1 Food Safety and Inspection Service (FSIS) Low-Penetration and Low-Dose E-beam Irradiation as a Processing Aid Public Meeting September 18, 2008

1

Food Safety and Food Safety and Inspection Service Inspection Service

(FSIS)(FSIS)Low-Penetration and Low-Dose E-Low-Penetration and Low-Dose E-

beam Irradiation as a Processing Aidbeam Irradiation as a Processing Aid

Public MeetingPublic Meeting

September 18, 2008September 18, 2008

2

Low-Penetration and Low-Dose E-beam Low-Penetration and Low-Dose E-beam Irradiation as a Processing AidIrradiation as a Processing Aid

The Food Safety and Inspection The Food Safety and Inspection Service (FSIS) is announcing that it Service (FSIS) is announcing that it has received a petition from the has received a petition from the American Meat Institute (AMI) to American Meat Institute (AMI) to recognize the use of low penetration recognize the use of low penetration and low dose electron beam and low dose electron beam irradiation on the surface of chilled irradiation on the surface of chilled beef carcasses as a processing aid. beef carcasses as a processing aid.

3


One form of radiant energy used One form of radiant energy used commercially is electron beam (e-beam). commercially is electron beam (e-beam). Energy from accelerated electrons is Energy from accelerated electrons is absorbed as they enter the surface of the absorbed as they enter the surface of the product being irradiated. The electrons product being irradiated. The electrons cause chemical bond breakage in the cause chemical bond breakage in the microorganisms, immediately, in addition microorganisms, immediately, in addition to damaging their deoxyribonucleic acid to damaging their deoxyribonucleic acid (DNA) (DNA)

4


In 1999, FSIS amended its regulations In 1999, FSIS amended its regulations (64 FR 72168, December 23, 1999) to (64 FR 72168, December 23, 1999) to permit the use of ionizing radiation for permit the use of ionizing radiation for treating refrigerated or frozen, treating refrigerated or frozen, uncooked meat, meat by products, and uncooked meat, meat by products, and certain other meat food products to certain other meat food products to reduce levels of foodborne pathogens reduce levels of foodborne pathogens and to extend shelf-life. and to extend shelf-life.

The FSIS requires labeling of meat and The FSIS requires labeling of meat and meat food products that have been meat food products that have been irradiated. irradiated.

5


Under FDA’s regulations, processing aids Under FDA’s regulations, processing aids include substances that are added to a include substances that are added to a food for their technical or functional effect food for their technical or functional effect during processing but are present in the during processing but are present in the finished food at insignificant levels and do finished food at insignificant levels and do not have any technical or functional effect not have any technical or functional effect in that food (21 CFR §101.100 (a)(3)(ii)(in that food (21 CFR §101.100 (a)(3)(ii)(cc)). )).

FDA’s regulations provide that processing FDA’s regulations provide that processing aids are not required to be included on aids are not required to be included on product labels. product labels.

6


On July 8, 2005, AMI submitted a On July 8, 2005, AMI submitted a citizen’s petition to FSIS requesting citizen’s petition to FSIS requesting that the Agency officially recognize low that the Agency officially recognize low dose, low penetration e-beam dose, low penetration e-beam irradiation applied to the surface of irradiation applied to the surface of chilled beef carcasses as a processing chilled beef carcasses as a processing aid.aid.

The petition requested that information The petition requested that information concerning irradiation treatment not be concerning irradiation treatment not be required on the label of any products required on the label of any products derived from the carcass. derived from the carcass.

7


The petition argues that low dose (≤ The petition argues that low dose (≤ 1.0 kGy surface dose), low penetration 1.0 kGy surface dose), low penetration (20mm) e-beam irradiation is a (20mm) e-beam irradiation is a processing aid because the electron processing aid because the electron beam has a functional effect of beam has a functional effect of reducing pathogens on the carcass reducing pathogens on the carcass surface, but that once the energy from surface, but that once the energy from the electrons is absorbed, there were the electrons is absorbed, there were no further functional effects from the no further functional effects from the irradiation. irradiation.

8


According to the petition, low dose, According to the petition, low dose, low penetration e-beam application low penetration e-beam application results in only a small portion of the results in only a small portion of the carcass receiving the e-beam carcass receiving the e-beam irradiation exposure.irradiation exposure.

