National Organic Program; Proposed Amendments to the National List of Allowed and Prohibited Substances (Crops), 1555-1559 [2010-165]
Download as PDF
<![CDATA[
Federal Register / Vol. 75, No. 7 / Tuesday, January 12, 2010 / Proposed Rules
DHS is currently considering,
however, and seeks comments on,
whether it is feasible to refine existing
models or develop a new model for
uncontained pool fires (i.e., where the
contents of one or more gasoline storage
tanks escape from secondary
containment), so that such a model
could be used for future consequence
assessments for gasoline terminals—in
lieu of or in addition to the modified
VCE model.
IV. Issues for Commenters
Comments that will provide the most
assistance to DHS should address the
following issues and questions.
Commenters should include
explanations and relevant supporting
materials with their comments
whenever possible.
a. Comments on the inclusion of 6
CFR 27.203(b)(1)(v) (counting of
Release-COI in gasoline, diesel,
kerosene, or jet fuel in aboveground
storage tanks) and 6 CFR 27.204(a)(2)
(the flammable mixtures rule), as they
apply to gasoline terminals.
b. Comments on the applicability of
the modified VCE model to gasoline
terminals, including: whether the
reduction of the vapor yield for gasoline
from ten percent (as in EPA’s VCE
model) to one percent reasonably
reflects the potential consequences for a
vapor cloud explosion from gasoline (as
compared to other liquid flammable
chemicals); and whether a different
yield factor adjustment might better
reflect the potential consequences for a
vapor cloud explosion from gasoline.
c. Comments on whether a reasonable
model exists or should be developed for
future use that would allow DHS to
estimate the plausible worst-case
consequences of an uncontained pool
fire resulting from a successful attack on
gasoline terminals.
Dated: January 4, 2010.
Rand Beers,
Under Secretary for National Protection and
Programs.
[FR Doc. 2010–234 Filed 1–11–10; 8:45 am]
WReier-Aviles on DSKGBLS3C1PROD with PROPOSALS
BILLING CODE P
VerDate Nov<24>2008
17:46 Jan 11, 2010
Jkt 220001
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 205
[Document Number AMS–NOP–09–0081;
TM–09–04]
RIN 0581–AC93
National Organic Program; Proposed
Amendments to the National List of
Allowed and Prohibited Substances
(Crops)
AGENCY: Agricultural Marketing Service,
USDA.
ACTION: Proposed rule.
SUMMARY: This proposed rule would
amend the U.S. Department of
Agriculture’s (USDA’s) National List of
Allowed and Prohibited Substances
(National List) to reflect
recommendations submitted to the
Secretary of Agriculture (Secretary) by
the National Organic Standards Board
(NOSB) on November 19, 2008, and May
6, 2009. The recommendations
addressed in this proposed rule pertain
to amending an annotation for one
exempted material on the National List
and establishing an exemption (use) for
another material in organic crop
production. Consistent with the
recommendations from the NOSB, this
proposed rule would amend the
annotation for a listed substance and
add one substance, along with any
restrictive annotation, to the National
List.
DATES: Comments must be received by
March 15, 2010.
ADDRESSES: Interested persons may
comment on the proposed rule using the
following procedures:
• Internet: https://
www.regulations.gov.
• Mail: Comments may be submitted
by mail to: Toni Strother, Agricultural
Marketing Specialist, National Organic
Program, USDA–AMS–TMP–NOP,
Room 2646–So., Ag Stop 0268, 1400
Independence Ave., SW., Washington,
DC 20250–0268.
Written comments responding to this
proposed rule should be identified with
the document number AMS–NOP–09–
0081; TM–09–04. You should identify
the topic and section number of this
proposed rule to which your comment
refers. You should clearly state whether
you support the amendment of the
annotation for the substance on the
national list and/or the exemption for
the substance being proposed, with
clearly indicated reason(s) for your
position. You should also offer any
recommended language changes that
PO 00000
Frm 00004
Fmt 4702
Sfmt 4702
1555
would be appropriate for your position.
Please include relevant information and
data to support your position (e.g.
scientific, environmental,
manufacturing, industry, impact
information, etc.). Only relevant
material supporting your position
should be submitted.
It is USDA’s intention to have all
comments concerning this proposed
rule, including names and addresses
when provided, regardless of
submission procedure used, available
for viewing on the Regulations.gov
(https://www.regulations.gov) Internet
site. Comments submitted in response to
this proposed rule will also be available
for viewing in person at USDA—AMS,
National Organic Program, Room 2646–
South Building, 1400 Independence
Ave., SW., Washington, DC, from 9 a.m.
to 12 noon and from 1 p.m. to 4 p.m.,
Monday through Friday (except official
Federal holidays). Persons wanting to
visit the USDA South building to view
comments received in response to this
proposed rule are requested to make an
appointment in advance by calling (202)
720–3252.
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 §§ 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,
as amended, (7 U.S.C. 6501 et seq.),
(OFPA), and NOP regulations, in
§ 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 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,
E:\FR\FM\12JAP1.SGM
12JAP1
1556
Federal Register / Vol. 75, No. 7 / Tuesday, January 12, 2010 / Proposed Rules
(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, a proposed
amendment to the National List was
published on June 3, 2009, (74 FR
26591).
This proposed rule would amend the
National List to reflect two
recommendations submitted to the
Secretary by the NOSB on November 19,
2008, and May 6, 2009. Based upon
their evaluation of petitions submitted
by industry participants, the NOSB
recommended that the Secretary amend
§ 205.601 of the National List to amend
the annotation for one exempted
material (tetracycline) and add one
substance (sulfurous acid) for use in
organic crop production. The amended
annotation and the exemption for use of
the added substance in organic
production were evaluated by the NOSB
using the criteria specified in OFPA (7
U.S.C. 6517–6518).
