[Federal Register Volume 74, Number 146 (Friday, July 31, 2009)]
[Proposed Rules]
[Pages 38296-38317]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-17610]
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Part III
Department of Agriculture
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7 CFR Part 2904
Voluntary Labeling Program for Biobased Products; Proposed Rule
Federal Register / Vol. 74 , No. 146 / Friday, July 31, 2009 /
Proposed Rules
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DEPARTMENT OF AGRICULTURE
7 CFR Part 2904
RIN 0503-AA35
Voluntary Labeling Program for Biobased Products
AGENCY: Departmental Administration, USDA.
ACTION: Notice of proposed rulemaking.
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SUMMARY: The U.S. Department of Agriculture (USDA) is proposing to
establish a voluntary labeling program for biobased products under
section 9002 of the Farm Security and Rural Investment Act of 2002, as
amended by the Food, Conservation, and Energy Act of 2008. Under the
proposed labeling program, a biobased product, after being certified by
USDA, could be marketed using the ``USDA Certified Biobased Product''
label. The presence of the label will mean that the product meets USDA
standards for the amount of biobased content and that the manufacturer
or vendor has provided relevant information on the product for the USDA
BioPreferred Web site. The proposed rule applies to manufacturers and
vendors who wish to participate in the voluntary labeling program. The
proposed rule also applies to other entities (e.g., trade associations)
that wish to use the label to promote biobased products.
DATES: USDA will accept public comments on this proposed rule until
September 29, 2009.
ADDRESSES: You may submit comments by any of the following methods. All
submissions received must include the agency name and Regulatory
Information Number (RIN). The RIN for this rulemaking is 0503-AA35.
Also, please identify submittals as pertaining to the ``Proposed
Voluntary Labeling Program.''
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Mail/commercial/hand delivery: Mail or deliver your
comments to: Ron Buckhalt, USDA, Office of the Assistant Secretary for
Administration, Room 342, Reporters Building, 300 Seventh Street, SW.,
Washington, DC 20024.
Persons with disabilities who require alternative means
for communication for regulatory information (Braille, large print,
audiotape, etc.) should contact the USDA TARGET Center at (202) 720-
2600 (voice) and (202) 690-0942 (TTY).
You may also send comments on the information collection aspects of
this rule directly to the Office of Information and Regulatory Affairs
of OMB, Attention: Desk Officer for Agriculture, Margaret Malanoski,
725 17th Street, NW., Room 10202, Washington, DC 20503. Comments should
reference OMB control number 0503-NEW.
FOR FURTHER INFORMATION CONTACT: Ron Buckhalt, USDA, Office of the
Assistant Secretary for Administration, Room 342, Reporters Building,
300 Seventh Street, SW., Washington, DC 20024; e-mail:
[email protected]; phone (202) 205-4008. Information regarding the
Federal Procurement Program of Biobased Products (one part of the
BioPreferred Program) is available on the Internet at http://www.biopreferred.gov.
SUPPLEMENTARY INFORMATION: The information presented in this preamble
is organized as follows:
I. Background
A. Authority
B. Overview of Section 9002
II. Purposes of the Voluntary Labeling Program
III. Voluntary Labeling Program
A. Applicability
B. Criteria for Obtaining Certification
C. Initial Approval Process
D. Appeals
E. Information Posted on Web Site
F. Applications for Reformulated Products
G. Requirements Associated With the Label
H. Violations
I. Recordkeeping Requirements
J. Reporting
IV. Suggested Comment Topics
V. Regulatory Information
A. Executive Order 12866: Regulatory Planning and Review
B. Regulatory Flexibility Act (RFA)
C. Executive Order 12630: Governmental Actions and Interference
With Constitutionally Protected Property Rights
D. Executive Order 13132: Federalism
E. Unfunded Mandates Reform Act of 1995
F. Executive Order 12372: Intergovernmental Review of Federal
Programs
G. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
H. Paperwork Reduction Act
I. Government Paperwork Elimination Act Compliance
J. Small Business Regulatory Enforcement Fairness Act
I. Background
A. Authority
The voluntary labeling program for biobased products is proposed
under the authority of section 9002 of the Farm Security and Rural
Investment Act of 2002 (FSRIA)(referred to in this preamble as
``section 9002''), as amended by the Food, Conservation, and Energy Act
of 2008 (FCEA), 7 U.S.C. 8102.
B. Overview of Section 9002
Section 9002 establishes a program for the Federal procurement of
biobased products by Federal agencies and a voluntary program for the
labeling of biobased products. These two programs, which are referred
to collectively by USDA as the BioPreferred\SM\ Program, are briefly
discussed below.
Federal Procurement of Biobased Products. Section 9002 requires
Federal agencies to develop procurement programs that give preference
to the purchase of biobased products (hereafter referred to in this
Federal Register notice as the ``preferred procurement program'').
Federal agencies and their contractors are required to purchase
biobased products, as defined in regulations implementing the statute,
that are within designated items \1\ when the cumulative purchase price
of the procurement item(s) procured is more than $10,000 or when the
quantities of functionally equivalent items purchased over the
preceding fiscal year equaled $10,000 or more. Each Federal agency and
contractor must procure biobased products at the highest content levels
within each designated item unless the agency determines that the items
are not reasonably available, fail to meet applicable performance
standards, or are available only at an unreasonable price.
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\1\ The term ``designated item'' refers to items (generic
groupings of specific products that perform the same function) that
have been afforded preferred procurement by Federal agencies under
the BioPreferred Program.
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The final guidelines for the preferred procurement program were
published in the Federal Register on January 11, 2005 (70 FR 1792). The
guidelines are contained in 7 CFR part 2902, ``Guidelines for
Designating Biobased Products for Federal Procurement.''
Part 2902 is divided into two subparts, ``Subpart A--General,'' and
``Subpart B--Designated Items.'' Subpart A addresses the purpose and
scope of the guidelines and their applicability, provides guidance on
product availability and procurement, defines terms used in part 2902,
and addresses affirmative procurement programs and USDA funding for
testing. Subpart B identifies designated items and specifies their
minimum biobased contents, the effective date of the procurement
preference for biobased products within each designated item, and other
information (e.g., biodegradability). USDA is responsible for
designating biobased items at the highest practicable biobased content
levels for the Federal agencies' preferred procurement programs.
[[Page 38297]]
As part of the preferred procurement program, section 9002 also
requires USDA to provide information to Federal agencies on the
availability, relative price, performance, and environmental and public
health benefits of products within such items and, as applicable under
section 9002(e)(1)(C), to recommend the minimum level of biobased
content to be contained in the products within a designated item.
To date, USDA has designated 33 items used in a variety of
applications, including cafeteria ware, personal and institutional
cleaning products, construction products, and lubricants and greases.
Voluntary Labeling Program. Section 9002 also requires USDA to
establish a voluntary labeling program under which USDA authorizes
manufacturers and vendors of biobased products to use a ``USDA
Certified Biobased Product'' label (hereafter referred to in this
preamble as ``the label''). The voluntary labeling program is intended
to encourage the purchase and use of biobased products by reaching
beyond the Federal purchasing community and promoting the purchase of
biobased products by the general public. In establishing this program,
USDA must identify the criteria to determine those products on which
the label may be used and must develop specific requirements for how
the label can be used. It is USDA's intent that the presence of the
label on a product will mean that the labeled product is one for which
credible factual information is available as to the biobased content,
consistently measured across labeled products by use of the ASTM
radioisotope test D6866.
In developing the proposed voluntary labeling program, USDA held
discussions with other agencies that have implemented labeling
programs, such as the ``ENERGY STAR[supreg]'' program implemented by
the U.S. Department of Energy and the U.S. Environmental Protection
Agency (EPA). USDA has also consulted with representatives of the
Department of Agriculture's National Organic program and others of the
Agricultural Marketing Service. Further, USDA consulted the Federal
Trade Commission, which issues the ``Guides for the Use of
Environmental Marketing Claims'' to ensure that the provisions of the
proposed voluntary labeling program were consistent with the Guides.
USDA also held a public meeting on July 22, 2008, to seek input on the
content and use of the label from the public and industry stakeholders.
The following section of the preamble presents the goal of the
voluntary labeling program and the objectives toward achieving that
goal. That section is followed by a summary of the voluntary labeling
program that USDA is proposing to implement under section 9002(h).
II. Goal of the Voluntary Labeling Program
USDA's goal in proposing this voluntary labeling program is to
encourage the increased use of biobased products in all market sectors.
To achieve this goal, USDA has identified the following objectives:
Promotion of biobased products. The voluntary labeling program is
intended to promote and increase the use of biobased products. In
general, the labeling program supports this goal by recognizing
manufacturers and vendors that produce and market products that utilize
biobased materials and by encouraging consumers to purchase such
products.
Whereas the preferred procurement program is specific to Federal
agencies, the voluntary labeling program is intended to encompass all
individuals and organizations making purchasing decisions. We are
proposing that there be two slightly different versions of the label,
one for those biobased products that have been designated for Federal
preferred procurement because they are within a designated item, and
another for those products that are not within a designated item. The
label artwork for products within designated items would include the
letters ``FP'' to indicate that they are Federally preferred. USDA
believes that informing consumers that these products have been
designated for Federal preferred procurement will be beneficial. As
part of the process of designating items for preferred procurement,
USDA gathers and evaluates information regarding the biobased product's
life cycle costs and environmental performance as well as functional
performance. Thus, the ``FP'' on the label will inform consumers that
USDA has evaluated representative products within the designated item
and found them to be qualified for the Federal preferred procurement
program. USDA also notes that the identification of products that have
been designated for preferred procurement would also be accomplished by
listing those products on the USDA Web site and in Federal procurement
catalogues.
Furthermore, the voluntary labeling program will increase the
amount of information available to manufacturers whose products may
utilize biobased materials or products as a component of their finished
products or as part of their manufacturing process. USDA expects that
this increased information will encourage these manufacturers to
consider using and/or increasing the amount of biobased materials when
designing or manufacturing their products, thereby further increasing
the purchase of biobased materials. For example, manufacturers of
equipment that uses hydraulic fluids are encouraged to consider the use
of biobased hydraulic fluids if available information indicates that
the performance of these fluids meets or exceeds their requirements.
Increase public awareness of biobased products. The voluntary
labeling program will raise the visibility of biobased products within
the Federal government and within the commercial marketplace. The
labeling program will also provide a unique and identifiable designator
recognized in the U.S. and foreign markets.
To the extent that the voluntary labeling program achieves these
objectives, there may be an increased purchase of biobased products,
which is then expected to reduce petroleum consumption, increase the
use of renewable resources, better manage the carbon cycle, and, may
contribute to reducing adverse environmental and health impacts. The
program is also expected to promote economic development for biobased
product manufacturers and vendors by creating new jobs and providing
new markets for farm commodities.
III. Voluntary Labeling Program
In developing the voluntary labeling program, USDA has one primary
goal--to encourage the purchase of biobased products. In implementing
this goal, USDA aims to ensure that only biobased products that meet
the criteria set forth in the voluntary labeling program are labeled
with the ``USDA Certified Biobased Product'' label and that the label
is used properly. USDA believes that products carrying the label will
become readily recognizable as biobased products, distinct from those
that do not carry the label. Further, as the label will have the
percent of biobased material printed on it, consumers will recognize
that products carrying the label meet certain criteria that set them
apart from other products.
A. Applicability
The proposed rule would apply to manufacturers and vendors of
biobased products, as well as to other entities (e.g., trade
associations, public interest groups) that promote, sell, or use the
products. USDA believes that each of these groups must comply with the
labeling requirements in order to ensure that only certified biobased
products
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(i.e., biobased products that have been approved for use of the label
under this program) carry the label and that the label is used
correctly. USDA believes that the goals of the voluntary labeling
program can be achieved, and the beneficial impacts of the BioPreferred
program can be increased, if manufacturers, vendors, and other entities
are allowed to market and promote the manufacturers' biobased products
with a credible biobased products labeling program.
Once USDA has approved a biobased product for labeling by its
manufacturer or vendor, an equally important aspect in ensuring the
integrity of the labeling program is the proper use of the label. Label
misuse can occur at the manufacturer level (e.g., affixing the label to
a non-certified biobased product) and at the retail level (e.g., using
the label to imply that a non-certified biobased product has been
certified), or by other entities wishing to use the label in promoting
the sales or public awareness of non-certified biobased products (e.g.,
on a Web site or in promotional materials).
While the labeling of biobased products is voluntary,
manufacturers, vendors, and other entities wishing to use the label in
their marketing, promotional, or educational efforts would be required
to comply with regulatory requirements as proposed herein. USDA
believes these requirements for use of the label are necessary to avoid
misleading consumers regarding whether a product has been certified by
USDA under the voluntary labeling program.
B. Criteria for Obtaining Certification
To be eligible for USDA certification to use the label, USDA
proposes that a product meet two criteria, as discussed below.
Criterion 1: Biobased Product. The product must be a biobased
product. Biobased product is defined in section 2904.2 of today's
proposed rule as follows: ``The term `biobased product' means a product
determined by the Secretary to be a commercial or industrial product
(other than food or feed) that is--(A) composed, in whole or in
significant part, of biological products, including renewable domestic
agricultural materials and forestry materials; or (B) an intermediate
ingredient or feedstock. For the purposes of this subpart, the term
`biobased product' does not include motor vehicle fuels, heating oil,
electricity produced from biomass, or any mature market products.
Products from a mature market will be determined on a case-by-case
basis.''
