Federal Register, Volume 79 Issue 189 (Tuesday, September 30, 2014)

[Federal Register Volume 79, Number 189 (Tuesday, September 30, 2014)]
[Rules and Regulations]
[Pages 58655-58663]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-23135]

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Rules and Regulations
Federal Register
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Federal Register / Vol. 79, No. 189 / Tuesday, September 30, 2014 /
Rules and Regulations

[[Page 58655]]

DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 205

[Document Number AMS-NOP-13-0011; NOP-13-01FR]
RIN 0581-AD32

National Organic Program (NOP); Amendments to the National List
of Allowed and Prohibited Substances (Crops and Processing)

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Final rule.

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SUMMARY: This final rule amends the U.S. Department of Agriculture's
(USDA's) National List of Allowed and Prohibited Substances (National
List) to reflect a recommendation submitted to the Secretary of
Agriculture (Secretary) by the National Organic Standards Board (NOSB)
on October 18, 2012, and removes two previously expired substances.
Consistent with the recommendation from the NOSB, this final rule adds
biodegradable biobased mulch film to the National List with restrictive
annotations. This action also adds a new definition for biodegradable
biobased mulch film. This rule also removes two listings for nonorganic
agricultural substances from the National List, hops (Humulus lupulus)
and unmodified rice starch, as their use exemptions expired on January
1, 2013, and June 21, 2009, respectively. Two other substances that
were recommended by the NOSB to the Secretary for addition to the
National List, Citrus hystrix, leaves and fruit, and curry leaves
(Murraya koenigii), have not been added to the National List based on
comments received on the proposed rule.

DATES: Effective Date: This rule is effective October 30, 2014. The
incorporation by reference of certain publications listed in this rule
is approved by the Director of the Federal Register as of October 30,
2014.

FOR FURTHER INFORMATION CONTACT: Melissa Bailey, Ph.D., Director,
Standards Division, National Organic Program, Telephone: (202) 720-
3252; Fax: (202) 205-7808.

SUPPLEMENTARY INFORMATION:

I. Background

On December 21, 2000, the Secretary established within the National
Organic Program (NOP) (7 CFR part 205) the National List regulations
sections 205.600 through 205.607. The 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 nonagricultural synthetic, nonagricultural
nonsynthetic, and nonorganic agricultural substances that may be used
in organic handling. The Organic Foods Production Act of 1990 (OFPA),
as amended (7 U.S.C. 6501-6522), and USDA organic regulations, in
section 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 must also be on the National List.
Under the authority of OFPA, the National List can be amended by
the Secretary based on proposed amendments developed by the NOSB. Since
established, the Agricultural Marketing Service (AMS) has published
multiple amendments to the National List beginning on October 31, 2003
(68 FR 61987). AMS published the most recent amendment to the National
List on October 3, 2013 (78 FR 61154).
This final rule amends the National List to enact one
recommendation submitted to the Secretary by the NOSB on October 18,
2012. This rule also removes two previously expired substances from the
National List. Two other recommendations that were submitted by the
NOSB to the Secretary on May 25, 2012, have not been finalized based on
comments received on AMS' August 22, 2013 proposed rule (78 FR 52100).

II. Overview of Amendments

The following provides an overview of the amendments made to
designated sections of the National List regulations:

Section 205.2 Terms defined.
Section 205.3 Incorporation by reference.
Section 205.601 Synthetic substances allowed for use in organic crop
production.

This final rule amends sections 205.2 and 205.601 of the National
List by adding a new definition and new substance to the National List
for organic crop production. In addition, section 205.3 has been added
to comply with incorporation by reference requirements.

Biodegradable Biobased Mulch Film

This rule adds a new definition for biodegradable biobased mulch
film that includes criteria and third-party standards for
compostability, biodegradability, and biobased content. These third-
party standards are incorporated by reference at new section 205.3. For
the final rule, we have added new section 205.3 to specify the current
versions of the cited third-party standards and include information on
the availability of these standards to meet requirements for
incorporation by reference.\1\ Additional text regarding the
availability of these standards has also been added to new section
205.3.
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\1\ Federal Register Document Drafting Handbook, Chapter 6: What
is Incorporation by Reference, and How do I do it? April 2014
Revision. http://www.archives.gov/federal-register/write/handbook/chapter-6.pdf.
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This rule also adds the substance ``biodegradable biobased mulch
film,'' with restrictions, to new subparagraph (b)(2)(iii) of section
205.601. The new listing reads as follows: ``Biodegradable biobased
mulch films as defined in Sec. 205.2. Must be produced without
organisms or feedstock derived from excluded methods.''

Section 205.606 Nonorganically produced agricultural products allowed
as ingredients in or on processed products labeled as ``organic.''

This final rule amends section 205.606 of the National List
regulations by removing paragraphs (l) and (w)(2) to remove two
previously expired substances, hops (Humulus lupulus) and unmodified
rice starch, whose use

[[Page 58656]]

expired on January 1, 2013, and June 21, 2009, respectively. Further,
this final rule redesignates paragraph (w)(3) as (w)(2) and paragraphs
(m) through (aa) as (l) through (z).

III. Related Documents

Two notices were published regarding meetings of the NOSB and its
deliberations on recommendations and substances petitioned for amending
the National List. Substances and NOSB recommendations addressed in
this final rule were announced for NOSB deliberation in the following
Federal Register notices: (1) 77 FR 21067, April 9, 2012 (curry leaves
and C. hystrix); and (2) 77 FR 52679, August 30, 2012 (biodegradable
biobased mulch film).
The expiration date of January 1, 2013, for the listing for hops
was added to the National List on June 27, 2012, by a final rule (77 FR
33290) published in the Federal Register notice on June 6, 2012.
The listing and expiration date of June 21, 2009 for unmodified
rice starch was added to the National List on June 21, 2007, by an
interim final rule (72 FR 35137) published in the Federal Register on
June 27, 2007.
The proposal to allow the use of three new substances, along with
the deletion of two expired substances, was published as a proposed
rule on August 22, 2013 (78 FR 52100).
Additional information on substances, including petitions,
technical reports, and NOSB recommendations, are available on the NOP
Web site at http://www.ams.usda.gov/NOPNationalList.

