[Federal Register Volume 77, Number 109 (Wednesday, June 6, 2012)]
[Rules and Regulations]
[Pages 33290-33303]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-13523]
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DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 205
[Document Number AMS-NOP-09-0074; NOP-09-01FR]
RIN 0581-AC96
National Organic Program (NOP); Sunset Review (2012)
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Final rule.
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SUMMARY: This final rule addresses recommendations submitted to the
Secretary of Agriculture (Secretary) by the National Organic Standards
Board (NOSB) on April 29, 2010, October 28, 2010, and April 29, 2011.
These recommendations pertain to the 2012 Sunset Review of substances
on the U.S. Department of Agriculture's (USDA) National List of Allowed
and Prohibited Substances (National List). Consistent with the NOSB
recommendations, this final rule continues, without change, the
exemptions (use) and prohibitions for multiple listings on the National
List for 5 years after their respective sunset dates. This final rule
also amends the exemptions (use) for 7 substances and removes the
exemptions for 3 substances on the National List.
DATES: Effective Dates: This rule is effective June 27, 2012, except
for the amendments to Sec. Sec. 205.601(g) and 205.605(a), which are
effective October 21, 2012. For more information on these effective
dates and renewals, see the SUPPLEMENTARY INFORMATION.
FOR FURTHER INFORMATION CONTACT: Melissa R. Bailey, Ph.D., Director,
Standards Division, Telephone: (202) 720-3252; Fax: (202) 205-7808.
SUPPLEMENTARY INFORMATION:
I. Background
The Organic Foods Production Act of 1990 (OFPA) (7 U.S.C. 6501-
6522) authorizes the establishment of the National List of Allowed and
Prohibited Substances (National List). The National List identifies
synthetic substances that may be used in organic production and
nonsynthetic (natural) substances that are prohibited in organic crop
and livestock production. The National List also identifies
nonagricultural nonsynthetic, nonagricultural synthetic and nonorganic
agricultural substances that may be used in organic handling.
The exemptions and prohibitions granted under the OFPA are required
to be reviewed every 5 years by the National Organic Standards Board
[[Page 33291]]
(NOSB). The Secretary of Agriculture has authority under the OFPA to
renew such exemptions and prohibitions. If the substances are not
reviewed by the NOSB within 5 years of their inclusion on the National
List and addressed by the Secretary, then their authorized use or
prohibition expires under OFPA's sunset provision.
In response to the sunset provisions in the OFPA, this final rule
addresses multiple recommendations submitted to the Secretary by the
NOSB pertaining to substances due to expire from the National List in
2012. AMS published an Advanced Notice of Proposed Rulemaking (ANPR) in
the Federal Register on March 26, 2010 (75 FR 14500), announcing the
NOSB's review of exempted and prohibited substances codified at the
National List of the National Organic Program (NOP) regulations and set
to expire in 2012. AMS provided the comments received in response to
the ANPR to the NOSB in advance of their review of these substances.
Based upon the NOSB's recommendations, AMS published a proposed rule in
the Federal Register on January 12, 2012, (77 FR 1996) to address the
continued use of these substances on the National List in organic
production and handling.
Consistent with the recommendations from the NOSB, this final rule
renews, without change, multiple exemptions (uses) and prohibitions on
the National List (along with any restrictive annotations) for 5 years.
This final rule also amends the exemptions for 7 substances and removes
the exemptions for 3 substances on the National List. A list of these
substances is provided in the Appendix to this final rule. As
referenced in the proposed rule for this 2012 Sunset Review, AMS notes
that the listings for nutrient vitamins and minerals at section
205.605(b) and sodium nitrate at section 205.602 will be dealt with in
separate actions.
Under the authority of the OFPA, the National List can be amended
by the Secretary based on recommendations developed by the NOSB. Since
established, the NOP has published multiple amendments to the National
List: October 31, 2003 (68 FR 61987); November 3, 2003 (68 FR 62215);
October 21, 2005 (70 FR 61217); June 7, 2006 (71 FR 32803); September
11, 2006 (71 FR 53299); June 27, 2007 (72 FR 35137); October 16, 2007
(72 FR 58469); December 10, 2007 (72 FR 69569); December 12, 2007 (72
FR 70479); September 18, 2008 (73 FR 54057); October 9, 2008 (73 FR
59479); July 6, 2010 (75 FR 38693); August 24, 2010 (75 FR 51919),
December 13, 2010 (75 FR 77521); March 14, 2011 (76 FR 13501); August
3, 2011 (76 FR 46595); and February 14, 2012 (77 FR 8089).
Additionally, proposed amendments to the National List were published
on May 5, 2011 (76 FR 25612); November 8, 2011 (76 FR 69141); January
12, 2012 (77 FR 1980); and February 6, 2012 (77 FR 5717).
II. Overview of Final Actions
A complete overview of final actions for designated sections of the
National List regulations is presented in the Appendix.\1\ In the
proposed rule, AMS indicated that proposed actions for each listing
would be effective on the sunset date in 2012 for that listing (e.g. a
listing due to sunset on October 21, 2012 would be renewed effective
October 21, 2012). However, AMS determined that the effective dates for
this sunset review should be streamlined to the extent possible through
this final rule. Therefore, the actions pertaining to all listings,
with the exception of the amendment to yeast at section 205.605(a) and
the removal of sulfur dioxide at section 205.601, will be effective on
one date, June 27, 2012. The effective date for each listing is
specified in the Appendix. In accordance with the sunset provisions in
the OFPA, the new sunset date for all listings is five years from the
effective date of their renewal or amendment.
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\1\ The Appendix shows a simplified listing for each substance;
use categories and any restrictive annotations are not included in
this overview.
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Renewals
Consistent with the NOSB recommendations and in consideration of
the public comments received on the proposed rule (77 FR 1996), AMS is
renewing multiple listings pertaining to the National List through this
final rule.
This final rule continues the exemptions at section 205.601, along
with any restrictive annotations, for the synthetic substances allowed
for use in organic crop production as shown in the Appendix.
This final rule continues the prohibitions at section 205.602,
along with any restrictive annotations, for the nonsynthetic substances
prohibited for use in organic crop production as shown in the Appendix.
It should be noted that the nonsynthetic, prohibited substance ``Ash
from manure burning'' was listed incorrectly in Table 1 of the proposed
rule as ``Ash for manure burning'' (emphasis added). The correct
listing is included in the Appendix of this final rule.
This final rule continues the exemptions at section 205.603, along
with any restrictive annotations, for the synthetic substances allowed
for use in organic livestock production as shown in the Appendix.
This final rule continues the prohibition at section 205.604, for
the nonsynthetic substance prohibited for use in organic livestock
production as shown in the Appendix.
This final rule continues the exemptions at section 205.605(a),
along with any restrictive annotations, for the nonsynthetic,
nonagricultural (nonorganic) substances allowed as ingredients in or on
processed products labeled as ``organic'' or ``made with organic
(specified ingredients or food group(s))'' as shown in the Appendix.
This final rule continues the exemptions at section 205.605(b),
along with any restrictive annotations, for the synthetic,
nonagricultural (nonorganic) substances allowed as ingredients in or on
processed products labeled as ``organic'' or ``made with organic
(specified ingredients or food group(s))'' as shown in the Appendix.
This final rule continues the exemptions at section 205.606, along
with any restrictive annotations, for the nonorganically produced
agricultural products allowed as ingredients in or on processed
products labeled as ``organic'' as shown in the Appendix.
Nonrenewals
This final rule amends the National List by removing the exemptions
as shown in the Appendix for the following 3 substances in organic
production and handling:
Section 205.601 Synthetic Substances Allowed for Use in Organic Crop
Production
This final rule amends section 205.601 of the National List
regulations by removing the exemption for sulfur dioxide at paragraph
(g)(1) and redesignating current paragraph (g)(2) as (g) to read: (g)
As rodenticides. Vitamin D3. This amendment is effective on
the sunset date for sulfur dioxide, October 21, 2012.
