[Federal Register Volume 76, Number 13 (Thursday, January 20, 2011)]
[Rules and Regulations]
[Pages 3790-3813]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-968]
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Part IV
Department of Agriculture
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7 CFR Part 2904
Voluntary Labeling Program for Biobased Products; Final Rule
Federal Register / Vol. 76 , No. 13 / Thursday, January 20, 2011 /
Rules and Regulations
[[Page 3790]]
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DEPARTMENT OF AGRICULTURE
7 CFR Part 2904
RIN 0503-AA35
Voluntary Labeling Program for Biobased Products
AGENCY: Departmental Management, USDA.
ACTION: Final rule.
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SUMMARY: The U.S. Department of Agriculture (USDA) is establishing 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 voluntary
labeling program, a biobased product, after being certified by USDA,
can 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 Program Web site. This final rule applies to manufacturers
and vendors who wish to participate in the voluntary labeling component
of the BioPreferred Program. The final rule also applies to other
entities (e.g., trade associations) that wish to use the label to
promote biobased products.
DATES: This final rule is effective February 22, 2011.
FOR FURTHER INFORMATION CONTACT: Ron Buckhalt, USDA, Office of the
Assistant Secretary for Administration, Room 361, Reporters Building,
300 7th Street, SW., Washington, DC 20024; e-mail:
biopreferred@usda.gov; phone (202) 205-4008. Information regarding the
Federal Biobased Products Preferred Procurement Program (one part of
the BioPreferred\SM\ Program) is available on the Internet at http://www.biopreferred.gov.
SUPPLEMENTARY INFORMATION: The information presented in this preamble
is organized as follows:
I. Authority
II. Background
III. Summary of Changes
IV. Discussion of Public Comments
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 12988: Civil Justice Reform
E. Executive Order 13132: Federalism
F. Unfunded Mandates Reform Act of 1995
G. Executive Order 12372: Intergovernmental Review of Federal
Programs
H. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
I. Paperwork Reduction Act
J. E-Government Act Compliance
K. Congressional Review Act
I. Authority
Today's final rule establishes the voluntary labeling program for
biobased products under the authority of section 9002 of the Farm
Security and Rural Investment Act of 2002 (FSRIA), as amended by the
Food, Conservation, and Energy Act of 2008 (FCEA), 7 U.S.C. 8102
(referred to in this document as ``section 9002'').
II. Background
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, 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 a preference
to the purchase of biobased products (hereafter referred to in this
Federal Register notice as the ``Federal 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 item(s) to be 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 product category 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 product categories
(generic groupings of products that perform the same function)
within which the products have been afforded a procurement
preference by Federal agencies under the BioPreferred Program. For
example, under the designated product category ``mobile equipment
hydraulic fluid,'' all brands and grades of hydraulic fluid
formulated for use in mobile equipment and meeting the specified
minimum biobased content are included in the procurement preference
program.
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The final guidelines for the Federal 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 product categories and specifies their
minimum biobased contents, the effective date of the procurement
preference for biobased products within each product category, 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.
As part of the Federal 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 product categories 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 product
category.
To date, USDA has identified 50 product categories in a variety of
applications, including cafeteria ware, personal and institutional
cleaning products, construction products, and lubricants and greases.
There are presently approximately 5,100 individual BioPreferred
Products (products that are within product categories that are eligible
for Federal preferred procurement) within these 50 product categories.
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 certification mark''). 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 commercial
[[Page 3791]]
entities and the general public. In establishing this program, USDA
must identify the criteria to determine those products on which the
certification mark may be used and must develop specific requirements
for how the mark can be used. It is USDA's intent that the presence of
the certification mark 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 American Society of Testing and Materials (ASTM) radioisotope
test D6866.
In developing the 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 (FTC),
which issues the ``Guides for the Use of Environmental Marketing
Claims'' to ensure that the provisions of the voluntary labeling
program are consistent with the Guides. USDA also held a public meeting
on July 22, 2008, to seek input on the content and use of the
certification mark from the public and industry stakeholders.
As part of the BioPreferred Program, on July 31, 2009, USDA
published a proposed rule for the voluntary labeling program for
biobased products under the authority of section 9002. This proposed
rule can be found at 74 CFR 38295.
The following section of the preamble presents a summary of the
changes that have been made to the rule as a result of USDA's
consideration of the comments that were received on the proposed rule.
Section IV presents a summary of the public comments received on the
proposed voluntary labeling program and USDA's responses to the
comments.
III. Summary of Changes
As a result of comments received on the proposed rule (section IV),
USDA made changes to the rule, which are summarized below. USDA
discusses the rationale for these changes in section IV.
Minimum biobased content. For finished biobased products that are
not within the designated product categories and for intermediate
ingredients or feedstocks that are also not within the designated
product categories, USDA has lowered the applicable minimum biobased
content from the proposed 51 percent to 25 percent.
Mature market products. As a result of USDA consideration of public
comments concerning the difficulty of implementing case-by-case
exemptions, USDA has decided to categorically exclude mature market
products from the labeling program at this time.
Preliminary notice of violations. USDA has added a provision to the
rule to provide manufacturers and vendors with a preliminary notice of
violation.
Initial approval process. Based on a commenter's recommendation
that USDA allow representative biobased content testing for products
with similar biobased contents but slightly different formulations,
USDA has agreed to allow representative content testing to suffice if
the product's formulation does not vary by more than 3 percent for
multiple products.
IV. Discussion of Public Comments
USDA solicited comments on the proposed rule for 60 days ending on
September 29, 2009. USDA received comments from 25 commenters by that
date. These comments were from individuals, manufacturers, and trade
organizations.
Who can apply for the certification mark?
Comments: One industry commenter states that vendors, especially
those who sell private-labeled manufactured products, should be allowed
to apply for biobased labeling. An example is a product that has been
labeled by the manufacturer for one purpose; and the vendor would like
to package it under its private label and for a different application
(e.g., a road dust suppressant labeled by the manufacturer, could be
labeled by a vendor as a ``COAL dust control agent'' under the vendor's
private label). The latter product may require slight modifications by
the manufacturer or be exactly the same. The vendor would use the
documentation that the manufacturer has established along with
additional information to apply for separate labeling.
One industry commenter supports both manufacturers and vendors
being eligible to apply for the certification mark and stated that this
approach provides the maximum flexibility for all participants.
One industry organization commenter and one industry commenter
support manufacturers, but not vendors, being eligible to apply for the
certification mark. The commenters state that it is the manufacturers
who have the information on product composition (e.g., whether a
product meets the definition of a biobased product) and biobased
content (e.g., testing results on the formulated product). Having both
vendors and manufacturers apply will result in USDA having to process
many more applications for no reason. Furthermore, it is critical that
manufacturers maintain control over who uses the certification mark on
their products. Having a proliferation of vendors apply for the mark
without the knowledge of the manufacturer will lead to confusion and
potential misunderstandings.
One individual commenter does not believe it would be a good idea
to allow vendors to be eligible to obtain the certification marks. The
commenter pointed out that, as noted in the proposed rule, it is the
manufacturer and not the vendor who determines a product's formulation
and production process. In addition, some manufacturers have become
very upset when finding out that some vendors of their products were
participating in the BioPreferred Program without their knowledge. The
commenter envisions lawsuits arising when allowing vendors to apply for
labels without documented consent from the manufacturer.
Response: USDA continues to believe that the goals of the voluntary
labeling program can be achieved, and the beneficial impacts of the
BioPreferred Program can be increased, if both manufacturers and
vendors are allowed to market and promote the manufacturers' biobased
products with a credible biobased product labeling program. For
example, many vendors purchase products from manufacturers and then
repackage or offer these products as private label items. Allowing
these vendors into the program will increase the number of biobased
products in the market, thus furthering the goals of the program.
Therefore, USDA will allow vendors as well as manufacturers to
participate in the program as long as they meet all program
requirements.
Applicable Minimum Biobased Contents
Comment: One industry commenter states that he believes that a
minimum biobased content of 50 percent should be required for products
not within product categories that have been identified for Federal
preferred procurement. Requiring half or more of a product's content to
be biobased will bring credibility to the certification mark and
prevent potential ``greenwashing'' by allowing lower biobased content
product manufacturers to advertise the certification mark.
[[Page 3792]]
Products containing less than 50 percent biobased content can still be
identified through the BioPreferred designation process for Federal
preferred procurement.
One industry commenter recommends that USDA consider lowering the
biobased content level to 20 percent for intermediate ingredients and
feedstocks to be eligible to receive the BioPreferred certification
mark. The commenter has commercialized a family of unsaturated
polyester resins that are used to fabricate fiberglass-reinforced and
particulate reinforced composites used in an increasingly wide variety
of applications in the transportation and building and construction
industries. The biobased content in these commercially-available resins
falls in the 8 to 22 percent range. They currently have developmental
products with biobased content in the 30 to 40 percent range. The
commenter recommends that the biobased content eligibility cut-off for
a label be set at 20 percent, not only for these types of products but
for chemical intermediates and feedstocks in general. The commenter
believes that this level will stimulate further consumption of existing
resins and incentivize companies to continue to develop biobased resins
with even higher biorenewable content.
One industry organization commenter believes that for finished
products that do not fall within an existing product category
identified for Federal preferred procurement the default biobased
content percentage should be lower (e.g., 25 percent). More flexibility
is needed in setting a default standard for finished biobased products
that have not yet been identified for Federal preferred procurement.
This is a new industry that is creating a range of end products, each
of which needs to meet different performance standards depending upon
the type of product. It is not always possible to meet accepted
industry performance standards and achieve a 51 percent or greater
biobased content.
One industry organization supports a minimum biobased content of
anywhere between 20 and 51 percent for both intermediate ingredients
and products that do not fall within an existing product category
identified for Federal preferred procurement.
Two industry commenters believe the proposed 51 percent minimum
biobased content is inappropriately high. One of the commenters states
that they understand the desire to establish the highest possible
biobased content, but that performance requirements in many
applications cannot be met with such high biobased content. The
commenter suggested that USDA review the minimum biobased contents that
USDA has set for products within the existing product categories
identified for Federal preferred procurement, and establish a minimum
for products not within those categories which would be more inclusive
than the proposed 51 percent. The commenter stated that this would
allow program expansion without greatly increasing the administrative
burden. The commenter stated that, for example, if the minimum biobased
content was set at 20 percent, then 44 of the 49 categories of
identified items would meet this criterion. Selecting 51 percent
appears to be arbitrary as there is no rationale provided in the
proposed rulemaking for this minimum. The commenter further stated that
USDA has developed a rigorous process for identifying the BioPreferred
Products that have been identified for Federal preferred procurement.
The BioPreferred Products to date represent a reasonably sized
``sample'' of biobased products currently on the market. Selecting a
minimum biobased content of 20 percent for the labeling program covers
at least 90 percent of the product categories identified for preferred
procurement to date by USDA. The other commenter notes that the
existing minimums for several of the product categories are well below
that 51 percent threshold and states that if the bar had been set so
high when products within these categories were being developed, it
could have inhibited that development. Additionally, these products
were developed even before the incentive from USDA. To the degree that
the USDA program will incentivize future development, setting the bar
this high could inhibit that same development. The commenter believes
it might be more realistic to set the default minimum biobased content
somewhere in the lower end of the range (15 to 20 percent) of the
minimum biobased contents specified for product categories already
included in the BioPreferred Program, with the expectation that most
products' biobased contents will increase as technology advances.
