[Federal Register: November 3, 2003 (Volume 68, Number 212)]
[Rules and Regulations]
[Page 62215-62218]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03no03-3]
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DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 205
[Docket Number TM-03-02]
RIN 0581-AC27
National Organic Program; Amendments to the National List of
Allowed and Prohibited Substances
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Final rule.
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SUMMARY: This final rule amends the U.S. Department of Agriculture's
(USDA) National List of Allowed and Prohibited Substances (National
List) to reflect recommendations submitted to the Secretary by the
National Organic Standards Board (NOSB). Consistent with
recommendations from the NOSB, this final rule adds four substances,
along with any restrictive annotations, to the National List, and
revises the annotation of one substance.
EFFECTIVE DATE: This rule becomes effective November 4, 2003.
FOR FURTHER INFORMATION CONTACT: Richard H. Mathews, Program Manager,
National Organic Program, Telephone: (202) 720-3252; Fax: (202) 205-
7808.
SUPPLEMENTARY INFORMATION:
I. Background
On December 21, 2000, the Secretary established, within the
National Organic Standards (NOS) [7 CFR part 205], the National List
(Sec. Sec. 205.600 through 205.607). The National List is the Federal
list that identifies synthetic substances and ingredients that are
allowed and nonsynthetic (natural) substances and ingredients that are
prohibited for use in organic production and handling. Since
established, the National List has not been amended. However, under the
authority of the Organic Foods Production Act of 1990 (OFPA), as
amended (7 U.S.C. 6501 et seq.), the National List can be amended by
the Secretary based on proposed amendments developed by the NOSB.
This final rule amends the National List to reflect recommendations
submitted to the Secretary by the NOSB from November 15, 2000, through
September 17, 2002. Between the specified time period, the NOSB has
recommended that the Secretary add five substances to Sec. 205.605 of
the National List based on petitions received from industry
participants. These substances were evaluated by the NOSB using the
criteria specified in OFPA (7 U.S.C. 6517 and 6518) and the NOS. The
NOSB also recommended that the Secretary revise the annotation of one
substance included within Sec. 205.605.
The NOSB has recommended that the Secretary add additional
substances to Sec. Sec. 205.605 and 205.606 that have not been
included in this final rule but are under review and, as appropriate,
will be included in future rulemaking.
II. Overview of Amendments
The following provides an overview of the amendments made to
designated sections of the National List:
Sec. 205.605 Nonagricultural (nonorganic) substances allowed as
ingredients in or on processed products labeled as ``organic'' or
``made with organic (specified ingredients or food group(s)).''
This final rule amends paragraph (a) of Sec. 205.605 by adding
animal enzymes--without Lysosyme, calcium sulfate--mined, and glucono
delta-lactone. This final rule also amends paragraph (b) of Sec.
205.605 by adding cellulose.
This final rule revises current paragraph (b) of Sec. 205.605 by
amending an annotation to read as follows:
Potassium hydroxide--prohibited for use in lye peeling of fruits
and vegetables except when used for peeling peaches during the
Individually Quick Frozen (IQF) production process.
III. Related Documents
Eight 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 final rule were announced for NOSB deliberation in the following
Federal Register Notices: (1) 65 FR 64657, October 30, 2000, (Animal
enzymes); (2) 66 FR 10873, February 20, 2001, (Calcium sulfate); (3) 66
FR 48654, September 21, 2001, (Cellulose, and Potassium hydroxide); and
(4) 67 FR 54784, August 26, 2002, (Glucono delta-lactone, and
Tetrasodium pyrophosphate).
IV. Statutory and Regulatory Authority
The OFPA, as amended (7 U.S.C. 6501 et seq.), authorizes the
Secretary, at Sec. 6517(d)(1), to make amendments to the National List
based on proposed amendments developed by the NOSB. Sections 6518(k)(2)
and 6518(n) of OFPA authorize the NOSB to develop proposed amendments
to the National List for submission to the Secretary and establish a
petition process by which persons may petition the NOSB for the purpose
of having substances evaluated for inclusion onto or deletion from the
[[Page 62216]]
National List. The National List petition process is implemented under
Sec. 205.607 of the NOS. The current petition process (65 FR 43259)
can be accessed through the NOP Web site at http://www.ams.usda.gov/nop
.
A. Executive Order 12866
This action has been determined to be non-significant for purposes
of Executive Order 12866, and therefore, does not have to be 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. The final rule was
reviewed under this Executive Order and no additional related
information has been obtained since then. This final rule is not
intended to have a retroactive effect.
