[Federal Register Volume 80, Number 87 (Wednesday, May 6, 2015)]
[Rules and Regulations]
[Pages 25897-25901]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-10446]



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  Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Rules 
and Regulations  

[[Page 25897]]



DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 205

[Docket Numbers AMS-NOP-11-0005; AMS-NOP-11-01]


National Organic Program Regulations; Section 610 Review

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Confirmation of regulations.

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SUMMARY: This document summarizes the findings of a USDA Agricultural 
Marketing Service (AMS) review of the National Organic Program (NOP) 
which is implemented under the Organic Food Production Act (OFPA). The 
review criteria are stipulated by the Regulatory Flexibility Act (RFA), 
in section 610. Based upon this review, the AMS has determined that the 
USDA organic regulations meet the objectives of the OFPA and should 
continue. Since becoming effective on the October 21, 2002, there have 
been multiple amendments to the USDA organic regulations. Most of these 
amendments were additions to or deletions from the National List of 
Allowed and Prohibited Substances (National List).

DATES: Effective May 6, 2015.

FOR FURTHER INFORMATION CONTACT: Interested persons may obtain a copy 
of the review. Requests for a copy of the review should be sent to 
Jennifer Tucker, Ph.D., Acting Director, Standards Division, National 
Organic Program, USDA-AMS-NOP, 1400 Independence Ave. SW., Room 2648-
S., Ag Stop 0268, Washington, DC 20250-0268. Telephone: (202) 720-3252, 
Fax. (202) 205-7808 or email: [email protected], or by 
accessing the Web site at http://www.ams.usda.gov/nop.

SUPPLEMENTARY INFORMATION: The National Organic Program (NOP) is 
authorized by the Organic Foods Protection Act (OFPA) of 1990, as 
amended (7 U.S.C. 6501-6522). The USDA Agricultural Marketing Service 
(AMS) administers the NOP. Final regulations implementing the NOP were 
published December 21, 2000 (65 FR 80548), and became effective on 
October 21, 2002. Through these regulations, the AMS oversees national 
standards for the production, handling, and labeling of organically 
produced agricultural products.
    The OFPA authorizes the certification and inspection of crop, wild 
crop, livestock, or handling operations that label, market or represent 
agricultural products as organic. The OFPA also provides authorization 
for the NOP to accredit state and private certifying agents to certify 
organic crop, wild crop, livestock, or handling operations to the USDA 
organic regulations in the United States and internationally. Since 
becoming fully effective in 2002, the USDA organic regulations have 
been frequently amended. Most of these amendments were changes to the 
National List of Allowed and Prohibited Substances (National List) in 7 
CFR 205.601-205.606.
    This National List identifies the synthetic substances that may be 
used and the nonsynthetic (natural) substances that may not be used in 
organic production. The National List also identifies synthetic, 
nonsynthetic nonagricultural, and nonorganic agricultural substances 
that may be used in organic handling. The OFPA and the NOP regulations, 
in Sec.  205.105, specifically prohibit the use of any synthetic 
substance in organic production and handling unless the synthetic 
substance is on the National List. Section 205.105 also requires that 
any nonorganic agricultural and any nonsynthetic nonagricultural 
substance used in organic handling appear on the National List.
    Recommendations to amend the National List are developed by the 
National Organic Standards Board (NOSB), a 15-member advisory board 
composed of four organic farmers; two organic handlers; one retailer; 
three experts in environmental protection and resource conservation; 
three consumer or public interest group members; one expert in 
toxicology, ecology, or biochemistry and; one certifying agent 
representative. The NOSB is organized under the Federal Advisory 
Committee Act (5 U.S.C. App. 2 et seq.) to assist in the development of 
standards for substances to be used or not used in organic production 
and handling, and to advise the Secretary on any other sections of the 
USDA organic regulations. NOSB members are nominated by the organic 
community and selected by the Secretary. The OFPA also requires a 
review of all substances on the National List within 5 years of their 
addition or renewal. If a substance is not reviewed by the NOSB and 
renewed through rulemaking by the USDA within the five year period, its 
allowance or prohibition on the National List is no longer in effect (7 
U.S.C. 6517(e)).
    As of January 2, 2014, there are 27,108 producer and handler 
operations certified to the USDA organic regulations. Some of these 
certified operations are certified as ``grower groups,'' certified as a 
single entity, but consisting of groups of ten to thousands of small 
organic producers. The USDA organic regulations, as authorized by the 
OFPA, are implemented and applied uniformly and are designed to benefit 
all entities, regardless of size.
    On March 24, 2006, the AMS published in the Federal Register (71 FR 
14827), its schedule to review certain regulations, including the NOP, 
under criteria contained in section 610 of the RFA (5 U.S.C. 601-612). 
Because many AMS regulations impact small entities, AMS decided, as a 
matter of policy, to periodically review certain regulations, 
irrespective of whether specific regulations meet the threshold 
requirement for mandatory review established by the RFA.
    A Notice of Regulatory Flexibility Act: Section 610 Review of the 
USDA organic regulations was published in the Federal Register on 
February 25, 2011 (76 FR 10527). This notice indicated AMS would 
implement specific criteria contained in section 610 of the RFA during 
the review of the USDA organic regulations that have a significant 
effect on a substantial number of small entities to determine whether 
any effect can be decreased or minimized. The purpose of the review is 
for AMS to determine whether the USDA organic regulations should be 
continued without change, amended or rescinded, consistent with the 
objectives of OFPA, to minimize impact on small entities. The review