Two industry organization commenters and one industry commenter
state that USDA's proposed approach to establishing and enforcing
biobased content levels does not take into account the imprecision in
the analytical testing method used to determine biobased content or
manufacturing variations in the production of different batches of
products or small formulation changes.
On the first point, the ASTM D6866 test method has precision of +/-
3 percent on the mean biobased content reported. Because of this, USDA
has previously recognized the need for flexibility when establishing
minimum biobased content levels for BioPreferred Products. The
commenters urge that USDA take the same approach in the labeling rule.
Products should be eligible for certification if their biobased content
falls within 3 percentage points of the minimum content level and
should be considered in compliance if their content falls within 3
percentage points of their label statement. Manufacturers should not
have to reapply for certification if their product's biobased content
falls within 3 percentage points of their label statement.
On the second point, the commenter stated that in any manufacturing
process there will be some production variation. Also, small changes
can be made to formulas over time. Therefore, the commenters urge USDA
to allow a manufacturer applying for a label certification to establish
a biobased content for the purpose of the label that may be below the
actual D6866 test results in order to account for manufacturing
variations. The commenter stated that, as currently written, the
applicant does not appear to have that flexibility. The proposed rule
appears to require that the percentage biobased content used for the
label be exactly what is reported in the lab test results submitted
with the application.
One industry commenter stated that he supports allowing
intermediate ingredients such as biobased plastic resin to be eligible
for the voluntary labeling program and that, for those products, the
certification mark should reference the product's biobased content,
with a minimum of 50 percent biobased content.
One industry organization commenter requests clarification of the
definition of ``intermediate ingredients or feedstocks,'' but states
that he supports a required biobased content level of anywhere within
20 to 50 percent for intermediate ingredients and for the final
products that are not within product categories identified for Federal
preferred procurement. The commenter also supports the inclusion of
biobased intermediates as eligible to receive the certification mark
under the current rulemaking.
Response: The majority of the public comments received on the
proposed 51 percent minimum biobased content for finished biobased
products, as well as intermediate ingredients and feedstocks, that are
not within product categories
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identified for Federal preferred procurement recommended that the level
be lowered. Based on USDA consideration of these public comments, as
well as other factors, USDA has reconsidered the applicable minimum
biobased content requirement and concluded that a 25 percent minimum
biobased content is more appropriate.
As pointed out by the commenters, several product categories that
have been identified for Federal preferred procurement have applicable
minimum biobased contents less than the 51 percent minimum that had
been proposed for (1) finished biobased products and (2) intermediate
ingredients or feedstocks that are not within product categories that
have been identified for Federal preferred procurement. For example,
``general purpose laundry products'' which were identified in Round 4
of the ``Designation of Biobased Items for Federal Procurement'' have
an applicable minimum biobased content level of 34 percent, 17 percent
lower than the proposed biobased content minimum for certification.
USDA considered the fact that, on a global basis, many other
entities promoting the development and use of biobased products
recognize those products that have biobased contents of less than the
proposed 51 percent. For example, two European Union independent
certifying organizations, DIN-CERTCO (Germany) and AB Vincotte
(Belgium), specify 20 percent as the minimum acceptable biobased
content for products they certify as biobased. The Japan BioPlastics
Association, which certifies biobased products for Japan, Korea, and
China, specifies 25 percent as the minimum acceptable biobased content
for products they certify as biobased.
USDA also considered that adopting a lower minimum biobased content
criteria for these products will allow a greater number of new biobased
products to receive the benefits of the label. This, in turn, is
expected to lead to increase sales of those biobased products. In
addition, many of these new products will increase in biobased content
over time with advances in materials engineering and technology. For
example, the biobased foam used in automobiles originally had a
biobased content in the 5 to 10 percent range but has now increased to
over 30 percent biobased.
Therefore, USDA believes that lowering the applicable minimum
biobased content for both finished products and intermediate materials
that are not at present BioPreferred Products would further the goals
of the program and allow for a greater number of biobased products to
use the certification mark. This will create more visibility for the
labeling program, helping to achieve the goals of the program, and
further encourage emerging markets because it will, as one commenter
noted, ``incentivize future development.''
Because of the variability in product testing, as noted by one
commenter, USDA is setting the minimum biobased content levels for
products eligible for the Federal preferred procurement program 3
percent lower than that of the tested product upon which the minimum
level is based. However, for the labeling program, the 25 percent
minimum biobased content is not based on testing of an actual product,
but is a USDA policy decision based on consideration of the factors
described above. Applicants must meet the minimum biobased content
percentage they report for a product and should take the testing
variability into account when applying for product certification. As
such, a manufacturer or vendor may want to claim a more conservative
biobased content percentage for a product in its application for
certification to use the label. Thus, to ensure that test results
consistently meet or exceed the biobased content stated in the
application, manufacturers may want to claim a biobased content 3 to 5
percent lower than test results have indicated.
Comment: Two industry organization commenters urge USDA to clearly
specify the procedure and steps by which an applicant can request an
exception to any specific minimum biobased content chosen for the final
rule.
Response: USDA is working to standardize this process and
anticipates that it will be similar to the process used to set product
minimum biobased contents for eligible products in the Federal
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
in providing products for testing. However, similar to the process used
in the Federal preferred procurement program, the establishment of
alternative minimum biobased 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.
The Labeling of ``Complex Products''
Comment: Three industry organizations strongly agree with USDA that
complex products are finished products, are separate and distinct from
biobased products, and should be included in the BioPreferred Program's
labeling program. The commenters support including ``complex products''
in the labeling effort. The commenters believe that complex products
can be included in the rule even in the absence of a test method to
determine the overall biobased content of a complex product. If a
complex product, such as a car, includes components that contain
biobased products (e.g., seats, headliners, dashboards), it is not
practical, or even meaningful, to test and or calculate the overall
biobased content of the car. Rather, there should be an option to label
the components with the biobased content. Two of the commenters state
that one approach for doing this would allow a component (e.g., seat)
that contained a ``USDA Certified Biobased Product'' to be eligible to
use the certification mark. For example, if the foam used to make the
seat had a certification to use the mark then that certification could
be carried through to the seat. The mark could read: ``Seat: Contains
Foam with XX Percent Biobased Content.'' Another approach would be to
allow the component to be tested separately for biobased content or a
weighted average of the biobased ingredients could be calculated and if
it met the default percentage it would be eligible for the
certification mark. If it did not, the manufacturer or vendor could
apply to USDA for an ``alternative applicable minimum biobased
content.''
Three commenters propose that, to determine the biobased content of
a complex product, an interim approach would be to (1) take a weighted
sum (e.g., weight of component 1 x new carbon content of the feedstock
material used in component 1 + weight of component 2 x new carbon
content of the feedstock material used in component 2; etc. until all
components have been included) and then (2) normalize this number by
the total
[[Page 3794]]
weight of the complex product. Consistent with USDA's current
requirements, the new carbon content should be determined using ASTM
D6866.
These commenters recommend that, as a long term approach, USDA
continue to consult with ASTM to gather information on complex products
to proceed with the development of a method that can be used to
determine the biobased content of these products. Once an acceptable
test method is available, the commenters agree that USDA should amend
the voluntary labeling rule to allow for the labeling of complex
products.
One industry commenter states that care should be taken to not
complicate the labeling process. A wind generator that uses biobased
grease or gear lubricants, and biobased composites for the blades
should indicate that the blades are biobased and the gear lube is
biobased. Trying to qualify what percent of the total wind generator is
biobased would complicate the process.
One industry commenter suggests modifying the term ``complex
products'' in the labeling program to ``complex finished products'' to
avoid any confusion with polymer systems. The commenter believes that
``complex finished products'' can be included in the rule even in the
absence a test method to determine the overall biobased content of a
complex finished product.
One individual commenter believes that, for complex products, it
would be unwise to base the biobased content on weighted averages for
the biobased content of all the biobased components. This approach
would be too costly for some product manufacturers to consider and
could hinder participation in the program. In addition, the total error
associated with the weighted average will increase considerably (due to
cumulative errors) as the number of components within a complex product
increases. As a result, the total error associated with any given item
(or between individual products within an item) will be product-
specific, which is undesirable from a designation perspective.
One industry commenter states that many of these complex products
will contain components manufactured from biobased and non-biobased
materials. In some cases, the use of biobased intermediate ingredients
or feedstocks in components may not represent a significant amount of
the finished product (i.e., contains less than 51 percent biobased
content). However, the use of biobased materials may represent a
significant improvement for the finished product that should be
encouraged.
One industry commenter also believes that it is important to look
at subcategories as well as categories of products because there are
often performance requirements that place limits on the amount of
biobased materials that can be used for certain specific applications
within the same product categories. For example, the amount of biobased
content in foam used in automotive seating can vary from the amount
used in foam seating for sofas due to performance requirements.
Response: USDA appreciates the comments on this subject but has
decided it is best not to include complex products in the voluntary
labeling program at this time. USDA recognizes the importance of
complex products but believes there are many issues to be resolved
before such products can be included in and recognized by the labeling
program. These issues include establishing a minimum biobased content
and other criteria for approval, development of an acceptable test
procedure to determine the biobased content of complex products, and
the appropriate certification mark content and placement. USDA does not
want to delay the implementation of the labeling program for other
categories of more simple, finished products while this development
work for the labeling of complex products is being completed.
The Labeling of ``Mature Market Products''
Comment: Six commenters agree with USDA's proposal that products
that are considered to be ``mature market products'' (i.e., products
that had significant market penetration in 1972) should not be eligible
for participation in the labeling program of the BioPreferred Program
as mature market products could affect the entry of new (i.e., post-
1972) biobased products into market segments in which mature products
already have significant market shares. The commenters believe that
inclusion of ``mature market products'' would be counter to USDA's
objective to promote development and adoption of new technologies and
biobased products.
Two of the commenters questioned why the date of 1972 was selected
as the cut-off year for products to be included in the ``mature
market'' category and one commenter requested that USDA provide
additional information including defense and rationale regarding the
selection of 1972. The commenter notes that USDA may decide to allow
manufacturers of mature market products to appeal and states that USDA
should make clear the information regarding the criteria by which a
manufacturer of mature market products can appeal, the details of the
appeal process and how USDA will determine if an appeal is approved or
not. The commenter also recommends that if manufacturers of ``mature
market products'' are allowed to appeal, then the appeal process should
include a public comment period to allow the public to review the
appeal and to submit comment about it.
Two commenters recommend that USDA not allow manufacturers of
biobased products to appeal, on a case-by-case basis, the exclusion of
their mature market products. The commenters state that, in enacting
section 9002, Congress made it clear that the purpose of the program,
including the labeling program, was to grow the market for new biobased
products. The value of the certification mark for manufacturers and
vendors of these products is to inform consumers that these new and
innovative products are available and that USDA has certified the
biobased content. The ``currency'' of being a new and innovative
product loses its meaning and quickly the label may become
``devalued.'' Furthermore, mature market products have other already-
established, and well known labels (like the cotton logo and FSC
certification for wood and paper products) that they can use. The
commenters recommended that any government label for mature market
products be developed separately and under different authority than
Section 9002.