WReier-Aviles on DSKGBLS3C1PROD with PROPOSALS
II. Overview of Proposed Amendments
The following provides an overview
of the proposed amendments to
designated sections of the National List
regulations:
Section 205.601 Synthetic Substances
Allowed for Use in Organic Crop
Production
This proposed rule would amend
§ 205.601 of the National List
regulations by: (1) Amending the
annotation of paragraph (i)(11) by
eliminating the parenthetical reference
to a form of the exempted material and
adding an expiration date; and (2)
adding new paragraph (j)(9), for the
purpose of allowing the use of the
following substances:
Tetracycline. Tetracycline, in the form
of oxytetracycline calcium complex,
was included in the National List as
originally published on December 21,
2000 (FR 65 80548), for use for fire
blight control only. In October 2007, a
petition was submitted to add
oxytetracycline hydrochloride complex
for fireblight control in organic crop
production. Tetracycline is a broadspectrum 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
VerDate Nov<24>2008
15:05 Jan 11, 2010
Jkt 220001
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.
Oxytetracyclines are derived from the
soil bacteria, Streptomyces, by a
fermentation process. Technical grade
tetracycline is a pale yellow to tan
crystalline powder, is freely soluble in
water, and decomposes above 180
degrees Celsius. Formulated products
containing the technical grade
oxytetracycline calcium complex and
oxytetracyline hydrochloride for
fireblight are wettable powders which
are spray-applied using ground or
aircraft equipment at early bloom stage,
when fire blight infection usually
occurs. In addition to agronomic uses,
oxytetracyclines are also antibiotics
used in human and animal drugs.
Per the Federal Food, Drug, and
Cosmetic Act (FFDCA) (21 U.S.C. 301 et
seq.), as amended by the Food Quality
Protection Act of 1996 (FQPA) (Pub. L.
104–170, August 3, 1996), the EPA
established tolerances for residues of
these oxytetracycline pesticides in or on
raw apples, peaches, nectarines, and
pears of 0.35 parts per million (ppm) (40
CFR 180.337). In the 2006 Tolerance
Reassessment Progress and Risk
Management Decision (TRED), EPA
deemed that the toxicity of the
oxytetracylines would be similar and
thus treated oxytetracycline
hydrochloride and oxytetracycline
calcium as equivalent for hazard
characterization. In conducting the
tolerance reassessment for
oxytetracycline, EPA considered the
aggregate risk from exposure via food
and water intake and concluded that the
dietary risk for all U.S. populations was
below the level of concern. In regards to
ecological effects, the EPA reported the
potential for terrestrial and aquatic
species to be exposed to
oxytetracyclines due to use patterns on
food crops, and the potential for acute
and/or chronic toxicity. The EPA
concluded that it is unlikely that
antibiotic resistance from pesticidal use
of oxytetracycline would result from
food exposure, but could theoretically
occur among bacteria in orchards. The
EPA is conducting a registration review
of oxytetracycline to ensure that the
intended function is achieved without
unreasonable adverse effects on human
health or the environment. That review
is scheduled for completion in 2014.
PO 00000
Frm 00005
Fmt 4702
Sfmt 4702
At its November 18–20, 2008, meeting
in Washington, DC, the NOSB
recommended revising the tetracycline
listing at 205.601(i)(11) to remove the
qualifying words, ‘‘oxytetracycline
calcium complex,’’ from the annotation
and, in effect, permit the use of either
form of oxytetracycline, i.e.,
oxytetracycline calcium complex and
oxytetracycline hydrochloride until
October 21, 2012. Both forms of
oxytetracycline have EPA registered
uses for fire blight control. In this open
meeting, the NOSB evaluated the
available technical forms of
oxytetraclycline against the evaluation
criteria of 7 U.S.C. 6517 and 6518 of the
OFPA, received public comment, and
concluded that the two forms of
tetracycline are comparable, and that
allowing the use of both substances is
consistent with the prior decision to
allow the use of oxytetracycline calcium
complex.
The NOSB, however, recommended
adding an expiration date of October 21,
2012, after which no form of
tetracycline could be used in organic
crop production. Therefore, tetracycline
will be removed from the National List
by the expiration date rather than
through a petition for removal or sunset.
The recommendation to change the
annotation for tetracycline would have
reset the sunset date to 5 years from the
date on which the annotation was
changed through this rulemaking. The
NOSB did not support prolonging the
exemption for tetracycline and
recommended an expiration date to
prevent that occurrence. The NOSB did
not find tetracycline to be essential to,
nor compatible with, organic
production, but approved the use of
oxytetracycline hydrochloride solely on
the basis that a functionally equivalent
form is already allowed for use in
organic crop production. The Board was
informed during the meeting, and this
information is supported by EPA
references, that oxytetracycline calcium
complex and oxytetracycline
hydrochloride are the only forms of
oxytetracycline that have registered
agricultural uses. NOSB approval of this
petition is not expected to increase the
overall use of tetracycline in organic
crop production, but would allow
growers to substitute one form for
another until October 21, 2012.
The NOP engaged in consultations
with the EPA and Food and Drug
Administration (FDA). The EPA
informed the NOP that the proposed
amendment to exempt oxytetracycline
hydrochloride for use in organic crops
is consistent with EPA regulations.