[[Page 25898]]

considered these factors: (1) The continued need for the regulations; 
(2) the nature of complaints or comments received from the public 
concerning the regulations; (3) the complexity of the regulations; (4) 
the extent to which the regulations overlap, duplicate, or conflict 
with other Federal rules, and, to the extent feasible, with State and 
local government rules; and (5) the length of time since the 
regulations have been evaluated or the degree to which technology, 
economic conditions, or other factors have changed in the area affected 
by the regulations. The notice invited the general public and 
interested parties to submit written comments on the impact of the 
regulations on small business.
    In response to this notice, the NOP received written comments from 
five organic producers (two crop, one wild crop, and two livestock), 
three accredited certifying agents, three handlers (an ingredient 
supplier, a retailer, and a beverage association), two consumers, and 
an organic business consultant, for a total of fourteen comments.
    Of the fourteen comments received, eight commenters specifically 
addressed the need for the regulations to continue, and not be 
terminated or rescinded. Five additional commenters proposed amendments 
or made recommendations about issues for the NOP to consider. One 
commenter stated that certification of organic products was unfair 
because of time commitment and expense. This commenter alternatively 
proposed that conventional operations should be certified to assess 
inputs used on these operations. Nine commenters described their 
concerns with the program or described concerns regarding the 
regulations. Eight commenters specifically addressed the complexity of 
the regulations either by indicating that the complexity of the 
regulations can be problematic at times, or that a significant level of 
complexity is needed to ensure organic product integrity. There were 
five comments on whether the regulations overlap, duplicate, or 
conflict with other Federal, State or Local government regulation. Four 
commenters specifically addressed the RFA section 610 review criteria 
regarding impacts on small entities as a result of changes in 
technology, economic conditions, or other factors that may have 
impacted an area affected by the regulations since the regulations 
became effective on October 21, 2002.
    One commenter, a certifying agent, addressed all of the factors 
considered in the RFA section 610 review of the USDA organic 
regulations. Most of the commenters addressed three out of five of the 
review factors. Comments are categorically grouped and discussed below.
    Comments from organic producers supported continuation of the 
regulations, but some did include concerns with the program or included 
proposed amendments for improving it. An organic seed producer 
expressed support for the continuation of the regulations, but 
suggested that NOP has not adequately enforced the requirement for the 
use of organic seed when commercially available as required by 7 CFR 
205.204(a). This commenter also suggested that some certifying agents 
may be routinely allowing the use of non-organic seed, even though high 
quality organic seed is available in commercial quality and quantity. 
The commenter requested increased enforcement of the organic seed 
regulation requirements to ensure organic seed is being utilized by 
organic producers. In response to comments received at public meetings, 
the NOSB provided the NOP with recommendations that outlined concepts 
and procedures for determining commercial availability of organic seeds 
and planting stock. In response, the NOP published final guidance NOP 
5029: Seeds, Annual Seedlings, and Planting Stock in Organic Crop 
Production, in the NOP Program Handbook on February 28, 2013.\1\ This 
guidance describes practices for certified operations to use to obtain 
all organic seeds, annual seedlings, and planting stock in support of 
