[Federal Register Volume 74, Number 12 (Wednesday, January 21, 2009)]
[Notices]
[Pages 3541-3545]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-1007]
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Notices
Federal Register
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This section of the FEDERAL REGISTER contains documents other than rules
or proposed rules that are applicable to the public. Notices of hearings
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Federal Register / Vol. 74, No. 12 / Wednesday, January 21, 2009 /
Notices
[[Page 3541]]
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
[Doc. No. AMS-LS-07-0131; LS-07-16]
United States Standards for Livestock and Meat Marketing Claims,
Naturally Raised Claim for Livestock and the Meat and Meat Products
Derived From Such Livestock
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Notice.
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SUMMARY: The Agricultural Marketing Service (AMS) is establishing a
voluntary standard for a naturally raised marketing claim that
livestock producers may request to have verified by the Department of
Agriculture (USDA). This standard incorporates revisions made as a
result of comments received from an earlier proposed standard. A number
of livestock producers make claims associated with production practices
in order to distinguish their products in the marketplace and there are
a growing number of entities that are capturing value-added
opportunities by using alternative production methods to meet the
demands of consumers and markets seeking meat and meat products from
naturally raised livestock. This voluntary standard will allow
livestock producers to utilize AMS' voluntary, third party verification
services to provide validity to such naturally raised livestock claims
and, in certain cases, access to markets that require AMS verification.
AMS verification of this claim would be accomplished through an audit
of the production process in accordance with procedures that are
contained in Part 62 of Title 7 of the Code of Federal Regulations (7
CFR part 62).
DATES: Effective Date: Standard will become effective once related
information collection provisions pursuant to the Paperwork Reduction
Act (44 U.S.C. 3501-3520) are met.
FOR FURTHER INFORMATION CONTACT: Martin E. O'Connor, Chief, Standards,
Analysis, and Technology Branch, Livestock and Seed Program, AMS, USDA,
Room 2607-S, 1400 Independence Avenue, SW., Washington, DC 20250-0254;
facsimile: (202) 720-1112; telephone: (202) 720-4486; or e-mail:
[email protected]. Additional information can also be found by
accessing the Web site at http://www.ams.usda.gov/SAT.
SUPPLEMENTARY INFORMATION: Section 203(c) of the Agricultural Marketing
Act of 1946, as amended (7 U.S.C. 1622), directs and authorizes the
Secretary of Agriculture ``to develop and improve standards of quality,
condition, quantity, grade, and packaging, and recommend and
demonstrate such standards in order to encourage uniformity and
consistency in commercial practices.'' USDA is committed to carrying
out this authority in a manner that facilitates the marketing of
agricultural products. One way of achieving this objective is through
the development and maintenance of voluntary standards by AMS.
Utilization of this voluntary standard would be accomplished through an
audit of the production process in accordance with procedures that are
contained in Part 62 of Title 7 of the Code of Federal Regulations (7
CFR Part 62).
Paperwork Reduction Act
Pursuant to the Paperwork Reduction Act (PRA) (44 U.S.C. 3501-
3520), the information collection provisions associated with this
notice have been submitted to OMB for approval as a new collection and
will be published for public comment.
Background
Individuals and companies often highlight production and marketing
practices in advertisements and promotions to distinguish their
products in the marketplace. Since the late 1970s, livestock and meat
producers (individuals and companies) have requested the voluntary
services of AMS to verify or certify specific practices to increase the
value of their products. The Livestock and Seed (LS) Program of AMS has
provided certification through direct product examination for a number
of production claims related to livestock and carcass characteristics.
The validity of such claims utilizing LS Program voluntary
certification services is enhanced since the product is labeled as
``USDA Certified.'' The LS Program also offers verification services
through Quality System Verification Programs (QSVP; http://www.ams.usda.gov/ARCaudits) to substantiate claims that cannot be
determined by direct examination of livestock, their carcasses,
component parts, or the finished product. The QSVP provides suppliers
of agricultural products or services the opportunity to distinguish
specific activities involved in the production and processing of their
agricultural products and to assure customers of their ability to
provide products or services of a consistently high quality. This is
accomplished by documenting the quality management system and having
the manufacturing or service delivery processes verified through
independent, third-party audits by AMS.