Section 205.605 Nonagricultural (Nonorganic) Substances Allowed as
Ingredients in or on Processed Products Labeled as ``Organic'' or
``Made With Organic (Specified Ingredients or Food Group(s))''
This final rule amends section 205.605(b) of the National List
regulations by removing the exemption for pectin (low-methoxy), and the
exemption, along with its restrictive annotation, for potassium iodide.
These amendments are effective on June 27, 2012.
[[Page 33292]]
Renewals With Amendment
This final rule amends the National List regulations by amending
the exemptions as shown in the Appendix for the following 7 substances
in organic production and handling:
Section 205.601 Synthetic Substances Allowed for Use in Organic Crop
Production.
This final rule amends the listing for chlorine materials at
section 205.601(a)(2) to read as follows: Chlorine materials--For pre-
harvest use, residual chlorine levels in the water in direct crop
contact or as water from cleaning irrigation systems applied to soil
must not exceed the maximum residual disinfectant limit under the Safe
Drinking Water Act, except that chlorine products may be used in edible
sprout production according to EPA label directions. (i) Calcium
hypochlorite. (ii) Chlorine dioxide. (iii) Sodium hypochlorite. This
amendment is effective on June 27, 2012.
This final rule amends section 205.601(i)(11) to add an expiration
date to the listing for streptomycin to read as follows: Streptomycin,
for fire blight control in apples and pears only until October 21,
2014. This amendment is effective on June 27, 2012.
This final rule amends the listing for lignin sulfonate at section
205.601(j)(4) to remove the words ``floatation agent.'' The new listing
will read: Lignin sulfonate--chelating agent, dust suppressant. This
amendment is effective on June 27, 2012. It should be noted that the
amendatory language for lignin sulfonate was incorrectly listed in the
proposed rule as ``Lignin sulfate--chelating agent, dust suppressant''
(emphasis added). This error is corrected in this final rule.
Section 205.605 Nonagricultural (Nonorganic) Substances Allowed as
Ingredients in or on Processed Products Labeled as ``Organic'' or
``Made With Organic (Specified Ingredients or Food Group(s)) ''
This final rule amends the listing for yeast section 205.605(a) to
read as follows: Yeast--When used as food or a fermentation agent in
products labeled as ``organic,'' yeast must be organic if its end use
is for human consumption; nonorganic yeast may be used when organic
yeast is not commercially available. Growth on petrochemical substrate
and sulfite waste liquor is prohibited. For smoked yeast, nonsynthetic
smoke flavoring process must be documented. This amendment is effective
on the sunset date for yeast, October 21, 2012.
Section 205.606 Nonorganically Produced Agricultural Products Allowed
as Ingredients in or on Processed Products Labeled as ``Organic ''
This final rule adds a restrictive annotation to the listing for
colors at section 205.606(d) to read as follows: Colors derived from
agricultural products--Must not be produced using synthetic solvents
and carrier systems or any artificial preservative. This amendment is
effective on the sunset date for colors derived from agricultural
products, June 27, 2012.
This final rule adds an expiration date to the listing for hops at
section 205.606(l) to read as follows: Hops (Humulus lupulus) until
January 1, 2013. This amendment is effective on the sunset date for
hops, June 27, 2012.
This final rule amends the listing for pectin at section 205.606(t)
to read as follows: Pectin (non-amidated forms only). This amendment is
effective on June 27, 2012.
III. Related Documents
An Advance Notice of Proposed Rulemaking with request for comments
was published in the Federal Register on March 26, 2010 (75 FR 14500),
to make the public aware that the exemptions and prohibitions for over
200 listings of synthetic and nonsynthetic substances in organic
production and handling would expire, if not reviewed by the NOSB and
addressed by the Secretary. Substances and recommendations addressed
through this final rule were announced for NOSB deliberation in the
following Federal Register notices: (1) March 17, 2010 (75 FR 12723);
September 20, 2010 (75 FR 57194); and (2) March 4, 2011 (76 FR 12013).
The proposal to address the substances in this final rule was published
as a proposed rule in the Federal Register on January 12, 2012 (77 FR
1996).
IV. Statutory and Regulatory Authority
The 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 NOP
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.
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.
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 the 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 the OFPA
(7 U.S.C. 6514(b)). States are also preempted by the OFPA (7 U.S.C.
6503 through 6507) 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 the OFPA.
Pursuant to the OFPA (7 U.S.C. 6507(b)(2)), 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 the OFPA, (b) not be inconsistent with the 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 the OFPA (7 U.S.C. 6519(f)), 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 EPA under the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA) (7 U.S.C. 136-136(y)).
[[Page 33293]]
The OFPA (7 U.S.C. 6520) 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. The 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 of
the RFA is to fit regulatory actions to the scale of businesses subject
to such actions in order that small business will not be unduly or
disproportionately burdened. 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.
Pursuant to the requirements set forth in the RFA, AMS performed an
economic impact analysis on small entities in the final rule published
in the Federal Register on December 21, 2000 (65 FR 80548). AMS has
also considered the economic impact of this final rule on small
entities and has determined that this rule would not have a significant
economic impact on a substantial number of small entities. The effect
of this final rule would be to allow the continued use of multiple
substances in agricultural production and handling. AMS concludes that
the economic impact of the renewals and renewals with amendment of
allowed substances, if any, would be minimal and beneficial to small
agricultural service firms. For the substances removed or further
restricted through this final action, AMS determined that their use is
either not prevalent or that alternatives to their use are available to
organic producers and handlers.
Small agricultural service firms, which include producers,
handlers, and accredited certifying agents, have been defined by the
Small Business Administration (SBA) (13 CFR 121.201) as those having
annual receipts of less than $7,000,000 and small agricultural
producers are defined as those having annual receipts of less than
$750,000.
According to NOP's Accreditation and International Activities
Division, the number of certified U.S. organic crop and livestock
operations totaled over 17,000 in 2010. According to USDA, Economic
Research Service (ERS) data based on information from USDA-accredited
certifying agents, certified organic acreage exceeded 4.8 million acres
in 2008.\2\ In 2009, U.S. certified organic apple acreage exceeded
21,000 acres, primarily concentrated in Washington and California.\3\
ERS, based upon the list of certified operations maintained by the NOP,
estimated the number of certified handling operations was 3,225 in
2007.\4\ AMS believes that most of these entities would be considered
small entities under the criteria established by the SBA.
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\2\ U.S. Department of Agriculture, Economic Research Service.
2009. Data Sets: U.S. Certified Organic Farmland Acreage, Livestock
Numbers and Farm Operations, 1992-2008. http://www.ers.usda.gov/Data/Organic/.
\3\ Kirby, Elizabeth, and David Granatstein. Status of Organic
Tree Fruit in Washington State--2009, Washington State University,
March 2010.
\4\ U.S. Department of Agriculture, Economic Research Service,
2009. Data Sets: Procurement and Contracting by Organic Handlers:
Documentation. http://www.ers.usda.gov/Data/OrganicHandlers/Documentation.htm.
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The U.S. sales of organic food and beverages have grown from $3.6
billion in 1997 to nearly $21.1 billion in 2008.\5\ The organic
industry is viewed as the fastest growing sector of agriculture,
representing over 3 percent of overall food sales in 2009. Between 1990
and 2008, organic food sales historically demonstrated a growth rate
between 15 to 24 percent each year. In 2010, organic food sales grew
7.7%.\6\
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\5\ Dimitri, C., and L. Oberholtzer. 2009. Marketing U.S.
Organic Foods: Recent Trends From Farms to Consumers, Economic
Information Bulletin No. 58, U.S. Department of Agriculture,
Economic Research Service, http://www.ers.usda.gov/Publications/EIB58.
\6\ Organic Trade Association's 2011 Organic Industry Survey,
http://www.ota.com.
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In addition, USDA has 93 accredited certifying agents who provide
certification services to producers and handlers. 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.
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 NOP-09-01
AMS received approximately 40 comments on the proposed rule. AMS
received comments from consumers, organic producers and handlers, trade
representatives, certifying agents, ingredient manufacturers,
consultants, and an environmental organization. Most comments
specifically addressed proposed amendments for individual substances. A
few comments were received in support of multiple or all of the
substances under this sunset review. A few comments presented concerns
that were not within the scope of the sunset review action.
