Food

Arsenic in Pear Juice Analytical Results, 2005-2011

Updated February 2012

From 2005 to 2011, FDA analyzed 142 samples of pear juice and pear juice concentrate. Of these, 23 had levels of inorganic arsenic at or above 23 parts per billion (ppb), the level of concern for inorganic arsenic in pear juice. In each of these cases, product was recalled (9), refused entry into the United States (11), or the company received a warning letter (3). 

In those samples where pear juice concentrate was analyzed, a conversion calculation was used to convert the arsenic (total and individual arsenical species) concentrations in the pear juice concentrate to respective concentrations in single strength pear juice. In cases where the single strength concentration for total arsenic was greater than 23 ppb that sample was further analyzed for inorganic arsenic, and in certain cases, organic arsenic (monomethylarsonic acid (MMA) and dimethylarsinic acid (DMA)) concentrations.

FDA is interested in minimizing public exposure to this contaminant and is considering setting a guidance level for inorganic arsenic in pear juice and pear juice concentrate.

In updating this chart, we determined that the original chart posted in October 2011, did not contain the results for 26 samples, including the 23 samples that resulted in recalls, refused entry, or issuance of a warning letter.  We are developing new procedures now to ensure that future postings capture all sample results. 

Product Description Sample Number Fiscal Year Arsenic (As) Concentration (µg/kg or ppb)*1*2 FDA Action
Total As Single Strength Concentration Total As iAs MMA DMA
pear juice concentrate 297451 FY-05 ND ND NA NA NA none
pear juice 421576 FY-08 ND ND NA NA NA none
pear juice 421577 FY-08 6 6 NA NA NA none
pear juice 434571 FY-08 13 13 NA NA NA None
pear juice*3 438968 FY-08 63 63 51 NR NR Recall
pear juice*3 438971 FY-08 66 66 46 NR NR Recall
pear juice 438972 FY-08 33*4 33*4 18 NR NR None
pear juice*3 453798 FY-08 52 52 36 NR NR Recall
pear juice*3 453799 FY-08 35 35 27 NR NR Recall
pear juice*3 453800 FY-08 62 62 I I I None
pear juice concentrate*3 455152 FY-08 360 62 36 NR NR Recall
pear juice concentrate 446174 FY-08 94 16*5 NA NA NA None
pear juice concentrate 453801 FY-08 50*4 9*4 NA NA NA None
pear juice concentrate 455153 FY-08 420 72*5 20 NR NR none
pear juice concentrate*3 455154 FY-08 209 36 8 NR NR none
pear juice concentrate*3 455155 FY-08 299 51 29 NR NR recall
pear juice concentrate*3 455156 FY-08 523 90 60 NR NR recall
pear juice concentrate 455157 FY-08 66 11*5 NA NA NA none
pear juice 455734 FY-08 0 0 NA NA NA none
pear juice concentrate*3 482278 FY-08 514 88 20 58 2 none
pear juice concentrate 461046 FY-08 92 16*5 NA NA NA none
pear juice concentrate*3 461043 FY-08 430 74 37 NR NR recall
pear juice concentrate*3 461044 FY-08 360 62 37 NR NR recall
pear juice concentrate*3 461047 FY-08 336 58 SD SD SD none
pear juice concentrate 461207 FY-08 62 11*5 NA NA NA none
pear juice concentrate 461208 FY-08 63 11*5 NA NA NA none
pear juice concentrate 461209 FY-08 76 13*5 NA NA NA none
pear juice concentrate 461837 FY-08 123 21*5 NA NA NA none
pear juice concentrate 461915 FY-08 38 7*5 NA NA NA none
pear juice concentrate 462012 FY-08 60*4 10*4 NA NA NA none
pear juice concentrate 464464 FY-08 ND ND NA NA NA none
pear juice concentrate 464863 FY-08 55 9 NA NA NA none
pear juice concentrate 465471 FY-08 48 8*5 NA NA NA none
pear juice concentrate 466027 FY-08 101 17*5 NA NA NA none
pear juice concentrate 466029 FY-08 49 8 NA NA NA none
pear juice concentrate 466073 FY-08 14 2 NA NA NA none
pear juice concentrate 470018 FY-08 67 11*5 NA NA NA none
