Citizen Petition Seeking Cancer Warning on Cosmetics Containing DEA

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Citizen Petition Seeking Cancer Warning on Cosmetics Containing DEA

October 22, 1996

David A. Kessler, M.D.
Commissioner
Food and Drug Administration
Room #14-71
Rockville, MD 20857

The undersigned submits on behalf of the Cancer Prevention Coalition, Inc., and its Chairman, Samuel S. Epstein, M.D., and on behalf of the Center for Constitutional Rights, Michael Deutsch, Esquire. This petition is based on scientific evidence of increased cancer risks from exposure to nitrosamines in cosmetics.

The undersigned submits this petition under 21 U.S.C. 321 (n), 361, 362 and 371 (a); and 21 CFR 740.1, 740.2 of 21 CFR 10.30 of the Federal Food, Drug, and Cosmetic Act to the Commissioner of Food and Drugs requiring that all cosmetic products containing diethanolamine (DEA) bear labels with a warning: "Caution -- This product may contain N-nitrosodiethanolamine, a known cancer -causing agent."

A. AGENCY ACTION REQUESTED

This petition requests that FDA takes the following action:

(1) Issue a regulation under the Federal Food, Drug and Cosmetic Act, Section 601(a), stating that "All cosmetics containing diethanolamine (DEA), a constituent of diethanolamide soaps that may react with nitrosating agents to form N-nitrosodiethanolamine (NDEA), bear a label as an adulterated product containing poisonous and deleterious substances which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual: that which contains DEA also bears the following legend conspicuously displayed thereon: 'Caution -- This product may contain N-nitrosodi-ethanolamine, a known cancer-causing agent. '"

(2) For purposes of enforcement of this act, the Secretary should conduct examinations and investigations of products which may be contaminated with NDEA through regular and routine analytical testing by officers and employees of the Department or through any health, food, or drug officer or employee of any State, Territory or political subdivision thereof, duly commissioned by the Secretary of the Department. Such examinations should result in removal of products from the shelves if products do not comply with labeling regulations.

(3) Pursuant to 21 CFR 10.30 (h) (2), a hearing at which time we can present our scientific evidence.

B. STATEMENT OF GROUNDS

Widespread Contamination of Cosmetics with DEA and NDEA

Diethanolamine (DEA) is a high production chemical used in a wide range of cosmetic pro-ducts, including shampoos, lotions and creams. In the presence of long-chain fatty acids DEA reacts to form neutral ethanolamide soaps, which are used as wetting agents in cosmetics. These soaps contain unreacted DEA. Triethanolamine (TEA), also used widely in cosmetics, may also be contaminated with DEA.1According to the Cosmetics, Toiletries and Fragrance Association,

Cocamide DEA, Lauramide DEA, Linoleamide DEA and Oleamide DEA are fatty acid diethanolamides which may contain 4 to 33 percent diethanolamine. These ingredients are used in cosmetics at concentrations of<0.1 percent to 50 percent, with most products containing 1 percent to 25 percent diethanolamide.2

As of 1980, FDA reported that approximately 42 percent of all cosmetic products were contaminated with NDEA at the following concentrations: facial cosmetics from .042 to 49 mg/kg, lotions from less than .010 to .140 mg/kg, shampoos from less than 10 to 160 mg/kg.3 In two surveys of cosmetics, 27 out of 29 American products contained up to 48 mg/kg NDEA.4 A more recent FDA analysis (1991-1992) found that NDEA is present in some products at mg/kg concentrations.5

DEA Is a Precursor of NDEA

N-nitrosodiethanolamine (NDEA), is readily formed in cosmetic by nitrosation of DEA. Even small amounts of DEA in cosmetics can react with nitrosating agents to form nitrosamines. According to the Cosmetics, Toiletries and Fragrance Association: Nitrosamine contamination of diethanolamine and fatty acid diethanolamides, and nitrosamine formation are potential problems in using these diethanolamides. The diethanolamides used in cosmetic products should be free of nitrosamines, and the finished product should not contain nitrosating agents as ingredients. 6

