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U.S. Department of Health and Human Services

Food

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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