Document ID: EPA-HQ-OPP-2006-0524-0005
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-11-07T05:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF              

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES 

MEMORANDUM

DATE:  	06-FEB-2007

SUBJECT:	Oxytetracycline Chronic Dietary Exposure Assessment to Include
the Revised Projected Percent Crop Treated (PPCT) Estimate for Apple.

PC Code:	006304

DP Barcode:	D335284

REVIEWER:	William H. Donovan, Ph.D., Chemist

Reregistration Branch 3

Health Effects Division (7509P)

THROUGH:	Sheila Piper, Chemist

Dietary Exposure Science Advisory Council (DESAC)

Health Effects Division (7509P)

and

Danette Drew, Branch Senior Scientist

Reregistration Branch 3

Health Effects Division (7509P)

TO:		Shaja Brothers, Risk Manager Reviewer

Risk Integration and Minor Use Emergency Response (RIMUER) Branch

Registration Division (7505P)

			and

		Lance Wormell, Chemical Review Manager

Reregistration Branch 3

Special Review and Registration Division (7508P)

NOTE: This assessment is an update of the previous dietary analysis for
oxytetracycline (D315686, W. Donovan, 06-FEB-2006).  The change included
in the present analysis consists of the use of a PPCT value of 10%
instead of 5% for apples in the chronic analysis.  This change was made
to reflect new information as reported by BEAD (D334459, A. Halvorson,
11-JAN-2006).  

Executive Summary

A chronic dietary risk assessment was conducted using the Dietary
Exposure Evaluation Model (DEEM-FCID(),Version 2.0, which use food
consumption data from the USDA’s Continuing Surveys of Food Intakes by
Individuals (CSFII) from 1994-1996 and 1998.  The assessment was
performed to support the tolerance reregistration eligibility decision
(TRED) for oxytetracycline.

   

Chronic Dietary Exposure Results and Characterization

The chronic analysis used anticipated  residue levels for apples,
peaches (and nectarines), and pears, percent crop treated information as
supplied by BEAD together with default processing factors, and FSIS
monitoring data from 2002, 2003, and 2004 to estimate residue levels in
livestock commodities.  Drinking water was incorporated directly in the
dietary assessment using the chronic estimated drinking water
concentration (EDWC) for surface water generated by the FIRST model.

The resulting chronic dietary exposure estimates using the DEEM-FCID
model were less than or equal to 95% of the cPAD for the U.S. population
and all population subgroups.  Oxytetracycline chronic dietary exposure
(food + water) was estimated at 0.000160 mg/kg/day for the U.S.
population (32% of the cPAD) and 0.000473 mg/kg/day (95% of the cPAD)
for the most highly exposed population subgroup (All infants (<1 year)),
where water was the most significant contributor to total dietary
exposure.

I.	Introduction

Dietary risk assessment incorporates both exposure and toxicity of a
given pesticide.  For chronic assessments, the risk is expressed as a
percentage of a maximum acceptable dose (i.e., the dose which HED has
concluded will result in no unreasonable adverse health effects).  This
dose is referred to as the population adjusted dose (PAD).  The PAD is
equivalent to the Reference Dose (RfD) divided by the special FQPA
Safety Factor.

For non-cancer chronic exposures, HED is concerned when estimated
dietary risk exceeds 100% of the PAD.  References which discuss the
chronic risk assessment in more detail are available on the
EPA/pesticides web site:  “Available Information on Assessing Exposure
from Pesticides, A User’s Guide,” 6/21/2000, web link: 
http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf ; or see
SOP 99.6 (8/20/99).

II.	Residue Information

Residues of Concern in Plants and Livestock:  The nature of the residue
in plants and livestock was addressed previously; due to the widespread
use of oxytetracycline as a drug, and the low residue levels expected in
or on tree fruit, no metabolism data are required for plants or
livestock (see memo of W.J. Hazel dated 4/12/1988; memo of W.B. Greer
dated 4/19/1988; and memo of R.B. Perfetti dated 10/13/1992).  The
residue of concern is the parent compound, oxytetracycline, only, as
specified in 40 CFR 180.337. 

Residues of Concern in Water: EFED provided Tier 1 estimated drinking
water concentrations (EDWCs) for oxytetracycline per se (D315690, G.
Orrick, 04-AUG-2005).  The surface water estimates were considerably
higher than the ground water estimates and the highest applicable
surface water value of 4.6 ppb was then used in the dietary analysis. 
This value was obtained from FIRST analysis using the highest supported
use rate for oxytetracycline of 9 applications at a maximum rate of 0.69
lb ai/A for peach and nectarine.  The value of 8.0 ppb used in the
previous dietary analysis was based on a higher use rate of
oxytetracycline calcium that is no longer being supported.

Tolerances:  Tolerances are currently established under 40 CFR §180.337
for residues of oxytetracycline per se in/on peach and pears at 0.35
ppm.  As indicated in 40 CFR §180.1(h), tolerances for peaches also
cover nectarines.  Therefore, nectarines were included in the present
analysis using the peach residue data.  Contingent on the submission of
an adequate analytical method, these levels are adequate for pear,
peach, and nectarine (see Table 1).  For apples, an anticipated residue
level of 0.033 ppm was used, based on the mean residue level measured in
the field trial studies reflecting a total oxytetracycline application
rate of 1.53 lb ai/A (D298424, W. Cutchin, 03-JAN-2005).  For peach (and
nectarine), and pears, an anticipated residue level of 0.20 ppm was
used, based on average residue levels from the available field trial
data. 