their organic production. The guidance also describes the 
responsibilities of organic operations and certifying agents for 
sourcing organic seeds and planting stock and emphasizes the 
utilization of organic seed is a requirement of the regulations.
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    \1\ NOP final guidance, instructions, and policy memos can be 
found in the NOP Program Handbook, available on the NOP Web site at: 
http://www.ams.usda.gov/NOPProgramHandbook.
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    A certified organic fruit producer commented on being prevented 
from using an organic label claim on his organic fruit alcohol product 
because of added sulfites. The commenter stated that because of the 
restriction with added sulfites limited for use with only organic 
grapes, a ``made with organic. . .'' claim could not be used on the 
product label. On October 31, 2011, the NOP published Policy Memo 10-2: 
Sulfur Dioxide in wine made with organic fruit, in the Program 
Handbook.\2\ This policy memo stipulates that added sulfites, as sulfur 
dioxide, can only be used in organic wine made from organic grapes as 
specified on the National List in Sec.  205.605(b). The allowance for 
sulfur dioxide on the National List limits the use of sulfur dioxide to 
only wine made with organic grapes and can only be labeled as ``made 
with organic grapes.'' Changing the allowance of sulfur dioxide in 
organic wine can be considered through submission of a National List 
petition to amend the annotation, and subsequent rulemaking to amend 
the regulations. As per 7 CFR 205.607 of the USDA organic regulations, 
any person may submit a petition to change or amend the National List 
according to petition procedures published on January 18, 2007 (72 FR 
2167).\3\
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    \2\ Ibid.
    \3\ Notice of Guidelines on Procedures for Submitting National 
List Petitions, January 18, 2007, available on the NOP Web site: 
http://www.ams.usda.gov/AMSv1.0/ams.fetchTemplateData.do?template=TemplateN&navID=NationalOrganicProgram&leftNav=NationalOrganicProgram&page=NOPFilingaPetition&description=Filing%20a%20Petition.
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    An organic wild crop producer supported continuation of the 
regulations, concluding there is an ongoing need for Federal regulation 
and oversight of the term ``organic'' as it applies to all products 
being produced and handled organically. The commenter also stated 
accredited certifying agents should ensure that organic livestock 
producers are providing organic livestock with organic feed 
ingredients. The commenter specifically mentioned organic wild 
harvested kelp. The commenter claimed ensuring the feeding of organic 
kelp would enhance his organization's opportunity to develop and 
maintain additional certified organic wild crop harvesting sites for 
kelp, and would support the growth of the business. On February 28, 
2013, the NOP published guidance document NOP 5057: The Use of Kelp in 
Organic Livestock Feed.\4\ This guidance establishes that kelp may be 
certified organic as a wild crop under 7 CFR 205.207 and must be 
certified organic if used as an ingredient in livestock feed per Sec.  
205.237. The guidance applies to all NOP certifying agents that certify 
kelp and certified organic operations that feed kelp to organic 
livestock.
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    \4\ NOP 5057: The Use of Kelp in Organic Livestock Feed, 
available in the NOP Program Handbook on the NOP Web site at: http://www.ams.usda.gov/NOPProgramHandbook.
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    A small livestock producer requested the program increase the 
$5,000 exemption limit for organic certification. There is an exemption 
from certification for organic producers and handlers who sell less 
than $5,000 in organic agricultural products per year

[[Page 25899]]

