[Federal Register Volume 77, Number 149 (Thursday, August 2, 2012)]
[Rules and Regulations]
[Pages 45903-45907]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-18819]



 ========================================================================
 Rules and Regulations
                                                 Federal Register
 ________________________________________________________________________
 
 This section of the FEDERAL REGISTER contains regulatory documents 
 having general applicability and legal effect, most of which are keyed 
 to and codified in the Code of Federal Regulations, which is published 
 under 50 titles pursuant to 44 U.S.C. 1510.
 
 The Code of Federal Regulations is sold by the Superintendent of Documents. 
 Prices of new books are listed in the first FEDERAL REGISTER issue of each 
 week.
 
 ========================================================================
 

  Federal Register / Vol. 77, No. 149 / Thursday, August 2, 2012 / 
Rules and Regulations  

[[Page 45903]]



DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 205

[Document Number AMS-NOP-11-0058; NOP-11-09FR]
RIN 0581-AD15


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

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This final rule amends the U.S. Department of Agriculture's 
(USDA's) National List of Allowed and Prohibited Substances (National 
List) to enact recommendations submitted to the Secretary of 
Agriculture (Secretary) by the National Organic Standards Board (NOSB) 
on October 28, 2010, and April 29, 2011. This final rule amends the 
annotation for tetracycline for use in organic crop production and adds 
two substances: formic acid and attapulgite, along with any restrictive 
annotations, for use in organic livestock production and organic 
processing, respectively.

DATES: Effective Date: This final rule is effective August 3, 2012.

FOR FURTHER INFORMATION CONTACT: Melissa Bailey, Ph.D., Director, 
Standards Division, 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 
Sec. Sec.  205.600 through 205.607. This National List identifies 
synthetic substances that may be used and nonsynthetic (natural) 
substances that may not be used in organic production. The National 
List also identifies nonagricultural synthetic, nonsynthetic 
nonagricultural 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 et seq.), and the NOP regulations, in Sec.  
205.105, specifically prohibit the use of any synthetic substance in 
organic production and handling unless the synthetic substance is on 
the National List. Section 205.105 also requires that any nonorganic 
agricultural and any nonsynthetic nonagricultural substance used in 
organic handling must also be on the National List.
    Under the authority of the OFPA, as amended (7 U.S.C. 6501-6522), 
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 13504); August 3, 2011 (76 FR 46595); February 
14, 2012 (77 FR 8089); May 15, 2012 (77 FR 28472); and June 6, 2012 (77 
FR 33290). Additionally, proposed amendments to the National List were 
published on January 12, 2012 (77 FR 1980), and on February 6, 2012 (77 
FR 5717).
    This final rule amends the National List to enact three 
recommendations submitted to the Secretary by the NOSB on October 28, 
2010, and April 29, 2011. One recommendation addressed the annotation 
for tetracycline in organic crop production. The other recommendations 
pertained to the addition of two substances, formic acid for use in 
organic livestock production and attapulgite for use in organic 
handling.

Tetracycline

    Tetracycline is a broad-spectrum antibiotic for control of 
bacteria, fungi and mycoplasma-like organisms which functions by 
inhibiting protein synthesis in bacteria and altering bacterial 
membranes so that vital genetic material is leaked. For regulatory 
purposes, Environmental Protection Agency (EPA) uses the term 
oxytetracycline to refer to pesticides containing either calcium 
oxytetracycline or hydroxytetracycline monohydrochloride 
(oxytetracycline hydrochloride). Oxytetracycline is registered with the 
EPA for the following agronomic uses: fire blight of apples, pears, 
peaches and nectarines; pear decline; bacterial spot on peaches and 
nectarines; lethal yellowing of coconut palm; and lethal decline of 
pritchardia palm.
    The current listing for tetracycline on the National List at Sec.  
205.601(i)(12) is as follows:
    Tetracycline, for fire blight control only and for use only until 
October 21, 2012.
    Tetracycline (oxytetracycline calcium complex) was added to the 
National List by a final rule published in the Federal Register on 
December 21, 2000 (65 FR 80548). Since 2000, four notices have been 
published announcing the meetings of the NOSB and its planned 
deliberations involving the use of tetracycline in organic crop 
production. The four notices were published in the Federal Register as 
follows: (1) 71 FR 14493, March 22, 2006 (to consider the sunset 
recommendation for the continued listing of oxytetracycline calcium 
complex for fire blight control); (2) 73 FR 18491, April 4, 2008 (to 
consider a recommendation to add a second form of tetracycline, 
oxytetracycline hydrochloride, as plant disease control for all 
diseases on the crops registered by EPA); (3) 73 FR 54781, September 
23, 2008 (to consider a recommendation to add a second form of 
tetracycline, oxytetracycline hydrochloride, for fire blight control 
and to place an expiration date on the use of all forms); and (4) 76 FR 
12013, March 4, 2011 (to consider removal of the expiration date of 
tetracycline for fire blight control). The most recent final rule 
pertaining to tetracycline added an allowance for the use of 
oxytetracycline hydrochloride, and added an expiration date of October 
21, 2012. This rule was published in the Federal Register on July 6, 
2010 (75 FR 38693).

