[Federal Register: August 26, 2009 (Volume 74, Number 164)]
[Notices]
[Page 43134-43138]
[DOCID:fr26au09-58]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0393]

Acrylamide in Food; Request for Comments and for Scientific Data
and Information

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments and scientific data and
information.

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SUMMARY: The Food and Drug Administration (FDA) is requesting comments
and scientific data and information on acrylamide in food. Acrylamide
is a chemical that can form in some foods during certain types of high-
temperature cooking. FDA is seeking information on practices that
manufacturers have used to reduce acrylamide in food and the reductions
they have been able to achieve in acrylamide levels. FDA is considering
issuing guidance for industry on reduction of acrylamide levels in food
products.

DATES: Submit comments and scientific data and information by November
24, 2009.

ADDRESSES: Submit written comments and scientific data and information
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments and scientific data and information to
http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT:  Lauren Posnick Robin, Center for Food
Safety and Applied Nutrition (HFS-317), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

A. Introduction

    In 2002, scientists in Sweden announced the discovery of the
chemical acrylamide in a variety of heated foods (Ref. 1). Further
research subsequently determined that acrylamide can form in some foods
during certain types of high-temperature cooking (Refs. 2 and 3).
Acrylamide in food is a concern because it has been found to be
carcinogenic in rodents and is therefore considered a potential
carcinogen for humans (Refs. 4 and 5).
    Since the identification of acrylamide in food, research around the
world has centered on measuring acrylamide exposure in the diet,
studying the toxicology and epidemiology of acrylamide exposure, and
reducing (mitigating) acrylamide levels in food. Information on FDA's
activities on acrylamide can be found on FDA's Web site (Ref. 6). FDA's
research program has focused on toxicology but has also included
research on mitigation for consumers (Ref. 7). Based on this research
and other findings, FDA added information to its Web site in 2008 for
consumers interested in reducing their acrylamide exposure from food.
However, FDA's general advice for acrylamide and eating is for
consumers to adopt a healthy eating plan consistent with the Dietary
Guidelines for Americans (Refs. 6 and 8). The Dietary Guidelines for
Americans suggests a diet that emphasizes fruits, vegetables, whole
grains, and fat-free or low-fat milk and milk products; includes lean
meats, poultry, fish, beans, eggs, and nuts; and is low in saturated
fats, trans fats, cholesterol, salt (sodium), and added sugars.
    FDA has not issued guidance for manufacturers on reducing
acrylamide in food. However, it is anticipated that new information
will soon be available about the toxicology of acrylamide, which may
confirm acrylamide's carcinogenicity in laboratory animals.
International efforts to develop approaches to acrylamide mitigation
are also beginning to prove successful. Moreover, FDA is aware that at
least some manufacturers in the United States are seeking ways to
reduce acrylamide in their products. For these reasons, FDA is
considering issuing guidance for industry on reduction of acrylamide
levels in food products.
    This document summarizes information available to FDA about
acrylamide formation, exposure, toxicology, levels in food, and
techniques to mitigate acrylamide. This notice also identifies areas in
which additional data and information would be helpful to FDA in
learning more about acrylamide mitigation techniques and levels of
acrylamide in food. These areas are outlined in more detail in section
II of this document.

B. Formation and Exposure

    Acrylamide forms in foods primarily from a reaction between
asparagine, an amino acid, and reducing sugars such as glucose and
fructose. This reaction is part of the Maillard reaction, which leads
to color, flavor, and aroma changes in cooked foods (Refs. 2, 3, and
9). Acrylamide formation usually occurs at elevated temperatures used
when frying or baking (above 120 [deg]C (248 [deg]F)) and in low
moisture conditions, although acrylamide has also been identified in
some fruit and vegetable products heated at lower temperatures or
higher moisture conditions (Refs. 10 through 13). Also, formation
occurs primarily in plant-based foods, notably potato products such as
French fries and potato chips; coffee; and cereal-grain-based foods
such as cookies, crackers, breakfast cereals, and toasted bread.
    Thousands of food samples have been analyzed for acrylamide since
2002. Based on its own database of acrylamide levels in U.S. foods
(Refs. 12 and 13), FDA estimates acrylamide intake for the average U.S.
consumer as 0.4 microgram/kilogram body weight/day (microg/kg-bw/d)
(Ref. 14). International estimates for the average consumer range from
0.2 to 1.4 microg/kg-bw/d (Ref. 15). Based on estimates from different
countries, the Joint Food and Agriculture Organization/World Health
Organization (FAO/WHO) Expert Committee on Food Additives (JECFA)
identified an average acrylamide intake of 1 microg/kg-bw/d for the
general consumer and 4 microg/kg-bw/d for high consumers (Ref. 4).
    Based on measured levels of acrylamide in certain foods and on how
frequently these foods are consumed in the United States, FDA
identified the following 10 foods (in ranked order) that contribute the
most acrylamide to the U.S. diet: French fries (restaurant prepared),
French fries (oven baked), potato chips, breakfast cereals, cookies,
brewed coffee, toast, pies and cakes, crackers, and soft (nontoasted)
breads (Ref. 14). The JECFA evaluation concurred that the major foods
contributing to total exposure for most countries were French fries,
potato chips, coffee, pastry and sweet cookies, and breads and toasts
(Ref. 4).

C. Toxicology

    Several international toxicology evaluations of acrylamide have
been completed since the identification of

acrylamide in food in 2002 (Refs. 4 and 5). An initial FAO/WHO
consultation in 2002 called the presence of acrylamide in food ``a
major concern'' based on acrylamide's ability to induce cancer and
heritable mutations in laboratory animals. In 2005, an international
evaluation of acrylamide by JECFA identified margins of exposure (MOEs)
for acrylamide of 300 for general consumers and 75 for high consumers.
JECFA considers the MOE of 300 calculated for acrylamide to be low for
a compound that is genotoxic and carcinogenic and concluded that the
levels of acrylamide in food were of concern.
    Under the sponsorship of the National Toxicology Program, FDA's
National Center for Toxicological Research (NCTR) embarked in 2002 on a
series of new toxicology assays for acrylamide. These studies were
designed to address deficiencies in earlier carcinogenicity studies and
to provide more reliable data on potential carcinogenic risk of
acrylamide and other potential effects of acrylamide exposure. The work
at NCTR includes long-term carcinogenicity bioassays of acrylamide and
its metabolite glycidamide in mice and rats, as well as toxicokinetic,
bioavailability, mutagenicity, and neurodevelopmental studies (Refs. 16
through 34). NCTR's work also includes the development of a
physiologically based pharmacokinetic model for acrylamide and
glycidamide (Refs. 19 and 34).