All comments on the proposed amendments for hops and lignin
sulfonate and the proposed removal of potassium iodide were supportive
of the actions as proposed. Therefore, AMS is finalizing the amendments
and removals as proposed through this final rule.
Some comments suggested changes to the proposal rule for specific
substances. These comments are described below in conjunction with AMS'
response, including any amendments that will be addressed through this
final rule.
Chlorine Materials
AMS received six comments regarding the amendment for chlorine
materials allowed in crop production at section 205.601(a)(2). Comments
were received from trade associations, an environmental organization
and a sprout producer. Four comments supported the proposed amendment
for chlorine materials, while two comments raised issues associated
with the use of chlorine in sprouts.
AMS requested comments in the proposed rule on the use of chlorine
in treatment of seeds for organic sprout production. Consistent with
the NOSB recommendation, the proposed rule included an annotation
change which, in part, intended to clarify the use of chlorine in
edible sprout production. AMS specifically asked commenters to provide
information on whether using
[[Page 33294]]
the Environmental Protection Agency (EPA) labeled rate of chlorine for
sprouts (20,000 ppm), followed by a rinse of potable water, is
appropriate for organic production. AMS also sought input from
commenters on whether there are other Food and Drug Administration
(FDA) and EPA approved materials or methods suitable for sprout
treatment.
One commenter responded that methods to ensure sprout safety are
complex and stated that no single practice will completely eliminate
pathogens. This commenter supported the clarification on chlorine as
proposed and urged further development of criteria and procedures for
assessing alternatives that would be both acceptable to FDA and in
organic products.
One commenter stated that there are other equally effective
alternatives that would be more consistent with organic principles.
This commenter, however, noted that the 20,000 ppm soak in calcium
hypochlorite, a chlorine material currently allowed under the NOP
regulations, is the only treatment for sprouts addressed by FDA in
their guidance document.\7\ This commenter recommended that FDA clarify
other treatment options that are permitted and effective for sprout
treatment. AMS believes that this comment is pertinent to FDA's
guidance, rather than AMS' proposed amendment for chlorine. In the
absence of comments demonstrating acceptable alternatives for treatment
of seed for sprouting, AMS concludes that the annotation change on
chlorine specifying its allowance in spout production is appropriate
and will codify this change through this final rule.
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\7\ FDA, Guidance for Industry: Microbial Food Safety Hazards
for Sprouted Seeds. October 27, 1999. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ProduceandPlanProducts/ucm120244.htm.
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One commenter opposed all uses of chlorine in organic production,
other than unavoidable residues of chlorine from its use in treated
drinking water. This commenter stated that chlorine is a reactive
chemical that can combine with organic matter to form persistent
organochlorines and other disinfection byproducts. For this reason, the
commenter felt that added chlorine should not be used in organic crop
production. The commenter requested that AMS amend the annotation for
chlorine to restrict all chlorine used in direct contact with crops, in
irrigation systems, and in disinfection of equipment or tools to levels
no greater than the maximum residual disinfectant limit under the Safe
Drinking Water Act.
AMS disagrees with the commenter on this issue. The NOSB reviewed
and recommended chlorine for inclusion on the National List in 1995,
2003, 2006 and 2011, according to the OFPA evaluation criteria in 7
U.S.C. 6517 and 6518. In these reviews, the NOSB assessed the impact of
using chlorine on the environment and human health, but concluded that
the need for this substance in some instances is necessary to ensure
prevention of food borne pathogens. Consistent with the April 2011 NOSB
recommendation, AMS proposed an annotation to chlorine, which would
limit its direct use on crops and in soil contact to levels no higher
than those found in municipal drinking water. The NOSB has not
recommended any limitation on the use of chlorine for disinfecting
tools and equipment when necessary to prevent spread of plant diseases.
Therefore, AMS is codifying the annotation change to chlorine as
proposed through this final rule.
Pheromones
AMS received one comment about the continued allowance for
pheromones for insect management at section 205.601(f). The commenter
objected to the categorical relisting of pheromones and indicated that
the NOSB acted without sufficient information. The commenter indicated
that although pheromone products are valuable to organic producers,
there are many types of pheromones, and that the different types of
pheromones were not reviewed by the NOSB. The commenter also indicated
that the NOSB should address the use of additional ingredients in
pheromone product formulations. The commenter suggested that the
annotation be changed to list pheromones for insect management on
section 205.601, provided that they are exempt from regulation under
FIFRA (7 U.S.C. 136-136(y)) by 40 CFR 152.25(b).
AMS disagrees with the commenter on this issue. The NOSB is
responsible for reviewing generic materials, not specific product
formulations. The NOSB has previously reviewed and recommended
pheromones for inclusion on the National List according to the OFPA
criteria. The NOP regulations currently allow the use of inert
ingredients in pesticide formulations under a separate listing at
section 205.601(m). During their sunset deliberations, the NOSB
reviewed pheromones against the evaluation criteria in 7 U.S.C. 6517
and 6518 of the OFPA and concluded that they remain essential to
organic production since no organic alternatives exist. The NOSB
recommended that the exemption for pheromones continue as previously
allowed. AMS concurs with the NOSB's evaluation and recommendation of
this substance, and therefore, does not find that sufficient
information was provided by the commenter to justify the addition of an
annotation to the listing for pheromones on the National List.
Consistent with the NOSB recommendation, AMS is renewing the listing
for pheromones through this final rule as proposed.
Sulfur Dioxide
AMS received one comment that objected to the removal of sulfur
dioxide from section 205.601(g) based upon its use for rodent control
on organic farms. However, AMS did not receive any comments from
organic producers that this substance is commonly used. Furthermore, as
explained in the proposed rule, the NOSB determined that the EPA does
not register any products for use as a rodenticide that contain sulfur
dioxide as an active ingredient. Therefore, consistent with the NOSB
recommendation, AMS is removing the listing for sulfur dioxide as a
rodenticide from the National List through this final rule.
EPA List 4--Inerts of Minimal Concern
AMS received one comment about the continued allowance for
synthetic inert ingredients under the listing at section 205.601(m)(1)
for ``EPA List 4--Inerts of Minimal Concern.'' The commenter opposes
the inclusion of EPA List 4 as a category on the National List and
indicated that all substances included on EPA List 4 should be
individually considered by the NOSB. The commenter also objected to the
use of the term ``inert'' in describing other ingredients in pesticide
products. The commenter noted that ``inert'' ingredients may be
biologically active or have toxicological affects. AMS disagrees with
the commenter on this issue of redefining the term ``inert ingredient''
at this time. The term ``inert ingredient,'' is defined under the NOP
regulations for consistency with EPA regulations under FIFRA. AMS does
not conclude that sufficient information was provided by the commenter
to justify the removal of this listing from the National List.
Therefore, AMS is renewing the listing for EPA List 4 through this
final rule as proposed.
The commenter also suggested that the NOSB adopt a policy to
transition to the individual review of inert ingredients. This comment
is outside the scope of this rulemaking; however,
[[Page 33295]]
AMS notes that a working group is currently in place to address the
allowance of inerts that were previously classified as EPA List 4,
since the EPA is no longer maintaining this list.
Streptomycin
AMS received eight comments on the proposed rule to relist
streptomycin at section 205.601(i)(11) with an expiration date of
October 21, 2014. Comments were received from a university-affiliated
researcher, an agricultural pest and disease management specialist, an
apple producer, a trade association, certifying agents, a streptomycin
product manufacturer and an environmental organization.
One comment supported the proposal to set October 21, 2014, as the
expiration date for the use of streptomycin as recommended by the
NOSB.\8\ This comment cited the following factors in support of phasing
out streptomycin in organic apple and pear production: (i) Potential
for the substance's continued use to result in antibiotic resistance in
human pathogens; (ii) inconsistency with the prohibition on antibiotic
use in organic livestock production; and, (iii) incompatibility with
organic and sustainable agriculture. The commenter further clarified
the third point by stating that streptomycin use discourages cultural
and biological controls, such as disease-resistant varieties and
rootstock, site selection, careful fertilization, adequate tree
spacing, proper pruning, as well as newer biological control products.