Nitrosating agents are added to cosmetics in one of three ways: (a) Nitrites are added directly as anti-corrosive agents; (b) Nitrites are released by the degradation of 2-nitro-1,3-propanediol (BNDP); and (c) Nitrites are contaminants in the raw materials or resulting from the exposure of cosmetics to air. Secondary amines, such as DEA, are rapidly nitrosated by nitrogen oxides. Nitrosamines formation from nitrite and amines is accelerated under specific conditions by formaldehyde, paraformaldehyde, thiocyanate, nitrophenols and certain metal salts (e.g ZnI2, CuCl, AgNO3, SnCl2 and HgCl2).7,8,9,10,11

Cosmetics remain on store shelves and in cabinets of consumers for long periods of time, allowing nitrosamines to form. If DEA is present, nitrosamines can continue to form throughout storage, especially at elevated temperatures.12

Acidic pH is an optimal reaction condition for nitrosamine formation. Although cosmetics generally have neutral pH, 13 N-nitrosamines can be formed at neutral or alkaline pH by the reaction of a nitrosating agent with an amine in the presence of carbonyl compounds such as formaldehyde.14,15 Formaldehyde is present in cosmetics either from in situ formaldehyde-releasing agents, such as BNDP, or from its use as a preservative.16

Dermal Absorption of NDEA

There is substantial evidence of the dermal absorption of NDEA in both rodents and humans. "[NDEA] is a known carcinogen in laboratory animals; it is absorbed through the skin. The absorption rate is a function of the nature of the cosmetic; absorption is fastest in nonpolar vehicles ".17 Dermal absorption of NDEA was demonstrated by Lijinsky et al. In 1981.18 As a fat-soluble chemical NDEA can be absorbed dermally in rats and humans.19,20

NDEA Increases Cancer Risk

There is substantial evidence of potent carcinogenicity of NDEA in a wide range of animal species.21,22, 23, 24, 25, 26, 27, 28, 29 According to the International Agency for Research on Cancer (IARC).

There is sufficient evidence of a carcinogenic effect of N-nitrosodiethanolamine -- . In view of the widespread exposure to appreciable concentrations of N-nitrosodiethanol-amine, efforts should be made to obtain epidemiological information.30

The National Toxicology Program similarly concluded: There is sufficient evidence for the carcinogenicity of N-nitrosodiethanolamine in experimental animals.31 Of over 44 different species in which N-nitroso compounds have been tested, all have been susceptible. 32 Humans are most unlikely to be the only exception to this trend.

In 1978, the IARC concluded that "although no epidemiological data were available, nitrosodiethanolamine should be regarded for practical purposes as if it were carcinogenic to humans". 33 In 1987 the IARC further confirmed the carcinogenicity of NDEA.

Based on early evidence of the carcinogenicity of NDEA and evidence of cutting fluid contamination, 20 years ago NIOSH recommended that action be taken to protect workers including elimination of nitrosamines from the fluids.34 More recently, NIOSH published a hazard review of cutting fluids used in metal working that contain NDEA among other nitrosamines. This hazard review indicates that, based on epidemiological evidence in human beings, "Increased cancer risk has been generally attributed to worker exposure to nitrosamine or PAH (polyaromatic hydrocarbon) contaminants in metal working fluids". 35

The Failure of the FDA to Take Appropriate Regulatory Action

In the Federal Register of April 10, 1979, the FDA called for industry "to take immediate measures to eliminate to the extent possible [NDEA] and any other N-nitrosamines from cosmetic products, " and further insisted that "cosmetic products may be analyzed by FDA for nitrosamine contamination and that individual products could be subject to enforcement action."

FDA has taken no subsequent enforcement actions despite the limited compliance with this Federal Register order. According to the FDA officials Don Havery and Hardy Chou in 1994.

In the United States...the personal care industry has invested resources in understanding both the mechanisms of N-nitrosamine formation in cosmetic systems and the means of inhibiting N-nitrosamine formation. However, there is still room for improvement. New products containing nitrosatable amines with formaldehyde and nitrite-releasing preservatives are still appearing on the U.S. market. Manufacturers have a responsibility to be aware of the potential for N-nitrosamine formation and to take steps necessary to keep N-nitrosamine levels as low as possible as part of their good manufacturing practices.36

The goal of good manufacturing practices is to reduce "human exposure to N-nitrosamines to the lowest level technologically feasible by reducing levels in all personal care products. With the information and technology currently available to cosmetic manufacturers, N-nitrosamine levels can and should be further reduced in consumer products ". 37

The FDA has failed to act on the Federal Register recommendations made in 1979. More recently, the FDA has not fully recognized the consumer hazards of this carcinogen. Measurements have not been made to determine total daily exposure to nitrosamines and it is inappropriate to quantify exposures without such data.

