43134 Federal Register / Vol. 74, No. 164 / Wednesday, August 26, 2009 / Notices 

appears to have no conflict of interest 

that would preclude membership. 

Potential candidates are required to 

provide detailed information concerning 

such matters as financial holdings, 

consultancies, and research grants or 

contracts to permit evaluation of 

possible sources of conflict of interest. 

Dated: August 21, 2009. 

Wanda K. Jones, 

Executive Secretary, Chronic Fatigue 

Syndrome Advisory Committee. 

[FR Doc. E9–20568 Filed 8–25–09; 8:45 am] 

BILLING CODE 4150–42–P 

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. 

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, 301–436–1639. 

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 °C (248 °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-grainbased 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 

(μg/kg-bw/d) (Ref. 14). International 

estimates for the average consumer 

range from 0.2 to 1.4 μg/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 μg/kg-bw/d for the general 

consumer and 4 μg/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 


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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 smalland 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 °C (43 °F) to avoid lowtemperature 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 °C (347 °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-grainbased 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 ingredientdirected measures that may reduce 

acrylamide in baked goods include 

substitution of ammonium-based raising 

agents with potassium- and sodiumbased 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 μg/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 μg/kg to 

over 1200 μg/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 


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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 instore 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. 


jlentini on DSKJ8SOYB1PROD with NOTICES
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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.) 

1. Tareke, E., P. Rydberg, P. Karlsson, S. 

Eriksson, and M. To ̈rnqvist, ‘‘Analysis of 

acrylamide, a carcinogen formed in heated 

foodstuffs,’’ Journal of Agricultural and Food 

Chemistry 50: 4998–5006, 2002. 

2. Mottram, D.S., B.L. Wedzicha, and A.T. 

Dodson, ‘‘Acrylamide is formed in the 

Maillard reaction,’’ Nature 419(6906): 448– 

449, 2002. 

3. Stadler, R.H., I. Blank, N. Varga, F. 

Robert, J. Hau, P.A. Guy, M.C. Robert, and S. 

Riediker, ‘‘Acrylamide from Maillard 

reaction products,’’ Nature 419(6906): 449– 

450, 2002. 

4. Joint FAO/WHO Expert Committee on 

Food Additives (JECFA), ‘‘Summary and 

conclusions, Sixty-fourth Meeting,’’ 2005. 

Accessed online at http://www.who.int/ipcs/ 

food/jecfa/summaries/summary_

report_64_final.pdf. 

5. Joint FAO/WHO Consultation on Health 

Implications of Acrylamide in Food, ‘‘Health 

Implications of Acrylamide in Food: Report 

of a Joint FAO/WHO Consultation,’’ WHO 

Headquarters, Geneva, Switzerland, June 25– 

27, 2002. Accessed online at http:// 

www.who.int/foodsafety/publications/chem/ 

en/acrylamide_full.pdf. 

6. U.S. Food and Drug Administration, 

‘‘Acrylamide in Food.’’ Accessed online at 

http://www.fda.gov/Food/FoodSafety/Food

ContaminantsAdulteration/Chemical

Contaminants/Acrylamide/default.htm. 

7. Jackson, L.S., and F. Al-Taher, ‘‘Effects 

of consumer food preparation on acrylamide 

formation,’’ Advances in Experimental 

Medicine and Biology 561: 447–465, 2005. 

8. U.S. Department of Health and Human 

Services, ‘‘Dietary Guidelines for 

Americans,’’ 2005. Accessed online at http:// 

www.health.gov/dietaryguidelines/dga2005/ 

document/default.htm. 

9. Stadler, R.H., ‘‘Understanding the 

formation of acrylamide and other Maillardderived vinylogous compounds in foods,’’ 

European Journal of Lipid Science and 

Technology 105(5): 199–200, 2003. 

10. Amrein, T.M., L. Andres, F. Escher, and 

R. Amado`, ‘‘Occurrence of acrylamide in 

selected foods and mitigation options,’’ Food 

Additives and Contaminants, Supplement 1, 

2007: 24(S1): 13–25, 2007. 

11. Roach, J.A.G., D. Andrzejewski, M.L. 

Gay, D. Nortrup, and S.M. Musser, ‘‘Rugged 

LC–MS/MS survey analysis for acrylamide in 

foods,’’ Journal of Agricultural and Food 

Chemistry 51:7547–7554, 2003. 

12. U.S. Food and Drug Administration, 

‘‘Survey Data on Acrylamide in Food: 

Individual Food Products,’’ 2002–2006. 

Accessed online at http://www.fda.gov/Food/ 

FoodSafety/FoodContaminantsAdulteration/ 

ChemicalContaminants/Acrylamide/ 

ucm053549.htm. 

13. U.S. Food and Drug Administration, 

‘‘Survey Data on Acrylamide in Food: Total 

Diet Study Results,’’ 2004–2006. Accessed 

online at http://www.fda.gov/Food/ 

FoodSafety/FoodContaminantsAdulteration/ 

ChemicalContaminants/Acrylamide/ 

ucm053566.htm. 

