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Environmental Assessment for Food Contact Notification FCN 1665 httpwwwfdagovFoodIngredientsPackagingLabelingEnvironmentalDecisionsdefaulthtm
Environmental Assessment
1 Date July 1st 2016
~- Name of ApplicantNotifier Clordisys Solutions Inc 3 Address PO Box 549
Lebanon NJ 08833
4 Description of Proposed Action a Requested action
The requested action is for the safe use of chlorine dioxide generated by the reaction between chlorine gas and a solid matrix of sodium chlorite (GasSolid process 1
) for use as an antimicrobial agent in air to treat fruits and vegetables including raw agricultural commodities in an amount not to exceed 3 ppm total residual in the air as an antimicrobial agent to treat fruits and vegetables including raw agricultural commodities Fruits and vegetables that are not raw agricultural commodities treated in this way shall be followed by an air flush or by blanching cooking or canning or consumed as fresh-cut fruits and vegetables The fumigation is intended to be performed in food processing facilities warehouses storageholding locations packaging andor distribution centers In raw agricultural commodities the FCS will be applied in the surrounding air in the preparing packaging or holding of food for commercia purposes con~istent with the FDampC Act section 201(q)(1)(B)(i) but not applied for use unner 201(q)(l)(B)(i)(I) (q)(l)(B)(i)(II) or (q)(I)(B)(i)(III) ofthe FDampC Act Treatment of raw agricultural commodities shall be followed by an air flush or by blanching cooking or canning In all applications the chlorine dioxide will be applied in the dark Fumigation will never be performed on products that were also subject to aqueous chlorine dioxide treatment where
mitigation steps were not taken post application or at the point of sale
middot b Need for action
Chlorine dioxide use as described in this Food Contact Notice is a currently accepted method by FDA for fruit and vegetable fumigations including raw agricultural commodities and poultry processing Since a notification for an FCS will be effective only for the manufacturer(s) identified in the notification Clordisys is submitting this notification in order to be an effective manufacturer of chlorine dioxide for this use in the gas phase Futhermore chlorine is the
1 US Patent No 6824756 B2 Rosenblatt et al Process for manufacturing and using a more stable formulation of
sodium chlorite Nov 30 2004
Clordisys Solutions Inc Page 23 of 51
typical method used to wash fruits and vegetables which forms trihalomethanes and chlorine dioxide does not making it a safer altemative2
bull
5 Identification of Substances that are the Subject of the Proposed Action
a Chemical Name Chlorine dioxide b Common or Trade Names Chlorine (IV) oxide c CAS 10049-04-4 d Chemical formula Cl02 e Structural formula f Properties
1 Molecular weight 675 11 Color Gas phase - Yell ow green
111 Melting point -59degC lV Boiling point l1degC v Odor chlorine-like
Vl Density 164 gmL (0degC liquid) V11 s~lubility 301 gL at (25degC 345 mm Hg)
Vlll Structure
Cl Cl4 ~ ~
~~ 0 0 0 0
g Use Rates The Notifier of this Food Contact Notice is proposing that chlorine dioxide can be applied as a gaseous air treatment for fruits and vegetables in closed environments See Figure 1 below
Toxicological Profile for Chlorine middotDioxide and Chlorite Agency for Toxic Substances and Disease Registry
httpwwwatsd r cdcgov toxprofi lestp160pdf
2
Environmental Assessment for Food Contact Notification FCN 1665 httpwwwfdagovFoodIngredientsPackagingLabelingEnvironmentalDecisionsdefaulthtm
Clordisys Solutions Inc Page 24 of 51
Chi onne 2 chlorine Dioxide
gas gas
EnvironmentalCD Cartridge Mediumcontaining
Sodium chlorite
Figure 1
Application timing and holding periods of chlorine dioxide in closed environments will be dependent on the foodstuff loading organic demand of the environment and products treated and the amount of microbiological decontamination desired It is estimated that the combined application and hold time can range from seconds to hours depending on volumes of environmental mediums amount of foodstuffs organic demand of the environmental and the amount of antimicrobial reduction required Treatment of the fruits and vegetables in this way shall be followed by an air flush or by blanching cooking or canning or consumed as fresh-cut fruits and vegetables
h Impurities There will be a negligible amount of impurities on food products from use of chlorine dioxide produced under this Food Contact Notice The chlorine dioxide
gas produced under the method proposed produces extremely high purity (at least 997) chlorine dioxide gas and the only impurity from the method is solid sodium chloride which will be remain in the reaction cartridge as well as any impurities originally in the solid technical grade sodium chlorite matrix The only reaction product reaching the environmental air is going to be chlorine dioxide
The reaction cartridge is not part of the FCS application process and only serves as a precursor to producing the FCS that is the subject of this FCN Certificates of Aralysis can be found in the Confidential Appendix Cross Reference 3
6 Introduction of Substances into the Environment a Manufacturing Process
The Food Contact Substance (FCS) that is the subject of this FCN will be produced on site at the point of application The Notifier does not expect there to be any release of the FCS into the environment under normal manufacturing conditions Under 21 CFR 2540(a) an environmental assessment should focus on relevant environmental issues relating to the use and Jisposal from use rather
Environmental Assessment for Food Contact Notification FCN 1665 httpwwwfdagovFoodIngredientsPackagingLabelingEnvironmentalDecisionsdefaulthtm
Clordisys Solutions Inc Page 25 of 51
than the production of FDA-regulated articles Information available to the Notifier suggests no extraordinary circumstances suggesting an adverse environmental impact as a result of the manufacture of the antimicrobial agent Consequently information on the manufacturing site and compliance with the relevant emissions requirements is not provided here
b Use Releases
The FCS that is the subject of this FCN is intended to be released into closed environments containing fruits and vegetabks for treatment
In the method proposed by this FCN the generation chemistry of chlorine dioxide production is as follows
2NaC102Cs) + Cb (g) ~ 2Cl02 (g)+ NaClcs) middot Chlorine gas is passed through a matrix of solid sodium chlorite flakes to produce
a high purity chlorine dioxide gas which will be applied to closed environments such as drying rooms holding rooms storage rooms freezers etc
The only byproduct formed as a result of this generation chemistry is sodium chloride (NaCl) This will not be present in the gaseous stream as it will stay as a solid in the reaction cartridge Potential releases from the use of this Food Contact Substance to both water and air are discussed below
Chlorite may be expected to form as a degradation product on the surface of food treated with the FCS Food treated with the FCS may be consumed without a mitigation step or may be subject to blanching cooking or canning However since chlorite is expected to decompose during blanching cooking or canning and treated food not subject to a mitigation step post application of the FCS will be ingested by the consumer without the opportunity for release into the environment (ie no aqueous rinse step) we do not expect any environmental releases of chlorite from the proposed use
c Water Releases Since no wastewater or discharged processing water will be involved with the
application of the FCS proposed in this FCN no FCS or its degradation products will be present in either of these water sources
d Air Releases middot
Since the FCS is intended to be released into closed environments air releases will occur primarily due to unreacted FCS after treatment Since the generation of chlorine dioxide gas will be contained and the treatment areas will be sealed possible air releases will occur only when venting the closed treatment areas As stated in the toxicological profile of Chlorine Dioxide and Chlorite chlorine dioxide gas is an
Environmental Assessment for Food Contact Notification FCN 1665 httpwwwfdagovFoodIngredientsPackagingLabelingEnvironmentalDecisionsdefaulthtm
Clordisys Solutions Inc Page 26 of 51
