Crops: BiodegradableMulchFilm

National Organic Standards Board

Crops Subcommittee

Petitioned Material Proposal

Biodegradable Mulch Film Made from Bioplastics

August 15, 2012

Introduction

A petition was submitted requesting the addition of biodegradable biobased bioplastic mulch to 

section 205.601(h) of the National List. This petition involves definitions of new substances, 

which the subcommittee recommends be incorporated into the listing. The subcommittee 

explicitly seeks public comment on the definitions and possible restrictions on use.

Background

Biodegradable mulch film made from bioplastics is petitioned to section 205.601 of the 

National List for use in organic crop production. This is an alternative to petroleum-based 

plastic mulches that do not completely biodegrade. Over the past 50 years much research and 

development has gone into developing biodegradable mulches which are the subject of this 

petition. As product development has been underway, removal and disposal of polyethylene 

plastic mulches has become increasingly difficult because its removal is time-consuming, 

delays cover cropping and must largely be sent to landfills. The OFPA requires the removal of 

plastic mulches at the end of the growing or harvest season (7 U.S.C. 6508). 

The petitioner argues that OFPA’s mention of plastic was not intended to refer to 

biodegradable mulch film. Biodegradable mulch is intended to biodegrade by the end of the 

season or prior to the beginning of the following season. This distinction leads us to question 

whether the approval of the petition would require a rule change to allow the mulch to 

biodegrade in the field or whether the two substances should be treated as separate and

distinct. However, bioplastics are defined in terms of “plastics,” according to the petitioner, 

“Biodegradable Plastic Mulch is defined as plastic mulching material that meets both of the 

following requirements.” Furthermore, bioplastics fit the definition of plastic, “Any of various 

organic compounds produced by polymerization, capable of being molded, extruded, cast into 

various shapes and films, or drawn into filaments used as textile fibers.” (American Heritage 

Dictionary) The petition defines biodegradable mulch film as mulching materials that:

1) meet the requirements of ASTM International (formerly American Society for Texting 

and Materials) Standard D6400 or D6868 specifications, or of other international 

standard specifications with essentially identical criteria, i.e. EN 13432, EN 14995, 

ISO 17088; and

2) show at least 90% biodegradation absolute or relative to microcrystalline cellulose2 

in less than two years, in soil, tested according to ISO 17556 or ASTM 5988.

Additionally, the petitioner suggests that the reference to “fully biodegradable” in section 

205.206(c)(1) be defined when referencing bioplastic degradation in soil. Full biodegradation is 

covered under several standards which discuss the compostability of the petitioned product. 

These include, American Society for Testing and Materials (ASTM) Standard D5988 

(biodegradability of bioplastic in soil), ASTM Standard D6400 (biodegradability of bioplastic in 

compost), and ASTM Standard D6868 (biodegradability of bioplastic specifications). The 
Revised March 2012

ASTM definition of “biodegradable plastic” is, “a degradable plastic in which the degradation 

results from the action of naturally occurring microorganisms such as bacteria, fungi, and 

algae.”

The petition further clarifies, that according to the European Bioplastics’ definition, bioplastics 

are biobased, biodegradable, or both. The ASTM definition of “biobased material” is “organic 

material in which carbon is derived from a renewable resource via biological processes. 

Biobased materials include all plant and animal mass derived from carbon dioxide recently 

fixed via photosynthesis, per definition of a renewable resource.” Biobased materials are 

certified using the ASTM D6866 method, which certifies the biologically derived content of 

bioplastics. 

The petition provides the following description: biodegradable films are produced from 

bioplastics that meet standards for aerobic biodegradation in soil. These bioplastics are 

comprised of structural units which may be easily broken down into carbon substrates by soil 

microorganisms. Under aerobic conditions, these microorganisms are able to utilize the carbon 

substrates as a food source. This metabolism of the carbon substrates ultimately results in two 

simple compounds – carbon dioxide and water.

Relevant areas in the Rule

OFPA §6508 (c) says

For a farm to be certified under this chapter, producers on such farm shall not -

...(2) use plastic mulches, unless such mulches are removed at the end of each 

growing or harvest season;

The regulations provide at §205.206(c) that 

Weed problems may be controlled through:

... (6) Plastic or other synthetic mulches: Provided, That, they are removed from the 

field at the end of the growing or harvest season.

And the National List includes at §205.601(b)(2)

Mulches.

...(ii) Plastic mulch and covers (petroleum-based other than polyvinyl chloride (PVC)).

