XXV. Analysis of Environmental Impact

     We have carefully considered the potential environmental effects of
this action.  We have concluded under 21 CFR 25.30(h) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment.  Therefore, neither an
environmental assessment nor an environmental impact statement is
required.

XXVI. Federalism

	We have analyzed this final rule in accordance with the principles set
forth in Executive Order 13132.  We have determined that the interim
final rule does not contain policies that have substantial direct
effects on the States, on the relationship between the National
Government and the States, or on the distribution of power and
responsibilities among the various levels of government.  Furthermore,
we did not receive any comments from States or their representative
organizations regarding to our analysis of the proposed rule regarding
the principles set forth in Executive Order 13132.  Accordingly, we
conclude that the final rule does not contain policies that have
federalism implications as defined in the Executive Order and,
consequently, a federalism summary impact statement is not required.

XXVII. References

1. U.S. Food and Drug Administration, Memorandum of Site Visit, August
10, 1999, to General Nutrition Products, Inc., Greenville, SC. 
Memorandum dated October 25, 1999 by Roslyn F. Powers, Ph.D., Center for
Food Safety and Applied Nutrition.

2. U.S. Food and Drug Administration, Memorandum of Site Visit, August
11, 1999, to Perrigo Company of South Carolina, Inc., Greenville, SC. 
Memorandum dated October 25, 1999 by Roslyn F. Powers, Ph.D., Center for
Food Safety and Applied Nutrition.

3. U.S. Food and Drug Administration, Memorandum of Site Visit, August
17, 1999, to Takeda Vitamin and Food, Inc., Wilmington, NC.  Memorandum
dated October 25, 1999 by Roslyn F. Powers, Ph.D., Center for Food
Safety and Applied Nutrition.

4. U.S. Food and Drug Administration, Memorandum of Site Visit,
September 21, 1999, to Pharmavite Corporation, San Fernando, CA. 
Memorandum dated October 25, 1999 by Roslyn F. Powers, Ph.D., Center for
Food Safety and Applied Nutrition.

5. U.S. Food and Drug Administration, Memorandum of Site Visit,
September 21, 1999, to Shaklee Manufacturing Center, Norman, OK. 
Memorandum dated October 25, 1999 by Roslyn F. Powers, Ph.D., Center for
Food Safety and Applied Nutrition.

6. U.S. Food and Drug Administration, Memorandum of Site Visit,
September 22, 1999, to Botanicals International, Long Beach, CA. 
Memorandum dated October 25, 1999 by Roslyn F. Powers, Ph.D., Center for
Food Safety and Applied Nutrition.

7. Slifman NR, Obermeyer WR, Aloi BK, Musser SM, Correll WA, Cichowicz
SM, Betz JM, Love LA.  Contamination of Botanical Dietary Supplements by
Digitalis Lanata.  The New England Journal of Medicine. 1996;339:806-11.


8. U.S. Food and Drug Administration, “Aloe Commodities International,
Inc., Recalls Solutions IE Ageless Formula II Due to Excess Vitamin
D.” March 26, 2004. Information accessed on June 22, 2006.  Available
at   HYPERLINK "http://www.fda.gov/bbs/topics/news/2004/NEW01043.html" 
http://www.fda.gov/bbs/topics/news/2004/NEW01043.html 

9. Juran's Quality Control Handbook (J.M. Juran, editor in chief & Frank
M. Gryna, associate editor, 4th ed., 1988).

 U.S. Food and Drug Administration, “RECALLS AND FIELD CORRECTIONS:
FOODS - CLASS I. Enforcement Report,” November 24, 2004. Information
accessed on June 22July 11, 2006.  Available at   HYPERLINK
"http://www.fda.gov/bbs/topics/enforce/2004/ENF00875.html" 
http://www.fda.gov/bbs/topics/enforce/2004/ENF00875.html 

11.7.  Lee LA, Ostroff SM, McGee HB, Johnson DR, Downes FP, Cameron DN,
Bean NH.  An outbreak of shigellosis at an outdoor music festival.  Am J
Epidemiol 1991;133:608-15.

12.8.  “Guidance for Industry: Product Recalls, Industry Removals and
Corrections,” Division of Compliance Management and Operations, Office
of Enforcement, Office of Regulatory Affairs, U.S. Food and Drug
Administration, November 3, 2003. Available on the Internet at  
HYPERLINK "http://www.fda.gov/oc/industry/default.htm" 
http://www.fda.gov/oc/industry/default.htm 

or available at www.fda.gov/opacom/7alerts.html.