IV. Statutory and Regulatory Authority

OFPA authorizes the Secretary to make amendments to the National
List based on proposed amendments developed by the NOSB. Sections
6518(k)(2) and 6518(n) of OFPA authorize the NOSB to develop proposed
amendments to the National List for submission to the Secretary and
establish a petition process by which persons may petition the NOSB for
the purpose of having substances evaluated for inclusion on or deletion
from the National List. The National List petition process is
implemented under section 205.607 of the USDA organic regulations. The
current petition process (72 FR 2167, January 18, 2007) can be accessed
through the NOP Web site at http://www.ams.usda.gov/nop.

A. Executive Order 12866

This action has been determined not significant for purposes of
Executive Order 12866, and, therefore, has not been reviewed by the
Office of Management and Budget (OMB).

B. Executive Order 12988

Executive Order 12988 instructs each executive agency to adhere to
certain requirements in the development of new and revised regulations
in order to avoid unduly burdening the court system. This final rule is
not intended to have a retroactive effect.
States and local jurisdictions are preempted under OFPA from
creating programs of accreditation for private persons or State
officials who want to become certifying agents of organic farms or
handling operations. A governing State official would have to apply to
USDA to be accredited as a certifying agent, as described in section
6514(b) of OFPA. States are also preempted under sections 6503 through
6507 of OFPA from creating certification programs to certify organic
farms or handling operations unless the State programs have been
submitted to, and approved by, the Secretary as meeting the
requirements of OFPA.
Pursuant to section 6507(b)(2) of OFPA, a State organic
certification program may contain additional requirements for the
production and handling of organically produced agricultural products
that are produced in the State and for the certification of organic
farm and handling operations located within the State under certain
circumstances. Such additional requirements must: (a) Further the
purposes of OFPA, (b) not be inconsistent with OFPA, (c) not be
discriminatory toward agricultural commodities organically produced in
other States, and (d) not be effective until approved by the Secretary.
Pursuant to section 6519(f) of OFPA, this final rule would not
alter the authority of the Secretary under the Federal Meat Inspection
Act (21 U.S.C. 601-624), the Poultry Products Inspection Act (21 U.S.C.
451-471), or the Egg Products Inspection Act (21 U.S.C. 1031-1056),
concerning meat, poultry, and egg products, nor any of the authorities
of the Secretary of Health and Human Services under the Federal Food,
Drug and Cosmetic Act (21 U.S.C. 301-399), nor the authority of the
Administrator of the Environmental Protection Agency under the Federal
Insecticide, Fungicide and Rodenticide Act (7 U.S.C. 136-136(y)).
Section 6520 of OFPA provides for the Secretary to establish an
expedited administrative appeals procedure under which persons may
appeal an action of the Secretary, the applicable governing State
official, or a certifying agent under this title that adversely affects
such person or is inconsistent with the organic certification program
established under this title. OFPA also provides that the U.S. District
Court for the district in which a person is located has jurisdiction to
review the Secretary's decision.

C. Regulatory Flexibility Act

The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) requires
agencies to consider the economic impact of each rule on small entities
and evaluate alternatives that would accomplish the objectives of the
rule without unduly burdening small entities or erecting barriers that
would restrict their ability to compete in the market. The purpose is
to fit regulatory actions to the scale of businesses subject to the
action. Section 605 of the RFA allows an agency to certify a rule, in
lieu of preparing an analysis, if the rulemaking is not expected to
have a significant economic impact on a substantial number of small
entities.
The Small Business Administration (SBA) defines small agricultural
producers and handlers as those having annual receipts of less than
$750,000 (13 CFR 121.201). SBA defines small agricultural service
firms, which would include accredited certifying agents, as those
having annual receipts of less than $7,000,000 (13 CFR 121.201).
The NOP reported that there were 18,513 certified organic farms and
processing facilities in the United States at the end of 2013.\2\
According to the 2011 Certified Organic Production Survey, nearly 90%
of certified organic farms reported annual organic product sales of
less than $500,000.\3\ AMS believes that most of these entities would
be considered to be small entities under the criteria established by
the SBA.
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\2\ Information about the 2013 List of Certified Operations is
available on the NOP Web site at: http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5097484&acct=nopgeninfo.
\3\ U.S. Department of Agriculture, National Agricultural
Statistics Service. 2011 Certified Organic Production Survey.
October 2012. Available at: http://bit.ly/2011OrganicSurvey.
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In addition, the USDA has 82 accredited certifying agents that
provide certification services to producers and handlers; 49 of these
are based in the United States. A complete list of names and addresses
of accredited certifying agents may be found on the AMS NOP Web site,
at http://www.ams.usda.gov/nop. AMS believes that most of these
accredited certifying agents would be considered small entities under
the criteria established by the SBA.
In accordance with RFA, AMS has considered the impact of this
action on

[[Page 58657]]

small entities. The effect of this final rule would be to allow the use
of one additional substance, biodegradable biobased mulch film, in
organic crop production and to remove two previously expired
substances. The new allowance for biodegradable biobased mulch film
will provide small entities with more tools to use in day-to-day
farming operations. AMS concludes that the economic impact of this
addition, if any, will be minimal and beneficial to small agricultural
producers. Accordingly, AMS certifies that this rule would not have a
significant impact on a substantial number of small entities.

D. Paperwork Reduction Act

No additional collection or recordkeeping requirements are imposed
on the public by this final rule. Accordingly, OMB clearance is not
required by the Paperwork Reduction Act of 1995, 44 U.S.C. 3501,
Chapter 35.

E. Executive Order 13175

This final rule has been reviewed in accordance with the
requirements of Executive Order 13175, Consultation and Coordination
with Indian Tribal Governments. The review reveals that this regulation
will not have substantial and direct effects on Tribal governments and
will not have significant Tribal implications.