In addition to the market differentiation that AMS certification
and verification services provide, certain other markets require AMS
certification or verification services as a prerequisite. This is
especially true with certain foreign markets that require a competent
government entity, such as AMS to provide the certification or
verification activity. Since animal raising claims cannot be evaluated
in finished products through direct product examination (as
certification provides), the claims must be verified through the QSVP
program.
The majority of claims currently citing naturally raised animal
production methods are defined by the individual company selling the
product. Depending upon the branded program making the claims, the
production activities and associated requirements can vary since there
is currently no standard to specify which attributes must be addressed
and to what level, other than to be truthful and not misleading. This
has led to confusion in the industry and the marketplace as to what
requirements must be met in order to have a uniform, explicit claim
that can be easily understood.
There has also been growing recognition that livestock producers
targeting niche markets can provide the
[[Page 3542]]
most value-added alternatives by developing production systems that
include the widest array of marketing opportunities. Thus, instead of
losing the market premium of an animal intended to be marketed for a
specific marketing claim because it no longer met program requirements,
some premium could be obtained if the animal qualified for other value-
added markets.
The key to the success of this approach for the producer is to
ensure that he or she develops a program scope, which encompasses all
requirements that need to be addressed in any of the potentially
applicable marketing strategies. Thus, animals may be shifted into
other programs depending upon circumstances and management decisions.
This allows producers more flexibility than an all or nothing approach,
which would be the case if only one program was included in a marketing
strategy. Producers must determine whether viable markets exist for any
verification program they wish to make use of.
Another critical key to success is understanding that there are
commonly understood and verifiable programs available in the market,
but that AMS' verification can augment or complement these programs.
Consistent with its mission, AMS has determined that it can best
support producers and the development of markets, by providing
verification services and, as necessary, defining standards based on
their experience with USDA Certified Programs and USDA QSVP, research
into standard practices and procedures, and requests from the livestock
and meat industries.
With respect to the Naturally Raised Claim, AMS developed and
proposed a standard with explicit attributes that could easily be
understood by market participants as the basis for a naturally raised
marketing claim as it relates to live animal production practices. As
part of this process, AMS has obtained input from a number of
individual experts in government, industry, academia, and other
interested parties while establishing this voluntary standard.
Relationship of the Naturally Raised Claim to Other Marketing Claims
The U.S. Standard for the Naturally Raised Claim for Livestock and
the Meat and Meat Products Derived from such Livestock is intended to
stand alone or to be used in conjunction with other marketing claims.
This flexibility is intended to allow producers to develop marketing
plans utilizing recognized standards and terms, and to ensure product
characteristics are expressed and understood more clearly by market
participants. It does not limit in any way the ability of market
participants to make additional marketing claims.
USDA's Food Safety and Inspection Service (FSIS), under the
authority of the Federal Meat Inspection Act (FMIA; 21 U.S.C. 601, 607)
and the Poultry Products Inspection Act (PPIA; 21 U.S.C. 451, 457),
regulates domestic and imported meat and poultry product labeling,
standards, and ingredients. AMS' standard for a naturally raised
marketing claim would be verified, as provided in 7 CFR Part 62.
However, since this is a voluntary marketing claim standard, FSIS will
not necessarily limit the use of the term naturally raised to labels in
which participants employ and meet AMS' standard. FSIS label approval
requirements for the use of the term naturally raised and other claims
about livestock production practices are based upon the substantiation
provided at the time of label approval application. QSVP verified
claims, like other label approval applications, must be submitted to
FSIS for approval. Any specific labeling questions not related to AMS
services should be directed to FSIS.
Meat products marketed under a specific production marketing claim
should not be construed to imply that it is safer or somehow better
than conventionally produced livestock and the meat and meat products
derived from such livestock. Rather, marketing claims are meant to
distinguish or differentiate products in the marketplace; thus,
allowing purchasers to assess the value of their purchase on factors
other than price.