D. Reduction of Acrylamide Levels in Food

    Since the discovery of acrylamide in food in 2002, the
international research community has explored numerous strategies for
reducing acrylamide levels in food products. This work is summarized in
the scientific literature (e.g., Refs. 35 through 48), as well as in
guidance materials prepared by industry, other governments, and
international organizations. Notable guidance materials include the
Acrylamide ``Toolbox'' produced by the Confederation of Food and Drink
Industries of the European Union (CIAA) (Ref. 49), CIAA ``Toolbox''
brochures on selected foods for small- and medium-sized businesses
(Refs. 50 through 54), the ``Review of Acrylamide Mitigation in
Biscuits, Crackers and Crispbread'' produced by the Association of the
Chocolate, Biscuits, and Confectionary Industries of the European Union
(CAOBISCO) (Ref. 55), and ``Guidelines to Authorities and Consumer
Organisations on Home Cooking and Consumption'' and ``Manual on
strategies to food industries, restaurants, etc., to minimize
acrylamide formation'' produced by the Heat-Generated Food Toxicants:
Identification, Characterization and Risk Minimisation (HEATOX) Project
(Refs. 56 and 57). The Codex Committee on Contaminants in Foods (CCCF)
has also prepared a Code of Practice for the Reduction of Acrylamide in
Foods (Ref. 58), with the U.S. Delegation to CCCF participating in
preparation of the code of practice as co-lead of the document working
group.
    Research on acrylamide mitigation has focused on reducing
acrylamide in potato products, cereal-grain-based products (e.g., baked
goods), and coffee through interventions directed at raw materials,
additional ingredients, and processing (Ref. 58). As a result of this
research, effective mitigation measures have been identified for
reducing acrylamide levels in some potato and cereal products; however,
no proven mitigation measures have been devised for coffee (Refs. 49
and 58).
    Potato products. For potato products, mitigation practices directed
at raw materials focus on controlling reducing sugar levels, for
example: (1) Selecting potato cultivars that are low in reducing
sugars, (2) checking sugar levels of incoming potato lots using
chemical analysis or fry testing, (3) storing potatoes above 6 [deg]C
(43 [deg]F) to avoid low-temperature sweetening, (4) using
reconditioning to lower sugar levels in stored potatoes, and (5)
avoiding use of immature potatoes, which have higher sugar levels.
Other mitigation practices for potato products address additional
ingredients, including using the enzyme asparaginase to reduce levels
of the acrylamide precursor asparagine, partially substituting potato
ingredients with nonpotato ingredients, and formulating recipes to
include ingredients such as sodium pyrophosphate and calcium salts
(Refs. 49 and 58). Finally, acrylamide mitigation practices for potato
products also address processing steps. For French fries, such
practices include: (1) Washing or blanching (with or without added
ingredients such as sodium pyrophosphate and cation salts), (2) cutting
thicker potato pieces, (3) removing fines (fine pieces of potato), (4)
setting fryer temperature no higher than 175 [deg]C (347 [deg]F), and
(5) cooking fries to a golden yellow color rather than a golden brown
color. For potato chips, such practices include: (1) Optimizing time
and temperature cooking conditions, (2) cooking to a golden yellow
color, (3) utilizing vacuum frying or flash frying with rapid cooling,
and (4) using optical sorting to remove darker chips (Refs. 49 and 58).
    Cereal grain products. In cereal-grain-based foods, strain
selection and agronomic practices targeted at reducing asparagine
levels in raw materials (such as ensuring adequate sulfur
fertilization) show potential to reduce acrylamide (Refs. 49 and 58).
Mitigation measures directed at additional ingredients include use of
asparaginase to deplete asparagine and partial substitution of higher-
asparagine flours (e.g., wheat, rye) with lower-asparagine flours
(e.g., rice). Substitution of whole-grain flours with highly processed
flours can also reduce acrylamide, but use of highly processed flours
does not provide the nutritional benefits associated with whole-grain
flours. Other ingredient-directed measures that may reduce acrylamide
in baked goods include substitution of ammonium-based raising agents
with potassium- and sodium-based raising agents, avoidance of reducing
sugars during baking, addition of calcium salts, and modification of
the use of minor ingredients (e.g., spices) and rework (Refs. 49 and
58). Processing changes shown to decrease acrylamide in cereal-based
foods include adjusting the time-temperature profile of baking
processes, extending dough fermentation times, controlling final
moisture content, and not over-baking or over-toasting foods (Refs. 49
and 58).

E. Levels of Acrylamide in Food

    Measured acrylamide levels in food are summarized in multiple
databases, publications, and evaluations (e.g., Refs. 4, 12, 13, and
59). Levels of acrylamide in food vary widely, from undetectable
amounts in some cereal grain- and potato-based products (e.g.,
untoasted bread and mashed potatoes) to more than 5000 microg/kg in a
cereal grain product (e.g., grain-based coffee substitute) (Refs. 12
and 13). Acrylamide levels also can vary widely within individual food
types (e.g., Ref. 12). For example, in data collected by FDA, levels of
acrylamide in potato chips varied from nearly 120 microg/kg to over
1200 microg/kg (Ref. 12). There may also be considerable variation
within different lots of the same product due to variation in raw
materials and processing conditions. Despite the wide range of
acrylamide levels for a given food, the availability of proven
mitigation practices (Refs. 49 through 58) suggests that it may be
feasible to recommend, for some foods, levels for acrylamide that all
manufacturers should be capable of achieving.