F. Comments Received on Proposed Rule AMS-NOP-13-0011; NOP-13-01PR

AMS received 120 comments on the proposed rule. Comments were
received from organic producers and handlers, nonprofit organizations,
industry groups, trade associations, input suppliers, accredited
certifying agents, and private citizens.
Most comments addressed the proposed allowance of biodegradable
biobased mulch film and supported its use in organic crop production.
Thirteen comments addressed the proposed allowance of two new
nonorganic ingredients and did not support their addition to the
National List. Comments received for each substance are described in
more detail below.
Several comments opposed the allowance of any nonorganic material
in organic crop production and handling, but did not provide specific
comments on the proposed amendments.
Comments on the proposed removal of expired listings for hops and
unmodified rice starch were supportive of this action. Therefore, AMS
is finalizing the amendments that remove these two previously expired
substances from section 205.606 of the National List.

Biodegradable Biobased Mulch Film

Over one hundred comments addressed the proposed definition and
allowance for biodegradable biobased mulch film. The majority of
comments received were supportive of the proposed action.
One comment claimed that the proposed listing would allow materials
to be used in ways that were not intended by the NOSB recommendation.
We disagree. The definition and listing ensure that mulch film is
biobased and meets additional standards for biodegradability and
compostability consistent with the NOSB recommendation. Additional
information on these issues is discussed in more detail below.
Two comments requested that other materials, herbicidal soaps for
food crops and synthetic fabric weed barrier cloth (non-plastic), be
allowed for weed control in organic crop production. AMS did not
propose any action with respect to these materials in the proposed rule
and, therefore, is not addressing these materials in this final rule.
Parties interested in the allowance of these materials in organic crop
production may submit a petition to the NOSB. This process can be
initiated in accordance with the Notice of Guidelines on Procedures for
Submitting National List Petitions (72 FR 2167).
Many commenters supported mulch film as a more environmentally
sustainable alternative to traditional plastic mulch. Commenters
indicated that mulch film would reduce landfill waste, reduce air
pollution from burning of traditional plastic mulch, and be more
sustainable and ecological since it uses renewable biobased resources.
Some commenters also cited farms that have voluntarily surrendered
their organic certification in order to use mulch film instead of
traditional plastic film since they felt the mulch film is better for
the environment.
AMS received a number of comments from certified organic producers
who supported the use of biobased mulch film. Organic producers cited
many environmental and economic benefits from the use of mulch film
including reduced plastic landfill waste, reduced labor costs, and
reduced removal and disposal costs. Several producers noted that labor
costs associated with hand weeding are a major expense for their
operation and that that the use of mulch film would reduce these costs.
Producers also noted that mulch films may allow for more effective
weed control and improved cultivation of living mulches and cover
crops. Comments specifically noted that mulch film would be beneficial
to organic farmers without compromising the integrity of organic
farming. One producer provided limited information about a successful
on-farm trial using mulch film. Another producer noted that they used
mulch film prior to becoming certified organic and expressed support
for the use of the substance. One grower who supported the allowance of
mulch film indicated that organic straw mulch, an alternative natural
material, is increasingly hard to find.
One producer who supported the use of mulch film stated that
biodegradable mulch films should be required instead of plastic mulch,
and that biodegradable mulch films should be required to be tilled into
the soil. We have not adopted the commenter's suggestion for required
tilling, as discussed further below. Another commenter also indicated
that traditional plastic mulch should be prohibited in organic
agriculture. Removing the allowance for traditional plastic mulch on
the National List is outside of the scope of this rulemaking action
and, therefore, no further action was taken on this comment. Parties
interested in a prohibition for traditional plastic mulch may submit a
petition to the NOSB. This process can be initiated in accordance with
the Notice of Guidelines on Procedures for Submitting National List
Petitions (72 FR 2167).
Two comments supporting the use of mulch film indicated that
foreign operations certified to other organic standards can currently
use mulch films and export their certified organic products into the
United States; which puts domestic growers as at competitive
disadvantage. This rulemaking action to allow the use of mulch film
would address this concern.
Many comments indicated their support of the proposed listing at
section 205.601 that prohibits mulch films made from or with excluded
methods (i.e., genetically modified organisms or GMOs) because GMOs are
not allowed for use in organic production. Several comments supported
the use of mulch only if it does not contain any genetically modified
material. Another comment stated that the proposed rule was unclear
about biodegradable film that may contain genetically modified
organisms and requested that the final rule require the mulch to be GMO
free. One comment requested additional clarification on how far back in
the production process that the use of excluded methods must be
verified. One comment supported the prohibition on

[[Page 58658]]