Comments and Responses on the Proposed Naturally Raised Marketing Claim
Standard
AMS proposed the Naturally Raised Marketing Claim standard as a
notice and request for comments in the November 28, 2007, Federal
Register Notice (72 FR 67266). AMS then reopened and extended the
comment period in the January 31, 2008, Federal Register Notice (73 FR
5789) because a number of interested producers, processors, and
marketers requested additional time to evaluate the impact of the
requirements of the proposed standard in order to provide more
meaningful and substantive comments.
By the close of the comment period, AMS received over 44,000
comments concerning the Naturally Raised Marketing Claim standard from
consumers, veterinarians, trade and professional associations, non-
profit organizations, national organic associations, as well as
consumer, agriculture, and animal advocacy organizations, retail and
meat product companies, food service, livestock producers, and allied
animal industries. Approximately 43,000 of the over 44,000 comments
received were form letter comments. A breakout of the comments by
issues raised, including the comments from form letters, and AMS'
responses follow.
The majority of the commenters felt the scope of the Naturally
Raised Marketing Claim standard was too narrow and thus opposed the
standard as proposed; however, nearly all of the commenters concurred
that the three core criteria proposed (animals raised without growth
promotants and antibiotics and have never been fed mammalian or avian
by-products) in the November 28, 2007, Federal Register Notice (72 FR
67266) should be a part of a naturally raised marketing claim standard.
AMS has determined that these three core criteria best represent
the current industry consensus of naturally raised claims existing in
the marketplace and that broadening the focus of the proposed standard
would limit the usefulness of the claim to a very small segment of
producers, would render it unlikely to be used, and would be of little
value in facilitating the marketing of agricultural products.
Commenters that were in favor of the standard identified additional
clarifications, practices, and attributes for consideration which will
be addressed below in the specific sections for each issue raised. The
revisions incorporated into the standard include (1) a clarification of
the meaning of animal by-products, (2) the addition of a prohibition of
aquatic by-products, and (3) a provision that would allow coccidiostats
for parasite control as long as their use is disclosed. The majority of
the comments received provided information related to one or more of
the categories below as a justification for or against the proposed
standard or as a suggested revision to the proposed standard.
Diet
Comments: AMS received many comments regarding the diet of
naturally raised livestock. Some commenters wanted the diet of
naturally raised livestock to be restricted to a vegetarian diet or a
grass diet, while other commenters suggested allowing a grain fed diet.
Some commenters stated that AMS should regulate the diet to be natural
to the species. Others commented that the diet of naturally raised
livestock should allow organic
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grains only while other commenters stated that the proposed standard
should prohibit genetically modified feedstuffs.
The only diet requirement addressed in the proposed standard was
that livestock have never been fed mammalian or avian by-products. Many
commenters expressed support for this requirement; however, numerous
commenters asked that the definition of animal by-products be
clarified. Some commenters asserted that pigs were omnivores and that
eggs and milk were commonly used in pigs' diet and requested that the
requirement of no mammalian and avian derived products be clarified to
prohibit slaughter by-products but not food items such as eggs and milk
in the porcine diet. Some commenters also suggested aquatic by-products
be prohibited.
Agency Response: As stated previously, the only diet requirement
addressed in the proposed standard was that livestock have never been
fed mammalian or avian by-products. After reviewing the comments
received suggesting the clarification of the definition of mammalian
and avian by-products, AMS has determined to revise the standard to
clarify the definition of animal by-product to specifically state what
is prohibited. For the purpose of the Naturally Raised Marketing Claim
standard, AMS will prohibit animal (mammalian, avian, and aquatic) by-
products derived from the slaughter/harvest processes including meat
and fat, animal waste materials (e.g., manure and litter), and aquatic
by-products (e.g., fishmeal and fish oil). This prohibition includes
meat by-products as defined by FSIS in 9 CFR 301.2. Mammalian and avian
products (e.g., milk and eggs) that are not derived from the slaughter/
harvest processes are allowed.
The remainder of the comments regarding diet were considered, but
not incorporated into the standard as AMS has determined the standard,
with the revisions made, is appropriate and will be most useful in
meeting the needs of producers as they develop a program scope and
marketing strategies. In addition, as we point out above, the Naturally
Raised Marketing Claim can be used in conjunction with other marketing
claims, thus accommodating many of the suggestions made regarding diet.