[[Page 45904]]

    In October 2010, a petition was submitted to the NOSB to remove the 
expiration date for tetracycline. In effect, the petitioner requested 
an allowance for the use of tetracycline to control fire blight in 
organic apples and pears beyond the substance's current expiration date 
of October 21, 2012. On April 29, 2011, the NOSB issued a 
recommendation to extend the use of tetracycline to control fire blight 
in apples and pears only until October 21, 2014, by a vote of 13 in 
favor and 1 against. Consistent with this NOSB recommendation, AMS 
published a proposal on November 8, 2011 to amend the annotation for 
tetracycline by extending its use for fire blight control in apples and 
pears only until October 21, 2014 (76 FR 61941).

Formic Acid

    Formic acid was petitioned for use in May 2010, as a pesticide for 
suppression of Varroa mites.\1\ The Environmental Protection Agency 
(EPA) has exempted synthetic formic acid from the requirement of a 
tolerance in or on honey and honeycomb when used to control tracheal 
mites and suppress Varroa mites in bee colonies, and applied in 
accordance with label use directions (40 CFR 180.1178).\2\
---------------------------------------------------------------------------

    \1\ The petition was submitted by the Hawaii Department of 
Agriculture, and is retrievable from the NOP Web site in the 
Petitioned Substances Database: http://www.ams.usda.gov/NOPPetitionedSubstancesDatabase.
    \2\ Tracheal mites lay eggs inside bees' tracheal tubes, and 
their larvae feed on the bee after the eggs hatch.
---------------------------------------------------------------------------

    At its October 25-28, 2010, meeting, the NOSB recommended adding 
formic acid to the National List for use in organic livestock 
production solely as a pesticide within honeybee hives. Consistent with 
this NOSB recommendation, AMS published a proposal on November 8, 2011 
to amend Sec.  205.603(b) of the National List by adding formic acid, 
with a restrictive annotation (76 FR 61941).

Attapulgite

    Attapulgite was petitioned in May 2009 for two uses: (1) as a 
nonsynthetic processing aid in organic handling for purifying vegetable 
and animal oils; and (2) as a livestock feed additive.\3\ The FDA has 
listed this substance in the database, ``Everything Added to Food in 
the United States (EAFUS) (Doc. No. 1943)'' and references this 
substance among those generally regarded as safe in 21 CFR Part 582.99 
when used as an adjuvant for pesticide chemicals. The EPA permits 
attapulgite as an inert ingredient eligible in minimum risk pesticides 
applied for food and non-food uses which are exempt from federal 
registration under Section 25(b) of the Federal Insecticide, Fungicide, 
and Rodenticide Act (FIFRA). The EPA has determined that attapulgite is 
exempt from the requirement of a tolerance when used as an inert 
ingredient in pesticide formulations applied pre- and post-harvest per 
40 CFR 180.910.\4\
---------------------------------------------------------------------------

    \3\ Due to the nonsynthetic classification of this substance, a 
petition for use as an additive for organic livestock feed is not 
required.
    \4\ Technical Report on Attapulgite. February 1, 2010. A copy of 
this report is available in the petitioned substances database, 
http://www.ams.usda.gov/NOPPetitionedSubstancesDatabase.
---------------------------------------------------------------------------

    At its April 26-29, 2011, meeting, the NOSB recommended adding 
attapulgite to the National List for use as a processing aid in organic 
handling of plant and animal oils. Consistent with this NOSB 
recommendation, AMS published a proposal on November 8, 2011, to amend 
Sec.  205.605(b) the National List by adding attapulgite, with a 
restrictive annotation (76 FR 61941).

II. Overview of Amendments

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

Section 205.601 Synthetic Substances Allowed for Use in Organic Crop 
Production

    This final rule amends Sec.  205.601(i)(12) of the National List 
regulations by: (1) Inserting the qualifying words ``in apples and 
pears''; between the words ``control'' and ``only,'' in the current 
annotation and (2) replacing the current expiration date of ``October 
21, 2012'' with the new expiration date, ``October 21, 2014'', after 
which tetracycline may not be used in organic crop production.