Rationale for Criterion 1: As discussed earlier, section 9002
requires USDA to establish a voluntary labeling program under which
USDA authorizes manufacturers and vendors of biobased products to use a
``USDA Certified Biobased Product'' label. USDA is proposing that
mature market products not be eligible to use the label except on a
case-by-case basis. Mature market products are those biobased products
that had significant national market penetration in 1972. Examples of
mature market products include cotton shirts or towels, paper plates,
and wood furniture. USDA has excluded mature market products from the
Federal preferred procurement program. In USDA's explanation for
excluding mature market products from the preferred procurement
program, USDA stated in the preamble to the final Guidelines (70 FR
1802), ``The intent of section 9002, as described in the conference
report accompanying FSRIA, `is to stimulate the production of new
biobased products and to energize emerging markets for those products.'
''
Based on conference report, it is clear that Congress did not
intend for mature market products to be given Federal procurement
preference. It is not clear, however, whether this exclusion of mature
market products was intended to apply to the voluntary labeling
program. The procurement preference program and the labeling program
are contained in different paragraphs of the statute, and the
conference report does not specifically state whether the language
quoted above refers to just one or to both paragraphs.
USDA believes, however, that the widespread labeling of mature
market products could negatively impact the entry of new biobased
products into market segments in which mature products already have
significant market shares. Thus, USDA believes that it is reasonable to
exclude many mature market products from the labeling program, as it
has done for the preferred procurement program. USDA is, however,
proposing to allow manufacturers of mature market products to appeal
(on a case-by-case basis) the exclusion of their products from the
program.
Criterion 2: Minimum Biobased Content. For a biobased product to
receive certification under this proposed rule, the biobased content of
that product must be at or above its applicable minimum biobased
content, as described below. USDA believes this requirement is
necessary so that the label is not used to promote products with de
minimis biobased content. As discussed below, the applicable minimum
biobased content depends under which of the three proposed categories
the product falls.
1. Biobased products within one or more designated items. If a
biobased product (including an intermediate ingredient or feedstock) is
within a designated item at the time of submitting an application for
certification, the applicable minimum biobased content for use of the
label would be the minimum biobased content specified for that item in
7 CFR 2902. As discussed in more detail below, once an item has been
designated, its minimum biobased content, as specified in 7 CFR part
2902, becomes the applicable minimum biobased content for all products
within that designated item, regardless of any previous minimum
biobased content used to qualify a product for using the label.
If a biobased product is marketed within more than one designated
item, and uses the same packaging, its biobased content must meet or
exceed the specified minimum biobased content for each of the
designated items in order to use the label for each item. For example,
Product A is currently marketed as a ``glass cleaner'' and a ``bath and
tile cleaner'' and uses the same packaging in both markets. USDA has
designated both these categories of products as items under its
BioPreferred procurement program. Product A has a biobased content of
60 percent. The minimum biobased content of designated item ``glass
cleaners'' is 49 percent and the minimum biobased content of designated
item ``bath and tile cleaners'' is 74 percent. The manufacturer would
not be eligible to apply for use of the label for Product A under
either designated item. If the biobased content of Product A were
instead 80 percent, the manufacturer would be eligible to use the label
under both designated items.
If, on the other hand, the manufacturer packaged the product in
different packaging for marketing within the two designated items
(e.g., a blue bottle for the glass cleaner and a green bottle for the
bath and tile cleaner), the product marketed as a glass cleaner would
be eligible to apply to use the label while the product marketed as
bath and tile cleaner would not be eligible.
2. Finished biobased products that are not within designated items.
If a biobased product is not within a designated item at the time the
application for certification is submitted, the applicable minimum
biobased content for the product for using the label would be 51
percent,
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unless USDA approves an alternative applicable minimum biobased
content. The proposed rule would allow manufacturers, vendors, and
trade associations (individually or collectively) who believe that the
51 percent minimum biobased content is not appropriate for the biobased
product to conduct an analysis, as discussed under ``Alternative
Minimum Biobased Content Analysis'' later in this preamble, to support
an alternative applicable minimum biobased content. If USDA approves
the alternative applicable minimum biobased content, then that content
becomes the applicable minimum biobased content for that product.
USDA recognizes that there will be groups of biobased products that
will be certified to use the label that will never be designated for
preferred procurement, primarily because these products are produced by
only one manufacturer and, thus, there is not sufficient market
competition to justify preferred procurement or they are not used
prevalently in the Federal marketplace. However, USDA expects that the
majority of the biobased products certified to use the label will be
within a group of products that USDA designates for preferred
procurement. In those cases where USDA subsequently designates an item
under which the certified biobased product falls for inclusion in the
preferred procurement program, the applicable minimum biobased content
for the product will then become the minimum biobased content
established for the designated item under which the product falls. As
of the effective date of the designation, only those products that meet
the new minimum biobased content may continue to use the label.
3. Products that are intermediate ingredients or feedstocks that
are not within designated items. If a biobased product is an
intermediate ingredient or feedstock and is not within a designated
item at the time the application for certification is submitted, the
applicable minimum biobased content for the product for using the label
would be 51 percent, unless USDA approves an alternative applicable
minimum biobased content. As with the previous product category, the
proposed rule would allow manufacturers, vendors, and trade
associations (individually or collectively) who believe that the 51
percent minimum biobased content is not appropriate to conduct an
analysis, as discussed under ``Alternative Minimum Biobased Content
Analysis'' later in this preamble, to support an alternative applicable
minimum biobased content. If USDA approves the alternative applicable
minimum biobased content, then that content becomes the applicable
minimum biobased content for that product.
Rationale for Criterion 2: USDA believes setting the applicable
minimum biobased content of products within designated items at the
minimum biobased content specified under the preferred procurement
program is appropriate, as USDA has had an opportunity to perform an
analysis on these products, including identifying similar biobased
products and their manufacturers, and obtaining biobased contents for
similar biobased products. USDA intends to proceed with the designation
of numerous items for which it has, or is currently gathering,
information. Once the designation process has been completed for those
items that have been identified for designation, USDA intends to
revisit, on a periodic basis, the minimum biobased content that was
established for designated items at the time of their designation. As
scientific advances and economic conditions warrant, USDA would expect
that the applicable minimum biobased content for designated items will
rise as competitors apply advances and increase the biobased content of
designated products. Thus, it is USDA's expectation that the applicable
minimum biobased content of designated items will increase as
advancements are made in biobased product technology. USDA also notes
that proposed revisions to the applicable minimum biobased content for
designated items will be announced in the Federal Register and the
public will have an opportunity to provide comments on the proposal.
For the second and third categories of products (finished biobased
products and intermediate ingredients and feedstocks that are not
within designated items) USDA considered several options for setting
the minimum biobased content, including the use of the lowest minimum
biobased content for any item designated to date. USDA decided,
however, that in the absence of the level of detailed product
information for setting a minimum biobased content based on product-
specific data (as is used under the preferred procurement program), and
in an effort to discourage minimal use of biobased feedstocks in what
are otherwise not biobased products, it is reasonable to consider such
finished products as ``biobased'' if they contain a significant amount
of biobased materials; that is, at least 51 percent of the product is
biobased. Thus, USDA is proposing that all finished products that are
not within designated items and all intermediate ingredients and
feedstocks that are not within designated items must contain at least
51 percent biobased content to be qualified for the label.
USDA recognizes, however, that for some finished products (and
intermediate ingredients) a 51 percent minimum biobased content may
result in a product that is not viable. USDA also recognizes that the
51 percent minimum biobased content could discourage the development of
new biobased products or the continued development of existing biobased
products. With this in mind, USDA will continue to gather product-
specific data under the preferred procurement program to determine
applicable minimum biobased contents. Additionally, USDA believes that
it is reasonable to provide a procedure to allow manufacturers,
vendors, and trade associations to propose an alternative applicable
minimum biobased content for such products.
Alternative Minimum Biobased Content Analysis
As noted above, manufacturers, vendors, and trade associations
would be allowed to propose an alternative minimum biobased content for
products not within a designated item if they believe that the proposed
minimum biobased content is not appropriate for their product(s). For
USDA to consider an alternative minimum biobased content for these
types of products, manufacturers, vendors, and trade associations would
be required to develop an analysis, in consultation with USDA, that
demonstrates the need for an alternative applicable minimum biobased
content. USDA believes that manufacturers, vendors, and trade
associations should consult with the Department in developing the
analysis to help ensure that an appropriate analysis is conducted.
While the analysis of the data supporting a specific request for an
alternative minimum biobased content will be performed on a case-by-
case basis, USDA anticipates that the evaluation process will be
standardized and will be similar to the process used to set minimum
biobased contents under the preferred procurement program. Such a
process would include identifying similar biobased products and their
manufacturers and determining biobased contents for similar biobased
products. USDA recognizes the difficulties involved in collecting
biobased contents, due in large part to the unpredictability of
manufacturer and vendor participation
[[Page 38300]]
in providing products for testing. Similar to the process used in the
preferred procurement program, the establishment of alternative minimum
contents for the labeling program will require a measure of flexibility
to address the variability in product type and level of industry
development. In general, the number of samples that should be obtained
for the biobased content analysis would depend on the number of
manufacturers of a product and similar products available. USDA would
expect applicants to coordinate with program officials to identify and
agree upon a reasonable number of samples for the analysis. Emphasis
would be focused on obtaining the maximum number of samples possible
without restricting the analysis process.
C. Initial Approval Process
Application
Manufacturers and vendors seeking use of the label on a qualified
biobased product must submit to USDA a separate USDA-approved
application for certification for each product for which the
manufacturer or vendor wishes to receive USDA approval to use the
label. Both the application and instructions for submittal of the
application will be available on the USDA BioPreferred Web site.
Each application must contain both contact and product information.
Contact information would include the applicant's name, mailing
address, e-mail address, and telephone number, and the name, mailing
address, telephone number, and e-mail address (if available) of the
person who prepared the application.
Product information would include the brand names or other product
identifying information (such as model name or number, or UPC number)
for the product, the biobased content of the product for which
certification is sought, contact information on the third-party testing
entity that tested the biobased content and documentation that the
testing entity is ISO 9001 conformant, the product category under which
the product falls, and the intended uses of the product. If the product
falls within a designated item(s), the applicant would also identify
the name of the designated item(s).
Lastly, the applicant would be required to sign a statement that
certifies that the product identified in the application is a biobased
product as defined in the labeling program and commits the applicant to
provide to USDA, and to keep up-to-date, the product's brand name(s),
or other identifying information; contact information, including the
name, mailing address, e-mail address, and telephone number of the
applicant; the biobased content of the product; and a hot link directly
to the applicant's Web site (if available). USDA is also requiring that
if manufacturers make claims on the product packaging about the
environmental and human health effects, life-cycle costs,
sustainability benefits, and performance of their products that
documentation supporting such claims be maintained.
Justification for Required Information
USDA considers the information required for the initial approval
process to be the minimum that will be needed by USDA to confirm that
products meet the criteria for certification. The following paragraphs
summarize the rationale for requiring the information specified.
Contact Information. This information is necessary for
communicating with the applicant concerning any issues with the
application, whether the application is deficient, and whether the
application has been approved.
Brand Names. Because a manufacturer or vendor may market the same
product under different brand names (or other product identifiers such
as model names or numbers), the application requires that all brand
names or other applicable product identifiers for that product be
provided. This will prevent the necessity of multiple applications from
the same manufacturer or vendor for the same product.
Biobased Content Information. For products in the three categories
discussed earlier, the biobased content of the product for which
certification is sought would be determined by ISO 9001 certified or
conformant,\2\ third-party testing firms using ASTM Method D6866,
``Standard Test Methods for Determining the Biobased Content of Natural
Range Materials Using Radiocarbon and Isotope Ratio Mass Spectrometry
Analysis.''
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\2\ ISO 9001 conformant means that the entity meets the
requirements of ISO 9001, but is not required to be ISO 9001
certified.
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In the case of a product that is marketed under different brand
names, the proposed rule would allow the manufacturer or vendor to test
the product once rather than requiring brand-name specific data,
thereby minimizing unnecessary testing of the same product that is
simply marketed under different brand names.
The applicant is required to provide the product's biobased
content, as determined using ASTM Method D6866, and contact information
on the entity that performed the testing. The applicant is also
required to provide documentation that the third-party testing entity
that determined the biobased content reported for the product is ISO
9001 conformant. This information is necessary to demonstrate that the
product's biobased content meets or exceeds the applicable minimum
biobased content and that a qualified, independent, third-party testing
entity conducted the testing.
Product Category. The applicant is required to identify whether the
product (1) falls within one or more designated items under the
preferred procurement program (and if so, the applicant is required to
identify the item(s)), (2) is a finished biobased product that is not
within a designated item, or (3) is an intermediate ingredient or
feedstock that is not within a designated item. This information is
necessary to identify the applicable minimum biobased content and then
to ensure that the biobased content of the product meets or exceeds the
applicable minimum biobased content.
Intended use(s). The applicant is required to provide a description
of the intended uses of the product (e.g., as a glass cleaner or as a
penetrating lubricant). USDA will use this description to confirm that
the product is assigned to the appropriate designated item(s), if
applicable. This will also allow USDA to determine if a product should
have been assigned to a designated item, if the application incorrectly
indicates that the product falls outside the designated item category.
Certifications and statements. The applicant must certify that the
product for which certification is sought is a biobased product, as
defined by the labeling program. USDA is proposing that applicants
certify to this criterion and keep appropriate records to demonstrate
that the product complies with this certifying statement, which USDA
can then review during an audit. This condition must be met in order to
ensure compliance with statutory requirements under which the voluntary
labeling program is being established.
As noted earlier in this preamble, the applicant is also required
to commit to providing to USDA information, and keeping it up-to-date,
for posting by USDA on the BioPreferred Web site. This information
includes the product's brand name(s) or other product identifiers;
contact information, including the name, mailing address, e-mail
address, and telephone number of the applicant; biobased content; and a
[[Page 38301]]
hot link directly to the applicant's Web site (if available).