unstable gas that rapidly decomposes in air It can decompose to chlorine and oxygen with exposure to mild heat and will decompose upon exposure to sunlight3
Due to this photodegradation release of the FCS into the atmosphere is not expected to pose any adverse environmental effects As a worst case scenario the EEC value for purposes of this Food Contact Notice will be the use concentration of 3 ppm middot
7 Environmental Fate of Substances Released into the Environment a Air
Since the FCS is intended to be released into closed environments air releases will occur primarily due to unreacted FCS after treatment Since the generation of chlorine dioxide gas will be contained and the treatment areas will be sealed
possible air releases will occur only when venting the closed treatment areas If this occurs the chlorine dioxide will be rapidly diluted by the surrounding air and also undergo photodecomposition to molecular chlorine and oxygen chlorine will be further reduced to chloride in the presence of UV light Therefore it is estimated that chlorine dioxide releases to air will ultimately result in the formation of chloride As stated in the Final Risk Assessment for Chlorine dioxide Case 4023 as conducted by the US Environmental Protection Agency Chlorine dioxide has a short half-life and in the presence of sunlight and will break down into chloride and chlorate ions (between pH 4 and 7) At pH lower than 4 its breakdown products are chlorite and chlorate Chlorite is the dominant breakdown product Ultimately oxygen is formed
b Water Releases Since no wastewater or discharged processing water will be involved with the application of the FCS proposed in this FCN no FCS or its degradation products will be present in either of these water sources
8 Environmental Effects of Released Substances a Air
It is estimated that there will be no significant environmental impact for an air
release of chlorine dioxide This is due to a relatively low potential for release of chlorine dioxide into the air by use of the FCS in the way as stated in this FCN as well as the decomposition and dilution of chlorine dioxide in air
Table f Acute toxicit)lprofilefor Sodium chlorite and Ch lorin e dioxide
3 Toxicological Profile for Chlodne Dioxide and Chlorite Agency for Toxic Substances and Disease Registry
httpwwwatsd rcdcgov toxprofilestp160pdf
Environmental Assessment for Food Contact Notification FCN 1665 httpwwwfdagovFoodIngredientsPackagingLabelingEnvironmentalDecisionsdefaulthtm
Clordisys Solutions Inc Page 27 of 51
D9te Study Type MRID Species Results Toxicity Categorv
1982 Acute oral (79 chlorine dioxide)
43558601 Rat LD50 = 292 mglkg (males) LD50 = 340 mglkg (females)
II
1985 Acute dermal (80 sodium chlorite)
40168704 Rabbit LD50 gt 2000 mgkg
III
1992 Acute inhalation (806 sodium chlorite)
42484101 Rat LC50 = 029 mgiL
II
1994 Primary eye irritation (2 chlorine dioxide)
43441903 Rabbit Mild irritant III
1985 Primary dermal irritation (80 sodium chlorite)
40168704 Rabbit Primary irritant II
Table reprinted from USEPA Reregistration Eligibility Decision (RED) for Chlorine Dwxide and Sodmm Chlonte case 4023
To estimate an air release concentration we will use the application concentration stated in this FCN (3 ppm) as an estimate for the environmental concentration (EEC) This number will serve as a worst case scenario estimate since an actual environmental release would be less due to organic demand of foodstuffs dilution due to HV AC venting and photodecomposition in the open atmosphere
As shown in the table above the acute inhalation ( ecotoxicity value) LC50 for rats is 029 mgL which is equivalent to 105 ppm as shown in the calculation below
PPM calculation for 1 mgJL of Chlorine Dioxide Gas PPM= (mgm3
) (2445 ) I Molecular Weight of Chlorine Dioxide PPM = (mgiL) (1000) (2445) I Molecular Weight of Chlorine Dioxide CD ppm = (mgL) (1000Lm3
) (2445) I 675 CD ppm = 3622 1 mgL
For 029 mgiL CD ppm = 3622029 mgiL = 105 ppm
The number 2445 in the equations above is the volume (liters) of a mole (gram molecularweight) of a gas at 1 atmosphere and at 25degC 675 =molecular weight ofCl02
Environmental Assessment for Food Contact Notification FCN 1665 httpwwwfdagovFoodIngredientsPackagingLabelingEnvironmentalDecisionsdefaulthtm
Clordisys Solutions Inc Page 28 of 51
Thus it can be estimated that even in a worst case scenario potential air releases do not middot
pose a threat at the levels that may be released The ecotoxicity value of 029 mgL (1 05
ppm) is much higher than EEC value of 3 ppm
b Water
Since no wastewater or discharged processing water will be involved with the
application of the FCS proposed in this FCN no FCS or its degradation products
will be present in either of these water sources
9 Use of Resources and Energy The production of the FCS using the method described in this FCN will replace existing
methods of generation and is not expected to result in an increased use of natural
resources
10 Mitigation Measures Since no environmental effects are anticipated with respect to use of this FCS mitigation
measures are not required
11 Alternatives to the Proposed Action Alternatives to this proposed action are not required since no potential adverse environmental impacts have been identified If the requested action should not go forward treatment with chlorine would most likely be the substituted method
12 List of Preparers This EA was prepared by Paul Lorcheim Director of Operations BS Electrical
Engineering Professional Engineer Daniel Paznek Project Engineer BS Biochemical
Engineering Kevin Lorcheim Engin~er BS Mechanical Engineering
Environmental Assessment for Food Contact Notification FCN 1665 httpwwwfdagovFoodIngredientsPackagingLabelingEnvironmentalDecisionsdefaulthtm
Clordisys Solutions Inc Page 29 of 51
13 Certification The undersigned certifies that the information presented is true accurate and complete to
the best knowledge of all preparers
Name fA--vL Lopoundctnn~
Title Director of Operations SignatureDate 7 It (
Name Kev Lcvcht 7 Title Engineer Signature
Date 7--G
Name i) (I Pcz-( )( Title Project_EJlgi~r
Signature
Date 7r J1b
Environmental Assessment for Food Contact Notification FCN 1665 httpwwwfdagovFoodIngredientsPackagingLabelingEnvironmentalDecisionsdefaulthtm
Clordisys Solutions Inc Page 30 of 51
References
I US Patent No 6824 756 B2 Rosenblatt et al Process for manufacturing and using a more stable formulation of sodium chlorite Nov 30 2004
2 Toxicological Profile for Chlorine Dioxide and Chlorite Agency for Toxic Substances and Disease Registry http wwwatsdrcdcgovtoxprofilestp 160pdf
3 Chlorine Dioxide Final Risk Assessment Case 4023 August 2006 EPA Docket Number EPA-HQ-OPPshy2006-0328-017 available at http www regulationsgov documentDetail D=EP A-H Q-OPP-2006-0328-00 17
4 US Environmental Protection Agency Reregistration Eligibility Decision (RED) for Chlorine Dioxide and Sodium Chlorite (Case 4023) August 2006 Available at http www epagovoppsrrd 1REDschlorine _dioxide _red pdf
Environmental Assessment for Food Contact Notification FCN 1665 httpwwwfdagovFoodIngredientsPackagingLabelingEnvironmentalDecisionsdefaulthtm
Clordisys Solutions Inc Page 23 of 51
typical method used to wash fruits and vegetables which forms trihalomethanes and chlorine dioxide does not making it a safer altemative2
bull
5 Identification of Substances that are the Subject of the Proposed Action
a Chemical Name Chlorine dioxide b Common or Trade Names Chlorine (IV) oxide c CAS 10049-04-4 d Chemical formula Cl02 e Structural formula f Properties
1 Molecular weight 675 11 Color Gas phase - Yell ow green
111 Melting point -59degC lV Boiling point l1degC v Odor chlorine-like
Vl Density 164 gmL (0degC liquid) V11 s~lubility 301 gL at (25degC 345 mm Hg)
Vlll Structure
Cl Cl4 ~ ~
~~ 0 0 0 0
g Use Rates The Notifier of this Food Contact Notice is proposing that chlorine dioxide can be applied as a gaseous air treatment for fruits and vegetables in closed environments See Figure 1 below
Toxicological Profile for Chlorine middotDioxide and Chlorite Agency for Toxic Substances and Disease Registry
httpwwwatsd r cdcgov toxprofi lestp160pdf
2
Environmental Assessment for Food Contact Notification FCN 1665 httpwwwfdagovFoodIngredientsPackagingLabelingEnvironmentalDecisionsdefaulthtm
Clordisys Solutions Inc Page 24 of 51
Chi onne 2 chlorine Dioxide
gas gas
EnvironmentalCD Cartridge Mediumcontaining
Sodium chlorite