Based on the registered uses of oxytetracycline on pears, peaches, and
nectarines, and the proposed use on apples, no quantifiable residues in
meat, milk, poultry, and eggs (MMPE) are expected.  However, the FDA has
established tolerances in MMPE commodities for the sum of the residues
of the tetracyclines including chlortetracycline, oxytetracycline, and
tetracycline as listed in 21 CFR 556.500.  Accordingly, the present
analysis includes estimates of possible oxytetracycline residues in
livestock commodities making use of monitoring data from the Food Safety
and Inspection Service (FSIS) collected in 2002, 2003, and 2004.  These
data were taken from the FSIS National Residue Program Data publications
(Red Books).  

The relevant FSIS data sampled kidney tissue from a variety of
livestock (cattle, swine, poultry, goats, etc), analyzing for
oxytetracycline residues.  As tetracycline residues partition
preferentially into fat and kidney, measured oxytetracycline residues in
kidney were used as worst-case level for all other livestock tissues. 
In 2004 and 2002, no oxytetracycline residues were detected in 4270 and
6942 samples, respectively.  In 2003, three kidney samples had finite
oxytetracycline residue levels out of 5260 samples.  To compute an
estimated residue level for use in DEEM-FCID, an average residue level
was calculated using ½ LOD for nondetects (0.005 ppm) together with the
three detected levels of 2.5, 5.0, and 5.0 ppm.  This provided an
estimated residue level of oxytetracycline in livestock commodities of
0.0058 ppm.  This value was used for all livestock commodities in the
DEEM-FCID analyses.  

The tolerance reassessment summary for oxytetracycline is presented
below:

Table 1.   Tolerance Reassessment Summary for Oxytetracycline.

Commodity	

Current Tolerance (ppm)	

Tolerance Reassessment (ppm)	

Comments

	Tolerances Listed in 40 CFR §180.337

Peach	

0.35	

0.35	

Contingent on an adequate enforcement method.

Pear	

0.35	

0.35	

Contingent on an adequate enforcement method.

Apple	

–	

0.35	

Contingent on an adequate enforcement method.

Residue Data Used in the Chronic Assessment:

Food Residues used in the Chronic Analyses:  The chronic analyses made
use of anticipated residue levels for peach (and nectarine), pear, and
apples; percent crop treated information as supplied by BEAD (see
Attachment 5); and DEEM default processing factors for all food
commodities.

Water Residues Used in the Chronic Analyses:

The drinking water values used in the dietary risk assessment were
provided by the Environmental Fate and Effects Division (EFED) (D315690,
G. Orrick, 04-AUG-2005).  Water residues were incorporated directly in
the DEEM-FCID chronic analysis.  

The estimated drinking water concentrations (EDWCs) from surface and
ground water sources were calculated using the Tier I FIRST and SCI-GROW
models.  The highest relevant chronic EDWCs for surface and ground water
were 4.6 and 0.033 ppb, respectively.  The surface water value of 4.6
ppb was used in the DEEM-FCID chronic analyses.

III  Program and Consumption Information

An oxytetracycline chronic dietary exposure assessment was conducted
using the Dietary Exposure Evaluation Model software with the Food
Commodity Intake Database (DEEM-FCID(, Version 2.0), which incorporates
consumption data from USDA’s Continuing Surveys of Food Intakes by
Individuals (CSFII), 1994-1996 and 1998.  The 1994-96, 98 data are based
on the reported consumption of more than 20,000 individuals over two
non-consecutive survey days.  Foods “as consumed” (e.g., apple pie)
are linked to EPA-defined food commodities (e.g. apples, peeled fruit -
cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S,
baked) using publicly available recipe translation files developed
jointly by USDA/ARS and EPA.  For chronic exposure assessment,
consumption data are averaged for the entire U.S. population and within
population subgroups, but for acute exposure assessment are retained as
individual consumption events.  Based on analysis of the 1994-96, 98
CSFII consumption data, which took into account dietary patterns and
survey respondents, HED concluded that it is most appropriate to report
risk for the following population subgroups: the general U.S.
population, all infants (<1 year old), children 1-2, children 3-5,
children 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50+
years old.

For chronic dietary exposure assessment, an estimate of the residue
level in each food or food-form (e.g., orange or orange juice) on the
food commodity residue list is multiplied by the average daily
consumption estimate for that food/food form to produce a residue intake
estimate.  The resulting residue intake estimate for each food/food form
is summed with the residue intake estimates for all other food/food
forms on the commodity residue list to arrive at the total average
estimated exposure.  Exposure is expressed in mg/kg body weight/day and
as a percent of the cPAD.  This procedure is performed for each
population subgroup.

