Decision Sheets

December 2006

NOSB COMMITTEE RECOMMENDATION

Form NOPLIST1. Committee Transmittal to NOSB

For NOSB Meeting: __Fall 2011 Substance: _ Arachidonic acid single-cell oil (ARA)

_______________________________________

Committee: Crops • Livestock • Handling X Petition is for:__Inclusion on the National List 7CFR § 205.605(a)

A. Evaluation Criteria (Applicability noted for each category; Documentation attached) Criteria Satisfied? (see B below) 

1. Impact on Humans and Environment Yes X No • N/A •

2. Essential & Availability Criteria Yes X No • N/A •

3. Compatibility & Consistency Yes X No • N/A •

4. Commercial Supply is Fragile or Potentially Unavailable as Organic (only for 606) Yes • No • N/A X 

B. Substance Fails Criteria Category: _________ Comments: ___________________________________________________ 

________________________________________________________________________________________________________

C. Proposed Annotation (if any): _____________________________________________________________________________

________________________________________________________________________________________________________

 Basis for annotation: To meet criteria above: _______ Other regulatory criteria: _______ Citation:______________________

D. Recommended Committee Action & Vote (State Actual Motion): ____Approve as 

Motion is list the material as a non-synthetic, designating the material for §205.605(a)

Motion by: _Tracy MIedema______________ Seconded:_Steve DeMuri_______________ Yes: 6_____ No: _0____ 

Absent: __1_____ Abstain: ___0__ 

 Motion is to list the petitioned material Arachidonic acid single-cell oil (ARA) on the National List 7 CFR, §205.605(a) 

as Arachidonic acid single-cell oil (ARA)

Motion by: _Tracy Miedema______________ Seconded:___Steve DeMuri_____________ Yes: ___6__ No: __0___ 

Absent: __1_____ Abstain: __0___ 

 

 

1) Substance voted to be added as “allowed” on National List to § 205. with Annotation (if any) ______________________

________________________________________________________________________________________________________

2) Substance to be added as “prohibited” on National List to § 205. with Annotation (if any) _________________________

________________________________________________________________________________________________________

Describe why a prohibited substance:__________________________________________________________________________

________________________________________________________________________________________________________ 

 

3) Substance was rejected by vote for amending National List to § 205. _____ Describe why material was rejected:___________ 

________________________________________________________________________________________________________

4) Substance was recommended to be deferred because ___________________________________________________________

_____________________________________________________________________________ If follow-up needed, who will 

follow up ________________________________________________________________________________________________

Crops Agricultural Allowed1 X

Livestock Non-Synthetic X Prohibited2 

Handling X Synthetic Rejected3

No restriction 

Commercially UnAvailable as Organic1

 

Deferred4
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December 2006

E. Approved by Committee Chair to transmit to NOSB:

Steve DeMuri__________________________________ October 7, 2011

 Committee Chair Date
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December 2006

NOSB EVALUATION CRITERIA FOR SUBSTANCES ADDED TO THE NATIONAL LIST

Category 1. Adverse impacts on humans or the environment? Substance Arachidonic acid single-cell oil 

(ARA)

Question Yes No N/A1 Documentation

(TAP; petition; regulatory agency; other)

1. Are there adverse effects on 

environment from manufacture, 

use, or disposal?1

[§205.600 b.2]

x The TR concluded that the petitioned substance, ARA Singlecell Oil, is produced primarily by a “non-genetically-modified

soil fungus Mortierella alpina,” and that the fungus is safe for 

consumption by humans and other life. See TR at lines 204-

205 (fungus “not believed to cause disease in humans and 

biota.”) 

The TR described the production, extraction and purification 

method of the natural oil. See TR lines 212-256. The TR 

noted that the post-extraction and purification processes 

“remove any extraction and purification solvents from the oil,” 

see TR at lines 270-73, and concluded that the removed 

solvents are typically “recycled and reused.” See TR at 271-2 

Any other impurities such as “trace metals, and oxidation 

products” are “removed physically through filtration or 

addition of adsorbents” See TR at lines 249-50 

Lastly, the TR stated at 273: “No residual hexane from the 

extraction process has been detected in samples of ARA 

Single-cell Oil using methods with detection limits of 0.3 ppm 

.” The TR also cited a single Swiss study that tested more 

than 40 non-organic vegetable oils that used a similar 

extraction technology for hexane residues and concluded that 

less than 13% had any detectable residue and the level was 

“below acceptable tolerances.” See TR at line 237

See also Question 2 below

2. Is there environmental 

contamination during manufacture, 

use, misuse, or disposal? [§6518 

(m)(3)]

x The TR concluded that the petitioned substance is produced 

under completely controlled conditions--“aerobic fermentation 

of the fungus in shake flasks containing a growth medium.” 