Discussion

Neither conventional plastic mulch nor biodegradable bioplastic mulch can perform all of the 

functions—particularly, feeding the soil—that organic mulches perform. However, there are 

times—such as when cold soil is a problem—when the qualities of plastic or bioplastic have 

been viewed as necessary. As always, it is our understanding that the use of synthetic mulch 

products will be limited to those circumstances when natural organic mulches are inappropriate 

or impossible to use. When this is the case, it makes sense to use a material that degrades in 

place rather than one that is removed and taken to a landfill. On the other hand, the 

subcommittee believes that it may be difficult to separate claims from truth concerning 

biodegradability and the source of the material. In addition, the subcommittee would like to 

make a robust recommendation that correctly describes biodegradable biobased bioplastic 

mulches that meet the three criteria above. According to the European Bioplastics definition, 

bioplastics are biobased, biodegradable, or both. The committee intends this recommendation 

to cover those bioplastics that are both biobased and biodegradable.
Revised March 2012

The subcommittee understands the importance of a definition, which it is proposing, and is 

particularly interested in public comment on the biobased classification and the ASTM 

standard. Meeting this standard, however, does not automatically ensure that the mulch will be 

“removed from the field at the end of each growing or harvest season.” This removal may 

require steps like tilling the film into the ground. The subcommittee therefore proposes the 

annotation that growers take appropriate actions to guarantee that the mulch decomposes 

within the appropriate time frame.

Evaluation Criteria 

(Applicability noted for each category; Documentation attached) Criteria Satisfied? (see 

“B” below)

1. Impact on Humans and Environment ☒ Yes ☐ No ☐ N/A 

2. Essential & Availability Criteria ☒ Yes ☐ No ☐ N/A

3. Compatibility & Consistency ☒ Yes ☐ No ☐ N/A 

4. Commercial Supply is Fragile or Potentially Unavailable ☐ Yes ☐ No ☒ N/A 

as Organic (only for § 205.606)

Substance Fails Criteria Category: [ ] Comments:

Proposed Annotation:

List on §205.601(b)(2) Mulches: (iii) Biodegradable biobased bioplastic mulch meeting the 

following criteria: (A) Completely biodegradable as shown by: 1) meeting the requirements of 

ASTM Standard D6400 or D6868 specifications, or of other international standard 

specifications with essentially identical criteria, i.e. EN 13432, EN 14995, ISO 17088; and 2) 

showing at least 90% biodegradation absolute or relative to microcrystalline cellulose in less 

than two years, in soil, tested according to ISO 17556 or ASTM 5988; (B) Biobased certified 

using the ASTM D6866 method; (C) Must be produced without excluded methods; (D) Must be 

produced without engineered nanomaterials; and (E) Grower must take appropriate actions to 

ensure complete degradation at the end of each growing or harvest season.

Basis for annotation: ☒ To meet criteria above ☒ Other regulatory criteria ☐ Citation 

Notes: Annotation is necessary to meet the requirements of OFPA §6508(c).

Recommended Subcommittee Action & Vote, including classification recommendation 

(state actual motion):

Classification Motion: 

Biodegradable Mulch Film Made from Bioplastics is synthetic.

Motion by: Colehour Bondera Seconded by: Jay Feldman

Yes__8___ No__0__ Abstain__0__ Recuse__0__ Absent__0__

Listing Motion:

To list on §205.601(b)(2) Mulches: (iii) Biodegradable biobased bioplastic mulch meeting 

the following criteria: (A) Completely biodegradable as shown by: 1) meeting the 

requirements of ASTM Standard D6400 or D6868 specifications, or of other international 

standard specifications with essentially identical criteria, i.e. EN 13432, EN 14995, ISO 

17088; and 2) showing at least 90% biodegradation absolute or relative to microcrystalline 
Revised March 2012

cellulose in less than two years, in soil, tested according to ISO 17556 or ASTM 5988; (B) 

Biobased certified using the ASTM D6866 method; (C) Must be produced without excluded 

methods; (D) Must be produced without engineered nanomaterials; and (E) Grower must 

take appropriate actions to ensure complete degradation at the end of each growing or 

harvest season.

Motion by: Colehour Bondera Seconded by: Barry Flamm

Yes__7___ No__0__ Abstain__1__ Recuse__0__ Absent__0__

Crops ☒ Agricultural ☐ Allowed1 ☐

Livestock ☐ Non-synthetic ☐ Prohibited2 ☐

Handling ☐ Synthetic ☒ Rejected3 ☐

No restriction ☐ Commercial unavailable as 

organic

☐ Deferred4 ☐

1

Substance voted to be added as “allowed” on National List to § 20 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: 

Approved by Subcommittee Chair to Transmit to NOSB

Jay Feldman, Subcommittee Chair August 15, 2012

NOSB Evaluation Criteria for Substances Added To the National List

Category 1. Adverse impacts on humans or the environment? Substance: Biodegradable

Mulch Film Made from Bioplastics

Question Yes No N/A1 Documentation (TAP; petition; 

regulatory agency; other)

1. Are there adverse effects on 

environment from manufacture, use, 

or disposal?

