```

[Federal Register: July 6, 2010 (Volume 75, Number 128)]
[Rules and Regulations]               
[Page 38693-38696]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06jy10-1]                         

========================================================================
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.

========================================================================

[[Page 38693]]

DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 205

[Document Number AMS-NOP-09-0081; TM-09-04 FR]
RIN 0581-AC93

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

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 two recommendations submitted to the Secretary of 
Agriculture (Secretary) by the National Organic Standards Board (NOSB) 
on November 19, 2008, and May 6, 2009. This final rule revises the 
annotation for tetracycline to eliminate the parenthetical reference 
and add an expiration date, and adds sulfurous acid, along with a 
restrictive annotation, to the National List for use in organic crop 
production.

DATES: Effective Date: This final rule becomes effective July 7, 2010.

FOR FURTHER INFORMATION CONTACT: Shannon Nally, Acting 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 the synthetic substances that may be used and the 
nonsynthetic (natural) substances that may not be used in organic 
production. The National List also identifies synthetic, nonsynthetic 
nonagricultural and nonorganic agricultural substances that may be used 
in organic handling. The Organic Foods Production Act of 1990 (OFPA), 
as amended, (7 U.S.C. 6501 et seq.), and 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, the National List can be amended 
by the Secretary based on proposed amendments developed by the NOSB. 
Since established, the National List has been amended eleven times: 
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 70479); December 12, 2007, (72 
FR 70479); September 18, 2008, (73 FR 59479); October 9, 2008 (73 FR 
59479). Additionally, amendments to the National List, proposed on June 
3, 2009 (74 FR 26591), are currently pending.
    This final rule amends the National List to enact two 
recommendations submitted to the Secretary by the NOSB on November 19, 
2008, and May 6, 2009.

II. Overview of Amendments

    The following provides an overview of the amendments to Sec.  
205.601 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)(11) of the National List 
regulations by eliminating the parenthetical reference and adding an 
expiration date to read as follows:
    Tetracycline, for fire blight control only and for use only until 
October 21, 2012.
    This final rule amends Sec.  205.601 of the National List 
regulations by adding a new paragraph (j)(9) to read as follows:
    Sulfurous acid (CAS  7782-99-2) for on-farm generation of 
substance utilizing 99% purity elemental sulfur per Sec.  
205.601(j)(2).

III. Related Documents

    Three notices have been published announcing the meetings of the 
NOSB and its planned deliberations on recommendations involving the use 
of tetracycline in organic crop production. The two notices were 
published in the Federal Register as follows: (1) 73 FR 18491, April 4, 
2008 (to consider a recommendation to add oxytetracycline hydrochloride 
as plant disease control for all diseases on the crops registered by 
EPA), (2) 73 FR 54781, September 23, 2008 (to consider a recommendation 
to add oxytetracycline hydrochloride for fire blight control), and (3) 
71 FR 14493, March 22, 2006 (to consider the sunset recommendation for 
the continued listing of oxytetracycline calcium complex for fire 
blight control). Tetracycline (oxytetracycline calcium complex for fire 
blight control) was added to the National List by final rule in the 
Federal Register on December 21, 2000 (65 FR 80548). The listing of 
tetracycline (oxytetracycline calcium complex for fire blight control) 
was due to sunset on October 21, 2007. In 2006, during the sunset 
review process, the NOSB reviewed the listing of tetracycline and 
streptomycin for fire blight control and recommended the renewal of 
tetracycline and streptomycin on April 20, 2006, by a vote of 7 in 
favor and 4 against. Tetracycline (oxytetracycline calcium complex), 
for fire blight control was renewed by final rule in the Federal 
Register on October 16, 2007 (72 FR 58469). A proposal to amend the 
annotation for tetracycline was published in the Federal Register on 
January 12, 2010 (74 FR 1555). One notice has been published announcing 
the meeting of the NOSB and its planned deliberations on a 
recommendation involving sulfurous acid in organic crop production. The 
notice was published in the Federal Register on March 20, 2009 (74 FR 
11904). Sulfurous acid was first proposed for addition to the National 
List on January 12, 2010 (74 FR 1555).

IV. Statutory and Regulatory Authority

    The OFPA authorizes the Secretary to make amendments to the 
National List

[[Page 38694]]

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 (OMB).