Concerning the use of tetracycline, FDA
deferred to EPA as the appropriate
E:\FR\FM\12JAP1.SGM
12JAP1
Federal Register / Vol. 75, No. 7 / Tuesday, January 12, 2010 / Proposed Rules
WReier-Aviles on DSKGBLS3C1PROD with PROPOSALS
regulatory body. Therefore, after
consultation with the EPA and FDA
regarding NOSB’s recommendation to
amend the annotation for tetracycline
use in organic crops, the Secretary
proposes to accept NSOB’s
recommendation and amend § 205.601
of the National List by: (1) Removing the
qualifying words in parenthesis from
the annotation at (i)(11) which currently
specifies, ‘‘oxytetracycline calcium
complex’’ to allow either form of
oxyetracycline to be used; and, adding
the expiration date, October 21, 2012,
after which no tetracycline may be used
in organic crop production for fireblight
control.1
Sulfurous Acid (CAS #–7782–99–2).
Sulfurous Acid was petitioned for use in
organic crop production as a soil
amendment. It functions as an
acidifying agent to neutralize and
reduce the excessive alkalinity
(bicarbonates and carbonates) in soil or
water. This substance also has transient
biocide properties that contribute to
keeping irrigation conveyance systems
clean by suppressing growth of bacteria
and pathogenic microorganisms.
Sulfurous acid is a clear, nearly
colorless solution (6–12%) which has a
pungent odor, and is soluble in water.
Sulfurous acid degrades through
microbial decomposition to hydrogen
ion and sulfate ion. The hydrogen ions
cause the acidifying effects. The sulfate
ion is a nutrient to plants and microorganisms as long as the soil is aerobic.
Sulfurous acid is produced through
natural and man-made processes by
reacting sulfur dioxide with water. In
nature, sulfurous acid is produced by
wild fires, hydro-thermal vents on the
ocean floor, vents on the earth’s surface,
volcanic eruptions and fumaroles
emitting sulfur dioxide and reacting
with water. Sulfur dioxide is also
produced by burning coal to produce
heat or electricity. Sulfurous acid can be
manufactured by oxidizing elemental
sulfur in a burner chamber with
1 EPA (U.S. Environmental Protection Agency).
2006. Report of the Food Quality Protection Act
(FQPA) Tolerance Reassessment Progress and Risk
Management Decision (TRED) for Oxytetracycline.
EPA 738–R–06–011. https://www.epa.gov/oppsrrd1/
REDs/oxytetracycline_tred.pdf.
EPA. 2008. Oxytetracycline Summary Document
Registration Review: Initial Docket December 2008
Case #0655. EPA–HQ–OPP–2008–0686. https://
www.epa.gov/oppsrrd1/registration_review/
oxytetracycline/index.htm.
ICF Consulting. Technical Evaluation Report
Tetracycline (Oxytetracycline Calcium Complex).
January 27, 2006. https://tinyurl.com/ygdtys4.
National Organic Standards Board (NOSB). Final
recommendation on Tetracycline. November 19,
2008, https://tinyurl.com/y9gds87.
NOSB Meeting Transcripts. November 18, 2008,
pp. 185–201. November 19, 2008, pp. 130–148;
191–213. https://tinyurl.com/ycaqqdq.
VerDate Nov<24>2008
15:05 Jan 11, 2010
Jkt 220001
pressurized water. The sulfur dioxide
that is produced is immediately
captured to form an aqueous solution of
sulfurous acid which can be added to
the irrigation water stream for
application to fields. Within hours of
formation, sulfurous acid degrades to a
hydrogen ion and a bi-sulfite ion and is
not sufficiently stable for transporting to
a farm sites for use.
The EPA does not regulate the
application of sulfurous acid as a soil
amendment to reduce alkalinity.
Sulfurous acid can cause burns from all
routes of exposure and is corrosive.
Handlers should have protective
clothing, eyeware and gloves, and
respirators may be needed in some
circumstances. Sulfurous acid should be
used in a well-ventilated area. Repeated
exposure may cause damage to mucous
membranes, upper respiratory tract, skin
and eyes.
Adverse biological or chemical
reactions are not likely from the
proposed use in organic crops soil
amendment purposes due to the quick
degradation of sulfurous acid, provided,
that the sulfurous acid is applied at the
intended use rate and that soil pH is
closely monitored. If anaerobic
conditions develop in waterlogged soil,
anaerobic bacteria could convert the
sulfate ion to hydrogen sulfide which
would be toxic to the immediate
ecosystem.
At its May 4–6, 2009, meeting in
Washington, DC, the NOSB
recommended adding sulfurous acid to
the National List as a soil amendment
for use in organic crop production, to be
generated on-farm only by burning 99%
pure elemental sulfur per
§ 205.601(j)(2), due to the transient
nature of the sulfurous acid. In this
open meeting, the NOSB evaluated
sulfurous acid against the evaluation
criteria of 7 U.S.C. 6517 and 6518 of the
OFPA, received public comment, and
concluded that the use of the substance,
as annotated, is consistent with the
OFPA evaluation criteria. The NOSB
explained that the on-farm generation is
necessary because the short half-life of
sulfurous acid would prohibit shipping
from off-farm sites. Furthermore, the
NOSB specified elemental sulfur at 99%
purity as it is typically available in this
form.
The NOSB also examined whether the
addition of sulfurous acid was necessary
in consideration of other substances on
the National List, specifically elemental
sulfur and organic acids. The Board
indicated that the controlled application
of sulfurous acid via irrigation is
preferable to broadcast applications of
elemental sulfur, which acts slower and
can negatively impact the microbial soil
PO 00000
Frm 00006
Fmt 4702
Sfmt 4702
1557
life at the application rates used.
Furthermore, the Board determined that
relying upon organic acids, such as
citric, would require the importation
and application of such large quantities
as to make the use of those substances
impractical.
The NOP engaged in consultations
with the EPA and FDA. FDA deferred to
EPA as the appropriate regulatory body.
EPA concurred that the use of this
substance as specified would not
conflict with EPA regulations.