IV.	Toxicological Information

The following toxicological profile is a brief summary of the data
relevant for this dietary analysis.  For a more complete discussion of
the toxicological information pertaining to oxytetracycline, see the
oxytetracycline TRED document (D315684, W. Donovan and K. Morgan,
06-FEB-2006).  The oxytetracycline team selected a chronic dietary
toxicity endpoint based on the results of the chronic toxicity study in
dogs.  Based on the data available in the literature and historical
precedence, the UF for the dog study is 100X for inter- and
intra-species variations.  The selected chronic RfD of 0.0005 mg/kg body
wt/day is based on the NOAEL of 0.05 mg/kg/day and a standard 100-fold
uncertainty factor to account for inter- and intra-species variations. 
The Special FQPA Safety Factor was reduced to 1x.  Therefore, the
chronic PAD (cPAD) is equal to the chronic RfD of 0.0005 mg/kg/day.  An
endpoint of concern attributable to a single dose was not identified for
this chemical; therefore, an acute RfD was not established.

Oxytetracycline was previously classified by the HED RfD Review
Committee as “not classifiable as to human carcinogen”, Group D,
based on the results of rat and mouse carcinogenicity studies.

Toxicological doses and endpoints for oxytetracycline are summarized in
Table 2.

Table 2.  Summary of Toxicological Doses and Endpoints for
Oxytetracycline for Use in Human Dietary Risk Assessments

Exposure

Scenario	

Dose Used in Risk Assessment, UF 	

Special FQPA SF and Level of Concern for Risk Assessment	

Study and Toxicological Effects

Acute Dietary

(females 13-49 and general population)	

NA	

NA	

NA

Chronic Dietary

(all populations)	

NOAEL = 0.05 mg/kg/day

UF = 100

Chronic RfD = 0.0005 mg/kg/day	

FQPA SF = 1

cPAD =	0.0005 mg/kg/d

        1

= 0.0005 mg/kg/day	

Microbiological Study in Dogs

LOAEL = 0.25 mg/kg/day based on a shift from a predominantly
drug-susceptible population of enteric lactose-fermenting organisms to a
multiple antibiotic-resistant population.

Cancer	

Classification: The Agency’s Peer Review Committee has classified
oxytetracycline as a “Group D” carcinogen (“Not Classifiable as to
Human Carcinogenicity”).

UF = uncertainty factor, FQPA SF = Special FQPA safety factor, NOAEL =
no observed adverse effect  level, LOAEL = lowest observed adverse
effect level

V.	Results/Discussion

As stated above, for chronic assessments, HED is concerned when dietary
risk exceeds 100% of the PAD.  The DEEM-FCID( analyses estimate the
dietary exposure of the U.S. population and various population
subgroups.  The results reported in Table 3 are for the general U.S.
Population, all infants (<1 year old), children 1-2, children 3-5,
children 6-12, youth 13-19, females 13-49, adults 20-49, and adults 50+
years. 

Results of Chronic Dietary Exposure Analysis

Chronic dietary (food + water) exposure estimates using the DEEM-FCID
model were less than or equal to 97% of the cPAD for the U.S. population
and all population subgroups.  The results of the chronic dietary
exposure analyses are reported in Table 3 below. 



Table 3.	 Results of Chronic Dietary (Food + Water) Exposure Analysis
Using DEEM FCID Software

Population Subgroup	

cPAD (mg/kg/day)	

DEEM-FCID(

Exposure (mg/kg/day)	

% cPAD

General U.S. Population	

0.0005	

0.000162	

32

All Infants (< 1 year old)	

0.0005	

0.000486	

97

Children 1-2 years old	

0.0005	

0.000459	

92

Children 3-5 years old	

0.0005	

0.000339	

68

Children 6-12 years old	

0.0005	

0.000209	

42

Youth 13-19 years old	

0.0005	

0.000122	

24

Adults 20-49 years old	

0.0005	

0.000127	

26

Adults 50+ years old	

0.0005	

0.000133	

27

Females 13-49 years old 	

0.0005	

0.000127	

25

For comparison purposes, a second chronic dietary analysis was conducted
to depict exposure levels resulting from food uses only.  Table 4
summarizes the results of the food only analysis, which, when compared
to the food + water results in Table 3, shows that a significant portion
of the total exposure to residues of oxytetracycline comes from water
sources. 

Table 4.	 Results of Chronic Dietary (Food Only) Exposure Analysis Using
DEEM FCID Software

Population Subgroup	

cPAD (mg/kg/day)	

DEEM-FCID(

Exposure (mg/kg/day)	

% cPAD

General U.S. Population	

0.0005	

0.000065	

13

All Infants (< 1 year old)	

0.0005	

0.000168	

34

Children 1-2 years old	

0.0005	

0.000315	

63

Children 3-5 years old	

0.0005	

0.000205	

41

Children 6-12 years old	

0.0005	

0.000116	

23

Youth 13-19 years old	

0.0005	

0.000052	

10

Adults 20-49 years old	

0.0005	

0.000037	

7.4

Adults 50+ years old	

0.0005	

0.000037	

7.5

Females 13-49 years old 	

0.0005	

0.000037	

7.4

VI.	Characterization of Inputs/Outputs

These chronic dietary exposure and risk estimates are refined since they
made use of percent crop treated estimates together with anticipated
residues for apple, peach (and nectarine), pear, and monitoring data for
residue estimates in livestock commodities.  Screening level estimates
of drinking water concentrations were generated by the FIRST model. 