See generally TR line212; see also generally TR lines 204-256 

(describing inputs, manufacturing process and waste 

byproducts) Because the fungus is grown in a controlled 

environment, there appear to be no environmental issues 

arising from the process. see also lines 407-409 (noting FDA 

GRAS notice reported no heavy metals or pesticides detected 

in petitioned substance)

3. Is the substance harmful to the 

environment?

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

x See Question 2 above, citing TR lines 204-256; see also TR at 

lines 204-205 (fungus “not believed to cause disease in 

humans and biota.”)

4. Does the substance contain List 

1, 2, or 3 inerts? 

[§6517 c (1)(B)(ii); 205.601(m)2]

x This is a substance used as an ingredient in an organic 

processed food. It is not used in production and contains no 

listed inerts.

 

1The criteria set forth in 7 CFR §205.600(b) are applicable solely to “synthetic substances used as a processing aid 

or adjuvant.” The petitioned substance is not a processing aid or adjuvant. See TR at line 90-94 The TR 

determined the petitioned substance be a non-synthetic. See TR at line 286 (“ARA Single-cell Oil does not appear 

to be a synthetic substance.”) Accordingly, the criteria listed in §205.600(b) are inapplicable to the petitioned 

substance. See e.g. 7 CFR §205.600(c)(“Non-synthetics...will be evaluated using the criteria [in the OFPA].”) 

However, the TR included review of most of these questions so the results are cited out of an abundance of caution.
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December 2006

5. Is there potential for detrimental 

chemical interaction with other 

materials used?

[§6518 m.1]

x The substance is used as an ingredient in an organic processed 

food. No detrimental interactions were noted in the TR. See 

TR lines 123-145 (discussing combinations with substances in 

formulations); see also TR at lines 204-205 (fungus “not 

believed to cause disease in humans and biota.”)

6. Are there adverse biological and 

chemical interactions in agroecosystem? [§6518 m.5]

x This is a substance used as an ingredient in an organic 

processed food. It is no longer in the agro-ecosystem. See also 

TR at lines 204-205 (fungus “not believed to cause disease in 

humans and biota.”)

7. Are there detrimental 

physiological effects on soil 

organisms, crops, or livestock? 

[§6518 m.5]

x This is a substance used as an ingredient in an organic 

processed food. It is no longer in the agro-ecosystem. See also 

TR at lines 204-205 (fungus “not believed to cause disease in 

humans and biota.”)

8. Is there a toxic or other adverse 

action of the material or its 

breakdown products? 

[§6518 m.2]

x This is a substance used as an ingredient in an organic 

processed food. It is no longer in the agro-ecosystem. See also 

TR at lines 204-205 (fungus “not believed to cause disease in 

humans and biota.”)

9. Is there undesirable persistence 

or concentration of the material or 

breakdown products in 

environment?[§6518 m.2]

x This is a substance used as an ingredient in an organic 

processed food. It is no longer in the agro-ecosystem. See also 

TR at lines 204-205 (fungus “not believed to cause disease in 

humans and biota.”)

10. Is there any harmful effect on 

human health? 

[§6517 c (1)(A)(i) ; 6517 c(2)(A)i; 

§6518 m.4]

x The Safety of the Fungus: The TR concluded that the 

scientific literature regarding the fungus from which the oil is 

extracted discloses that there is no reason to believe that any 

harm to humans or other life will occur. See TR at lines 204-

205 

Health Benefits from Consumption: With regard to the 

health of those that consume the petitioned substance, the TR 

concluded: “Research suggests that a balance of ARA and 

DHA are necessary to the normal growth and development of 

infants.” See TR at lines 126-27 The TR also noted that many 

studies have reported “statistically significant improvements 

to retinal maturation, visual acuity, and cognitive function” 

while one study cited “reported no benefit.” See TR at lines 

418-32 The TR appears to conclude the vast body of evidence 

of health benefits far outweighed the single study that found 

no measurable benefit. 