B. Executive Order 12988

    Executive Order 12988 instructs each executive agency to adhere to 
certain requirements in the development of new and revised regulations 
in order to avoid unduly burdening the court system. This final rule is 
not intended to have a retroactive effect.
    States and local jurisdictions are preempted under 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 Sec.  
2115(b) of the OFPA (7 U.S.C. 6514(b)). States are also preempted under 
Sec. Sec.  2104 through 2108 of 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 Sec.  2108(b)(2) of 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 Sec.  2120(f) of 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 et seq.), the Poultry 
Products Inspections Act (21 U.S.C. 451 et seq.), or the Egg Products 
Inspection Act (21 U.S.C. 1031 et seq.), 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 et seq.), nor the authority of the Administrator of the 
Environmental Protection Agency (EPA) under the Federal Insecticide, 
Fungicide and Rodenticide Act (7 U.S.C. 136 et seq.).
    Section 2121 of 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 et seq.) 
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). The 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. The 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, USDA 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 the USDA, Economic Research Service, U.S. sales of 
organic food and beverages grew from $3.6 billion in 1997 to $21.1 
billion in 2008.1 2 Fresh produce remains the most popular 
organic category for retail sales, accounting for 37% of U.S. organic 
food sales and averaging 15% growth per year between 1997 and 2007. The 
percentage of U.S. farmland in fruit production that was certified 
organic in 2008 reached nearly 3%. The Organic Trade Association's 
``2010 Organic Industry Survey'' reports that sales of organic fruits 
and vegetables reached $9.5 billion in 2009 and comprise 11.4% of all 
U.S. fruit and vegetable sales.
---------------------------------------------------------------------------

    \1\ 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.
    \2\ According to the Organic Trade Association's 2010 Organic 
Industry Survey, organic food sales reached $24.8 billion in 2009, 
http://www.ota.com.
---------------------------------------------------------------------------

    According to ERS data based on information from USDA-accredited 
certifying agents, the U.S. organic industry included approximately 
14,540 certified organic crop and livestock operations in 2008, 
comprising almost 4.0 million acres. There were 2,790 organic handlers 
(brokers, distributors, wholesalers, and manufacturers) in 2005; in an 
ERS survey in 2005, just three (3) percent reported over $100 million 
in sales, and 48 percent reported $1 million or less in total gross 
sales (both organic and conventional products).\3\ AMS believes that 
most of these entities would be considered

[[Page 38695]]

small entities under the criteria established by the SBA.
---------------------------------------------------------------------------

    \3\ Greene, C., C. Dimitri, B. Lin, W. McBride, L. Oberholtzer 
and T. Smith. 2009. Emerging issues in the U.S. Organic Industry, 
Economic Information Bulletin No. 55, U.S. Department of 
Agriculture, Economic Research Service, http://www.ers.usda.gov/Publications/EIB55.
---------------------------------------------------------------------------

    In addition, USDA has accredited 97 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.

D. Paperwork Reduction Act

    Under the OFPA, no additional collection or recordkeeping 
requirements are imposed on the public by this final rule. Accordingly, 
OMB clearance is not required by Sec.  350(h) of the Paperwork 
Reduction Act of 1995, 44 U.S.C. 3501, et seq., or OMB's implementing 
regulation at 5 CFR part 1320.
    AMS is committed to compliance with the Government Paperwork 
Elimination Act (GPEA), which requires Government agencies in general 
to provide the public the option of submitting information or 
transacting business electronically to the maximum extent possible.

E. Received Comments on Proposed Rule TM-09-04

    AMS received 35 comments on proposed rule TM-09-04. Comments were 
received from organic crop producers, consumers, an accredited 
certifying agent, a foreign government, a trade association, state 
extension personnel, a state advisory board, consultants and a 
manufacturer of crop protection products. A number of the comments 
opposed any use of tetracycline or sulfurous acid in organic crop 
production, and asserted that such amendments weakened the NOP 
regulations and compromised the integrity of organic foods. Other 
comments conveyed support for either or both of the proposed 
amendments; however, a few of those supportive comments suggested 
modifications to the wording of the proposed amendments.
    Twenty-two of the comments submitted addressed tetracycline. Nearly 
all of the comments which opposed the proposed amendment for the 
tetracycline listing were directed at any use of tetracycline in 
organic production; the comments did not specifically address the 
proposed action to remove the identification of oxytetracycline calcium 
complex from the annotation for tetracycline, thereby permitting an 
equivalent form, oxytetracycline hydrochloride to also be available for 
controlling fire blight. Most of the comments that were supportive of 
the proposed action to remove the specification on the form of 
tetracycline expressed opposition to the proposed expiration date of 
October 21, 2012.