VII.	Conclusions

Chronic dietary exposure analysis using DEEM-FCID(  indicates that
chronic dietary exposure to oxytetracycline from food and drinking water
is below HED’s level of concern for this pesticide.  Estimated chronic
dietary exposures to oxytetracycline from food and water sources are
less than or equal to 97% of the cPAD for the general U.S. population
and all population subgroups.  For comparison purposes, estimated
chronic dietary exposures to oxytetracycline from just food sources are
less than or equal to 63% of the cPAD for the general U.S. population
and all population subgroups.  

VIII.		List of Attachments

Chronic Food plus Water Residue Input file

Chronic Results file for Food plus Water Analysis

Chronic Food Only Residue Input file

Chronic Results file for Food Only Analysis

Percent Crop Treated Information for Oxytetracycline

Attachment 1.  Chronic Food plus Water Residue Input file

Filename: C:\Documents and Settings\wdonovan\My
Documents\WDONOVAN\DEEMFCID\Oxytet\oxytet2007.R98

Chemical: Oxytetracycline

RfD(Chronic): .0005 mg/kg bw/day  NOEL(Chronic): 0 mg/kg bw/day

RfD(Acute): 0 mg/kg bw/day  NOEL(Acute):  0 mg/kg bw/day

Date created/last modified: 02-06-2007/12:20:05/8          Program ver.
2.03

Comment: Resistance endpoint; peach, pear, nectarine, apple AR; water
4.6 ppb, mmpe .0058, new apple %CT

------------------------------------------------------------------------
--------

  EPA    Crop                                   Def Res     Adj.Factors 
 Comment

  Code    Grp  Commodity Name                    (ppm)       #1    #2   

-------- ---- -------------------------------  ----------  ------ ------
 -------