Cosmetic Industry Response to FDA Action

In response to the FDA Federal Register order, the Nitrosamine Task Force of the Cosmetics, Toiletries and Fragrance Association failed to eliminate the use of DEA, but rather, they investigated ways to inhibit the formation of NDEA. 38

There are no known nitrosation inhibitors that eliminate nitrosamine contamination. Inhibitors have failed for the following reasons:

The compound a-tocopherol has been used as an inhibitor but this compound is useful only when the nitrosating agent is nitrite itself. It is not effective against nitrogen oxide, a gas found in polluted air. It has also been shown to be ineffective in some cosmetic systems.39

Many cosmetics make inhibition of nitrosamine formation more difficult. If they are two-phase emulsion systems the inhibitor must be soluble in both hydrophilic and hydrophobic media to be effective as an inhibitor.40,41

Ascorbic acid, sodium bisulfite, butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT) sodium ascorbated, ascorbyl palmitate and a-tocopherol have all been used in attempts to inhibit nitrosamine formation. None of these inhibitors have been adequate against all possible nitrosation agents to which a shelved cosmetic is exposed.42

Industry has had no success in reducing NDEA below 1984 levels.43 As a result, in 1996 the Cosmetics, Toiletries and Fragrance Association stated in 1996, "These chemicals [Cocamide DEA, Lauramide DEA, Linoleamide DEA, and Oleamide DEA] should not be used as ingredients in cosmetic products containing nitrosating agents".44 Nevertheless, DEA is still widely used by major cosmetic manufacturers.

In contrast, some other manufacturers such as Aubrey Organics 7, have ceased to use diethanolamide soaps entirely. According to Aubrey Hampton of Aubrey Organics7, None of our products perform less effectively because they do not contain DEA. There are many alternative soap bases available without DEA that can be used by cosmetic manufacturers. In short, the removal of DEA does not pose a manufacturing problem to the cosmetic industry.45 There is no reason for high levels of NDEA to be found in cosmetic products. With safe alternatives available, the elimination of DEA should not be an economic burden for the cosmetic industry.

Response of National Institutes for Occupational Safety and Health

In striking contrast to the FDA's position on NDEA, The National Institutes for Occupational Safety and Health (NIOSH) has issued two reports, one as early as 1976, stating that protective measures should be taken when workers are exposed to levels of NDEA similar to those found in cosmetics.46, 47

Response of German Industry and European Union

The German Federal Health Office issued a request to eliminate all secondary amines from cosmetics in 1987 and in response, the German manufacturers ' association has voluntarily complied and sharply reduced the use of secondary amines in cosmetics and toiletries.48 Included in the specifications of the German Federal Health Office were that fatty acid diethanolamides contain as low as achievable contamination by unreacted diethanolamine. Eisenbrand et al. explained:

Commercially available products from the German market analyzed six to 18 months after the recommendation had been issued showed that only 15 percent were contaminated with [NDEA] or NDHPA.... The overall results of this study demonstrate however, a strong downward trend in both levels and frequency of contamination. They prove that nitrosamine contamination of cosmetics can be minimized by simple preventive measures.49

The European Union has stated specific maximum allowable concentrations of inadvertently formed N-nitrosodialkanolamine. In legislation that was most recently amended in 1993, the European Union asserted that monoalkanolamines and trialkanolamines must be stored in nitrite free containers, cannot be used in nitrosating systems, must have purity of at least 99% and can contain no more than .5% secondary alkanolamine. With regards to N-nitrosodialkanolamine specifically, the maximum content that the EU allows is 50 micrograms per kilogram (50ppb).50 In comparison, U.S. cosmetic levels for NDEA as high as 2,960 parts per billion were reported in 1992.51

Conclusion

There is strong evidence proving: the widespread use of DEA in cosmetics, nitrosation of DEA to form NDEA, contamination of cosmetics with NDEA, the potent carcinogenicity of NDEA, and the availability of alternatives to DEA. The FDA should take prompt action to require labels on all products containing DEA that reads: "Caution -- This product may contain N-nitrosodi-ethanolamine, a known cancer-causing agent."