One industry commenter states that the labeling of mature products
would harm the BioPreferred Program's labeling process in the early
stages. A 5- to 10-year delay before such mature products are allowed
to be included and labeled would be helpful.
Two commenters are concerned that the proposed regulations exclude
mature market products from the program, except on a case-by-case
basis, and could be interpreted as excluding forestry materials that
fit properly within the definition of biobased products in the
authorizing legislation.\2\ One of the commenters believes such an
[[Page 3795]]
exclusion would be arbitrary and capricious in violation of the
Administrative Procedure Act, 5 U.S.C. 706. Additionally, the commenter
believes the proposed certification mark violates the consumer
advertising rules of the FTC.
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\2\ The definition of ``biobased products'' found in the 2008
Farm Bill is 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.''
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This commenter, and another individual commenter, believe that the
exclusion of mature market products from automatic inclusion in the
voluntary labeling program should be eliminated for the following
reasons:
There is no legitimate difference between new and mature
products in a voluntary public information program;
There is no guidance on recognizing a product as ``new'';
The proposal provides for a case-by-case determination
that would allow some mature market products to use the voluntary
label; and
USDA assumes that Congress intended that the voluntary
label program exclude mature market products, but the legislative
history does not reflect this interpretation.
One of the commenters states that USDA needs to understand that
even ``mature'' products can be ``renewed'' through innovations and
following new industry standards such as sustainable forestry
management programs.
One industry commenter suggests that USDA extend applicability of
the label to all biobased products. Alternatively, USDA should amend
the proposed language on the label to clearly designate it as intended
for emerging market products only.
One nonprofit organization commenter has concerns about the nature
of this label on the consumer market especially where it might lead a
consumer to make assumptions about the overall sustainability of their
purchase. The BioPreferred Program seems to provide a quantitative
basis to the natural content. However, the commenter believes that
exceptions for materials like wool or cotton for rugs, for example,
could mislead a consumer to make a less environmentally preferable
choice if they relied on the certified biobased product certification
mark.
One industry commenter believes that specifically excluding the
mature market products will establish a system that creates the
perception that USDA endorses the use of ``new'' products over mature
market products, even if the new products contain less biobased
materials than a competing mature product. This will, in turn,
encourage consumers to make purchasing decisions that are counter to
Congressional intent. For example, a paper plate, which USDA has
characterized as a ``mature market'' product, could not use a certified
biobased label despite the fact that it is made with close to 100%
biobased material. On the other hand, a new plastic plate that is
composed of only 51% corn-based PLA could qualify for the certification
mark under USDA's proposed rule. This would be both confusing and
misleading to the consumer resulting in the conclusion that the
conspicuous use of a USDA-backed certification mark on the plastic
plate constitutes a government endorsement. The consumer may also
conclude that forestry practices, no matter how sustainable, are less
environmentally preferable to synthetic polymers made from agricultural
products. The commenter believes that excluding mature products will
provide an unfair competitive disadvantage for these products and
severely discount the environmental contributions of biobased forest
products.
One industry commenter states that since the label will be limited
to a small pool of biobased products, they are concerned that the
proposed label will increase customer confusion in an already chaotic
labeling environment. Consumers will have no basis to determine why one
biobased product carries the certification mark and one does not. While
the designation between emerging and mature market products may be
acceptable in a relatively closed Federal purchasing system, expanding
this concept to the broad consumer marketplace under a simplistic
labeling scheme will only increase consumer confusion. The proposed on-
product USDA label does not provide clarification that it is intended
for emerging market products only. A consumer, looking at a mature
market biobased product, will have no idea why it is not (or cannot be)
USDA certified as biobased.
One environmental group commenter states that he does not
understand why the labeling program would exclude mature market
products while allowing biobased labeling of more recent entrants in
the same market. This has the effect of favoring one biobased product
over another based solely on their market maturity, rather than being
based on any rational criteria related to reduced use of fossil fuels,
carbon cycle benefits, or environmental sensitivity. The commenter
states that the rules should be amended to avoid punishing
environmentally favorable ``mature'' products, while encouraging
environmentally less favorable ``new'' market entrants.
Response: USDA received numerous comments both for and against the
exclusion of mature market products from the voluntary labeling
program. While USDA has carefully considered the comments received on
the subject, 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.'' Thus, USDA believes it is appropriate for the guidelines to
exclude products having mature markets from the program.
The conference report does not specifically state whether the
language quoted above refers to only the Federal preferred procurement
program, the voluntary labeling program, or both. However, USDA
believes that the widespread labeling of mature market products could
negatively affect the entry of new biobased products into market
segments in which mature products already have significant market
shares. Therefore, USDA continues to believe that it is reasonable to
exclude mature market products from the labeling program, as it has
done for the Federal preferred procurement program.
Regarding the 1972 cutoff year, as explained in the preamble to the
final guidelines, the oil supply and price shocks that began in this
country around 1972 provided the impetus for sustained serious new
development of biobased alternatives to fossil-based energy and other
products. Additionally, there was a return to existing, perhaps
neglected or under-utilized, biobased products. Thus, at its
discretion, USDA has selected 1972 as the baseline year in its mature
market guidance, consistent with the approach taken for the Federal
preferred procurement program. In using 1972 as a point in time
standard, rather than a dividing line between two eras, USDA believes
this can provide for the identification (for Federal preferred
purchasing) and labeling of some products that would otherwise be
excluded.
The Appropriate Lengths for the Certification Periods
Comment: Four commenters recommend that certifications should
remain valid as long as the certified product is manufactured. However,
any change that would have any effect on the new carbon content and
impact biobased content would necessitate the product being retested
and recertified using ASTM D6866. Since USDA will be implementing an
audit and enforcement program, this program should be adequate to
ensure that applicants remain in compliance with the BioPreferred
Program.
[[Page 3796]]
One industry commenter states that the appropriate length of
certification in the early stages should be longer (5 years) and once
the industry matures, reduced to 3 years. A simple annual response to a
survey by USDA indicating that there have not been any changes to the
labeled product could help USDA monitor products that are discontinued
and keep the vendors active.
Response: Most commenters agree with USDA's proposal that a
product's certification should remain valid indefinitely unless USDA
raises the minimum biobased content requirements for that specific
product or the formulation of the product changes such that it falls
below the minimum biobased content allowed for that product to be
labeled. USDA has received no additional data or information to
consider changing its decision in this regard and is making no change
to the proposed regulation based on these comments.
Preliminary Notice of Violations
Comment: Two industry commenters support USDA adding a provision to
allow for the Agency to issue ``preliminary'' notices of violation
before violation notices are issued. It is a sensible safety valve to
add to the regulations to prevent triggering violation notices
prematurely. This step can provide time to allow a manufacturer or
vendor to work with USDA to clarify whether, due to confusion or
misinformation, a violation really has not occurred. Also, if there was
a paperwork or recordkeeping error it could be corrected in response to
a preliminary notice without triggering a violation notice and all its
consequences.
Response: USDA agrees with the commenters and will include a
provision for a preliminary notice of violation. Doing so will give
manufacturers and vendors the opportunity to work with USDA to make
corrections or clear up any issues which might place the manufacturer
or vendor in violation. USDA believes that the labeling program is
designed to encourage the production, marketing, and distribution of
biobased products, not to be punitive in nature, and the use of a
preliminary notice of violation will best serve the goals of the
program.
Biobased Content Testing Facilities
Comment: Four commenters agree with USDA's proposal requiring that
biobased content testing facilities be ISO 9001 conformant to promote
data and results credibility. This would ensure that the manufacturer
is complying with some basic quality requirements. One commenter
believes ISO 17025 will be too demanding.
Two industry commenters also state that they support allowing
biobased content to be tested by any third-party ASTM/ISO compliant
test facility.
One industry organization commenter believes that USDA should not
select a single standard, such as ISO 9001 or ISO 17025, for biobased
content testing laboratories but rather should allow for the biobased
content testing to be done by any third party ASTM/ISO compliant
testing facility. The USDA Guidelines for Item Designation take this
approach and the labeling rule should be consistent with the testing
facility provisions in the Guidelines.
One individual commenter recommends that neither ISO certification
nor ISO compliance should be a requirement. The commenter states that
there are basically only two labs in the country that are performing
biobased content determinations for the BioPreferred Program, and no
new radiocarbon testing labs with interest in performing biobased
content measurements have ever started up. Since there are so few
suitable labs available, the commenter does not believe USDA should
risk restricting the field further. The focus should be on
qualifications rather than ISO compliance.
Response: USDA continues to believe that it is in the best interest
of the labeling program that biobased testing be performed by ISO 9001
conformant testing facilities. This will ensure that biobased products
using the certification mark meet the high standards of the program.
USDA believes it is important that the presence of the certification
mark on a product will clearly indicate that the product is one for
which credible information is available as to the biobased content,
consistently measured across labeled products, as use of the ASTM
radioisotope test D6866 standard will provide.
Contents and Appearance of the Certification Mark
Comment: Three commenters agree that the material (e.g., product,
packaging or both product and packaging) to which the label applies
should be clearly identified, and believe that USDA's suggested wording
for ``product'' and ``packaging'' is clear.
One industry commenter states that he has no issues with the ``FP''
on the USDA certified biobased product graphic (i.e., the certification
mark) and that as long as the program includes an educational campaign
that describes the mark, there should be no consumer confusion about
what it means.
Two commenters believe the way the ``FP'' lettering is placed on
the certification mark may not be adequate to distinguish the products
that are eligible for Federal preferred procurement. One commenter
states that the ``FP'' visually seems to disappear on the mark. Also
the letters ``FP'' are not likely to have any identifiable meaning to
either Federal employees or the general public without an outreach and
education program on what ``FP'' means and how the Federal preferred
procurement program works. The commenter does believe that it is
important for Federal buyers to have an easy way to recognize products
that fall within designated product categories. The commenter suggests
that the following language be on the final label (under the text that
now reads ``USDA Certified Biobased Product'') for BioPreferred
Products currently eligible for Federal preferred procurement:
``Federal BioPreferred Designated Product.'' In addition, the commenter
recommends implementing a targeted outreach and education campaign to
Federal buyers to educate them on the meaning of the label for a
product eligible for preferred Federal purchasing versus a product
likely to be labeled that is not currently eligible.
Two commenters oppose the proposed ``FP'' designator to indicate
that a product is eligible for Federal preferred procurement. One of
the commenters does not believe that the ``FP'' designator is necessary
to inform Federal procurement officials about these items because these
officials already have access to a list of the products eligible for
Federal procurement preference. The commenters believe that consumers
will not recognize the ``FP'' lettering on products, nor will they
understand that these products, or similar products, have undergone
life cycle costs and environmental performance analyses. Incorporation
of the ``FP'' lettering may confuse the consumer regarding the purpose
of the certification mark and will unnecessarily clutter and interfere
with what is otherwise needs to be a clean, simple graphic.
One commenter believes that the certification mark will provide
little benefit to the average consumer and that using ``FP'' will tend
to confuse matters, while another commenter believes that the ``FP''
information is irrelevant to the labeling program as currently
proposed.