Therefore, after consultation with the
EPA and FDA regarding NOSB’s
recommendation to permit the use of
sulfurous acid as a soil amendment in
organic crop production when limited
to on-farm generation by burning 99%
pure elemental sulfur, the Secretary is
proposing to accept the NOSB’s
recommendation and amend
§ 205.601(j) of the National List by
adding sulfurous acid at new paragraph
(j)(9) as follows:
Sulfurous acid (CAS #–7782–99–2)—
from on-farm generation of substance,
by burning only 99% elemental sulfur,
exempted at (j)(2) in this section.2
III. Related Documents
Three notices were published
regarding the meetings of the NOSB and
its deliberations on recommendations
and substances petitioned for amending
the National List. Substances and
recommendations included in this
proposed rule were announced for
NOSB deliberation in the following
Federal Register Notices: (1) 73 FR
18491, April 4, 2008 (Tetracycline); (2)
73 FR 54781, September 23, 2008
(Tetracycline); (3) 74 FR 11904, March
20, 2009 (Sulfurous Acid). NOSB
meetings are open to the public and
allow for public participation.
IV. Statutory and Regulatory Authority
The OFPA, as amended [7 U.S.C. 6501
et seq.], 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
2 Agricultural Marketing Service Science &
Technology Branch. Technical Evaluation Report
Sulfurous Acid. April 3, 2009.
Harmon Systems International, LLC. Petition for
sulfurous acid for inclusion on the National List.
July 30, 2008. https://tinyurl.com/yh6wsv9.
NOSB Final Recommendation on sulfurous acid.
May 6, 2009. https://tinyurl.com/yf9s6mb.
NOSB Meeting Transcripts. May 5, 2009, pp.
163–173. May 6, 2009, pp. 34–57.
E:\FR\FM\12JAP1.SGM
12JAP1
1558
Federal Register / Vol. 75, No. 7 / Tuesday, January 12, 2010 / Proposed Rules
purpose of having substances evaluated
for inclusion on or deletion from the
National List. The National List petition
process is implemented under § 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 https://
www.ams.usda.gov/AMSv1.0/getfile?
dDocName=STELPRDC5048809&acct=
nopgeninfo.
WReier-Aviles on DSKGBLS3C1PROD with PROPOSALS
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 proposed 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
§ 2115(b) of the OFPA (7 U.S.C.
6514(b)). States are also preempted
under §§ 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 § 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 § 2120(f) of the OFPA (7
U.S.C. 6519(f)), this proposed rule
would not alter the authority of the
Secretary under the Federal Meat
Inspection Act (21 U.S.C. 601 et seq.),
VerDate Nov<24>2008
15:05 Jan 11, 2010
Jkt 220001
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 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 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 proposed rule
would not be significant. The effect of
this proposed rule would be to allow the
use of additional substances in
agricultural production. This action
would relax 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 to small
agricultural producers and service firms.
Accordingly, USDA certifies that this
rule will not have a significant
PO 00000
Frm 00007
Fmt 4702
Sfmt 4702
economic impact on a substantial
number of small entities.
Small agricultural service firms,
which include 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 USDA, Economic
Research Service data based on
information from USDA-accredited
certifying agents, the U.S. organic
industry included nearly 6,949 certified
organic crop and livestock operations at
the end of 2001. These operations
reported certified acreage totaling more
than 2.09 million acres of organic farm
production. By the end of 2005, the
number of U.S. certified organic crop
and livestock operations totaled about
8,500 and certified organic acreage
exceeded 4 million acres. ERS, based
upon information provided by domestic
accredited certifying agents, estimated
the number of certified handling
operations as exceeding 2,790 in 2004.
AMS believes that most of these entities
would be considered small entities
under the criteria established by the
SBA.
The U.S. sales of organic food and
beverages have grown from $1 billion in
1990 to nearly $17 billion in 2006. The
organic industry is viewed as the fasting
growing sector of agriculture,
representing almost 3 percent of overall
food and beverage sales. Since 1990,
organic retail sales have historically
demonstrated a growth rate between 20
to 24 percent each year, including a 22
percent increase in 2006.
In addition, USDA has 100 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 https://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 proposed
rule. Accordingly, OMB clearance is not
required by section 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.
The AMS is committed to compliance
with the Government Paperwork
Elimination Act (GPEA), which requires
E:\FR\FM\12JAP1.SGM
12JAP1
Federal Register / Vol. 75, No. 7 / Tuesday, January 12, 2010 / Proposed Rules
Government agencies in general to
provide the public the option of
submitting information or transacting
business electronically to the maximum
extent possible.
The AMS is committed to complying
with the E-Government Act to promote
the use of the Internet and other
information technologies to provide
increased opportunities for citizen
access to Government information and
services, and for other purposes.
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
proposed to be amended as follows:
PART 205—NATIONAL ORGANIC
PROGRAM
1. The authority citation for 7 CFR
part 205 continues to read as follows:
Authority: 7 U.S.C. 6501–6522.
2. Section 205.601 is amended by:
A. Revising paragraph (i)(ll).
B. Adding new paragraph (j)(9).
The revision and addition read as
follows:
§ 205.601 Synthetic substances allowed
for use in organic crop production.
*
*
*
*
(i) * * *
(11) Tetracycline, for fire blight
control only, and for use in organic crop
production only until October 21, 2012.
*
*
*
*
*
(j) * * *
(9) Sulfurous acid (CAS #–7782–99–2)
from on-farm generation of substance by
burning only 99% purity elemental
sulfur per § 205.601(j)(2).
*
*
*
*
*
WReier-Aviles on DSKGBLS3C1PROD with PROPOSALS
*
Dated: January 5, 2010.