    Eighteen of the 35 comments addressed sulfurous acid. Comments in 
support of the proposed amendment to add sulfurous acid were primarily 
submitted by producers or persons who advise growers, such as, state 
extension specialists or consultants. They asserted that sulfurous acid 
is an important tool for organic growers enabling the use of water 
containing bicarbonates or having a high pH without degrading the soil 
as a result of that use. Comments that were opposed to the addition of 
sulfurous acid were primarily from consumers and did not offer specific 
reasons for their position. One commenter asserted that only large 
corporate farms would be able to afford the costs of specialized 
employees to manufacture the sulfurous acid.
Changes Requested But Not Made
    Several comments expressed total opposition to the use of 
tetracycline and/or sulfurous acid in organic production asserting that 
these substances weaken the NOP regulations and undermine the integrity 
of organic foods; some of these comments opposed the use of pesticides 
in organic production altogether. A number of the comments in 
opposition did not include any evidence that would support the position 
stated.
    Some of the reasons cited by comments in opposition to tetracycline 
included: The substance is harmful to human health and the environment; 
the diminished host resistance to fire blight; resistance to 
tetracycline; and alternative practices, such as, moving the crop to 
another location. One comment advised that the addition of tetracycline 
be postponed pending completion of EPA's registration review of 
tetracycline in 2014. We considered these comments, but have determined 
that the record supports the need for the continued availability of 
tetracycline for restricted use.
    With regard to sulfurous acid, one comment threatened that organic 
products exported from the U.S. to the nation submitting the comment, 
could require certification as having been produced without use of 
sulfurous acid unless the need for sulfurous acid is clarified. The 
commenter also stated that elemental sulfur, already allowed for use in 
organic crop production, would be sufficient as an acidifying agent of 
the soil. The record indicates that the use of sulfurous acid to lower 
the pH of irrigation water is preferable, from an environmental 
standpoint, to spreading elemental sulfur on the soil to address 
alkaline conditions that develop due to the alkalinity of the 
irrigation water. The later practice is currently allowed per Sec.  
205.601(j)(2). According to the record, the application of sulfurous 
acid in comparison to elemental sulfur, is better controlled, in terms 
of the quantity applied, and more benign to soil organisms.
    The comment which stated that the use of sulfurous acid would be 
affordable to only large corporate farms did not present evidence to 
support that assertion. Furthermore, that stance was refuted by other 
comments submitted on the proposed rule which stated that the addition 
of sulfurous acid would benefit many stakeholders and is more cost 
effective than citric acid that is currently used for pH adjustment.
Expiration Date for Tetracyline
    A number of comments, particularly from tree fruit growers and 
associations in the Pacific Northwest, argued for the continued use of 
tetracycline after the expiration date of October 21, 2012. Those who 
argue for the continued use of tetracycline after October 21, 2012, 
stated that there was no other effective alternative treatment 
available for fire blight and that the expiration for the use of 
tetracycline for organic apple and pear production would force them to 
exit the organic production industry. One comment informed that newer 
reigning varieties, such as Gala, Fuji, Jonagold, Pink Lady and 
Honeycrisp apples and Bartlett, Bosc and Asian pear varieties are 
highly susceptible to the disease and tetracycline is the most 
effective tool for controlling moderate to severe fire blight 
particularly after bloom period. These commenters also conveyed that 
the Pacific Northwest, Washington, Oregon and Idaho, produce 66% and 
86% of all U.S. apples and pears and 14,000 tons of organic pears in 
Washington and Oregon.