excluded methods but did not feel that it was necessary to specify the
exclusion at section 205.601 since excluded methods are generally
prohibited in organic production and handling. The comment indicated
that targeting a single material with this restriction may lead to
inconsistent certification decisions.
AMS has considered these comments and has retained the text that
was proposed at section 205.601 that requires that mulch film must be
produced without organisms or feedstock derived from excluded methods.
There may be questions about whether the use of mulch film derived from
genetically modified organisms should be interpreted as the use of an
excluded method as prohibited under section 205.105(e), particularly if
the manufacturing process eliminates any genetically engineered traits
that are only detectible in the raw agricultural feedstock. Our
intention is to implement the NOSB recommendation to prohibit the use
of genetically engineered feedstock or organisms in the production of
mulch film, regardless of whether the genetically engineered trait is
retained or detectible in the finished product. We also note that the
NOSB indicated in its recommendation some concerns about consistency in
the review of soil inputs for excluded methods and noted that it did
not intend for this annotation to be interpreted as applying to other
soil inputs.
Consistent with the NOSB recommendation and with the listing
finalized at section 205.601, certifying agents and material evaluation
programs will need to verify that mulch films are produced without
organisms or feedstock derived from excluded methods. This includes
verification that feedstock, including plant materials, microorganisms,
enzymes, or other additives, are not genetically engineered or derived
from genetically modified organisms. We have retained the language of
``derived from excluded methods,'' rather than ``produced using
excluded methods,'' as suggested by one commenter, as we feel the
proposed regulatory text is adequate to describe the intent.
Two comments that did not support the allowance of mulch film
requested that, if approved, that the regulations should explicitly
state that engineered nanomaterials are prohibited in this material. We
have not adopted by the commenters' suggestion on this issue. AMS
acknowledges that the NOSB considers engineered nanomaterials to be
synthetic and prohibited under the organic regulations, and that the
NOSB issued a separate recommendation on this topic in 2010.\4\ On
December 17, 2010, NOP responded to this NOSB recommendation that (1)
it would be difficult to identify and verify the absence of
nanomaterials in organic products; and (2) NOP needed more information
about how nanomaterials are defined, regulated and used in agricultural
products.\5\ Since this time, AMS continues to analyze information
received from various sources on this issue to determine next steps. We
also noted that the NOSB recommendation for mulch film specifically
indicates that a proposed clause prohibiting nanomaterials was omitted
from the final recommendation due to the lack of a legal definition.
For these reasons, AMS has not accepted the commenters' suggestion to
amend the annotation for mulch film to specifically prohibit
nanomaterials.
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\4\ NOSB Recommendation. Guidance Document--Engineered
Nanomaterials in Organic Production, Processing and Packaging.
October 28, 2010. Available on the NOP Web site at http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5087795&acct=nosb.
\5\ Memorandum for the Chairperson of the National Organic
Standards Board, National Organic Program, December 17, 2010.
Available on the NOP Web site at http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5088266&acct=nosb.
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One comment from an accredited certifying agent requested
clarification on the allowance of mulch film as a compost feedstock.
The certifying agent indicated that they have received requests from
producers about compostable cutlery and plates and encouraged further
consideration by AMS of whether these materials may be used as a
compost feedstock. The NOSB did not consider the use of mulch film or
compostable cutlery and plates as a compost feedstock in its
recommendation on mulch film and is outside the scope of this
rulemaking action. Parties interested in a broader allowance for
compostable bioplastic materials, such as compostable cutlery, may
submit a petition to the NOSB. This process can be initiated in
accordance with the Notice of Guidelines on Procedures for Submitting
National List Petitions (72 FR 2167).
Several comments raised concerns about the potential adverse
environmental impacts from use of this material. Comments cited
concerns about accumulation of polymer fragments and mulch additives,
such as dyes, fillers, and other synthetic film additives that may not
completely biodegrade. Comments stated that inadequate data are
available regarding potential long-term accumulation of additives that
remain in the soil and provided details or references in support of
these claims. One comment opposed the allowance of mulch films because
potential adverse impacts on wildlife and soil microbial communities.
One comment claimed that AMS should not approve the use of mulch film
in organics because the environmental impacts are largely unknown and
due to a lack of ecotoxicological studies to test for potential
residues or harmful compounds. Another comment asked a question about
microbiological risk, but did not provide additional details about
their concerns. One comment expressed concerns about the potential for
inadvertent spread of mulch pieces from farms to adjacent ecosystems
and indicated a need for further research in this area to assess risks
to wildlife, aquatic life, and adjacent ecosystems. Another comment
indicated that the question of residue left by the mulch film should be
weighed against the tiny scraps of broken and stretched plastic that
remain in the field after removal of traditional plastic mulch, despite
efforts for complete removal.
AMS has considered the comments about the potential adverse
environmental impacts from the use of mulch film and considered this
issue in comparison to the current use of traditional plastic mulches.
In addition, the NOSB evaluated this substance against the criteria in
OFPA, which includes consideration of the potential for detrimental
chemical interaction with materials used in organic farming systems;
the persistence and areas of concentration in the environment of the
substance and its breakdown products or other contaminants; the
probability of environmental contamination during manufacture, use,
misuse or disposal of the substance; the effects of the substance on
biological and chemical interactions in the agroecosystem; and
available alternatives.\6\ We understand that additional studies may be
helpful on these topics and that the NOSB Materials Subcommittee has
proposed that this topic be added to the NOSB's list of research
priorities.\7\ At this time, however, we believe that the environmental
benefits gained by the use of mulch film that were raised by the
majority of commenters outweigh the potential benefits from delaying a
decision until more studies are completed. In consideration of the
comment on ecotoxicological effects, we

[[Page 58659]]