II. Request for Comments and for Scientific Data and Information

    FDA is seeking additional scientific data and information on (1)
methods for

reducing acrylamide levels in food and (2) reductions that
manufacturers have been able to achieve in acrylamide levels.
Accordingly, FDA invites all interested parties to submit comments and
scientific data and information on the topics identified. FDA is also
seeking specific data and other information on the following questions:

A. Methods for Reducing Acrylamide Levels in Food

    1. Are you (manufacturers) currently taking any steps to reduce
acrylamide levels in your food products? If yes, what methods are you
using? Please list mitigation methods by food type (e.g., potato chip)
and, where possible, by product line (e.g., potato chip line one). It
is not necessary to identify product line by brand name. Please provide
as many details as possible, including being specific about changes to
methods, e.g., identify new and previous frying temperatures rather
than simply indicating that the frying temperature was lowered.
    2. Which methods, if any, have not proved successful or cost-
effective for reducing acrylamide in your products? Please identify
food types and/or product lines for which particular methods have not
proved successful or cost-effective. Where possible, identify the
reasons these methods have not proved successful or cost-effective.
    3. What changes in ingredients (e.g., addition of cation salts,
amino acids, or spices; blanching with sodium pyrophosphate;
substitution of grains or sugars; replacement of ammonium bicarbonate)
have proved effective and feasible in lowering acrylamide levels in
your products? Please provide specific details about product types and
manufacturing process changes.
    4. Do you use asparaginase to lower acrylamide levels in any of
your products? If so, in which of your products has asparaginase proved
effective and feasible in lowering acrylamide levels? Please provide
specific details about product types and manufacturing process changes.
    5. What changes in precooking parameters (e.g., blanching,
fermentation) and cooking parameters (e.g., time and temperature of
cooking, final moisture content) have proved effective and feasible in
lowering acrylamide levels in your products? Please provide specific
details about product types and manufacturing process changes. Are
techniques such as flash frying and vacuum frying feasible methods of
acrylamide reduction?
    6. What mitigation methods might be more or less appropriate for
small manufacturers? Please provide a rationale for your response.
    7. Do you monitor acrylamide formation and reduction? If yes, what
endpoint (e.g., browning, measurement of acrylamide levels) do you use?
    8. What are standard practices in the United States for delivery,
storage, temperature control, reconditioning, and screening (e.g., by
fry testing) of potatoes? What potato cultivars in the United States
are appropriate for production of French fries, potato chips, and other
potato-based snacks? What cultivars are not acceptable for producing
these products and/or roasting or frying potatoes at home? Is it
appropriate to specify an acceptable level of reducing sugars in
incoming lots of potatoes and, if so, what level is appropriate?
    9. What changes have you made, if any, to the instructions on food
packaging to reduce acrylamide formation during final preparation of
food products by consumers?
    10. Aside from changes to the instructions on food packaging, are
there other steps that manufacturers can take to help consumers reduce
acrylamide in food, such as labeling in-store potatoes for appropriate
use?
    11. Are there other important sources of information on reducing
acrylamide levels in food that FDA has not identified in this document?
If yes, please identify such sources.
    12. Are there any other sources of information about proposed
acrylamide mitigation techniques (particularly as applied to U.S.
products) that might be more useful or accurate than the information
described in this document?

B. Levels of Acrylamide in Food

    Among the information that would be helpful to FDA in potentially
recommending levels for acrylamide in food is data on reductions
achieved by manufacturers using mitigation techniques. Some information
on acrylamide levels can be found in existing databases and
publications (Refs. 4, 12, 13, and 59), but these databases may
reflect, at least in part, acrylamide levels before mitigation measures
were applied. Data from more targeted or ongoing sampling plans (e.g.,
Refs. 60 through 64) and from legal settlements (Ref. 65) may also be
useful sources of information on acrylamide levels in food, although
some of this information may be limited in scope or applicable
primarily to European products.
    1. What acrylamide levels have you observed before and after
applying mitigation practices? Please break down your data by food type
(e.g., potato chip) and, where possible, by product line (e.g., potato
chip line one). It is not necessary to identify a product line by brand
name. Please include, if possible, measurements of acrylamide levels in
individual samples, as well as statistical endpoints (e.g., means,
medians, standard deviations). Finally, please identify the acrylamide
mitigation measures you used to achieve these reductions.
    2. Do you anticipate being able to achieve further reductions by
applying different or additional approaches? If yes, please identify
the approaches. If no, please explain what limits your ability to
further reduce the levels of acrylamide in particular products.
    3. What factors, if any, have affected your ability to consistently
achieve certain levels of acrylamide or certain percentage reductions?
    4. For what food types, if any, would it be appropriate to
recommend levels for acrylamide? Please provide an explanation of your
response.
    5. What reduced acrylamide levels should manufacturers be able to
achieve for the following foods: French fries, potato chips, breakfast
cereals, coffee, and cookies and other baked goods? What reduced
acrylamide levels should manufacturers be able to achieve for other
potato- or corn-based snacks?
    6. What additional factors, if any, should FDA consider if it
recommends levels for acrylamide in foods?
    7. Are there important sources of information that FDA has not
identified in this document on levels of acrylamide in food and
reductions in acrylamide levels achieved by manufacturers? If yes,
please identify such sources.
    8. Are there any other sources of information about attainable
levels of acrylamide in food that might be more useful or accurate than
the information described in this notice?

C. Comments

    Interested parties may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

III. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
(FDA has verified the Web site addresses, but FDA is not responsible
for any subsequent changes to the Web sites after this document
publishes in the Federal Register.)