11000070 11   Apple, fruit with peel             0.033000   1.000  0.100
 

11000080 11   Apple, peeled fruit                0.033000   1.000  0.100
 

11000081 11   Apple, peeled fruit-babyfood       0.033000   1.000  0.100
 

11000090 11   Apple, dried                       0.033000   8.000  0.100
 

11000091 11   Apple, dried-babyfood              0.033000   8.000  0.100
 

11000100 11   Apple, juice                       0.033000   1.300  0.100
 

11000101 11   Apple, juice-babyfood              0.033000   1.300  0.100
 

11000110 11   Apple, sauce                       0.033000   1.000  0.100
 

11000111 11   Apple, sauce-babyfood              0.033000   1.000  0.100
 

21000440 M    Beef, meat                         0.005800   1.000  1.000
 

21000441 M    Beef, meat-babyfood                0.005800   1.000  1.000
 

21000450 M    Beef, meat, dried                  0.005800   1.920  1.000
 

21000460 M    Beef, meat byproducts              0.005800   1.000  1.000
 

21000461 M    Beef, meat byproducts-babyfood     0.005800   1.000  1.000
 

21000470 M    Beef, fat                          0.005800   1.000  1.000
 

21000471 M    Beef,fat-babyfood                  0.005800   1.000  1.000
 

21000480 M    Beef, kidney                       0.005800   1.000  1.000
 

21000490 M    Beef, liver                        0.005800   1.000  1.000
 

21000491 M    Beef, liver-babyfood               0.005800   1.000  1.000
 

40000930 P    Chicken, meat                      0.005800   1.000  1.000
 

40000931 P    Chicken, meat-babyfood             0.005800   1.000  1.000
 

40000940 P    Chicken, liver                     0.005800   1.000  1.000
 

40000950 P    Chicken, meat byproducts           0.005800   1.000  1.000
 

40000951 P    Chicken, meat byproducts-babyfoo   0.005800   1.000  1.000
 

40000960 P    Chicken, fat                       0.005800   1.000  1.000
 

40000961 P    Chicken, fat-babyfood              0.005800   1.000  1.000
 

40000970 P    Chicken, skin                      0.005800   1.000  1.000
 

40000971 P    Chicken, skin-babyfood             0.005800   1.000  1.000
 

70001450 P    Egg, whole                         0.005800   1.000  1.000
 

70001451 P    Egg, whole-babyfood                0.005800   1.000  1.000
 

70001460 P    Egg, white                         0.005800   1.000  1.000
 

70001461 P    Egg, white (solids)-babyfood       0.005800   1.000  1.000
 

70001470 P    Egg, yolk                          0.005800   1.000  1.000
 

70001471 P    Egg, yolk-babyfood                 0.005800   1.000  1.000
 

80001570 F    Fish-freshwater finfish            0.005800   1.000  1.000
 

80001580 F    Fish-freshwater finfish, farm ra   0.005800   1.000  1.000
 

80001590 F    Fish-saltwater finfish, tuna       0.005800   1.000  1.000
 

80001600 F    Fish-saltwater finfish, other      0.005800   1.000  1.000
 

80001610 F    Fish-shellfish, crustacean         0.005800   1.000  1.000
 

80001620 F    Fish-shellfish, mollusc            0.005800   1.000  1.000
 

23001690 M    Goat, meat                         0.005800   1.000  1.000
 

23001700 M    Goat, meat byproducts              0.005800   1.000  1.000
 

23001710 M    Goat, fat                          0.005800   1.000  1.000
 

23001720 M    Goat, kidney                       0.005800   1.000  1.000
 

23001730 M    Goat, liver                        0.005800   1.000  1.000
 

24001890 M    Horse, meat                        0.005800   1.000  1.000
 

27002220 D    Milk, fat                          0.005800   1.000  1.000
 

27002221 D    Milk, fat - baby food/infant for   0.005800   1.000  1.000
 

27012230 D    Milk, nonfat solids                0.005800   1.000  1.000
 

27012231 D    Milk, nonfat solids-baby food/in   0.005800   1.000  1.000
 

27022240 D    Milk, water                        0.005800   1.000  1.000
 

27022241 D    Milk, water-babyfood/infant form   0.005800   1.000  1.000
 

27032251 D    Milk, sugar (lactose)-baby food/   0.005800   1.000  1.000
 

12002300 12   Nectarine                          0.200000   1.000  0.050
 

12002600 12   Peach                              0.200000   1.000  0.050
 

12002601 12   Peach-babyfood                     0.200000   1.000  0.050
 

12002610 12   Peach, dried                       0.200000   7.000  0.050
 

12002611 12   Peach, dried-babyfood              0.200000   7.000  0.050
 

12002620 12   Peach, juice                       0.200000   1.000  0.050
 

12002621 12   Peach, juice-babyfood              0.200000   1.000  0.050
 

11002660 11   Pear                               0.200000   1.000  0.250
 

11002661 11   Pear-babyfood                      0.200000   1.000  0.250
 

11002670 11   Pear, dried                        0.200000   6.250  0.250
 

11002680 11   Pear, juice                        0.200000   1.000  0.250
 

11002681 11   Pear, juice-babyfood               0.200000   1.000  0.250
 

25002900 M    Pork, meat                         0.005800   1.000  1.000
 

25002901 M    Pork, meat-babyfood                0.005800   1.000  1.000
 

25002920 M    Pork, meat byproducts              0.005800   1.000  1.000
 

25002921 M    Pork, meat byproducts-babyfood     0.005800   1.000  1.000
 

25002930 M    Pork, fat                          0.005800   1.000  1.000
 

25002931 M    Pork, fat-babyfood                 0.005800   1.000  1.000
 

25002940 M    Pork, kidney                       0.005800   1.000  1.000
 

25002950 M    Pork, liver                        0.005800   1.000  1.000
 

60003010 P    Poultry, other, meat               0.005800   1.000  1.000
 

60003020 P    Poultry, other, liver              0.005800   1.000  1.000
 

60003030 P    Poultry, other, meat byproducts    0.005800   1.000  1.000
 

60003040 P    Poultry, other, fat                0.005800   1.000  1.000
 

60003050 P    Poultry, other, skin               0.005800   1.000  1.000
 

26003390 M    Sheep, meat                        0.005800   1.000  1.000
 

26003391 M    Sheep, meat-babyfood               0.005800   1.000  1.000
 

26003400 M    Sheep, meat byproducts             0.005800   1.000  1.000
 

26003410 M    Sheep, fat                         0.005800   1.000  1.000
 

26003411 M    Sheep, fat-babyfood                0.005800   1.000  1.000
 

26003420 M    Sheep, kidney                      0.005800   1.000  1.000
 

26003430 M    Sheep, liver                       0.005800   1.000  1.000
 

50003820 P    Turkey, meat                       0.005800   1.000  1.000
 

50003821 P    Turkey, meat-babyfood              0.005800   1.000  1.000
 

50003830 P    Turkey, liver                      0.005800   1.000  1.000
 

50003831 P    Turkey, liver-babyfood             0.005800   1.000  1.000
 

50003840 P    Turkey, meat byproducts            0.005800   1.000  1.000
 

50003841 P    Turkey, meat byproducts-babyfood   0.005800   1.000  1.000
 

50003850 P    Turkey, fat                        0.005800   1.000  1.000
 

50003851 P    Turkey, fat-babyfood               0.005800   1.000  1.000
 

50003860 P    Turkey, skin                       0.005800   1.000  1.000
 

50003861 P    Turkey, skin-babyfood              0.005800   1.000  1.000
 

86010000 O    Water, direct, all sources         0.004600   1.000  1.000
 

86020000 O    Water, indirect, all sources       0.004600   1.000  1.000
 

Attachment 2.  Chronic Results File (Food Plus Water)

U.S. Environmental Protection Agency                                
Ver. 2.00

DEEM-FCID Chronic analysis for OXYTETRACYCLINE                  (1994-98
data)

Residue file name: C:\Documents and Settings\wdonovan\My
Documents\WDONOVAN\DEEMFCID\Oxytet\oxytet2007.R98

                                                     Adjustment factor
#2 used.