(7 U.S.C. 6505; 7 CFR 205.101(a)). The livestock producer pointed out 
that the OFPA was passed in 1990, and the $5,000 limit has been subject 
to inflation since 1990. This commenter proposed that the small 
operation exemption be raised to $10,000 or $20,000. Since the $5,000 
exemption from certification is a specific OFPA requirement, an 
increase in the exemption amount must be enacted through Congress and 
cannot be amended through the regulatory process.
    A veterinarian, who also is an organic egg producer, supports the 
NOP, stating there is a good system of certifiers and inspectors in 
place. However, this commenter expressed concern with changes in 
poultry health care practices and living condition standards being 
advocated by some organizations. The comments addressed issues on 
poultry access to pasture, animal behavior, bird stocking rate, age of 
bird, and temporary confinement. According to the commenter, changes in 
the organic standards on these issues should be based upon scientific 
merit, and not on human desires and social interactions. During NOSB 
deliberations, the NOSB considered technical information on livestock 
practice standards. In 2009 and 2011, the NOSB forwarded several 
recommendations on establishing more specific animal welfare 
requirements. These recommendations addressed issues on animal handling 
and transport and animal welfare, including stocking rates and 
livestock health care. The NOP is currently evaluating these 
recommendations to determine how to effectively process these 
recommendations through rulemaking.
    Three accredited certifying agents provided comments in support of 
continuation of the regulations. A small accredited certifying agent 
commented on the burden of the expense of the periodic USDA-required 
accreditation audits on small organic certifiers and requested that 
audit fees should be scaled upon the size of the certifier. The two 
larger certifying agents also commented on the paperwork burden on 
operations seeking certification or continuing with certification. One 
certifying agent affirmed the need for regulations as critical to 
assure integrity and maintain consumer confidence in the organic 
industry. However, comments received from clients regarding the 
regulations were mostly concerned with the amount of paperwork required 
for recordkeeping, which some considered to be excessive and 
burdensome. This certifying agent stated there is a need to streamline 
paperwork and recordkeeping requirements for all organic operations. 
Another certifying agent also addressed the burden faced by certified 
operations, specifically organic dairy operations complying with 
pasture practice standards. This commenter stated that the pasture 
practice standards rule (75 FR 7154) was not needed, was excessively 
complex, would cause significant adverse effects for many small farms, 
and would be difficult for certifying agents to effectively implement. 
The NOP is aware of the commenter's concerns and notes that the pasture 
practice standards were developed over a period of five years with 
input of multiple stakeholders. There were a significant number of oral 
and written responses submitted during public comment periods 
associated with the development of this rule. The majority of 
commenters, including many dairy operations, supported the addition of 
detailed pasture practice standards.
    During NOP trainings for accredited certifying agents conducted in 
2012 and 2013, the NOP received statements from certifying agents on 
farmers reporting that they are spending too much of their time 
completing program forms and maintaining program records. As required 
in 7 CFR 205.103, recordkeeping is essential to ensure organic 
operations are implementing required organic practice standards. The 
NOP has considered how to minimize the regulatory burden when 
implementing the regulations. As a result, the NOP began implementing 
an initiative in 2013 to identify and remove barriers to certification, 
to streamline the certification process, to focus enforcement 
activities, and to work with organic producers and handlers to correct 
small issues before they become larger issues. When developing this 
initiative, the NOP outlined five objectives: (1) Develop efficient 
processes by eliminating bureaucratic processes that do not contribute 
to organic integrity; (2) streamline recordkeeping requirements to 
ensure that required records support organic integrity and are not a 
barrier for farms and businesses to maintain organic compliance; (3) 
apply common sense to an operation's organic system plans that clearly 
capture organic practices; (4) implement fair and focused enforcement; 
and (5) maintain or improve organic integrity by focusing on factors 
that impact organic integrity. The NOP continues to work with 
certifying agents to implement these objectives with regard to the 
recordkeeping and reporting requirements for certifying agents and 
organic producers and handlers.
    Three organic handlers commented on the RFA Section 610 review. An 
ingredient processor submitted a comment requesting clarification on 
why non-organic ethanol is not permitted in the U.S. for use in 
processing organic products. The processor stated that their product, 
processed with ethanol, was marketed with an organic label in the 
European Union (EU), where ethanol is allowed for organic processing in 
the EU regulations. In the U.S., ethanol is available in certified 
organic, natural, and synthetic forms. The use of certified organic 
ethanol would be permitted in the production of the processor's product 
under the USDA organic regulations. Non-organic ethanol is allowed for 
use in organic crop and livestock production as a sanitizer. Non-
organic ethanol cannot be used in organic processing under the USDA 
organic regulations since it is not included on the National List in 
either 7 CFR 205.605 or 7 CFR 205.606. Use of non-organic ethanol in 
organic processing requires amendment of the National List through the 
petition process to include non-organic ethanol on the National List, 
and subsequent rulemaking.
    A beverage association comment disagreed with Alcohol, Tobacco Tax, 
and Trade Bureau (TTB) labeling requirements for wine that requires 
approval for changes to a vintage year on an organic wine label that 
was previously approved. This requirement is outside of the scope of 
the USDA organic regulations. The TTB reviews and approves wine labels, 
including any requirements for changing the vintage year. Under a 
Memorandum of Understanding between AMS and TTB, the TTB receives, 
reviews, and approves or rejects labeling applications for alcohol 
products bearing an organic claim. TTB has informed the NOP of their 
change in the TTB list of the allowable revisions that may be made to 
an approved label without the need for resubmission contained on the 
TTB Application for and certification of label/bottle approval. TTB 
removed the caveat that the change in vintage dates did not apply to 
organic products.
    A comment from an organic co-operative retailer supported the 
continued need for the regulations. The commenter gave a description of 
the positive impacts of the complexity of the regulation on their 
business, and emphasized that the regulations do not overlap, 
duplicate, or conflict with other Federal, state or local rules for the 
operation.