Figure 1
Application timing and holding periods of chlorine dioxide in closed environments will be dependent on the foodstuff loading organic demand of the environment and products treated and the amount of microbiological decontamination desired It is estimated that the combined application and hold time can range from seconds to hours depending on volumes of environmental mediums amount of foodstuffs organic demand of the environmental and the amount of antimicrobial reduction required Treatment of the fruits and vegetables in this way shall be followed by an air flush or by blanching cooking or canning or consumed as fresh-cut fruits and vegetables
h Impurities There will be a negligible amount of impurities on food products from use of chlorine dioxide produced under this Food Contact Notice The chlorine dioxide
gas produced under the method proposed produces extremely high purity (at least 997) chlorine dioxide gas and the only impurity from the method is solid sodium chloride which will be remain in the reaction cartridge as well as any impurities originally in the solid technical grade sodium chlorite matrix The only reaction product reaching the environmental air is going to be chlorine dioxide
The reaction cartridge is not part of the FCS application process and only serves as a precursor to producing the FCS that is the subject of this FCN Certificates of Aralysis can be found in the Confidential Appendix Cross Reference 3
6 Introduction of Substances into the Environment a Manufacturing Process
The Food Contact Substance (FCS) that is the subject of this FCN will be produced on site at the point of application The Notifier does not expect there to be any release of the FCS into the environment under normal manufacturing conditions Under 21 CFR 2540(a) an environmental assessment should focus on relevant environmental issues relating to the use and Jisposal from use rather
Environmental Assessment for Food Contact Notification FCN 1665 httpwwwfdagovFoodIngredientsPackagingLabelingEnvironmentalDecisionsdefaulthtm
Clordisys Solutions Inc Page 25 of 51
than the production of FDA-regulated articles Information available to the Notifier suggests no extraordinary circumstances suggesting an adverse environmental impact as a result of the manufacture of the antimicrobial agent Consequently information on the manufacturing site and compliance with the relevant emissions requirements is not provided here
b Use Releases
The FCS that is the subject of this FCN is intended to be released into closed environments containing fruits and vegetabks for treatment
In the method proposed by this FCN the generation chemistry of chlorine dioxide production is as follows
2NaC102Cs) + Cb (g) ~ 2Cl02 (g)+ NaClcs) middot Chlorine gas is passed through a matrix of solid sodium chlorite flakes to produce
a high purity chlorine dioxide gas which will be applied to closed environments such as drying rooms holding rooms storage rooms freezers etc
The only byproduct formed as a result of this generation chemistry is sodium chloride (NaCl) This will not be present in the gaseous stream as it will stay as a solid in the reaction cartridge Potential releases from the use of this Food Contact Substance to both water and air are discussed below
Chlorite may be expected to form as a degradation product on the surface of food treated with the FCS Food treated with the FCS may be consumed without a mitigation step or may be subject to blanching cooking or canning However since chlorite is expected to decompose during blanching cooking or canning and treated food not subject to a mitigation step post application of the FCS will be ingested by the consumer without the opportunity for release into the environment (ie no aqueous rinse step) we do not expect any environmental releases of chlorite from the proposed use
c Water Releases Since no wastewater or discharged processing water will be involved with the
application of the FCS proposed in this FCN no FCS or its degradation products will be present in either of these water sources
d Air Releases middot
Since the FCS is intended to be released into closed environments air releases will occur primarily due to unreacted FCS after treatment Since the generation of chlorine dioxide gas will be contained and the treatment areas will be sealed possible air releases will occur only when venting the closed treatment areas As stated in the toxicological profile of Chlorine Dioxide and Chlorite chlorine dioxide gas is an
Environmental Assessment for Food Contact Notification FCN 1665 httpwwwfdagovFoodIngredientsPackagingLabelingEnvironmentalDecisionsdefaulthtm
Clordisys Solutions Inc Page 26 of 51
unstable gas that rapidly decomposes in air It can decompose to chlorine and oxygen with exposure to mild heat and will decompose upon exposure to sunlight3
Due to this photodegradation release of the FCS into the atmosphere is not expected to pose any adverse environmental effects As a worst case scenario the EEC value for purposes of this Food Contact Notice will be the use concentration of 3 ppm middot
7 Environmental Fate of Substances Released into the Environment a Air
Since the FCS is intended to be released into closed environments air releases will occur primarily due to unreacted FCS after treatment Since the generation of chlorine dioxide gas will be contained and the treatment areas will be sealed
possible air releases will occur only when venting the closed treatment areas If this occurs the chlorine dioxide will be rapidly diluted by the surrounding air and also undergo photodecomposition to molecular chlorine and oxygen chlorine will be further reduced to chloride in the presence of UV light Therefore it is estimated that chlorine dioxide releases to air will ultimately result in the formation of chloride As stated in the Final Risk Assessment for Chlorine dioxide Case 4023 as conducted by the US Environmental Protection Agency Chlorine dioxide has a short half-life and in the presence of sunlight and will break down into chloride and chlorate ions (between pH 4 and 7) At pH lower than 4 its breakdown products are chlorite and chlorate Chlorite is the dominant breakdown product Ultimately oxygen is formed
b Water Releases Since no wastewater or discharged processing water will be involved with the application of the FCS proposed in this FCN no FCS or its degradation products will be present in either of these water sources
8 Environmental Effects of Released Substances a Air
It is estimated that there will be no significant environmental impact for an air
release of chlorine dioxide This is due to a relatively low potential for release of chlorine dioxide into the air by use of the FCS in the way as stated in this FCN as well as the decomposition and dilution of chlorine dioxide in air
Table f Acute toxicit)lprofilefor Sodium chlorite and Ch lorin e dioxide
3 Toxicological Profile for Chlodne Dioxide and Chlorite Agency for Toxic Substances and Disease Registry
httpwwwatsd rcdcgov toxprofilestp160pdf
Environmental Assessment for Food Contact Notification FCN 1665 httpwwwfdagovFoodIngredientsPackagingLabelingEnvironmentalDecisionsdefaulthtm
Clordisys Solutions Inc Page 27 of 51
D9te Study Type MRID Species Results Toxicity Categorv
1982 Acute oral (79 chlorine dioxide)
43558601 Rat LD50 = 292 mglkg (males) LD50 = 340 mglkg (females)
II
1985 Acute dermal (80 sodium chlorite)
40168704 Rabbit LD50 gt 2000 mgkg
III
1992 Acute inhalation (806 sodium chlorite)
42484101 Rat LC50 = 029 mgiL
II
1994 Primary eye irritation (2 chlorine dioxide)
43441903 Rabbit Mild irritant III
1985 Primary dermal irritation (80 sodium chlorite)
40168704 Rabbit Primary irritant II
Table reprinted from USEPA Reregistration Eligibility Decision (RED) for Chlorine Dwxide and Sodmm Chlonte case 4023
To estimate an air release concentration we will use the application concentration stated in this FCN (3 ppm) as an estimate for the environmental concentration (EEC) This number will serve as a worst case scenario estimate since an actual environmental release would be less due to organic demand of foodstuffs dilution due to HV AC venting and photodecomposition in the open atmosphere
As shown in the table above the acute inhalation ( ecotoxicity value) LC50 for rats is 029 mgL which is equivalent to 105 ppm as shown in the calculation below
PPM calculation for 1 mgJL of Chlorine Dioxide Gas PPM= (mgm3