Section 205.603 Synthetic Substances Allowed for Use in Organic 
Livestock Production

    This final rule amends Sec.  205.603 of the National List 
regulations by redesignating current paragraphs (b)(2) through (b)(7) 
as paragraphs (b)(3) through (b)(8) for the purpose of adding the 
following substance as an external parasiticide at (b)(2):
    Formic acid (CAS 64-18-6)--for use as a pesticide solely 
within honeybee hives.

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 Sec.  205.605(a) of the National List by 
adding attapulgite as follows:
    Attapulgite--as a processing aid in the handling of plant and 
animal oils.

III. Statutory and Regulatory Authority

    The OFPA, as amended (7 U.S.C. 6501-6522), 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 the 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 Sec.  
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/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.

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 section 
6514(b) of the OFPA. States are also preempted under sections 6503 
through 6507 of the 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 the OFPA.
    Pursuant to section 6507(b)(2) of the OFPA, a State organic 
certification program may contain additional

[[Page 45905]]

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 the EPA under the Federal Insecticide, Fungicide and 
Rodenticide Act (7 U.S.C. 136-136(y)).
    Section 6520 of the 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. 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 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.
    Pursuant to the requirements set forth in the RFA, the Agricultural 
Marketing Service (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 action on small entities. The impact on entities 
affected by this final rule would not be significant. The effect of 
this final rule would be to allow the use of additional substances in 
agricultural production and handling. This action would modify the 
regulations published in the final rule and would provide small 
entities with more tools to use in day-to-day operations. AMS concludes 
that the economic impact of this addition of allowed substances, if 
any, would be minimal and beneficial to small agricultural service 
firms. Accordingly, AMS certifies that this rule will not have a 
significant economic impact on a substantial number of small entities.
    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.\5\ In 2009, U.S. certified organic apple acreage exceeded 
21,000 acres, primarily concentrated in Washington and California.\6\ 
ERS, based upon the list of certified operations maintained by the NOP, 
estimated the number of certified handling operations was 3,225 in 
2007.\7\ AMS believes that most of these entities would be considered 
small entities under the criteria established by the SBA.
---------------------------------------------------------------------------

    \5\ 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/.
    \6\ Kirby, Elizabeth, and David Granatstein. Status of Organic 
Tree Fruit in Washington State--2009, Washington State University, 
March 2010.
    \7\ 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.
---------------------------------------------------------------------------

    U.S. sales of organic food and beverages have grown from $1 billion 
in 1990 to $26.7 billion in 2010. Sales in 2010 represented 7.7 percent 
growth over 2009 sales.\8\ The USDA has 93 accredited certifying agents 
who provide certification services to producers and handlers under the 
NOP. 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.
---------------------------------------------------------------------------

    \8\ Organic Trade Association. 2011. Organic Industry Survey. 
www.ota.com.
---------------------------------------------------------------------------

D. Paperwork Reduction Act

    No additional collection or recordkeeping requirements are imposed 
on the public by this proposed 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-11-09

    AMS received 25 comments on proposed rule AMS-11-0058; NOP-11-09PR. 
Comments were received from organic crop producers, crop distributors, 
consumers, accredited certifying agents, trade associations, non-profit 
organizations, growers associations, advocacy groups and an industry 
working group.
    Twenty one of the comments submitted addressed tetracycline. 
Seventeen comments supported a continued allowance for tetracycline in 
organic crop production after its current expiration date of October 
21, 2012. Two commenters opposed any use of tetracycline in organic 
crop production, and asserted that antibiotic use is contrary to 
organic principles. These two comments concurred with the NOSB's 
concerns over engendering antibiotic resistance and supported the 
eventual prohibition of all antibiotic use, including that for 
tetracycline, in organic crop production. One commenter specifically 
supported the 2014 expiration date on the grounds that current research 
efforts are too heavily focused on antibiotic product replacement 
instead of on the NOSB's principle of achieving agro-ecosystems that 
are ecologically, socially, and economically sustainable.\9\ The same

[[Page 45906]]

commenter stated that, in the absence of alternative materials that 
could meet organic standards, organic consumers would support the 
planting of existing varieties that are more resistant to fire blight 
than those varieties favored by the conventional market.
---------------------------------------------------------------------------

    \9\ NOSB's Principles of Organic Production and Handling, 
Adopted October 17, 2001. http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELDEV3013893.
---------------------------------------------------------------------------