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\8\ NOSB Formal Recommendation on Streptomycin Sunset. April 29,
2011. Available on the NOP Web site: http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5091714.
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Seven comments supported the proposal to relist streptomycin, but
opposed the addition of the October 21, 2014 expiration date. These
commenters stated that a longer allowance time is needed and provided
the following reasons for this opinion: (i) In practice, applications
of streptomycin are coupled with management strategies to reduce
susceptibility to fire blight and are generally limited to situations
when computer models warn that an infection is likely to occur; (ii)
there is a lack of viable, commercially available alternatives to
streptomycin for fire blight control in apple and pear production;
(iii) the research community is engaged in an ongoing effort to develop
alternatives to antibiotics for controlling fire blight; (iv)
streptomycin is particularly effective in humid areas where fire blight
has not developed resistance; and, (v) without the availability of
streptomycin to treat fire blight, some U.S. organic apple and pear
producers may exit organic production and imported products could
compensate for any decrease in U.S. production.
These commenters further stated that there is no assurance that
current research efforts will yield any commercially viable
alternative(s) to streptomycin in time for the October 21, 2014,
expiration date. A number of commenters specifically cited a USDA-
Organic Agriculture Research and Extension Initiative grant for the
development of non-antibiotic programs for fire blight control in
organic apple and pear production. Commenters explained that the
findings of this project, which started in September 2011, will not be
available until 2016, and would enable the NOSB to assess the
strategies for controlling fire blight without antibiotics after that
time.
Comments also addressed the efficacy of several of alternatives to
streptomycin, including resistant rootstocks and varieties, and
biological controls, all of which the NOSB cited in its justification
for recommending an expiration date. Several commenters explained that
resistant rootstocks are still in development and that resistance would
not convey to the upper part of the tree where the fire blight
infection takes hold. Some commenters stated that apple and pear
varieties have varying degrees of susceptibility to fire blight, but
none are immune. One commenter reported that consumers demand newer
apple and pear varieties, which are susceptible to fire blight, and
stated that there is no market for other varieties. One commenter noted
the slow progress in developing new varieties that exhibit favorable
eating and storage qualities, as well as fire blight resistance. Some
comments described biological controls as a component of an overall
fire blight management strategy, which are most effective when
supplemented with antibiotics. Comments also contended that years of
research have not yielded any biological control product that matches
the effectiveness of streptomycin.
Commenters specifically requested that the proposed expiration date
for streptomycin be deleted. In effect, such an action would renew the
current listing for streptomycin on the National List for five years,
until 2017, when it would be subject to sunset review.
Consistent with the NOSB recommendation, AMS is maintaining the
proposed amendment to allow streptomycin for fire blight control in
organic apple and pear production until October 21, 2014. During
deliberations, the NOSB reviewed technical information on streptomycin
in accordance with the criteria in OFPA (7 U.S.C. 6517-6518) and the
NOP regulations for synthetic substances on the National List (Sec.
205.600). The Technical Report considered by the NOSB addressed the
same issues raised by the commenters to the proposed rule concerning
the efficacy of alternatives to streptomycin.\9\ These alternatives
include biological controls, allowed synthetic substances, the
selection of varieties with low susceptibility to fire blight, and
agronomic practices including careful and timely pruning, maintaining
well-drained soil, limiting or excluding the use of manure and blossom
removal. The NOSB is mandated by OFPA to evaluate whether alternative
practices make the use of a substance such as streptomycin unnecessary.
In this case, the NOSB found widespread fire blight resistance to
streptomycin in apple production and continued use of apple and pear
varieties that are highly susceptible to fire blight. Ultimately, the
NOSB recommendation conveyed the expectation that preparation for the
removal of streptomycin would augment the development and use of
resistant rootstocks and cultivars, preventive management methods and
the use of allowed biological and chemical controls.
---------------------------------------------------------------------------
\9\ Technical Report on Streptomycin. March 8, 2011. Available
in petitioned substances database, under ``S,'' at the NOP Web site:
www.ams.usda.gov/nop.
---------------------------------------------------------------------------
The NOSB also considered additional factors in its decision,
including antibiotic resistance in humans and the high susceptibility
of leading varieties of organic apple and pears, in terms of acreage,
to fire blight. Consistent with the OFPA, the NOSB evaluated the
effects of the use of streptomycin upon human health. The NOSB
considered information from the Technical Report that streptomycin
sprays can leave detectable residues in apple cores and skins. Based on
this information, the NOSB was concerned that the continued use of
streptomycin could contribute to antibiotic resistance which would be
inconsistent with the principles of organic production and the OFPA
criteria. The NOSB also stated that consumers expect that organic
products are not produced with antibiotics.
At the April 2011 meeting, the NOSB Crops Committee put forth a
proposal to extend the exemption for streptomycin until October 21,
2014. This proposal was intended to phase out use of this
[[Page 33296]]
substance while providing a sufficient timeframe for industry members
to prepare for the removal of streptomycin from the National List. At
the April 2011 NOSB meeting, the NOSB took two votes on the proposal
for streptomycin: one vote on their recommendation to list streptomycin
with the October 21, 2014, expiration date, and one ``back up vote'' to
relist streptomycin without restriction. The NOSB conducted these votes
in accordance with their sunset review process.\10\ The April 2011 NOSB
recommendation for streptomycin specified their intent to phase out use
of the substance over time through addition of the October 21, 2014,
expiration date.\11\ Therefore, consistent with the recommendation of
the NOSB, AMS published a rule proposing the October 21, 2014,
expiration date for streptomycin.
---------------------------------------------------------------------------
\10\ The NOSB sunset review process is described on pg. 54 of
the NOSB Policy and Procedures Manual. Available at NOP Web site:
http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELDEV3013893.
This process is further described in the October 28, 2010, NOSB
Recommendation on Sunset Review Process. Available at NOP Web site:
http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5088004&acct=nosb.
\11\ NOSB Recommendation on Streptomycin, April 29, 2011.
Available at NOP Web site: http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5091714.
---------------------------------------------------------------------------
While some commenters submitted comments advocating for relisting
streptomycin without restriction, AMS did not receive any new
information from commenters on this issue that the NOSB had not
considered during their April 2011 deliberations on streptomycin.
Furthermore, AMS believes that relisting streptomycin without an
expiration date would not meet the intent of the NOSB to phase out the
use of this substance in organic apple and pear production over time.
Therefore, consistent with the NOSB recommendation, AMS is codifying
the addition of an expiration date to the listing for streptomycin
through this final rule. Finally, AMS notes that extending the
allowance for the use of streptomycin after the October 21, 2014,
expiration date would require 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).
Flavors
AMS received one comment from a trade association that specifically
addressed the proposed relisting of flavors, nonsynthetic sources only,
on section 205.605(a). The commenter supported the continued listing of
nonsynthetic flavors with the existing restriction, ``must not be
produced using synthetic solvents and carrier system or any artificial
preservatives.'' AMS is renewing the listing for flavors as proposed
through this final rule.
The commenter, however, further requested that the NOP issue a
guidance document to request that certifying agents use a standardized
industry questionnaire to verify compliance of the use of nonsynthetic
flavors in organic handling. AMS concludes this request is beyond the
scope of this final rule.
Yeast
AMS received over twenty comments in response to the proposed
amendment for yeast. The majority of comments were supportive of the
amendment in the proposed rule.
One commenter noted that the proposed amendment for yeast would
require producers of products labeled ``made with organic (specified
ingredients or food group(s))'' to be subject to commercial
availability before using a nonorganic ingredient, which is not
required for products in this labeling category. Under section
205.301(c) of the NOP regulations, products sold, labeled, or
represented as ``made with organic (specified ingredients or food
group(s))'' are not subject to the requirement that the product must
not be produced using nonorganic ingredients when organic ingredients
are available. AMS concludes that a modification to the proposed
amendment for yeast is necessary to ensure consistency with the NOP
regulations. Therefore, AMS has amended the yeast annotation through
this final rule to clarify that the requirement that yeast be organic
when commercially available is only applicable to products labeled
``organic.''