) (2445 ) I Molecular Weight of Chlorine Dioxide PPM = (mgiL) (1000) (2445) I Molecular Weight of Chlorine Dioxide CD ppm = (mgL) (1000Lm3
) (2445) I 675 CD ppm = 3622 1 mgL
For 029 mgiL CD ppm = 3622029 mgiL = 105 ppm
The number 2445 in the equations above is the volume (liters) of a mole (gram molecularweight) of a gas at 1 atmosphere and at 25degC 675 =molecular weight ofCl02
Environmental Assessment for Food Contact Notification FCN 1665 httpwwwfdagovFoodIngredientsPackagingLabelingEnvironmentalDecisionsdefaulthtm
Clordisys Solutions Inc Page 28 of 51
Thus it can be estimated that even in a worst case scenario potential air releases do not middot
pose a threat at the levels that may be released The ecotoxicity value of 029 mgL (1 05
ppm) is much higher than EEC value of 3 ppm
b Water
Since no wastewater or discharged processing water will be involved with the
application of the FCS proposed in this FCN no FCS or its degradation products
will be present in either of these water sources
9 Use of Resources and Energy The production of the FCS using the method described in this FCN will replace existing
methods of generation and is not expected to result in an increased use of natural
resources
10 Mitigation Measures Since no environmental effects are anticipated with respect to use of this FCS mitigation
measures are not required
11 Alternatives to the Proposed Action Alternatives to this proposed action are not required since no potential adverse environmental impacts have been identified If the requested action should not go forward treatment with chlorine would most likely be the substituted method
12 List of Preparers This EA was prepared by Paul Lorcheim Director of Operations BS Electrical
Engineering Professional Engineer Daniel Paznek Project Engineer BS Biochemical
Engineering Kevin Lorcheim Engin~er BS Mechanical Engineering
Environmental Assessment for Food Contact Notification FCN 1665 httpwwwfdagovFoodIngredientsPackagingLabelingEnvironmentalDecisionsdefaulthtm
Clordisys Solutions Inc Page 29 of 51
13 Certification The undersigned certifies that the information presented is true accurate and complete to
the best knowledge of all preparers
Name fA--vL Lopoundctnn~
Title Director of Operations SignatureDate 7 It (
Name Kev Lcvcht 7 Title Engineer Signature
Date 7--G
Name i) (I Pcz-( )( Title Project_EJlgi~r
Signature
Date 7r J1b
Environmental Assessment for Food Contact Notification FCN 1665 httpwwwfdagovFoodIngredientsPackagingLabelingEnvironmentalDecisionsdefaulthtm
Clordisys Solutions Inc Page 30 of 51
References
I US Patent No 6824 756 B2 Rosenblatt et al Process for manufacturing and using a more stable formulation of sodium chlorite Nov 30 2004
2 Toxicological Profile for Chlorine Dioxide and Chlorite Agency for Toxic Substances and Disease Registry http wwwatsdrcdcgovtoxprofilestp 160pdf
3 Chlorine Dioxide Final Risk Assessment Case 4023 August 2006 EPA Docket Number EPA-HQ-OPPshy2006-0328-017 available at http www regulationsgov documentDetail D=EP A-H Q-OPP-2006-0328-00 17
4 US Environmental Protection Agency Reregistration Eligibility Decision (RED) for Chlorine Dioxide and Sodium Chlorite (Case 4023) August 2006 Available at http www epagovoppsrrd 1REDschlorine _dioxide _red pdf
Environmental Assessment for Food Contact Notification FCN 1665 httpwwwfdagovFoodIngredientsPackagingLabelingEnvironmentalDecisionsdefaulthtm
Clordisys Solutions Inc Page 24 of 51
Chi onne 2 chlorine Dioxide
gas gas
EnvironmentalCD Cartridge Mediumcontaining
Sodium chlorite
Figure 1
Application timing and holding periods of chlorine dioxide in closed environments will be dependent on the foodstuff loading organic demand of the environment and products treated and the amount of microbiological decontamination desired It is estimated that the combined application and hold time can range from seconds to hours depending on volumes of environmental mediums amount of foodstuffs organic demand of the environmental and the amount of antimicrobial reduction required Treatment of the fruits and vegetables in this way shall be followed by an air flush or by blanching cooking or canning or consumed as fresh-cut fruits and vegetables
h Impurities There will be a negligible amount of impurities on food products from use of chlorine dioxide produced under this Food Contact Notice The chlorine dioxide
gas produced under the method proposed produces extremely high purity (at least 997) chlorine dioxide gas and the only impurity from the method is solid sodium chloride which will be remain in the reaction cartridge as well as any impurities originally in the solid technical grade sodium chlorite matrix The only reaction product reaching the environmental air is going to be chlorine dioxide
The reaction cartridge is not part of the FCS application process and only serves as a precursor to producing the FCS that is the subject of this FCN Certificates of Aralysis can be found in the Confidential Appendix Cross Reference 3
6 Introduction of Substances into the Environment a Manufacturing Process
The Food Contact Substance (FCS) that is the subject of this FCN will be produced on site at the point of application The Notifier does not expect there to be any release of the FCS into the environment under normal manufacturing conditions Under 21 CFR 2540(a) an environmental assessment should focus on relevant environmental issues relating to the use and Jisposal from use rather
Environmental Assessment for Food Contact Notification FCN 1665 httpwwwfdagovFoodIngredientsPackagingLabelingEnvironmentalDecisionsdefaulthtm
Clordisys Solutions Inc Page 25 of 51
than the production of FDA-regulated articles Information available to the Notifier suggests no extraordinary circumstances suggesting an adverse environmental impact as a result of the manufacture of the antimicrobial agent Consequently information on the manufacturing site and compliance with the relevant emissions requirements is not provided here
b Use Releases
The FCS that is the subject of this FCN is intended to be released into closed environments containing fruits and vegetabks for treatment
In the method proposed by this FCN the generation chemistry of chlorine dioxide production is as follows
2NaC102Cs) + Cb (g) ~ 2Cl02 (g)+ NaClcs) middot Chlorine gas is passed through a matrix of solid sodium chlorite flakes to produce
a high purity chlorine dioxide gas which will be applied to closed environments such as drying rooms holding rooms storage rooms freezers etc
The only byproduct formed as a result of this generation chemistry is sodium chloride (NaCl) This will not be present in the gaseous stream as it will stay as a solid in the reaction cartridge Potential releases from the use of this Food Contact Substance to both water and air are discussed below
Chlorite may be expected to form as a degradation product on the surface of food treated with the FCS Food treated with the FCS may be consumed without a mitigation step or may be subject to blanching cooking or canning However since chlorite is expected to decompose during blanching cooking or canning and treated food not subject to a mitigation step post application of the FCS will be ingested by the consumer without the opportunity for release into the environment (ie no aqueous rinse step) we do not expect any environmental releases of chlorite from the proposed use
c Water Releases Since no wastewater or discharged processing water will be involved with the
application of the FCS proposed in this FCN no FCS or its degradation products will be present in either of these water sources
d Air Releases middot
Since the FCS is intended to be released into closed environments air releases will occur primarily due to unreacted FCS after treatment Since the generation of chlorine dioxide gas will be contained and the treatment areas will be sealed possible air releases will occur only when venting the closed treatment areas As stated in the toxicological profile of Chlorine Dioxide and Chlorite chlorine dioxide gas is an
Environmental Assessment for Food Contact Notification FCN 1665 httpwwwfdagovFoodIngredientsPackagingLabelingEnvironmentalDecisionsdefaulthtm
Clordisys Solutions Inc Page 26 of 51
unstable gas that rapidly decomposes in air It can decompose to chlorine and oxygen with exposure to mild heat and will decompose upon exposure to sunlight3