The TR also cited the World Health Organization (“WHO”) 

recommendation that “ARA should be supplied in the diets of 

infants aged 0–6 months” and noted the Institute of Medicine 

has established intake levels for infants aged 0–6 months and 

small children. See TR at lines, 593-596

Safety Analysis

“ARA Single-cell Oil is generally recognized as safe for 

human consumption, even in vulnerable infant populations.” 

See TR at lines, 496-97 The TR cited the “most recent safety 

assessment of ARA Single-cell Oil” in the scientific literature,

TR at lines 448-52, and summarized its findings: “All results 

of the genotoxicity assays were negative” and “No adverse 

effects attributed to consumption of the ARA Single-cell Oil 

were observed even at the highest dose” which in the study 

was “29-times higher than the anticipated intake” for term 

infants. See also TR at lines 459-62 (noting that Australia and 

New Zealand “reviewed the toxicological database for ARA 

Single-cell Oil and determined that ARA Single-cell oil did 
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December 2006

not induce any histopathological, biochemical, or 

hematological changes that would be indicative of toxicity” at 

doses far higher than allowed for infant formula.) 

With regard to the safety of the consumption of the petitioned 

substance by infants (the extracted ARA) the TR at lines 430-

32, stated: “Despite mixed results on many of the purported 

benefits of ARA supplementation in infant formula, adverse 

effects in infants fed formulas enriched with ARA/DHA have 

not been observed in randomized trials for up to one year.” 

The TR noted that a now ten year old from 2001 study 

reported incidents of “flatulence, diarrhea, apnea, and jaundice 

in infants that were fed formulas with long-chain PUFA.” TR 

at lines 438-9 However, the TR did not did attribute these 

common infant ailments to any particular infant formula 

ingredient. To the extent these common infant ailments have 

been reported to FDA as “adverse events” arising from infant 

formula consumption, FDA’s review has apparently concluded 

the events are de minimis in light of the nearly universal 

consumption of infant formula, and thus below the threshold 

of regulatory action. 

Excessive Consumption

The TR cited one study that examined “the effect of increasing 

dietary ARA seven-fold” and concluded, “no effects on 

platelet aggregation, bleeding times, balance of vasoactive 

metabolites, serum lipid levels, or immune response were 

observed” TR at lines 438-9 In addition, after review of a 

meta-analysis of 25 case-control studies evaluating a variety 

of effects, the TR concluded: “No effects in humans at high 

ARA doses were identified.” See TR at lines 438-9 

Absence of Contaminants

The TR accepted the data provided by Petitioner that was also 

provided to the FDA and concluded: “No residues of heavy 

metals or other contaminants have been reported in ARA 

Single-cell Oils at levels higher than FDA tolerances.” See TR 

at lines 378-9 The TR also accepted as unrebutted by other 

literature the finding that no solvent used in processing the 

ARA oil was detectable in the final product, and that the sole 

study in the scientific literature that tested more than 40 

conventional (non-organic) vegetable oils for residues from 

processing solvents found no residue at an actionable level. 

See TR at lines 386-90

Global Regulatory Treatment on Safety

Because organic authorities do not assess food safety 

generally, the TR surveyed a few jurisdictions to assess the 

regulatory treatment by agencies charged with safety 

evaluations. Of course, the TR noted that the substance is 

recognized as GRAS in the U.S. See e.g. TR at lines 90-92 

(petitioned substance is GRAS); TR, at lines 616-17 (noting 

one GRAS petition that cited 5 safety studies) 
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December 2006

The petitioned substance has been evaluated from a safety 

perspective by several countries and multi-lateral institutions. 

See e.g. TR at lines, 459 (citing Australia and New Zealand). 

In particular, the TR noted that in Canada approved the 

petitioned substance “after assessing the toxicology, 

chemistry, microbiology, and nutrition of ARASCO®as a 

food ingredient.” See TR at lines 185-89 Other regulatory 

approvals for the petitioned substance for use in infant formula 

include, Australia, New Zealand, China, France, and the 

Netherlands—of note also, the European Union similarly 

allows “ARA Single-cell Oil from M. alpina" in infant 

formula. See TR at lines 190-93 Lastly, the TR noted that the 

petitioned substance would fall under Codex’s general rule for 

food grade oils that allows their use provided they are free of 

prohibited additives like coloring agents etc. See TR at lines 

197-98 

In the United States, ARA Single-cell Oil is proposed for 

addition to infant formula and other organic food products. 