This flexibility allows producers to develop marketing plans
incorporating other recognized standards and terms in the livestock and
meat industries thereby allowing product characteristics to be
articulated in the marketplace and to be more clearly understood by
market participants.
Production Issues
Comments: AMS received numerous comments regarding the living and
raising conditions of livestock to be included in a naturally raised
marketing claim standard. Commenters suggested that animals be raised
in an environment natural to the species, allowed to exhibit natural
behaviors, and allowed to socialize. Some commenters wanted animals to
graze or be pastured only and many commenters stated that animals
should not be confined (e.g., free range, no Confined Animal Feeding
Operations (CAFOs), no cages, or no crates). Other commenters also
suggested that livestock be raised in sunshine, allowed fresh air,
provided clean water, and in inclement weather, provided un-crowded
enclosure with good manure handling.
Commenters also provided input regarding animal handling and
welfare (live animal and slaughter). Numerous commenters stated that
the standard should require animals to be treated and raised humanely
using acceptable animal welfare practices, and that animals should be
humanely slaughtered. Some commenters specifically requested that the
standard include requirements regarding the humane handling of downers
while other commenters requested that downer animals be prohibited.
AMS received comments on environmental stewardship and
sustainability. Commenters stated that sustainable production methods
should be used and that AMS should require conservation and sustainable
environmental measures.
Additional production/management practices that AMS received
comments on were suggestions to prohibit genetic selection, early
weaning, artificial insemination, tail docking, and surgical
mutilation. Many commenters also expressed the view that meat from
cloned animals be prohibited. Some commenters also stated that the
standard should require smaller herd sizes and allow as little
interference from humans as possible. AMS received comments requesting
that the proposed standard also include poultry and dairy production
requirements.
Agency Response: The comments received provided no clear, unified
approach other than that the three core criteria proposed (animals
raised without growth promotants and antibiotics and that have never
been fed mammalian or avian by-products) should be a part of a
naturally raised marketing claim. Accordingly, the comments did not
provide an adequate basis to establish a broader, more encompassing
standard.
Therefore, AMS determined that it was not appropriate to expand the
scope of this standard to incorporate the diverse range of suggested
practices or attributes into the naturally raised standard.
Furthermore, attempting to broaden the list of practices or attributes
incorporated in a standard to be applied on a nationwide basis would be
inherently difficult as practices vary from region to region and by
producer. Due to the geographic diversity of the United States,
livestock production practices vary considerably due to soils, climate,
and availability of the production inputs and other necessities such as
shelter, feedstuffs, and labor.
AMS concluded that many of the production activities identified
through the comment process would be more appropriately addressed as
standards themselves or incorporated into other more encompassing
standards or marketing programs that they would be more appropriately
associated with. AMS reiterates that the naturally raised standard was
designed to stand alone or be used in conjunction with other marketing
claims. For example, the naturally raised claim can be used in
conjunction with other descriptive marketing claims such as ``grass
(forage) fed.'' This flexibility is intended to allow producers to
develop marketing plans incorporating a variety of appropriate
standards, assuring that their products' characteristics are
communicated to and understood by market participants.
Thus, while these comments regarding production practices were
considered, they were not incorporated into the standard. Finally, the
inclusion of poultry and dairy production requirements in the standard
is outside the scope of the standard which is intended for livestock
and the meat and meat products derived from such livestock.
Use of Antibiotics, Growth Promotants, Health Treatments, and
Pesticides and Chemicals
Comments: Many commenters agreed with the proposed standard that
for naturally raised livestock, antibiotics should be prohibited at all
stages of the animal's life. However, other commenters expressed that
medical treatment should be allowed only when sick. One specific issue
commenters raised involved the question of whether to allow
coccidiostats for parasite control. The majority of the commenters who
specifically commented on this topic were in favor of the use of
coccidiostats/parasite control while
[[Page 3544]]
others felt coccidiostats should not be allowed. AMS also received a
few comments on whether the proposed standard should or should not
allow vaccines. One commenter specifically stated that the proposed
standard should address what is excluded rather than what is allowed.
Regarding the use of growth promotants, many commenters agreed with the
proposed standard that for naturally raised livestock growth promotants
and hormones should be prohibited. Other commenters also suggested that
the proposed standard should prohibit chemicals and use of pesticides.