Due to this photodegradation release of the FCS into the atmosphere is not expected to pose any adverse environmental effects As a worst case scenario the EEC value for purposes of this Food Contact Notice will be the use concentration of 3 ppm middot
7 Environmental Fate of Substances Released into the Environment a Air
Since the FCS is intended to be released into closed environments air releases will occur primarily due to unreacted FCS after treatment Since the generation of chlorine dioxide gas will be contained and the treatment areas will be sealed
possible air releases will occur only when venting the closed treatment areas If this occurs the chlorine dioxide will be rapidly diluted by the surrounding air and also undergo photodecomposition to molecular chlorine and oxygen chlorine will be further reduced to chloride in the presence of UV light Therefore it is estimated that chlorine dioxide releases to air will ultimately result in the formation of chloride As stated in the Final Risk Assessment for Chlorine dioxide Case 4023 as conducted by the US Environmental Protection Agency Chlorine dioxide has a short half-life and in the presence of sunlight and will break down into chloride and chlorate ions (between pH 4 and 7) At pH lower than 4 its breakdown products are chlorite and chlorate Chlorite is the dominant breakdown product Ultimately oxygen is formed
b Water Releases Since no wastewater or discharged processing water will be involved with the application of the FCS proposed in this FCN no FCS or its degradation products will be present in either of these water sources
8 Environmental Effects of Released Substances a Air
It is estimated that there will be no significant environmental impact for an air
release of chlorine dioxide This is due to a relatively low potential for release of chlorine dioxide into the air by use of the FCS in the way as stated in this FCN as well as the decomposition and dilution of chlorine dioxide in air
Table f Acute toxicit)lprofilefor Sodium chlorite and Ch lorin e dioxide
3 Toxicological Profile for Chlodne Dioxide and Chlorite Agency for Toxic Substances and Disease Registry
httpwwwatsd rcdcgov toxprofilestp160pdf
Environmental Assessment for Food Contact Notification FCN 1665 httpwwwfdagovFoodIngredientsPackagingLabelingEnvironmentalDecisionsdefaulthtm
Clordisys Solutions Inc Page 27 of 51
D9te Study Type MRID Species Results Toxicity Categorv
1982 Acute oral (79 chlorine dioxide)
43558601 Rat LD50 = 292 mglkg (males) LD50 = 340 mglkg (females)
II
1985 Acute dermal (80 sodium chlorite)
40168704 Rabbit LD50 gt 2000 mgkg
III
1992 Acute inhalation (806 sodium chlorite)
42484101 Rat LC50 = 029 mgiL
II
1994 Primary eye irritation (2 chlorine dioxide)
43441903 Rabbit Mild irritant III
1985 Primary dermal irritation (80 sodium chlorite)
40168704 Rabbit Primary irritant II
Table reprinted from USEPA Reregistration Eligibility Decision (RED) for Chlorine Dwxide and Sodmm Chlonte case 4023
To estimate an air release concentration we will use the application concentration stated in this FCN (3 ppm) as an estimate for the environmental concentration (EEC) This number will serve as a worst case scenario estimate since an actual environmental release would be less due to organic demand of foodstuffs dilution due to HV AC venting and photodecomposition in the open atmosphere
As shown in the table above the acute inhalation ( ecotoxicity value) LC50 for rats is 029 mgL which is equivalent to 105 ppm as shown in the calculation below
PPM calculation for 1 mgJL of Chlorine Dioxide Gas PPM= (mgm3
) (2445 ) I Molecular Weight of Chlorine Dioxide PPM = (mgiL) (1000) (2445) I Molecular Weight of Chlorine Dioxide CD ppm = (mgL) (1000Lm3
) (2445) I 675 CD ppm = 3622 1 mgL
For 029 mgiL CD ppm = 3622029 mgiL = 105 ppm
The number 2445 in the equations above is the volume (liters) of a mole (gram molecularweight) of a gas at 1 atmosphere and at 25degC 675 =molecular weight ofCl02
Environmental Assessment for Food Contact Notification FCN 1665 httpwwwfdagovFoodIngredientsPackagingLabelingEnvironmentalDecisionsdefaulthtm
Clordisys Solutions Inc Page 28 of 51
Thus it can be estimated that even in a worst case scenario potential air releases do not middot
pose a threat at the levels that may be released The ecotoxicity value of 029 mgL (1 05
ppm) is much higher than EEC value of 3 ppm
b Water
Since no wastewater or discharged processing water will be involved with the
application of the FCS proposed in this FCN no FCS or its degradation products
will be present in either of these water sources
9 Use of Resources and Energy The production of the FCS using the method described in this FCN will replace existing
methods of generation and is not expected to result in an increased use of natural
resources
10 Mitigation Measures Since no environmental effects are anticipated with respect to use of this FCS mitigation
measures are not required
11 Alternatives to the Proposed Action Alternatives to this proposed action are not required since no potential adverse environmental impacts have been identified If the requested action should not go forward treatment with chlorine would most likely be the substituted method
12 List of Preparers This EA was prepared by Paul Lorcheim Director of Operations BS Electrical
Engineering Professional Engineer Daniel Paznek Project Engineer BS Biochemical
Engineering Kevin Lorcheim Engin~er BS Mechanical Engineering
Environmental Assessment for Food Contact Notification FCN 1665 httpwwwfdagovFoodIngredientsPackagingLabelingEnvironmentalDecisionsdefaulthtm
Clordisys Solutions Inc Page 29 of 51
13 Certification The undersigned certifies that the information presented is true accurate and complete to
the best knowledge of all preparers
Name fA--vL Lopoundctnn~
Title Director of Operations SignatureDate 7 It (
Name Kev Lcvcht 7 Title Engineer Signature
Date 7--G
Name i) (I Pcz-( )( Title Project_EJlgi~r
Signature
Date 7r J1b
Environmental Assessment for Food Contact Notification FCN 1665 httpwwwfdagovFoodIngredientsPackagingLabelingEnvironmentalDecisionsdefaulthtm
Clordisys Solutions Inc Page 30 of 51
References
I US Patent No 6824 756 B2 Rosenblatt et al Process for manufacturing and using a more stable formulation of sodium chlorite Nov 30 2004
2 Toxicological Profile for Chlorine Dioxide and Chlorite Agency for Toxic Substances and Disease Registry http wwwatsdrcdcgovtoxprofilestp 160pdf
3 Chlorine Dioxide Final Risk Assessment Case 4023 August 2006 EPA Docket Number EPA-HQ-OPPshy2006-0328-017 available at http www regulationsgov documentDetail D=EP A-H Q-OPP-2006-0328-00 17
4 US Environmental Protection Agency Reregistration Eligibility Decision (RED) for Chlorine Dioxide and Sodium Chlorite (Case 4023) August 2006 Available at http www epagovoppsrrd 1REDschlorine _dioxide _red pdf
Environmental Assessment for Food Contact Notification FCN 1665 httpwwwfdagovFoodIngredientsPackagingLabelingEnvironmentalDecisionsdefaulthtm
Clordisys Solutions Inc Page 25 of 51
than the production of FDA-regulated articles Information available to the Notifier suggests no extraordinary circumstances suggesting an adverse environmental impact as a result of the manufacture of the antimicrobial agent Consequently information on the manufacturing site and compliance with the relevant emissions requirements is not provided here
b Use Releases
The FCS that is the subject of this FCN is intended to be released into closed environments containing fruits and vegetabks for treatment
In the method proposed by this FCN the generation chemistry of chlorine dioxide production is as follows
2NaC102Cs) + Cb (g) ~ 2Cl02 (g)+ NaClcs) middot Chlorine gas is passed through a matrix of solid sodium chlorite flakes to produce
a high purity chlorine dioxide gas which will be applied to closed environments such as drying rooms holding rooms storage rooms freezers etc
The only byproduct formed as a result of this generation chemistry is sodium chloride (NaCl) This will not be present in the gaseous stream as it will stay as a solid in the reaction cartridge Potential releases from the use of this Food Contact Substance to both water and air are discussed below