While USDA is not requiring manufacturers to analyze the
environmental and human health effects, life-cycle costs,
sustainability benefits, and performance of their products,
manufacturers making claims regarding these attributes of their
products must maintain documentation to substantiate those claims
pursuant to the Federal Trade Commission (FTC) Act. Section 5 of the
FTC Act (15 U.S.C. 45) makes unlawful deceptive acts and practices in
or affecting commerce. The FTC ``Guides for the Use of Environmental
Marketing Claims'' (16 CFR part 260) state that ``any party making an
express or implied claim that presents an objective assertion about the
environmental attribute of a product, package or service must, at the
time the claim is made, possess and rely upon a reasonable basis
substantiating the claim.''
Evaluation
USDA will evaluate each application to determine if it is a
``complete'' application (i.e., that it contains all of the required
information). If USDA determines that the application is not complete,
it will return the application to the applicant and provide an
explanation of the deficiencies in the application. Once the
deficiencies have been addressed, the applicant may resubmit the
application for review by USDA.
USDA will evaluate each complete application to determine if the
product meets the criteria for certification discussed above (and
specified in Sec. 2904.4). There will be no specified deadline for
application submissions; applications will be worked on in a first come
first serve basis. Based on this evaluation, USDA either will
conditionally approve the application or will disapprove the
application. USDA will provide to each applicant a written response
within 60 days after the receipt of a complete application, informing
the applicant whether or not its application has been conditionally
approved or has been disapproved. An applicant who receives notice from
USDA that its application has been conditionally approved may not begin
using the label on its product until the applicant receives a notice of
certification from USDA (see next paragraph). For those applications
that are not approved, USDA will notify the applicant and identify each
criterion not met. Applicants whose applications are not approved have
the right to appeal under the proposed program first to USDA's
BioPreferred program office and then to USDA policy officials.
Notice of Product Certification
After an applicant receives notice from USDA that its application
(for the product to bear the label) has been conditionally approved,
the applicant must provide certain information, as discussed in Section
E in this preamble, to USDA. Once USDA has confirmed that the
information supplied by the applicant is complete, USDA will approve
the product label application and will issue a notice of product
certification to the applicant. USDA will include in the notice of
certification information necessary for the applicant to access the
applicable label artwork from the USDA BioPreferred Web site. Upon
receipt of the notice of certification, the applicant may begin using
the label on the certified biobased product.
Term of Product Certification
The effective (beginning) date of the product certification is the
date that the applicant receives the notice of certification from USDA.
The certification will remain valid for as long as the biobased product
is manufactured in accordance with the information supplied in the
approved application and presented on the USDA Web site, with one
exception. As discussed earlier, it is USDA's intent that the
applicable minimum biobased content of designated items will increase
over time as advancements are made in biobased product technology. If
the applicable required minimum biobased content for a product to be
eligible to display the label is revised by USDA, manufacturers and
vendors may continue to label their previously certified product only
if it meets the new minimum biobased content level. In those cases
where the biobased content of a certified product fails to meet the new
minimum biobased content level, USDA will notify the manufacturer or
vendor that their certification is no longer valid. Such manufacturers
and vendors must increase the biobased content of their product to a
level at or above the new minimum biobased content level and must re-
apply for certification within 60 days of receiving USDA's notice if
they wish to continue to use the label. Manufacturers and vendors who
have re-applied for certification may continue using the existing label
until they receive notification from USDA on the results of their re-
application for certification.
USDA considered proposing a certification period of either three or
five years, but decided that a fixed certification period was
unnecessary and that the process of reapplying every three or five
years would impose an undue burden on manufacturers who did not
reformulate their products. In the case of items that become
designated, it is likely that the required minimum biobased content for
the item could be different from the 51 percent level used to qualify
the item before it was designated. USDA believes that, in those cases,
only those products that meet the new minimum biobased content should
be eligible to display the label. Thus, USDA is proposing that if a
certified product's biobased content is below the newly established
minimum biobased content, the manufacturer must discontinue applying
the label as of the effective date of the item designation. The same
would be true in any other case where USDA, through established notice
and comment rulemaking procedures, revises the minimum biobased content
applicable to a previously certified product.
USDA points out that affixing the label to a certified biobased
product does not imply that the useful life or the shelf life of the
product has been affected in any way. Purchasers of labeled certified
biobased products, therefore, should continue to look to information
from the manufacturer or vendor to ascertain whether a product will
perform as advertised at the time the purchase is made.
D. Appeals
Today's proposed rule includes provisions for appeal by an
applicant whose application for certification is denied by USDA. In
addition, entities that have been cited for a violation or that have
received a notice of suspension or a notice of revocation may also file
an appeal. All appeals must be filed within 30 days of receipt of the
applicable notice. Appeals must be made in writing to the Program
Manager of the Voluntary Labeling Program for Biobased Products and
must contain, in part, a statement, including appropriate
substantiating documentation, of the appellant's reasons for believing
that USDA wrongfully denied the application or issued a notice of
violation, suspension, or revocation. If the appellant is dissatisfied
with the results of this appeal, he/she may raise the appeal to the
Assistant Secretary for Administration by letter request. Appeals to
the Assistant Secretary for Administration must be filed within 30 days
of receipt of the notice of decision from the appeal to the Program
Manager.
[[Page 38302]]
The proposed rule also includes provisions for manufacturers or
vendors of mature market products to appeal the exclusion of their
products from the voluntary labeling program if they believe that
conditions justify the use of the label on their products.
E. Information Posted on Web Site
Before USDA issues the notice of certification to a manufacturer or
vendor to use the label on a biobased product, the manufacturer or
vendor must submit contact and product information to USDA, which USDA
will then post on the USDA BioPreferred Web site (which can be accessed
at http://www.biopreferred.gov). This information must be complete and
must be provided to USDA before USDA will provide to the manufacturer
or vendor, the notice of certification and the information for
accessing the label artwork. The information that must be provided to
USDA is:
Product brand name(s) or other identifying information;
Contact information for the applicant;
Biobased content level; and
A hot link directly to the applicant's Web site (if
available).
In addition to the information listed above, USDA encourages
manufacturers to provide other information related to product features
and applicability for posting to the Web site.
USDA believes that making the information identified above
available on the USDA BioPreferred Web site will be an extremely
valuable step in establishing a database of certified biobased
products. Ideally, both Federal agencies and public consumers will be
able to readily access information that will help them in their
decision-making regarding the purchase of biobased products. USDA
believes that making this information available not only to Federal
agencies, but also to public consumers will result in increased
consumer awareness of and use of biobased products. USDA is also
proposing that manufacturers of certified biobased products must
include the USDA Web site address on or in close proximity to the
label.
Manufacturers must provide to USDA updated information for posting
by USDA to the USDA BioPreferred Web site whenever any of the
information on the Web site becomes outdated or if additional relevant
information becomes applicable. As discussed in Section I of this
preamble, failure to provide USDA with updated information will be
considered a violation of the requirements of the labeling program.
F. Applications for Reformulated Products
A manufacturer may decide to change the formulation of a certified
biobased product for various reasons including performance issues, raw
material availability, or changes in production processes. As discussed
earlier, manufacturers may also be required to reformulate products
that are within designated items in response to USDA re-evaluating and
increasing the applicable minimum biobased content for products within
the designated item. For such reformulated products to be eligible for
USDA certification to use the label, USDA proposes that a new
application be submitted to USDA, as discussed below.
If a certified product's biobased content is decreased by any
amount, a new application would be required. In any case where the
biobased content of a product is decreased from the original
formulation, the biobased content of the reformulated product must
still be at or above the applicable minimum biobased content for the
product in order for the product to qualify for the label.
In the case of a product whose biobased content is reduced, the
manufacturer or vendor cannot affix the label to the reformulated
product until they have submitted a new application, provided USDA with
the required information on the reformulated product for posting to the
USDA BioPreferred Web site, and received the notice of certification
for the reformulated product from USDA. If the manufacturer or vendor
also continues to sell the product in its original formulation, the
manufacturer or vendor may continue to affix the label to the original
product.
If a certified product's biobased content is increased, and the
manufacturer wishes to change the label to report the higher value, a
new application would be required. The manufacturer or vendor may
continue to affix the label to the reformulated product. However, the
manufacturer or vendor may not revise the biobased content displayed on
the label until they have submitted a new application, provided USDA
with the required information on the reformulated product for posting
to the USDA BioPreferred Web site, and received the notice of
certification for the reformulated product from USDA.
G. Requirements Associated With the Label
Today's proposed rule establishes specific requirements for the use
of the label. The requirements in today's proposed rule specify who may
use the label, correct and incorrect uses of the label, the physical
appearance of the label, and restrictions on the use of the label.
These requirements are summarized in the remainder of this section.
USDA is also developing a Marketing Guide that will be made
available to manufacturers and vendors of labeled products. The purpose
of this Marketing Guide is to provide expanded discussions of, and
guidance on resolving, implementation issues that may arise related to
the use of the label. For example, USDA anticipates that there will be
questions related to the best way to apply the label on very small
products, such as those within the designated item ``lip care
products.'' USDA believes that a Marketing Guide, that can be updated
frequently, is the most efficient way to keep label users informed of
guidance provided by USDA in response to implementation issues that
arise.
Who May Use the Label?
Any manufacturer or vendor who has received notice of certification
from USDA, and any designated representative of such manufacturers and
vendors, may use the label on the product and its associated packaging
and in the advertising of the certified biobased product. As proposed,
only the manufacturer or vendor (and their designated representatives)
of a certified biobased product would be granted the authority to affix
the label to the product. The process of applying for and receiving
certification requires specific knowledge of the product and its
characteristics and formulation. Obtaining certification also imposes
the requirement on the manufacturer and vendor to provide certain
information to USDA, which USDA will then post on the USDA BioPreferred
Web site.
Other entities may use the label to advertise or promote certified
biobased products (e.g., in catalogs or procurement databases), as long
as the manufacturer or vendor of the product (or one of their
designated representatives) has affixed the label to the product or its
packaging. USDA believes that allowing other entities to use the label
in informational, promotional, and educational materials for certified
biobased products will promote the goal of encouraging the use of
biobased products.
Use of the Label
The label may be affixed only to products (or associated packaging)
for which a manufacturer or vendor has received a notice of
certification under
[[Page 38303]]
this part. USDA's intent is for the label to be used by manufacturers,
vendors, and other entities to distinguish biobased products that meet
or exceed the criteria established by USDA from those that do not meet
the criteria. It is also important that the label be used in a
consistent manner such that the label and its meaning will become
recognizable in the marketplace. Use of the label on non-certified
products or alterations in the appearance of the label may confuse
consumers and diminish the value of not only the label, but also the
entire biobased product program. Therefore, USDA has identified correct
and incorrect uses of the label, which are discussed in the following
paragraphs.
Correct Uses. Proposed section 2904.7 identifies correct usages of
the label. These include, but are not limited to the following:
The label may be used in advertisements, catalogs,
procurement databases, Web sites, and promotional and educational
materials;
The label may appear next to a picture of the product(s)
or text describing the product(s); and
The label may be used without reference to a specific
certified biobased product only when informing the public about the
purpose of the label. For example, the following or similar claim is
acceptable: ``Look for the `USDA Certified Biobased Product' label. It
means the product meets USDA standards for the amount of biobased
content and the manufacturer or vendor has provided relevant
information on the product for the USDA BioPreferred Web site.'' This
exception allows manufacturers, vendors, and other entities to use the
label in documents such as corporate reports, but only in an
informative manner, not as a statement of product certification.
Incorrect Uses. Proposed Sec. 2904.7 also identifies incorrect
usages of the label. These include, but are not limited to the
following:
The label may not be used on non-certified products or in
advertisements or informational materials for non-certified products;
The label may not be used to imply endorsement by USDA or
the BioPreferred Program of any particular product, service, or
company; and
The label may not be used in any form that could be
misleading to the consumer, or on business cards, company letterhead,
or company stationery.
Imported Products
Because other countries may have different definitions of
``biobased'' and/or use other terms, it is necessary to address the use
of the label on products for import. The ``USDA Certified Biobased
Product'' label signifies that a product meets specific USDA criteria
for biobased products. Therefore, in order for products imported for
sale in the U.S. to carry the label, they must meet the same criteria
as U.S.-sourced biobased products, and their manufacturers and vendors
must apply for certification to use the label, even if the products are
considered biobased products in the country in which they are
manufactured.
Contents of the Label
The label must consist of the following:
The logo with the phrase ``USDA Certified Biobased
Product'' and, where applicable, the letters ``FP'' to indicate that
the product is within a Federally preferred designated item (this label
content is collectively referred to as the ``label artwork''); and
A statement that identifies the biobased content of the
product, as reported in the approved application for the product at the
time the label is affixed to the product or its packaging, and whether
the label applies to the product or packaging.
USDA is proposing that the statement that identifies the biobased
content also indicate whether the label applies to the product or the
packaging (e.g., Product: 57% biobased; Packaging: 90% biobased). The
USDA is proposing that this statement be included in the label in order
to make it clear as to what the certified biobased product is. USDA
believes that there will be instances where the placement of the label
on a product or its packaging will not clearly identify the certified
biobased product. For example, it is possible that a label placed on a
container will refer to the container itself (in which case the
statement ``Packaging: XX% biobased'' would be used) or to the contents
within the container (Product: YY% biobased). It may also be possible
that both the container and its contents are certified biobased
products, in which case two statements would appear (Product: YY%
biobased. Packaging: XX% biobased). Without tying the label to the
product or the packaging, the consumer may be unable to determine which
product is the certified biobased product. Therefore, USDA is proposing
that the appropriate statement(s) be included in the label in order to
identify clearly the product or products to which the label applies.
Furthermore, the proposed rule requires that, at the time the label
is affixed to the product or its packaging, the biobased content shown
on the label is the same as the biobased content found in the approved
application for the product. It is possible, however, that the biobased
content of a certified product could be changed by the manufacturer. If
a certified product's biobased content is changed to a level below that
shown on the label, the product is considered a reformulated product
and a new application is required. If a certified product's biobased
content is increased and the manufacturer wishes to change the label to
the higher value, a new application is also required.