[[Page 25900]]

    A comment from a consumer claimed that certification requirements 
for organic operations are unfair because nonorganic operations are not 
required to disclose to the public the uses of harmful substances. All 
food products in the normal stream of commerce are subject to Federal, 
state, and local laws and regulatory requirements that contribute to 
maintaining food safety and restrict or prohibit the use of harmful 
substances.
    Another consumer comment expressed support for continuation of the 
regulations. This commenter chooses organic products to assure that the 
food is raised humanely and without synthetic ingredients. However, the 
commenter also expressed concern that the regulations may be more 
burdensome to small dairy operations. As noted in prior discussion, the 
NOP started an initiative on 2013 to reduce the regulatory burden on 
organic operations.
    An organic agricultural business expressed strong support for 
continuation of the regulations. This commenter stated that the 
regulations need to be routinely amended since organic production is 
based upon a concept of continual improvement, and the regulation 
should adhere to this principle. Such amendments should take into 
account innovations and improvements by organic practitioners. The 
commenter proposed several amendments to the regulations, some of these 
proposed amendments were identified as opportunities to decrease 
regulatory complexity and reduce regulatory burden without sacrificing 
organic integrity or compromise consumer confidence. A summary of these 
proposed amendments include:
     The NOP should prohibit blending of organic and non-
organic forms of the same ingredient in ``made with organic'' products. 
On May 2, 2014, the NOP published final guidance NOP 5032: Products in 
the ``made with Organic * * * Labeling Category to address this 
issue.\5\ This guidance describes requirements for products in the 
``made with organic (specified ingredients or food group(s))'' 
category. This guidance clarifies product composition, labeling claims, 
use of organic and nonorganic forms of the same ingredient, percentage 
of organic ingredient statements, and ingredients or food groups in the 
``made with organic * * *'' claim.
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    \5\ NOP 5032: Products in the ``made with Organic * * * Labeling 
Category, available in the NOP Program Handbook on the NOP Web site 
at: http://www.ams.usda.gov/NOPProgramHandbook.
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     The regulations should allow the use of non-synthetic 
substances allowed for use in crop production to control pest 
infestation in post-harvest handling pest control when preventive 
practices are ineffective. On April 25, 2014, the NOP published draft 
guidance, NOP 5023: Substances Used in Post-Harvest Handling of Organic 
Products.\6\ This draft guidance describes substances that may be used 
in post-harvest handling of organic products. The guidance clarifies: 
(1) What substances may be used; (2) the difference between post-
harvest handling of raw agricultural crops and further processing; and 
(3) the provisions for facility pest management.
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    \6\ Draft Guidance NOP 5023: Substances Used in Post-Harvest 
Handling of Organic Products. NOP draft guidance can be found on the 
NOP Web site at: http://www.ams.usda.gov/NOPDraftGuidance.
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     The NOP should amend 7 CFR 205.237(a) to allow commercial 
availability to be applied to minor agricultural ingredients fed to 
organic livestock to alleviate burden on small organic livestock 
producers. On February 28, 2013, the NOP published NOP 5030, Evaluating 
Allowed Ingredients and Sources of Vitamins and Minerals For Organic 
Livestock Feed.\7\ This guidance clarifies the agricultural, 
nonsynthetic, and synthetic ingredients permitted in organic livestock 
feed and also addresses the feed supplements and feed additives that 
must be reviewed for compliance with regulations. Under the USDA 
organic regulations, organic producers must provide livestock feed 