Chlorite may be expected to form as a degradation product on the surface of food treated with the FCS Food treated with the FCS may be consumed without a mitigation step or may be subject to blanching cooking or canning However since chlorite is expected to decompose during blanching cooking or canning and treated food not subject to a mitigation step post application of the FCS will be ingested by the consumer without the opportunity for release into the environment (ie no aqueous rinse step) we do not expect any environmental releases of chlorite from the proposed use
c Water Releases Since no wastewater or discharged processing water will be involved with the
application of the FCS proposed in this FCN no FCS or its degradation products will be present in either of these water sources
d Air Releases middot
Since the FCS is intended to be released into closed environments air releases will occur primarily due to unreacted FCS after treatment Since the generation of chlorine dioxide gas will be contained and the treatment areas will be sealed possible air releases will occur only when venting the closed treatment areas As stated in the toxicological profile of Chlorine Dioxide and Chlorite chlorine dioxide gas is an
Environmental Assessment for Food Contact Notification FCN 1665 httpwwwfdagovFoodIngredientsPackagingLabelingEnvironmentalDecisionsdefaulthtm
Clordisys Solutions Inc Page 26 of 51
unstable gas that rapidly decomposes in air It can decompose to chlorine and oxygen with exposure to mild heat and will decompose upon exposure to sunlight3
Due to this photodegradation release of the FCS into the atmosphere is not expected to pose any adverse environmental effects As a worst case scenario the EEC value for purposes of this Food Contact Notice will be the use concentration of 3 ppm middot
7 Environmental Fate of Substances Released into the Environment a Air
Since the FCS is intended to be released into closed environments air releases will occur primarily due to unreacted FCS after treatment Since the generation of chlorine dioxide gas will be contained and the treatment areas will be sealed
possible air releases will occur only when venting the closed treatment areas If this occurs the chlorine dioxide will be rapidly diluted by the surrounding air and also undergo photodecomposition to molecular chlorine and oxygen chlorine will be further reduced to chloride in the presence of UV light Therefore it is estimated that chlorine dioxide releases to air will ultimately result in the formation of chloride As stated in the Final Risk Assessment for Chlorine dioxide Case 4023 as conducted by the US Environmental Protection Agency Chlorine dioxide has a short half-life and in the presence of sunlight and will break down into chloride and chlorate ions (between pH 4 and 7) At pH lower than 4 its breakdown products are chlorite and chlorate Chlorite is the dominant breakdown product Ultimately oxygen is formed
b Water Releases Since no wastewater or discharged processing water will be involved with the application of the FCS proposed in this FCN no FCS or its degradation products will be present in either of these water sources
8 Environmental Effects of Released Substances a Air
It is estimated that there will be no significant environmental impact for an air
release of chlorine dioxide This is due to a relatively low potential for release of chlorine dioxide into the air by use of the FCS in the way as stated in this FCN as well as the decomposition and dilution of chlorine dioxide in air
Table f Acute toxicit)lprofilefor Sodium chlorite and Ch lorin e dioxide
3 Toxicological Profile for Chlodne Dioxide and Chlorite Agency for Toxic Substances and Disease Registry
httpwwwatsd rcdcgov toxprofilestp160pdf
Environmental Assessment for Food Contact Notification FCN 1665 httpwwwfdagovFoodIngredientsPackagingLabelingEnvironmentalDecisionsdefaulthtm
Clordisys Solutions Inc Page 27 of 51
D9te Study Type MRID Species Results Toxicity Categorv
1982 Acute oral (79 chlorine dioxide)
43558601 Rat LD50 = 292 mglkg (males) LD50 = 340 mglkg (females)
II
1985 Acute dermal (80 sodium chlorite)
40168704 Rabbit LD50 gt 2000 mgkg
III
1992 Acute inhalation (806 sodium chlorite)
42484101 Rat LC50 = 029 mgiL
II
1994 Primary eye irritation (2 chlorine dioxide)
43441903 Rabbit Mild irritant III
1985 Primary dermal irritation (80 sodium chlorite)
40168704 Rabbit Primary irritant II
Table reprinted from USEPA Reregistration Eligibility Decision (RED) for Chlorine Dwxide and Sodmm Chlonte case 4023
To estimate an air release concentration we will use the application concentration stated in this FCN (3 ppm) as an estimate for the environmental concentration (EEC) This number will serve as a worst case scenario estimate since an actual environmental release would be less due to organic demand of foodstuffs dilution due to HV AC venting and photodecomposition in the open atmosphere
As shown in the table above the acute inhalation ( ecotoxicity value) LC50 for rats is 029 mgL which is equivalent to 105 ppm as shown in the calculation below
PPM calculation for 1 mgJL of Chlorine Dioxide Gas PPM= (mgm3
) (2445 ) I Molecular Weight of Chlorine Dioxide PPM = (mgiL) (1000) (2445) I Molecular Weight of Chlorine Dioxide CD ppm = (mgL) (1000Lm3
) (2445) I 675 CD ppm = 3622 1 mgL
For 029 mgiL CD ppm = 3622029 mgiL = 105 ppm
The number 2445 in the equations above is the volume (liters) of a mole (gram molecularweight) of a gas at 1 atmosphere and at 25degC 675 =molecular weight ofCl02
Environmental Assessment for Food Contact Notification FCN 1665 httpwwwfdagovFoodIngredientsPackagingLabelingEnvironmentalDecisionsdefaulthtm
Clordisys Solutions Inc Page 28 of 51
Thus it can be estimated that even in a worst case scenario potential air releases do not middot
pose a threat at the levels that may be released The ecotoxicity value of 029 mgL (1 05
ppm) is much higher than EEC value of 3 ppm
b Water
Since no wastewater or discharged processing water will be involved with the
application of the FCS proposed in this FCN no FCS or its degradation products
will be present in either of these water sources
9 Use of Resources and Energy The production of the FCS using the method described in this FCN will replace existing
methods of generation and is not expected to result in an increased use of natural
resources
10 Mitigation Measures Since no environmental effects are anticipated with respect to use of this FCS mitigation
measures are not required
11 Alternatives to the Proposed Action Alternatives to this proposed action are not required since no potential adverse environmental impacts have been identified If the requested action should not go forward treatment with chlorine would most likely be the substituted method
12 List of Preparers This EA was prepared by Paul Lorcheim Director of Operations BS Electrical
Engineering Professional Engineer Daniel Paznek Project Engineer BS Biochemical
Engineering Kevin Lorcheim Engin~er BS Mechanical Engineering
Environmental Assessment for Food Contact Notification FCN 1665 httpwwwfdagovFoodIngredientsPackagingLabelingEnvironmentalDecisionsdefaulthtm
Clordisys Solutions Inc Page 29 of 51
13 Certification The undersigned certifies that the information presented is true accurate and complete to
the best knowledge of all preparers
Name fA--vL Lopoundctnn~
Title Director of Operations SignatureDate 7 It (
Name Kev Lcvcht 7 Title Engineer Signature
Date 7--G
Name i) (I Pcz-( )( Title Project_EJlgi~r
Signature
Date 7r J1b
Environmental Assessment for Food Contact Notification FCN 1665 httpwwwfdagovFoodIngredientsPackagingLabelingEnvironmentalDecisionsdefaulthtm
Clordisys Solutions Inc Page 30 of 51
References
I US Patent No 6824 756 B2 Rosenblatt et al Process for manufacturing and using a more stable formulation of sodium chlorite Nov 30 2004
2 Toxicological Profile for Chlorine Dioxide and Chlorite Agency for Toxic Substances and Disease Registry http wwwatsdrcdcgovtoxprofilestp 160pdf
3 Chlorine Dioxide Final Risk Assessment Case 4023 August 2006 EPA Docket Number EPA-HQ-OPPshy2006-0328-017 available at http www regulationsgov documentDetail D=EP A-H Q-OPP-2006-0328-00 17
4 US Environmental Protection Agency Reregistration Eligibility Decision (RED) for Chlorine Dioxide and Sodium Chlorite (Case 4023) August 2006 Available at http www epagovoppsrrd 1REDschlorine _dioxide _red pdf
Environmental Assessment for Food Contact Notification FCN 1665 httpwwwfdagovFoodIngredientsPackagingLabelingEnvironmentalDecisionsdefaulthtm
Clordisys Solutions Inc Page 26 of 51
unstable gas that rapidly decomposes in air It can decompose to chlorine and oxygen with exposure to mild heat and will decompose upon exposure to sunlight3