9. Juran's Quality Control Handbook (J.M. Juran, editor in chief & Frank
M. Gryna, associate editor, 4th ed., 1988).

130. ISO 9001, Quality Management Systems – Requirements.
International Organization for Standardization. 3rd ed.  2000.

141. H.R. Conf. Rep. No. 107-481, at 135 (2002).

152.  U.S. Food and Drug Administration, Memorandum dated April 14,
2005, Tracy Summers, Center for Food Safety and Applied Nutrition.

163. Pegues DA, Ohl ME, Miller SI.  Salmonella, including Salmonella
Typhi.  In, Infections of the gastrointestinal tract, 2nd ed.  Eds:
Blaser MJ, Smith PD, Ravdin JI, Greenberg HB, Guerrant RL.  Lippincott
Williams & Wilkins, Philadelphia, 2002.  Pages 669-697.

174. Skirrow MB, Blaser MJ.  Campylobacter jejuni.  In, Infections of
the gastrointestinal tract, 2nd ed.  Eds: Blaser MJ, Smith PD, Ravdin
JI, Greenberg HB, Guerrant RL.  Lippincott Williams & Wilkins,
Philadelphia, 2002.  Pages 720-739.

185. Griffin PM, Mead PS, Sivapalasingam S.  Escherichia coli O157:H7
and other enterohemorrhagic E. coli.  In, Infections of the
gastrointestinal tract, 2nd ed.  Eds: Blaser MJ, Smith PD, Ravdin JI,
Greenberg HB, Guerrant RL.  Lippincott Williams & Wilkins, Philadelphia,
2002.  Pages 627-642.

1916. Information accessed on February __, 2005.  Available at  
HYPERLINK "http://www.fsis.usda.gov/Science/Microbiology/index.asp" 
http://www.fsis.usda.gov/Science/Microbiology/index.asp .

2017. DePaola A, Ulaszek J, Kaysner CA, Tenge BJ, Nordstrom JL, Wells J,
Puhr N, Gendel SM.  Molecular, serological, and virulence
characteristics of Vibrio parahaemolyticus isolated from environmental,
food, and clinical sources in North America and Asia.  Appl Environ
Microbiol 2003;69:3999-4005.

2118. Monsalud RG, Magbanua FO, Tapay LM, Hedreyda CT, Olympia MS, Migo
VP, Kurahashi M, Yokota A.  Identification of pathogenic and
non-pathogenic Vibrio strains from shrimp and shrimp farms in the
Philippines.  J Gen Appl Microbiol 2003;49:309-314.

2219. do Nascimento SM, dos Fernandes Vieira RH, Theophilo GN, dos
Prazeres Rodrigues D, Vieira GH.  Vibrio vulnificus as a health hazard
for shrimp consumers.  Rev Inst Med Trop Sao Paulo 2001;43:263-266.

230. Hackney CR, Ray B, Speck ML.  Incidence of Vibrio parahaemolyticus
in and microbiological quality of seafoods in North Carolina.  J Food
Protect 1980;43:769-773.

241. Morris JG.  “Noncholera” Vibrio species.  In, Infections of the
gastrointestinal tract, 2nd ed.  Eds: Blaser MJ, Smith PD, Ravdin JI,
Greenberg HB, Guerrant RL.  Lippincott Williams & Wilkins, Philadelphia,
2002.  Pages 557-571.

252. Ibrahim YK; Olurinola PF, Comparative Microbial Contamination
Levels in Wet Granulation and Direct Compression Methods of Tablet
Production.  Pharm Acta Helv 1991; 66(11): 298-301.

263. U.S Food and Drug Administration, FDA Talk Paper, Solgar Vitamin
and Herb Company Recalls Solgar’s Digestive Aid 100’s Dietary
Supplements Because of Possible Salmonella Contamination, April 267,
2001; Karuna Corporation, Karuna Corporation Recalls HCl Nutritional
Product Because of Possible Health Risk, May 17, 2001; Licata
Enterprises, Licata Enterprises Recalls Digestive Aid Products Because
of Possible Health Risk, May 18, 2001; Natural Organics, Inc., Natural
Organics, Inc. Cooperates in the Recall of Digestive Aid Dietary
Supplements Because of Possible Salmonella Contaminated Raw Material
Supplied by American Laboratories, Inc., May 22, 2001. (Press releases
available at http://www.fda.gov/oc/po/firmrecalls/archive_2001.html 
HYPERLINK "http://www.fda.gov/opacom/Enforce.html" 
http://www.fda.gov/opacom/Enforce.html  under 2001 Enforcement Reports).