USDA also requires manufacturers and vendors to include the USDA
BioPreferred Web site address on or in close proximity to the label.
USDA is not proposing to require that the Web site address be on the
label itself because the label on many products will not be large
enough to accommodate this extra information. USDA believes that, where
practicable, the presence of the USDA BioPreferred Web site address on
the label will assist consumers in obtaining information about biobased
products.
Physical Aspects of the Label
The rule addresses the physical aspects of the label artwork and
the presentation of the biobased product statement. In addition to the
requirements of the rule, USDA anticipates that guidance on specific
issues related to the physical aspects of the label will be provided in
the Marketing Guide.
Label Artwork
To maintain the distinctiveness of the label artwork (which
consists of the logo, the phrase ``USDA Certified Biobased Product''
and, where applicable, the letters ``FP'') and to make sure that it is
readily recognizable, USDA has established requirements related to the
physical appearance of the label artwork. The applicable label artwork
provided by the BioPreferred Program must be used.
USDA is also proposing color requirements to ensure that the label
artwork remains distinctive and recognizable. USDA is proposing to
require that one of three label versions be used, depending on the need
of the product. (1) A three-color version of the label artwork (white
plus two shades of green); (2) a one-color version of the label artwork
as long as the color used is one of the two greens specified in section
2904.7(f) of today's proposed rule; and (3) a black and white version
of the label artwork is also acceptable. The contrast between the light
and dark
[[Page 38304]]
sections of the label artwork should be great enough to maintain the
distinctiveness of the design.
Finally, the label artwork may not be altered, cut, separated into
components, or distorted in appearance or perspective.
Biobased product statement. The applicable biobased product
statement(s), which identifies the product(s) to which the label
applies and the biobased content(s), would be placed below the label
artwork. The biobased content must be expressed as ``XX%,'' where XX%
represents the actual biobased content of the product. The biobased
content must be easily readable. Figure 1 illustrates the placement of
the biobased product statement.
[GRAPHIC] [TIFF OMITTED] TP31JY09.000
Placement of the Label
Whether the label is placed directly on a product, on associated
packaging, in user manuals, or in other material, it should always be
placed in a manner that ensures that the label (label artwork and
biobased product statement(s)) can be readily associated with the
applicable certified biobased product. The label should not be placed
in a manner that is ambiguous about which product is a certified
biobased product or that could indicate certification of a non-
certified product. If all products on a printed page are certified
biobased products, the label may be placed anywhere on the page.
However, if a printed page contains a mix of certified biobased
products and non-certified products, the label must be placed in close
proximity to the certified biobased products. An individual label
located near each certified biobased product may be necessary to avoid
confusion.
Minimum Size and Clear Space Recommendations for the Label
USDA recognizes that a specific size requirement for the label
would not be appropriate because of the variety of sizes and shapes of
products that may be certified. Therefore, the label may be sized to be
appropriate for the particular application as long as the correct
proportions are maintained and the label remains legible.
A border of clear space must surround the label and must be of
sufficient width to offset it from surrounding images and text and to
avoid confusion. If the label's color is similar to the background
color, an outlining color may be used to enhance contrast.
Where To Obtain Copies of the Label Artwork
The two versions of the label artwork (with and without the letters
``FP'', as applicable) will be available at the USDA BioPreferred Web
site. Only manufacturers and vendors approved for use of the label for
certified biobased products will be able to obtain the label from the
Web site. USDA will provide the necessary access (through the notice of
certification) once a manufacturer or vendor has provided USDA with the
required information, which USDA will post to the USDA BioPreferred Web
site, for a product whose application for certification has been
approved by USDA.
H. Violations
Although the decision to participate in the certified biobased
products labeling program is voluntary, compliance with the program
requirements and specifications will be essential to the success of the
program. Proposed section 2904.8 identifies examples of the types of
actions that would be violations of the labeling program.
To enforce the provisions of the voluntary labeling program, USDA
will implement an audit program. This audit program will include, but
not necessarily be limited to, conducting inspections of manufacturer
and vendor facilities, visiting retail facilities, and testing the
biobased content of certified biobased products. Visiting manufacturer
and vendor facilities and inspecting their records, for example, will
help USDA identify potential label and application violations. Testing
certified biobased products for their biobased contents will help USDA
determine any violations associated with biobased contents.
Manufacturers, vendors, and their designated representatives are
required to cooperate fully with all USDA audit efforts for the
enforcement of the voluntary labeling program. USDA envisions selecting
five to ten percent of labeled products at random for audit each year.
Both the violations being proposed and any penalties associated
with a violation would be applied on a per product basis. For example,
a manufacturer has two certified biobased products, Product A and
Product B. The manufacturer has been cited for a labeling violation for
Product A and the certification for Product A has been revoked. As
proposed, the manufacturer would be required to discontinue labeling
Product A, and USDA would remove the information for Product A from the
USDA BioPreferred Web site. If no actions were taken against the
manufacturer with regard to Product B, the manufacturer's certification
for Product B would not be affected by the violation associated with
Product A. Thus, the manufacturer would still be allowed to affix the
label to Product B, and Product B's information would
[[Page 38305]]
remain on the USDA BioPreferred Web site.
Finally, the appeals process described previously is also
applicable when a notice of violation, suspension, or revocation is
issued.
Biobased Content Violations. As noted earlier, as part of its audit
program, USDA will conduct random tests of certified biobased products
taken from market shelves to determine their biobased contents and
compare the results to a product's applicable minimum biobased content
and the biobased content reported by the manufacturer or vendor in the
approved application. USDA will conduct such testing using ASTM D6866,
Standard Test Methods for Determining the Biobased Content of Natural
Range Materials Using Radiocarbon and Isotope Ratio Mass Spectrometry
Analysis.
If the USDA testing shows that the biobased content of a certified
biobased product is less than the applicable minimum biobased content
identified in the approved application for the product, then a
violation of the labeling regulations has occurred.
If USDA testing shows that the biobased content of a certified
biobased product is less than that reported in the approved
application, but is still equal to or greater than the applicable
minimum biobased content, USDA will notify the manufacturer or vendor
of its results. USDA may forward the test results to the Federal Trade
Commission for possible enforcement. The manufacturer or vendor would
then have 30 days to submit a new application, showing a revised
biobased content for the product. The revised biobased content could be
either the biobased content from the USDA test or a biobased content
reported by the manufacturer or vendor based on a new test conducted by
the manufacturer or vendor. If the manufacturer or vendor elects to
conduct a new biobased content test, the manufacturer or vendor must
test a current sample of the product. Failure to provide a new
application (including new test results) with a revised biobased
content within 30 days of receipt of USDA's written notification would
be considered a violation.
USDA notes that if its testing shows that the biobased content of a
certified biobased product is greater than the biobased content
reported in the approved application, no violation would have occurred.
USDA will, however, notify the manufacturer or vendor of the results of
the testing, ask if they would like to submit a second product test,
and potentially be allowed to increase the biobased content shown on
their label.
Label Violations. Any usage or display of the label that does not
conform to the requirements proposed in section 2904.7 would be
considered a violation of the proposed labeling regulations. For
example, applying a label to a product that does not have a valid
certification would be a label violation.
Application Violations. Knowingly providing false or misleading
information in any application for certification of a biobased product
would be a violation of the proposed labeling regulations. For example,
certifying in the application that the product meets the definition of
a biobased product when it does not would be an application violation.
USDA BioPreferred Web site Violations. As proposed, failure to
provide to USDA updated information on a certified biobased product
when the information for the certified biobased product becomes
outdated (e.g., a change in a product's biobased content), would be a
violation.
Notice of Violations and Associated Actions. When a violation has
been identified, USDA will provide written notification of the
violation to the applicable entity, which may be the manufacturer,
vendor, or its designated representative or other entity. In all
instances, the manufacturer of the product for which USDA has
identified the violation will also be notified. The notice of violation
will identify the violation. In the case of biobased content
violations, the offending party will then have 30 days from the date
the notice of violation is received to correct the violation. For other
types of violations, the offending party will have 60 days from the
date the notice of violation is received to correct the violation. The
30-day period for resolving violations of biobased content violations
is more stringent than the 60-day period allowed for resolving other
types of violations because biobased content violations, whether
intentional or not, are viewed as misleading consumers and could result
in inappropriately influencing their purchasing decisions.
If the party receiving the notice of violation is an ``other
entity,'' USDA will pursue remedies as provided for under proposed
section 2904.8(c). If the party is a manufacturer, vendor, or one of
its designated representatives, USDA will first pursue notices of
suspension and revocation, as discussed below. USDA also reserves the
right to pursue other remedies as provided in Sec. 2904.8(c).
Suspension of Certification. After receiving a notice of violation,
if the manufacturer, vendor, or designated representative, as
applicable, fails to make the required corrections within 60 days (or
30 days, in the case of biobased content violations), USDA will notify
the manufacturer or vendor of the continuing violation and will suspend
USDA certification for that product. As of the date the manufacturer or
vendor receives a notice suspending product certification, the
manufacturer or vendor and any designated representatives must not
affix the label to any of that product, or associated packaging, not
already labeled. Also, the manufacturer or vendor must not distribute
any additional products bearing the label after receiving a notice of
suspension of product certification. When USDA suspends a product's
certification, USDA will issue a press release informing the public of
the suspension and will also remove the information on that product
from the USDA BioPreferred Web site. If USDA learns that entities whose
certification has been suspended continue to use the label, USDA will
refer that information to the Federal Trade Commission for enforcement.
In order to resume use of the label for a product whose
certification has been suspended, the manufacturer, vendor, or
designated representative must correct the violation and notify USDA
that the violation has been corrected within 30 days from receipt of
the notice of suspension and must receive approval from USDA before use
of the label can be resumed. Once USDA has approved the corrections to
the violation, USDA will restore the product information to the USDA
BioPreferred Web site.
Revocation of Certification. If a manufacturer or vendor whose USDA
product certification has been suspended fails to make the required
corrections within 30 days of the date of the suspension, USDA will
notify the manufacturer or vendor that the certification for that
product is revoked. As of the date that the manufacturer or vendor
receives the notice revoking USDA certification, the manufacturer or
vendor and any designated representatives must not affix the label to
any of that product, or associated packaging, not already labeled. In
addition, the manufacturer or vendor and its designated representatives
are prohibited from further sales of the product to which the label has
already been affixed to any entity. However, if, prior to receipt of a
notification of revocation, a manufacturer or vendor has stored a
supply of product with the label that has already been sold to
[[Page 38306]]
another entity, the manufacturer or vendor must notify the entity of
the label revocation and allow the entity to cancel the transaction. If
a manufacturer or vendor whose product certification has been revoked
wishes to use the label, the manufacturer or vendor must follow the
procedures required for original certification.
Other Remedies. In addition to the suspension or revocation of the
certification to use the label, depending on the nature of the
violation, USDA may pursue suspension or debarment of the entities
involved in accordance with part 3017 of this title. USDA further
reserves the right to pursue any other remedies available by law,
including any civil or criminal remedies, against any entity that
violates the provisions of this part.
I. Recordkeeping Requirements
Manufacturers and vendors who choose to participate in the
voluntary labeling program will be required to keep certain records
related to their labeled biobased products. USDA believes these records
are necessary to ensure compliance with the labeling regulations.
Manufacturers and vendors may keep these records in either electronic
or hard copy format. The records that must be kept include:
The results of all tests, and any associated calculations,
performed to determine the biobased content of the product;
The results, and the supporting documentation, of industry
standard functional performance tests to support product performance
claims made by the manufacturer or vendor;
The results, and the supporting documentation, of analyses
the manufacturer or vendor has performed to support claims of
environmental or human health effects, life cycle costs, and
sustainability benefits of the product;
Documentation that the product for which certification is
sought meets the definition of biobased product, as defined in Sec.
2904.2 of this part; and
The date of the certification by USDA and the dates when
the biobased content of certified biobased products was tested.
Records created under the requirements of today's proposed rule
must be maintained for at least three years beyond the end of the label
certification period (i.e., three years beyond the period of time when
manufacturers and vendors cease using the label). If electronic records
are maintained, they must be readily accessible during an audit by
USDA. USDA believes that a three-year record retention period is the
minimum necessary to allow verification of the information supporting
active certifications. Manufacturers, vendors, and their designated
representatives must allow Federal representatives access to these
records for inspection and copying during normal Federal business hours
to determine compliance with the applicable regulations.
J. Reporting
USDA encourages manufacturers certified to use the label to provide
data in order to enable USDA to estimate and publicly report the
benefits and general effectiveness of the Voluntary Labeling Program.
The quantity, frequency, and format of the data will be as the parties
mutually agree. Such data may include, if and as available: (1) The
total number of units of each product shipped by manufacturer for sale
in the U.S., and (2) the type of customer (e.g., government, other
public institution, private/corporate institution, private individual)
to whom such products were sold.
USDA recognizes that manufacturers and vendors may consider some of
the requested information to be confidential. USDA stresses that
information claimed as confidential by the manufacturer or vendor will
not be released and that individual manufacturer or vendor data will
not be reported. Only summary information regarding the benefits and
impacts of the entire program will be released.
IV. Suggested Comment Topics
USDA invites comment on any aspect of today's proposed requirements
for the voluntary labeling program for biobased products. USDA invites
specific comments in the areas identified below.
1. Who can apply for the label? Under the proposed rule, both
manufacturers and vendors of biobased products can apply for use of the
label for their products. USDA is interested in comments on whether it
is appropriate to include vendors as an entity eligible to apply for
use of the label. Some of the requirements associated with approval for
use of the label will require information generally only available to
the manufacturer. In addition, it is the manufacturer, not the vendor,
who determines a product's formulation and production process. What
issues would a vendor face in complying with the proposed rule in light
of this?