Four commenters disagree with the inclusion on the certification
mark of information on product performance, life-cycle costs and
environmental and
[[Page 3797]]
human health effects of the labeled products. The commenters believe
trying to add this information would likely make the certification mark
confusing to purchasers, is beyond the scope of the labeling program,
and is not authorized by the statute.
One industry commenter states that the Farm Bill requires USDA to
look at environmental impacts beyond biobased content as one of four
criteria for the Federal preferred procurement program but that they do
not think that this should be required for the voluntary labeling
program. Biobased products manufacturers should be encouraged to
provide additional environmental information and USDA should provide
space on the website to communicate this rather than requiring it on,
or near, the certification mark. If additional marketing claims are to
be made on the package for purpose of communicating with consumers,
this would fall under the jurisdiction of the FTC.
One industry commenter states that printing sustainability
information on a bag or package is an issue that needs further
consideration. This adds more cost and ink to each bag of insulation
which may go to landfill or be recycled. This information is normally
included in product literature and specifications. It is also typically
on the website of the manufacturer. It is more sustainable to provide
product information in this manner than to print it on the package.
Three commenters support including the percentage biobased content
on the certification mark. One of these commenters believes this
provides another critical way in which purchasers can select products
that have the highest biobased content possible. Another commenter
states that by displaying the percent biobased content, the consumer is
able to make a purchasing decision based on actual content.
One industry organization commenter states that there is not
complete agreement among manufacturers on whether biobased content
should appear on the certification mark. The commenter believes that
USDA should carefully weigh the pros and cons of this label content
issue. One approach would be not to list any content information on the
certification mark because the mark will only be used on products that
met the minimum biobased content established by USDA. Another approach
would be to add the words ``Meets or Exceeds USDA Minimum Biobased
Content.'' Another approach would be to give manufacturers the option
of listing the biobased content percent on the mark or simply stating
``Meets or Exceeds the USDA Minimum Biobased Content.'' If USDA
requires that a specific biobased content percent be placed on the
certification mark, then flexibility should be given to manufacturers
to use a number that reflects testing and manufacturing variability, as
long as the number equals or exceed the minimum content requirement.
One industry commenter states that including only the biobased
content on the certification mark implies that only that criterion is
relevant. USDA determines the minimum acceptable biobased content based
on several factors, including commercially available offerings,
performance requirements in the application, etc. Such multi-factor
considerations have lead to a wide range of minimum acceptable biobased
contents, from 7 to 95 percent, across the range of product categories
and applications. If the certification mark exclusively highlights the
biobased content, this could send a misleading signal to the consumer
that biobased content is the only relevant factor. The commenter
suggests that, instead of including the percent biobased content on the
mark, include the BioPreferred Program website URL in that proposed
location on the label/artwork. This would encourage consumers to become
more informed about the program. Individual manufacturers would still
have the option of including additional information regarding biobased
content elsewhere on the package, separate from the label itself. Such
claims would be subject to the guidance from the FTC ``Guides for the
Use of Environmental Marketing Claims.''
One industry commenter suggests that including the biobased content
on the label be left to the discretion of the various companies. The
commenter states that the current state-of-the-art of biobased analytic
calculation remains not very accurate and this could open the doors to
issues when a specific number will be indicated on a certification
mark.
One industry commenter states that as long as the products meet the
minimum biobased content set by USDA, what relevance does ``Product: x
percent biobased'' add? This would lead to a ``specmanship''
competition in the market.
One industry commenter recommended the following options for
including the percent biobased content on the label (listed in order of
preference):
A. Allow the manufacturers the option of listing the biobased
content or the wording ``Meets or Exceeds USDA Minimum Biobased
Content'';
B. Require the listing of actual biobased percent of the product
(within the tolerance of standard test variability); or,
C. If manufacturing variability of actual percent content is a
significant issue, then require a numerical percent value, but rather
than requiring listing actual percent or the minimum required percent,
the manufacturer has the option of stating a percent content higher
than the minimum but lower than their ``normal'' tested value.
The commenter states that the BioPreferred Program would benefit by
requiring one of the above label alternatives as they would serve as a
continual incentive for manufacturers to maximize their biobased
content. Conversely, it could be a deterrent to add lower cost non-
renewable blends to a level just above the minimum allowed.
One biobased industry commenter would like to see a very simple
label without the specific biobased content. The minimum biobased
content is established for BioPreferred Products and for other products
it will be 51 percent unless USDA approves an alternative. Therefore, a
supplier simply needs to certify that their product meets the minimum
standard for that product(s) and USDA needs to enforce to that biobased
content level. If a company has a higher biobased content than that
minimum, then they can market that product in their literature as such.
One industry commenter believes that the logo is quite large and
that USDA should reconsider the size. Product labels have limited
space, and the graphic as shown in the draft voluntary labeling rule,
is overly large. Although the label can be reduced, it would be to the
point of not being readable or recognizable.
One industry organization commenter supports the proposed
requirement that the BioPreferred Program's Web site address either be
on or in close proximity to the label. Directing people to the site
will be a good way to educate them about biobased products and what the
certification mark means.
One environmental group commenter states that the label should
include a detailed information box adjacent to the logo, so the
consumer knows the source of the bioproducts, the energy inputs used in
their manufacture, and if any native ecosystems were degraded in the
production process.
One industry organization commenter believes that products that use
the biobased product label must also state on the label the biological
components of the product.
[[Page 3798]]
One industry organization commenter believes that the information
USDA proposes be included is reasonable and should be legible on the
vast majority of products. For products that may be too small to affix
the certification mark in a legible form, USDA should consider
authorizing the use of a separate ``hang tag'' containing the
certification mark information that could be attached to the product.
This approach would address the small product issue without the need to
change the overall design of the mark artwork and accompanying
statement.
One individual commenter believes that, in order to better
accommodate labeling of small products (e.g., lip balm), it would be
advantageous to also offer a version of the certification mark that
does not contain the words ``USDA Certified Biobased Product.'' Such a
mark would be intended only for products where it would be very
problematic to use the certification mark as currently proposed.
One industry commenter states that he believes USDA should budget
an extensive education campaign to generate brand awareness of the
certification mark both within Government and to the public. Similarly,
brand guidelines should be developed to ensure proper stewardship of
the mark.
One industry commenter states that the certification mark must be
in full compliance with the FTC's Guides on the Use of Environmental
Marketing Claims. The commenter also states that consumer testing must
be undertaken to determine whether the intent of the certification mark
is clearly understood.
Two industry commenters recommend that USDA develop and make
available with its certification mark a simple set of guidelines
regarding the proper usage of the mark and accompanying text to ensure
a legible and consistent presentation of this information.
Response: As stated in the proposed rule, USDA will create
guidelines to address recommended certification mark size, given the
variability in biobased product and packaging dimensions. These
guidelines are referred to in the proposed rule as the ``Marketing
Guides.'' These guides/guidelines will be available to manufacturers
and vendors of labeled products to provide expanded discussions of, and
guidance on resolving, implementation issues that may arise related to
certification mark use. For example, USDA anticipates that there will
be questions related to the best way to apply the certification mark on
very small products, such as those within ``lip care products'', a
product category whose products are identified for preferred Federal
purchasing. USDA believes that the Marketing Guides, which can be
updated frequently, are the most efficient way to keep certification
mark users informed of guidance provided by USDA in response to
implementation issues that arise. Additional information on
sustainability and other data will be Web-hosted, not affixed to the
mark.
Additionally, USDA consulted the FTC, which issues the ``Guides for
the Use of Environmental Marketing Claims'' to ensure that the
provisions of the voluntary labeling program were consistent with the
Guides. If manufacturers or vendors include environmental claims about
biobased products on their products/packaging (beyond the application
of the certification mark) these statements and/or marketing language
may be flagged and forwarded to the FTC for their review and follow-up.
Further, while USDA appreciates the concerns of commenters who
would like to see more environmental and performance information on the
certification mark, USDA believes that the certification mark needs to
be kept as simple as possible to maintain legibility and clarity.
Adding further information to the mark will only make it more difficult
to read and understand, lessening the impact of the label and the
BioPreferred Program.
While some commenters believed that the ``FP'' acronym proposed to
appear on the certification mark was confusing, others believed that
the acronym would be helpful to Federal procurement officials and also
informative to the general public. Some commenters felt the biobased
content percentage proposed to appear on the certification mark was
confusing and/or misleading, and felt that a large-scale outreach and
educational campaign may be necessary to educate potential buyers on
the meaning and purpose of this information. USDA considered the
comments related to the proposed content of the certification mark and
believes that the mark would be most informative if it includes both
the ``FP'' (if the product has been designated for Federal preferred
procurement) and the biobased content percentage, as proposed. Also, to
ensure that the certification mark clearly indicates whether it applies
to the product, the packaging, or both, the mark will be available in
the following variations: ``USDA Certified Biobased Product'', ``USDA
Certified Biobased Product: Package'', or ``USDA Certified Biobased
Product & Package'', to be used as appropriate.
Timeframe for Correcting Violations
Comment: Four commenters agree with USDA's recommendation for 30-
and 60-day periods (from the date the notice of violation is received)
for the offending party to correct violations before a notice of
suspension or other remedy is sought. Two of the commenters state that
to provide more flexibility, USDA could consider adding a provision for
case-by-case extensions of the 30- and 60-day periods to deal with
special or extenuating circumstances (such as late reporting by a lab).
One industry commenter states that notice of violations should be
given 30 days to respond and 60 to 90 days to correct.
One industry association commenter proposes a 60-day time period to
correct violations pertaining to biobased content to ensure adequate
timing to correct any identified issues. In addition, the commenter
agrees with USDA's recommendation for a 60-day period for the offending
party to correct all other violations before a notice of suspension or
other remedy is sought.
Response: Most of the commenters addressing this issue agreed with
the proposed 60-day time period for correcting violations. However,
USDA recognizes that as the voluntary labeling program is not a
regulatory program but a market development program, USDA needs to be
as understanding as possible while maintaining a firm date of
enforcement. For these reasons, USDA has decided to allow 90 days for
the correction of a violation once a notice of violation is received.
Recordkeeping
Comment: Four commenters support USDA's proposal that appropriate
records be kept in order to allow USDA to verify all information
associated with the labeling program and that these records be kept for
at least 3 years beyond the end of the label certification period.
One commenter supports USDA's plan to require documentation
supporting claims made on product packaging about the environmental and
human health effects, life cycle costs, sustainability benefits, and
performance of their products. This is especially important given the
widespread misuse of biodegradability claims, and unsubstantiated
compostability claims, being made by product manufacturers. When
including claims regarding compostability on the certification mark or
product packaging, manufacturers
[[Page 3799]]
should have to detail the specific environment in which the product
will fully biodegrade and for which they can provide documentation.
One of the commenters states that records should not be required to
be kept for analyses of environmental, health, sustainability benefits,
life cycle costs, or product performance because these are outside the
scope of the labeling program. Even if manufacturers or vendors are
making specific claims in these areas, USDA does not have jurisdiction
to enforce the validity of such claims. Also, records should not be
required to be kept for formulation changes that are not relevant to
the label criteria, such as changes in non-biobased ingredients, or
changes in biobased ingredients that do not result in greater than a 3
percent change in the formula.