Rayne Pegg,
Administrator, Agricultural Marketing
Service.
[FR Doc. 2010–165 Filed 1–11–10; 8:45 am]
BILLING CODE 3410–02–P
VerDate Nov<24>2008
15:05 Jan 11, 2010
Jkt 220001
NUCLEAR REGULATORY
COMMISSION
10 CFR Part 32
[Docket No. PRM–32–6; NRC–2009–0547]
Association of State and Territorial
Solid Waste Management Officials;
Notice of Receipt of Petition for
Rulemaking
AGENCY: Nuclear Regulatory
Commission.
ACTION: Petition for rulemaking; Notice
of receipt.
SUMMARY: The Nuclear Regulatory
Commission (NRC) has received and
requests public comment on a petition
for rulemaking dated November 6, 2009,
filed by the Association of State and
Territorial Solid Waste Management
Officials (ASTSWMO) (petitioner). The
petition was docketed by the NRC and
has been assigned Docket No. PRM–32–
6. The petitioner requests that the NRC
amend its regulations and/or guidance
to improve the labeling and
accountability of tritium exit signs.
DATES: Submit comments by March 29,
2010. Comments received after this date
will be considered if it is practical to do
so, but the NRC is able to assure
consideration only for comments
received on or before this date.
ADDRESSES: Please include Docket ID
NRC–2009–0547 in the subject line of
your comments. Comments submitted in
writing or in electronic form will be
posted on the NRC Web site and on the
Federal rulemaking Web site
Regulations.gov. Because your
comments will not be edited to remove
any identifying or contact information,
the NRC cautions you against including
any information in your submission that
you do not want to be publicly
disclosed.
The NRC requests that any party
soliciting or aggregating comments
received from other persons for
submission to the NRC inform those
persons that the NRC will not edit their
comments to remove any identifying or
contact information, and therefore, they
should not include any information in
their comments that they do not want
publicly disclosed.
You may submit comments by any
one of the following methods:
Federal Rulemaking Web site: Go to
https://www.regulations.gov and search
for documents filed under Docket ID
NRC–2009–0547. Comments may be
submitted electronically through this
Web site. Address questions about NRC
dockets to Carol Gallagher 301–492–
3668; e-mail Carol.Gallagher@nrc.gov.
PO 00000
Frm 00008
Fmt 4702
Sfmt 4702
1559
Mail comments to: Secretary, U.S.
Nuclear Regulatory Commission,
Washington, DC 20555–0001, ATTN:
Rulemakings and Adjudications Staff.
E-mail comments to:
Rulemaking.Comments@nrc.gov. If you
do not receive a reply e-mail confirming
that we have received your comments,
contact us directly at 301–415–1677.
Hand deliver comments to: 11555
Rockville Pike, Rockville, Maryland
20852, between 7:30 a.m. and 4:15 p.m.
Federal workdays. (Telephone 301–415–
1677).
You can access publicly available
documents related to this document
using the following methods:
Federal e-Rulemaking Portal: Go to
https://www.regulations.gov and search
for documents filed under Docket ID
NRC–2009–0547.
NRC’s Public Document Room (PDR):
The public may examine and have
copied for a fee publicly available
documents at the NRC’s PDR, Room O1
F21, One White Flint North, 11555
Rockville Pike, Rockville, Maryland.
NRC’s Agencywide Documents Access
and Management System (ADAMS):
Publicly available documents created or
received at the NRC are available
electronically at the NRC’s Electronic
Reading Room at https://www.nrc.gov/
reading-rm/adams.html. From this page,
the public can gain entry into ADAMS,
which provides text and image files of
NRC’s public documents. If you do not
have access to ADAMS or if there are
problems in accessing the documents
located in ADAMS, contact the NRC’s
PDR reference staff at 1–800–397–4209,
301–415–4737, or by e-mail to
pdr.resource@nrc.gov.
You may also obtain a copy of the
petition from ADAMS under accession
number ML093410012.
FOR FURTHER INFORMATION CONTACT:
Michael T. Lesar, Chief, Rulemaking
and Directives Branch, Division of
Administrative Services, Office of
Administration, U.S. Nuclear Regulatory
Commission, Washington, DC 20555–
0001, Telephone 301–492–3663, toll
free 800–368–5642,
Michael.Lesar@nrc.gov.
SUPPLEMENTARY INFORMATION:
The Petitioner
The petitioner is an organization
representing the managers of solid
waste, hazardous waste, remediation,
and underground storage tank programs
of the States and territories. The
petitioner states it is tasked with
identifying national level radiation
issues of concern and promoting
partnerships between States and Federal
agencies to address these issues. The
E:\FR\FM\12JAP1.SGM
12JAP1
]]>Agencies
[Federal Register Volume 75, Number 7 (Tuesday, January 12, 2010)]
[Proposed Rules]
[Pages 1555-1559]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-165]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 205
[Document Number AMS-NOP-09-0081; TM-09-04]
RIN 0581-AC93
National Organic Program; Proposed Amendments to the National
List of Allowed and Prohibited Substances (Crops)
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: This proposed rule would amend the U.S. Department of
Agriculture's (USDA's) National List of Allowed and Prohibited
Substances (National List) to reflect recommendations submitted to the
Secretary of Agriculture (Secretary) by the National Organic Standards
Board (NOSB) on November 19, 2008, and May 6, 2009. The recommendations
addressed in this proposed rule pertain to amending an annotation for
one exempted material on the National List and establishing an
exemption (use) for another material in organic crop production.
Consistent with the recommendations from the NOSB, this proposed rule
would amend the annotation for a listed substance and add one
substance, along with any restrictive annotation, to the National List.