pursuant to 7 CFR 205.237. Section 205.237 states that agricultural 
ingredients included in the ingredients list for livestock feed 
products must be organically produced.
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    \7\ NOP 5030: Evaluating Allowed Ingredients and Sources of 
Vitamins and Minerals For Organic Livestock Feed, available in the 
NOP Program Handbook on the NOP Web site at: http://www.ams.usda.gov/NOPProgramHandbook.
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     The NOP should amend the National List petition procedures 
and processes as they are complicated, costly, lengthy, arbitrary, and 
may not provide due process to the petitioners. In May 2014, the NOP in 
collaboration with the NOSB initiated a process to revise National List 
petition procedures in an effort to make the petition submission 
procedures clearer for petitioners. The revised procedures will clarify 
how to submit complete petitions, explain to petitioners what to expect 
in the petition process, and make the review process for the NOSB 
clearer and more consistent.
     The NOP should increase collaboration between NOP and 
other government agencies with authority related to organic 
agricultural production. Historically, NOP has established and 
maintained collaborative interactions with the U.S. Food and Drug 
Administration (FDA) on organic food processing and handling and 
livestock healthcare products and feed ingredients; with the U.S. 
Environmental Protection Agency (EPA) on pest control ingredients and 
applications; with TTB on labeling of organic alcohol beverages; and 
with the Federal Trade Commission on product labeling. As part of these 
interactions, NOP continues to collaborate regarding agricultural 
products that fall within the scope of organic certification.
     The NOP should alter restrictions on the use of plastic 
mulch (Sec.  205.601(b)(2)(ii)) so that biodegradable plastic mulch 
could remain on the soil beyond harvest or end of the growing season. 
The commenter indicated there is no listing for mulch made from 
biodegradable plastic on the National List, and a petition would have 
to be submitted to add this new material. In August 2013, the NOP 
published proposed rule (78 FR 52100), based upon NOSB recommendations, 
which would add a new definition for biodegradable biobased mulch film 
to 7 CFR 205.2 and add biodegradable biobased mulch film to the 
National List in 7 CFR 205.601 for use in organic crop production.\8\
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    \8\ National Organic Program; Proposed Amendments to the 
National List of Allowed and Prohibited Substances (Crops and 
Processing); Proposed rule; Available on the NOP Web site: http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5104847

Upon the completion of the RFA Section 610 review of the USDA organic 
regulations, AMS has determined that there is no critical need to amend 
the regulations. Since becoming effective on the October 21, 2002, 
there have been multiple amendments of the regulations, mostly to the 
National List. Some of these amendments have reduced the burden on 
small operations, while some amendments, that have served to protect 
organic integrity and support consumer confidence, may have increased 
the burden on small operations. Based on the findings from the review, 
AMS has determined that the NOP is not overly complex and does not 
significantly overlap, or conflict with other regulations.
    Based upon the review, AMS has determined that the NOP should 
continue. The USDA organic regulations are dynamic in nature and the 
NOP continues to collaborate with the NOSB and the organic community on 
rulemaking and development of guidance documents, such as recently 
published rulemaking on pesticide residue testing, and published 
guidance on composting, wild crop harvesting,

[[Page 25901]]

handling unpackaged organic goods, and the list of permitted substances 
for crops.

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

    Dated: April 30, 2015.
Rex A. Barnes,
Associate Administrator, Agricultural Marketing Service.
[FR Doc. 2015-10446 Filed 5-5-15; 8:45 am]
 BILLING CODE 3410-02-P