Agency Response: AMS has incorporated a suggested revision to the
proposed standard as a result of the comments received on this subject.
In the proposed standard, coccidiostats, which include ionophores and
sulfonamides, were prohibited. Based upon our evaluation of the
comments and after further consideration of the issue, AMS has
determined that coccidiostats in the form of ionophores (not
sulfonamides) when used as a preventative measure for coccidiosis, as
well as for the prevention and treatment of other types of parasitism,
should be allowable. Coccidiosis is a parasitic disease of the
intestinal tract of livestock animals, primarily of young or immune-
compromised animals. Coccidiosis is an infectious disease that causes
either severe illness with possible death or subtle illness causing
stress and debilitation of the animal, resulting in secondary disease
that further jeopardizes the health of the animal. Treatment and
control must include both good animal husbandry measures, as well as
the use of anticoccidial drugs to prevent further disease and premise
contamination. When marketed, the animals or meat product must be
clearly identified with a statement that no antibiotics other than
ionophores were used to prevent parasitism. Ionophores may only be used
according to the manufacturer's label recommendations for coccidiostat
levels (parasite control).
AMS has concluded that for the Naturally Raised Marketing Claim
standard, the use of vaccines is acceptable and appropriate. The use of
vaccines, according to manufacturers' label recommendations, is an
important component of control and prevention of infectious diseases
and protects against losses from disease in livestock herds.
Vaccination is an essential part of good herd management and animal
husbandry practices. AMS has also concluded that if antibiotics are
used for medical treatment when animals are sick, the animals cannot be
marketed as naturally raised. AMS has not incorporated standards
related to the use of pesticides and chemicals because it is unclear
whether the variation in practices from region to region would allow
such a standard to meet the needs of producers throughout the Nation as
they define and determine the scope of their programs and develop
marketing plans.
Finally, AMS is clarifying the standard to make clear that
production promotants are included within the term ``growth
promotants.''
Additional Issues Raised Including Perceptions Associated With the
Naturally Raised Claim
Comments: AMS received numerous comments comparing the Naturally
Raised Marketing Claim standard to the FSIS label approval policies
with respect to the term natural for meat products. Many commenters
requested that AMS address what the commenters perceive as confusion
between the terms natural and naturally raised. Some commenters felt
that the Naturally Raised Marketing Claim should be linked to the FSIS
policies regarding the use of the natural claim and that a single
standard cover naturally raised livestock all the way to the meat
product and meat processing (make naturally raised a class of natural);
however, there were many other commenters who asserted that the
naturally raised claim should continue to be distinct from the natural
claim.
Many commenters tended to compare the Naturally Raised Marketing
Claim standard to other marketing programs. Commenters requested that
the Naturally Raised Marketing Claim standard not compromise other
labels such as organic and Certified Naturally Grown. Some commenters
requested that the requirements for a naturally raised standard be
created at a higher threshold than organic, while other commenters
thought it should be similar to organic or ``organic-like'', while
others thought it was or should be ``organic-light''.
AMS received comments stating that the Naturally Raised Marketing
Claim standard would contribute to confusion in the marketplace but
also received other comments stating that the proposed standard
provided clarity. Many commenters stated that the proposed standard
would mislead consumers; however, other commenters stated that the
proposed standard is a step in the right direction and is long overdue.
Many commenters felt that single, separate standards (e.g., ``no
antibiotics used,'' and ``no supplemental growth promotants
administered,'' and ``no animal by-products'') would indicate raising
practices more accurately rather than one umbrella claim and urged AMS
to abandon or withdraw the proposed naturally raised standard.
Some commenters also stated that the proposed standard would create
a competitive disadvantage for small farmers and companies and confer
an advantage on large corporate farms and businesses. Some commenters
stated that the Naturally Raised Marketing Claim standard should be
mandatory while other commenters asserted that the standard should be
voluntary. A few commenters stated that the Government should not be
involved with marketing claims and should leave the development of
marketing claims to producers and industry.