pear juice concentrate 470810 FY-08 69 12*5 NA NA NA none
pear juice concentrate 470811 FY-08 ND ND NA NA NA none
pear juice concentrate 470812 FY-08 422 72*5 10*5 39*5 2 none
pear juice concentrate 470813 FY-08 56 10*5 NA NA NA none
pear juice concentrate 471248 FY-08 41 7*5 NA NA NA none
pear juice concentrate 471348 FY-08 48*4 8*4 NA NA NA none
pear juice 472402 FY-08 ND ND NA NA NA none
pear juice concentrate 473188 FY-08 180 31*5 13*5 10*5 Trace*6 none
pear juice concentrate 473194 FY-08 283 48*5 16*5 29*5 Trace none
pear juice concentrate 473195 FY-08 415 71*5 16*5 50*5 Trace none
pear juice concentrate*3 473419 FY-08 410 70 30 51 2 refused entry
pear juice concentrate 476746 FY-08 53*4 9*4 NA NA NA none
pear juice concentrate 477484 FY-08 43 7 NA NA NA none
pear juice concentrate 477486 FY-08 30 5 NA NA NA none
pear juice concentrate 478054 FY-08 356 61*5 15*5 41*5 Trace none
pear juice concentrate 478066 FY-08 341 58*5 16*5 35*5 2 none
pear juice concentrate 478204 FY-08 92 16*5 NA NA NA none
pear juice concentrate 479721 FY-08 125 21*5 NA NA NA none
pear juice concentrate 479732 FY-08 126 22*5 NA NA NA none
pear juice concentrate*3 481294 FY-08 386 66 NR NR NR none
pear juice concentrate 483530 FY-08 53 9*5 NA NA NA none
pear juice concentrate 478592 FY-08 567 97*5 15*5 50*5 Trace none
pear juice concentrate*3 478594 FY-08 497 85 31 29 Trace refused entry
pear juice concentrate 483513 FY-08 245 42*5 8*5 30*5 1 none
pear juice concentrate 483517 FY-08 505 87*5 16*5 60*5 2 none
pear juice concentrate 483525 FY-08 355 61*5 11*5 39*5 3 none
pear juice concentrate 483528 FY-08 227 39*5 10*5 28*5 3*5 none
pear juice concentrate 470809 FY-08 189 32*5 21*5 ND 2*5 none
pear juice concentrate 473191 FY-08 371 64*5 21*5 34*5 Trace none
pear juice concentrate 477962 FY-08 722 124*5 22*5 88*5 2 none
pear juice concentrate 478074 FY-08 290*4 50*4 19*5 27*5 Trace none
pear juice concentrate 478078 FY-08 358 61*5 23*5 31*5 1 refused entry
pear juice concentrate 474223 FY-08 444 76*5 10*5 62*5 Trace none
pear juice concentrate*3 475075 FY-08 466 80 31 51 Trace refused entry
pear juice concentrate*3 475079 FY-08 498 85 33 59 Trace refused entry
pear juice concentrate*3 476407 FY-08 434 74 32 41 Trace refused entry
pear juice concentrate*3 476408 FY-08 545 93 28 59 Trace refused entry
pear juice concentrate*3 476409 FY-08 424 73 31 38 Trace refused entry
pear juice concentrate*3 476410 FY-08 276 47 31 17 Trace refused entry
pear juice concentrate 482281 FY-09 279 48*5 9*5 38*5 1 none
pear juice concentrate 482571 FY-09 386 66*5 20*5 44*5 1 none
pear juice concentrate 484001 FY-09 143 24*5 NR NR NR none
pear juice concentrate 501038 FY-09 23 4 NA NA NA none
pear juice concentrate*3 485562 FY-09 ND ND NA NA NA none
pear juice concentrate 502205 FY-09 127 22*5 NA NA NA none
pear juice concentrate*3 502270 FY-09 221 38 31 ND ND refused entry
pear juice concentrate 504616 FY-09 ND ND NA NA NA none
pear juice concentrate 513262 FY-09 13 2 NA NA NA none
pear juice concentrate 514666 FY-09 Trace Trace NA NA NA none
pear juice concentrate 526796 FY-09 ND ND NA NA NA none
pear juice concentrate 526803 FY-09 82 14*5 NA NA NA none
pear juice concentrate 531384 FY-09 ND ND NA NA NA none
pear juice concentrate 531394 FY-09 ND ND NA NA NA none
pear juice concentrate 531398 FY-09 ND ND NA NA NA none
pear juice concentrate 548581 FY-09 273*4 47*4 7*5 34*5 1 none
pear juice concentrate 566102 FY-09 46 8*5 NA NA NA none
pear juice concentrate 482567 FY-09 396 68*5 12*5 54*5 1 none
pear juice concentrate 490204 FY-09 159 27*5 19*5 1 Trace none
pear juice concentrate 480047 FY-09 334 57*5 11*5 46*5 1 none
pear juice concentrate*3 500951 FY-09 268 46 28 9 ND refused entry