See TR at lines 141-143 ARA has not currently been 

petitioned for GRAS designation as an addition to food items 

other than infant formula. See TR at lines, 573-4

11. Is there an adverse effect on 

human health as defined by 

applicable Federal regulations? 

[205.600 b.3]

x The TR concluded that there is no adverse human health 

impact under federal regulations. “ARA Single-cell Oil is 

considered by FDA as GRAS in infant formula when used in 

combination with docosahexaenoic acid (DHA).” See TR at 

lines 90-92 Also, “ARA Single-cell Oil is generally 

recognized as safe for human consumption, even in vulnerable 

infant populations.” See e.g. TR at lines, 496-97ARA is 

presently allowed for use solely in infant formula and 

growing-up milks. See TR at lines, 650-51. 

The TR plainly stated that the state of the science is that, 

“adverse effects in infants fed formulas enriched with 

ARA/DHA have not been observed in randomized trials for up 

to one year.” See TR at lines, 431-32

12. Is the substance GRAS when 

used according to FDA’s good 

manufacturing practices? [§205.600 

b.5]

x The TR concluded: “ARA Single-cell Oil is characterized as 

GRAS under three different names submitted by four different 

applicants” See TR at lines 332-36 (citing Martek Biosciences 

(GRN No. 41), Mead Johnson Nutritionals (GRN No. 80), 

Abbott Laboratories (GRN No. 94), and Cargill, Inc. (GRN 

No. 326)) when used in term and preterm infant formula 

along with GRAS concentrations of DHA. 

In addition to GRAS status, when ARA oil appears as an 

ingredient in infant formulas, the manufacturers submit 

premarket notification to FDA under section 412 of the 

Federal Food, Drug, and Cosmetic Act (FFDCA). Section 412 

of FFDCA describes the more stringent statutory requirements 

that apply to infant formula as compared to the regulation of 

other foods (FDA, 2006)

13. Does the substance contain 

residues of heavy metals or other 

contaminants in excess of FDA 

tolerances? [§205.600 b.5]

x The TR described the production, extraction and purification 

method of the natural oil. See TR lines 212-256. The TR 

noted that the post-extraction and purification processes 

“remove any extraction and purification solvents from the oil,” 

see TR at lines 270-73, and concluded that the removed 
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December 2006

solvents are typically “recycled and reused.” See TR at 271-2 

Any other impurities such as “trace metals, and oxidation 

products” are “removed physically through filtration or 

addition of adsorbents” See TR at lines 249-50 

Lastly, the TR cited Petitioner’s evidence at line 273: “No 

residual hexane from the extraction process has been detected 

in samples of ARA Single-cell Oil using methods with 

detection limits of 0.3 ppm.” The TR also cited a single Swiss 

study that tested more than 40 non-organic vegetable oils that 

used a similar extraction technology for hexane residues and 

concluded that less than 13% had any detectable residue and 

the level was “below acceptable tolerances.” See TR at line 

237

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—not applicable.
Decision Sheets

December 2006

Category 2. Is the Substance Essential for Organic Production? Substance Arachidonic acid single-cell oil 

(ARA)

Question Yes No N/A1 Documentation

(TAP; petition; regulatory agency; other)

1. Is the substance formulated or 

manufactured by a chemical 

process? [6502 (21)]

x The TR concluded the fungus from which the petitioned 

substance is isolated is “produced naturally via fermentation”

line 260-63, but the extraction process typically involves a 

“nonpolar solvent.” See TR at 263 (“ARA Single-cell Oil is 

produced naturally via fermentation of M. alpina and some 

other single-celled organisms. However, to extract the ARA 

Single-cell Oil from the fungus, a nonpolar solvent (usually 

hexane) is used.”) See TR at 260-63

2. Is the substance formulated or 

manufactured by a process that 

chemically changes a substance 

extracted from naturally occurring 

plant, animal, or mineral, sources? 