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``Occurrence of acrylamide in selected foods and mitigation
options,'' Food Additives and Contaminants 24(Suppl 1): 13-25, 2007.
    36. Claus, A., R. Carle, and A. Schieber, ``Acrylamide in cereal
products: a review,''

Journal of Cereal Science 47(2): 118-133, 2008.
    37. Friedman, M., and C.E. Levin, ``Review of methods for the
reduction of dietary content and toxicity of acrylamide,'' Journal
of Agricultural and Food Chemistry 56(15): 6113-40, 2008.
    38. Foot, R.J., N.U. Haase, K. Grob, and P. Gond[eacute],
``Acrylamide in fried and roasted potato products: a review on
progress in mitigation,'' Food Additives and Contaminants 24(Suppl
1): 37-46, 2007.
    39. Guenther, H., E. Anklam, T. Wenzl, and R.H. Stadler,
``Acrylamide in coffee: review of progress in analysis, formation
and level reduction,'' Food Additives and Contaminants 24(Suppl 1):
60-70, 2007.
    40. Halford, N.G., N. Muttucumaru, T.Y. Curtis, and M.A. Parry,
``Genetic and agronomic approaches to decreasing acrylamide
precursors in crop plants,'' Food Additives and Contaminants
24(Suppl 1): 26-36, 2007.
    41. Konings, E.J., P. Ashby, C.G. Hamlet, and G.A. Thompson,
``Acrylamide in cereal and cereal products: a review on progress in
level reduction,'' Food Additives and Contaminants 24(Suppl 1): 47-
59, 2007.
    42. Morales, F., E. Capuano, and V. Fogliano, ``Mitigation
strategies to reduce acrylamide formation in fried potato
products,'' Annals of the New York Academy of Sciences 1126: 89-100,
2008.
    43. Muttucumaru, N., J.S. Elmore, T. Curtis, D.S. Mottram, M.A.
Parry, and N.G. Halford, ``Reducing acrylamide precursors in raw
materials derived from wheat and potato,'' Journal of Agricultural
and Food Chemistry 56(15): 6167-72, 2008.
    44. Stadler, R.H., ``Acrylamide formation in different foods and
potential strategies for reduction,'' Advances in Experimental
Medicine and Biology 561: 157-169, 2005.
    45. Stadler, R.H., and G. Scholz, ``Acrylamide: an update on
current knowledge in analysis, levels in food, mechanisms of
formation, and potential strategies of control,'' Nutrition Reviews
62(12): 449-67, 2004.
    46. Taeymans, D., A. Andersson, P. Ashby, I. Blank, P.
Gond[eacute], P. van Eijck, V. Faivre, S.P. Lalljie, H. Lingnert, M.
Lindblom, R. Matissek, D. M[uuml]ller, R.H. Stadler, A. Studer, D.
Silvani, D. Tallmadge, G. Thompson, T. Whitmore, J. Wood, and D.
Zyzak. ``Acrylamide: update on selected research activities
conducted by the European food and drink industry,'' Journal of AOAC
International 88(1): 234-41, 2005.
    47. Taeymans, D., J. Wood, P. Ashby, I. Blank, A. Studer, R.H.
Stadler, P. Gond[eacute], P. Van Eijck, S. Lalljie, H. Lingnert, M.
Lindblom, R. Matissek, D. M[uuml]ller, D. Tallmadge, J. O'Brien, S.
Thompson, D. Silvani, and T. Whitmore, ``A review of acrylamide: an
industry perspective on research, analysis, formation, and
control,'' Critical Reviews in Food Science and Nutrition 44(5):
323-47, 2004.
    48. Zhang, Y., and Y. Zhang, ``Formation and reduction of
acrylamide in Maillard reaction: a review based on the current state
of knowledge,'' Critical Reviews in Food Science and Nutrition
47(5): 521-542, 2007.
    49. Confederation of Food and Drink Industries of the EU (CIAA),
``The CIAA Acrylamide `Toolbox', Revision 12,'' 2009. Accessed
online at http://www.ciaa.be/documents/brochures/ac_toolbox_
20090216.pdf.
    50. CIAA, ``A `Toolbox' for the Reduction of Acrylamide in
Biscuits, Crackers & Crispbreads,'' 2007. Accessed online at http://
www.ciaa.be/documents/others/biscuits-EN-final.pdf.
    51. CIAA, ``A `Toolbox' for the Reduction of Acrylamide in Bread
Products,'' 2007. Accessed online at http://www.ciaa.be/documents/
others/bread-EN-final.pdf.
    52. CIAA, ``A `Toolbox' for the Reduction of Acrylamide in
Breakfast Cereals,'' 2007. Accessed online at http://www.ciaa.be/
documents/others/cereals-EN-final.pdf.
    53. CIAA, ``A `Toolbox' for the Reduction of Acrylamide in Fried
Potato Products Potato Crisps,'' 2007. Accessed online at http://
www.ciaa.be/documents/others/crisps-EN-final.pdf.
    54. CIAA, ``A `Toolbox' for the Reduction of Acrylamide in Fried
Potato Products/French Fries,'' 2007. Accessed online at http://
www.ciaa.be/documents/others/french%20fries-EN-final.pdf.
    55. Association of the Chocolate, Biscuits, and Confectionery
Industries of the EU (CAOBISCO), CAOBISCO Review of Acrylamide
Mitigation in Biscuits, Crackers and Crispbread, 2006. Accessed
online at http://www.caobisco.com/doc_uploads/7254639e.pdf.
    56. The HEATOX Project, ``Guidelines to Authorities and Consumer
Organisations on Home Cooking and Consumption,'' 2006. Accessed
online at http://www.slv.se/upload/heatox/documents/D59_
guidelines_to_authorities_and_consumer_organisations_on_
home_cooking_and_consumption.pdf.
    57. The HEATOX Project, ``Manual on strategies to food
industries, restaurants, etc., to minimize acrylamide formation,''
2006. Accessed online at http://www.slv.se/upload/heatox/documents/
D60_manual_on_strategies_to_food_industries_restaurants_
etc_to_minimise_acrylamide_formation.pdf.
    58. Joint FAO/WHO Food Standards Programme Codex Committee on
Contaminants in Foods (CCCF), ``Draft Code of Practice for the
Reduction of Acrylamide in Foods (N06-2006),'' In: Report of the 3rd
Session of the CCCF, Rotterdam, The Netherlands, March 23-27 2009,
ALINORM 09/32/41, 2009, Appendix IV. Accessed online at http://
www.codexalimentarius.net/download/report/722/al32_41e.pdf.
    59. European Commission Joint Research Centre--Institute for
Reference Materials and Measurements, ``Monitoring database on
acrylamide levels in food,'' 2006. Accessed online at http://
irmm.jrc.ec.europa.eu/html/activities/acrylamide/database.htm.
    60. European Food Safety Authority (EFSA), ``Call for occurrence
data on acrylamide levels in food,'' 2007. Accessed online at http:/
/www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_
1178656289168.htm.
    61. The Commission of the European Communities, ``Commission
Recommendation of 3 May 2007 on the monitoring of acrylamide levels
in food (2007/331/EC),'' Official Journal of the European Union, 12/
5/2007, L 123/33-40. Accessed online at http://eur-lex.europa.eu/
LexUriServ/site/en/oj/2007/l_123/l_12320070512en00330040.pdf.
    62. Bundesamt f[uuml]r Verbraucherschutz und
Lebensmittelsicherheit (BVL), ``Concept of minimising acrylamide
contents in foodstuffs,'' 2005. Accessed online at http://
www.bvl.bund.de/cln_007/nn_521138/EN/01_Food/04_Acrylamid_en/
acrylamid_EN_node.html_nnn=true.
    63. Bonneck, S., ``Acrylamide Risk Governance in Germany,'' In
O. Renn and K.D. Walker, Eds., Global Risk Governance, 2008.
Accessed online at http://www.irgc.org/IMG/pdf/Chapter_11_
Acrylamides_final.pdf.
    64. Health Canada, ``Health Canada's Acrylamide Monitoring
Program,'' 2009. Accessed online at http://www.hc-sc.gc.ca/fn-an/
securit/chem-chim/food-aliment/acrylamide/monitoring-prog-
surveillance-eng.php.
    65. Office of the Attorney General, State of California, News
release: ``Atty. Gen. Brown Settles Potato Chip Lawsuit With Heinz,
Frito-Lay & Kettle Foods,'' August 1, 2008. Accessed online at
https://ag.ca.gov/newsalerts/release.php?id=1595&.