[§205.600 b.2]

x TER 525-531: The production of PLA 

& PHA involves fermentation 

processes & feedstocks derived from 

natural sources (with the exception of 

genetically-modified organisms). The 

potential for environmental 
Revised March 2012

contamination from these products is 

limited, with the exception of the 

metal salt catalysts used to 

polymerize PLA (Bastioli, 2005). No 

reports of tin contamination from 

production of bioplastics were found.

2. Is there environmental contamination 

during manufacture, use, misuse, or 

disposal? [§6518 m.3]

x TER 533-537: Many of the feedstocks 

used in the production of AAC could 

be hazardous if they were spilled or 

discharged into the environment 

during manufacture & processing. No 

specific reports of environmental 

contamination from these compounds 

as a result of manufacturing 

bioplastics were found. Systematic 

reviews of the environmental impact 

from manufacturing of bioplastics 

were not found. TER 547-550: 

Erucamide, glycerol, & searic acid 

amide could be released to the 

environment through multiple 

manufacturing processes, including 

bioplastics production. No research 

reports were found that described 

environmental releases of these 

chemicals from bioplastics 

manufacturing.

3. Is the substance harmful to the 

environment and biodiversity?

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

x TER 614-621: The researchers 

concluded that using PE mulch may 

have a harmful effect on the 

environment due to increased runoff 

& is less sustainable than vegetative 

mulch (Rice et al., 2001). Based on 

their similarities in construction & 

intended use, bioplastic mulches 

would likely have similar 

environmental impacts to PE mulch, 

though their greater tendency to 

degrade sooner than PE mulch may 

decrease some of the adverse 

environmental impacts. TER 623-627: 

Anaerobic degradation of bioplastics 

may produce methane (greenhouse 

gas). Research was not found that 

quantified methane emissions from 

bioplastic mulch use. Degradation of 

bioplastic mulches must take place in 

an aerobic environment in the soil to 

prevent methane emissions. TER 
Revised March 2012

629-630: Adverse environmental 

impacts from the use of bioplastic 

mulches are only likely to occur if the 

material does not completely 

biodegrade in soil. TER 652-657: 

Some reports have shown that 

bioplastics containing terephthalic 

acid at concentrations over 50% do 

not completely biodegrade in soil 

(Bastioli, 2005). 

4. Does the substance contain List 1, 2 

or 3 inerts? [§6517 c (1)(B)(ii); 

205.601(m)2]

x

5. Is there potential for detrimental 

chemical interaction with other 

materials used?

[§6518 m.1]

x TER 566-567: The plastics are inert in 

the soil when they are intact, and are 

biodegraded by soil microorganisms.

6. Are there adverse biological and 

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

x TER 582-587: Given the complete 

aerobic biodegradation of bioplastic 

mulches, the by-products are carbon 

dioxide, water, & soil biomass. Soil 

biomass refers to the total amount of 

microorganisms in the soil, excluding 

plant roots & macrofauna (NRCS, 

2012). The increase in biomass may 

cause a concomitant increase in the 

populations of microorganisms that 

degrade the mulches on a local basis. 

This could lead to changes in the 

population dynamics of 

microorganisms in the soil. TER 593-

595: Complete degradation of the 

bioplastics depends on blending the 

polymers to maximize degradability & 

depends on the composition of soil 

microorganisms. 

7. Are there detrimental physiological 

effects on soil organisms, crops, or 

livestock? [§6518 m.5]

x TER 352-354 ASTM standard D5988 

is designed to be applicable to 

bioplastic materials that are “not 

inhibitory to the bacteria & fungi 

present in the soil”...it could be 

assumed that the bioplastic does not 

inhibit soil bacteria or fungi by its 

breakdown processes. TER 357-358: 

Many bacteria & fungi in the soil can 

use bioplastics derived from starch as 

a carbon source (Shah et al., 2008).

TER 409-410: Biochar, a method of 

generating carbon black for soil 
Revised March 2012

amendment, may help promote 

nutrient use efficiency in treated soils 

(Chan, 2008; Hunt, 2010).

8. Is there a toxic or other adverse 

action of the material or its 

breakdown products?