Analysis Date 02-06-2007/12:23:40     Residue file dated:
02-06-2007/12:20:05/8

Reference dose (RfD, Chronic) = .0005 mg/kg bw/day

COMMENT 1: Resistance endpoint; peach, pear, nectarine, apple AR; water
4.6 ppb, mmpe .0058, new apple %CT

========================================================================
=======

                    Total exposure by population subgroup

------------------------------------------------------------------------
-------

                                                    Total Exposure

                                        
-----------------------------------

          Population                         mg/kg             Percent
of   

           Subgroup                       body wt/day             Rfd   
   

--------------------------------------   -------------      
---------------

U.S. Population (total)                     0.000162               
32.4%

U.S. Population (spring season)             0.000160               
32.1%

U.S. Population (summer season)             0.000167               
33.4%

U.S. Population (autumn season)             0.000162               
32.4%

U.S. Population (winter season)             0.000159               
31.8%

Northeast region                            0.000155               
31.1%

Midwest region                              0.000166               
33.1%

Southern region                             0.000151               
30.2%

Western region                              0.000182               
36.4%

Hispanics                                   0.000189               
37.9%

Non-hispanic whites                         0.000158               
31.5%

Non-hispanic blacks                         0.000154               
30.7%

Non-hisp/non-white/non-black                0.000195               
39.1%

All infants (< 1 year)                      0.000486               
97.2%

Nursing infants                             0.000195               
39.0%

Non-nursing infants                         0.000596              
119.2%

Children 1-6  yrs                           0.000370               
73.9%

Children 7-12 yrs                           0.000195               
39.1%

Females 13-19 (not preg or nursing)         0.000113               
22.7%

Females 20+ (not preg or nursing)           0.000132               
26.4%

Females 13-50 yrs                           0.000138               
27.6%

Females 13+ (preg/not nursing)              0.000150               
30.1%

Females 13+ (nursing)                       0.000191               
38.3%

Males 13-19 yrs                             0.000130               
26.0%

Males 20+ yrs                               0.000125               
25.1%

Seniors 55+                                 0.000133               
26.7%

Children 1-2 yrs                            0.000459               
91.7%

Children 3-5 yrs                            0.000339               
67.9%

Children 6-12 yrs                           0.000209               
41.7%

Youth 13-19 yrs                             0.000122               
24.4%

Adults 20-49 yrs                            0.000127               
25.5%

Adults 50+ yrs                              0.000133               
26.5%

Females 13-49 yrs                           0.000127               
25.4%

------------------------------------------------------------------------
-------

Attachment 3.  Chronic Food Only Residue Input file

Filename: C:\Documents and Settings\wdonovan\My
Documents\WDONOVAN\DEEMFCID\Oxytet\oxytet2007_nowater.R98

Chemical: Oxytetracycline

RfD(Chronic): .0005 mg/kg bw/day  NOEL(Chronic): 0 mg/kg bw/day

RfD(Acute): 0 mg/kg bw/day  NOEL(Acute):  0 mg/kg bw/day

Date created/last modified: 02-06-2007/12:22:23/8          Program ver.
2.03

Comment: Resistance endpoint; peach, pear, nectarine, apple AR; no
water, mmpe .0058, new apple %CT

------------------------------------------------------------------------
--------

  EPA    Crop                                   Def Res     Adj.Factors 
 Comment

  Code    Grp  Commodity Name                    (ppm)       #1    #2   

-------- ---- -------------------------------  ----------  ------ ------
 -------