Response: Most of the commenters agreed with the recordkeeping
requirements that USDA has proposed for the rule. USDA disagrees with
the commenter who claims that the requirement to keep documentation to
support environmental, health, sustainability benefits, life cycle
costs, or product performance claims is outside the jurisdiction of
USDA. Because the labeling of biobased products is voluntary, USDA
believes that making the use of the label contingent upon keeping such
documentation is justified and reasonable. If a labeled biobased
product also includes such claims of product benefits without proper
justification and documentation of the benefits, then UDSA believes
that the integrity of the label is compromised. Thus, USDA does not
believe that manufacturers who make such product benefit claims without
documentation should be allowed to include the Certified Biobased
Product label on their products.
Regarding the commenter's concern about formulation changes, USDA's
intent is that manufacturers must keep records of changes in the
product formulation that result in the products biobased content
changing. USDA has clarified the text of the recordkeeping provisions
in the final rule to limit the recordkeeping to formulations that
affect the biobased content of the product.
Benefits and Costs
Comment: Three commenters agree that the benefits outweigh the
costs of the program (e.g., testing, submitting applications and
associated information, and recordkeeping). One of the commenters adds
that USDA must take great care to ensure that it emphasizes the
collection and use of complete, technically sound information on which
to base its decisions.
Response: The commenters generally agreed with the goals of the
program and did not offer any specific data or suggestions that would
necessitate any changes to the program.
Comment: One environmental group commenter states that USDA should
prepare an environmental impact statement (EIS) to show the
environmental impacts of these proposed rules and alternatives. The
commenter also states that this program should avoid creating
incentives to transfer of large acreage from bio-diverse ``conservation
reserve programs'' to monocropping for biobased products and that the
consequences must be disclosed in a National Environmental Policy Act
(NEPA) analysis.
Response: While the commenter's concerns are appreciated, USDA
believes that the rule complies with all regulatory requirements and
does not agree that any additional NEPA analysis, such as an EIS, is
also required.
Application Fee
Comment: Three commenters state that a proposed future application
fee of $500 is reasonable as long as the fee is allocated towards a
certification mark auditing and/or monitoring program.
One individual commenter states some fee is justified to help with
implementing portions of the labeling program but that many companies
are reluctant to participate in the BioPreferred Program because they
are not convinced that doing so will increase product sales
significantly. The commenter states that the economic benefits of
participating in the BioPreferred Program are yet to be verified, so
any fee should not exceed $500.
One commenter does not support imposition of any future labeling
fees that would unduly burden companies, particularly small- and
medium-size biobased product manufacturers. An application fee could
cause an economic burden for companies with multiple products and
small- and medium-size companies, and discourage them from applying for
the label. For companies with multiple products, fees can add up
quickly and adding another $500 per product on top of the testing fees
could put the labeling program out of reach for many companies,
particularly small- and medium-size companies.
Response: While most commenters support the collection of a fee,
particularly if the proceeds from this fee supported efforts to audit/
monitor compliance with the voluntary labeling program, USDA is not
currently authorized to impose an application fee and, thus, cannot do
so. USDA has, however, included in today's final rule the regulatory
text necessary to implement a $500 application fee. The effective date
of the fee provision is pending until USDA is granted the legislative
authority to impose the fee. A Federal Register notice will be issued
amending the final rule to add the effective date of the application
fee provisions once the authority is granted.
General Comments
Comment: One environmental group states that the proposed rules
over-generalize the benefits of biobased products and fail to recognize
that some biobased products are more preferred than others. The
commenter states that these rules raise the prospect of
``greenwashing'' by potentially misleading the public into thinking
that some products are environmentally benign when they are not benign,
relative to existing products or alternatives.
Response: While USDA appreciates the commenter's concerns, the
purpose of the voluntary labeling program is to promote and increase
the use of biobased products as defined in the rule. The labeling
program is designed to support this goal by recognizing manufacturers
and vendors that produce and market products that utilize biobased
materials and by encouraging consumers outside the Federal Government
to purchase such products. It is not USDA's intent to mislead or
otherwise misinform the public about the potential benefits of one
particular product over another. In addition, manufacturers and vendors
are required to post certain information about their products on USDA's
Web-hosted BioPreferred Program site.
Comment: One industry organization and two industry commenters
state that Congressional intent in enacting section 9002 was to
stimulate the development of a value-added biobased products industry
with a focus on expanding demand for new uses and applications. This
purpose was made even clearer when Congress enacted the 2008 Farm Bill
and changed the name of the section 9002 program to the ``Biobased
Markets Program.'' To grow the market for biobased products, it is
essential to recognize the role of the entire value chain, from
feedstocks (e.g., soy, corn, canola, sunflowers) to intermediate
ingredients (e.g., polyols, resins, biosolvents) to formulated products
(e.g., cleaners, lubricants, insulation, foams, plastics) to finished
products
[[Page 3800]]
that contain biobased components (e.g., chairs or bedding with biobased
foam).
One industry commenter states that the voluntary labeling program
presents the opportunity for USDA to affect stakeholders within the
bioproducts/biomaterials value chain and create additional market pull
for the biobased intermediates upon which the final products are based.
Intermediates are derived more directly from agricultural products and
encompass the transformational technologies that enable the final
products to have biobased content. This is the essential link in
converting agricultural feedstock to final products. Including
intermediates along with final products is also critical to the success
of the BioPreferred Program.
Response: USDA agrees with the commenters and has included
intermediate ingredients and feedstocks in its proposed and final
definition of ``biobased product.''
Definitions
Comment: One industry organization commenter states that to avoid
ambiguity, USDA should include a definition of what is considered a
``complex product'' in the Definitions section of the rule.
One industry organization commenter and one industry commenter
recommend that USDA include vendors, distributors, and re-packagers
under the definition of ``Designated Representative.'' As part of the
application process, manufacturers could provide USDA with a list of
the ``designated representatives'' who would be using the certification
mark. USDA should also allow certified manufacturers to update this
list from time to time without requiring that a new application being
submitted. Finally, if a vendor, distributor, or re-packager is
included as a ``Designated Representative,'' they should be held
directly accountable by USDA for any violations in how they use the
certification mark or any changes they make to a product's biobased
content that violates the use of the mark. Section 2904.7 of the
proposed rule would need to be modified to make sure that manufacturers
are not held responsible for the way the mark is used by the vendors,
distributors, or re-packagers that are listed as ``Designated
Representatives.'' It is important that USDA hold the vendors,
distributors, and re-packagers to the same standards that they will
hold the manufacturer and use the same enforcement mechanisms against
those entities if a violation occurs. In addition, USDA should clarify
the definition of ``Manufacturer'' to include any ``vendor'' that
alters a product. Such a vendor should be considered a formulator and
formulators should be considered manufacturers.
Two industry organization commenters state that the proposed
labeling contains a definition of ``Intermediate Ingredients or
Feedstocks'' that varies from the statutory definition. USDA adds the
following language to the definition: ``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.''
The commenter states that USDA provides no justification for this
additional language, the language is inconsistent with the statute, and
it should not be included in the labeling program rule.
Two commenters state that the proposed labeling rule's definition
of ``Intermediate Ingredients or Feedstocks'' needs more clarity. One
of the commenters states that all of the currently designated items
appear to be finished products (e.g., something a consumer could buy)
and that he does not understand how any intermediate itself could be
identified as a BioPreferred Product (a product eligible for preferred
Federal purchasing). The commenter asked whether polymers would be
considered to be intermediates, since they would be converted into
finished products which may be eligible for Federal preferred
procurement.
One individual commenter states that a biobased product is defined
as a commercial or industrial product 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. The commenter believes USDA
should consider removing part ``B'' from the definition since it is
redundant. The commenter believes that anything falling into part B
will also fall within the definition provided in part A.
One commenter feels it is very important that the Agency carefully
define what ``renewable'' means. Without a specific definition, the
commenter felt, a surge in biobased agriculture could spawn a severe
uptick in unsustainable agriculture, the use of genetically modified
organisms, and toxic farming chemicals that would be even more
polluting to the land and water. The commenter stated that this has
already been the case with corn-based fuels and industrialized farming.
The commenter suggests adding these definitions to the renewable
criteria--``Bio material is (1) grown in a sustainable manner,
including in relation to soils, waterways, forests, and animals, (2)
does not take away from the natural biodiversity of the material in the
wild, organic, and farmed environments, (3) does not pollute or degrade
soils and waterways as materials are grown and managed, and (4)
genetically modified plants should not be acceptable as renewable.''
Response: USDA is in the process of completing a ``term
definitions'' section on the BioPreferred Program Web site and will
consider the various comments received on the definitions in the
development of that section. Regarding the comment concerning the
definition of a ``complex product'', a complex product is a finished,
consumer product composed of many different types of components.
Today's rule does not contain provisions to allow for the labeling of
complex products.
Regarding the definition of ``biobased product,'' USDA makes no
change to this definition as it thinks it is important to point out
that for the purposes of this subpart ``intermediate ingredients or
feedstocks'' can meet the definition of a ``biobased product.''
Regarding the definition of ``intermediate ingredients or
feedstocks,'' one commenter opposed USDA's proposed addition of the
following language to the statutory definition: ``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.''
USDA proposed the definition that included this sentence to clarify
that it does not intend for the label to be used on raw, unprocessed
agricultural or forestry materials such as corn kernels, soybeans, or
forestry thinnings. However, once these raw materials have been
``processed'' into feedstock materials such as corn starch, soybean
oil, or wood fibers, they can be labeled as intermediate ingredients or
feedstocks if they meet the other criteria for certification. USDA does
not believe that the proposed definition is inconsistent with the
statutory language that states that an intermediate ingredient or
feedstock means ``* * * a material or compound made in whole or in
significant part from biological products * * *.''
[[Page 3801]]
Criteria for Obtaining Certification
Comment: One industry organization commenter recommends that USDA
clarify and explicitly state whether domestic biobased carbon content
is required. On ``Criteria for Obtaining Certification,'' biobased
product is defined with the language ``including renewable domestic
agricultural materials.'' The commenter states that it appears that
domestic versus foreign source new carbon content is irrelevant in the
label application.
Response: The regulations implementing the biobased preference
program under 7 CFR 2902.2 define biobased products as ``A product
determined by USDA to be a commercial or industrial product (other than
food or feed) that is composed, in whole or in significant part, of
biological products or renewable domestic agricultural materials
(including plant, animal, and marine materials) or forestry
materials.''
Subsequent amendments to 7 CFR 2902.4(b)(3) clarify that biobased
products from any designated country would receive the same preference
extended to U.S.-sourced biobased products.
As stated in CFR 2902.4(b)(3) ``In implementing the preference
program, Federal agencies shall treat as eligible for the preference
biobased products from `designated countries', as that term is defined
in section 25.003 of the Federal Acquisition Regulation, provided that
those products otherwise meet all requirements for participation in the
preference program.''
Designated countries include countries that have entered into
specific trade agreements with the United States (such as the North
American Free Trade Agreement [NAFTA]) or offer reciprocal equal
treatment to U.S.-sourced goods. However, manufacturers and vendors
must register their products with USDA in order to qualify as an
approved supplier of biobased products.
Comment: One environmental group commenter states that an
additional criterion should be included in the labeling evaluation. The
commenter states that production of the biobased product should not
result in net reduction in biological carbon storage in ecosystems such
as forests, woodlands, rangelands, grasslands, wetlands, croplands,
waterways, etc.