DATES: Comments must be received by March 15, 2010.
ADDRESSES: Interested persons may comment on the proposed rule using
the following procedures:
Internet: https://www.regulations.gov.
Mail: Comments may be submitted by mail to: Toni Strother,
Agricultural Marketing Specialist, National Organic Program, USDA-AMS-
TMP-NOP, Room 2646-So., Ag Stop 0268, 1400 Independence Ave., SW.,
Washington, DC 20250-0268.
Written comments responding to this proposed rule should be
identified with the document number AMS-NOP-09-0081; TM-09-04. You
should identify the topic and section number of this proposed rule to
which your comment refers. You should clearly state whether you support
the amendment of the annotation for the substance on the national list
and/or the exemption for the substance being proposed, with clearly
indicated reason(s) for your position. You should also offer any
recommended language changes that would be appropriate for your
position. Please include relevant information and data to support your
position (e.g. scientific, environmental, manufacturing, industry,
impact information, etc.). Only relevant material supporting your
position should be submitted.
It is USDA's intention to have all comments concerning this
proposed rule, including names and addresses when provided, regardless
of submission procedure used, available for viewing on the
Regulations.gov (https://www.regulations.gov) Internet site. Comments
submitted in response to this proposed rule will also be available for
viewing in person at USDA--AMS, National Organic Program, Room 2646-
South Building, 1400 Independence Ave., SW., Washington, DC, from 9
a.m. to 12 noon and from 1 p.m. to 4 p.m., Monday through Friday
(except official Federal holidays). Persons wanting to visit the USDA
South building to view comments received in response to this proposed
rule are requested to make an appointment in advance by calling (202)
720-3252.
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, as
amended, (7 U.S.C. 6501 et seq.), (OFPA), 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 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,
[[Page 1556]]
(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, a proposed
amendment to the National List was published on June 3, 2009, (74 FR
26591).
This proposed rule would amend the National List to reflect two
recommendations submitted to the Secretary by the NOSB on November 19,
2008, and May 6, 2009. Based upon their evaluation of petitions
submitted by industry participants, the NOSB recommended that the
Secretary amend Sec. 205.601 of the National List to amend the
annotation for one exempted material (tetracycline) and add one
substance (sulfurous acid) for use in organic crop production. The
amended annotation and the exemption for use of the added substance in
organic production were evaluated by the NOSB using the criteria
specified in OFPA (7 U.S.C. 6517-6518).
II. Overview of Proposed Amendments
The following provides an overview of the proposed amendments to
designated sections of the National List regulations:
Section 205.601 Synthetic Substances Allowed for Use in Organic Crop
Production
This proposed rule would amend Sec. 205.601 of the National List
regulations by: (1) Amending the annotation of paragraph (i)(11) by
eliminating the parenthetical reference to a form of the exempted
material and adding an expiration date; and (2) adding new paragraph
(j)(9), for the purpose of allowing the use of the following
substances:
Tetracycline. Tetracycline, in the form of oxytetracycline calcium
complex, was included in the National List as originally published on
December 21, 2000 (FR 65 80548), for use for fire blight control only.
In October 2007, a petition was submitted to add oxytetracycline
hydrochloride complex for fireblight control in organic crop
production. 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.
Oxytetracyclines are derived from the soil bacteria, Streptomyces,
by a fermentation process. Technical grade tetracycline is a pale
yellow to tan crystalline powder, is freely soluble in water, and
decomposes above 180 degrees Celsius. Formulated products containing
the technical grade oxytetracycline calcium complex and oxytetracyline
hydrochloride for fireblight are wettable powders which are spray-
applied using ground or aircraft equipment at early bloom stage, when
fire blight infection usually occurs. In addition to agronomic uses,
oxytetracyclines are also antibiotics used in human and animal drugs.
Per the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 301
et seq.), as amended by the Food Quality Protection Act of 1996 (FQPA)
(Pub. L. 104-170, August 3, 1996), the EPA established tolerances for
residues of these oxytetracycline pesticides in or on raw apples,
peaches, nectarines, and pears of 0.35 parts per million (ppm) (40 CFR
180.337). In the 2006 Tolerance Reassessment Progress and Risk
Management Decision (TRED), EPA deemed that the toxicity of the
oxytetracylines would be similar and thus treated oxytetracycline
hydrochloride and oxytetracycline calcium as equivalent for hazard
characterization. In conducting the tolerance reassessment for
oxytetracycline, EPA considered the aggregate risk from exposure via
food and water intake and concluded that the dietary risk for all U.S.
populations was below the level of concern. In regards to ecological
effects, the EPA reported the potential for terrestrial and aquatic
species to be exposed to oxytetracyclines due to use patterns on food
crops, and the potential for acute and/or chronic toxicity. The EPA
concluded that it is unlikely that antibiotic resistance from
pesticidal use of oxytetracycline would result from food exposure, but
could theoretically occur among bacteria in orchards. The EPA is
conducting a registration review of oxytetracycline to ensure that the
intended function is achieved without unreasonable adverse effects on
human health or the environment. That review is scheduled for
completion in 2014.
At its November 18-20, 2008, meeting in Washington, DC, the NOSB
recommended revising the tetracycline listing at 205.601(i)(11) to
remove the qualifying words, ``oxytetracycline calcium complex,'' from
the annotation and, in effect, permit the use of either form of
oxytetracycline, i.e., oxytetracycline calcium complex and
oxytetracycline hydrochloride until October 21, 2012. Both forms of
oxytetracycline have EPA registered uses for fire blight control. In
this open meeting, the NOSB evaluated the available technical forms of
oxytetraclycline against the evaluation criteria of 7 U.S.C. 6517 and
6518 of the OFPA, received public comment, and concluded that the two
forms of tetracycline are comparable, and that allowing the use of both
substances is consistent with the prior decision to allow the use of
oxytetracycline calcium complex.