274. “Sanitizing Rinses (for previously cleaned food-contact
surfaces), DIS/TSS-4 Efficacy Data Requirements” Disinfectant
Technical Science Section (DIS/TSS), U.S. Environmental Protection
Agency, Jan 30, 1979. Available on the internet at   HYPERLINK
"http://www.epa.gov/cgi-bin/epaprintonly.cgi" 
http://www.epa.gov/cgi-bin/epaprintonly.cgi    HYPERLINK
"http://www.epa.gov/oppad001/sciencepolicy.htm" 
http://www.epa.gov/oppad001/sciencepolicy.htm 

285. “Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits
and Vegetables,” U.S. Food and Drug Administration, October 26, 1998.
Available on the Internet at
http://www.cfsan.fda.gov/~dms/prodguid.htmlhttp://www.cfsan.fda.gov/~dms
/guidance.html#prod.  

2926. Human Drug CGMP Notes, Volume 5, Number 4, Division of
Manufacturing and Product Quality, Office of Compliance, Center for Drug
Evaluation and Research, U. S. Food and Drug Administration, December
1997.  Available on the Internet at
http://www.fda.gov/cder/hdn/cnotesd7.pdfhttp://www.fda.gov/cder/dmpq/cgm
pnotes.htm

3027. “Action Levels For Poisonous Or Deleterious Substances In Human
Food And Animal Feed,” Industry Activities Staff, Center for Food
Safety and Applied Nutrition, U.S. Food and Drug Administration, August
2000. Available on the Internet at
http://www.cfsan.fda.gov/~lrd/fdaact.htmlhttp://www.cfsan.fda.gov/~dms/g
uidance.html#chem 

3128. “Hazard Analysis and Critical Control Point Principles and
Application Guidelines,” National Advisory Committee on
Microbiological Criteria for Foods, August 14, 1997. (Reference #42 in
the proposed rule).

3229.  “Draft Report of the Food Advisory Committee Dietary Supplement
Working Group on Ingredient Identity Testing and Records and
Retention,” FDA Food Advisory Committee Dietary Supplement Working
Group, Center for Food Safety and Applied Nutrition, FDA, June 25, 1999.
(Reference #4 in the proposed rule).

330. “Guidance for Industry Part 11, Electronic Records; Electronic
signatures – Scope and Application”, available at
http://www.fda.gov/cder/guidance/5667fnl.htm.

341. “Dietary Supplement Labels: Key Elements,” U.S. Department of
Health and Human Services (HHS). Office of the Inspector General (OIG),
Publication No. OEI-01-01-00120. Available on the Internet at  
HYPERLINK "http://oig.hhs.gov/oei/reports/oei-01-01-00120.pdf" 
http://oig.hhs.gov/oei/reports/oei-01-01-00120.pdf .

35. NSF International Standard/American National Standard. 2006. Dietary
Supplements.

E1. NPR/Kaiser Family Foundation/Kennedy School of Government. Survey of
Americans and Dietary Supplements, 1999.

E2E1.  Research Triangle Institute (RTI). Economic Characterization of
the Dietary Supplement Industry.  Contract No. 223-96-2290: Task Order
3, March 1999.

E3E2. Research Triangle Institute (RTI). Survey of Manufacturing
Practices in the Dietary Supplement Industry. Contract No. 223-96-2290: 
Task Order 6, May 2000. Revised, March 20032004.

E3. “Herbal Rx: The Promises and Pitfalls.” 1999. Consumer Reports
(March): 44-48.

E4. ConsumerLab. 2000. Independent tests of herbal, vitamin, and mineral
supplements. Accessed on March 16, 2005 at
http://www.consumerlab.com/results.

E5. Rothman, G. “Herbal Remedy Rip-offs.” D Magazine (April): 39-44.

E6. Saper, Robert B., Stefanos N. Kales, Janet Parquin, Michael J.
Burns, David M. Eisenberg, Roger B. Davis, and Russell S. Phillips.
“Heavy Metal Content of Ayurvedic Herbal Medicine Products.” JAMA
292 (December 15, 2004): 2868-2873.

E7. Research Triangle Institute (RTI). Dietary Supplement Sales
Information. Contract No. 223-96-2290: Task Order 4, October, 1999.

E4E8. National Nutritional Foods Association. Facts about the Nutrition
Industry. National Nutritional Foods Association NNFA facts and stats.
Accessed on November 29, 2004. Available at   HYPERLINK
"http://www.nnfa.org/facts/index.htm. 

"  http://www.nnfa.org/facts/index.htm. 