Response: USDA appreciates the commenter's concerns but believes
that these concerns fall outside the scope of the voluntary labeling
program.
Criteria for Obtaining Certification--Criterion 1: Biobased Product
Comment: One industry consultant commenter states that the USDA
Certified Biobased Product Label implies a biobased product results in
climate change impact reduction and energy/environmental security
compared to non-biobased products. However, this is not backed up by a
product life-cycle analysis.
Response: The aims of the labeling program are to increase the
purchase and use of sustainable biobased products while providing
``green'' jobs and new markets for farmers, manufacturers, and vendors.
USDA is hosting an informational BioPreferred Program Web site and
requires manufacturers and vendors to provide relevant information
concerning their products for posting on this site so that purchasers
may access the information for use in making purchasing decisions.
Comment: One environmental group commenter states that the proposed
criteria for Biopreferred Products include: ``Renewable domestic
agricultural materials and forestry materials.'' These criteria raise
some important questions such as: (i) Does the word ``renewable''
describe just agricultural products, or also forestry materials? It
should be clarified that renewable modifies both agriculture and
forestry products.
(ii) What is the definition of renewable? Products derived from
logging mature and old-growth forests, or habitat of imperiled or
declining species, or short-rotation logging are not renewable and
should be excluded.
Response: The statutory definition refers to ``biological products,
including renewable domestic agricultural materials and forestry
materials.'' 7 U.S.C. 8101(4). USDA considers the qualifier
``domestic,'' as well as the qualifier ``renewable,'' to apply to both
agricultural materials and forestry materials. The Guidelines for
implementing the BioPreferred Program include the following definition
for the term ``forestry materials'': ``materials derived from the
practice of planting and caring for forests and the management of
growing timber. Such materials must come from short rotation woody
crops (less than 10 years old), sustainably managed forests, wood
residues, or forest thinnings.'' Thus, products derived from mature and
old growth forests would be excluded.
Criteria for Obtaining Certification--Criterion 2: Minimum Biobased
Content
Comment: One industry organization commenter states that it should
be made clear at the beginning of the rule with a definition or in
every criterion that biobased content is verified based on an
analytical test (ASTM Method D6866).
Response: USDA points out that the definition of ``biobased
content'' in this subsection clearly states that ``For BioPreferred
Products (products that have been identified for Federal preferred
procurement), 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 Solid, Liquid, and Gaseous Samples Using Radiocarbon
Analysis.''
Comment: One industry organization commenter states that criterion
2 seems to duplicate criterion 1. The commenter states that the term
``significant part'' (from criterion 1) would be the same as ``at or
above its applicable minimum biobased content'' (from criterion 2). The
commenter states that criterion 2 needs to be more clear to distinguish
it from criterion 1.
Response: USDA continues to believe that it is important to retain
the language of both Criterion 1 and Criterion 2. Criterion 1 states
that a biobased product must be composed ``in whole or significant part
of biological products, including renewable domestic agricultural
materials and forestry materials; or (B) an intermediate ingredient or
feedstock.'' Criterion 2 expands upon this criterion by further
explaining how ``significant'' is determined for each type of product
within the three biobased product groups: BioPreferred Products (those
that have been identified for preferred Federal purchasing), finished
biobased products that are not currently BioPreferred Products, and
products that are intermediate ingredients or feedstocks that are also
not currently recognized as BioPreferred Products.
Comment: One industry organization commenter believes that any
biobased claim on a product with less than 95 percent biobased content
should not be permitted to use the ``artwork'' or certification mark.
It may, however, state ``made with * * *'' based on the amount of
biobased material verified in the product where the claim is being made
(not in small print that is not readily apparent to the consumer).
While this was partially addressed by requiring the product statement
with the artwork, allowing the use of the artwork is misleading. This
program will mislead consumers into thinking they are purchasing a
biobased product that has better attributes than other products.
[[Page 3802]]
Response: USDA continues to believe that the goal of program is to
encourage the production and purchase of biobased products. Rather than
being exclusionary, USDA thinks it is important to set the minimum
biobased content for items at levels that will allow for a larger
number of participants while maintaining meaningful standards. This
will further the goals of the program by allowing for greater
manufacturer and vendor participation, greater purchasing and, as a
consequence, greater awareness of the BioPreferred Program.
Comment: One individual commenter noted that ASTM test method D6866
has been renamed for simplicity and to better reflect the broad
applicability of the test method. The final rule should reflect this
change. The title of the method is now ``Standard Test Methods for
Determining the Biobased Content of Solid, Liquid, and Gaseous Samples
Using Radiocarbon Analysis.''
Response: USDA agrees with the commenter and has revised the rule
to reflect this test method name change.
Criteria for Obtaining Certification--Criterion 2: Minimum Biobased
Content--Products That Are Intermediate Ingredients or Feedstocks That
Are Not Within Product Categories Identified for Federal Preferred
Procurement
Comment: One industry association commenter states that USDA has
provided a definition of ``intermediate ingredients or feedstocks''
that varies from the statutory definition.\3\ In the proposed rule,
USDA adds the following language to the definition, ``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.''
USDA provides no justification for this additional language which is
ambiguous and should not be included in the labeling rule.
---------------------------------------------------------------------------
\3\ The definition of ``intermediate ingredient or feedstock''
found in the 2008 Farm Bill is as follows: ``The term `intermediate
ingredient or feedstock' means 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.''
---------------------------------------------------------------------------
Response: USDA believes that the additional language does not
change the definition in any significant way, but simply further
clarifies USDA's intent to exclude raw agricultural or forestry
materials from the labeling program at this time. USDA further believes
that it is important to include this language in the regulatory text
(i.e., the text of part 2904) rather than only presenting it in the
preamble.
Comment: One industry commenter states that, as proposed, the
default minimum for intermediate ingredients and feedstocks is equal to
the default minimum for finished products. Regardless of what the
default minimum is in the final rule, it is still unclear how the
minimum biobased content of a feedstock translates into the minimum
biobased content of the final product. If the feedstock is above the
minimum, but the finished product is below the minimum due to other
non-biobased ingredients, would that finished product be eligible?
Conversely, if a feedstock were below the minimum, but the finished
product above the minimum due to other biobased ingredients, would that
finished product be eligible for the certification mark? The commenter
requested that USDA provide additional clarity on this matter.
Response: The commenter asks if the feedstock is above the minimum,
but the finished product is below the minimum due to other non-biobased
ingredients, is the finished product eligible? No, the finished product
in this example would not be eligible for use of the certification mark
as the finished product would not meet the 25 percent minimum biobased
content requirement. However, any biobased component of the finished
product with a minimum 25 percent biobased content itself would be
eligible for use of the mark as a biobased feedstock. Alternatively, if
a finished product composed of several biobased feedstocks of varying
percentages of biobased content has a biobased content in sum that
equals or exceeds 25 percent, this finished product would be eligible
for use of the mark, though not all of its individual components may be
eligible.
Criteria for Obtaining Certification--Alternative Minimum Biobased
Content Analysis
Comment: One industry commenter agrees with the proposal to have a
procedure whereby manufacturers, vendors, and trade associations can
request an alternative minimum biobased content for products which are
not within a designated category. The commenter encouraged USDA to
ensure that this procedure be as streamlined as possible and suggested
that leveraging the designation process may be a route to streamlining.
One industry commenter opposes the concept of allowing
manufacturers to apply for alternative applicable minimum biobased
contents.
One industry organization commenter agrees with USDA's approach to
the establishment of alternative minimum contents for the labeling
program. However, the commenter states that the proposed rule provides
the opportunity to request that USDA approve an alternative to the
default content percentage for finished products that do not fall
within a USDA designated item category but that the proposed rule
language does not provide this same option for intermediate ingredients
and feedstocks. The preamble to the rule indicates that USDA intended
that the same option be available for intermediate ingredients and
feedstocks. The commenter strongly supports this provision for finished
products as well as intermediate ingredients and feedstocks and
requests that USDA correct the final rule language so the ``alternative
applicable minimum biobased content'' provision is included for
intermediate ingredients and feedstocks.
Response: USDA continues to believe that offering a procedure
whereby manufacturers, vendors, and trade associations can request an
alternative minimum biobased content for products is in the best
interest of the labeling program. USDA agrees with the commenter that
the intent of the program is to allow, under consultation with USDA, an
alternative minimum biobased content for intermediate ingredients and
feedstocks as well as finished products that are not currently
BioPreferred Products. USDA has revised the appropriate rule language
(section 2904.4) to reflect this intent.
Initial Approval Process--Justification for Required Information
Comment: One biobased industry commenter states that the proposed
rule requires that each finished product be tested under ASTM D6866.
The commenter states that they have eight hydraulic oils that can be
listed under the program and each has exactly the same feedstock as the
biobased content. The commenter recommends that they be able to certify
in a lab per the proposed rule the common feedstock (in this case
vegetable oil) as biobased and then be able to use that feedstock as a
basis to calculate finished product biobased content. The commenter
states that the number of products they have, given that many have only
very slightly different viscosities and additives, will result in more
testing costs than needed and cause them to carefully evaluate whether
they should list them on the program based on the testing costs. The
[[Page 3803]]
commenter thinks this recommendation ensures the program standards are
met and allows a low cost of participation.
Response: USDA agrees with the commenter's recommendation and will
allow representative content testing to suffice provided the product
formulation does not vary more than 3 percent for multiple products
with a common feedstock. This will facilitate manufacturers and vendors
more rapidly and economically adding more biobased products to the
labeling program without unnecessary regulatory obstacles.
Initial Approval Process--BEES/Life Cycle Analysis
Comment: One industry commenter states that designated biobased
products were required to be evaluated using life cycle assessment
(LCA), specifically using the Building for Environmental and Economic
Sustainability (BEES) analyses. With the BEES analyses, purchasers have
been able to better understand the environmental impacts and aspects of
biobased products. By undertaking BEES analyses, biobased product
manufacturers have been able to set themselves apart from other
manufacturers in their proactive stance toward environmental issues,
thereby generating environmental awareness in the biobased community
and beyond. The commenter is very concerned that the proposed labeling
program has eliminated the requirement to perform an LCA. The commenter
presented the following concerns:
A. Biobased products potentially have significant impacts on
climate change, biodiversity, food security, and many other impact
categories. Without the application of LCA to these products, it is
impossible to tell what actions should be pursued to make these
products more environmentally friendly.
B. By omitting the requirement for an LCA-based labeling program,
USDA is losing a major opportunity toward the global competitiveness of
U.S. Agricultural Products.
C. USDA's proposed biobased certification mark does not follow the
international consensus standards on Ecolabels (the ISO 14020 series)
because it does not take environmental life cycle consideration into
account.
D. USDA is missing an opportunity to build overall LCA capacity and
competitiveness in the U.S. Requiring LCAs of biobased products would
help supply U.S. average data on their environmental impacts.
The commenter urges USDA to reconsider the elimination of
environmental LCAs from their biobased products labeling scheme. Its
inclusion made the program a strong driver for sustainability and
helped biobased American products be more competitive not only through
Federal purchases but also in national and international markets.