pear juice concentrate

480075 FY-09 285 49*5 11*5 38*5 1 none
pear juice concentrate 572572 FY-10 42 7*5 NA NA NA none
pear juice concentrate 597297 FY-10 ND ND NA NA NA none
pear juice concentrate 627119 FY-10 47 8*5 NA NA NA none
pear juice concentrate*3 593866 FY-10 169 29 5 28 2 none
pear juice concentrate 638289 FY-10 46 8*5 NA NA NA none
pear juice 637930 FY-11 9 9 NA NA NA none
pear juice 503090 FY-11 18 18 NA NA NA none
pear juice 503110 FY-11 3 3 NA NA NA none
pear juice 638428 FY-11 8 8 NA NA NA none
pear juice 638430 FY-11 9 9 NA NA NA none
pear juice 649643 FY-11 Trace Trace NA NA NA none
pear juice 654795 FY-11 ND ND NA NA NA none
pear juice 663114 FY-11 9 9 NA NA NA none
pear juice 666050 FY-11 9 9 NA NA NA none
pear juice 666379 FY-11 I I NR NR NR none
pear juice 674596 FY-11 ND ND NA NA NA none
pear juice 684703 FY-11 ND ND NA NA NA none
pear juice 684704 FY-11 ND ND NA NA NA none
pear juice 695119 FY-11 10 10 NA NA NA none
pear juice 637932 FY-11 Trace Trace NA NA NA none
pear juice 631799 FY-11 ND ND NA NA NA none
pear juice concentrate 665478 FY-11 27 5*5 NA NA NA none
pear juice concentrate 669042 FY-11 ND ND NA NA NA none
pear juice concentrate 669067 FY-11 56 10*5 NA NA NA none
pear juice concentrate 673918 FY-11 31 5 NA NA NA none
pear juice concentrate 679332 FY-11 ND ND NA NA NA none
pear juice concentrate 697790 FY-11 ND ND NA NA NA none
pear juice concentrate 671277 FY-11 149 26*5 18*5 ND ND none
Data from new 2011 samples unavailable for October 12, 2011 posting. 
pear juice concentrate 671270 FY-11 344 59 50 ND ND warning letter
pear juice concentrate 671271 FY-11 72 12 NA NA NA none
pear juice concentrate 671272 FY-11 84 14 NA NA NA none
pear juice concentrate 671273 FY-11 28 5 NA NA NA none
pear juice concentrate 671274 FY-11 34 6 NA NA NA none
pear juice concentrate 671275 FY-11 45 8 NA NA NA none
pear juice concentrate 671276 FY-11 60 10 NA NA NA none
pear juice 685559 FY-11 19 19 NA NA NA none
pear juice 702365 FY-11 9 9 NA NA NA none
pear juice 703456 FY-11 Trace Trace NA NA NA none
pear juice concentrate 704951 FY-11 78 13 NA NA NA none
pear juice concentrate 704952 FY-11 269 46 34 ND 2 warning letter
pear juice concentrate 704953 FY-11 109 19 NA NA NA none
pear juice concentrate 704954 FY-11 171 29 24 ND 1 warning letter
pear juice concentrate 668174 FY-11 177 30 NR NR NR none
pear juice 699572 FY-11 10 10 NA NA NA none