have retained the criteria for compostability in the definition of
biodegradable biobased mulch film since it provides a screen for
ecotoxic effects via plant growth and seedling germination tests in
soil, as further discussed below.
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\6\ OFPA, 7 U.S.C. 6518(m).
\7\ NOSB Materials Subcommittee Proposal: Research Priorities
for 2013. December 10, 2013. Available on the NOP Web site at http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5106662.
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In addition, we believe that the potential inadvertent spread of
mulch film can be adequately addressed by certifiers under the existing
regulations at section 205.200, which require that the operation
implement production practices that maintain or improve the natural
resources of the operation, including soil and water quality. If an
operation allows materials to negatively impact soil or water quality,
certifying agents must address this issue as a noncompliance under
section 205.200.
Several comments raised questions about the biodegradability of
mulch films. One comment claimed that complete degradation is required
to ensure that mulch meets the requirement under OFPA that synthetic
mulches be ``removed'' at the end of the growing season and did not
believe that this requirement was met by the proposed listing.
Section 6508(c)(2) of OFPA prohibits the use of plastic mulches,
unless such mulches are removed at the end of each growing or harvest
season. This provision is implemented under the USDA organic
regulations at sections 205.206(c)(6) and 205.601(b)(2)(ii). As
supported by comments, AMS considers biodegradation of biofilm mulch as
a form of removal at the end of the growing or harvest season. If an
operation uses practices that does not allow mulch to biodegrade, and,
therefore, it accumulates over time, certifying agents must address
this issue as noncompliance under sections 205.200, 205.206(c)(6), and
205.601(b)(2)(iii).
One comment indicated that more investigation is needed on the
different types of biodegradable mulches and claimed that not all are
biodegradable. Another comment cited a study that showed that none of
the biodegradable plastic mulches tested fully biodegraded in the soil
after a two year period of soil incorporation following a cropping
season.
One comment indicated that the NOSB recommendation is inadequate to
ensure that biofilm mulches have completely biodegraded at the end of
the growing or harvest season. Two comments indicated that complete
degradation is necessary to qualify as ``removal'' at the end of the
growing or harvest season, as required by OFPA under section
6508(c)(2). Another commenter posed questions on what the mulch film
may degrade to.
Two comments did not support the rule and indicated that more
research is needed to ensure adequate breakdown of mulch films. One
comment indicated that it is not yet possible to establish adequate
criteria that can be implemented by material review organizations,
certifiers, and growers, while another commenter stated that no
products currently exist in the marketplace that have been proven to
fully degrade. Comments also cited a forthcoming ASTM standard that
addresses aerobically biodegradable plastics in the soil environment.
One comment suggested that AMS withdraw the proposed rule and postpone
approval until an applicable standard is identified and products are
developed that meet biodegradability requirements.
AMS has considered these comments. As explained in the proposed
rule, we agree that growers will need to take appropriate actions to
ensure complete degradation. These actions may be site-specific and be
impacted by a number of factors, including climate, soil type, pH, soil
microbial activity, irrigation, and other production practices. Section
205.200 requires that production practices maintain or improve the
natural resources of the operation, including soil and water quality.
In addition, section 205.203 requires that the producer select and
implement practices that maintain or improve the physical, chemical,
and biological condition of soil. Thus, the use of a mulch film in a
manner that causes it to accumulate in the field and not biodegrade
over time would not be compliant with the existing requirements at
sections 205.200 and 205.203. We believe the definition and criteria
for biodegradable biobased mulch film as finalized at section 205.2
provide an adequate baseline for biodegradability. Additionally, the
existing requirements at sections 205.200 and 205.203 provide adequate
safeguards against misuse. If misuse is identified, certifying agents
may reference these standards when issuing notices of noncompliance to
operations as required under section 205.662.
Another comment raised questions about possible to changes to
product formulations and indicated that manufacturers change
formulations frequently based on costs of available feedstock. Supplier
and ingredient substitution is not unique to mulch film manufacturing
and occurs with other formulated inputs products, such as blended
fertilizers and soil amendments that are marketed for organic
production. As part of the review process for input products,
certifying agents and material evaluation programs must continue to
ensure that any alternate formulations of approved mulch film products
comply with any annotations provided on the National List.

Definition at Section 205.2

This rule adds a new definition for biodegradable biobased mulch
film that includes criteria and third-party standards for
compostability, biodegradability, and biobased content.
One comment indicated that certifying agents may not have the
resources to perform the testing methods referenced in the proposed
definition and recommended that AMS require separate third-party
verification to these standards and allow certifying agents to accept
their verification. They also requested that AMS identify which third-
party verifications can be accepted. AMS does not expect that
certifying agents have equipment or resources to perform the tests
referenced at section 205.2. Instead, as with review of any input used
in organic production or handling, certifying agents and material
evaluation programs that review these materials must have sufficient
expertise to determine whether the appropriate tests have been
conducted by the manufacturer or party seeking review. Alternatively,
certifying agents may accept reviews (i.e., third-party verifications)
conducted by other certifying agents or other approved third parties as
explained under NOP Policy Memo 11-4.\8\
---------------------------------------------------------------------------

\8\ NOP Policy Memo 11-4 on Evaluation of Materials is available
at http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5088949.
---------------------------------------------------------------------------

One commenter suggested that AMS use the word ``plastic'' in the
definition to clarify that the rule is intended to regulate
biodegradable bioplastic mulch film. We have not adopted the
commenter's suggestion, as the term ``biodegradable biobased mulch
film'' is adequate to describe the intended material. In addition, the
term used is consistent with the name used in the petition and the NOSB
recommendation.

Compostability

In the proposed rule, AMS specifically requested comments on the
applicability of the proposed compostability standards for
biodegradable biobased mulch film.
Many comments supported the definition proposed at section 205.2
and indicated that all three testing standards--compostability,
biodegradation, and biobased--that

[[Page 58660]]

define biodegradable biobased mulch film are necessary because they
ensure that the material is compatible with good soil management and
principles. One comment supported the inclusion of this standard since
it provides additional evidence that approved mulch films will break
down through biological processes.
Several comments indicated that both the compostability standards
and biodegradability testing requirements serve an important screening
purpose. The comments noted that the compostability standard provides
an initial rejection point earlier in the timeline of reviewing mulch
film and confirms the absence of any ecotoxic effects via plant growth
and seedling germination tests in soil.
Three comments did not support the reference to the compostability
testing, stating that it is designed for commercial composting and does
not correlate between conditions found in the field or environmental
conditions present on farms, which have lower achievable temperatures.
We have considered these comments and have retained the standards
for compostability. We agree with the comments that compostability
testing is important as an initial screen for ecotoxity which is not
otherwise addressed by the other criteria for biodegradability and
biobased content; therefore, we have retained the compostability
standards recommended by the NOSB and included in the proposed rule.
The text was updated to cite the current version of this standard to
meet incorporation by reference requirements.

Biodegradation

Some commenters noted that a new ASTM work item, ASTM WK29802, is
under development with the working title, ``New Specification for
Aerobically Biodegradable Plastics in Soil Environment in the Temperate
Zone.'' This work item was initiated by ASTM on July 29, 2010.\9\
According to several commenters, this new specification is expected to
be a better fit for testing the biodegradability of mulch film in a
soil environment when compared to ASTM D5988.\10\ Since this new
standard has not yet been published, we are unable to fully consider
this alternative. Once the standard has been published, parties
interested in further consideration of this alternative standard may
submit a petition to the NOSB. This process can be initiated in
accordance with the Notice of Guidelines on Procedures for Submitting
National List Petitions (72 FR 2167).
---------------------------------------------------------------------------

\9\ This work item, ASTM WK29802, has since been renamed as
``New Specification for plastics that are innately biodegradable in
soil under aerobic conditions,'' http://www.astm.org. Accessed
August 4, 2014.
\10\ ASTM D5988-12, Standard Test Method for Determining Aerobic
Biodegradation of Plastic Materials in Soil. ASTM International.
http://www.astm.org.
---------------------------------------------------------------------------