    Dated: August 17, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-20495 Filed 8-25-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 79, Number 58 (Wednesday, March 26, 2014)]
[Notices]
[Page 16842]
[FR Doc No: 2014-06605]

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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:
    Rule 425, OMB Control No. 3235-0521, SEC File No. 270-462.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget the request for extension of the previously approved
collection of information discussed below.
    Rule 425 (17 CFR 230.425) under the Securities Act of 1933 (15
U.S.C. 77a et seq.) requires the filing of certain prospectuses and
communications under Rule 135 (17 CFR 230.135) and Rule 165 (17 CFR
230.165) in connection with business combination transactions. The
purpose of the rule is to permit more oral and written communications
with shareholders about tender offers, mergers and other business
combination transactions on a more timely basis, so long as the written
communications are filed on the date of first use. The information
provided under Rule 425 is made available to the public upon request.
Also, the information provided under Rule 425 is mandatory.
Approximately 2,650 issuers file communications under Rule 425 at an
estimated 0.25 hours per response for a total of 663 annual burden
hours (0.25 hours per response x 2,650 responses).
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    The public may view the background documentation for this
information collection at the following Web site, www.reginfo.gov.
Written comments regarding the above information should be directed to
the following persons: (i) Desk Officer for the Securities and Exchange
Commission, Office of Information and Regulatory Affairs, Office of
Management and Budget, Room 10102, New Executive Office Building,
Washington, DC 20503 or send an email to<EMAIL_ADDRESS>
and (ii) Thomas Bayer, Director/Chief Information Officer, Securities
and Exchange Commission, c/o Remi Pavlik-Simon, 100 F Street NE.,
Washington, DC 20549; or send an email to<EMAIL_ADDRESS>
Comments must be submitted to OMB within 30 days of this notice.

    Dated: March 20, 2014.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-06605 Filed 3-25-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: August 11, 2009 (Volume 74, Number 153)]
[Notices]
[Page 40205-40206]
[DOCID:fr11au09-86]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-E-0053]

Determination of Regulatory Review Period for Purposes of Patent
Extension; NPLATE

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for NPLATE and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of an application to the Director of Patents
and Trademarks, Department of Commerce, for the extension of a patent
which claims that human biological product.

ADDRESSES: Submit written or electronic comments and petitions to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
comments to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 6222, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Public Law 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological product becomes effective and runs
until the approval phase begins. The approval phase starts with the
initial submission of an application to market the human biological
product and continues until FDA grants permission to market the
biological product. Although only a portion of a regulatory review
period may count toward the actual amount of extension that the
Director of Patents and Trademarks may award (for example, half the
testing phase must be subtracted as well as any time that may have
occurred before the patent was issued), FDA's determination of the
length of a regulatory review period for a human biological product
will include all of the testing phase and approval phase as specified
in 35 U.S.C. 156(g)(1)(B).
    FDA recently approved for marketing the human biologic product
NPLATE (romiplostim). NPLATE is indicated for the treatment of
thrombocytopenia in patients with chronic immune (idiopathic)
thrombocytopenic purpura (ITP) who have had an insufficient response to
corticosteroids, immunoglobulins, or splenectomy. Subsequent to this
approval, the Patent and Trademark Office received a patent term
restoration application for NPLATE (U.S. Patent No. 6,835,809) from
Amgen Inc., and the Patent and Trademark Office requested FDA's
assistance in determining this patent's eligibility for patent term
restoration. In a letter dated February 26, 2009, FDA advised the
Patent and Trademark Office that this human biological product had
undergone a regulatory review period and that the approval of NPLATE
represented the first permitted commercial marketing or use of the
product. Thereafter, the Patent and Trademark Office requested that FDA
determine the product's regulatory review period.
    FDA has determined that the applicable regulatory review period for
NPLATE is 2,319 days. Of this time, 2,014 days occurred during the
testing phase of the regulatory review period, while 305 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: April 19,
2002. The applicant claims April 23, 2002, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was April 19, 2002,
the date of the FDA correspondence removing the clinical hold on the
application.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): October 23, 2007. FDA has verified the
applicant's claim that the biologics license application (BLA) for
NPLATE (BLA 125268/0) was initially submitted on October 23, 2007.
    3. The date the application was approved: August 22, 2008. FDA has
verified the applicant's claim that BLA 125268/0 was approved on August
22, 2008.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and Trademark Office applies several statutory limitations in
its calculations of the actual period for patent extension. In its
application for patent extension, this applicant seeks 818 days of
patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) written or electronic comments and ask for a redetermination
by October 13, 2009. Furthermore, any interested person may petition
FDA for a determination regarding whether the applicant for extension
acted with due diligence during the regulatory review period by
February 8, 2010. To meet its burden, the petition must contain
sufficient facts to merit an FDA investigation. (See H. Rept. 857, part
1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the
format specified in 21 CFR 10.30.
    Comments and petitions should be submitted to the Division of
Dockets Management. Three copies of any mailed information are to be
submitted, except that individuals may submit one copy. Comments are to
be identified with the docket number found in brackets in the heading
of this

document. Comments and petitions may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: June 8, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E9-19233 Filed 8-10-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 79, Number 72 (Tuesday, April 15, 2014)]
[Notices]
[Pages 21220-21221]
[FR Doc No: 2014-08492]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. P-2464-015; Project No. P-2484-018]