One environmental group states that the rules should reflect the
carbon consequences of the underlying production processes, including
long-term, life-cycle effects. The simple fact of being biobased does
not guarantee that a product is preferred from the standpoint of
environmental or social values. It is far better to conduct a more
comprehensive evaluation of the life-cycle impacts of alternative
products.
Response: USDA has given extensive consideration to the subject of
LCA and, specifically, the BEES analysis. This subject was the primary
topic of a public meeting hosted by USDA in Washington, DC on January
5, 2010 (visit the BioPreferred Program Web site to read a transcript
of the meeting). Opinions vary widely among Federal agency personnel,
industry representatives, members of the academic community, and the
general public regarding the accuracy of, and the usefulness of, the
results of these analyses. USDA is currently continuing its efforts to
formulate a final decision on any requirements to perform LCA analyses
on products in conjunction with the BioPreferred Program. At this time,
USDA is performing BEES analyses on a small number of sample products
within each product category as part of the identification of product
categories for Federal preferred procurement. For the voluntary
labeling program, the only requirement is that claims made by
manufacturers regarding the environmental or life cycle benefits of
their labeled products must be supported by appropriate documentation.
USDA believes this requirement is a reasonable way to discourage false
or undocumented claims on labeled products. Once USDA has made a final
decision about the role of LCA or environmental analyses for products
identified and certified by the BioPreferred Program, that decision and
any associated requirements for participants in the program will be
announced in the Federal Register with an opportunity for public
comment.
Violations--Audit Program
Comment: One industry organization commenter believes that USDA
should, as proposed, implement its own audit program, with particular
focus on ensuring that the biobased content of the products actually
being marketed with the certification mark meet the minimum criteria.
USDA's enforcement program should also be directed to take action
against those who use the certification mark or create a similar label
of their own and place it on products without the USDA biobased product
certification. The commenter urges USDA to add explicit language to its
proposed rule to cover violations and enforcement mechanisms for ``Use
of the Certification Mark Without Certification,'' which would include
using the certification mark or a facsimile or other artwork or
statements that imply a product is a ``USDA Certified Biobased
Product'' when it is not. In addition, USDA should work closely with
the FTC to encourage FTC to pursue its enforcement authority against
any stakeholder who makes misleading or false claims that state or
imply that they have USDA certification to use the certification mark
when they do not.
To maintain the integrity of the mark, one industry commenter
supports a strong and fair product audit and certification mark
enforcement program and believes that USDA should, as proposed,
implement its own audit program and the $500 fee suggested should be
used to set up such program.
One individual commenter does not believe it is a good use of
taxpayer dollars to inspect manufacturer and vendor facilities
(including their records, etc.) as part of a random audit program. This
will be very costly and time consuming, at a time when the public eye
on government waste is at a high point. The commenter states that
simply visiting retail facilities and testing the biobased content of
labeled products purchased from those facilities is the best way to
conduct the audit program. That approach will address the most
important aspects of an audit program.
One nonprofit organization states that, as with any labeling
program, they do not believe that affidavits from manufacturers suffice
for label certification and that without adequate verification, testing
and inspection that a program of this size would not be able to
maintain integrity over time and ultimately would cloud an already
murky green labeling marketplace.
Response: USDA received several comments for and against the
imposition of an auditing requirement. USDA continues to believe that
adequate recordkeeping and auditing are necessary to ensure the
standards of the program and will work with other agencies, as
appropriate, to make certain that manufacturers and vendors comply with
all labeling program regulations.
[[Page 3804]]
Violations--Other Remedies
Comment: One government agency commenter states that, if a
manufacturer of a labeled product were found to be in violation of the
labeling rule requirements, USDA could supply the name of the
manufacturer to the General Services Administration (GSA) and they
would add the name to the Excluded Parties List. This list is checked
by buyers as part of a responsibility determination before making an
award, so if the manufacturer's/vendor's name is on the list, they
would not be awarded a contract with the Federal government.
Response: The proposed rule (at 74 FR 38316) already includes the
penalty suggested by the commenter. It states that, in cases of
violations, ``* * * USDA may pursue suspension or debarment of the
entities involved in accordance with part 3017 of this title.'' As of
the publication date of the proposed rule, part 3017 provided for the
inclusion of a name on GSA's Excluded Parties List System once the
party is suspended or debarred.
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 final rule has been reviewed
under Executive Order (EO) 12866 and has been determined to be
significant. Today's rule establishes a voluntary labeling program that
allows manufacturers and vendors of certified biobased products to use
the ``USDA Certified Biobased Product'' certification mark. 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 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 Program Web site, maintaining applicable
records, and redesigning the product packaging to incorporate the
certification mark. USDA estimates that the combined annualized cost of
the voluntary program 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 voluntary 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 USDA
believes that the program is likely 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. Additional
information regarding the primary industry sectors expected to be
affected by today's final rule is presented under the discussion of the
Regulatory Flexibility Act below.
2. Benefits of the Rule
As an integral part of USDA's BioPreferred Program, the voluntary
labeling program may 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; and to enhance the Nation's energy security by
substituting biobased products for products derived from imported oil
and natural gas. On a national and regional level, today's final rule
may 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 required to prepare an initial
regulatory flexibility analysis of any rule subject to notice and
comment rulemaking requirements under the Administrative Procedure Act
or any other statute unless the agency can certify that the rule will
not have a significant economic impact on a substantial number of small
entities, and the agency can provide a factual basis to support the
certification. Based upon its assessment of the projected impact of
this rulemaking, USDA certifies that the rule will not have a
significant economic impact on 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 (SBA) 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.
To assess the potential effects of this rulemaking on small
businesses, USDA conducted a review of U.S. Census Bureau data compiled
by the Small Business Administration's (SBA) Office of Advocacy. USDA
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. USDA
then used the Census Bureau data to determine the number of small
businesses in those categories and the average total receipts for those
businesses. This data and the associated analysis was valuable in
determining whether the rulemaking would have a significant economic
impact on a substantial number of small businesses. Based upon the data
and accompanying analysis, USDA identified 2,493 small businesses in
the six identified manufacturing categories. The total receipts for
these small businesses averaged $11.4 million. USDA will note, however,
that this average receipt data does not convey the differences between
certain manufacturing categories, such as those reflected between the
plastics materials and carpet manufacturing sectors. Additional
information supporting USDA's analysis is available in the following
table. USDA requests comments on the quality of this analysis and ways
to improve it.
[[Page 3805]]
----------------------------------------------------------------------------------------------------------------
Average small
Number of Small business business
NAICS category * small total receipts receipts ($ in
businesses ($ in thousands) thousands)
----------------------------------------------------------------------------------------------------------------
Petroleum lubricating oil and grease manufacturing............. 261 3,354,088 12,850.91
Plastics material and resin manufacturing...................... 475 10,929,491 23,009.45
Soap and other detergent manufacturing......................... 623 5,351,973 8,590.65
Urethane and other foam product (except polystyrene) 413 2,815,231 6,816.54
manufacturing.................................................
Carpet and rug mills manufacturing............................. 258 1,733,880 6,720.47
Fertilizer manufacturing....................................... 463 4,133,533 8,927.72
----------------------------------------------------------------------------------------------------------------
* Information provided in this table is available on the SBA's Office of Advocacy Web site and was derived from
the U.S. Census Bureau's 2007 Survey of Business Owners. The information can be found at: http://www.sba.gov/advo/research/data.html#susb.
Census Bureau data on firm size also indicates that, collectively,
more than 91 percent of the firms in the six categories meet the SBA
definition of small business. Despite the high percentage of program
participants that will be small businesses, the total number of small
businesses affected by this rulemaking will not be substantial. USDA
estimates that 352 manufacturers and vendors will apply to participate
in the program annually. That number would represent around 14 percent
of the total small businesses identified in the six NAICS categories
identified above. The 14 percent figure can likely be further reduced
when considering that the six NAICS categories represent only product
manufacturing and not product vendors. In addition, the 352
manufacturers and vendors cited above does not reflect solely small
businesses since large businesses will also be eligible to participate
in the program.
The benefit-cost analysis USDA conducted for the rule, discussed in
Section VI.A.1. above, indicates that the annualized cost associated
with participating in the voluntary labeling program is about $7,994 on
average and, relative to total receipts by small businesses in the
NAICS categories where many biobased products are manufactured, appears
not to represent an undue burden in most cases.
In some cases, however, where a small business may experience a
burden of conducting multiple biobased content tests as a result of
manufacturing multiple biobased products, USDA has decided to reduce
the testing burden. As indicated earlier in the preamble of this rule,
USDA has agreed to allow representative product testing for products
with a similar formulation. This allowance should further reduce any
undue burden faced by small businesses participating in the program.
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 certification mark 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 Program 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.
C. Executive Order 12630: Governmental Actions and Interference With
Constitutionally Protected Property Rights
This 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 rule does not have sufficient federalism implications to
warrant the preparation of a Federalism Assessment. Provisions of this
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 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 rule does not significantly or uniquely affect the
communities of Indian tribal governments. The 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 through 3520), the information collection provisions associated
with this final rule have been submitted to the Office of Management
and Budget (OMB) for approval as a new collection and assigned OMB
number 0503-XXXX. In the publication of the proposed rule on July 31,
2009, USDA solicited comments on the estimated burden. USDA received no
public comment letters in response to this solicitation. This
information collection requirement will not become effective until
approved by OMB. Upon approval of this information collection, USDA
will publish a notice in the Federal Register.
I. E-Government Act Compliance
USDA is committed to compliance with the E-Government Act to
promote the use of the Internet and other information technologies to
provide increased opportunities for citizen access to government
information and services, and for other purposes. For
[[Page 3806]]
information pertinent to E-Government Act compliance related to this
rule, please contact Ron Buckhalt at (202) 205-4008.
J. Small Business Regulatory Enforcement Fairness Act
The 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.
K. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, that includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. USDA has submitted a report containing this rule and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register.
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) is amending 7 CFR chapter XXIX as follows:
CHAPTER XXIX--OFFICE OF ENERGY, DEPARTMENT OF AGRICULTURE
0
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 certification
mark.
2904.5 Initial approval process.
2904.6 Appeals process.
2904.7 Requirements for the use of the certification mark.
2904.8 Violations.
2904.9 Recordkeeping requirements.
2904.10 Oversight and monitoring.
Authority: 7 U.S.C. 8102.
PART 2904--VOLUNTARY LABELING PROGRAM FOR BIOBASED PRODUCTS
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''
certification mark. 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'' mark 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 certification mark, 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 certification
mark.
ASTM International (ASTM). American Society for Testing and
Materials is 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 BioPreferred Products (products
that have been identified for Federal preferred procurement), 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 Solid,
Liquid, and Gaseous Samples Using Radiocarbon 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.
BioPreferred Product. A biobased product that meets or exceeds
minimum biobased content levels set by USDA, and that is found within
any of the product categories that have been identified, in subpart B
of 7 CFR part 2902, whose products within are eligible for Federal
preferred procurement/purchasing.
Certification mark. A combination of the certification mark artwork
(as defined in this subpart); one of three statements identifying
whether the USDA certification applies to the product, the package, or
both the product and package; and, where applicable, the letters ``FP''
to indicate that the product is within a designated product category
and eligible for Federal preferred procurement. The certification mark
is owned, and its use is managed by, USDA (standard trademark law
definition applies).