2. Applicable minimum biobased contents. For products (including
intermediate ingredients and feedstocks) not within a designated item,
USDA is interested in comments associated with; (a) the 51 percent
applicable minimum biobased contents that products within this category
must meet in order to be eligible for use of the label, and (b) the
procedure under which an applicant can request an alternative
applicable minimum biobased content (i.e., an applicable minimum
biobased content other than 51 percent).
3. The labeling of ``complex products.'' In addition to the three
categories of products (products within designated items, those that
are not within designated items, and those that are intermediate
ingredients and feedstocks that are not within designated items) that
would be eligible to use the label under today's proposed rule, USDA
also intends to develop provisions for the labeling of ``complex
products'' once several implementation issues have been resolved. A
complex product is considered to be a finished, consumer product that
is composed of many different types of components. Examples of complex
products would be products such as computers, vacuum cleaners, lawn
mowers, and automobiles. Each of these products contains many component
parts made of different materials. For products such as these, it may
be feasible to produce one or more of the component parts with biobased
materials.
Today's proposed rule does not contain provisions to allow for the
labeling of complex products because there is currently no approved
method to determine the biobased content of a complex product. USDA has
consulted with ASTM representatives regarding the lack of an approved
test method. ASTM is gathering information on complex products and they
intend to proceed with the development of a method that can be used to
determine the biobased content of complex products. USDA will continue
to work closely with ASTM and the manufacturers of complex products
and, once an acceptable test method is available, expects to amend the
voluntary labeling rule to allow for the labeling of complex products.
USDA requests that commenters provide information on the types of
complex products containing biobased components that are in the
marketplace today, as well as those which may be in the developmental
stage. Information on the types of components that contain biobased
materials, the typical biobased content of these components, and the
market share of the biobased components is requested by USDA.
Information on current research efforts to develop new biobased
components for complex products is also requested. USDA is also
interested in commenters' opinions regarding how complex
[[Page 38307]]
products and their biobased components should be addressed in the
designation process as well as the voluntary labeling program.
4. The labeling of ``mature market products.'' The proposed rule
does not allow the label to be applied to products that are considered
to be ``mature market products'' (i.e., products that had significant
market penetration in 1972), except on a case-by-case basis. Section
2902.5(c)(2) of the final Guidelines also excludes mature market
products from the designation process. However, USDA is proposing to
allow manufacturers of mature market products to appeal (on a case-by-
case basis) the exclusion of their products from the voluntary labeling
program if they believe that conditions justify special consideration
for their products. A possible example would be the manufacturer of a
traditional biobased product that had a significant market share in
1972, lost that market share to petroleum-based alternative products
during the years between 1980 and 2000, is now attempting to re-enter
the market, and believes the label will be helpful in this attempt.
Other instances where USDA might consider granting appeals of the
exclusion of mature market products include those where labeling a
product could be shown to: reduce dependence on foreign petroleum
sources; create new ``green'' jobs; or reduce greenhouse gas emissions.
USDA welcomes comment on whether mature market products should be
eligible for labeling and whether the labeling of mature market
products could negatively affect the entry of new (i.e., post-1972)
biobased products into market segments in which mature products already
have significant market shares. USDA also requests comments regarding
what criteria should be used to evaluate appeals to include mature
market products in the labeling program and what types of information
manufacturers and vendors should be required to submit as justification
for their appeal. Commenters should provide specific reasons why the
use of the label on mature market products should be considered,
including information on the expected benefits of the label. USDA is
also seeking comments on why this label might be preferred over, or how
it could be used in conjunction with, other available labels such as
the ``cotton,'' ``renewable,'' or ``organic'' labels that can be used
on many mature market products.
5. The appropriate lengths for the certification periods. USDA is
proposing that certifications remain valid for as long as the certified
product is manufactured in accordance with the approved application.
USDA considered a certification of either three or five years, but
chose not to propose a specified time period, primarily to reduce the
burden that would be associated with reapplying for certification. USDA
welcomes comments on the appropriate length of time that a
certification should be valid. Be sure to include rationale for any
recommendations of alternative certification periods.
6. Preliminary notice of violations. USDA welcomes comments on
whether a preliminary notice of violation for any of the proposed
violations should be issued before action is taken by USDA against the
violators and, if so, how long a violator should be given to correct
the violation before action is taken.
7. Biobased content testing facilities. USDA solicits comments on
the appropriateness of requiring that labs be ISO 9001 conformant.
Specifically, are there benefits in such a requirement in terms of the
quality of the resulting data and, if so, is ISO 9001 the appropriate
standard? Commenters are encouraged to provide their opinions on
whether there are other standards (such as ISO 17025) that would be
more appropriate.
8. Clarification of biobased content of product vs. packaging on
label. As discussed earlier in this preamble, USDA believes that it is
important to identify for the consumer the item to which the label
applies. Therefore, USDA is proposing that the label include the
appropriate biobased product statement(s) to make this clear.
USDA seeks comments to determine if the use of the word ``product''
in the statement ``Product: YY% biobased'' is clear enough. For
example, if the label applies to a biobased hydraulic fluid, but not to
its container, does the statement ``Product: YY% biobased'' found on
the container clearly convey that the label applies to the hydraulic
fluid and not the container? If this statement does not clearly convey
this, please suggest alternatives that would more clearly accomplish
this.
When the label applies to both the product and its packaging, is it
necessary to provide the biobased content of both the product and its
packaging? As proposed, two statements would be included on the label
(Product: YY% biobased. Packaging: XX% biobased). USDA welcomes
suggestions on how to address providing biobased content information
when the label applies to both the product and its packaging.
9. Identifying products that are also eligible for a Federal
procurement preference under the preferred procurement program. As
proposed, biobased products that fall within designated items and are,
therefore, eligible for Federal preferred procurement, would use a
label with the letters ``FP'' included in the label artwork. USDA
considered simply allowing manufacturers to indicate in the product's
literature that the product is eligible for preferred procurement
rather than requiring such information on the label itself. USDA
decided that there may be a benefit to either Federal agencies or to
the public consumers to have this information on the label. USDA is
seeking comments on whether the ``FP'' lettering on the label will be
sufficient to distinguish products that are eligible for Federal
preferred procurement. USDA is also requesting comments on whether
consumers will recognize that the lettering on products means that
these products, or similar products, have undergone life cycle costs
and environmental performance analyses. USDA also welcomes comments on
how the labeling program and the preferred Federal procurement program
should work together.
10. Other possible label content. As discussed above, USDA is
proposing that the label include the biobased content (expressed as a
percentage), a statement indicating whether the biobased content refers
to the product or the packaging or both, and the BioPreferred Web site
address (either on or in close proximity to the label). USDA also
considered the possible advantages and disadvantages of requiring
additional information on the label. For example, USDA is proposing
that information on product performance and on the life-cycle costs and
environmental and human health effects of the labeled products be
maintained if manufactures make claims regarding these attributes for
their products. USDA considered whether providing this type of
additional information on the label would be beneficial to purchasers.
The primary advantage of providing additional information on the
label is to further educate purchasers about the attributes of the
biobased products they choose to purchase. However, because the results
of these analyses would typically be available only for labeled
biobased products, a comparison to non-labeled biobased, or non-
biobased, competing products may often be impossible. Also, the amount
of space that would be needed for a legible presentation of this
information could be a serious drawback for many small products (e.g.,
household cleaners, hair care products, lip care products).
[[Page 38308]]
USDA is proposing to require manufacturers to include the
BioPreferred Web site address either on or in close proximity to the
label. USDA is requesting comments on the possible benefits of this
proposed requirement and also on any expected drawbacks or negative
impacts.
USDA requests comments and recommendations regarding the value of
providing the types of additional information discussed above on the
label and specifically requests input on what types of information
should be included and how it should be presented.
11. Legibility of the label. As proposed, the label would consist
of two items, the label artwork and the biobased product statement(s)
with the accompanying biobased content(s). This is a significant amount
of information and, for some small products, could result in a label
that is difficult to read. Therefore, USDA is seeking comment on ways
to help ensure that the information proposed to be included will be
legible. Depending on the comments it receives and the rationale behind
those comments, USDA may require a different presentation of this
information.
12. Timeframe for correcting violations. Under the proposed rule,
USDA would allow up to 60 days for entities to correct violations (30
days for biobased content violations) before a notice of suspension or
other remedy is sought. USDA is seeking comment on whether it is
preferable for the timeframe to correct a violation to be fixed,
including the appropriate length to allow (e.g., are the 30- and 60-day
periods in the proposed rule reasonable?) or to be determined on a
case-by-case basis to be specified in the notice of violation.
13. Recordkeeping. The proposed rule requires certain records be
kept in order to allow USDA to verify information associated with the
labeling program and that these records be kept for at least three
years beyond the end of the label certification period (i.e., three
years beyond the period of time when manufacturers and vendors cease
using the label). USDA welcomes comments on the specific records to be
kept and the length of time they must be kept, including comments
related to recordkeeping costs.
14. Benefits and Costs. USDA requests comments on the potential
benefits (social and private) and costs (e.g., testing, submitting
applications and associated information, and recordkeeping) of the
proposed rule.
15. Application Fee. USDA is considering the option of charging an
application fee for each application to use the label. While
Departmental Administration does not currently have the statutory
authority to collect such a fee, available options are being explored.
As discussed elsewhere in this preamble, USDA plans to implement an
audit program to ensure compliance with the requirements for the use of
the label. Based on experience with other programs, USDA believes it
may be necessary to assess user fees in order to maintain a viable
audit program. The proceeds from the application fee would, therefore,
be used to help offset the cost of the audit program. USDA believes
that it is in the best interest of not only USDA but also the
manufacturers of labeled products that an audit program be implemented
so that the integrity of the label can be assured. Were authority
provided to do so, USDA would consider charging a fee of $500 for each
submitted application and requests comments on the appropriateness of
that amount as well as on the charging of a fee at all.
Please be sure to include your rationale for all suggested changes
to the proposed rule. Comments must be submitted as directed in the
ADDRESSES section of this notice.
V. Regulatory Information
A. Executive Order 12866: Regulatory Planning and Review
Executive Order 12866 requires agencies to determine whether a
regulatory action is ``significant.'' This proposed rule has been
reviewed under Executive Order (EO) 12866 and has been determined to be
significant. Today's proposed rule establishes a voluntary labeling
program that allows manufacturers and vendors of certified biobased
products to use the ``USDA Certified Biobased Product'' label. Although
the labeling program is voluntary, there will be costs associated with
meeting the criteria for, and applying for, certification to use the
label.
1. Costs of the Proposed Rule
The primary costs associated with participating in this program are
those for developing applications, testing to document the biobased
content of products, providing information to USDA for posting by USDA
on the USDA BioPreferred Web site, maintaining applicable records, and
redesigning the product packaging to incorporate the label. USDA
estimates that the combined annualized cost of the voluntary program,
as proposed, to manufacturers and vendors would average approximately
$2,813,811 per year for the first three years of the program. USDA
estimates an average of 352 manufacturers and vendors per year will
submit applications to participate in the labeling program for the
first three years of the program. This yields an average annualized
cost per manufacturer/vendor of approximately $7,994.
The level of presumed impact is not expected to exceed $100 million
because of the offsetting nature of the labeling program (i.e., an
increase in demand for biobased products is likely to be offset by a
decrease in demand for non-biobased products). While the program is
anticipated to have a widespread effect on the marketplace (including
shifting purchases away from non-biobased products toward the purchase
of biobased products), it is not expected to have a widespread adverse
effect on the economy.
2. Benefits of the Proposed Rule
As an integral part of USDA's BioPreferred\SM\ Program, the
voluntary labeling program is expected to raise public awareness of,
and increase the demand for, biobased products. While the benefits of
the labeling program are not quantifiable at this time, an increased
demand for biobased products will, in turn, achieve the benefits as
outlined in the objectives of section 9002: To increase domestic demand
for many agricultural commodities that can serve as feedstocks for
production of biobased products; to spur development of the industrial
base through value-added agricultural processing and manufacturing in
rural communities; to enhance the Nation's energy security by
substituting biobased products for products derived from imported oil
and natural gas; and to substitute products with a possibly more benign
or beneficial environmental impact, as compared to the use of fossil
energy-based products. On a national and regional level, today's
proposed rule can result in expanding and strengthening markets for
biobased materials used in these items. The program is also expected to
promote economic development for biobased product manufacturers and
vendors by creating new jobs and providing new markets for farm
commodities.
B. Regulatory Flexibility Act (RFA)
Under the RFA, an agency is not required to prepare a regulatory
flexibility analysis of any rule subject to notice and comment
rulemaking requirements under the Administrative Procedure Act or any
other statute if the agency can certify that the rule will not have a
significant economic impact on
[[Page 38309]]
a substantial number of small entities. Small entities include small
businesses, small organizations, and small governmental jurisdictions.
Of these three types of entities, the labeling requirements in
today's rulemaking would be applicable to small businesses only. For
purposes of assessing the impacts on small entities, a small business
is defined by the RFA using the definitions for small business based on
Small Business Administration size standards, which vary depending on
the type of business (e.g., less than 500 employees, less than 1,000
employees). Most of the manufacturing companies and vendors associated
with products within items that USDA has designated or proposed for
designation would qualify as small businesses under SBA guidelines.
While we do not have enough information to evaluate fully the
potential effect of this proposed rule on small entities, we have some
information to make some initial conclusions. We identified six North
American Industrial Classification System (NAICS) categories under
which many biobased products are manufactured: Petroleum lubricating
oil and grease manufacturing, plastics material and resin
manufacturing, soap and other detergent manufacturing, urethane and
other foam product (except polystyrene) manufacturing, carpet and rug
mills manufacturing, and fertilizer manufacturing. We then used
economic census data to determine the average value of shipments, a
reasonable surrogate for annual sales, for companies in these
categories. The analysis indicates that the average value of shipments
in 2002, the most recent year for which there are complete census data,
for the six NAICS categories examined is over $10 million per year per
establishment. USDA requests comments on the quality of this analysis
and ways to improve it.