Agency Response: AMS reiterates that the Naturally Raised Marketing
Claim standard is independent of and distinct from FSIS label approval
policies governing use of natural claims with regard to post-harvest
processing. The naturally raised claim pertains only to pre-harvest
livestock production practices. AMS developed the Naturally Raised
Marketing Claim standard to be a distinct standard. AMS is adopting
this standard at this time because it fills a need that has been
identified to AMS. Nonetheless, AMS recognizes that there is
considerable merit in the comments that suggested that there is a need
for AMS and FSIS to coordinate the definitions of `naturally raised'
and `natural' to avoid creating consumer confusion. AMS and FSIS are
committed to developing a coordinated approach to defining labeling
terms that will maximize consistency and minimize differences when
similar terminology is addressed by the two agencies. FSIS intends to
address this matter in a forthcoming Federal Register document, and AMS
will work with FSIS on that document. It is clearly distinguishable
from the USDA organic standard, as well as from other marketing claims
(e.g., grass fed) and similar programs.
AMS has concluded that the standard is clear, reasonable, and
attainable. AMS believes this standard will create marketing
opportunities for all businesses, small and large. AMS QSVP is
voluntary and not mandatory. Producers will choose to comply with the
standard, be certified by AMS, and/or place a claim on their product
based on whether doing so would meet their production and marketing
needs. They will not be required to do so.
Accordingly, AMS establishes the following voluntary U.S. Standard
for
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Livestock and Meat Marketing Claims, by this notice.
U.S. Standards for Livestock and Meat Marketing Claims, Naturally
Raised Claim for Livestock and the Meat and Meat Products Derived From
Such Livestock
Background: This claim applies to livestock used for meat and meat
products that were raised entirely without growth promotants,
antibiotics, and animal (mammalian, avian, and aquatic) by-products
derived from the slaughter/harvest processes including meat and fat,
animal waste materials (e.g., manure and litter), or aquatic by-
products (e.g., fishmeal and fish oil).
The administration of growth promotants, including natural
hormones, synthetic hormones, production promotants, estrus
suppressants, beta agonists, or other synthetic growth promotants is
prohibited from birth to slaughter. Collectively, these substances are
referred to in the Naturally Raised Marketing Claim standard as
``growth promotants.''
No antibiotics can be administered, by any method (e.g., through
feed or water, or by injection), from birth to slaughter. This includes
low-level (sub-therapeutic) or therapeutic level doses, sulfonamides,
ionophores (except for ionophores used as coccidiostats for parasite
control as long as the animals marketed or meat product label states no
antibiotics other than ionophores were used to prevent parasitism), or
any other synthetic antimicrobial. Ionophores may only be used
according to manufacturer's label recommendations for coccidiostat
levels (parasite control). If an animal is in need of medical
attention, proper treatment should be administered in an attempt to
improve the health of the animal. If any prohibited substances are
administered, the treated animal must be identified and excluded from
the program. Vitamin and mineral supplementation is permissible.
Verification of the claim will be accomplished through an audit of
the production process. The producer must be able to verify for AMS
that the Naturally Raised Marketing Claim standard requirements are
being met through a detailed, documented quality management system.
Claim and Standard:
Naturally Raised--Livestock used for the production of meat and
meat products that have been raised entirely without growth promotants,
antibiotics (except for ionophores used as coccidiostats for parasite
control), and have never been fed animal (mammalian, avian, or aquatic)
by-products derived from the slaughter/harvest processes, including
meat and fat, animal waste materials (e.g., manure and litter), and
aquatic by-products (e.g., fishmeal and fish oil). All products labeled
with a naturally raised marketing claim must incorporate information
explicitly stating that animals have been raised in a manner that meets
the following conditions: (1) No growth promotants were administered to
the animals; (2) no antibiotics (other than ionophores used to prevent
parasitism) were administered to the animal; and (3) no animal by-
products were fed to the animals. If ionophores used only to prevent
parasitism were administered to the animals, they may be labeled with
the naturally raised marketing claims if that fact is explicitly noted.
Authority: 7 U.S.C. 1621-1627.
Dated: January 13, 2009.
James E. Link,
Administrator, Agricultural Marketing Service.
[FR Doc. E9-1007 Filed 1-16-09; 8:45 am]
BILLING CODE 3410-02-P