    According to the NOSB discussion at the November 2008 meeting, 
tetracycline was originally exempted for use in 2000, with the 
anticipation that alternative treatments for fire blight would be 
developed, or that new cultivars not susceptible to fire blight would 
become available for organic production. October 21, 2012, was selected 
as the expiration because the exemption for oxytetracycline calcium 
chloride was due to sunset on that date. It was determined that the 
effect of amending the annotation to delete the specification for 
oxytetracycline calcium chloride would reset the sunset

[[Page 38696]]

date to 5 years from the date of this final rule. As conveyed in the 
discussion at the NOSB meeting, the exemption for tetracycline has 
remained divisive and the NOSB did not want to extend the listing for 
another 5 years. Peracetic acid and copper fungicides were specifically 
mentioned as alternative substances for fire blight control, although 
these were noted as only partially or marginally effective. This is 
consistent with a comment to the proposed rule which acknowledged that 
Bordeaux mix (copper sulfate and lime) and other copper formulations 
sprayed at green-tip stage provide some protection, but can cause fruit 
scarring and are phytotoxic to some cultivars. It was noted anecdotally 
at the NOSB meeting that there are apple and pear varieties with 
limited resistance to fire blight and that some producers are growing 
pears without the use of tetracycline for the organic market in the 
European Union, where the use of antibiotics for organic crop 
production is not permitted.
    Based on all public comment and documentation received, the NOP 
believes that issues regarding the availability and viability of 
alternatives to tetracycline for fire blight control remain 
outstanding. At the same time, we note the NOSB's recommendation to 
only allow the continued use of tetracycline for fire blight control 
until October 21, 2012. Though some commenters have requested the 
removal of the expiration date from use of tetracycline, the NOP 
recommends that such interested parties petition the NOSB, using the 
petition process outlined in 72 FR 2167 (January 18, 2007), to have the 
expiration date removed from the authorized use of the substance.
Classification of Tetracycline as a Bactericide
    One comment asserted that oxytetracycline calcium complex was 
naturally produced in the soil by bacterial fermentation and therefore 
it is not an antibiotic, but a bactericide. This comment argued for the 
approval of the use of ``natural'' oxytetracycline to be extended 
indefinitely for organic production so that the organic apple and pear 
industry would not be lost to fire blight. The comment did not provide 
evidence to affirm that the entire production of oxytetracycline to its 
commercial form would qualify as nonsynthetic (natural) in accordance 
with the NOP regulations. Tetracycline, in technical literature and 
common use, is universally identified as an antibiotic. While 
tetracycline is derived from bacteria and has bactericidal properties, 
we believe that ``antibiotic'' is the proper and accurate 
classification.
On-Site Rather Than On-Farm Generation of Sulfurous Acid
    One of the comments expressed support for the addition of sulfurous 
acid, but requested that the annotation to refer to on-site generation 
instead of on-farm, because ``farm'' is not defined in the NOP 
regulation or in the Organic Food Production Act (OFPA), and use of 
that word could cause confusion in the organic industry. We recognize 
that there was considerable discussion over the precise wording to use 
in the annotation to capture the intent that it be produced at the 
location where the sulfurous acid would be used to prevent the use of 
sulfurous acid in forms that would be synthetically stabilized or 
preserved for shipping. Both terms, ``farm'' and ``site'', appear in 
the NOP regulations. However, we believe these are distinct, as farm 
refers specifically to land area in crop production, while ``site'' can 
refer to production or handling areas. We believe that ``farm'' is 
readily understood by the organic industry and is the more appropriate, 
specific term in this annotation.

F. Effective Date

    This final rule reflects recommendations submitted to the Secretary 
by the NOSB. The revisions being made in the listing of one exempted 
substance and the substance being added to the National List were based 
on petitions from the industry and evaluated by the NOSB using criteria 
in the Act and the regulations. Because these revisions and the 
exemption have been subject to extensive discussion and comments and 
are considered vital to the most efficient organic crop production, NOP 
believes that producers should be able to use them in their operations 
as soon as possible. In crop production, the effective period for use 
of any practice or crop input may be limited by the progress of the 
growing season, and the utility of an exempted substance for organic 
production in any one year is dependent upon that substance being 
available when it is needed for use, as its use may be quite 
ineffective at any other time in the growing season. 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.

0
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. Sec.  205.601 is amended by:
0
A. Revising paragraph (i)(11).
0
B. Adding new paragraph (j)(9).
    The addition and revision read as follows:

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

* * * * *
    (i) * * *
    (11) Tetracycline, for fire blight control only and for use only 
until October 21, 2012.
    (j) * * *
    (9) Sulfurous acid (CAS  7782-99-2) for on-farm generation 
of substance utilizing 99% purity elemental sulfur per paragraph (j)(2) 
of this section.
* * * * *

    Dated: June 29, 2010.
Rayne Pegg,
Administrator, Agricultural Marketing Service.
[FR Doc. 2010-16335 Filed 7-2-10; 8:45 am]
BILLING CODE P
```