One commenter noted that the use of the term ``equivalent organic
yeast'' in the proposed amendment was unclear since ``equivalent'' was
not defined. The commenter noted that organic yeast may have lower
leavening activity than conventional yeast, or may only be available in
a specific form (e.g. dry and not fresh), and therefore would not be
considered ``equivalent.'' AMS notes that the amendment allows the use
of conventional yeast when organic yeast is not commercially available.
Under the NOP regulations, ``commercially available'' is defined as the
ability to obtain a production input in an appropriate form, quality,
or quantity to fulfill an essential function in a system of organic
production or handling, as determined by the certifying agent in the
course of reviewing the organic plan. Thus, organic yeast is not
required to be used if it is not available in the appropriate form or
quality, as noted in the commenter's examples. To reduce confusion over
the use of the term ``equivalent,'' AMS has removed this term from the
amendment in the final rule as we believe the inclusion is redundant
with the existing criteria for commercial availability.
One commenter requested that AMS develop guidelines specifically
for changes to the National List for which label revisions will be
necessary. The commenter specifically noted that an operator presently
using nonorganic yeast that successfully sources organic yeast will
need to update the ingredient statement in their product labels to
indicate the yeast is organic. The commenter suggested these guidelines
allow at least one year for label revisions.
AMS notes that the effective date of this amendment requires that
product formulations be compliant by October 21, 2012. The publication
of this final rule provides almost four months of notice to the
industry about this change. Sections 205.304-205.306 of the NOP
regulations require that each organic ingredient in the ingredient
statement be identified with the word, ``organic,'' or with an asterisk
or other reference mark which is defined below the ingredient statement
to indicate the ingredient is organically produced. Therefore, if
product formulations must be compliant by October 21, 2012, then the
labels for these products should also be compliant with the regulations
at sections 205.304-205.306 by the effective date for this amendment.
Products entering the stream of commerce prior to the effective date do
not have to be relabeled. AMS further notes that development of broad
guidelines on label use up for any National List change is beyond the
scope of this rulemaking.
Two commenters requested that yeast be moved from section 205.605
of the National List to section 205.606, as an agricultural product.
One commenter noted that listing yeast on section 205.605 would allow
products labeled ``made with organic (specified ingredients or food
group(s))'' to use non-organic yeast without the requirements for
documenting commercial availability. The NOP has addressed the concerns
for products labeled ``made with organic (specified ingredients or food
group(s))'' by clarifying that the annotation which requires organic
yeast is applicable only to products labeled ``organic.'' One commenter
noted that yeast is an
[[Page 33297]]
organism grown for food and that it should be considered an
agricultural product for listing on section 205.606, rather than
section 205.605. Based on review of the record, the NOSB considered
this perspective during its deliberations before issuing its formal
recommendation to the NOP; therefore, AMS has chosen to retain the
listing on section 205.605, as recommended by the NOSB, rather than
moving the listing to section 205.606.
One commenter was opposed to the proposed amendment for yeast and
supported the existing listing. The commenter noted that organic yeast
is only available in dry form, not fresh. In addition, the commenter
claimed that leavening activity in organic yeast is much lower than
conventional yeast and that organic yeast is costly, and, therefore, is
not equivalent in performance and cost. AMS notes that the current
annotation permits the use of nonorganic yeast when organic yeast is
not commercially available. Under the NOP regulations, section 205.2,
commercially available is defined as the ability to obtain a production
input in an appropriate form, quality, or quantity to fulfill an
essential function in a system of organic production or handling, as
determined by the certifying agent in the course of reviewing the
organic plan. The commenter's concern about sourcing an appropriate
form (e.g. fresh, rather than dry) or quality (e.g. better leavening
activity) could be considered by the certifying agent to determine
whether nonorganic yeast would be allowed under the regulations in
specific applications. The higher cost of organic yeast is not one of
the permitted criteria for determining commercial availability under
the NOP regulations. The NOSB considered the issues raised by the
commenters, and AMS concludes that the inclusion of a commercial
availability clause addresses the commenter's concern about the
allowance for conventional yeast when organic yeast is not available in
an appropriate form, quality, or quantity.
Silicon Dioxide
The NOP received one comment stating that the listing for silicon
dioxide at section 205.605(b) should be amended to reflect a December
2011 NOSB recommendation on this substance. In their December 2011
recommendation, the NOSB recommended the addition of a restrictive
annotation to specify that silicon dioxide, a synthetic used in
processed products, could only be used if a nonsynthetic alternative
for certain uses is not commercially available. However, the December
2011 NOSB recommendation was not available when drafting the proposed
rule for this 2012 Sunset Review. Therefore, consistent with the
October 2010 NOSB recommendation pertaining to the 2012 Sunset Review
for this substance, AMS published a proposed rule on January 12, 2012,
to renew silicon dioxide at section 205.605(b) as currently listed
(i.e. without annotation). Because the proposal to amend the annotation
for silicon dioxide was not included in the proposed rule and AMS did
not receive public comment on such a change, AMS is not amending the
annotation in this final rule. AMS is, therefore, renewing the existing
listing for silicon dioxide through this final rule as proposed. AMS
intends to address the December 2011 NOSB recommendation for this
substance through a separate rulemaking action for National List
amendments.
Xanthan Gum
AMS received one comment from a trade association in support of
relisting xanthan gum; however, this commenter also suggested
reclassifying the substance as nonsynthetic and relisting it at section
205.605(a) of the National List. This commenter describes xanthan gum
as a natural extracellular polysaccharide. The NOSB reviewed xanthan
gum in April 2010 and did not propose any change in classification at
that time. Therefore, AMS is renewing the listing for xanthan gum as
codified.
Pectin
In accordance with the October 2010 NOSB recommendation, the NOP
proposed to remove the listing of synthetic pectin (low methoxy) at
section 205.605(b), and to amend the listing for pectin (high-methoxy)
at section 205.606(t) to ``Pectin (non-amidated forms only).'' The NOP
received five comments in support of these proposed changes from trade
associations, a beverage and dairy products manufacturer, and a
consulting firm. The commenters agreed generally that non-amidated
forms of pectin are adequate for use in organic products.
One commenter opposed the proposed changes for technical reasons.
This commenter disagreed with the October 2010 NOSB recommendation that
considered both low-methoxy and high-methoxy pectin to be derived from
a similar non-synthetic extraction process, with the difference in the
final substance resulting from a longer extraction period. The
commenter pointed out that the low-methoxy pectin is produced as a
result of esterification (by removal of methyl groups, or
demethylation) of high-methoxy pectin which is initially derived from
citrus peel or apple pomace.\12\ This commenter agreed that amidated
forms of pectin (forms treated with ammonia) are not necessary for use
in organic production, but noted that only low-methoxy pectin is
available in amidated form. This commenter suggested that the listing
at section 205.605(b) be amended to: ``Low-methoxy pectin, non-amidated
forms only'' and that the existing listing for high-methoxy pectin be
retained at section 205.606.
---------------------------------------------------------------------------
\12\ This process is also described in the 2009 Technical Report
for Non Amidated Low Methoxyl Pectin. Available at NOP Web site:
http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5087206.
---------------------------------------------------------------------------
While AMS believes that the commenter has merit regarding technical
classification of the substance, the intent of the NOSB was to require
that all forms of pectin used in organic products be subject to the
requirement that organic sources be used when commercially available.
Therefore, consistent with the intent of the NOSB, we have retained the
proposed amendments for pectin in this final rule.
Colors
AMS received four comments in support of the proposed amendment to
the listing for colors at section 205.606(d). The proposed listing was
``Colors derived from agricultural products--Must not be produced using
synthetic solvents and carrier systems or any artificial
preservative.'' These commenters, however, requested that AMS clarify
whether synthetic substances allowed under section 205.605(b) for
solvent extraction, or as carriers, preservatives or stabilizers, and
which are currently allowed for use in organic colors, would also be
allowed for use in nonorganic colors at section 205.606. Commenters
specifically referenced ascorbic acid, carbon dioxide, glycerin,
silicon dioxide and tocopherols, as examples of substances listed at
section 205.605(b), which are currently allowed to produce organic
colors. These substances were previously recommended by the NOSB and
are currently codified as allowed synthetics at section 205.605(b) of
the National List. The commenters requested clarification as to whether
such substances at section 205.605(b) would still be allowed in the
production of nonorganic colors under the proposed amendment.