C. CLAIM FOR CATEGORICAL EXCLUSION

A claim for categorical exclusion is asserted pursuant to 21 CFR 25.24 (a)(11).

D. CERTIFICATION

The undersigned certifies, that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petitioner which are unfavorable to the petition.

This petition is submitted by:
Samuel S. Epstein, M.D.
Michael Deutsch, Esq. Legal Director, Counsel for Constitutional Rights, New York

References

  1. Havery, Donald C. and Chou, Hardy J. "N-Nitrosamines in Cosmetics Product." Cosmetics & Toiletries, 109(5):53, May 1994.
  2. Cosmetics, Toiletries and Fragrance Association. 1996 CIR Compendium, Cosmetic Ingredient Review, Washington, D.C., 1996.
  3. NTP, Seventh annual Report on Carcinogens. U.S. Department of helth and Human Services, Public Health Services, natinal Toxicology Program, National Institute of Environmental Health Sciences, Technical Resources Inc., Rockville, MD 1994.
  4. Eisenbrand, G., M. Blankar, H. Sommer, and B. Weber. "N-Nitrosoalkanolamines in Cosmetics." In: Relevance to Human Cancer of N-nitroso Compounds, tobacco Smoke and Mycotoxins, Ed. I.K. O'Neill, J. Chen and H. Bartsch. International Agency for Research on Cancer , Lyon, 1991.
  5. Havery, Donald C. and Hardy J. Chou. "Nitrosamines in Sunscreens and Cosmetic Products." Nitrosamines and Related N-nitroso Compounds,, ACS Monograph No. 553. Ed. Richard N. Loeppky and Christopher J. Michejda. American Chemical Society, Washington, D.C., 1994.
  6. Cosmetics, Toiletries and Fragrance Association. 1996 CIR Compendium, Cosmetic Ingredient Review, Washington, D.C., 1996.
  7. Keefer, L.K. and P.P. Roller, "N-Nitrosation by nitrite ion in neutral and basic medium." Science 181:1245-1246, 1973.
  8. Archer, M.C. and J.D. Okum. "Kinetics of nitrosamine formation in the presence of micelle-forming surfactants." Journal of the National Cancer Institute 58:409, 1977. (Cited In: National Institutes for Occupational Safety and Health. Draft Criteria for Recommended Standards: Occupational Exposures to Metal Working Fluids. U.S. Department of Health and Human Services, February 19, 1996.)
  9. Davies, R. and D.J. McWeeny. "Catalytic effect of nitrosophenols on N-nitrosamine formation." Nature 266:657-658, 1977. (Cited In: National Institutes for Occupational Safety and Health. Draft Criteria for Recommended Standards: Occupational Exposures to Metal Working Fluids. U.S. Department of Health and Human Services, February 19, 1996).
  10. Challis, B.D., A. Edward, R.R. Hunma, S.A. Kyrtopoulos, and J.R. Outram. "Rapid formation of N-nitrosamines from nitrogen oxides under neutral and alkaline conditions." IARC Scientific Publication, Lyon, France, 19:127, 1978. (Cited In: National Institutes for Occupational Safety and Health. Draft Criteria for Recommended Standards: Occupational Exposures to Metal Working Fluids. U.S. Department of Health and Human Services, February 19, 1996.)
  11. Loeppky, R.N., T.J. Hansen, L.P. Keefer. "Reducing nitrosamine contamination in cutting fluids." Fd. Cosmet. Toxicol. 21(5):607-613, 1983. (Cited In: National Institutes for Occupational Safety and Health. Draft Criteria for Recommended Standards: Occupational Exposures to Metal Working Fluids. U.S. Department of Health and Human Services, February 19, 1996.)
  12. Havery, Donald C. and Hardy J. Chou. "Nitrosamines in Sunscreens and Cosmetic Products." Nitrosamines and Related N-nitroso Compounds, ACS Monograph No. 553, Ed. Richard N. Loeppky and Christopher J. Michejda. American Chemical Society, Washington, D.C. , 1994.