Due to this photodegradation release of the FCS into the atmosphere is not expected to pose any adverse environmental effects As a worst case scenario the EEC value for purposes of this Food Contact Notice will be the use concentration of 3 ppm middot
7 Environmental Fate of Substances Released into the Environment a Air
Since the FCS is intended to be released into closed environments air releases will occur primarily due to unreacted FCS after treatment Since the generation of chlorine dioxide gas will be contained and the treatment areas will be sealed
possible air releases will occur only when venting the closed treatment areas If this occurs the chlorine dioxide will be rapidly diluted by the surrounding air and also undergo photodecomposition to molecular chlorine and oxygen chlorine will be further reduced to chloride in the presence of UV light Therefore it is estimated that chlorine dioxide releases to air will ultimately result in the formation of chloride As stated in the Final Risk Assessment for Chlorine dioxide Case 4023 as conducted by the US Environmental Protection Agency Chlorine dioxide has a short half-life and in the presence of sunlight and will break down into chloride and chlorate ions (between pH 4 and 7) At pH lower than 4 its breakdown products are chlorite and chlorate Chlorite is the dominant breakdown product Ultimately oxygen is formed
b Water Releases Since no wastewater or discharged processing water will be involved with the application of the FCS proposed in this FCN no FCS or its degradation products will be present in either of these water sources
8 Environmental Effects of Released Substances a Air
It is estimated that there will be no significant environmental impact for an air
release of chlorine dioxide This is due to a relatively low potential for release of chlorine dioxide into the air by use of the FCS in the way as stated in this FCN as well as the decomposition and dilution of chlorine dioxide in air
Table f Acute toxicit)lprofilefor Sodium chlorite and Ch lorin e dioxide
3 Toxicological Profile for Chlodne Dioxide and Chlorite Agency for Toxic Substances and Disease Registry
httpwwwatsd rcdcgov toxprofilestp160pdf
Environmental Assessment for Food Contact Notification FCN 1665 httpwwwfdagovFoodIngredientsPackagingLabelingEnvironmentalDecisionsdefaulthtm
Clordisys Solutions Inc Page 27 of 51
D9te Study Type MRID Species Results Toxicity Categorv
1982 Acute oral (79 chlorine dioxide)
43558601 Rat LD50 = 292 mglkg (males) LD50 = 340 mglkg (females)
II
1985 Acute dermal (80 sodium chlorite)
40168704 Rabbit LD50 gt 2000 mgkg
III
1992 Acute inhalation (806 sodium chlorite)
42484101 Rat LC50 = 029 mgiL
II
1994 Primary eye irritation (2 chlorine dioxide)
43441903 Rabbit Mild irritant III
1985 Primary dermal irritation (80 sodium chlorite)
40168704 Rabbit Primary irritant II
Table reprinted from USEPA Reregistration Eligibility Decision (RED) for Chlorine Dwxide and Sodmm Chlonte case 4023
To estimate an air release concentration we will use the application concentration stated in this FCN (3 ppm) as an estimate for the environmental concentration (EEC) This number will serve as a worst case scenario estimate since an actual environmental release would be less due to organic demand of foodstuffs dilution due to HV AC venting and photodecomposition in the open atmosphere
As shown in the table above the acute inhalation ( ecotoxicity value) LC50 for rats is 029 mgL which is equivalent to 105 ppm as shown in the calculation below
PPM calculation for 1 mgJL of Chlorine Dioxide Gas PPM= (mgm3
) (2445 ) I Molecular Weight of Chlorine Dioxide PPM = (mgiL) (1000) (2445) I Molecular Weight of Chlorine Dioxide CD ppm = (mgL) (1000Lm3
) (2445) I 675 CD ppm = 3622 1 mgL
For 029 mgiL CD ppm = 3622029 mgiL = 105 ppm
The number 2445 in the equations above is the volume (liters) of a mole (gram molecularweight) of a gas at 1 atmosphere and at 25degC 675 =molecular weight ofCl02
Environmental Assessment for Food Contact Notification FCN 1665 httpwwwfdagovFoodIngredientsPackagingLabelingEnvironmentalDecisionsdefaulthtm
Clordisys Solutions Inc Page 28 of 51
Thus it can be estimated that even in a worst case scenario potential air releases do not middot
pose a threat at the levels that may be released The ecotoxicity value of 029 mgL (1 05
ppm) is much higher than EEC value of 3 ppm
b Water
Since no wastewater or discharged processing water will be involved with the
application of the FCS proposed in this FCN no FCS or its degradation products
will be present in either of these water sources
9 Use of Resources and Energy The production of the FCS using the method described in this FCN will replace existing
methods of generation and is not expected to result in an increased use of natural
resources
10 Mitigation Measures Since no environmental effects are anticipated with respect to use of this FCS mitigation
measures are not required
11 Alternatives to the Proposed Action Alternatives to this proposed action are not required since no potential adverse environmental impacts have been identified If the requested action should not go forward treatment with chlorine would most likely be the substituted method
12 List of Preparers This EA was prepared by Paul Lorcheim Director of Operations BS Electrical
Engineering Professional Engineer Daniel Paznek Project Engineer BS Biochemical
Engineering Kevin Lorcheim Engin~er BS Mechanical Engineering
Environmental Assessment for Food Contact Notification FCN 1665 httpwwwfdagovFoodIngredientsPackagingLabelingEnvironmentalDecisionsdefaulthtm
Clordisys Solutions Inc Page 29 of 51
13 Certification The undersigned certifies that the information presented is true accurate and complete to
the best knowledge of all preparers
Name fA--vL Lopoundctnn~
Title Director of Operations SignatureDate 7 It (
Name Kev Lcvcht 7 Title Engineer Signature
Date 7--G
Name i) (I Pcz-( )( Title Project_EJlgi~r
Signature
Date 7r J1b
Environmental Assessment for Food Contact Notification FCN 1665 httpwwwfdagovFoodIngredientsPackagingLabelingEnvironmentalDecisionsdefaulthtm
Clordisys Solutions Inc Page 30 of 51
References
I US Patent No 6824 756 B2 Rosenblatt et al Process for manufacturing and using a more stable formulation of sodium chlorite Nov 30 2004
2 Toxicological Profile for Chlorine Dioxide and Chlorite Agency for Toxic Substances and Disease Registry http wwwatsdrcdcgovtoxprofilestp 160pdf
3 Chlorine Dioxide Final Risk Assessment Case 4023 August 2006 EPA Docket Number EPA-HQ-OPPshy2006-0328-017 available at http www regulationsgov documentDetail D=EP A-H Q-OPP-2006-0328-00 17
4 US Environmental Protection Agency Reregistration Eligibility Decision (RED) for Chlorine Dioxide and Sodium Chlorite (Case 4023) August 2006 Available at http www epagovoppsrrd 1REDschlorine _dioxide _red pdf
Environmental Assessment for Food Contact Notification FCN 1665 httpwwwfdagovFoodIngredientsPackagingLabelingEnvironmentalDecisionsdefaulthtm
Clordisys Solutions Inc Page 27 of 51
D9te Study Type MRID Species Results Toxicity Categorv
1982 Acute oral (79 chlorine dioxide)
43558601 Rat LD50 = 292 mglkg (males) LD50 = 340 mglkg (females)
II
1985 Acute dermal (80 sodium chlorite)
40168704 Rabbit LD50 gt 2000 mgkg
III
1992 Acute inhalation (806 sodium chlorite)
42484101 Rat LC50 = 029 mgiL
II
1994 Primary eye irritation (2 chlorine dioxide)
43441903 Rabbit Mild irritant III
1985 Primary dermal irritation (80 sodium chlorite)
40168704 Rabbit Primary irritant II
Table reprinted from USEPA Reregistration Eligibility Decision (RED) for Chlorine Dwxide and Sodmm Chlonte case 4023
To estimate an air release concentration we will use the application concentration stated in this FCN (3 ppm) as an estimate for the environmental concentration (EEC) This number will serve as a worst case scenario estimate since an actual environmental release would be less due to organic demand of foodstuffs dilution due to HV AC venting and photodecomposition in the open atmosphere
As shown in the table above the acute inhalation ( ecotoxicity value) LC50 for rats is 029 mgL which is equivalent to 105 ppm as shown in the calculation below
PPM calculation for 1 mgJL of Chlorine Dioxide Gas PPM= (mgm3
) (2445 ) I Molecular Weight of Chlorine Dioxide PPM = (mgiL) (1000) (2445) I Molecular Weight of Chlorine Dioxide CD ppm = (mgL) (1000Lm3