At their October 2010 meeting, the NOSB discussed the need for an
annotation to clarify the allowance of synthetic solvents in the
preparation of
[[Page 33298]]
the colors listed on section 205.606.\13\ The NOSB recommended an
amendment to restrict the use of synthetic solvents, carrier systems
and artificial preservatives in the production of colors. However, in
their recommendation, the NOSB did not address whether this restriction
would apply to synthetics already listed at section 205.605(b).
---------------------------------------------------------------------------
\13\ This NOSB discussion is available on the NOP Web site in
the meeting transcript for Oct. 26, 2010 at http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5088302&acct=nosb.
---------------------------------------------------------------------------
The NOSB has already reviewed and recommended the synthetics listed
at section 205.605(b) of the National List. Therefore, the synthetics
listed at section 205.605(b) of the National List are already allowed
in organic processed products, including in the formulation of colors.
AMS believes the intent of the NOSB recommendation for colors is to
prevent the use of synthetic substances that are not on the National
List in the formulation of colors. Substances at section 205.605(b) of
the National List will still be allowed in the production of nonorganic
colors under the amendment.
One commenter stated that unrestricted use of synthetic solvents or
carriers permitted by FDA should be acceptable in colors used for
organic production. AMS disagrees with this comment. While certain
synthetic solvents or carriers may be permitted by FDA, these
synthetics would need to be petitioned and reviewed by the NOSB for
inclusion on the National List under the NOP regulations.
Some commenters requested that AMS provide a one year compliance
date from the effective date of the amendment to colors. Commenters
stated that, while they believe that colors that comply with the
amendment are available, manufacturers will need time to reformulate
products that contained colors produced with synthetic solvents or
carrier systems no longer allowed under the amendment. Based on the
comments received, AMS understands that some product reformulation may
be necessary. The effective date for this amendment is June 27, 2012,
the sunset date for the current listing for colors. While this
amendment is effective on June 27, 2012, AMS considers a one year
period from that date as reasonable and appropriate for the industry to
reformulate products in order to ensure that the amendment is
effectively and rationally implemented. AMS will be conducting outreach
to the industry and training for certifying agents as appropriate.
Cornstarch
AMS received one comment opposed to the continued listing of
cornstarch (native) at section 205.606(w)(1) of the National List. This
commenter cited several sources for organic cornstarch that include a
number of types for different applications, and suggested that
nonorganic cornstarch should no longer be given an exemption for
organic use. The commenter also believes that nonorganic cornstarch
should not be included on the National List since most nonorganic
sources could be derived from genetically engineered corn.
During the October 2010 NOSB deliberations on the 2012 Sunset
Review for cornstarch, the NOSB did not receive public comments
objecting to relisting of cornstarch, and received several in support
of relisting on section 205.606. In their review, the NOSB did not
identify risks to the environment, human or animal health resulting
from the use or manufacture of the substance. Based upon the NOSB's
recommendation, AMS is relisting cornstarch as codified at section
205.606. AMS notes that all nonorganic ingredients, including
cornstarch, used in products labeled ``organic'' or ``made with organic
(specified ingredients or food group(s)'' must not be produced using
excluded methods, and that organic cornstarch should be used if
commercially available.
F. Effective Date
This final rule reflects recommendations submitted to the Secretary
by the NOSB for the purpose of fulfilling the requirements of 7 U.S.C.
6517(e) of the OFPA. Section 7 U.S.C. 6517(e) requires the NOSB to
review each substance on the National List within 5 years of its
publication. The substances being renewed or reauthorized with amended
annotations on the National List were most recently reauthorized for
use in organic agriculture on June 27, 2007, October 21, 2007, December
11, 2007, and December 13, 2007. In the case of substances reauthorized
for use on June 27, 2007 and due to expire on June 27, 2012, the
substances being renewed and amended are critical to organic production
and handling operations.
Accordingly, pursuant to 5 U.S.C. 553, it is found and determined
that good cause exists for not postponing the effective date for
amendments and renewals contained in this rule that are due to expire
on June 27, 2012, until 30 days after publication in the Federal
Register. The effective dates for all substances are indicated in the
Appendix.
List of Subjects in 7 CFR Part 205
Administrative practice and procedure, Agriculture, Animals,
Archives and records, 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.
0
2. Section 205.601 is amended by:
0
A. Revising paragraph (a)(2);
0
B. Revising paragraph (g);
0
C. Revising paragraph (i)(11); and
0
D. Revising paragraph (j)(4) to read as follows:
Sec. 205.601 Synthetic substances allowed for use in organic crop
production.
* * * * *
(a) * * *
(2) Chlorine materials--For pre-harvest use, residual chlorine
levels in the water in direct crop contact or as water from cleaning
irrigation systems applied to soil must not exceed the maximum residual
disinfectant limit under the Safe Drinking Water Act, except that
chlorine products may be used in edible sprout production according to
EPA label directions.
(i) Calcium hypochlorite.
(ii) Chlorine dioxide.
(iii) Sodium hypochlorite.
* * * * *
(g) As rodenticides. Vitamin D3.
* * * * *
(i) * * *
(11) Streptomycin, for fire blight control in apples and pears only
until October 21, 2014.
* * * * *
(j) * * *
(4) Lignin sulfonate--chelating agent, dust suppressant.
* * * * *
0
3. Section 205.605 is amended by:
0
A. Revising the annotation for ``Yeast'' under paragraph (a);
0
B. Removing ``Pectin (low-methoxy)'' from paragraph (b); and
0
C. Removing the paragraph for ``Potassium iodide'' from paragraph (b).
The revision reads as follows:
[[Page 33299]]
Sec. 205.605 Nonagricultural (nonorganic) substances allowed as
ingredients in or on processed products labeled as ``organic'' or
``made with organic (specified ingredients or food group(s)).''
* * * * *
(a) * * *
* * * * *
Yeast--When used as food or a fermentation agent in products
labeled as ``organic,'' yeast must be organic if its end use is for
human consumption; nonorganic yeast may be used when organic yeast is
not commercially available. Growth on petrochemical substrate and
sulfite waste liquor is prohibited. For smoked yeast, nonsynthetic
smoke flavoring process must be documented.
* * * * *
0
4. Section 205.606 is amended by:
0
A. Revising paragraph (d);
0
B. Revising paragraph (l); and
0
C. Revising paragraph (t).
0
The revisions read as follows:
Sec. 205.606 Nonorganically produced agricultural products allowed as
ingredients in or on processed products labeled ``organic''.
* * * * *
(d) Colors derived from agricultural products--Must not be produced
using synthetic solvents and carrier systems or any artificial
preservative.
* * * * *
(l) Hops (Humulus lupulus) until January 1, 2013.
* * * * *
(t) Pectin (non-amidated forms only).
* * * * *
Dated: May 30, 2012.
David R. Shipman,
Administrator, Agricultural Marketing Service.
Note: The following Appendix will not appear in the Code of Federal
Regulations.
---------------------------------------------------------------------------
\14\ This Appendix shows a simplified listing for each
substance; use categories and any restrictive annotations are not
included in this overview.
Appendix--Overview of Final Actions for Sunset 2012 \14\
----------------------------------------------------------------------------------------------------------------
National list section Substance NOSB meeting Effective date Final action
----------------------------------------------------------------------------------------------------------------
Sec. 205.601 Synthetic Alcohols April 2011............. June 27, 2012.......... Renew.
substances allowed for use (Ethanol; April 2010 *........... June 27, 2012.......... Renew.
in organic crop production. Isopropanol). April 2010 *........... June 27, 2012.......... Renew.
Ammonium
carbonate.
Aquatic plant
extracts
(other than
hydrolyzed).
Boric acid..... April 2010 *........... June 27, 2012.......... Renew.
Chlorine April 2011............. June 27, 2012.......... Amend: Chlorine
materials at materials--For
Sec. pre-harvest
205.601(a)(2) use, residual
(Calcium chlorine
hypochlorite; levels in the
chlorine water in
dioxide; direct crop
sodium contact or as
hypochlorite). water from
cleaning
irrigation
systems
applied to
soil must not
exceed the
maximum
residual
disinfectant
limit under
the Safe
Drinking Water
Act, except
that chlorine
products may
be used in
edible sprout
production
according to
EPA label
directions.