  13. Havery, Donald C. and Hardy J. Chou. "N-Nitrosamines in Cosmetic Products." Cosmetics & Toiletries, 109(5):53, May 1994.
  14. Ibid.
  15. Keefer, L.P. and P.P. Roller, "N-nitrosation by nitrite Ion in Neutral and Basic Medium." Science, 181:1245-46, 1973.
  16. Havery, Donald C. and Hardy J. Chou. "N-Nitrosamines in Cosmetic Products." Cosmetics & Toiletries, 109(5):53, May 1994.
  17. Havery, Donald C. and Hardy J. Chou. "Nitrosamines in Sunscreens and Cosmetic Products." Nitrosamines and Related N-nitroso Compounds,, ACS Monograph No. 553. Ed. Richard N. Loeppky and Christopher J. Michejda. American Chemical Society, Washington, D.C., 1994.
  18. Lijinsky, W., A.M. Losikoff, and E.B. Sansone. Journal of the National Cancer Institute 66:125-127, 1981.
  19. Edwards, G.S., M. Peng, D. J. Fine, B. Spiegelhalder, and J. Kann. "Detection of N-nitroso-diethanolamine in human urine following application of contaminated cosmetics." Toxicol. Lett. 4:217-222, 1979. (Cited In: National Institutes for Occupational Safety and Health. Draft Criteria for Recommended Standards: Occupational Exposures to Metal Working Fluids. U.S. Department of health and Human Services, Feb. 19, 1996).
  20. Preussman, R. "Occurrence and Exposure to N-nitroso Compounds and Precursors." In: N-Nitroso Compounds: Occurrence, Biological Effects and Relevance to Human Cancer. Ed. I.K. O'Neill, R.C. Von Borstel, C.T. Miller, J. Long and H. Bartsch, IARC Scientific publications No. 57, IARC, Lyon, 1984.
  21. Druckrey, H., R. Preussman, S. Ivankovic, and D. Schmahl. Organotrope Carcinogene Wirkungen Bei 65 verschiedenen N-Nitroso-verbindugen an BD-ratten. Z Krebsforsch 69:103-201, 1967. (Cited In: National Institutes for Occupational Safety and Health. Draft Criteria for Recommended Standards: Occupational Expousres to Metal Working Fluids. U.S. Department of Health and Human Services, February 19, 1996.)
  22. Hilfrich, J., I. Schmeltz, and D. Hoffmann. "Effects of N-nitrosodiethanolamine and 1,2-diethanolhydrazine in Syrian golden Hamsters. "Cancer Letters 4:55-60, 1978. (Cited In: National Institutes for Occupational Safety and Health. Draft Criteria for Recommended Standards: Occupational Exposures to metal Working Fluids. U.S. Department of Health and Human Services, February 19, 1996.)
  23. International Agency for Research on Cancer, Monograph on the Evaluation of the Carcinogenic Risk of Chemicals to Humans: Some N-nitroso Compounds 17:77-82, 1978.
  24. Lijinsky, W. M.D. Reuber, and W.B. Manning. "Potent carcinogenicity of nitrosodiethanolamine in rats. " Nature 288:589-590, 1980.
  25. Pour, P. and L. Wallcave. "The carcinogenicity of n-Nitrosodiethanolamine, An Environmental Pollutant, In Syrian Hamsters. " Cancer Letters 14:23-27, 1981.
  26. Preussman,R., M. Habs, H. Habs, and D. Schmahl. "Carcinogenicity of N-Nitrosodiethanolamine in Rats at Five Different Dose Levels. "Cancer Research, 42:5167-5171, 1982.
  27. Lijinsky, W. and M.D. Reuber, "Dose-response study with N-nitrosodiethanolamine in F344 rats." Fd. Cosmet. Toxicol. 22(1):23-26, 1984.
  28. Lijinsky, W. And R.M. Kovatch. "Induction of liver tumor in rats by nitrosodiethanolamine at low doses. " Carcinogenesis 6(12):1679-1681, 1985.
  29. NTP, Seventh Annual Report on Carcinogens. U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program, National Institute of Environmental Health Sciences, Technical Resources Inc., Rockville, MD., 1994.
  30. International Agency for Research on Cancer, Monograph on the Evaluation of the Carcinogenic Risk of Chemicals to Humans: Some N-nitroso Compounds 17:77-82, 1978.