One comment noted that a label of a commercial product which
references ASTM D5988 only implies that the product was tested, but
does guarantee any level to which the product actually degraded. We
believe this comment is addressed through the definition for
biodegradable biobased mulch film which states that the substance
``demonstrates at least 90% biodegradation absolute or relative to
microcrystalline cellulose in less than two years, in soil.'' This
requirement provides a baseline for biodegradability which is
consistent with the NOSB recommendation.
One commenter indicated that it was unclear whether the
biodegradability specifications (i.e., ASTM D5988) apply to mulches
received from the vendor, or mulches exposed to weathering, or both.
AMS intends for the specifications provided under section 205.2 to
apply to mulch films as received from the manufacturer or supplier by
the producer.
One commenter indicated that the biodegradation standard ASTM D5988
was inappropriate because it is a laboratory test performed under a
controlled environment and it does not address the wide variety of
conditions found on organic farms. In addition, the comment indicated
the standard ASTM D5988 is insufficient because it does not require
complete degradation of mulch. Instead, the standard only requires
demonstrating 90% biodegradation in testing, which does not address
residual components of mulch that could build up in soils over time.
The commenter also indicated that different rates may be observed in
different climates and soil conditions.
Two additional comments cited research studies and ongoing field
studies that found that several biodegradable mulches that comply with
the ASTM biodegradation standards showed variable levels of
decomposition during the growing season.
AMS understands that the complete degradation of mulch film may be
impacted by a number of factors, including climate, soil type, pH,
irrigation, and other production practices. The two referenced
standards for biodegradability, ISO 17556 and ASTM D5988, are intended
to provide a baseline that any mulch film must meet. These standards do
not exempt the producer from other parts of the USDA organic
regulations that require production practices that maintain or improve
soil quality and other environmental conditions, as discussed earlier.

Biobased Content

One comment indicated that there is no correlation between the
percentage of biobased content and rate of complete biodegradation. The
commenter stated that biobased infers that materials are being used
that have renewable content, but nothing more. We have not amended the
regulatory text in response to this comment since the requirement for
biobased content is intended to ensure that feedstock is derived from
renewable materials, rather than fossil fuel sources, to be consistent
with the NOSB recommendation. We understand that some minor additives,
e.g., plasticizers, colorants, etc., may not be available in biobased
form; however, we expect that the feedstock will be biobased and that
content will determined using ASTM D6866 testing methods. If there are
questions about whether a particular formula is in compliance, AMS
encourages certifying agents and material evaluation programs that
review these materials to contact NOP prior to making decisions on
materials and products that are potentially problematic or
controversial.
One comment suggested an amendment to the language for biobased
content to read as follows (suggested text italicized): ``Must be
biobased with all carbon derived from a renewable resource via
biological processes, with content determined using ASTM D6866 testing
method.'' The commenter claims that the NOSB recommendation stated that
all the carbon must be ``derived from a renewable resource via a
biological process.'' The comment further states that, by not
explicitly including this component, AMS would be broadening the use
allowance for mulch film beyond that which was recommended by NOSB.
We have reviewed the comment against the NOSB recommendation and
noted that the NOSB recommended a definition for biobased as ``organic
material in which carbon is derived from a renewable resource via
biological processes. Biobased materials include all plant and animal
mass derived from carbon dioxide recently fixed via photosynthesis, per
definition of a renewable resource (ASTM).'' As previously explained in
the proposed rule, we have not incorporated a separate definition for
biobased and believe that the definition of

[[Page 58661]]

``biodegradable biobased mulch film'' incorporates the intent of the
NOSB on this issue. Therefore, we have not adopted the commenter's
suggestion. The ASTM D6866 testing method is a standard test method to
quantify the biobased content of samples. The test methods directly
discriminate between product carbon resulting from contemporary carbon
input and that derived from fossil-based input.\11\ We have not
included the term ``all carbon,'' as suggested by the comment, to
account for trace amounts of carbon that may be present from additives
(e.g., plasticizers, colorants including carbon black, etc.) used in
the manufacturing process. The suggested text could also cause
confusion in interpretation when a margin of error is reported as part
of testing results. In addition, we have not included the term ``carbon
derived from a renewable resource via biological testing methods''
since it is redundant with the term ``biobased'' and the testing
criteria for biobased content. AMS believes that the proposed
definition meets use the intended use that was recommended by the NOSB.
As this use was recommended by the NOSB and was included in a proposed
amendment to the National List published August 22, 2013 (78 FR 52100),
the allowance for biodegradable biobased mulch film is consistent with
the authority granted by AMS under OFPA.\12\
---------------------------------------------------------------------------

\11\ http://www.astm.org/Standards/D6866.htm.
\12\ Section 6517(d)(2) states: No additions.--The Secretary may
not include exemptions for the use of specific synthetic substances
in the National List other than those exemptions contained in the
Proposed National List or Proposed Amendments to the National List.
---------------------------------------------------------------------------