9


The petition presents evidence that The petition presents evidence that the use of e-beam irradiation is the use of e-beam irradiation is effective in reducing levels of effective in reducing levels of Escherichia coliEscherichia coli O157:H7 on the O157:H7 on the carcass; carcass;

has no effect on organoleptic has no effect on organoleptic properties or appearance of the properties or appearance of the carcass; carcass;

10


has no lasting effect on shelf life of has no lasting effect on shelf life of the carcass or of product derived the carcass or of product derived from the carcass; from the carcass;

and produces no significant loss of and produces no significant loss of either macro- or micro-nutrients in either macro- or micro-nutrients in the carcass or the product derived the carcass or the product derived from the carcass. from the carcass.

11

E. coliE. coli O157:H7 O157:H7

In an Arthur et al 2004 study, In an Arthur et al 2004 study, E. coliE. coli O157:H7 was found on 76% of beef cattle O157:H7 was found on 76% of beef cattle animal hides.animal hides.

In a McEvoy et al 2003 study, results In a McEvoy et al 2003 study, results showed that showed that E. coliE. coli O157:H7 can be O157:H7 can be transferred to beef carcasses during hide transferred to beef carcasses during hide removal.removal.

There is a high probability that irradiation There is a high probability that irradiation of beef carcasses could eliminate of beef carcasses could eliminate E. coliE. coli O157:H7 from the beef carcasses.O157:H7 from the beef carcasses.

12

The Process is Effective at Reducing Levels of The Process is Effective at Reducing Levels of E. coliE. coli O157:H7 O157:H7

The USDA Agricultural Research The USDA Agricultural Research Service’s Meat Animal Research Service’s Meat Animal Research Center (MARC) conducted a study Center (MARC) conducted a study on the effectiveness of low-dose, low on the effectiveness of low-dose, low penetration e-beam irradiation in penetration e-beam irradiation in reducing levels of reducing levels of E. coliE. coli O157:H7 O157:H7 on chilled beef carcass surface cuts. on chilled beef carcass surface cuts.

13


Forty cutaneous trunci pieces were Forty cutaneous trunci pieces were inoculated with inoculated with E. coli E. coli O157:H7O157:H7

Twenty with a high concentration of Twenty with a high concentration of 6 log cfu/cm2 (high inoculation) and 6 log cfu/cm2 (high inoculation) and

Twenty with a low concentration of 3 Twenty with a low concentration of 3 log cfu/cm2 (low inoculation) log cfu/cm2 (low inoculation)

14


One half of the high inoculated and One half of the high inoculated and low inoculated samples were treated low inoculated samples were treated with surface dosage of 1 kGy with with surface dosage of 1 kGy with approximately 15 mm of penetration. approximately 15 mm of penetration.

The remaining samples were not The remaining samples were not treated. treated.

15


Results for direct cell count plating show Results for direct cell count plating show that the that the E. coliE. coli O157:H7 contamination O157:H7 contamination of the untreated samples remained of the untreated samples remained around the high inoculation level (7.2 around the high inoculation level (7.2 logs after attachment, 6.6 logs at 48 logs after attachment, 6.6 logs at 48 hours and 5.9 logs at 120 hours) hours and 5.9 logs at 120 hours)

E. coliE. coli O157:H7 was undetectable after O157:H7 was undetectable after 48 hours in irradiated samples that had 48 hours in irradiated samples that had been inoculated at the high level and was been inoculated at the high level and was present at approximately 0.1 log after present at approximately 0.1 log after 120 hours. 120 hours.

16


Results for direct cell count plating show Results for direct cell count plating show that while the that while the E. coliE. coli O157:H7 O157:H7 contamination of the untreated samples contamination of the untreated samples remained around the low inoculation level remained around the low inoculation level (3.9 logs after attachment, 2.9 logs after (3.9 logs after attachment, 2.9 logs after 48 hours, and 2.6 logs after 120 hours) 48 hours, and 2.6 logs after 120 hours)

For the low inoculation level, the For the low inoculation level, the irradiation treated samples were irradiation treated samples were undetectable for undetectable for E. coliE. coli O157:H7 after 48 O157:H7 after 48 and 120 hours. and 120 hours.