[§6518 m.2]

x TER 446-447: Studies were not found 

that specifically assessed the 

ecotoxicity of bioplastics following 

degradation in the soil, & a better 

understanding of bioplastic 

degradation & soil environmental 

effects is needed. TER 462-466: It 

seems unlikely that the source 

material (the bioplastic film) would 

interact with other organisms & cause 

toxicity. The material is manufactured 

to remain intact & inert during its 

intended use, then (ideally) break 

down at the end of the season.

9. Is there undesirable persistence or 

concentration of the material or 

breakdown products in environment?

[§6518 m.2]

x x TER 330-333: The petitioner states 

that biodegradable mulch film is 

defined in two ways...Second, by

“show[ing] at least 90% 

biodegradation absolute or relative to 

microcrystalline cellulose in less than 

two years, in soil, tested according to 

ISO 17556 or ASTM 5988.” TER 347-

350: ISO 17556 & ASTM 5988 are 

equivalent standards. They “describe 

the standard test method for 

determining aerobic biodegradation of 

plastic materials in soil.” This 

standard is most applicable to the 

proposed use of the bioplastic mulch 

because the mulches will be left in the 

field at the end of the season to 

biodegrade according to their 

petitioned use. TER 356-357: 

Biodegradability is quantified by 

measuring the amount of carbon 

dioxide released from the soil over 

time. TER 362-370: degradation 

occurs quicker when chiseled or tilled 

into the soil during times of warm 

temperatures & moisture in soils with 

high organic matter. TER 374-375: 

Hydrolysis breaks PLA into lactic acid 

& water-soluble compounds. Once 

this breakdown occurs, PLA is 

completely mineralized to CO2, water, 

& biomass. TER 384-386: 
Revised March 2012

Degradation of PHA occurs by 

enzymatic hydrolysis at the surface of 

the film, which is carried out by soil 

microbial populations. Hydrolysis 

breaks the PHA polymers into 

oligomers & monomers which are 

subsequently consumed & 

assimilated by microbes in the soil as 

nutrients. TER 395-399: All of the 

commercially available AAC polymer 

materials contain terephthalic acid, 

which is most responsible for 

determining the degradation rates in 

AAC plastics. As the fraction of 

terephthalic acid increases, the 

degradation rate decreases. No 

significant biological degradation was 

found when the molar fraction of AAC 

was increased to more than 60%, 

which is thought to be due to the 

relatively low melting point of 

terephthalic acid (Bastioli, 2005). TER 

405-410: Carbon black is elemental 

carbon in the form of a particulate that 

is manufactured from burning or 

partial combustion of hydrocarbons 

(NLM, 2011)...it is resistant to 

breakdown in the soil environment.

TER 412-419: Titanium dioxide is 

found as the minerals rutile, 

octahedrite, brookite, ilmenite, & 

perovskite. Titanium dioxide may 

persist in soil as the by-product of 

titanium tetrachloride hydrolysis 

(ATSDR, 1997), so it may persist from 

use in bioplastic mulch as well. 

Titanium dioxide may settle out into 

sediments & persist for long periods 

of time (ATSDR, 1997). The 

compound is characterized by 

ATSDR as “ a very inert compound” 

(ATSDR, 1997). TER 421-425: 

Erucamide (plasticizer) binds strongly 

to soil & sediments in water & is likely 

to bioconcentrate in aquatic 

organisms, meaning it will occur at 

higher levels up the food chain (NLM, 

2011). The physical properties of 

erucamide suggest that the material 
Revised March 2012

will persist in the environment, and 

would be found in the water, soil & air 

if released (NLM, 2011). TER 427-

431: Glycerol (plasticizer) released to

the environment will be present as 

both a vapor & a particle in the 

atmosphere, but will be degraded 

within hours (NLM, 2011). The 

potential for bioconcentration in 

aquatic organisms is low for glycerol 

in aquatic environments (NLM, 2011).

10.Are there any harmful effects on 

human health? [§6517 c (1)(A)(i); 

6517 c(2)(A)i; §6518 m.4]

x TER 663-673: Pesticide runoff may 

be increased if plastic mulches are 

used in agricultural production due to 

the creation of impervious surfaces 

(Rice et al., 2001). The increase in 

pesticide loads may lead to an overall 

increase in the pesticide load in 

waterways which could potentially 

impact human health by causing 

increases in pesticide loads in 

downstream drinking water sources. 

No other reports of impacts on human 

health from the use of bioplastic 

mulches were found in the published 

literature.