Coppers, fixed April 2011............. June 27, 2012.......... Renew.
(Copper
hydroxide;
copper oxide;
copper
oxychloride,
includes
products
exempted from
EPA tolerance).
Copper sulfate. April 2011............. June 27, 2012.......... Renew.
Elemental April 2010 *........... June 27, 2012.......... Renew.
sulfur (3
uses).
EPA List 4-- October 2010........... June 27, 2012.......... Renew.
Inerts of
Minimal
Concern.
Ethylene gas... April 2011............. June 27, 2012.......... Renew.
Herbicides, April 2010 *........... June 27, 2012.......... Renew.
soap-based.
Humic acids.... April 2010 *........... June 27, 2012.......... Renew.
Hydrated lime.. April 2010 *........... June 27, 2012.......... Renew.
Hydrogen April 2010 *........... June 27, 2012.......... Renew.
peroxide (2
uses).
Lignin April 2011............. June 27, 2012.......... Amend: Lignin
sulfonate at sulfonate--che
Sec. lating agent,
205.601(j)(4). dust
suppressant.
Lignin April 2011............. June 27, 2012.......... Renew.
sulfonate at
Sec.
205.601(l)(1).
Lime sulfur (2 April 2010 *........... June 27, 2012.......... Renew.
uses).
Liquid fish April 2010 *........... June 27, 2012.......... Renew.
products.
Magnesium April 2011............. June 27, 2012.......... Renew.
sulfate.
Micronutrients April 2010 *........... June 27, 2012.......... Renew.
(Soluble boron
products;
Sulfates,
carbonates,
oxides, or
silicates of
zinc, copper,
iron,
manganese,
molybdenum,
selenium, and
cobalt).
[[Page 33300]]
Mulches April 2011............. June 27, 2012.......... Renew.
(Newspapers or
other recycled
paper, without
glossy or
colored inks;
Plastic mulch
and covers).
Newspapers or April 2011............. June 27, 2012.......... Renew.
other recycled
paper, without
glossy or
colored inks.
Oils, April 2010 *........... June 27, 2012.......... Renew.
horticultural-
narrow range
oils as
dormant,
suffocating,
and summer
oils (2 uses).
Pheromones..... April 2011............. June 27, 2012.......... Renew.
Potassium April 2010 *........... June 27, 2012.......... Renew.
bicarbonate.
Soap-based April 2010 *........... June 27, 2012.......... Renew.
algicide/
demossers.
Soaps, ammonium April 2010 *........... June 27, 2012.......... Renew.
Soaps, April 2010 *........... June 27, 2012.......... Renew.
insecticidal.
Sodium silicate April 2011............. June 27, 2012.......... Renew.
Sticky traps/ April 2010 *........... June 27, 2012.......... Renew.
barriers.
Streptomycin... April 2011............. June 27, 2012.......... Amend:
Streptomycin,
for fire
blight control
in apples and
pears only
until October
21, 2014.
Sucrose April 2010 *........... June 27, 2012.......... Renew.
octanoate
esters (CAS
s--42
922-74-7;
58064-47-4).
Sulfur dioxide. April 2011............. October 21, 2012....... Remove.
Vitamin B1, C, April 2010 *........... June 27, 2012.......... Renew.
and E.
Vitamin D3..... April 2011............. June 27, 2012.......... Renew.
Sec. 205.602 Nonsynthetic Arsenic........ April 2010 *........... June 27, 2012.......... Renew.
substances prohibited for Ash from manure April 2010 *........... June 27, 2012.......... Renew.
use in organic crop burning. April 2010 *........... June 27, 2012.......... Renew.
production. Lead salts.....
Potassium April 2010 *........... June 27, 2012.......... Renew.
chloride.
Sodium April 2010 *........... June 27, 2012.......... Renew.
fluoaluminate
(mined).
Sodium nitrate. April 2011............. ....................... Addressed in
separate
rulemaking
action.
Strychnine..... April 2010 *........... June 27, 2012.......... Renew.
Tobacco dust April 2010 *........... June 27, 2012.......... Renew.
(nicotine
sulfate).
Sec. 205.603 Synthetic Alcohols October 2010........... June 27, 2012.......... Renew.
substances allowed for use (Ethanol; October 2010........... June 27, 2012.......... Renew.
in organic livestock Isopropanol). April 2010 *........... June 27, 2012.......... Renew.
production. Aspirin........ April 2010 *........... June 27, 2012.......... Renew.
Atropine (CAS
-51-5
5-8).
Biologics--Vacc
ines.
Butorphanol April 2010 *........... June 27, 2012.......... Renew.
(CAS -
42408-82-2).
Chlorhexidine.. April 2010 *........... June 27, 2012.......... Renew.
Chlorine October 2010........... June 27, 2012.......... Renew.
materials
(Calcium
hypochlorite;
chlorine
dioxide;
sodium
hypochlorite).
Copper sulfate. October 2010........... June 27, 2012.......... Renew.
Electrolytes... April 2010 *........... June 27, 2012.......... Renew.
EPA List 4-- October 2010........... June 27, 2012.......... Renew.
Inerts of
Minimal
Concern.
Excipients..... April 2010 *........... June 27, 2012.......... Renew.
Flunixin (CAS April 2010 *........... June 27, 2012.......... Renew.
-3867
7-85-9).
Furosemide..... October 2010........... June 27, 2012.......... Renew.
Glucose........ October 2010........... June 27, 2012.......... Renew.
Glycerine...... October 2010........... June 27, 2012.......... Renew.
Hydrogen April 2010 *........... June 27, 2012.......... Renew.
peroxide.
Iodine (2 uses) April 2010 *........... June 27, 2012.......... Renew.
Ivermectin..... April 2010 *........... June 27, 2012.......... Renew.
Lidocaine...... April 2010 *........... June 27, 2012.......... Renew.
Lime, hydrated. April 2010 *........... June 27, 2012.......... Renew.
Magnesium April 2010 *........... June 27, 2012.......... Renew.
hydroxide (CAS
-1309
-42-8).
Magnesium October 2010........... June 27, 2012.......... Renew.
sulfate.
Mineral oil.... April 2010 *........... June 27, 2012.......... Renew.
Oxytocin....... April 2010 *........... June 27, 2012.......... Renew.
Peroxyacetic/ April 2010 *........... June 27, 2012.......... Renew.
peracetic acid
(CAS -
79-21-0).
Phosphoric acid April 2010 *........... June 27, 2012.......... Renew.
Poloxalene (CAS April 2010 *........... June 27, 2012.......... Renew.
-9003
-11-6).
Procaine....... April 2010 *........... June 27, 2012.......... Renew.
[[Page 33301]]
Sucrose April 2010 *........... June 27, 2012.......... Renew.
octanoate
esters (CAS
s--42
922-74-7;
58064-47-4).
Tolazoline (CAS April 2010 *........... June 27, 2012.......... Renew.
-59-9
8-3).
Trace minerals. April 2010 *........... June 27, 2012.......... Renew.
Vitamins....... April 2010 *........... June 27, 2012.......... Renew.
Xylazine (CAS April 2010 *........... June 27, 2012.......... Renew.
-7361
-61-7).
Sec. 205.604 Nonsynthetic Strychnine..... April 2010 *........... June 27, 2012.......... Renew.
substances prohibited for
use in organic livestock
production.
Sec. 205.605(a) Acids (Alginic; April 2010 *........... June 27, 2012.......... Renew.
Nonsynthetic, citric; April 2010 *........... June 27, 2012.......... Renew.
nonagricultural substances lactic). April 2010 *........... June 27, 2012.......... Renew.
allowed as ingredients in Bentonite...... April 2010 *........... June 27, 2012.......... Renew.
or on processed products Calcium April 2010 *........... June 27, 2012.......... Renew.
labeled as ``organic'' or carbonate. April 2010 *........... June 27, 2012.......... Renew.