More recent manufacturing census data on firm size, from 2006,
indicates that, collectively, over 94 percent of the firms in the six
categories meet the Small Business Administration definition of small
business for the six categories.
The benefit-cost analysis USDA conducted for the proposed rule,
discussed in Section I. below, indicates that the annualized cost
associated with participating in the voluntary labeling program is
about $7,994 on average and, relative to total sales by small
businesses in the NAICS categories where many biobased products are
manufactured, appears not to represent an undue burden in most cases.
Moreover, participation in the voluntary labeling program would
provide manufacturers and vendors a marketing advantage over those who
choose not to participate. This marketing advantage could lead to
greater sales, thus offsetting some of the costs associated with
participating in the labeling program.
Finally, the program requirements for the voluntary labeling
program are applicable to all manufacturers and vendors of biobased
products seeking to use the label under this program, regardless of the
size of their business. For instance, all manufacturers and vendors are
required to submit an application, conduct certain testing, and provide
to USDA certain information that USDA will post to the BioPreferred Web
site. These requirements are necessary to certify biobased products and
are independent of the size of the manufacturer or vendor. The
integrity of the labeling program would be compromised if biobased
products manufactured by small businesses were allowed to be subject to
different criteria in order to reduce costs to small businesses.
Based on this initial analysis, USDA has not prepared a Regulatory
Flexibility Analysis because USDA has determined that this rule does
not have a significant impact on a substantial number of small
entities.
C. Executive Order 12630: Governmental Actions and Interference With
Constitutionally Protected Property Rights
This proposed rule has been reviewed in accordance with Executive
Order 12630, Governmental Actions and Interference with
Constitutionally Protected Property Rights, and does not contain
policies that would have implications for these rights.
D. Executive Order 13132: Federalism
This proposed rule does not have sufficient Federalism implications
to warrant the preparation of a Federalism Assessment. Provisions of
this proposed rule will not have a substantial direct effect on States
or their political subdivisions or on the distribution of power and
responsibilities among the various government levels.
E. Unfunded Mandates Reform Act of 1995
This proposed rule contains no Federal mandates as defined under
the regulatory provisions of Title II of the Unfunded Mandates Reform
Act of 1995 (UMRA), 2 U.S.C. 1531-1538, for State, local, and tribal
governments, or the private sector. Therefore, a statement under
section 202 of UMRA is not required.
F. Executive Order 12372: Intergovernmental Review of Federal Programs
For the reasons set forth in the Final Rule Related Notice for 7
CFR part 3015, subpart V (48 FR 29115, June 24, 1983), this program is
excluded from the scope of Executive Order 12372, which requires
intergovernmental consultation with State and local officials. This
program does not directly affect State and local governments.
G. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
Today's proposed rule does not significantly or uniquely affect the
communities of Indian tribal governments. The proposed rule does not
impose any mandate on tribal governments or impose any duties on these
entities. Thus, no further action is required under Executive Order
13175.
H. Paperwork Reduction Act
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3501 et seq.), USDA is seeking OMB approval of the reporting and
recordkeeping requirements contained in this proposed rule. USDA
conducted a burden analysis of the costs associated with this proposed
rule, as well as a benefit-cost analysis. The primary costs of
participating in the voluntary labeling program are the costs of
testing the biobased content of products and the costs of labor
associated with reading the rule, applying for certification, gathering
and submitting the information for posting to the BioPreferred Web
site, and keeping applicable records for the products for which
certification is sought. See the contact information at the end of this
section for details on how to request a copy of materials related to
the Information Collection Request.
Methodology
To estimate the average annual burden over the first three years of
the rule, USDA estimated the number of hours that each activity (e.g.,
read the rule, complete the application, submit information to USDA,
appeal denied applications, keep records) would take, summed the
estimates for each activity to get an average total number of hours per
manufacturer/vendor, and multiplied that total by the estimated number
of manufacturers/vendors. The total cost of biobased content testing
was then projected by multiplying the estimated total number of
biobased
[[Page 38310]]
products for which certification is expected to be sought by the cost
of the test. The labor component of the cost and the testing component
were then summed to give a total estimated burden.
Assumptions
In estimating the costs for the burden analysis, USDA made the
following assumptions.
1. In the first year of the voluntary labeling program, USDA
estimates that 100 items will have been designated as eligible to
receive the procurement preference, another 36 items will have been
designated in the second year of the labeling program, and another 30
items will have been designated in the third year of the labeling
program.
2. Based on information gathered during the item designation
rulemakings, USDA estimates that approximately 830 manufacturers of
products within these 166 designated items and an additional 830
manufacturers of biobased products (including intermediate ingredients
or feedstocks) within items that are not designated for preferred
procurement are expected to have an interest in using the label,
yielding 1,660 manufacturers with eligible biobased products over the
first three years. USDA estimates that an additional 200 vendors over
the first three years would be interested in the voluntary labeling
program. This yields a total of 1,860 manufacturers and vendors.
Finally, USDA estimates that 166 other entities over the first three
years would be interested in the voluntary labeling program.
3. Because the voluntary labeling program is new and the benefits
to manufacturers of labeling their biobased products are not yet
demonstrated, USDA anticipates that many manufacturers may be reluctant
to participate during the first few years of the program. USDA expects
that during the first three years of the program, participation by one
half to two thirds of eligible manufacturers/vendors would be a
reasonable estimate. Therefore, USDA assumed that sixty percent of the
manufacturers of products within designated items, sixty percent of the
manufacturers of products that are not within designated items, and
thirty percent of the vendors with eligible biobased products would
apply for certification to use the label. Thus, 1,056 manufacturers and
vendors ((830 x 0.6) + (830 x 0.6) + (200 x 0.3) = 1,056) would apply
to use the label over the first three years (an average of 352 per
year).
4. Based on information gathered to support the designation of
items for preferred procurement, the average number of biobased
products per manufacturer is between six and seven. For this analysis,
USDA estimates that each applicant would submit applications for six
products. This results in the submittal of 2,112 applications (352
applicants times 6 products per applicant) for products, on average,
for each of the first three years. Of these, USDA estimates that 95
percent will be approved for use of the label.
5. In estimating the cost of the labor for reading the rule,
completing applications, gathering and submitting information for
posting on the BioPreferred Web site, and maintaining the applicable
records, USDA used an average labor cost of $49.98 per hour. This
hourly rate is based on the Federal salary schedule, step 6, GS 14
``rest of the United States'' salary of $103,957 per annum (with 2080
hours worked per annum). The salary level is deemed reasonable under
the expectation that at least half the burden hours would likely be
provided by private sector employees earning less than this hourly rate
and up to half the private sector employees would be earning more.
6. Based on the biobased content testing performed to support the
item designation rulemakings, USDA estimated an average cost of $500 to
perform biobased content testing.
Estimated Burden
During the first three years the labeling program is in effect, the
total annual burden on all respondents is estimated to be $2,813,811.
For the estimated 352 manufacturers/vendors (see item 3 above)
certified to use the label, the average burden is, therefore, estimated
to be $7,994 ($2,813,811 / 352 = $7,994).
Abstract
The Farm Security and Rural Investment Act of 2002 (2002 Act), as
amended by the Food, Conservation, and Energy Act of 2008, established
the Biobased Markets Program under Title IX, Section 9002. The 2002 Act
requires the Secretary of Agriculture to create a voluntary labeling
program for biobased products.
The information requirements contained in this proposed rule
require information from manufacturers and vendors of biobased products
that seek to use the label on qualified biobased products. The
information is vital for USDA to evaluate the qualifications of
biobased products to carry the USDA label and to ensure that the label
is used properly. This collection of information is necessary in order
to implement the voluntary labeling program for biobased products
established under the 2002 Act.
Copies of this information collection can be obtained from Ron
Buckhalt at the following address: Ron Buckhalt, USDA, Office of the
Assistant Secretary for Administration, Room 300, Reporters Building,
300 Seventh Street SW., Washington, DC 20024; e-mail:
[email protected]; phone (202) 205-4008.
As part of our continuing effort to reduce paperwork and respondent
burdens, USDA invites the public and other Federal agencies to comment
on any aspect of the reporting burden in the proposed rule. Comments
are invited on: (1) Whether the proposed collection of information is
necessary for the proper performance of the functions of USDA in the
operation and management of this labeling program; (2) the accuracy of
the burden of the proposed collection of information, including the
validity of the methodology and assumptions used; (3) ways to enhance
the quality, utility, and clarity of the information to be collected;
and (4) ways to minimize the burden of the collection of information on
those who are to respond, including through the use of appropriate
automated, electronic, mechanical, or other technological collection
techniques or other forms of information technology. Comments may be
sent to: Office of Information and Regulatory Affairs of OMB,
Attention: Desk Officer for Agriculture, Margaret Malanoski, 725 17th
Street, NW., Room 10202, Washington, DC 20503. Comments should
reference OMB control number 0503-NEW. All responses to this notice
will be summarized and included in the request for OMB approval. All
comments will also become a matter of public record.
I. Government Paperwork Elimination Act Compliance
USDA is committed to compliance with the Government Paperwork
Elimination Act (GPEA) (44 U.S.C. 3504 note), which requires Government
agencies in general to provide the public the option of submitting
information or transacting business electronically to the maximum
extent possible. USDA is implementing an electronic information system
for posting information submitted by manufacturers and vendors on the
products they intend to label under the voluntary labeling program for
biobased products. For information pertinent to GPEA compliance related
to this rule, please contact Ron Buckhalt at (202) 205-4008.
[[Page 38311]]
J. Small Business Regulatory Enforcement Fairness Act
The proposed rule is not a major rule under the Small Business
Regulatory Enforcement Fairness Act, 5 U.S.C. 804(2). This rule will
not have an annual effect on the economy of $100 million or more; will
not cause a major increase in costs or prices for consumers, individual
industries, Federal, State, or local government agencies, or geographic
regions; and does not have significant adverse effects on competition,
employment, investment, productivity, innovation, or the ability of
U.S.-based enterprises to compete with foreign-based enterprises.
List of Subjects in 7 CFR Part 2904
Biobased products, Labeling.
For the reasons stated in the preamble, the U.S. Department of
Agriculture (USDA) proposes to amend 7 CFR chapter XXIX as follows:
CHAPTER XXIX--DEPARTMENTAL ADMINISTRATION, DEPARTMENT OF AGRICULTURE
1. A new part 2904 is added to chapter XXIX to read as follows:
PART 2904--VOLUNTARY LABELING PROGRAM FOR BIOBASED PRODUCTS
Sec.
2904.1 Purpose and scope.
2904.2 Definitions.
2904.3 Applicability.
2904.4 Criteria for product eligibility to use the label.
2904.5 Initial approval process.
2904.6 Appeals process.
2904.7 Requirements for the use of the label.
2904.8 Violations.
2904.9 Recordkeeping requirements.
2904.10 Oversight and monitoring.
Authority: 7 U.S.C. 8102.
Sec. 2904.1 Purpose and scope.
The purpose of this part is to set forth the terms and conditions
for voluntary use of the ``USDA Certified Biobased Product'' label.
This part establishes the criteria that biobased products must meet in
order to be eligible to become certified biobased products to which the
``USDA Certified Biobased Product'' label can be affixed, the process
manufacturers and vendors must use to obtain and maintain USDA
certification, and the recordkeeping requirements for manufacturers and
vendors who obtain certification. In addition, this part establishes
specifications for the correct and incorrect uses of the label, which
apply to manufacturers, vendors, and other entities. Finally, this part
establishes actions that constitute voluntary labeling program
violations.
Sec. 2904.2 Definitions.
Applicable minimum biobased content. The biobased content at or
above the level set by USDA to qualify for use of the label.
ASTM International (ASTM). A nonprofit organization that provides
an international forum for the development and publication of voluntary
consensus standards for materials, products, systems, and services.
Biobased content. The amount of biobased carbon in the material or
product expressed as a percent of weight (mass) of the total organic
carbon in the material or product. For products within designated
items, the biobased content shall be defined and determined as
specified in the applicable section of subpart B of part 2902. For all
other products, the biobased content is to be determined using ASTM
Method D6866, Standard Test Methods for Determining the Biobased
Content of Natural Range Materials Using Radiocarbon and Isotope Ratio
Mass Spectrometry Analysis.
Biobased product. A product determined by the Secretary to be a
commercial or industrial product (other than food or feed) that is:
(1) Composed, in whole or in significant part, of biological
products, including renewable domestic agricultural materials and
forestry materials; or
(2) An intermediate ingredient or feedstock. For the purposes of
this subpart, the term `biobased product' does not include motor
vehicle fuels, heating oil, electricity produced from biomass, or any
mature market products. Products from a mature market will be
determined on a case-by-case basis.
Certified biobased product. A biobased product for which the
manufacturer or vendor of the product has received approval from USDA
to affix to the product the ``USDA Certified Biobased Product'' label.
Days. As used in this part means calendar days.
Designated item. For the purposes of this part means a generic
grouping of biobased products designated for preferred procurement
under subpart B of part 2902 of this title.
Designated representative. An entity authorized by a manufacturer
or vendor to affix the USDA label to the manufacturer's or vendor's
certified biobased product or its packaging.
Intermediate ingredients or feedstocks. A material or compound made
in whole or in significant part from biological products, including
renewable agricultural materials (including plant, animal, and marine
materials) or forestry materials, that are subsequently used to make a
more complex compound or product. For the purposes of this subpart,
intermediate ingredients or feedstocks do not include raw agricultural
or forestry materials, but represent those materials that can be put
into a new cycle of production and finishing processes to create
finished materials, ready for distribution and consumption.