17


The results of the Most Probable The results of the Most Probable Number (MPN) analysis were similar Number (MPN) analysis were similar to that from direct plating to that from direct plating

There was no low-inoculation sample There was no low-inoculation sample at 48 hours and only one low-at 48 hours and only one low-inoculation sample at 120 hours that inoculation sample at 120 hours that had a MPN value above the limit of had a MPN value above the limit of detection (minimum level of detection (minimum level of detection was 0.036 CFU/cm2) detection was 0.036 CFU/cm2)

All of the high-inoculation samples All of the high-inoculation samples were above the limit of detectionwere above the limit of detection

18

The Process does not have any Effect on The Process does not have any Effect on Quality or AppearanceQuality or Appearance

The MARC’s study also addressed The MARC’s study also addressed effects of low dose, low penetration effects of low dose, low penetration e-beam process on organoleptic e-beam process on organoleptic properties of treated product. properties of treated product.

In MARC’s assessment of In MARC’s assessment of organoleptic impact, the flank steak organoleptic impact, the flank steak was used as the model muscle. was used as the model muscle.

19


None of the flank steak sensory None of the flank steak sensory attributes (aroma intensity, off-attributes (aroma intensity, off-aroma, tenderness, juiciness, flavor aroma, tenderness, juiciness, flavor intensity, and off-flavor) were intensity, and off-flavor) were affected by any penetration affected by any penetration treatment (10%-75% penetration). treatment (10%-75% penetration).

20


Three Hunter Color measurements Three Hunter Color measurements (lightness, redness, and yellowness) (lightness, redness, and yellowness) were made in the MARC study, and were made in the MARC study, and all showed some treatment effects. all showed some treatment effects.

the effects on lightness and the effects on lightness and yellowness were not linear with yellowness were not linear with dose, and thus the investigators did dose, and thus the investigators did not consider them to be meaningful not consider them to be meaningful treatment-related differences. treatment-related differences.

21

The Process does not have any Effect on The Process does not have any Effect on

Quality or AppearanceQuality or Appearance

The effects of treatment on redness The effects of treatment on redness values were linear. However, the values were linear. However, the researchers concluded that the researchers concluded that the magnitude of the effect was slight magnitude of the effect was slight and would likely have no impact on and would likely have no impact on consumer acceptance. consumer acceptance.

22

The Process does not have an Effect on Shelf-The Process does not have an Effect on Shelf-LifeLife

A study of the effects of low dose, A study of the effects of low dose, low-penetration e-beam surface low-penetration e-beam surface exposure on the shelf life of beef was exposure on the shelf life of beef was performed by Silliker Inc. performed by Silliker Inc.

23


Six beef plates were designated “air-Six beef plates were designated “air-exposed,” and three of these six were left exposed,” and three of these six were left untrimmed. untrimmed.

Six beef plates were designated “vac-Six beef plates were designated “vac-pac,” and all were trimmed. pac,” and all were trimmed.

Six of these twelve were treated with low Six of these twelve were treated with low level (1 kGy), low penetration (15 mm) level (1 kGy), low penetration (15 mm) surface e-beam irradiation. surface e-beam irradiation.

The other six were left untreated as The other six were left untreated as controls. controls.

24


After the six beef plates were After the six beef plates were irradiated, the irradiated and control irradiated, the irradiated and control plates were randomly subdivided plates were randomly subdivided into four equal segments. into four equal segments.

Each segment was allocated into Each segment was allocated into time slots of 1, 3, 6, and 9 days for time slots of 1, 3, 6, and 9 days for air exposed, and 1, 10, 20 and 30 air exposed, and 1, 10, 20 and 30 days for vac-pac. days for vac-pac.

25


Microbiological tests were performed Microbiological tests were performed at each measurement time: at each measurement time:

Total aerobic plate count (APC) (35°C Total aerobic plate count (APC) (35°C with aerobic atmosphere), with aerobic atmosphere),

Hetero- and homo-lactic acid bacteria Hetero- and homo-lactic acid bacteria (LAB) (30°C with micro-aerobic (LAB) (30°C with micro-aerobic atmosphere), atmosphere),

26

The Process does not have an Effect on The Process does not have an Effect on Shelf-LifeShelf-Life

Total coliforms (35°C with aerobic Total coliforms (35°C with aerobic atmosphere), and Biotype I atmosphere), and Biotype I E. coliE. coli (35-45°C with aerobic atmosphere). (35-45°C with aerobic atmosphere).