 

E5E9.  McCarthy, P. and B. Timbo. Memorandum: Report of 

Adverse Health Outcomes Associated With the Consumption of Dietary
Supplements Which Were Prepared Using Poor Manufacturing Practices,
November 17, 1999.

E6. Prevention Magazine and Food Marketing Institute (FMI). “The
Growing Self-Care Movement.” Prevention/FMI Survey, 2000.

E6107. Watson, W. A., T.L. Litovitz, W. Klein-Schwartz, G. C. Rodgers,
Jr., J. Youniss, N. Reid, W.G. Rouse, R. S. Rembert, and D. Borys.
“2003 Annual report of the American Association of Poison Control
Centers Toxic Exposure Surveillance System.” American Journal of
Emergency Medicine 22 (September 2004): 335-392.

E7118. U.S. Food and Drug Administration, Memorandum, Koehler, K. M.: 
Tally of AERs Regarding Dietary Supplements, May 30, 2000.

E812. U.S. Food and Drug Administration, “RECALLS AND FIELD
CORRECTIONS: FOODS - CLASS I. Enforcement Report,” November 24, 2004.
Information accessed on June 22, 2006.  Available at   HYPERLINK
"http://www.fda.gov/bbs/topics/enforce/2004/ENF00875.html" 
http://www.fda.gov/bbs/topics/enforce/2004/ENF00875.html ; 

Slifman NR, Obermeyer WR, Aloi BK, Musser SM, Correll WA, Cichowicz SM,
Betz JM, Love LA.  Contamination of Botanical Dietary Supplements by
Digitalis Lanata.  The New England Journal of Medicine. 1996;339:806-11;
 U.S. Food and Drug Administration, “Aloe Commodities International,
Inc., Recalls Solutions IE Ageless Formula II Due to Excess Vitamin
D.” March 26, 2004. Information accessed on June 22, 2006.  Available
at   HYPERLINK "http://www.fda.gov/bbs/topics/news/2004/NEW01043.html" 
http://www.fda.gov/bbs/topics/news/2004/NEW01043.html .

 

E9E13. Walker, A. M. “The Relation Between Voluntary Notification and
Material Risk in Dietary Supplement Safety.” Harvard School of Public
Health, March 9, 2000.

E10E14. HCUPnet, Healthcare Cost and Utilization Project. Agency for
Healthcare Research and Quality, Rockville, MD.   HYPERLINK
http://www.ahrq.gov/HCUPnet. http://www.ahrq.gov/HCUPnet. 

E11E15. U.S. Departments of Health and Human Services and Agriculture.
Dietary Guidelines for Americans, 2005.

E12E16. Institute of Medicine, Food and Nutrition Board. Dietary
Reference Intakes Tables – The Complete Set,   HYPERLINK
"http://www.iom.edu/board. Accessed on December 3" 
http://www.iom.edu/board. Accessed on December 3 , 2004.

E17. U.S. Department of Health and Human Services. Bone Health and
Osteoporosis: A Report of the Surgeon General. Rockville, MD: U.S.
Department of Health and Human Services, Office of the Surgeon General,
2004.

E18. Centers for Disease Control and Prevention. “Use of Vitamins
Containing Folic Acid Among Women of Childbearing Age – United Sates,
2004.” MMWR 2004; 53:847-850.

E19. Botto, Lorenzo B, Cynthia A. Moore, Muin J. Khoury, and J. David
Erickson, “Neural Tube Defects.” New England Journal of Medicine 341
(November 11, 1999): 1509-1519.

E20. Alison E. Kelly, Anne C. Haddix, Kelley S. Scanlon, Charles G.
Helmick, and Joseph Mulinare, “Cost-Effectiveness of Strategies to
Prevent Neural Tube Defects.” In Cost-Effectiveness in Health and
Medicine, edited by Marthe R. Gold, Joanna A. Siegel, Louise B. Russell,
and Milton C. Weinstein. (New York: Oxford University Press, 1996), pp.
313-348.

E21. U.S. Food and Drug Administration, Memorandum: Vardon, P.
Conversation with industry expert regarding inventory practices, April
4, 2000.

E22. Plant Bioactives Research Institute. “Costs for Analysis.”
Accessed on April 10, 2000. Available at   HYPERLINK
http://www.plant-bioactives.com http://www.plant-bioactives.com . 

E23. “Fees, Methods, and Analytical Capabilities of
Laboratories–Summary.” Unpublished summary of prices listed on the
Internet, 1999.