The NOSB, however, recommended adding an expiration date of October
21, 2012, after which no form of tetracycline could be used in organic
crop production. Therefore, tetracycline will be removed from the
National List by the expiration date rather than through a petition for
removal or sunset. The recommendation to change the annotation for
tetracycline would have reset the sunset date to 5 years from the date
on which the annotation was changed through this rulemaking. The NOSB
did not support prolonging the exemption for tetracycline and
recommended an expiration date to prevent that occurrence. The NOSB did
not find tetracycline to be essential to, nor compatible with, organic
production, but approved the use of oxytetracycline hydrochloride
solely on the basis that a functionally equivalent form is already
allowed for use in organic crop production. The Board was informed
during the meeting, and this information is supported by EPA
references, that oxytetracycline calcium complex and oxytetracycline
hydrochloride are the only forms of oxytetracycline that have
registered agricultural uses. NOSB approval of this petition is not
expected to increase the overall use of tetracycline in organic crop
production, but would allow growers to substitute one form for another
until October 21, 2012.
The NOP engaged in consultations with the EPA and Food and Drug
Administration (FDA). The EPA informed the NOP that the proposed
amendment to exempt oxytetracycline hydrochloride for use in organic
crops is consistent with EPA regulations. Concerning the use of
tetracycline, FDA deferred to EPA as the appropriate
[[Page 1557]]
regulatory body. Therefore, after consultation with the EPA and FDA
regarding NOSB's recommendation to amend the annotation for
tetracycline use in organic crops, the Secretary proposes to accept
NSOB's recommendation and amend Sec. 205.601 of the National List by:
(1) Removing the qualifying words in parenthesis from the annotation at
(i)(11) which currently specifies, ``oxytetracycline calcium complex''
to allow either form of oxyetracycline to be used; and, adding the
expiration date, October 21, 2012, after which no tetracycline may be
used in organic crop production for fireblight control.\1\
---------------------------------------------------------------------------
\1\ EPA (U.S. Environmental Protection Agency). 2006. Report of
the Food Quality Protection Act (FQPA) Tolerance Reassessment
Progress and Risk Management Decision (TRED) for Oxytetracycline.
EPA 738-R-06-011. https://www.epa.gov/oppsrrd1/REDs/oxytetracycline_tred.pdf.
EPA. 2008. Oxytetracycline Summary Document Registration Review:
Initial Docket December 2008 Case 0655. EPA-HQ-OPP-2008-
0686. https://www.epa.gov/oppsrrd1/registration_review/oxytetracycline/index.htm.
ICF Consulting. Technical Evaluation Report Tetracycline
(Oxytetracycline Calcium Complex). January 27, 2006. https://tinyurl.com/ygdtys4.
National Organic Standards Board (NOSB). Final recommendation on
Tetracycline. November 19, 2008, https://tinyurl.com/y9gds87.
NOSB Meeting Transcripts. November 18, 2008, pp. 185-201.
November 19, 2008, pp. 130-148; 191-213. https://tinyurl.com/ycaqqdq.
---------------------------------------------------------------------------
Sulfurous Acid (CAS -7782-99-2). Sulfurous Acid was
petitioned for use in organic crop production as a soil amendment. It
functions as an acidifying agent to neutralize and reduce the excessive
alkalinity (bicarbonates and carbonates) in soil or water. This
substance also has transient biocide properties that contribute to
keeping irrigation conveyance systems clean by suppressing growth of
bacteria and pathogenic microorganisms. Sulfurous acid is a clear,
nearly colorless solution (6-12%) which has a pungent odor, and is
soluble in water. Sulfurous acid degrades through microbial
decomposition to hydrogen ion and sulfate ion. The hydrogen ions cause
the acidifying effects. The sulfate ion is a nutrient to plants and
micro-organisms as long as the soil is aerobic.
Sulfurous acid is produced through natural and man-made processes
by reacting sulfur dioxide with water. In nature, sulfurous acid is
produced by wild fires, hydro-thermal vents on the ocean floor, vents
on the earth's surface, volcanic eruptions and fumaroles emitting
sulfur dioxide and reacting with water. Sulfur dioxide is also produced
by burning coal to produce heat or electricity. Sulfurous acid can be
manufactured by oxidizing elemental sulfur in a burner chamber with
pressurized water. The sulfur dioxide that is produced is immediately
captured to form an aqueous solution of sulfurous acid which can be
added to the irrigation water stream for application to fields. Within
hours of formation, sulfurous acid degrades to a hydrogen ion and a bi-
sulfite ion and is not sufficiently stable for transporting to a farm
sites for use.
The EPA does not regulate the application of sulfurous acid as a
soil amendment to reduce alkalinity. Sulfurous acid can cause burns
from all routes of exposure and is corrosive. Handlers should have
protective clothing, eyeware and gloves, and respirators may be needed
in some circumstances. Sulfurous acid should be used in a well-
ventilated area. Repeated exposure may cause damage to mucous
membranes, upper respiratory tract, skin and eyes.
Adverse biological or chemical reactions are not likely from the
proposed use in organic crops soil amendment purposes due to the quick
degradation of sulfurous acid, provided, that the sulfurous acid is
applied at the intended use rate and that soil pH is closely monitored.
If anaerobic conditions develop in waterlogged soil, anaerobic bacteria
could convert the sulfate ion to hydrogen sulfide which would be toxic
to the immediate ecosystem.