ISO. The International Organization for Standardization, a network
of national standards institutes working in partnership with
international organizations, governments, industries, business, and
consumer representatives.
ISO 9001 conformant. An entity that meets all of the requirements
of the ISO 9001 standard, but that is not required to be ISO 9001
certified. ISO 9001 refers to the International Organization for
Standardization's standards and guidelines relating to ``quality
management'' systems. ``Quality management'' is defined as what the
manufacturer does to ensure that its products or services satisfy the
customer's quality requirements and comply with any regulations
applicable to those products or services.
Label. Collectively, the label artwork (as defined in this section)
and the biobased product statement(s), including the applicable
biobased content(s).
Label artwork. The certification marks, ``USDA Certified Biobased
Product'' and the ``USDA Certified Biobased Product'' logo, and, where
applicable, the letters ``FP'' to indicate that the product is within a
designated item and eligible for Federal preferred procurement, as
shown in Figure 1. Application of either certification mark by a
manufacturer or vendor signifies that USDA has certified that the
product meets the qualifications in this part.
[[Page 38312]]
[GRAPHIC] [TIFF OMITTED] TP31JY09.001
Manufacturer. An entity that performs the necessary chemical and/or
mechanical processes to make a final marketable product.
Mature market products. Biobased products that are not eligible for
designation for BioPreferred preferred procurement or labeling as
defined under subpart B of part 2902 of this title because they had
significant national market penetration in 1972. The eligibility of
mature market products for the voluntary labeling program will be
considered on a case-by-case basis, based on manufacturer's or vendor's
appeal of the exclusion.
Other entity. Any person, group, public or private organization, or
business other than USDA, or manufacturers or vendors of biobased
products that may wish to use the ``USDA Certified Biobased Product''
label in informational or promotional material related to a certified
biobased product.
Program Manager. The manager of the BioPreferred Program.
USDA. The United States Department of Agriculture.
Vendor. An entity that offers for sale final marketable biobased
products that are produced by manufacturers.
Sec. 2904.3 Applicability.
(a) Manufacturers, vendors, and designated representatives. The
requirements in this part apply to all manufacturers and vendors, and
their designated representatives, who wish to participate in the USDA
voluntary labeling program for biobased products. Manufacturers and
vendors wishing to participate in the voluntary labeling program are
required to obtain and maintain product certification.
(b) Other entities. The requirements in this part apply to other
entities who wish to use the label in promoting the sales or the public
awareness of certified biobased products.
Sec. 2904.4 Criteria for product eligibility to use the label.
A product must meet each of the criteria specified in paragraphs
(a) and (b) of this section in order to be eligible to receive biobased
product certification.
(a) Biobased product.
(1) Except as specified in paragraph (a)(2) of this section, the
product for which certification is sought must be a biobased product as
defined in Sec. 2904.2 of this part.
(2) Products that meet the definition of mature market products, as
defined in Sec. 2904.2 of this part, will be considered for
certification only in those cases where the Program Manager sustains an
appeal by the manufacturer or vendor of the product for inclusion in
the voluntary labeling program, as specified in Sec. 2904.6(c) of this
part.
(b) Minimum biobased content. The biobased content of the product
must be equal to or greater than the applicable minimum biobased
content, as described in paragraphs (b)(1) through (b)(4) of this
section.
(1) Biobased products within designated items.
(i) Product is within a single designated item. If the product is
within a single item that, at the time the application for
certification is submitted, has been designated by USDA for preferred
procurement, the applicable minimum biobased content is the minimum
biobased content specified for the item as found in subpart B of 7 CFR
part 2902.
(ii) Product is within multiple designated items. If a biobased
product is marketed within more than one designated item, uses the same
packaging for each designated item, and the applicant seeks
certification of the product, the product's biobased content must meet
or exceed the specified minimum biobased content for each of the
applicable designated items in order to use the label on the product.
However, if the manufacturer packages the product differently for each
designated item then the applicable minimum biobased contents are those
established under paragraph (b)(1)(i) of this section for each
designated item for which the applicant seeks to use the label.
(2) Finished biobased products that are not within designated
items.
(i) If the product is not an intermediate ingredient or feedstock
and is not within a designated item at the time the application for
certification is submitted, the applicable minimum biobased content is
51 percent. Manufacturers, vendors, groups of manufacturers and/or
vendors, and trade associations may propose an alternative applicable
minimum biobased content for the product by developing, in consultation
with USDA, and conducting an analysis to support the proposed
alternative applicable minimum biobased content. If approved by USDA,
the proposed alternative applicable minimum biobased content would
become the applicable minimum biobased content for the product.
(ii) If a product certified under paragraph (2)(i) of this section
is within an item that USDA subsequently designates for preferred
procurement, the applicable minimum biobased content shall become, as
of the effective
[[Page 38313]]
date of the final designation rule, the minimum biobased content
specified for the item as found in subpart B of 7 CFR part 2902.
(3) Products that are intermediate ingredients or feedstocks and
are not within designated items.
(i) If the product is an intermediate ingredient or feedstock that
is not within a designated item at the time the application for
certification is submitted, the applicable minimum biobased content is
51 percent.
(ii) If a product certified under paragraph (3)(i) of this section
is within an item that USDA subsequently designates for preferred
procurement, the applicable minimum biobased content shall become, as
of the effective date of the final designation rule, the minimum
biobased content specified for the item as found in subpart B of 7 CFR
part 2902.
(4) [reserved]
Sec. 2904.5 Initial approval process.
(a) Application. Manufacturers and vendors seeking USDA
certification to use the label for an eligible biobased product must
submit a USDA-approved application for certification for each biobased
product. A standardized application form and instructions are available
on the USDA BioPreferred Web site (http://www.biopreferred.gov). The
contents of an acceptable application are as specified in paragraphs
(a)(1) through (3) of this section.
(1) General content. The applicant must provide contact information
and product information including all brand names or other identifying
information, biobased content and testing information, product
category, intended uses, and, if applicable, the corresponding
designated item type. The applicant must attach to the application
documentation demonstrating that the reported biobased content was
tested by a third-party testing entity that is ISO 9001 conformant.
(2) Certifications. The applicant must certify in the application
that the product for which use of the label is sought is a biobased
product as defined in Sec. 2904.2 of this part.
(3) Commitments. The applicant must sign a statement in the
application that commits the applicant to submitting to USDA the
information specified in paragraph (c)(1) through (4) of this section,
which USDA will post to the USDA BioPreferred Web site, and to
providing USDA with up-to-date information for posting on this Web
site.
(b) Evaluation of applications.
(1) USDA will evaluate each application to determine if it contains
the information specified in paragraph (a) of this section. If USDA
determines that the application is not complete, USDA will return the
application to the applicant with an explanation of its deficiencies.
Once the deficiencies have been addressed, the applicant may resubmit
the application, along with a cover letter explaining the changes made,
for re-evaluation by USDA. USDA will evaluate resubmitted applications
separately from first-time applications, and those with the earliest
original application submittal date will be given first priority.
(2)(i) USDA will evaluate each complete application to determine
compliance with the criteria specified in Sec. 2904.4. USDA will
provide a written response to each applicant within 60 days after the
receipt of a complete application, informing the applicant of whether
the application has been conditionally approved or has been
disapproved.
(ii) For those applications that are conditionally approved, a
notice of certification, as specified in paragraph (c) of this section,
must be issued before the use of the label can begin.
(iii) For those applications that are disapproved, USDA will issue
a notice of denial of certification and will inform the applicant in
writing of each criterion not met. Applicants who receive a notice of
denial of certification may appeal using the procedures specified in
Sec. 2904.6.
(c) Notice of certification. After notification that its
application has been conditionally approved, the applicant must provide
to USDA (for posting by USDA on the USDA BioPreferred Web site) the
information specified in paragraphs (c)(1) through (4) of this section.
Once USDA confirms that the information is received and complete, USDA
will issue a notice of certification to the applicant. Upon receipt of
a notice of certification, the applicant may begin using the label on
the certified biobased product.
(1) The product's brand name(s), or other identifying information.
(2) Contact information, including the name, mailing address, e-
mail address, and telephone number of the applicant.
(3) The biobased content of the product.
(4) A hot link directly to the applicant's Web site (if available).
(d) Term of certification.
(1) The effective date of certification is the date that the
applicant receives a notice of certification from USDA. Except as
specified in paragraphs (2)(i) through (2)(iv) of this section,
certifications will remain in effect as long as the product is
manufactured and marketed in accordance with the approved application
and the requirements of this subpart.
(2)(i) If the product formulation of a certified product is changed
such that the biobased content of the product is reduced to a level
below that reported in the approved application, the existing
certification will not be valid for the product under the revised
conditions and the manufacturer or vendor, as applicable, and its
designated representatives must discontinue affixing the label to the
product and must not initiate any further advertising of the product
using the label. USDA will consider a product under such revised
conditions to be a reformulated product, and the manufacturer or
vendor, as applicable, must submit a new application for certification
using the procedures specified in paragraph (a) of this section.
(ii) If the product formulation of a certified product is changed
such that the biobased content of the product is increased from the
level reported in the approved application, and the manufacturer wishes
to report the higher value on the label, a new application must be
submitted using the procedures specified in paragraph (a) of this
section.
(iii) If the product formulation of a certified product is changed
such that the biobased content of the product is increased, but the
label is not revised, the existing certification will continue to be
valid for the product.
(iv) If the applicable required minimum biobased content for a
product to be eligible to display the label is revised by USDA,
manufacturers and vendors may continue to label their previously
certified product only if it meets the new minimum biobased content
level. In those cases where the biobased content of a certified product
fails to meet the new minimum biobased content level, USDA will notify
the manufacturer or vendor that their certification is no longer valid.
Such manufacturers and vendors must increase the biobased content of
their product to a level at or above the new minimum biobased content
level and must re-apply for certification within 60 days if they wish
to continue to use the label. Manufacturers and vendors who have re-
applied for certification may continue using the existing label until
they receive notification from USDA on the results of their re-
application for certification.
[[Page 38314]]
Sec. 2904.6 Appeal processes.
An applicant for certification may appeal a notice of denial of
certification to the Program Manager. Entities that have received a
notice of violation, and manufacturers and vendors of certified
biobased products who have received a notice of suspension or
revocation, may appeal to the Program Manager. Manufacturers and
vendors of mature market products may appeal the exclusion of their
products from the voluntary labeling program to the Program Manager.
(a)(1) Appeals to the Program Manager must be filed within 30 days
of receipt by the appellant of a notice of denial of certification, a
notice of violation, a notice of suspension, or a notice of revocation.
Appeals must be filed in writing and addressed to: Program Manager,
USDA Voluntary Labeling Program for Biobased Products, Room 300,
Reporters Building, 300 Seventh Street SW., Washington, DC 20024.
(2) All appeals must include a copy of the adverse decision and a
statement of the appellant's reasons for believing that the decision
was not made in accordance with applicable program regulations,
policies, or procedures, or otherwise was not proper.
(b)(1) If the Program Manager sustains an applicant's appeal of a
notice of denial of certification, USDA will issue a notice of
certification to the applicant for its biobased product.
(2) If the Program Manager sustains a manufacturer's or vendor's
appeal of a notice of violation, USDA will rescind the notice and no
further action will be taken by USDA.
(3) If the Program Manager sustains a manufacturer's or vendor's
appeal of a notice of suspension, the manufacturer, vendors, and their
designated representative(s) may immediately resume affixing the label
to the certified biobased product and USDA will reinstate the product's
information to the USDA BioPreferred Web site.
(4) If the Program Manager sustains a manufacturer's or vendor's
appeal of a notice of revocation, the manufacturer or vendor, and its
designated representatives may immediately resume affixing the label to
the certified biobased product and sell and distribute the certified
biobased product with the label. In addition, USDA will reinstate the
product's information to the USDA BioPreferred Web site.
(c)(1) Manufacturers or vendors of mature market products may
appeal the exclusion of their products from the voluntary labeling
program if they believe that special conditions or circumstances
warrant the inclusion of their products in the program. Appeals to the
Program Manager from manufacturers or vendors of mature market products
must be filed in writing and addressed to: Program Manager, USDA
Voluntary Labeling Program for Biobased Products, Room 300, Reporters
Building, 300 Seventh Street, SW., Washington, DC 20024.
(2) Appeals for the inclusion of mature market products must
include detailed justification showing why the product should be
allowed to use the label.
(3) If the Program Manager sustains a manufacturer's or vendor's
appeal of its product's exclusion from the program, the manufacturers
or vendors may then apply for certification to use the label on that
product, as specified in Sec. 2904.5(a) of this part.
(4) Mature market products that are certified by USDA to use the
label will be considered to be ``finished biobased products that are
not within designated items'' and subject to all provisions of this
part that are applicable to that category of certified biobased
products.
(d) Appeals of any of the Program Manager's decisions may be made
to the USDA Assistant Secretary for Administration. Appeals must be
made, in writing, within 30 days of receipt of the Program Manager's
decision and addressed to: Assistant Secretary for Administration, Room
209A, Whitten Building, 1400 Independence Avenue, SW., Washington, DC
20250-0103. If the Assistant Secretary for Administration sustains an
appeal, the provisions of paragraph (b) of this section will apply.
Sec. 2904.7 Requirements associated with the label.
(a) Who may use the label?
(1) Manufacturers and vendors. Only manufacturers and vendors who
have received a notice of certification, or designated representatives
of the manufacturer or vendor, may affix the label to the product or
its packaging. A manufacturer or vendor who has received a notice of
certification for a product under this part:
(i) May use the label on the product, its packaging, and other
related materials including, but not limited to, advertisements,
catalogs, procurement databases, promotional material, Web sites, or
user manuals for that product, according to the requirements set forth
in this section; and
(ii) is responsible for the manner in which the label is used by
its companies, as well as its designated representatives, including
advertising agencies and subcontractors.