14. DiNovi, M., ‘‘The 2006 exposure 

assessment for acrylamide,’’ 2006. Accessed 

online at http://www.fda.gov/Food/ 

FoodSafety/FoodContaminantsAdulteration/ 

ChemicalContaminants/Acrylamide/ 

ucm053566.htm. 

15. Council for Agricultural Science and 

Technology (CAST), ‘‘Acrylamide in food,’’ 

Issue paper 32, CAST, Ames, Iowa, 2006. 

16. Bowyer, J.F., J.R. Latendresse, R.R. 

Delongchamp, L. Muskhelishvili, A.R. 

Warbritton, M. Thomas, E. Tareke, L.P. 

McDaniel, and D.R. Doerge, ‘‘The effects of 

subchronic acrylamide exposure on gene 

expression, neurochemistry, hormones, and 

histopathology in the hypothalamuspituitary-thyroid axis of male Fischer 344 

rats,’’ Toxicology and Applied Pharmacology 

230(2): 208–15, 2008. 

17. Doerge, D.R., G.G. da Costa, L.P. 

McDaniel, M.I. Churchwell, N.C. Twaddle, 

and F.A. Beland, ‘‘DNA adducts derived from 

administration of acrylamide and 

glycidamide to mice and rats,’’ Mutation 

Research 580(1–2): 131–41, 2005. 

18. Doerge D.R., N.C. Twaddle, M.I. 

Boettcher, L.P. McDaniel, and J. Angerer, 

‘‘Urinary excretion of acrylamide and 

metabolites in Fischer 344 rats and B6C3F(1) 

mice administered a single dose of 

acrylamide,’’ Toxicology Letters 169(1): 34– 

42, 2007. 

19. Doerge, D.R., J.F. Young, J.J. Chen, M.J. 

Dinovi, and S.H. Henry, ‘‘Using dietary 

exposure and physiologically based 

pharmacokinetic/pharmacodynamic 

modeling in human risk extrapolations for 

acrylamide toxicity,’’ Journal of Agricultural 

and Food Chemistry 56(15): 6031–8, 2008. 

20. Doerge, D.R., J.F. Young, L.P. McDaniel, 

N.C. Twaddle, and M.I. Churchwell, 

‘‘Toxicokinetics of acrylamide and 

glycidamide in B6C3F1 mice,’’ Toxicology 

and Applied Pharmacology 202(3): 258–67, 

2005. 

21. Doerge, D.R., J.F. Young, L.P. McDaniel, 

N.C. Twaddle, and M.I. Churchwell, 

‘‘Toxicokinetics of acrylamide and 

glycidamide in Fischer 344 rats,’’ Toxicology 

and Applied Pharmacology 208(3): 199–209, 

2005. 

22. Gamboa da Costa, G., M.I. Churchwell, 

L.P. Hamilton, L.S. Von Tungeln, F.A. 

Beland, M.M. Marques, and D.R. Doerge, 

‘‘DNA adduct formation from acrylamide via 

conversion to glycidamide in adult and 

neonatal mice,’’ Chemical Research in 

Toxicology 16(10): 1328–37, 2003. 

23. Garey, J., S.A. Ferguson, and M.G. 

Paule, ‘‘Developmental and behavioral effects 

of acrylamide in Fischer 344 rats,’’ 

Neurotoxicology and Teratology 27(4): 553– 

63, 2005. 

24. Garey J., and M.G. Paule, ‘‘Effects of 

chronic low-dose acrylamide exposure on 

progressive ratio performance in adolescent 

rats,’’ Neurotoxicology 28(5): 998–1002, 2007. 

25. Ghanayem, B.I., L.P. McDaniel, M.I. 

Churchwell, N.C. Twaddle, R. Snyder, T.R. 

Fennell, and D.R. Doerge, ‘‘Role of CYP2E1 

in the epoxidation of acrylamide to 

glycidamide and formation of DNA and 

hemoglobin adducts,’’ Toxicological Sciences 

88(2): 311–8, 2005. 

26. Manie`re, I., T. Godard, D.R. Doerge, 

M.I. Churchwell, M. Guffroy, M. Laurentie, 

and J.M. Poul, ‘‘DNA damage and DNA 

adduct formation in rat tissues following oral 

administration of acrylamide,’’ Mutation 

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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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–09–0789] 

Proposed Data Collections Submitted 

for Public Comment and 

Recommendations 

In compliance with the requirement 

of Section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995 for 

opportunity for public comment on 

proposed data collection projects, the 

Centers for Disease Control and 

Prevention (CDC) will publish periodic 

summaries of proposed projects. To 

request more information on the 

proposed projects or to obtain a copy of 

the data collection plans and 

instruments, call 404–639–5960 or send 

comments to Maryam I. Daneshvar, CDC 

Acting Reports Clearance Officer, 1600 

Clifton Road, MS–D74, Atlanta, GA 

30333 or send an e-mail to 

omb@cdc.gov. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 


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