``made with organic Calcium April 2011............. June 27, 2012.......... Renew.
(specified ingredients or chloride. October 2010........... June 27, 2012.......... Renew.
food group(s))''. Dairy cultures. April 2010 *........... June 27, 2012.......... Renew.
Diatomaceous
earth.
Enzymes........
Flavors........
Kaolin.........
Magnesium October 2010........... June 27, 2012.......... Renew.
sulfate.
Nitrogen....... April 2010 *........... June 27, 2012.......... Renew.
Oxygen......... April 2010 *........... June 27, 2012.......... Renew.
Perlite........ April 2010 *........... June 27, 2012.......... Renew.
Potassium April 2010 *........... June 27, 2012.......... Renew.
chloride.
Potassium April 2011............. June 27, 2012.......... Renew.
iodide.
Sodium April 2010 *........... June 27, 2012.......... Renew.
bicarbonate.
Sodium April 2010 *........... June 27, 2012.......... Renew.
carbonate.
Waxes (Carnauba April 2010 *........... June 27, 2012.......... Renew.
wax; Wood
resin).
Yeast October 2010........... October 21, 2012....... Amend: Yeast--
(Autolysate; When used as
Bakers; food or a
Brewers; fermentation
Nutritional; agent in
Smoked). products
labeled
``organic'',
yeast must be
organic if its
end use is for
human
consumption;
nonorganic
yeast may be
used when
organic yeast
is not
commercially
available.
Growth on
petrochemical
substrate and
sulfite waste
liquor is
prohibited.
For smoked
yeast,
nonsynthetic
smoke
flavoring
process must
be documented.
Sec. 205.605(b) Synthetic, Alginates...... April 2010 *........... June 27, 2012.......... Renew.
nonagricultural substances Ammonium April 2010 *........... June 27, 2012.......... Renew.
allowed as ingredients in bicarbonate. April 2010 *........... June 27, 2012.......... Renew.
or on processed products Ammonium April 2010 *........... June 27, 2012.......... Renew.
labeled as ``organic'' or carbonate. April 2010 *........... June 27, 2012.......... Renew.
``made with organic Ascorbic Acid.. April 2010 *........... June 27, 2012.......... Renew.
(specified ingredients or Calcium citrate April 2010 *........... June 27, 2012.......... Renew.
food group(s))''. Calcium April 2010 *........... June 27, 2012.......... Renew.
hydroxide.
Calcium
phosphates
(monobasic;
dibasic;
tribasic).
Carbon dioxide.
Chlorine October 2010........... June 27, 2012.......... Renew.
materials
(Calcium
hypochlorite;
chlorine
dioxide;
sodium
hypochlorite).
Ethylene....... April 2010 *........... June 27, 2012.......... Renew.
Ferrous sulfate October 2010........... June 27, 2012.......... Renew.
Glycerides April 2010 *........... June 27, 2012.......... Renew.
(mono; di).
Glycerin....... April 2010 *........... June 27, 2012.......... Renew.
Hydrogen April 2010 *........... June 27, 2012.......... Renew.
peroxide.
Magnesium April 2010 *........... June 27, 2012.......... Renew.
carbonate.
Magnesium April 2010 *........... June 27, 2012.......... Renew.
chloride.
Magnesium April 2010 *........... June 27, 2012.......... Renew.
stearate.
Nutrient April 2011............. ....................... Addressed in
vitamins and separate
minerals. rulemaking
action.
Ozone.......... April 2010 *........... June 27, 2012.......... Renew.
Pectin (low- October 2010........... June 27, 2012.......... Remove.
methoxy).
Phosphoric acid October 2010........... June 27, 2012.......... Renew.
Potassium acid April 2010 *........... June 27, 2012.......... Renew.
tartrate.
Potassium April 2010 *........... June 27, 2012.......... Renew.
carbonate.
Potassium April 2010 *........... June 27, 2012.......... Renew.
citrate.
Potassium April 2010 *........... June 27, 2012.......... Renew.
hydroxide.
[[Page 33302]]
Potassium April 2011............. June 27, 2012.......... Remove.
iodide.
Potassium April 2010 *........... June 27, 2012.......... Renew.
phosphate.
Silicon dioxide October 2010........... June 27, 2012.......... Renew.
Sodium citrate. October 2010........... June 27, 2012.......... Renew.
Sodium October 2010........... June 27, 2012.......... Renew.
hydroxide.
Sodium October 2010........... June 27, 2012.......... Renew.
phosphates.
Sulfur dioxide. October 2010........... June 27, 2012.......... Renew.
Tocopherols.... April 2011............. June 27, 2012.......... Renew.
Xanthan gum.... April 2010 *........... June 27, 2012.......... Renew.
Sec. 205.606 Casings, from April 2010 *........... June 27, 2012.......... Renew.
Nonorganically produced processed April 2010 *........... June 27, 2012.......... Renew.
agricultural products intestines. April 2010 *........... June 27, 2012.......... Renew.
allowed as ingredients in Celery powder.. October 2010........... June 27, 2012.......... Amend: Colors
or on processed products Chia (Salvia derived from
labeled as ``organic''. hispanica L.). agricultural
Colors (Annatto products--Must
extract color; not be
Beet juice produced using
extract color; synthetic
Beta-carotene solvents and
extract color; carrier
Black currant systems or any
juice color; artificial
Black/purple preservative.
carrot juice
color;
Blueberry
juice color;
Carrot juice
color; Cherry
juice color;
Chokeberry--Ar
onia juice
color;
Elderberry
juice color;
Grape juice
color; Grape
skin extract
color; Paprika
color; Pumpkin
juice color;
Purple potato
juice color;
Red cabbage
extract color;
Red radish
extract color;
Saffron
extract color;
Turmeric
extract
color). CAS
numbers are
provided in
the Renewals
with Amendment
section.
Cornstarch October 2010........... June 27, 2012.......... Renew.
(native).
Dillweed oil April 2010 *........... June 27, 2012.......... Renew.
(CAS
8006-75-5).
Fish oil (Fatty April 2010 *........... June 27, 2012.......... Renew.
acid CAS
's
10417-94-4 and
25167-62-8).
Fructooligosacc October 2010........... June 27, 2012.......... Renew.
harides (CAS
308066-66-2).
Galangal, April 2010 *........... June 27, 2012.......... Renew.
frozen.
Gelatin (CAS April 2010 *........... June 27, 2012.......... Renew.
9000-
70-8).
Gums (Arabic; April 2010 *........... June 27, 2012.......... Renew.
Guar; Locust
bean; Carob
bean).
Hops (Humulus October 2010........... June 27, 2012.......... Amend: Hops
luplus) at (Humulus
Sec. lupulus) until
205.606(l). January 1,
2013.
Inulin, October 2010........... June 27, 2012.......... Renew.
oligofructose
enriched.
(CAS
9005-80-5).
Kelp........... April 2010 *........... June 27, 2012.......... Renew.
Konjac flour April 2010 *........... June 27, 2012.......... Renew.
(CAS
37220-17-0).
Lemongrass, April 2010 *........... June 27, 2012.......... Renew.
frozen.
Orange shellac-- April 2010 *........... June 27, 2012.......... Renew.
unbleached
(CAS
9000-59-3).
Pectin (high- October 2010........... June 27, 2012.......... Amend: Pectin
methoxy). (non-amidated
forms only).
Peppers April 2010 *........... June 27, 2012.......... Renew.
(chipotle
chile).
Sweet potato April 2010 *........... June 27, 2012.......... Renew.
starch.
Turkish bay April 2010 *........... June 27, 2012.......... Renew.
leaves.
Wakame seaweed April 2010 *........... June 27, 2012.......... Renew.
(Undaria
pinnatifida).
Whey protein October 2010........... June 27, 2012.......... Renew.
concentrate.
----------------------------------------------------------------------------------------------------------------
* The NOSB originally recommended that these substances be relisted during their April 2010 meeting. Since
public comments were still being accepted for these substances, the NOSB decided to reaffirm their
recommendations on these substances at the October 2010 meeting after analyzing all public comments.
[FR Doc. 2012-13523 Filed 6-5-12; 8:45 am]
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