[6502 (21)]

x The TR concluded that the petitioned substance is a nonsynthetic. See TR at line 286 (“ARA Single-cell Oil does not 

appear to be a synthetic substance.”); see also TR at lines 274-

78 (Applying National Organic Standards Board (NOSB) 

Joint Materials and Handling Committee draft policy: 

“extraction with a synthetic not on the National List would not 

result in a material being classified as synthetic unless either 

the extraction resulted in chemical change or the synthetic 

remained in the final material at a significant level”(NOSB, 

2010).”)

3. Is the substance created by 

naturally occurring biological 

processes? [6502 (21)]

x The TR concluded that the petitioned substance is the product 

of a biological process. See TR lines 260-63

4. Is there a natural source of the 

substance? [§205.600 b.1]

x ARA is present in foods, but for use in infant formula, or as a 

supplemental micronutrient in adult food products, the ARA 

must be extracted by a chemical process. See TR lines 221-

240 (noting extraction methodologies). “Chicken and eggs are 

the primary sources of ARA in the U.S. diet.” TR at lines, 

660-61.

5. Is there an organic substitute? 

[§205.600 b.1]

There are no known certified organic sources of the extracted 

ARA oil. See TR lines 466-80 (citing no certified source of 

ARA oil)

The TR noted that fish oil is not an acceptable substitute 

because (a) “fish oil is not an organic agricultural product per 

se” and (b) “[f]ish oil does not contain high levels of preformed ARA” thus it must be “supplemented with another 

source of ARA (e.g., egg phospholipid or ARA Single-cell 

Oil) to achieve a fatty acid profile for optimal nutrition” and 

(c) “fish oil contains high levels of EPA, which can result in 

adverse effects on growth of pre-term infants even at low 

concentrations.” See TR at lines, 475-80 

The TR noted that using organic eggs as an ARA source is 

generally not commercially feasible because achieving an egg 

with sufficient phospholipids requires “feeding chickens the 

biomass of ARA-producing fungus.” See TR at lines, 468-72 

The TR also noted this approach is generally considered 

“wasteful of resources because ARA contents in egg 

phospholipids are relatively low and most of the egg is often 

discarded after phospholipid extraction.” (internal citations

omitted) See TR at lines, 303-07. Based on the TR, the 

necessary chicken feed would not be organic because ARA 
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December 2006

producing fungus would have to be added to complete its 

nutrient profile and it is not an organic material at this time. 

6. Is the substance essential for 

handling of organically produced 

agricultural products? [§205.600 

b.6]

x

 

The petitioned substance is unique because it is the only plantbased source of ARA currently available and is the most 

widely used ARA source in conventional and organic infant 

formulas. See e.g. TR at lines, 468-69 (“There are three main 

sources of ARA ...for supplementing infant formula: ARA 

Single-cell Oil, fish oil, and egg phospholipids.”) Unlike 

animal sources, such as eggs or animal flesh, ARA from 

fungal oil is vegetarian, carries no risk of containing harmful 

environmental contaminants that an animal may ingest, see TR 

at line 212 (noting fungus is grown in flasks) and there is no 

literature suggesting this production methodology adversely 

impacts biodiversity. See TR at lines 394-95 (“No information 

was found on the effect of ARA Single-cell Oil on the 

environment or biodiversity”)

7. Is there a wholly natural 

substitute product? 

[§6517 c (1)(A)(ii)]

x The TR concluded that there are “Three main sources of ARA 

...for supplementing infant formula: ARA Single-cell Oil, fish 

oil, and egg phospholipids.” See TR at lines, 468-69 The 

petitioned substance is the only plant-based source of ARA. 

Id. non-synthetic, non-agricultural substance under 

205.605(a). See TR 286 (“ARA Single-cell Oil does not 

appear to be a synthetic substance.”) There is no plant-based 

agricultural substitute for the petitioned substance. TR at 

lines, 657-665 (discussing common sources); TR at lines, 666 

(noting “ eggs, poultry, beef, some fish” are principle ARA 

sources.)

8. Is the substance used in 

handling, not synthetic, but not 

organically produced? 

[§6517 c (1)(B)(iii)]

x The TR concluded the substance is a non-synthetic, nonagricultural substance. See TR 286 (“ARA Single-cell Oil 

does not appear to be a synthetic substance.”)