At its May 4-6, 2009, meeting in Washington, DC, the NOSB
recommended adding sulfurous acid to the National List as a soil
amendment for use in organic crop production, to be generated on-farm
only by burning 99% pure elemental sulfur per Sec. 205.601(j)(2), due
to the transient nature of the sulfurous acid. In this open meeting,
the NOSB evaluated sulfurous acid against the evaluation criteria of 7
U.S.C. 6517 and 6518 of the OFPA, received public comment, and
concluded that the use of the substance, as annotated, is consistent
with the OFPA evaluation criteria. The NOSB explained that the on-farm
generation is necessary because the short half-life of sulfurous acid
would prohibit shipping from off-farm sites. Furthermore, the NOSB
specified elemental sulfur at 99% purity as it is typically available
in this form.
The NOSB also examined whether the addition of sulfurous acid was
necessary in consideration of other substances on the National List,
specifically elemental sulfur and organic acids. The Board indicated
that the controlled application of sulfurous acid via irrigation is
preferable to broadcast applications of elemental sulfur, which acts
slower and can negatively impact the microbial soil life at the
application rates used. Furthermore, the Board determined that relying
upon organic acids, such as citric, would require the importation and
application of such large quantities as to make the use of those
substances impractical.
The NOP engaged in consultations with the EPA and FDA. FDA deferred
to EPA as the appropriate regulatory body. EPA concurred that the use
of this substance as specified would not conflict with EPA regulations.
Therefore, after consultation with the EPA and FDA regarding NOSB's
recommendation to permit the use of sulfurous acid as a soil amendment
in organic crop production when limited to on-farm generation by
burning 99% pure elemental sulfur, the Secretary is proposing to accept
the NOSB's recommendation and amend Sec. 205.601(j) of the National
List by adding sulfurous acid at new paragraph (j)(9) as follows:
Sulfurous acid (CAS -7782-99-2)--from on-farm generation
of substance, by burning only 99% elemental sulfur, exempted at (j)(2)
in this section.\2\
---------------------------------------------------------------------------
\2\ Agricultural Marketing Service Science & Technology Branch.
Technical Evaluation Report Sulfurous Acid. April 3, 2009.
Harmon Systems International, LLC. Petition for sulfurous acid
for inclusion on the National List. July 30, 2008. https://tinyurl.com/yh6wsv9.
NOSB Final Recommendation on sulfurous acid. May 6, 2009. https://tinyurl.com/yf9s6mb.
NOSB Meeting Transcripts. May 5, 2009, pp. 163-173. May 6, 2009,
pp. 34-57.
---------------------------------------------------------------------------
III. Related Documents
Three notices were published regarding the meetings of the NOSB and
its deliberations on recommendations and substances petitioned for
amending the National List. Substances and recommendations included in
this proposed rule were announced for NOSB deliberation in the
following Federal Register Notices: (1) 73 FR 18491, April 4, 2008
(Tetracycline); (2) 73 FR 54781, September 23, 2008 (Tetracycline); (3)
74 FR 11904, March 20, 2009 (Sulfurous Acid). NOSB meetings are open to
the public and allow for public participation.
IV. Statutory and Regulatory Authority
The OFPA, as amended [7 U.S.C. 6501 et seq.], 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
[[Page 1558]]
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 https://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5048809&acct=nopgeninfo.
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 proposed 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
proposed 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 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 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 proposed
rule would not be significant. The effect of this proposed rule would
be to allow the use of additional substances in agricultural
production. This action would relax 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 to small
agricultural producers and 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 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 USDA, Economic Research Service data based on
information from USDA-accredited certifying agents, the U.S. organic
industry included nearly 6,949 certified organic crop and livestock
operations at the end of 2001. These operations reported certified
acreage totaling more than 2.09 million acres of organic farm
production. By the end of 2005, the number of U.S. certified organic
crop and livestock operations totaled about 8,500 and certified organic
acreage exceeded 4 million acres. ERS, based upon information provided
by domestic accredited certifying agents, estimated the number of
certified handling operations as exceeding 2,790 in 2004. AMS believes
that most of these entities would be considered small entities under
the criteria established by the SBA.
The U.S. sales of organic food and beverages have grown from $1
billion in 1990 to nearly $17 billion in 2006. The organic industry is
viewed as the fasting growing sector of agriculture, representing
almost 3 percent of overall food and beverage sales. Since 1990,
organic retail sales have historically demonstrated a growth rate
between 20 to 24 percent each year, including a 22 percent increase in
2006.
In addition, USDA has 100 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 https://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 proposed rule. Accordingly, OMB clearance is not
required by section 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.
The AMS is committed to compliance with the Government Paperwork
Elimination Act (GPEA), which requires
[[Page 1559]]
Government agencies in general to provide the public the option of
submitting information or transacting business electronically to the
maximum extent possible.
The AMS is committed to complying with the E-Government Act to
promote the use of the Internet and other information technologies to
provide increased opportunities for citizen access to Government
information and services, and for other purposes.
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 proposed to be amended as follows:
PART 205--NATIONAL ORGANIC PROGRAM
1. The authority citation for 7 CFR part 205 continues to read as
follows:
Authority: 7 U.S.C. 6501-6522.
2. Section 205.601 is amended by:
A. Revising paragraph (i)(ll).
B. Adding new paragraph (j)(9).
The revision and addition 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 in
organic crop production only until October 21, 2012.
* * * * *
(j) * * *
(9) Sulfurous acid (CAS -7782-99-2) from on-farm
generation of substance by burning only 99% purity elemental sulfur per
Sec. 205.601(j)(2).
* * * * *
Dated: January 5, 2010.
Rayne Pegg,
Administrator, Agricultural Marketing Service.
[FR Doc. 2010-165 Filed 1-11-10; 8:45 am]
BILLING CODE 3410-02-P