Certification mark artwork. The distinctive image, as shown in
Figures 1-3, that identifies products as USDA Certified.
[[Page 3807]]
[GRAPHIC] [TIFF OMITTED] TR20JA11.000
[GRAPHIC] [TIFF OMITTED] TR20JA11.001
[[Page 3808]]
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''
certification mark.
Days. As used in this part means calendar days.
Designated item. For the purposes of this part means product
categories (generic groupings of products that perform the same
function) within which the products have been afforded a procurement
preference by Federal agencies under the BioPreferred Program. These
BioPreferred Products have been identified for Federal 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 certification mark to the manufacturer's or
vendor's certified biobased product or its packaging.
Intermediate ingredients or feedstocks. Materials or compounds 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.
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
Federal preferred procurement or labeling as defined under subpart B of
part 2902 of this title because they had significant national market
penetration in 1972.
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''
certification mark 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 certification mark in promoting the sales
or the public awareness of certified biobased products.
Sec. 2904.4 Criteria for product eligibility to use the certification
mark.
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. The product for which certification is sought
must be a biobased product as defined in Sec. 2904.2 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) BioPreferred Products.
(i) Product is within a single product category. If the product is
within a single product category that, at the time the application for
certification is submitted, has been designated by USDA for Federal
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 product categories. If a biobased
product is marketed within more than one product category identified
for preferred Federal purchasing, uses the same packaging for each
product, 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 product categories in order
to use the certification mark on the product. However, if the
manufacturer packages the product differently for each product
category, then the applicable minimum biobased contents are those
established under paragraph (b)(1)(i) of this section for each product
category for which the applicant seeks to use the certification mark.
(2) Finished biobased products that are not BioPreferred Products.
(i) If the product is not an intermediate ingredient or feedstock,
and is not within a product category eligible for Federal preferred
procurement at the time the application for certification is submitted,
the applicable minimum biobased content is 25 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 to be labeled.
(ii) If a product certified under paragraph (b)(2)(i) of this
section is within a product category that USDA subsequently designates
for Federal 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.
(3) Products that are intermediate ingredients or feedstocks.
(i) If the product is an intermediate ingredient or feedstock that
is not eligible for Federal preferred procurement at the time the
application for certification is submitted, the applicable minimum
biobased content is 25 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.
[[Page 3809]]
If approved by USDA, the proposed alternative applicable minimum
biobased content would become the applicable minimum biobased content
for the intermediate ingredient or feedstock product to be labeled.
(ii) If a product certified under paragraph (b)(3)(i) of this
section is within a category that USDA subsequently designates for
Federal 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.
Sec. 2904.5 Initial approval process.
(a) Application. Manufacturers and vendors seeking USDA approval to
use the certification mark for an eligible biobased product must submit
a USDA-approved application for each biobased product. A standardized
application form and instructions are available on the USDA
BioPreferred Program Web site (http://www.biopreferred.gov). The
contents of an acceptable application are as specified in paragraphs
(a)(1) through (a)(4) 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 documentation, intended uses,
and, if applicable, the corresponding product category classification
for Federal preferred procurement. 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 certification mark 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 (c)(4) of this
section, which USDA will post to the USDA BioPreferred Program Web
site, and to providing USDA with up-to-date information for posting on
this Web site.
(4) Application fee. Effective (date to be added after authority to
collect fee is granted), applicants must submit an application fee of
$500 with each completed application for certification. Instructions
for submitting the application fee are available on the USDA
BioPreferred Program Web site (http://www.biopreferred.gov), along with
the application form and instructions.
(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 certification mark 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 Program Web site)
the information specified in paragraphs (c)(1) through (c)(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 certification mark on the certified biobased product.
(1) The product's brand name(s), or other identifying information.
(2) Contact information, including the name, mailing address, email
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 (d)(2)(i) through (d)(2)(iii) 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 certification
mark to the product and must not initiate any further advertising of
the product using the certification mark. 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, the existing certification
will continue to be valid for the product.
(iii) If the applicable required minimum biobased content for a
product to be eligible to display the certification mark 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 certification mark. Manufacturers and vendors
who have re-applied for certification may continue using the existing
certification mark until they receive notification from USDA on the
results of their re-application for certification.
[[Page 3810]]
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.
(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 361,
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, vendor, and their
designated representative(s) may immediately resume affixing the
certification mark to the certified biobased product and USDA will
reinstate the product's information to the USDA BioPreferred Program
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
certification mark to the certified biobased product and sell and
distribute the certified biobased product with the certification mark.
In addition, USDA will reinstate the product's information to the USDA
BioPreferred Program Web site.
(c) 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 certification
mark on that product, as specified in Sec. 2904.5(a) of this part.
(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 certification mark.
(a) Who may use the certification mark?
(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 official certification
mark (in one of the three variations, as applicable) 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 certification mark on the product, its packaging,
and other related materials including, but not limited to,
advertisements, catalogs, specification sheets, 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 mark is used by its
companies, as well as its designated representatives, including
advertising agencies, marketing and public relations firms and
subcontractors.
(2) Other entities.
(i) Other entities may use the mark 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 mark to the product or its packaging.
(ii) Other entities may use the certification mark; the phrase
``USDA Certified Biobased Product/Package/Product & Package,'' as
applicable; 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 certification mark.
(1) The certification mark can be affixed only to certified
biobased products and their associated packaging.
(2) The certification mark 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 certification mark may be used in advertisements for
both certified biobased products and non-certified/labeled products if
the advertisement clearly indicates which products are certified/
labeled. Care must be taken to avoid implying that any non-certified
products are certified.
(3) The certification mark may be used without reference to a
specific certified biobased product only when informing the public
about the purpose of the certification mark. For example, the following
or similar claim is acceptable: ``Look for the `USDA Certified Biobased
Product' certification mark. 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 to be posted on
the USDA BioPreferred Program Web site.'' This exception allows
manufacturers, vendors, and other entities to use the certification
mark in documents such as corporate reports, but only in an informative
manner, not as a statement of product certification.
(4) The certification mark may appear next to a picture of the
product(s) or text describing it.
(5) The certification mark must stand alone and not be incorporated
into any other certification mark or logo designs.
(6) The certification mark 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 certification mark must be written in
English and may not be translated, even when the certification mark is
used outside of the United States.
(c) Incorrect usage of the certification mark.
(1) The certification mark shall not be used on any product that
has not been certified by USDA as a ``USDA Certified Biobased
Product.''
(2) The certification mark 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
certification mark applies to only the certified biobased product(s).
(3) The certification mark shall not be used to imply endorsement
by USDA or the BioPreferred Program of any particular product, service,
or company.
(4) The certification mark shall not be used in any form that could
be misleading to the consumer.
(5) The certification mark shall not be used by manufacturers or
vendors of
[[Page 3811]]
certified products in a manner disparaging to USDA or any other
government body.
(6) The certification mark shall not be used with an altered
certification mark or incorporated into other label or logo designs.
(7) The certification mark shall not be used on business cards,
company letterhead, or company stationery.
(8) The certification mark 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 certification mark shall not be used in a manner that
violates any of the applicable requirements contained in this part.
(d) Imported products. The certification mark can be used only with
a product that is certified by USDA under this part. The certification
mark 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/Package/Product & Package'' must have received
certification from USDA.
(e) Contents of the certification mark. The certification mark
shall consist of the certification mark artwork, the biobased content
percentage, and one of the three variations of text specified in
paragraphs (e)(1) through (e)(3) of this section, as applicable.
(1) USDA Certified Biobased Product.
(2) USDA Certified Biobased Product: Package.
(3) USDA Certified Biobased Product & Package.
(f) Physical aspects of the certification mark. The certification
mark artwork may not be altered, cut, separated into components, or
distorted in appearance or perspective. Certification marks that are
applied to biobased products that have been designated for preferred
Federal procurement will include the letters ``FP'' as part of the
certification mark artwork. The certification mark must appear only in
the colors specified in paragraphs (f)(1) through (f)(3) of this
section, unless approval is given by USDA for an exception.
(1) A multi-color version of the certification mark is preferred.
The certification mark colors to be applied will be stipulated in the
``Marketing Guides'' document available on the USDA BioPreferred
Program Web site (http://www.biopreferred.gov).
(2) A one-color version of the certification mark may be
substituted for the multi-color version as long as the one color used
is one of the multi-color choices reapplied without modification.
Further guidance on the one-color certification mark application will
also be detailed in the ``Marketing Guides.''
(3) A black and white version of the certification mark is
acceptable.
(g) Placement of the certification mark.
(1) The certification mark 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 certification mark 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 certification mark 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
certification mark may be placed anywhere on the page.
(ii) If a page contains a mix of certified biobased products and
non-certified products, the certification mark shall be placed in close
proximity to the certified biobased products. An individual
certification mark near each certified biobased product may be
necessary to avoid confusion.
(h) Minimum size and clear space recommendations for the
certification mark.
(1) The certification mark may be sized to fit the individual
application as long as the correct proportions are maintained and the
certification mark remains legible.
(2) A border of clear space must surround the certification mark
and must be of sufficient width to offset it from surrounding images
and text and to avoid confusion. If the certification mark's color is
similar to the background color of the product or packaging, the
certification mark in a contrasting (i.e., black, white) color may be
used.
(i) Where to obtain copies of the certification mark artwork. The
certification mark artwork is available at the USDA BioPreferred
Program Web site http://www.biopreferred.gov.
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 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 90 days from receipt of USDA written notification, a new
application for the lower biobased content. Failure to submit a new
application within 90 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) Certification mark violations.
(i) Any usage or display of the certification mark that does not
conform to the requirements specified in Sec. 2904.7.
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(ii) Affixing the certification mark to any product prior to
issuance of a notice of certification from USDA.
(iii) Affixing the certification mark 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 Program 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. USDA will first
issue a preliminary notice that apparent violations have been
identified. If satisfactory resolution of the apparent violation is not
reached within 30 days from receipt of the preliminary notice, USDA
will issue a notice of violation. Entities who receive a notice of
violation for a biobased content violation must correct the
violation(s) within 90 days from receipt of the notice of violation.
Entities who receive a notice of violation for other types of
violations also must correct the violation(s) within 90 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 90 days 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 certification mark
to any of that product, or associated packaging, not already labeled
and must not distribute any additional products bearing the
certification mark. USDA will both remove the product information from
the USDA BioPreferred Program Web site and actively communicate the
product suspension to buyers in a timely and overt manner.
(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 certification mark. USDA will also
restore the product information to the USDA BioPreferred Program 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 certification mark
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 certification
mark is affixed.
(iii) If a manufacturer or vendor whose product certification has
been revoked wishes to use the certification mark, 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 7 CFR part 3017. 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 (a)(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 that affect the biobased content 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 certification mark). Records may be kept in
either electronic format or hard copy format. All records kept in
electronic format must be readily accessible, and/or provided by
request 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 product labeling 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
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inspection and copying during normal Federal business hours.
Dated: January 10, 2011.
Pearlie S. Reed,
Assistant Secretary for Administration, U.S. Department of Agriculture.
[FR Doc. 2011-968 Filed 1-19-11; 8:45 am]
BILLING CODE 3410-39-P