States and local jurisdictions are preempted under section 2115 of
the OFPA (7 U.S.C. 6514) 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 7 U.S.C. 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 section 2120(f) of the OFPA (7 U.S.C. 6519(f)), this
regulation 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. AMS has also considered the economic impact of this
action on small entities and has determined that this final rule will
have an impact on a substantial number of small entities. However, AMS
has determined that the impact on entities affected by this rule will
not be significant. The effect of this rule will be to allow the use of
additional substances in agricultural production and handling. This
action relaxes the regulations published in the final rule and provides
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, will be minimal and entirely beneficial to small
agricultural service firms. Accordingly, the Administrator of the AMS
hereby 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 $750,000 and small agricultural producers
are defined as those having annual receipts of less than $5,000,000.
The U.S. organic industry at the end of 2001 included nearly 6,600
certified crop and livestock operations, including organic production
and handling operations, producers, and handlers. These operations
reported certified acreage totaling more than 2.34 million acres,
72,209 certified livestock, and 5.01 million certified poultry. Data on
the numbers of certified handling operations are not yet available, but
likely number in the thousands, as they would include any operation
that transforms raw product into processed products using organic
ingredients. Growth in the U.S. organic industry has been significant
at all levels. From 1997 to 2001, the total organic acreage grew by 74
percent; livestock numbers certified organic grew by almost 300 percent
over the same period, and poultry certified organic increased by 2,118
percent over this time. Sales growth of organic products has been
equally significant, growing on average around 20 percent per year.
Sales of organic products were approximately $1 billion in 1993, but
are estimated to reach $13 billion this year, according to the Organic
Trade Association (the association that represents the U.S. organic
industry). In addition, USDA has accredited 85 certifying agents who
have applied to USDA to be accredited in order to provide certification
services to producers and handlers. A complete list of names and
addresses of accredited certifying agents may be found on the AMS NOP
Web site, at http://www.ams.usda.gov/nop. AMS believe that most of
these entities would be considered small entities under the criteria
established by the SBA.
D. Paperwork Reduction Act
Pursuant to the Paperwork Reduction Act of 1995, the existing
information collection requirements for the NOP are approved under OMB
number 0581-0181. No additional collection or recordkeeping
requirements are imposed on the public by this final rule. Accordingly,
OMB clearance is not required by section 350(h) of the
[[Page 62217]]
Paperwork Reduction Act, 44 U.S.C. 3501, et seq., or OMB's implementing
regulation at 5 CFR part 1320.
E. Discussion of Comments
The proposed rule was published in the Federal Register on May 22,
2003, with a ten-day comment period ending on June 2, 2003. Eighteen
comments were received on TM-03-02. All comments on the proposed rule
were posted on the NOP website.
Commenters on proposed rule TM-03-02 were consumers, producers,
processors, the NOSB, certifying agents, food industry organizations,
and trade organizations. The comments received were for amending the
National List of Allowed and Prohibited Substances by adding to: Sec.
205.605(a): Calcium sulfate-mined, and glucono delta-lactone; and to
Sec. 205.605(b): animal enzymes-without Lysosyme, cellulose, and
terasodium pyrophosphate. The commenters were also for amending the
annotation for potassium hydroxide as follows: Potassium hydroxide-
prohibited for use in lye peeling of fruits and vegetables except when
used for peeling peaches during the Individually Quick Frozen (IQF)
production process.
We received five comments on Calcium sulfate-mined, all of which
were in support of adding it to the National List. Two of the
commenters requested that the annotation be changed to the NOSB
recommendation ``allowed from non-synthetic sources only.'' They felt
this annotation would cover the mined calcium sulfate as well as any
other naturally derived forms, should they become commercially
available. This substance will be added to the National List as
published in the proposed rule because it would be redundant to state
``from non-synthetic sources only'' because the sub-section heading is
``Nonsysthetics allowed.''
Five comments were received in favor of adding Glucono delta-
lactone to the National List. Four of the commenters requested it be
added with the following annotation: ``produced through microbial
fermentation of carbohydrates only.'' This annotation would disallow
the use of oxidation of D-glucose with enzymes, but enzymes are allowed
in Sec. 205.605(a). Accordingly, this annotation is not adopted.
However, the listing is amended to add the annotation ``production by
the oxidation of D-glucose with bromine water is prohibited.'' This
will allow only the microbial and enzymes oxidation production methods.