    One commenter expressed support for the use of formic acid as a 
pesticide in bee hives, stating that the substance is a safe and 
effective treatment that is easy to apply. The commenter also conveyed 
that an allowance for this use of formic acid under the NOP regulations 
would be consistent with other international organic standards. In the 
proposed rule on November 8, 2011 (76 FR 61941), AMS specifically 
sought comments on the appropriate placement of formic acid on Sec.  
205.603 of the National List. No comments were received addressing this 
topic, therefore the proposal to list formic acid at Sec.  205.603(b) 
of the National List is retained in this final rule. No comments were 
received regarding attapulgite.
    Two comments stated their general opposition to the allowance of 
synthetics in organic production and handling, and two comments 
submitted statements unrelated to the proposed rulemaking action.
Changes Requested But Not Made
    Many comments supportive of continuing the allowance for 
tetracycline recommended that the substance be listed without an 
expiration date. Such an action would, in effect, extend the allowance 
for the substance until October 2017 under the five year sunset review 
process for the National List. These commenters believe that more 
alternatives to tetracycline could be available to organic producers by 
2017. These comments further stated that an October 21, 2014 expiration 
date for tetracycline will not provide a sufficient timeframe for 
development and implementation of suitable alternatives. These 
commenters described the following as specific concerns with the 
expiration of tetracycline from the National List: (1) An increase in 
streptomycin resistance by the pathogen, which will further limit the 
ability of producers to control fire blight;\10\ (2) consumer 
preference for apple and pear varieties which are more susceptible to 
fire blight; and (3) the lack of fire blight resistant root stocks and 
effective biological controls. Many of these comments stated that the 
expiration of tetracycline in 2014 could result in a reduced volume of 
U.S. organic apples and pears. Some commenters cited the potential 
costs to organic apple and pear growers (e.g. cost to replant trees, 
reduced productivity in existing trees) and organic handlers (e.g. 
constrained domestic supply of organic apples and pears) following the 
expiration of tetracycline from the National List in 2014. The 
commenters suggested that the slow development and limited availability 
of alternatives to control fire blight control in organic orchards 
could also trigger conversion to conventional production.
---------------------------------------------------------------------------

    \10\ Streptomycin is currently listed at Sec.  205.601 of the 
National List for fire blight control in organic apple and pear 
production. This allowance on the National List expires on October 
21, 2014.
---------------------------------------------------------------------------

    Several commenters expressed their preference that tetracycline be 
allowed beyond 2014 (e.g. until 2015, 2016, or 2017) to allow the 
industry time to develop more alternatives to this substance. Listing 
tetracycline with a later date or 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 October 21, 2014 
expiration date to the listing for tetracycline through this final 
rule. AMS notes that extending the allowance for the use of 
tetracycline 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).
    Some commenters also stated that allowing the substance to expire 
on October 21, 2014 would have a negative economic impact on small 
businesses and that this rulemaking action should therefore be 
classified as ``significant''. AMS disagrees. This action does not 
further restrict the use of this substance. This action extends the 
allowance for the substance in organic crop production for an 
additional two years after its current expiration date of October 21, 
2012. Parties interested in requesting an extension for the authorized 
use of tetracycline in organic crop production after October 21, 2014 
may submit a petition to the NOSB. The petition process is outlined in 
72 FR 2167 (January 18, 2007).
    Based on the public comments received, commenters remain concerned 
regarding the availability and efficacy of alternatives to tetracycline 
for fire blight control. Several commenters specifically requested that 
the NOSB reconsider the October 21, 2014 expiration date for 
tetracycline. Further, commenters asked that the NOP and the NOSB 
develop a phase-out plan for the use of antibiotics in fruit trees that 
has benchmarks and timelines based on consultations with appropriate 
stakeholders to ensure that the methods proposed to reach them are 
feasible. The NOSB recommended that tetracycline is allowed for fire 
blight control in apples and pears through October 21, 2014. Parties 
interested in requesting an extension for the authorized use of 
tetracycline in organic crop production after October 21, 2014 may 
submit a petition to the NOSB. Parties interested in having the NOSB 
develop a phase-out plan for the use of antibiotics in tree fruit 
production may submit public comments to the NOSB at any of their 
public meetings. The public comment process is outlined on the NOP Web 
site.
    Commenters also requested that the NOP establish a Fire Blight Task 
Force to assist in development of alternatives. After the NOSB issued 
their recommendation on tetracycline in April 2011, stakeholders from 
the research community and organic tree fruit industry established a 
working group to consolidate efforts and develop alternatives to 
tetracycline for fire blight control. This working group is expected to 
provide updates to the public on their progress at future NOSB 
meetings. Furthermore, in response to the requests by the NOSB and to 
comments from the public for additional resources to support research 
on alternatives to tetracycline in organic production, AMS submitted 
requests to the USDA Agricultural Research Service (ARS) and the 
National Institute of Food and Agriculture (NIFA) in May 2011 for 
assistance in prioritizing research in the following areas: (1) The 
efficacy of combinations of substances for fire blight management; (2) 
breeding, production, and propagation of resistant cultivars and 
rootstocks that are commercially viable; and (3) cultural practices, 
crop management, disease forecasting and other production practices 
that can optimize control of this disease.\11\ In fiscal year 2011, 
NIFA funded a project through the Organic Agriculture Research and 
Extension Initiative (OREI) for research on the development of non-
antibiotic treatments for the control of fire blight in organic apple 
and pear crops. In January 2012, NIFA included a targeted request for 
additional research proposals on alternatives to the use of 
tetracycline for fire blight control in organic production as part of 
their solicitation for proposals under OREI.\12\