One comment indicated that the biobased definition provides
inadequate information regarding what types of products will be allowed
and what will be prohibited. The comment indicated that the
``biobased'' definition from the USDA BioPreferred[supreg] program only
requires that a product have a minimum of 25% biobased content, allows
GMO biobased feedstocks, and does not provide clear information on what
is allowable for the remaining balance of the content. The comment
requested that AMS provide names of specific polymers that can be
synthesized from renewable sources and are proven to be biodegradable
in the soil.
AMS expects that all feedstock for biobased mulch films will be
biobased and that content will be determined using ASTM D6866 testing
methods. We understand that the criteria included in the USDA organic
regulations may exclude some products that are defined as ``biobased''
under the USDA BioPreferred[supreg] program, which allows a lower
percentage of biobased content and may contain petroleum or fossil fuel
derived feedstock, and allows genetically modified organisms. We
understand that some minor additives, e.g., plasticizers, colorants,
etc., used in mulch film allowed under this rule may not be available
in biobased form; however, we expect that the feedstock for the mulch
film will be derived from biobased sources. The use of feedstock
derived from excluded methods is specifically excluded under the
listing at section 205.601.
At this time, AMS is not prepared to issue a specific list of
polymers that are available from renewable (e.g., biobased) resources.
We noted that the NOSB intended to define biobased so that this
category would not allow products derived from petroleum. Based on
review of the petition and NOSB recommendation, we understand this to
mean that mulch films derived from aliphatic aromatic copolymers
(AACs), e.g. synthesized from adipic acid, terephthalic acid, and 1,4-
butanediol, would be prohibited. Further guidance in this area may be
more appropriate for other organizations or agencies with specialized
technical expertise in this area. We note that this list may need to be
updated over time in response to advances in technology. We believe
that the criteria outlined under sections 205.2 and 205.601 provide
adequate guidance to certifying agents and material evaluation programs
that will review these types of products for compliance with the USDA
organic regulations. Certifying agents would not review products to the
USDA BioPreferred[supreg] program criteria, which are established for
biobased products.
One comment stated that the proposed standard for measuring
biobased content, ASTM D6866, is a poor measurement tool for measuring
biobased content in reference to starch. The comment requested that AMS
recognize this shortcoming and grant a special consideration for
starch, since some mulch films are starch based. The comment indicated
that special consideration has been granted in Europe, but did not
provide additional information in support of this claim. We have
considered this comment but have not amended the text in response. In
the absence of an alternative third-party testing standard for biobased
content, we have retained the biobased testing method, ASTM D6866,
cited in the original petition and recommended by the NOSB. We have
amended the text for the final rule to specify the current version of
this standard to comply with incorporation by reference requirements.
Due to lack of additional information on this issue, parties interested
in further consideration of this topic may submit a petition to the
NOSB. This process can be initiated in accordance with the Notice of
Guidelines on Procedures for Submitting National List Petitions (72 FR
2167).

Additional Guidance

In the proposed rule, AMS specifically requested comments on
whether guidance on management practices is necessary to prevent mulch
film from accumulating in fields.
Two comments indicated that additional guidance was unnecessary at
this time if manufacturer's instructions are followed and with the
knowledge that each organic farmer has about their soil and climate
conditions.
One comment indicated that guidance could be useful since growers
will be eager to use this new material, but did not provide additional
details on the need or scope of the guidance. Another commenter
supported the creation of a guidance document to ensure that the
biodegradable mulch films are not accumulating in the soil and
indicated that it would help to prevent accumulation issues from
occurring due to a lack of experience.
One comment provided additional background on the rationale for
NOSB recommending the development of guidance so that growers would
understand what actions are needed to ensure complete degradation.
One comment indicated that regulations must be promulgated that
detail best management practices for using and degrading mulch film.
The commenter indicated that AMS should not wait until problems arise
with respect to the use and incomplete degradation of mulch film before
mandating best management practices since this would compromise organic
integrity.
AMS has considered the comments and determined not to move forward
with additional guidance on this topic at this time. As explained
above, we agree that growers may need to take appropriate actions to
ensure complete degradation. These actions may be site-specific and be
impacted by a number of factors, including climate, soil type, pH, soil
microbial activity, irrigation, and other production practices. AMS
encourages parties with specific technical expertise in this area, such
as product manufacturers and university research programs, to continue
to provide technical assistance to producers on this topic.

[[Page 58662]]

Substances Not Added to the National List

Citrus hystrix, Leaves and Fruit
Curry Leaves (Murraya koenigii)
Thirteen comments addressed the proposed allowance of two
nonorganic ingredients in organic processing: Citrus hystrix, leaves
and fruit, and curry leaves (Murraya koenigii). These substances were
proposed to be added to section 205.606 of the National List based on
two NOSB recommendations. Several comments opposed the allowance of any
nonorganic ingredients in organic processing, including nonorganic
Citrus hystrix and curry leaves. Several comments opposed the specific
allowance of Citrus hystrix and curry leaves due to concerns about
pesticide residues, particularly on imported ingredients, since the
majority of production occurs outside of the United States.\13\ One
comment opposed the import of any food into the United States, which is
outside of the scope of this action. One comment raised questions about
whether these ingredients would be checked for pesticides, other
substances, or evaluated for purity and another commenter raised
questions on how the nonorganic ingredients were produced. One comment
indicated that these plants are relatively easy to cultivate and that
companies need to contact growers to see if they are willing to grow
organic forms of these ingredients. One producer indicated that their
farm produces organic curry leaves in Hawaii, but did not provide
details on the amounts produced. Several comments raised questions
about organic search requirements for commercial availability and
claimed that allowing nonorganic ingredients would decrease the
incentive for developing organic sources of these ingredients. Another
comment supported the allowance of the nonorganic ingredients only
under an alternative labeling program whereby the products would not be
labeled as organic and only if the allowance of nonorganic ingredients
met additional criteria. These additional criteria are beyond the scope
of the USDA organic regulations.
---------------------------------------------------------------------------

\13\ One example cited: http://english.doolnews.com/curry-leaf-laced-with-deadly-pesticides-kerala-news-10453-10453.html.
---------------------------------------------------------------------------

After consideration of the comments, AMS has not amended section
205.606 to include Citrus hystrix and curry leaves. We noted a lack of
comments in support of the proposed rule to allow these ingredients in
organic handling. While an organic handler originally submitted the
petition for these ingredients for review by the NOSB, no handlers
commented on the need for nonorganic Citrus hystrix and curry leaves.
In the absence of comments in support of their allowance, we have not
determined at this time that these substances are necessary to the
production or handling of an agricultural product, as required by
section 6517 of OFPA; therefore, we have not added these substances to
the National List.
However, AMS believes that the majority of issues raised by
commenters that opposed the inclusion of curry leaves and Citrus
hystrix do not uniquely apply to these ingredients when compared to
other ingredients that are eligible for inclusion on section 205.606 of
the National List. For example, demonstrating that an organic form is
not commercially available is required prior to use of any nonorganic
substance listed at section 205.606. In addition, the use of imported
ingredients listed at section 205.606 is allowed, provided that the
ingredients comply with any food safety requirements under the
authorities of the Secretary of Health and Human Services under the
Federal Food, Drug and Cosmetic Act (21 U.S.C. 301-399) or the
authority of the Administrator of the Environmental Protection Agency
under the Federal Insecticide, Fungicide and Rodenticide Act (7 U.S.C.
136-136(y)) that apply to all food.
In addition, we specifically note that this action does not change
the eligibility of processed products that are labeled ``made with
organic (specified ingredients or food group(s))'' to contain
nonorganic forms of Citrus hystrix or curry leaves, as allowed under
section 205.304 of the USDA organic regulations. Handlers interested in
using nonorganic forms of these ingredients continue to be eligible for
the ``made with organic (specified ingredients or food group(s))''
label claim, provided that all other requirements under the USDA
organic regulations are met.