Gresham Municipal Utilities; Notice Of Application Accepted For
Filing, Ready For Environmental Analysis And Soliciting Comments,
Recommendations, Terms And Conditions, And Prescriptions

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: Subsequent License.
    b. Project Nos.: P-2464-015 and P-2484-018.
    c. Date filed: June 10, 2013.
    d. Applicant: Gresham Municipal Utilities (Gresham).
    e. Name of Projects: Weed Dam Hydroelectric Project and Upper Red
Lake Dam Hydroelectric Project.
    f. Location: On the Red River, in Shawano County, Wisconsin.
Neither project would occupy federal lands.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791 (a)--825(r).
    h. Applicant Contact: Mr. Art Bahr, Utilities Manager, Gresham
Municipal Utilities, 1126 Main Street, P.O. Box 50, Gresham, WI 54128;
Telephone<PHONE_NUMBER>.
    i. FERC Contact: Bryan Roden-Reynolds at<PHONE_NUMBER>, or via
email at<EMAIL_ADDRESS>    j. Deadline for filing comments, recommendations, terms and
conditions, and prescriptions: 60 days from the issuance date of this
notice; reply comments are due 105 days from the issuance date of this
notice.
    The Commission strongly encourages electronic filing. Please file
comments, recommendations, terms and conditions, and prescriptions
using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000
characters, without prior registration, using the eComment system at
http://www.ferc.gov/docs-filing/ecomment.asp. You must include your
name and contact information at the end of your comments. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, please send a paper copy to:
Secretary, Federal Energy Regulatory Commission, 888 First Street NE.,
Washington, DC 20426. The first page of any filing should include: Weed
Dam Hydroelectric Project No. P-2464-015 and Upper Red Lake Dam Project
No. P-2484-018.
    The Commission's Rules of Practice require all intervenors filing
documents with the Commission to serve a copy of that document on each
person on the official service list for the project. Further, if an
intervenor files comments or documents with the Commission relating to
the merits of an issue that may affect the responsibilities of a
particular resource agency, they must also serve a copy of the document
on that resource agency.
    k. This application has been accepted for filing, and is ready for
environmental analysis at this time.
    l. The existing Weed Dam Hydroelectric Project consists of: (1) A
gated 64-foot-long concrete spillway with four bays, each containing 5-
foot-high tainter gate; (2) two 700-foot-long earth embankments on
either side of the spillway; (3) a 244-acre reservoir with a storage
capacity of 1,200 acre-feet; (4) two buried steel penstocks; and (5) a
concrete powerhouse with one 500-kW turbine-generator unit and one 120-
kW turbine-generator unit having a total installed capacity of 620 kW;
(6) a 100-foot-long transmission line; (7) a substation; and (8)
appurtenant facilities. The project has an annual average generation of
approximately 1,490-megawatt-hours (MWh).

    The existing Upper Red Lake Dam Hydroelectric Project consists of:
(1) A 42-foot-long concrete dam with a gated spillway section, a
concrete overflow section, and a concrete non-overflow section; (2) two
short earth embankments on either side of the concrete dam; (3) a 239-
acre reservoir; (4) a penstock-and-surge-tank arrangement that delivers
flow to the powerhouse; and (5) a 61.5-foot-long by 53-foot-wide
concrete and brick powerhouse with one 275-kW turbine-generator unit
and one 175-kW turbine-generator unit having a total installed capacity
of 450 kW; (6) a substation with three 333-kVA transformers; and (7)
appurtenant facilities. The project has an annual average generation of
approximately 1,900 MWh.
    Gresham proposes to operate both projects in a run-of-river mode,
such that the water surface elevation of the impoundments would be
maintained at the existing normal pool elevation (crest of the dam
spillway) or above. No new or upgraded facilities, structural changes,
or operational changes are proposed for the projects.
    m. A copy of the application is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, contact
FERC Online Support. A copy is also available for inspection and
reproduction at the address in item h above.
    All filings must (1) bear in all capital letters the title
``COMMENTS'', ``REPLY COMMENTS'', ``RECOMMENDATIONS,'' ``TERMS AND
CONDITIONS,'' or ``PRESCRIPTIONS;'' (2) set forth in the heading the
name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person submitting the filing; and (4) otherwise comply
with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, recommendations, terms and conditions or prescriptions must
set forth their evidentiary basis and otherwise comply with the
requirements of 18 CFR 4.34(b). Agencies may obtain copies of the
application directly from the applicant. Each filing must be
accompanied by proof of service on all persons listed on the service
list prepared by the Commission in this proceeding, in accordance with
18 CFR 4.34(b) and 385.2010.
    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    n. A license applicant must file no later than 60 days following
the date of issuance of this notice: (1) A copy of the water quality
certification; (2) a copy of the request for certification, including
proof of the date on which the certifying agency received the request;
or (3) evidence of waiver of water quality certification.

    Dated: April 9, 2014.
Kimberly D. Bose,
 Secretary.
[FR Doc. 2014-08492 Filed 4-14-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 132 (Thursday, July 9, 2020)]
[Notices]
[Pages 41233-41234]
[FR Doc No: 2020-14804]

-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER20-2288-000]

Tatanka Ridge Wind, LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced Tatanka Ridge
Wind, LLC's application for market-based rate authority, with an
accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is July 22, 2020.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://ferc.gov) using the
``eLibrary'' link. Enter the docket number excluding the

last three digits in the docket number field to access the document. At
this time, the Commission has suspended access to the Commission's
Public Reference Room, due to the proclamation declaring a National
Emergency concerning the Novel Coronavirus Disease (COVID-19), issued
by the President on March 13, 2020. For assistance, contact the Federal
Energy Regulatory Commission at<EMAIL_ADDRESS>or call
toll-free,<PHONE_NUMBER> or TYY,<PHONE_NUMBER>.