[[Page 45907]]

AMS will continue to seek assistance across USDA as appropriate on this 
issue.
---------------------------------------------------------------------------

    \11\ May 2011 Letters submitted by NOP to USDA ARS and NIFA on 
fire blight research. Available at the NOP Web site: http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5091325.
    \12\ January 2012 OREI Request for Proposals. National Institute 
of Food and Agriculture. Available online at: http://www.nifa.usda.gov/funding/rfas/pdfs/12_orei.pdf.
---------------------------------------------------------------------------

    A few commenters requested that the NOP address concerns with the 
current use of antibiotics in organic tree fruit production through 
ensuring compliance with Sec.  205.206(a)(3). Section 205.206(a) 
requires producers to use management practices to prevent disease 
through crop rotation, sanitation measures and cultural practices. 
Section 205.206(a)(3) lists specific cultural practices that enhance 
crop health, including selection of plant species and varieties with 
regard to suitability to site-specific conditions and resistance to 
prevalent pests, weeds, and diseases. Certifying agents are responsible 
for ensuring that all organic producers use management practices to 
prevent disease. Certifying agents verify that organic producers are 
meeting all USDA organic requirements including utilizing preventative 
management practices to prevent disease.
    These same commenters also stated that, as part of a strategy for 
addressing fire blight in organic apple and pear production, the NOP 
should consider variances under Sec.  205.290 to allow antibiotic use 
in instances when fire blight disease puts orchards at risk. Temporary 
variances for the use of a synthetic substance that is not on the 
National List (i.e. use of tetracycline after October 21, 2014) cannot 
be granted per the current requirements at Sec.  205.290(e).

F. Effective Date

    This final rule reflects recommendations submitted to the Secretary 
by the NOSB. The amendment to the listing of one exempted substance and 
the addition of two substances to the National List were based on 
petitions from the industry and evaluated by the NOSB using criteria in 
OFPA and the NOP regulations. Because the amendments have been subject 
to extensive discussion and public comment and are considered vital to 
organic crops, processing and livestock production, AMS believes that 
producers and handlers should be able to use them on their operations 
as soon as possible. Furthermore, tetracycline is due to expire from 
the National List on October 21, 2012; this action must be finalized by 
October 21, 2012, to ensure that organic apple and pear producers have 
access to this substance for two additional years beyond its current 
expiration date. Accordingly, AMS finds that good cause exists under 5 
U.S.C. 553(d)(3) for not postponing the effective date of this rule 
until 30 days after publication in the Federal Register.

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, Subpart 
G 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 paragraph (i)(12) is revised to read as follows:


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

* * * * *
    (i) * * *
    (12) Tetracycline, for fire blight control in apples and pears only 
until October 21, 2014.
* * * * *

0
3. Section 205.603 is amended by:
0
A. Redesignating paragraphs (b)(2) through (b)(7) as paragraphs (b)(3) 
through (b)(8); and
0
B. Adding paragraph (b)(2) to read as follows:


Sec.  205.603  Synthetic substances allowed for use in organic 
livestock production.

* * * * *
    (b) * * *
    (2) Formic acid (CAS  64-18-6)--for use as a pesticide 
solely within honeybee hives.
* * * * *

0
4. In Sec.  205.605(a), the substance ``Attapulgite'' is added in 
alphabetical order to read as follows:


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 groups(s)).''

* * * * *
    (a) * * *
    Attapulgite--as a processing aid in the handling of plant and 
animal oils.
* * * * *

    Dated: July 27, 2012.
David R. Shipman,
Administrator, Agricultural Marketing Service.
[FR Doc. 2012-18819 Filed 8-1-12; 8:45 am]
BILLING CODE 3410-02-P