To provide a measure of oxidative To provide a measure of oxidative rancidity, thiobarbituric acid (TBA) rancidity, thiobarbituric acid (TBA) was analyzed throughout shelf life.was analyzed throughout shelf life.

27


For APC, LAB, and total coliform counts For APC, LAB, and total coliform counts of air-exposed beef after nine days, the of air-exposed beef after nine days, the irradiated samples were within 1.5 logs irradiated samples were within 1.5 logs of the non-irradiated samples. of the non-irradiated samples.

For APC and LAB counts of vacuum For APC and LAB counts of vacuum packed beef after thirty days, the packed beef after thirty days, the irradiated samples were within 1 log of irradiated samples were within 1 log of the non-irradiated samples, while the the non-irradiated samples, while the total coliform counts were equivalent. total coliform counts were equivalent.

28


The vacuum packed beef TBA values The vacuum packed beef TBA values ranged from limited, tolerably oxidized ranged from limited, tolerably oxidized to somewhat oxidized over 30 days of to somewhat oxidized over 30 days of shelf life. shelf life.

The air exposed beef TBA values ranged The air exposed beef TBA values ranged from limited, tolerably oxidized at 2 days from limited, tolerably oxidized at 2 days of shelf life to oxidized at 9 days of shelf of shelf life to oxidized at 9 days of shelf life. life.

All samples were below the range of All samples were below the range of rancidity. rancidity.

29


Based on the results of this study, the Based on the results of this study, the authors believe that the initial authors believe that the initial antimicrobial effects of the treatment antimicrobial effects of the treatment appear to have been minimal, and over appear to have been minimal, and over the course of shelf life, the APC and LAB the course of shelf life, the APC and LAB counts on the surface e-beam treated counts on the surface e-beam treated product increased to the point that product increased to the point that quantitative levels nearly approximated quantitative levels nearly approximated the non-treated controls at the end of the non-treated controls at the end of the storage period. the storage period.

30


In addition, one of the principal In addition, one of the principal measurements of shelf life and product measurements of shelf life and product spoilage—rancidity-–as measured by TBA spoilage—rancidity-–as measured by TBA indicated that the treated samples would indicated that the treated samples would turn rancid slightly before the non-turn rancid slightly before the non-treated controls. treated controls.

These data appear to demonstrate that These data appear to demonstrate that the e-beam surface treatment of beef the e-beam surface treatment of beef plates does not have a lasting effect on plates does not have a lasting effect on the product shelf-life. the product shelf-life.

31

The Process does not produce The Process does not produce significant loses of significant loses of

NutrientsNutrients

A literature review and analysis on A literature review and analysis on the effects of low dose, low-the effects of low dose, low-penetration e-beam irradiation on penetration e-beam irradiation on the levels of micro and macro the levels of micro and macro nutrients was conducted by Dr. nutrients was conducted by Dr. Donald W. Thayer, a retired USDA – Donald W. Thayer, a retired USDA – ARS researcher ARS researcher

32


NutrientsNutrients Concerning macro-nutrients, Dr. Thayer Concerning macro-nutrients, Dr. Thayer

found that there were no significant found that there were no significant differences in the peroxide and iodine differences in the peroxide and iodine values of lipids following irradiation up values of lipids following irradiation up to 10 kGy of the to 10 kGy of the m.m. longissimuslongissimus dorsidorsi of of beef. beef.

Also, there were no significant changes Also, there were no significant changes following irradiation in the following irradiation in the malonaldehyde concentration in beef malonaldehyde concentration in beef m.m. longissimuslongissimus dorsi.dorsi.

33


NutrientsNutrients

Concerning micro-nutrients, Dr. Concerning micro-nutrients, Dr. Thayer found the water soluble Thayer found the water soluble vitamins in beef (niacin, vitamin vitamins in beef (niacin, vitamin B12, chorine, instill, and folacin) B12, chorine, instill, and folacin) were “unaltered.” were “unaltered.”

One water soluble and one fat One water soluble and one fat soluble vitamin (thiamin and soluble vitamin (thiamin and tocopherol) would likely be tocopherol) would likely be decreased. decreased.