11.Is there an adverse effect on human 

health as defined by applicable 

Federal regulations? [205.600 b.3]

x

12.Is the substance GRAS when used 

according to FDA’s good 

manufacturing practices? [§205.600 

b.5]

x

13.Does the substance contain residues 

of heavy metals or other 

contaminants in excess of FDA 

tolerances? [§205.600 b.5]

x

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.
Revised March 2012

NOSB Evaluation Criteria for Substances Added To the National List

Category 2. Is the Substance Essential for Organic Production? Substance: 

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 TER 294-296: Bioplastic mulches are 

manufactured with the addition of 

synthetic plasticizers and colorants 

which are added using a synthetic 

process. 

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 TER 301-302: To develop PLA the 

lactic acid monomers must be 

polymerized. This is accomplished 

through the use of a chemical 

catalyst. TER 302-305: Fermentation 

is a naturally occurring process, but 

under laboratory conditions, the 

feedstocks and environmental 

conditions are manipulated in order to 

provide an environment that is most 

conducive to production of PLA, a 

process which would be unlikely to 

occur in nature. TER 309-310: 

Researchers have developed 

genetically-engineered bacterial 

strains that produce PHA more 

efficiently & in differing polymer 

amounts. TER 313-315: PHA 

production by fermentation is a 

natural process, but the conditions 

used in laboratories to maximize 

yields and polymer amounts are not 

naturally occurring. TER 317-319: 

Some feedstocks used to produce 

AAC are naturally occurring, but the 

chemical processes used to refine 

them for use do not occur in nature, 

nor do the synthetic processes that 

are used to create the ester linkages.

3. Is the substance created by naturally 

occurring biological processes? 

[6502 (21)]

x x

4. Is there a natural source of the 

substance? [§205.600 b.1]

x

5. Is there an organic substitute? 

[§205.600 b.1]

x

6. Is the substance essential for x
Revised March 2012

handling of organically produced 

agricultural products? [§205.600 b.6]

7. Is there a wholly natural substitute 

product?

[§6517 c (1)(A)(ii)]

x TER 679-682: The petitioned 

substance would be an alternative to 

synthetic, non-degradable substance, 

polyethylene plastic mulch. Bioplastic 

mulch is produced through synthetic 

processes as previously described, 

but is created to be biodegradable, a 

reason for its petitioned use in organic 

agriculture. TER 684-690: Mulches 

made from biomass include bark, 

cocoa-bean hulls, corncobs, grass 

clippings, leaves, pine needles, 

sawdust, straw, & wood chips. 

Biomass mulch availability may 

depend on what types of plants or 

crops are available in the area & the 

type of crop they are used in.

8. Is the substance used in handling, not 

synthetic, but not organically 

produced?

[§6517 c (1)(B)(iii)]

x

9. Is there any alternative substances? 

[§6518 m.6]

x TER 717-721: Living mulch involves 

planting a low-growing cover crop that 

is effective at competing with weed 

species. The drawback is that living 

mulches compete for nutrients & 

water & reduce yields. Reports 

discuss the need to strike a balance 

between environmental impact, cost,

ease of use, & crop yields to 

determine which alternative is most 

beneficial for individual farms & crops.

10.Is there another practice that would 

make the substance unnecessary? 

[§6518 m.6]

x

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.
Revised March 2012

NOSB Evaluation Criteria for Substances Added To the National List

Category 3. Is the substance compatible with organic production practices? 

Substance: 

Question Yes No N/A1 Documentation (TAP; petition; 

regulatory agency; other)

1. Is the substance compatible with 

organic handling? [§205.600 b.2]

x

2. Is the substance consistent with 

organic farming and handling? [§6517 

c (1)(A)(iii); 6517 c (2)(A)(ii)]

x x The substance is of synthetic origin 

but appears to completely biodegrade 

in a two-year timeframe. This serves 

as an alternative to the current 

practice of using synthetic, nondegradable, polyethylene plastic 

mulch.

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

5. Is the primary use as a preservative? 

[§205.600 b.4]

x

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

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

b. toxins derived from bacteria; x

c. pheromones, soaps, horticultural 

oils, fish emulsions, treated seed, 

vitamins and minerals?

x

d. livestock parasiticides and 

medicines?

x

e. production aids including netting, 

tree wraps and seals, insect traps,

sticky barriers, row covers, and 

equipment cleaners?

x TER 218- 221: Bioplastic mulch is 

used as a production aid, but is not 

technically considered a row cover 

because they increase soil 

temperature, reduce weed pressure, 

maintain soil moisture levels, and may 
Revised March 2012

help extend the growing season.

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.
Revised March 2012

NOSB Evaluation Criteria for Substances Added To the National List

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: Name

Question Yes No N/A1 Documentation (TAP; petition; 

regulatory agency; other)

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

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 

non-availability 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
Revised March 2012

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

e. Are there other issues which may 

present a challenge to a 

consistent supply?

x

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.