 
recommendation requesting that the NOP clarify the requirements and 
limitations of 7 CFR section 205.101(b) of the USDA organic 
regulations.\1\ This section of the regulations addresses the 
conditions that a handling operation must meet in order to be excluded 
from the organic certification requirements of 7 CFR Part 205. The NOSB 
recommended that the NOP issue guidance to clarify how these conditions 
apply to handlers of bulk, unpackaged organic products. The draft 
guidance can be viewed on the NOP Web site at http://www.ams.usda.gov/NopDraftGuidance. The 60-day comment period closed on April 3, 2012.
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    \1\ NOSB Recommendation: Clarifying Limitations of Sec.  
205.101(b). Issued on October 28, 2010. Available on the NOP Web 
site at: http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5087789&acct=nosb.
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    NOP received approximately 25 individual comments on the draft 
guidance document. Based upon the comments received, the NOP revised 
and is publishing a final guidance document on Certification 
Requirements for Handling Unpackaged Organic Products (NOP 5031). The 
guidance document includes an appendix (NOP 5031-1) where the NOP 
provides a complete discussion of the comments received and the 
rationale behind any changes made to the guidance documents.
    In addition to responding to the NOSB's October 2010 
recommendation, this final guidance addresses a finding from a February 
2012 Office of Inspector General (OIG) audit and a July 2013 OIG audit 
on organic milk.\2\ The OIG audits stated that the NOP needs to ensure 
that organic milk is not coming into contact with prohibited substances 
while being transported. In OIG's recommendations, it stated that the 
NOP should ensure that transporters are either certified or included in 
the responsible parties' Organic System Plan (OSP).
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    \2\ February 2012 OIG Audit on National Organic Program: Organic 
Milk. Available on the NOP Web site at: http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5100590. July 2013 OIG Audit on 
National Organic Program: Organic Milk. Available from OIG at: 
http://www.usda.gov/oig/webdocs/01601-0002-32.pdf.
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    In response to the OIG, this final guidance clarifies that 
transporters of unpackaged bulk products such as organic milk are not 
considered handlers under the USDA organic regulations and, therefore, 
do not need to obtain certification. The guidance states that it is the 
certified organic operation responsible for the organic products that 
are transported who must prevent commingling and contamination of the 
organic products during transportation, fully describe the 
transportation practices in their organic system plan, maintain 
sufficient records for the auditing and traceability of transported 
organic products, and ensure that the transportation records for 
organic products are available for inspection. This approach ensures 
that certifying agents have oversight regarding the transport of 
unpackaged organic products through their certified operations and can 
ensure that prohibited substances have not come into contact with these 
products through a complete, verifiable audit trail.
    The final guidance is available from the NOP through ``The Program 
Handbook: Guidance and Instructions for Accredited Certifying Agents 
(ACAs) and Certified Operations''. This Handbook provides those who 
own, manage, or certify organic operations with guidance and 
instructions that can assist them in complying with the USDA organic 
regulations. The current edition of the Program Handbook is available 
online at http://www.ams.usda.gov/nop.

II. Significance of Guidance

    This final guidance document is being issued in accordance with the 
Office of Management and Budget (OMB) Bulletin on Agency Good Guidance 
Practices (GGPs) (January 25, 2007, 72 FR 3432-3440). The purpose of 
GGPs is to ensure that program guidance documents are developed with 
adequate public participation, are readily available to the public, and 
are not applied as binding requirements. This guidance represents the 
NOP's current thinking on the topic. It does not create or confer any 
rights for, or on, any person and does not operate to bind the NOP or 
the public. Guidance documents are intended to provide a uniform

[[Page 3302]]

method for operations to comply with the Organic Foods Production Act 
(OFPA) and the USDA organic regulations that can reduce the burden of 
developing their own methods and simplify audits and inspections. 
Alternative approaches that can demonstrate compliance with the OFPA, 
as amended (7 U.S.C. 6501-6522), and its implementing regulations are 
also acceptable. As with any alternative compliance approach, the NOP 
strongly encourages industry to discuss alternative approaches with the 
NOP before implementing them to avoid unnecessary or wasteful 
expenditures of resources, and to ensure the proposed alternative 
approach complies with the OFPA and its implementing regulations.

Electronic Access

    Persons with access to Internet may obtain the final guidance at 
the NOP's Web site at http://www.ams.usda.gov/nop. Request for hard 
copies of the final guidance document can be obtained by submitting a 
written request to the person listed in the FOR FURTHER INFORMATION 
CONTACT section of this Notice.

    Authority: 7 U.S.C. 6501-6522.

    Dated: January 15, 2014.
Rex A. Barnes,
Associate Administrator, Agricultural Marketing Service.
[FR Doc. 2014-01071 Filed 1-17-14; 8:45 am]
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