11000070 11   Apple, fruit with peel             0.033000   1.000  0.100
 

11000080 11   Apple, peeled fruit                0.033000   1.000  0.100
 

11000081 11   Apple, peeled fruit-babyfood       0.033000   1.000  0.100
 

11000090 11   Apple, dried                       0.033000   8.000  0.100
 

11000091 11   Apple, dried-babyfood              0.033000   8.000  0.100
 

11000100 11   Apple, juice                       0.033000   1.300  0.100
 

11000101 11   Apple, juice-babyfood              0.033000   1.300  0.100
 

11000110 11   Apple, sauce                       0.033000   1.000  0.100
 

11000111 11   Apple, sauce-babyfood              0.033000   1.000  0.100
 

21000440 M    Beef, meat                         0.005800   1.000  1.000
 

21000441 M    Beef, meat-babyfood                0.005800   1.000  1.000
 

21000450 M    Beef, meat, dried                  0.005800   1.920  1.000
 

21000460 M    Beef, meat byproducts              0.005800   1.000  1.000
 

21000461 M    Beef, meat byproducts-babyfood     0.005800   1.000  1.000
 

21000470 M    Beef, fat                          0.005800   1.000  1.000
 

21000471 M    Beef,fat-babyfood                  0.005800   1.000  1.000
 

21000480 M    Beef, kidney                       0.005800   1.000  1.000
 

21000490 M    Beef, liver                        0.005800   1.000  1.000
 

21000491 M    Beef, liver-babyfood               0.005800   1.000  1.000
 

40000930 P    Chicken, meat                      0.005800   1.000  1.000
 

40000931 P    Chicken, meat-babyfood             0.005800   1.000  1.000
 

40000940 P    Chicken, liver                     0.005800   1.000  1.000
 

40000950 P    Chicken, meat byproducts           0.005800   1.000  1.000
 

40000951 P    Chicken, meat byproducts-babyfoo   0.005800   1.000  1.000
 

40000960 P    Chicken, fat                       0.005800   1.000  1.000
 

40000961 P    Chicken, fat-babyfood              0.005800   1.000  1.000
 

40000970 P    Chicken, skin                      0.005800   1.000  1.000
 

40000971 P    Chicken, skin-babyfood             0.005800   1.000  1.000
 

70001450 P    Egg, whole                         0.005800   1.000  1.000
 

70001451 P    Egg, whole-babyfood                0.005800   1.000  1.000
 

70001460 P    Egg, white                         0.005800   1.000  1.000
 

70001461 P    Egg, white (solids)-babyfood       0.005800   1.000  1.000
 

70001470 P    Egg, yolk                          0.005800   1.000  1.000
 

70001471 P    Egg, yolk-babyfood                 0.005800   1.000  1.000
 

80001570 F    Fish-freshwater finfish            0.005800   1.000  1.000
 

80001580 F    Fish-freshwater finfish, farm ra   0.005800   1.000  1.000
 

80001590 F    Fish-saltwater finfish, tuna       0.005800   1.000  1.000
 

80001600 F    Fish-saltwater finfish, other      0.005800   1.000  1.000
 

80001610 F    Fish-shellfish, crustacean         0.005800   1.000  1.000
 

80001620 F    Fish-shellfish, mollusc            0.005800   1.000  1.000
 

23001690 M    Goat, meat                         0.005800   1.000  1.000
 

23001700 M    Goat, meat byproducts              0.005800   1.000  1.000
 

23001710 M    Goat, fat                          0.005800   1.000  1.000
 

23001720 M    Goat, kidney                       0.005800   1.000  1.000
 

23001730 M    Goat, liver                        0.005800   1.000  1.000
 

24001890 M    Horse, meat                        0.005800   1.000  1.000
 

27002220 D    Milk, fat                          0.005800   1.000  1.000
 

27002221 D    Milk, fat - baby food/infant for   0.005800   1.000  1.000
 

27012230 D    Milk, nonfat solids                0.005800   1.000  1.000
 

27012231 D    Milk, nonfat solids-baby food/in   0.005800   1.000  1.000
 

27022240 D    Milk, water                        0.005800   1.000  1.000
 

27022241 D    Milk, water-babyfood/infant form   0.005800   1.000  1.000
 

27032251 D    Milk, sugar (lactose)-baby food/   0.005800   1.000  1.000
 

12002300 12   Nectarine                          0.200000   1.000  0.050
 

12002600 12   Peach                              0.200000   1.000  0.050
 

12002601 12   Peach-babyfood                     0.200000   1.000  0.050
 

12002610 12   Peach, dried                       0.200000   7.000  0.050
 

12002611 12   Peach, dried-babyfood              0.200000   7.000  0.050
 

12002620 12   Peach, juice                       0.200000   1.000  0.050
 

12002621 12   Peach, juice-babyfood              0.200000   1.000  0.050
 

11002660 11   Pear                               0.200000   1.000  0.250
 

11002661 11   Pear-babyfood                      0.200000   1.000  0.250
 

11002670 11   Pear, dried                        0.200000   6.250  0.250
 

11002680 11   Pear, juice                        0.200000   1.000  0.250
 

11002681 11   Pear, juice-babyfood               0.200000   1.000  0.250
 

25002900 M    Pork, meat                         0.005800   1.000  1.000
 

25002901 M    Pork, meat-babyfood                0.005800   1.000  1.000
 

25002920 M    Pork, meat byproducts              0.005800   1.000  1.000
 

25002921 M    Pork, meat byproducts-babyfood     0.005800   1.000  1.000
 

25002930 M    Pork, fat                          0.005800   1.000  1.000
 

25002931 M    Pork, fat-babyfood                 0.005800   1.000  1.000
 

25002940 M    Pork, kidney                       0.005800   1.000  1.000
 

25002950 M    Pork, liver                        0.005800   1.000  1.000
 

60003010 P    Poultry, other, meat               0.005800   1.000  1.000
 

60003020 P    Poultry, other, liver              0.005800   1.000  1.000
 

60003030 P    Poultry, other, meat byproducts    0.005800   1.000  1.000
 

60003040 P    Poultry, other, fat                0.005800   1.000  1.000
 

60003050 P    Poultry, other, skin               0.005800   1.000  1.000
 

26003390 M    Sheep, meat                        0.005800   1.000  1.000
 

26003391 M    Sheep, meat-babyfood               0.005800   1.000  1.000
 

26003400 M    Sheep, meat byproducts             0.005800   1.000  1.000
 

26003410 M    Sheep, fat                         0.005800   1.000  1.000
 

26003411 M    Sheep, fat-babyfood                0.005800   1.000  1.000
 

26003420 M    Sheep, kidney                      0.005800   1.000  1.000
 

26003430 M    Sheep, liver                       0.005800   1.000  1.000
 

50003820 P    Turkey, meat                       0.005800   1.000  1.000
 

50003821 P    Turkey, meat-babyfood              0.005800   1.000  1.000
 

50003830 P    Turkey, liver                      0.005800   1.000  1.000
 

50003831 P    Turkey, liver-babyfood             0.005800   1.000  1.000
 

50003840 P    Turkey, meat byproducts            0.005800   1.000  1.000
 

50003841 P    Turkey, meat byproducts-babyfood   0.005800   1.000  1.000
 

50003850 P    Turkey, fat                        0.005800   1.000  1.000
 

50003851 P    Turkey, fat-babyfood               0.005800   1.000  1.000
 

50003860 P    Turkey, skin                       0.005800   1.000  1.000
 

50003861 P    Turkey, skin-babyfood              0.005800   1.000  1.000
 

Attachment 4.  Chronic Results File (Food Only)

U.S. Environmental Protection Agency                                
Ver. 2.00

DEEM-FCID Chronic analysis for OXYTETRACYCLINE                  (1994-98
data)

Residue file name: C:\Documents and Settings\wdonovan\My
Documents\WDONOVAN\DEEMFCID\Oxytet\oxytet2007_nowater.R98

                                                     Adjustment factor
#2 used.