    Dated: July 2, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-14804 Filed 7-8-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 130 (Wednesday, July 8, 2015)]
[Proposed Rules]
[Pages 39020-39021]
[FR Doc No: 2015-16629]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2015-0164; FRL-9927-77-Region 9]

Revisions to the California State Implementation Plan, Feather
River Air Quality Management District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve revisions to the Feather River Air Quality Management District
(FRAQMD) portion of the California State Implementation Plan (SIP).
Included in this approval are the following three SIP demonstrations
from FRAQMD: 2006 Reasonably Available Control Technology (RACT)
Analysis for State Implementation Plan (SIP), November 2006; Reasonably
Available Control Technology State Implementation Plan Revision
Negative Declaration for Control Techniques Guidelines Issued 2006-
2008, June 1, 2009; and Reasonably Available Control Technology
Analysis and Negative Declarations, July 3, 2014. The first two
demonstrations address the 1997 8-hour National Ambient Air Quality
Standards (NAAQS) for ozone, and the third demonstration addresses the
2008 8-hour NAAQS for ozone. The submitted SIPs also contain negative
declarations for volatile organic compound (VOC) source categories for
the years 2006, 2009 and 2014. We are proposing to approve the
submitted SIP revisions under the Clean Air Act as amended in 1990 (CAA
or the Act). We are also proposing to approve a local rule that
regulates gasoline dispending facilities.

DATES: Any comments on this proposal must arrive by August 7, 2015.

ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-
2015-0164, by one of the following methods:
    1. Federal eRulemaking Portal: www.regulations.gov. Follow the on-
line instructions.
    2. Email<EMAIL_ADDRESS>    3. Mail or deliver: Andrew Steckel (Air-4), U.S. Environmental
Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA
94105-3901.
    Instructions: All comments will be included in the public docket
without change and may be made available online at www.regulations.gov,
including any personal information provided, unless the comment
includes Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Information that you
consider CBI or otherwise protected should be clearly identified as
such and should not be submitted through www.regulations.gov or email.
www.regulations.gov is an ``anonymous access'' system, and EPA will not
know your identity or contact information unless you provide it in the
body of your comment. If you send email directly to EPA, your email
address will be automatically captured and included as part of the
public comment. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment. Electronic files should avoid the use of
special characters, any form of encryption, and be free of any defects
or viruses.
    Docket: Generally, documents in the docket for this action are
available electronically at www.regulations.gov and in hard copy at EPA
Region IX, 75 Hawthorne Street, San Francisco, California 94105-3901.
While all documents in the docket are listed at www.regulations.gov,
some information may be publicly available only at the hard copy
location (e.g., copyrighted material, large maps), and some may not be
publicly available in either location

(e.g., CBI). To inspect the hard copy materials, please schedule an
appointment during normal business hours with the contact listed in the
FOR FURTHER INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: James Shears, EPA Region IX, (213)
244-1810<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This proposal addresses revisions to the
FRAQMD portion of the California SIP. In the rules and regulations
section of the Federal Register, we are approving the three RACT SIP
revisions in a direct final action without prior proposal because we
believe these SIP revisions are not controversial. This proposal also
addresses the following local rule: FRAQMD Rule 3.8, Gasoline
Dispensing Facilities. In the Rules and Regulations section of this
Federal Register, we are approving this local rule in a direct final
action without prior proposal because we believe this SIP revision is
not controversial. Please note that if we receive adverse comment on a
specific provision of these SIP revisions or the rule, we will publish
a timely withdrawal of the direct final rule and address the comments
in a subsequent action. If that provision may be severed from the
remainder of the SIP revisions or the rule, we may adopt as final those
provisions of the SIP revisions or the rule that are not the subject of
an adverse comment.
    We do not plan to open a second comment period, so anyone
interested in commenting should do so at this time. If we do not
receive adverse comments, no further activity is planned. For further
information, please see the direct final action.

    Dated: April 30, 2015.
Jared Blumenfeld,
Regional Administrator, Region IX.
[FR Doc. 2015-16629 Filed 7-7-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: November 8, 2007 (Volume 72, Number 216)]
[Notices]
[Page 63229-63231]
[DOCID:fr08no07-88]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2007-0022]

Notice of Receipt of Petition for Decision That Nonconforming
2005 Volkswagen Golf Passenger Cars are Eligible for Importation

AGENCY: National Highway Traffic Safety Administration, DOT.

ACTION: Notice of receipt of petition for decision that nonconforming
2005 Volkswagen Golf passenger cars are eligible for importation.

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SUMMARY: This document announces receipt by the National Highway
Traffic Safety Administration (NHTSA) of a petition for a decision that
2005 Volkswagen Golf passenger cars that were not originally
manufactured to comply with all applicable Federal motor vehicle safety
standards (FMVSS) are eligible for importation into the United States
because (1) they are substantially similar to vehicles that were
originally manufactured for sale in the United States and that were
certified by their manufacturer as complying with the safety standards,
and (2) they are capable of being readily altered to conform to the
standards.

DATES: The closing date for comments on the petition is December 10,
2007.

ADDRESSES: Comments should refer to the docket and notice numbers above
and be submitted by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov.
 Follow the online instructions for submitting

comments.
     Mail: Docket Management Facility: U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., between 9 a.m. and 5 p.m. ET,
Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    Instructions: Comments must be written in the English language, and
be no greater than 15 pages in length, although there is no limit to
the length of necessary attachments to the comments. If comments are
submitted in hard copy form, please ensure that two copies are
provided. If you wish to receive confirmation that your comments were
received, please enclose a stamped, self-addressed postcard with the
comments. Note that all comments

received will be posted without change to http://www.regulations.gov,

including any personal information provided. Please see the Privacy Act
heading below.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78) or you may visit http://DocketInfo.dot.gov
.