(2) Other entities.
(i) Other entities may use the label to advertise or promote
certified biobased products in materials including, but not limited to,
advertisements, catalogs, procurement databases, Web sites, and
promotional and educational materials, as long as the manufacturer or
vendor of the product, or one of their designated representatives, has
affixed the label to the product or its packaging.
(ii) Other entities may use the label and the BioPreferred Program
name in general statements as described in paragraph (b) of this
section, as long as the statements do not imply that a non-certified
biobased product is certified.
(b) Correct usage of the label.
(1) The label can be affixed only to certified biobased products
and their associated packaging.
(2) The label may be used in material including, but not limited
to, advertisements, catalogs, procurement databases, Web sites, and
promotional and educational materials to distinguish products that are
certified for use of the label from those that are not certified. The
label may be used in advertisements for both certified biobased
products and non-certified products if the advertisement clearly
indicates which products are certified. Care must be taken to avoid
implying that any non-certified products are certified.
(3) The label may be used without reference to a specific certified
biobased product only when informing the public about the purpose of
the label. For example, the following or similar claim is acceptable:
``Look for the `USDA Certified Biobased Product' label. It means that
the product meets USDA standards for the amount of biobased content and
the manufacturer or vendor has provided relevant information on the
product for the USDA BioPreferred Web site.'' This exception allows
manufacturers, vendors, and other entities to use the label in
documents such as corporate reports, but only in an informative manner,
not as a statement of product certification.
(4) The label may appear next to a picture of the product(s) or
text describing it.
(5) The label must stand alone and not be incorporated into any
other label or logo designs.
(6) The label may be used as a watermark provided the use does not
violate any usage restrictions specified in this part.
(7) The text portion of the label must be written in English and
may not be translated, even when the label is used outside of the
United States.
(c) Incorrect usage of the label.
(1) The label shall not be used on any product that has not been
certified by
[[Page 38315]]
USDA as a ``USDA Certified Biobased Product.''
(2) The label shall not be used on any advertisements or
informational materials where both certified biobased products and non-
certified products are shown unless it is clear that the label applies
to only the certified biobased product(s).
(3) The label shall not be used to imply endorsement by USDA or the
BioPreferred Program of any particular product, service, or company.
(4) The label shall not be used in any form that could be
misleading to the consumer.
(5) The label shall not be used by manufacturers or vendors of
certified products in a manner disparaging to USDA or any other
government body.
(6) The label shall not be used with an altered label or
incorporated into other label designs.
(7) The label shall not be used on business cards, company
letterhead, or company stationery.
(8) The label shall not be used in, or as part of, any company
name, logo, product name, service, or Web site, except as may be
provided for in this part.
(9) The label shall not be used in a manner that violates any of
the applicable requirements contained in this part.
(d) Imported products. The label can be used only with a product
that is certified by USDA under this part. The label cannot be used to
imply that a product meets or exceeds the requirements of biobased
programs in other countries. Products imported for sale in the U.S.
must adhere to the same guidelines as U.S.-sourced biobased products.
Any product sold in the U.S. as a ``USDA Certified Biobased Product''
must have received certification from USDA.
(e) Contents of the label. The label shall consist of the items
specified in paragraphs (e)(1) through (3) of this section, as
applicable.
(1) The label artwork provided by the BioPreferred Program.
(2) The biobased content and applicable biobased product
statement(s), as specified in paragraph (f)(2) of this section.
(3) The USDA BioPreferred Web site address must also be included
on, or in close proximity to, the label.
(f) Physical aspects of the label.
(1) Label artwork. The label artwork may not be altered, cut,
separated into components, or distorted in appearance or perspective.
Labels that are applied to biobased products that have been designated
for preferred procurement will include the letters ``FP'' as part of
the label artwork. The label must appear only in the colors specified
in paragraphs (f)(1)(i) through (iii) of this section, unless approval
is given by USDA for an exception.
(i) The three-color version of the label is preferred. The colors
used must be Pantone-White, Pantone 356C, and Pantone 362C.
(ii) A one-color version of the label may be substituted for the
three-color version as long as one of the following colors is used:
Pantone 356C or Pantone 362C.
(iii) A black and white version of the label is acceptable.
(2) Biobased content and applicable biobased product statement(s).
The biobased content and applicable biobased product statement(s) must
be placed directly below the label artwork and must be displayed in a
manner that makes it easily readable.
(i) One or both of the following two statements, as applicable,
must be used to identify the product to which the label applies:
(A) Product: XX% biobased.
(B) Packaging: XX% biobased.
(ii) The biobased content reported in the biobased product
statement(s) specified in paragraphs (f)(2)(i)(A) and (B) of this
section shall be expressed as ``XX%,'' where XX% represents the actual
biobased content of the product or packaging. The biobased content
displayed at the time the label is affixed to the product or its
packaging must be the same as the biobased content specified in the
most recent approved application for the certified biobased product.
(3) The USDA BioPreferred Web site address must be included either
on the label, below the product statement, if space allows or in close
proximity to the label on the product or packaging.
(g) Placement of the label.
(1) The label can appear directly on a product, its associated
packaging, in user manuals, and in other materials including, but not
limited to, advertisements, catalogs, procurement databases, and
promotional and educational materials.
(2) The label shall not be placed in a manner that is ambiguous
about which product is a certified biobased product or that could
indicate certification of a non-certified product.
(3) When used to distinguish a certified biobased product in
material including, but not limited to, advertisements, catalogs,
procurement databases, Web sites, and promotional and educational
materials, the label must appear near a picture of the product or the
text describing it.
(i) If all products on a page are certified biobased products, the
label may be placed anywhere on the page.
(ii) If a page contains a mix of certified biobased products and
non-certified products, the label shall be placed in close proximity to
the certified biobased products. An individual label near each
certified biobased product may be necessary to avoid confusion.
(h) Minimum size and clear space recommendations for the label.
(1) The label may be sized to fit the individual application as
long as the correct proportions are maintained and the label remains
legible.
(2) A border of clear space must surround the label and must be of
sufficient width to offset it from surrounding images and text and to
avoid confusion. If the label's color is similar to the background
color, an outlining color may be used to enhance contrast.
(i) Where to obtain copies of the label artwork. The label artwork
is available at the USDA BioPreferred Web site.
Sec. 2904.8 Violations.
This section identifies the types of actions that USDA considers
violations under this part and the penalties (e.g., the suspension or
revocation of certification) associated with such violations.
(a) General. Violations under this section occur on a per product
basis and the penalties are to be applied on a per product basis.
Entities cited for a violation under this section may appeal using the
provisions in Sec. 2904.6. If certification for a product is revoked,
the manufacturer or vendor whose certification has been revoked may
seek re-certification for the product using the procedures specified
under the provisions in Sec. 2904.5.
(b) Types of violations. Actions that will be considered violations
of this part include, but are not limited to, the following specific
examples:
(1) Biobased content violations. The Program Manager will utilize
occasional random testing of certified biobased products to compare the
biobased content of the tested product with the product's applicable
minimum biobased content and the biobased content reported by the
manufacturer or vendor in its approved application. Such testing will
be conducted using ASTM Method D6866. USDA will provide a copy of the
results of its testing to the applicable manufacturer or vendor.
(i) If USDA testing shows that the biobased content of a certified
biobased product is less than its applicable
[[Page 38316]]
minimum biobased content, then a violation of this part will have
occurred.
(ii) If USDA testing shows that the biobased content is less than
that reported by the manufacturer or vendor in its approved
application, but is still equal to or greater than its applicable
minimum biobased content(s), USDA will provide written notification to
the manufacturer or vendor. The manufacturer or vendor must submit,
within 30 days from receipt of USDA written notification, a new
application for the lower biobased content. Failure to submit a new
application within 30 days will be considered a violation of this part.
(A) The manufacturer or vendor can submit in the new application
the biobased content reported to it by USDA in the written
notification.
(B) Alternatively, the manufacturer or vendor may elect to retest
the product in question and submit the results of the retest in the new
application. If the manufacturer or vendor elects to retest the
product, it must test a sample of the current product.
(2) Label violations.
(i) Any usage or display of the label that does not conform to the
requirements specified in Sec. 2904.7.
(ii) Affixing the label to any product prior to issuance of a
notice of certification from USDA.
(iii) Affixing the label to a certified biobased product during
periods when certification has been suspended or revoked.
(3) Application violations. Knowingly providing false or misleading
information in any application for certification of a biobased product
constitutes a violation of this part.
(4) USDA BioPreferred Web site violations. Failure to provide to
USDA updated information when the information for a certified biobased
product becomes outdated or when new information for a certified
biobased product becomes available constitutes a violation of this
part.
(c) Notice of violations and associated actions. USDA will provide
the applicable manufacturer or vendor or their designated
representatives and any involved other entity known to USDA written
notification of any violations identified by USDA. Entities who receive
a notice of violation for a biobased content violation must correct the
violation(s) within 30 days from receipt of the notice of violation.
Entities who receive a notice of violation for other types of
violations must correct the violation(s) within 60 days from receipt of
the notice of violation. If the entity receiving a notice of violation
is a manufacturer, a vendor, or a designated representative of a
manufacturer or vendor, USDA will pursue notices of suspensions and
revocation, as discussed in paragraphs (c)(1) and (c)(2) of this
section. USDA reserves the right to further pursue action against these
entities as provided for in paragraph (c)(3) of this section. If the
entity receiving a notice of violation is an ``other entity'' (i.e.,
not a manufacturer, vendor, or designated representative), then USDA
will pursue action according to paragraph (c)(3) of this section.
Entities that receive notices of suspension or revocation may appeal
such notices using the procedures specified in Sec. 2904.6.
(1) Suspension.
(i) If a violation is applicable to a manufacturer, vendor, or
designated representative and the applicable entity fails to make the
required corrections within 30 days (for biobased content violations)
or 60 days (for other types of violations) of receipt of a notice of
violation, USDA will notify the manufacturer or vendor, as appropriate,
of the continuing violation, and the USDA certification for that
product will be suspended. As of the date that the manufacturer or
vendor receives a notice of suspension, the manufacturer or vendor and
their designated representatives must not affix the label to any of
that product, or associated packaging, not already labeled and must not
distribute any additional products bearing the label. USDA will issue a
press release informing the public of the suspension and will also
remove the product information from the USDA BioPreferred Web site.
(ii) If, within 30 days from receipt of the notice of suspension,
the manufacturer or vendor whose USDA product certification has been
suspended makes the required corrections and notifies USDA that the
corrections have been made, the manufacturer or vendor and their
designated representatives may, upon receipt of USDA approval of the
corrections, resume use of the label. USDA will also restore the
product information to the USDA BioPreferred Web site.
(2) Revocation.
(i) If a manufacturer or vendor whose USDA product certification
has been suspended fails to make the required corrections and notify
USDA of the corrections within 30 days of the date of the suspension,
USDA will notify the manufacturer or vendor that the certification for
that product is revoked.
(ii) As of the date that the manufacturer or vendor receives the
notice revoking USDA certification, the manufacturer or vendor and
their designated representatives must not affix the label to any of
that product not already labeled. In addition, the manufacturer or
vendor and their designated representatives are prohibited from further
sales of product to which the label is affixed.
(iii) If a manufacturer or vendor whose product certification has
been revoked wishes to use the label, the manufacturer or vendor must
follow the procedures required for original certification.
(3) Other remedies. In addition to the suspension or revocation of
the certification to use the label, depending on the nature of the
violation, USDA may pursue suspension or debarment of the entities
involved in accordance with part 3017 of this title. USDA further
reserves the right to pursue any other remedies available by law,
including any civil or criminal remedies, against any entity that
violates the provisions of this part.
Sec. 2904.9 Recordkeeping requirements.
(a) Records. Manufacturers and vendors shall maintain records
documenting compliance with this part for each product that has
received certification to use the label, as specified in paragraphs
(a)(1) through (3) of this section.
(1) The results of all tests, and any associated calculations,
performed to determine the biobased content of the product.
(2) The date the applicant receives certification from USDA, the
dates of changes in formulation of certified biobased products, and the
dates when the biobased content of certified biobased products was
tested.
(3) Documentation of analyses performed by manufacturers to support
claims of environmental or human health benefits, life cycle cost,
sustainability benefits, and product performance made by the
manufacturer.
(b) Record retention. For each certified biobased product, records
kept under paragraph (a) of this section must be maintained for at
least three years beyond the end of the label certification period
(i.e., three years beyond the period of time when manufacturers and
vendors cease using the label). Records may be kept in either
electronic format or hard copy format. All records kept in electronic
format must be readily accessible during a USDA audit.
Sec. 2904.10 Oversight and monitoring.
(a) General. USDA will conduct oversight and monitoring of
manufacturers, vendors, designated representatives, and other entities
involved with the voluntary labeling
[[Page 38317]]
program to ensure compliance with this part. This oversight will
include, but not be limited to, conducting facility visits of
manufacturers and vendors who have certified biobased products, and of
their designated representatives. Manufacturers, vendors, and their
designated representatives are required to cooperate fully with all
USDA audit efforts for the enforcement of the voluntary labeling
program.
(b) Biobased content testing. USDA will conduct biobased content
testing of certified biobased products, as described in Sec.
2904.8(b)(1) to ensure compliance with this Part.
(c) Inspection of records. Manufacturers, vendors, and their
designated representatives must allow Federal representatives access to
the records required under Sec. 2904.9 for inspection and copying
during normal Federal business hours.
Dated: July 17, 2009.
Pearlie S. Reed,
Assistant Secretary for Administration, U.S. Department of Agriculture.
[FR Doc. E9-17610 Filed 7-30-09; 8:45 am]
BILLING CODE 3410-93-P