34


NutrientsNutrients For these two vitamins, Dr. Thayer For these two vitamins, Dr. Thayer

estimated, worse case, that the estimated, worse case, that the maximum net decrease in the U.S. diet maximum net decrease in the U.S. diet would be only 0.021% for thiamin and would be only 0.021% for thiamin and 0.014% for tocopherol. 0.014% for tocopherol.

Dr. Thayer concluded that “beef carcass Dr. Thayer concluded that “beef carcass surface, low dosage (1.0 kGy) electron surface, low dosage (1.0 kGy) electron beam irradiation will not produce a beam irradiation will not produce a significant loss of either micro- or macro-significant loss of either micro- or macro-nutrients from the U.S. diet.” nutrients from the U.S. diet.”

35

FDAFDA

FSIS has consulted with FDA about this FSIS has consulted with FDA about this issue, and FDA has advised FSIS that, issue, and FDA has advised FSIS that, tentatively, it would not object to tentatively, it would not object to treating low dose, low penetration e-treating low dose, low penetration e-beam irradiation on the surface of beam irradiation on the surface of chilled beef carcasses as a processing chilled beef carcasses as a processing aid. aid.

FDA is still considering this issue and FDA is still considering this issue and will likely consult further with FSIS. will likely consult further with FSIS.

36

FSISFSIS

FSIS has tentatively concluded that FSIS has tentatively concluded that there is merit to consider low dose there is merit to consider low dose (≤1.0 kGy) and low penetration (20 (≤1.0 kGy) and low penetration (20 mm) e-beam irradiation on the mm) e-beam irradiation on the surface of chilled beef carcasses as a surface of chilled beef carcasses as a processing aid. processing aid.

37

FSISFSIS

Data submitted showed that low dose, low Data submitted showed that low dose, low penetration surface e-beam irradiation will penetration surface e-beam irradiation will produce a significant surface reduction of produce a significant surface reduction of E. coliE. coli O157:H7 on chilled beef carcasses. O157:H7 on chilled beef carcasses.

The e-beam treatment does not appear to The e-beam treatment does not appear to have a lasting antimicrobial effect that have a lasting antimicrobial effect that would extend the shelf-life of the products, would extend the shelf-life of the products, and it appears that there is no significant and it appears that there is no significant difference in color, odor, or taste between difference in color, odor, or taste between treated and untreated products. treated and untreated products.

38

FSISFSIS

Relevant studies appear to support the Relevant studies appear to support the assertion that the low dose, low assertion that the low dose, low penetration e-beam irradiation penetration e-beam irradiation treatment would not produce any treatment would not produce any significant changes in the macro and significant changes in the macro and micro nutrient content of the treated micro nutrient content of the treated products.products.

Further, the entire beef carcass is not Further, the entire beef carcass is not irradiated, only the surface of the irradiated, only the surface of the carcass.carcass.

39

Issues to be discussedIssues to be discussed

Is there any additional evidence to Is there any additional evidence to support or contradict the evidence support or contradict the evidence presented in the AMI petition on the presented in the AMI petition on the specific application of a low specific application of a low penetration of 20mm and low penetration of 20mm and low surface dosage of ≤ 1.0 kGy electron surface dosage of ≤ 1.0 kGy electron beam irradiation on the surfaces of beam irradiation on the surfaces of chilled beef carcasses as a chilled beef carcasses as a processing aid? processing aid?

40


Is there any evidence indicating that Is there any evidence indicating that FSIS should consider the cumulative FSIS should consider the cumulative effects of the absorbed dose effects of the absorbed dose delivered in accordance with the delivered in accordance with the AMI petition and any subsequent AMI petition and any subsequent absorbed dose, such as a result of absorbed dose, such as a result of further irradiation of ground beef?further irradiation of ground beef?

41


Should FSIS consider requiring Should FSIS consider requiring irradiation process controls if irradiation process controls if irradiation is considered a irradiation is considered a processing aid? If so, what would processing aid? If so, what would they be and what impact would they they be and what impact would they have on the low dose irradiation of have on the low dose irradiation of chilled carcasses?chilled carcasses?

42


Are there factors that FSIS has not Are there factors that FSIS has not considered? If so, what are they and considered? If so, what are they and what impact would they have?what impact would they have?

Documents

1 Food Safety and Inspection Service (FSIS) Low-Penetration and Low-Dose E-beam Irradiation as a Processing Aid Public Meeting September 18, 2008