  31. NTP, Seventh Annual Report on Carcinogens. U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program, National Institute of Environmental Health Sciences, Technical Resources Inc., Rockville, MD., 1994.
  32. Lijinsky, William. Chemistry and Biology of N-nitroso Compounds. Cambridge University Press, New York, 1992.
  33. International Agency for Research on Cancer, Monograph on the Evaluation of the Carcinogenic Risk of Chemicals to Humans: Some N-nitroso Compounds 17:77-82, 1978.
  34. NIOSH. "Nitrosamines in Cutting Fluids." Current Intelligence Bulletin, October 6, 1976.
  35. NIOSH. Draft Criteria for Recommended Standards: Occupational Exposures to Metal Working Fluids, U.S. Department of Health and Human Services, Public Health Service, Center for Disease Control and Prevention, National Institute for Occupational Safety and Health, Division of Standards Development and Technology Transfer. February 19, 1996.
  36. Havery, Donald C. and Hardy J. Chou. "N-Nitrosamines in Cosmetics Products." Cosmetics & Toiletries, 109(5):53, May 1994.
  37. Ibid.
  38. Kabacoff, B.L., R. J. Lechnir, S.F. Vielhuber, and M.L. Douglass. "Formation and Inhibition of N-nitrosodiethanolamine in Anionic Oil-Water Emulsion." ACS Monograph. American Chemical Society, 1981.
  39. Havery, Donald C. and Hardy J. Chou. "N-Nitrosamines in Cosmetic Products." Cosmetics & Toiletries, 109(5):53, May 1994.
  40. Kabacoff, B.L., R. J. Lechnir, S.F. Vielhuber, and M.L. Douglass. "Formation and Inhibition of N-nitrosodiethanolamine in Anionic Oil-Water Emulsion." ACS Monograph. American Chemical Society, 1981.
  41. Havery, Donald C. and Hardy J. Chou. "N-Nitrosamines in Cosmetic Products." Cosmetics & Toiletries, 109(5):53, May 1994.
  42. Ibid.
  43. Havery, Donald C. and Hardy J. Chou. "Nitrosamines in Sunscreens and Cosmetic Products." Nitrosamines and Related N-nitroso Compounds,, ACS Monograph No. 553. Ed. Richard N. Loeppky and Christopher J. Michejda. American Chemical Society, Washington, D.C., 1994.
  44. Cosmetics, Toiletries and Fragrance Association. 1996 CIR Compendium, Cosmetic Ingredient Review, Washington, D.C., 1996.
  45. Hampton, Aubrey. Personal Communication, May 30, 1996.
  46. NIOSH. "Nitrosamines in Cutting Fluids." Current Intelligence Bulletin, October 6, 1976.
  47. NIOSH. Draft Criteria for Recommended Standards: Occupational Exposures to Metal Working Fluids, U.S. Department of Health and Human Services, Public Health Service, Center for Disease Control and Prevention, National Institute for Occupational Safety and Health, Division of Standards Development and Technology Transfer. February 19, 1996.
  48. Eisenbrand, G., M. Blankar, H. Sommer, and B. Weber. "N-Nitrosoalkanolamines in Cosmetics." In: Relevance to Human Cancer of N-nitroso Compounds, Tobacco Smoke and Mycotoxins, Ed. I.K. O'Neill, J. Chen and H. Bartsch. International Agency for Research on Cancer , Lyon, 1991.
  49. Ibid.
  50. Council Directive of 27 July 1976, on the approximation of the Laws of the Member States Relating to Cosmetic Products (DIR. 76/768/EEC. DIR. Amendment 93/35/EC).
  51. Havery, Donald C. and Hardy J. Chou. "Nitrosamines in Sunscreens and Cosmetic Products." Nitrosamines and Related N-nitroso Compounds, ACS Monograph No. 553, Ed. Richard N. Loeppky and Christopher J. Michejda. American Chemical Society, Washington, D.C. , 1994.

FDA Response (February 13, 1997).

FDA has not been able to reach a decision because of "the limited availability of resources and other agency priorities."


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