*1 List of abbreviations used in the table:

iAs – the sum of Arsenite (AsIII) and Arsenate (AsV)

MMA –Monomethylarsonic Acid

DMA – Dimethylarsinic Acid

NA – not applicable (total arsenic was below 23 ppb and, therefore, sample was not speciated)

NR – not reported (sample was not analyzed and, therefore, results are not reported)

ND – not detected

I – inconclusive

SD – sample damaged

*2The sum of all arsenic species detected may not add up to 100% of total arsenic due to the inherent experimental variability in the different methods used for the two types of analyses.

*3Sample that was not included in the original version that posted on October 12, 2011.

*4Revised value from last posting to correct transcribing error.

*5 Revised value from last posting.  For the February 2012 posting, the calculations for converting total arsenic, iAs, MMA, and DMA concentrations in pear juice concentrate to single strength juice were updated to use a µg/kg basis rather than a µg/L basis for the calculation. This resulted in changes for single strength concentrations for 51 of the samples.

*6Trace – < Limit of Quantitation (LOQ) and > Limit of Detection (LOD)

Note: The conversion calculation used to convert total arsenic, iAs, MMA, and DMA concentration in pear juice concentrate to total arsenic, iAs, MMA, and DMA concentration in single strength juice assumes a pear juice concentrate at 70oBrix and single strength pear juice at 12oBrix (see sample calculation below).

Sample Calculation of Total Arsenic Level in Single Strength Pear Juice from Level in Concentrate using Pear Juice Concentrate Found to Contain 94 ppb Total Arsenic as an Example (FACTS Sample 446174).

Pear juice concentrate: 70oBrix, specific gravity 1.34956 found to contain 94 ppb total arsenic

Single strength pear juice: 12oBrix, specific gravity 1.04831

1. To calculate the amount of pear juice solids required to make 100 gallons of single strength apple juice (12oBrix).

100 gallons * 8.3283 lbs/gallon (water) * 1.04831* 0.12 = 104.7677 lbs of pear juice solids

2. To calculate the amount of pear juice concentrate (70oBrix) necessary to provide 104.7677 lbs of pear juice solids:

X gallons * 8.3283 lbs/gallon (water) * 1.34956* 0.7 = 104.7677 lbs of pear juice solids, Solving for X, gives the following result 13.32 gallons

3. The weight of 13.32 gallons of 70 ºBrix pear juice concentrate is calculated as follows:

13.32 gallons x 8.3283 lbs/gallon (water) x 1.34956 = 149.71 lbs

4. The weight of 100 gallons of single strength pear juice (12 ºBrix) into which 149.71 lbs of pear juice concentrate (70 ºBrix) is used is calculated as follows:

100 gallons x 8.3283 lbs/gallon (water) x 1.04831 = 873.06 lbs

5. The percentage by weight of the pear juice concentrate (70 ºBrix) in the single strength pear juice (12 ºBrix) is calculated as follows:

149.71 lbs/873.06 lbs x 100 = 17.15%

6. The amount of total arsenic in ppb in 873.064 lbs of single strength pear juice (12 ºBrix) due to addition of 149.7107 lbs of pear juice concentrate (70 ºBrix) containing 94 ppb total arsenic is calculated as follows:

94 ppb total arsenic x 0 .1715 = 16 ppb total arsenic

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