Six comments were received in favor of adding Animal enzymes-
(Rennet-animal derived; Catalase-bovine liver; Animal lipase;
Pancreatin; Pepsin; and Trypsin) to the National List. All agreed,
however, that it should be listed in Sec. 205.605 (a) as an allowed
nonsynthetic rather than Sec. 205.605 (b) as an allowed synthetic.
Because the NOSB recommended it as an allowed nonsynthetic, and it was
inadvertently listed as an allowed synthetic, the substance will be
moved to Sec. 205.605 (a), allowed nonsynthetics.
Six comments were received in favor of adding Cellulose to the
National List. One commenter was opposed to adding this substance to
the National List because the substance is synthetic and the commenter
believes that the substance is not essential to any product
formulation. The commenter also stated that there are a number of
analogous substances already on the National List as allowed substances
that can fulfill the role. One commenter requested that the annotation
be separated to avoid confusion with other cellulose derivates that are
used as food additives and have been rejected by the NOSB. The NOSB
considered the issues raised by both commenters in formulating its
recommendation and we believe that no further change is needed based on
these comments. In light of this, this substance will be added to the
National List as proposed.
Tertrasodium Pyrophospate received six comments, three in favor of
and three opposed to inclusion on the National List. Several commenters
expressed concern over the recommended annotation. They indicated that
the annotation is vague, confusing, undefined and needs clarification.
They stated that the primary use of this substance appears to be to
create a texture that is similar to a meat product, and that this
directly conflicts with the criterion established in Sec.
205.600(b)(4):
the substance's primary use is not as a preservative or to recreate
or improve flavors, colors, textures, or nutritive value lost during
processing, except where the replacement of nutrients is required by
law.
We believe these comments have merit, and accordingly, we have not
added this substance to the National List. We will return the NOSB's
recommendation on this substance to the NOSB for reconsideration.
Potassium hydroxide received six comments, five in favor of and one
opposed to amending the annotation. The commenter opposed to the
annotation amendment did not agree that the substance was essential to
the peeling of peaches. The commenter stated that peach peeling
production trials, without using the substance, were not exhaustive of
the possibilities they could have employed to gain a successful outcome
and therefore the substance should not be allowed. The petitioner of
this substance provided substantial supporting data that the NOSB
considered in its review of the substance. The NOSB's recommended
annotation change is based on all of the evidence provided. One
commenter suggested this not be restricted to just peaches, but allowed
for ``peeling of Stone Fruit.'' However, the petitioner and the NOSB
considered only peaches and not stone fruit generally. Accordingly, the
annotation is amended as proposed.
Pursuant to 5 U.S.C. 553, it is found and determined that good
cause exists for not postponing the effective date of this action until
30 days after publication in the Federal Register. This rule reflects
recommendations submitted to the Secretary by the NOSB. The substances
to be added to the National List were based on petitions from the
industry and evaluated by the NOSB using criteria in the Act and
regulations. Because these substances are critical to organic
production and handling, the National List should be amended as soon as
possible.
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, subpart G is
amended as follows:
PART 205--NATIONAL ORGANIC PROGRAM
0
1. The authority citation for 7 CFR part 205 continues to read as
follows:
Authority: 7 U.S.C. 6501-6522.
0
2. Section 205.605 is amended by:
0
a. Adding three substances to paragraph (a).
0
b. Adding one substance to paragraph (b).
0
c. Revising Potassium hydroxide in paragraph (b).
The additions and revisions read as follows:
Sec. 205.605 Nonagricultural (nonorganic) substances allowed as
ingredients in or on processed products labeled as ``organic'' or
``made with organic (specified ingredients or food group(s)).''
* * * * *
(a) * * *
[[Page 62218]]
Animal enzymes--(Rennet--animals derived; Catalase--bovine liver;
Animal lipase; Pancreatin; Pepsin; and Trypsin).
* * * * *
Calcium sulfate--mined.
* * * * *
Glucono delta-lactone--production by the oxidation of D-glucose
with bromine water is prohibited.
* * * * *
(b) * * *
* * * * *
Cellulose--for use in regenerative casings, as an anti-caking agent
(non-chlorine bleached) and filtering aid.
* * * * *
Potassium hydroxide--prohibited for use in lye peeling of fruits
and vegetables except when used for peeling peaches during the
Individually Quick Frozen (IQF) production process.
* * * * *
Dated: October 27, 2003.
A.J. Yates,
Administrator, Agricultural Marketing Service.
[FR Doc. 03-27416 Filed 10-31-03; 8:45 am]
BILLING CODE 3410-02-P