    How to Read Comments submitted to the Docket: You may read the
comments received by Docket Management at the address and times given
above. You may also see the comments on the Internet. To read the
comments on the Internet, take the following steps:
    (1) Go to the Federal Docket Management System (FDMS) Web page
http://www.regulations.gov.

    (2) On that page, click on ``search for dockets.''
    (3) On the next page (http://www.regulations.gov/fdmspublic/component/main
), select NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION

from the drop-down menu in the Agency field, enter the Docket ID number
and title shown at the heading of this document, and select
``Nonrulemaking'' from the drop-down menu in the Type field and
``Vehicle Import Eligibility'' in the drop-down menu in the Sub-Type
field.
    (4) After entering that information, click on ``submit.''
    (5) The next page contains docket summary information for the
docket you selected. Click on the comments you wish to see. You may
download the comments. Although the comments are imaged documents,
instead of the word processing documents, the ``pdf'' versions of the
documents are word searchable. Please note that even after the comment
closing date, we will continue to file relevant information in the
Docket as it becomes available. Further, some people may submit late
comments. Accordingly, we recommend that you periodically search the
Docket for new material.

FOR FURTHER INFORMATION CONTACT: Coleman Sachs, Office of Vehicle
Safety Compliance, NHTSA<PHONE_NUMBER>).

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 30141(a)(1)(A), a motor vehicle that was not
originally manufactured to conform to all applicable FMVSS shall be
refused admission into the United States unless NHTSA has decided that
the motor vehicle is substantially similar to a motor vehicle
originally manufactured for importation into and sale in the United
States, certified under 49 U.S.C. 30115, and of the same model year as
the model of the motor vehicle to be compared, and is capable of being
readily altered to conform to all applicable FMVSS.
    Petitions for eligibility decisions may be submitted by either
manufacturers or importers who have registered with NHTSA pursuant to
49 CFR part 592. As specified in 49 CFR 593.7, NHTSA publishes notice
in the Federal Register of each petition that it receives, and affords
interested persons an opportunity to comment on the petition. At the
close of the comment period, NHTSA decides, on the basis of the
petition and any comments that it has received, whether the vehicle is
eligible for importation. The agency then publishes this decision in
the Federal Register.
    Barry Taylor Enterprises of Richmond, California (BTE) (Registered
Importer 01-280) has petitioned NHTSA to decide whether nonconforming
2005 Volkswagen Golf passenger cars are eligible for importation into
the United States. The vehicles which BTE believes are substantially
similar are 2005 Volkswagen Golf passenger cars that were manufactured
for sale in the United States and certified by their manufacturer as
conforming to all applicable FMVSS.
    The petitioner claims that it compared non-U.S. certified 2005
Volkswagen Golf passenger cars to their U.S.-certified counterparts,
and found the vehicles to be substantially similar with respect to
compliance with most FMVSS.
    BTE submitted information with its petition intended to demonstrate
that non-U.S. certified 2005 Volkswagen Golf passenger cars, as
originally manufactured, conform to many FMVSS in the same manner as
their U.S. certified counterparts, or are capable of being readily
altered to conform to those standards.
    Specifically, the petitioner claims that non-U.S. certified 2005
Volkswagen Golf passenger cars are identical to their U.S. certified
counterparts with respect to compliance with Standard Nos. 103
Windshield Defrosting and Defogging Systems, 104 Windshield Wiping and
Washing Systems, 106 Brake Hoses, 108 Lamps, Reflective Devices and
Associated Equipment, 109 New Pneumatic Tires, 113 Hood Latch System,
114 Theft Protection, 116 Motor Vehicle Brake Fluids, 118 Power-
Operated Window, Partition, and Roof Panel Systems, 124 Accelerator
Control Systems, 135 Passenger Car Brake Systems, 201 Occupant
Protection in Interior Impact, 202 Head Restraints, 204 Steering
Control Rearward Displacement, 205 Glazing Materials, 206 Door Locks
and Door Retention Components, 207 Seating Systems, 208 Occupant Crash
Protection, 210 Seat Belt Assembly Anchorages, 212 Windshield Mounting,
214 Side Impact Protection, 216 Roof Crush Resistance, 219 Windshield
Zone Intrusion, 225 Child Restraint Anchorage Systems, 301 Fuel System
Integrity, and 302 Flammability of Interior Materials.
    In addition, the petitioner claims that the vehicles comply with
the Bumper Standard found in 49 CFR Part 581.
    The petitioner also contends that the vehicles are capable of being
readily altered to meet the following standards, in the manner
indicated:
    Standard No. 101 Controls and Displays: Installation of a U.S.-
model instrument cluster.
    Standard No. 102 Transmission Shift Lever Sequence, Starter
Interlock, and Transmission Braking Effect: Installation of U.S.-model
software.
    Standard No. 110 Tire Selection and Rims: installation of vehicle
placard.
    Standard No. 111 Rearview Mirrors: Installation of a U.S.-model
passenger side rearview mirror, or inscription of the required warning
statement on the face of that mirror.
    Standard No. 209 Seat Belt Assemblies: Installation of U.S.-
certified model seat belt assemblies.
    The petitioner states that a vehicle identification plate must be
affixed to the vehicles near the left windshield post to meet the
requirements of 49 CFR Part 565.
    The petitioner additionally states that the vehicles comply with
the requirements of the Theft Prevention Standard at 49 CFR part 541,
due to the presence of U.S.-model antitheft devices.
    All comments received before the close of business on the closing
date indicated above will be considered, and will be available for
examination in the docket at the above addresses both before and after
that date. To the extent possible, comments filed after the closing
date will also be considered. Notice of final action on the petition
will be published in the Federal Register pursuant to the authority
indicated below.

    Authority: 49 U.S.C. 30141(a)(1)(A) and (b)(1); 49 CFR 593.8;
delegations of authority at 49 CFR 1.50 and 501.8.

    Issued on: November 5, 2007.
Harry Thompson,
Acting Director, Office of Vehicle Safety Compliance.
[FR Doc. E7-21966 Filed 11-7-07; 8:45 am]

BILLING CODE 4910-59-P