E24. Personnel Employment, Hours, and Earnings. Series ID: EES00510006
Seasonally Adjusted, Industry: Goods-producing Data Type: Average hourly
earnings of production workers, Employment Cost Index, Bureau of Labor
Statistics.

E25. Eastern Research Group (ERG). “Economic Analysis of Proposed
Revisions to the Good Manufacturing Practices Regulation for Medical
Devices.” Contract No. 223-31-8100: Task Order 1, pp. 4-23 to 4-25,
November, 1993.

E26. U.S. Food and Drug Administration, Memorandum: McLaughlin, C.,
Costs of Pest Control, 2000.

E27. Eastern Research Group (ERG). Model for Estimating the Impacts of
Regulatory Costs on the Survival of Small Businesses and its Application
to Four FDA-Regulated Industries; Final Report. Contract No.
223-01-2461, Task Order 1, July 12, 2002.

E13. 2005 Dietary Guidelines Advisory Committee Report. Accessed on
December 12, 2004. Available at    HYPERLINK
"http://www.health.gov/dietaryguidelines/dga2005/report Accessed on
December 12"  http://www.health.gov/dietaryguidelines/dga2005/report. 

E14. U.S. Department of Health and Human Services. Bone Health and
Osteoporosis: A Report of the Surgeon General. Rockville, MD: U.S.
Department of Health and Human Services, Office of the Surgeon General,
2004.

E15. Centers for Disease Control and Prevention. “Use of Vitamins
Containing Folic Acid Among Women of Childbearing Age – United Sates,
2004.” MMWR 2004; 53:847-850.

E16. Alison E. Kelly, Anne C. Haddix, Kelley S. Scanlon, Charles G.
Helmick, and Joseph Mulinare, “Cost-Effectiveness of Strategies to
Prevent Neural Tube Defects.” In Cost-Effectiveness in Health and
Medicine, edited by Marthe R. Gold, Joanna A. Siegel, Louise B. Russell,
and Milton C. Weinstein. (New York: Oxford University Press, 1996), pp.
313-348.

E17. Botto, Lorenzo B, Cynthia A. Moore, Muin J. Khoury, and J. David
Erickson, “Neural Tube Defects.” New England Journal of Medicine 341
(November 11, 1999): 1509-1519. 

E18. Research Triangle Institute (RTI). Dietary Supplement Sales
Information. Contract No. 223-96-2290: Task Order 4, October, 1999.

E19. Personnel Employment, Hours, and Earnings. Series ID: EES00510006
Seasonally Adjusted, Industry: Goods-producing Data Type: Average hourly
earnings of production workers, Employment Cost Index, Bureau of Labor
Statistics.

E20. U.S. Food and Drug Administration, Memorandum: Vardon, P.
Conversation with industry expert regarding inventory practices, April
4, 2000.

E21. Plant Bioactives Research Institute. “Costs for Analysis.”
Accessed on April 10, 2000. Available at   HYPERLINK
http://www.plant-bioactives.com http://www.plant-bioactives.com . 

E22. “Fees, Methods, and Analytical Capabilities of
Laboratories–Summary.” Unpublished summary of prices listed on the
Internet, 1999.

E23. Eastern Research Group (ERG). “Economic Analysis of Proposed
Revisions to the Good Manufacturing Practices Regulation for Medical
Devices.” Contract No. 223-31-8100: Task Order 1, pp. 4-23 to 4-25,
November, 1993.

E24. U.S. Food and Drug Administration, Memorandum: McLaughlin, C.,
Costs of Pest Control, 2000.

E25. Eastern Research Group (ERG). Model for Estimating the Impacts of
Regulatory Costs on the Survival of Small Businesses and its Application
to Four FDA-Regulated Industries; Final Report. Contract No.
223-01-2461, Task Order 1, July 12, 2002.

E26. “Herbal Rx: The Promises and Pitfalls.” 1999. Consumer Reports
(March): 44-48.

E27. ConsumerLab. 2000. Independent tests of herbal, vitamin, and
mineral supplements. Accessed on March 16, 2005 at
http://www.consumerlab.com/results.

E28. Rothman, G. “Herbal Remedy Rip-offs.” D Magazine (April):
39-44.

E29. Saper, Robert B., Stefanos N. Kales, Janet Parquin, Michael J.
Burns, David M. Eisenberg, Roger B. Davis, and Russell S. Phillips.
“Heavy Metal Content of Ayurvedic Herbal Medicine Products.” JAMA
292 (December 15, 2004): 2868-2873.

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桤暦᠀–Confidential

Final Federalism-Ref 9-28-05, 6-28-06, 4-3-07, 5-04-07

Page   PAGE  1104 