List of Subjects in 7 CFR Part 205

Administrative practice and procedure, Agriculture, Animals,
Archives and records, Incorporation by reference, Imports, Labeling,
Organically produced products, Plants, Reporting and recordkeeping
requirements, Seals and insignia, Soil conservation.

For the reasons set forth in the preamble, 7 CFR part 205 is
amended as follows:

PART 205--NATIONAL ORGANIC PROGRAM

0
1. The authority citation for 7 CFR part 205 continues to read as
follows:

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

Subpart A--Definitions

0
2. Amend Sec. 205.2 by adding a new definition for ``Biodegradable
biobased mulch film'' in alphabetical order to read as follows:

Sec. 205.2 Terms defined.

* * * * *
Biodegradable biobased mulch film. A synthetic mulch film that
meets the following criteria:
(1) Meets the compostability specifications of one of the following
standards: ASTM D6400, ASTM D6868, EN 13432, EN 14995, or ISO 17088
(all incorporated by reference; see Sec. 205.3);
(2) Demonstrates at least 90% biodegradation absolute or relative
to microcrystalline cellulose in less than two years, in soil,
according to one of the following test methods: ISO 17556 or ASTM D5988
(both incorporated by reference; see Sec. 205.3); and
(3) Must be biobased with content determined using ASTM D6866
(incorporated by reference; see Sec. 205.3).
* * * * *

0
3. Add Sec. 205.3 to subpart A to read as follows:

Sec. 205.3 Incorporation by reference.

(a) Certain material is incorporated by reference into this part
with the approval of the Director of the Federal Register under 5
U.S.C. 552(a) and 1 CFR part 51. To enforce any edition other than that
specified in this section, we must publish notice of change in the
Federal Register and the material must be available to the public. All
approved material is available for inspection at the USDA Agricultural
Marketing Service, National Organic Program, 1400 Independence Avenue
SW., Washington, DC 20250; (202) 720-3252, and is available from the
sources listed below. It is also available for inspection at the
National Archives and Records Administration (NARA). For information on
the availability of this material at NARA, call (202) 741-6030 or go to
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(b) ASTM International, 100 Barr Harbor Drive, PO Box C700, West
Conshohocken, PA 19428; phone 1-877-909-2786; http://www.astm.org/.
(1) ASTM D5988-12 (``ASTM D5988''), ``Standard Test Method for
Determining Aerobic Biodegradation of

[[Page 58663]]

Plastic Materials in Soil,'' approved May 1, 2012, IBR approved for
Sec. 205.2.
(2) ASTM D6400-12 (``ASTM D6400''), ``Standard Specification for
Labeling of Plastics Designed to be Aerobically Composted in Municipal
or Industrial Facilities,'' approved May 15, 2012, IBR approved for
Sec. 205.2.
(3) ASTM D6866-12 (``ASTM D6866''), ``Standard Test Methods for
Determining the Biobased Content of Solid, Liquid, and Gaseous Samples
Using Radiocarbon Analysis,'' approved April 1, 2012, IBR approved for
Sec. 205.2.
(4) ASTM D6868-11 (``ASTM D6868''), ``Standard Specification for
Labeling of End Items that Incorporate Plastics and Polymers as
Coatings or Additives with Paper and Other Substrates Designed to be
Aerobically Composted in Municipal or Industrial Facilities,'' approved
February 1, 2011, IBR approved for Sec. 205.2.
(c) European Committee for Standardization; Avenue Marnix, 17-B-
1000 Brussels; phone 32 2 550 08 11; www.cen.eu.
(1) EN 13432:2000:E (``EN 13432''), September, 2000, ``Requirements
for packaging recoverable through composting and biodegradation--Test
scheme and evaluation criteria for the final acceptance of packaging,''
IBR approved for Sec. 205.2.
(2) EN 14995:2006:E (``EN 14995''), December, 2006, ``Plastics--
Evaluation of compostability--Test scheme and specifications,'' IBR
approved for Sec. 205.2.
(d) International Organization for Standardization, 1, ch. de la
Voie-Creuse, CP 56, CH-1211 Geneva 20, Switzerland; phone 41 22 749 01
11; www.iso.org.
(1) ISO 17088:2012(E), (``ISO 17088''), ``Specifications for
compostable plastics,'' June 1, 2012, IBR approved for Sec. 205.2.
(2) ISO 17556:2012(E) (``ISO 17556''), ``Plastics--Determination of
the ultimate aerobic biodegradability of plastic materials in soil by
measuring the oxygen demand in a respirometer or the amount of carbon
dioxide evolved,'' August 15, 2012, IBR approved for Sec. 205.2.

Subpart G--Administrative

0
4. Amend Sec. 205.601 by adding paragraph (b)(2)(iii) to read as
follows:

Sec. 205.601 Synthetic substances allowed for use in organic crop
production.

* * * * *
(b) * * *
(2) * * *
(iii) Biodegradable biobased mulch film as defined in Sec. 205.2.
Must be produced without organisms or feedstock derived from excluded
methods.
* * * * *

0
5. Amend Sec. 205.606 by:
0
A. Removing paragraph (l);
0
B. Redesignating paragraphs (m) through (aa) as (l) through (z)
respectively;
0
C. Removing newly redesignated paragraph (v)(2); and
0
D. Further redesignating newly redesignated paragraph (v)(3) as (v)(2).

Rex A. Barnes,
Associate Administrator, Agricultural Marketing Service.
[FR Doc. 2014-23135 Filed 9-29-14; 8:45 am]
BILLING CODE 3410-02-P