Arsenic in Pear Juice Analytical Results from 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 that resulted in product recalls (9), refusal of entry into the United States (11), or the company receiving 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 some cases in which there was a high single strength concentration for total arsenic 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
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