) (2445) I 675 CD ppm = 3622 1 mgL
For 029 mgiL CD ppm = 3622029 mgiL = 105 ppm
The number 2445 in the equations above is the volume (liters) of a mole (gram molecularweight) of a gas at 1 atmosphere and at 25degC 675 =molecular weight ofCl02
Environmental Assessment for Food Contact Notification FCN 1665 httpwwwfdagovFoodIngredientsPackagingLabelingEnvironmentalDecisionsdefaulthtm
Clordisys Solutions Inc Page 28 of 51
Thus it can be estimated that even in a worst case scenario potential air releases do not middot
pose a threat at the levels that may be released The ecotoxicity value of 029 mgL (1 05
ppm) is much higher than EEC value of 3 ppm
b Water
Since no wastewater or discharged processing water will be involved with the
application of the FCS proposed in this FCN no FCS or its degradation products
will be present in either of these water sources
9 Use of Resources and Energy The production of the FCS using the method described in this FCN will replace existing
methods of generation and is not expected to result in an increased use of natural
resources
10 Mitigation Measures Since no environmental effects are anticipated with respect to use of this FCS mitigation
measures are not required
11 Alternatives to the Proposed Action Alternatives to this proposed action are not required since no potential adverse environmental impacts have been identified If the requested action should not go forward treatment with chlorine would most likely be the substituted method
12 List of Preparers This EA was prepared by Paul Lorcheim Director of Operations BS Electrical
Engineering Professional Engineer Daniel Paznek Project Engineer BS Biochemical
Engineering Kevin Lorcheim Engin~er BS Mechanical Engineering
Environmental Assessment for Food Contact Notification FCN 1665 httpwwwfdagovFoodIngredientsPackagingLabelingEnvironmentalDecisionsdefaulthtm
Clordisys Solutions Inc Page 29 of 51
13 Certification The undersigned certifies that the information presented is true accurate and complete to
the best knowledge of all preparers
Name fA--vL Lopoundctnn~
Title Director of Operations SignatureDate 7 It (
Name Kev Lcvcht 7 Title Engineer Signature
Date 7--G
Name i) (I Pcz-( )( Title Project_EJlgi~r
Signature
Date 7r J1b
Environmental Assessment for Food Contact Notification FCN 1665 httpwwwfdagovFoodIngredientsPackagingLabelingEnvironmentalDecisionsdefaulthtm
Clordisys Solutions Inc Page 30 of 51
References
I US Patent No 6824 756 B2 Rosenblatt et al Process for manufacturing and using a more stable formulation of sodium chlorite Nov 30 2004
2 Toxicological Profile for Chlorine Dioxide and Chlorite Agency for Toxic Substances and Disease Registry http wwwatsdrcdcgovtoxprofilestp 160pdf
3 Chlorine Dioxide Final Risk Assessment Case 4023 August 2006 EPA Docket Number EPA-HQ-OPPshy2006-0328-017 available at http www regulationsgov documentDetail D=EP A-H Q-OPP-2006-0328-00 17
4 US Environmental Protection Agency Reregistration Eligibility Decision (RED) for Chlorine Dioxide and Sodium Chlorite (Case 4023) August 2006 Available at http www epagovoppsrrd 1REDschlorine _dioxide _red pdf
Environmental Assessment for Food Contact Notification FCN 1665 httpwwwfdagovFoodIngredientsPackagingLabelingEnvironmentalDecisionsdefaulthtm
Clordisys Solutions Inc Page 28 of 51
Thus it can be estimated that even in a worst case scenario potential air releases do not middot
pose a threat at the levels that may be released The ecotoxicity value of 029 mgL (1 05
ppm) is much higher than EEC value of 3 ppm
b Water
Since no wastewater or discharged processing water will be involved with the
application of the FCS proposed in this FCN no FCS or its degradation products
will be present in either of these water sources
9 Use of Resources and Energy The production of the FCS using the method described in this FCN will replace existing
methods of generation and is not expected to result in an increased use of natural
resources
10 Mitigation Measures Since no environmental effects are anticipated with respect to use of this FCS mitigation
measures are not required
11 Alternatives to the Proposed Action Alternatives to this proposed action are not required since no potential adverse environmental impacts have been identified If the requested action should not go forward treatment with chlorine would most likely be the substituted method
12 List of Preparers This EA was prepared by Paul Lorcheim Director of Operations BS Electrical
Engineering Professional Engineer Daniel Paznek Project Engineer BS Biochemical
Engineering Kevin Lorcheim Engin~er BS Mechanical Engineering
Environmental Assessment for Food Contact Notification FCN 1665 httpwwwfdagovFoodIngredientsPackagingLabelingEnvironmentalDecisionsdefaulthtm
Clordisys Solutions Inc Page 29 of 51
13 Certification The undersigned certifies that the information presented is true accurate and complete to
the best knowledge of all preparers
Name fA--vL Lopoundctnn~
Title Director of Operations SignatureDate 7 It (
Name Kev Lcvcht 7 Title Engineer Signature
Date 7--G
Name i) (I Pcz-( )( Title Project_EJlgi~r
Signature
Date 7r J1b
Environmental Assessment for Food Contact Notification FCN 1665 httpwwwfdagovFoodIngredientsPackagingLabelingEnvironmentalDecisionsdefaulthtm
Clordisys Solutions Inc Page 30 of 51
References
I US Patent No 6824 756 B2 Rosenblatt et al Process for manufacturing and using a more stable formulation of sodium chlorite Nov 30 2004
2 Toxicological Profile for Chlorine Dioxide and Chlorite Agency for Toxic Substances and Disease Registry http wwwatsdrcdcgovtoxprofilestp 160pdf
3 Chlorine Dioxide Final Risk Assessment Case 4023 August 2006 EPA Docket Number EPA-HQ-OPPshy2006-0328-017 available at http www regulationsgov documentDetail D=EP A-H Q-OPP-2006-0328-00 17
4 US Environmental Protection Agency Reregistration Eligibility Decision (RED) for Chlorine Dioxide and Sodium Chlorite (Case 4023) August 2006 Available at http www epagovoppsrrd 1REDschlorine _dioxide _red pdf
Environmental Assessment for Food Contact Notification FCN 1665 httpwwwfdagovFoodIngredientsPackagingLabelingEnvironmentalDecisionsdefaulthtm
Clordisys Solutions Inc Page 29 of 51
13 Certification The undersigned certifies that the information presented is true accurate and complete to
the best knowledge of all preparers
Name fA--vL Lopoundctnn~
Title Director of Operations SignatureDate 7 It (
Name Kev Lcvcht 7 Title Engineer Signature
Date 7--G
Name i) (I Pcz-( )( Title Project_EJlgi~r
Signature
Date 7r J1b
Environmental Assessment for Food Contact Notification FCN 1665 httpwwwfdagovFoodIngredientsPackagingLabelingEnvironmentalDecisionsdefaulthtm
Clordisys Solutions Inc Page 30 of 51
References
I US Patent No 6824 756 B2 Rosenblatt et al Process for manufacturing and using a more stable formulation of sodium chlorite Nov 30 2004
2 Toxicological Profile for Chlorine Dioxide and Chlorite Agency for Toxic Substances and Disease Registry http wwwatsdrcdcgovtoxprofilestp 160pdf
3 Chlorine Dioxide Final Risk Assessment Case 4023 August 2006 EPA Docket Number EPA-HQ-OPPshy2006-0328-017 available at http www regulationsgov documentDetail D=EP A-H Q-OPP-2006-0328-00 17
4 US Environmental Protection Agency Reregistration Eligibility Decision (RED) for Chlorine Dioxide and Sodium Chlorite (Case 4023) August 2006 Available at http www epagovoppsrrd 1REDschlorine _dioxide _red pdf
Environmental Assessment for Food Contact Notification FCN 1665 httpwwwfdagovFoodIngredientsPackagingLabelingEnvironmentalDecisionsdefaulthtm
Clordisys Solutions Inc Page 30 of 51
References
I US Patent No 6824 756 B2 Rosenblatt et al Process for manufacturing and using a more stable formulation of sodium chlorite Nov 30 2004
2 Toxicological Profile for Chlorine Dioxide and Chlorite Agency for Toxic Substances and Disease Registry http wwwatsdrcdcgovtoxprofilestp 160pdf
3 Chlorine Dioxide Final Risk Assessment Case 4023 August 2006 EPA Docket Number EPA-HQ-OPPshy2006-0328-017 available at http www regulationsgov documentDetail D=EP A-H Q-OPP-2006-0328-00 17
4 US Environmental Protection Agency Reregistration Eligibility Decision (RED) for Chlorine Dioxide and Sodium Chlorite (Case 4023) August 2006 Available at http www epagovoppsrrd 1REDschlorine _dioxide _red pdf
Environmental Assessment for Food Contact Notification FCN 1665 httpwwwfdagovFoodIngredientsPackagingLabelingEnvironmentalDecisionsdefaulthtm