Analysis Date 02-06-2007/12:24:09     Residue file dated:
02-06-2007/12:22:23/8

Reference dose (RfD, Chronic) = .0005 mg/kg bw/day

COMMENT 1: Resistance endpoint; peach, pear, nectarine, apple AR; no
water, mmpe .0058, new apple %CT

========================================================================
=======

                    Total exposure by population subgroup

------------------------------------------------------------------------
-------

                                                    Total Exposure

                                        
-----------------------------------

          Population                         mg/kg             Percent
of   

           Subgroup                       body wt/day             Rfd   
   

--------------------------------------   -------------      
---------------

U.S. Population (total)                     0.000065               
13.0%

U.S. Population (spring season)             0.000064               
12.8%

U.S. Population (summer season)             0.000063               
12.5%

U.S. Population (autumn season)             0.000068               
13.7%

U.S. Population (winter season)             0.000065               
13.1%

Northeast region                            0.000067               
13.4%

Midwest region                              0.000068               
13.5%

Southern region                             0.000059               
11.8%

Western region                              0.000071               
14.2%

Hispanics                                   0.000079               
15.9%

Non-hispanic whites                         0.000063               
12.6%

Non-hispanic blacks                         0.000062               
12.3%

Non-hisp/non-white/non-black                0.000076               
15.3%

All infants (< 1 year)                      0.000168               
33.6%

Nursing infants                             0.000077               
15.4%

Non-nursing infants                         0.000202               
40.5%

Children 1-6  yrs                           0.000234               
46.8%

Children 7-12 yrs                           0.000107               
21.5%

Females 13-19 (not preg or nursing)         0.000045                
9.0%

Females 20+ (not preg or nursing)           0.000035                
7.0%

Females 13-50 yrs                           0.000044                
8.8%

Females 13+ (preg/not nursing)              0.000056               
11.2%

Females 13+ (nursing)                       0.000057               
11.4%

Males 13-19 yrs                             0.000059               
11.7%

Males 20+ yrs                               0.000039                
7.7%

Seniors 55+                                 0.000038                
7.6%

Children 1-2 yrs                            0.000315               
62.9%

Children 3-5 yrs                            0.000205               
40.9%

Children 6-12 yrs                           0.000116               
23.1%

Youth 13-19 yrs                             0.000052               
10.4%

Adults 20-49 yrs                            0.000037                
7.4%

Adults 50+ yrs                              0.000037                
7.5%

Females 13-49 yrs                           0.000037                
7.4%

------------------------------------------------------------------------
-------

Attachment 5.  Percent Crop Treated Information for Oxytetracycline

Oxytetracycline, PC 006321: run by Alan Halvorson, BEAD/EAB. 1/3/05

The tables below contain “screening level” usage data for
agricultural crops.  This information is retrieved from our principal
agricultural pesticide usage databases.   At the present time data from
1998 to 2002 is being used.

All numbers reported are rounded.		

'<500' indicates less than 500 pounds of active ingredient.		

'<2.5' indicates less than 2.5 percent of crop is treated.		

Maximum percent of crop treated is the highest observed percent crop
treated during this time period.   For some crops there may have been
only one or two observations and it is quite possible that if usage
information had been available for more years that higher usage might
have been observed.   This situation is more likely to occur with low
acreage crops.

In some cases the percent crop treated column is blank.  This is because
information on acres grown was not readily available.

Some of the numbers may be based on information that does not cover all
50 states.  Therefore, it is possible that if the remaining (usually
minor states for the crop) had been included that pounds of active
ingredient would be slightly higher.

Arthur Grube   308-8095  		

  	 		

Last revised Feb 06, 2004

                              SAS               Monday, January 3, 2005
14:10          1

  	 		

                    Screening Level Estimates of Agricultural Uses of
Oxytetracycline		

                                         Sorted Alphabetically		

  	 		

  	 				Pounds of			Percent of  

OBS	Crop		Active Ingredient		Crop Treated

Avg           		Max

 	 		

1 	Apples		2,000			5            		10

2 	Peaches	2,000			5            		10

3 	Pears		8,000			25            		40  	 		

______________________________________		

  	 		

All numbers rounded.		

'<500' indicates less than 500 pounds of active ingredient.		

'<2.5' indicates less than 2.5 percent of crop is treated.		

Use of oxytetracycline on this crop may also have occurred in other
states.		

  	 		

  	 	( slua0001.sas oxytetracycline )

2007 UPDATE:  DP 334459, A. Halvorson, 11-JAN-2007

Based on new information, BEAD has revised the projected percent crop
treated (PPCT) estimate for oxytetracycline use on apple to 10% for the
average value [recommended for use in any chronic dietary analyses] and
18% for the maximum value [recommended for use in any acute dietary
analyses].  							

 PAGE   

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