9. Is there any alternative to using 

the petitioned substance in terms 

of practices or other available 

materials? [§6518(m)(6)]

 x According to the TR, there are no other plant-based sources of 

ARA, thus there is no vegetarian alternative to the petitioned 

substance. TR at lines, 657-665 (discussing common 

sources); TR at lines, 666 (noting “ eggs, poultry, beef, some 

fish” are principle ARA sources in adult diet.) For infants, the 

adult sources are not alternatives. See also Question 7

10. Is there an “alternative[s] to 

using the substance in terms of 

practices” that would make the 

substance unnecessary? [§6518 

(m)(6)] 

x The petitioned substance is a food additive and there are no 

“practices” that substitute for its presence.

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—not applicable.
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December 2006

Category 3. Is the substance compatible with organic production practices? Substance Arachidonic acid singlecell oil (ARA)

Question Yes No N/A1 Documentation

(TAP; petition; regulatory agency; other)

1. Is the substance compatible 

with organic handling? [§205.600 

b.2]

x The petitioned substance is not the product of an excluded 

method and is a non-synthetic according to the TR.

2. Is the substance consistent with 

organic farming and handling? 

[§6517 c (1)(A)(iii); 6517 c 

(2)(A)(ii)]

x

3. Is the substance compatible 

with a system of sustainable 

agriculture? [§6518 m.7]

x

4. Is the nutritional quality of the 

food maintained with the 

substance? [§205.600 b.3]

x The petitioned use of ARA Single-cell Oil is as a nutritional 

food ingredient added to infant formulas. ARA Single-cell Oil 

is added to infant formula to increase free ARA levels in 

formula to those comparable to ARA levels in human breast 

milk. TR at lines, 37-40

5. Is the primary use as a 

preservative? [§205.600 b.4]

x TR at lines, 37-40

6. Is the primary use to recreate or 

improve flavors, colors, textures, 

or nutritive values lost in 

processing (except when required 

by law, e.g., vitamin D in milk)? 

[205.600 b.4]

x TR at lines, 37-40

7. Is the substance used in 

production, and does it contain an 

active synthetic ingredient in the 

following categories:

a. copper and sulfur compounds;

x The petitioned substance is not used in production.

b. toxins derived from bacteria; x The petitioned substance is not used in production.

c. pheromones, soaps, 

horticultural oils, fish emulsions, 

treated seed, vitamins and 

minerals?

x The petitioned substance is not used in production.

d. livestock parasiticides and 

medicines?

x The petitioned substance is not used in production.

e. production aids including 

netting, tree wraps and seals, 

insect traps, sticky barriers, row 

covers, and equipment cleaners?

x The petitioned substance is not used in production.

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—not applicable.
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December 2006

Category 4. Is the commercial supply of an agricultural substance as organic, fragile or potentially 

unavailable? [§6610, 6518, 6519, 205.2, 205.105 (d), 205.600 (c) 205.2, 205.105 (d), 205.600 (c)] 

Substance Arachidonic acid single-cell oil (ARA)

Question Yes No N/A Comments on Information Provided (sufficient, 

plausible, reasonable, thorough, complete, unknown)

1. Is the comparative description 

provided as to why the non-organic 

form of the material /substance is 

necessary for use in organic handling? 

 x The substance is not petitioned for inclusion on 7 CFR 

§205.606

2. Does the current and historical 

industry information, research, or 

evidence provided explain how or why 

the material /substance cannot be 

obtained organically in the appropriate 

form to fulfill an essential function in 

a system of organic handling? 

x

3. Does the current and historical 

industry information, research, or 

evidence provided explain how or why 

the material /substance cannot be 

obtained organically in the appropriate 

quality to fulfill an essential function 

in a system of organic handling? 

x

4. Does the current and historical 

industry information, research, or 

evidence provided explain how or why 

the material /substance cannot be 

obtained organically in the appropriate 

quantity to fulfill an essential 

function in a system of organic 

handling?

x

5. Does the industry information 

provided on material / substance nonavailability as organic, include ( but 

not limited to) the following:

a. Regions of production (including 

factors such as climate and number of 

regions);

x

b. Number of suppliers and amount 

produced;

x

c. Current and historical supplies 

related to weather events such as 

hurricanes, floods, and droughts that 

may temporarily halt production or 

destroy crops or supplies; 

x

d. Trade-related issues such as 

evidence of hoarding, war, trade 

barriers, or civil unrest that may 

temporarily restrict supplies; or

x
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December 2006

e. Are there other issues which may 

present a challenge to a consistent 

supply?

x