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Health Effects Division Office of Pesticide Programs Dietary Exposure Assessment at the US EPA: Overview of Residue Chemistry Guidelines and Dietary Exposure Modeling David Hrdy Health Effects Division Office of Pesticide Programs US Environmental Protection Agency Presentation to AAPCO March 6, 2017 Health Effects Division Office of Pes5cide Programs

Dietary Exposure Assessment at the US EPA · Dietary Exposure Assessment at the US EPA: ... tolerance, or maximum residue limit, ... Dietary Exposure Assessment

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Page 1: Dietary Exposure Assessment at the US EPA · Dietary Exposure Assessment at the US EPA: ... tolerance, or maximum residue limit, ... Dietary Exposure Assessment

Health Effects Division Office of Pesticide Programs

Dietary Exposure Assessment at the US EPA: Overview of Residue Chemistry Guidelines and Dietary Exposure Modeling

David Hrdy Health Effects Division Office of Pesticide Programs US Environmental Protection Agency Presentation to AAPCO March 6, 2017

HealthEffectsDivisionOfficeofPes5cidePrograms

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Health Effects Division Office of Pesticide Programs

Objectives

1.  Provide overview of U.S. EPA’s Office of Pesticide Programs (OPP)

2.   OPP’s regulatory role in food safety

3.   Describe Residue Chemistry Guideline requirements

4.   Describe OPP’s dietary exposure assessment methodology

5.   Where to find tolerances.

6.   OECD calculator

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Health Effects Division Office of Pesticide Programs

EPA’s Office of Pesticide Programs

•  Roughly 700 Staff 4 Risk Assessment Divisions 2 Risk Management Divisions Communications & Stakeholder Engagement Economic and Lab Analysis IT Support

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Antimicrobials

Health Effects

Environmental Fate & Effects

Biopesticides & Pollution Prevention

Biological & Economic Analysis

Registration

Pesticide Re-Evaluation

Field & External Affairs

Information Technology & Resource Management

Office Director

March 6, 2017

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Health Effects Division Office of Pesticide Programs

EPA’s Office of Pesticide Programs

•  Registers pesticides for agricultural, residential, and public health applications

•  Evaluates safety of pesticides by assessing exposure and associated risks

•  Establishes legal limits (aka “tolerances”) for residues of pesticides in/on agricultural commodities

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Health Effects Division Office of Pesticide Programs

EPA’s Office of Pesticide Programs:

� Residential Assessments �  Information on use practices, activity patterns, and

pesticide concentrations in various residential media are used to produce estimates of exposures in the home

� Occupational Assessments �  Information on application rates, activities, contact rates,

and pesticide concentrations are used to assess exposures to mixers/loaders, applicators, and re-entry workers

� Dietary Assessments �  Information on pesticide residues in food and water are

combined with consumption information to produce distributions of estimated exposures

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Health Effects Division Office of Pesticide Programs

EPA’s Office of Pesticide Programs •  Registers pesticides used on food crops, in and

around the home, for industrial purposes, and for public health protection

•  In order to perform this, EPA must: –  Establish legal limits (aka “tolerances” or maximum

residue limits) for pesticides on agricultural commodities, which are enforced by FDA via monitoring

–  Determines safety of pesticides by assessing dietary and residential/occupational exposures and associated risks

•  EPA assessment rely on a review of registrant-submitted studies that follow a series of study guideline requirements

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•  Excellent publication summarizing OPP’s Risk Asssessments.

https://www.extension.purdue.edu/extmedia/PPP/PPP-48.pdf

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Health Effects Division Office of Pesticide Programs

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WHY We Require Data: The Statutes

•  Two Statutes:

–  The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)

–  The Federal Food Drug and Cosmetic Act (FFDCA)

•  In 1996, both were amended by: –  The Food Quality Protection Act (FQPA)

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Health Effects Division Office of Pesticide Programs

Regulatory Framework

Food Quality Protection Act of 1996 •  Amended both FIFRA and FFDCA •  Major impact on OPP Program Office

–  Established more health protective standard –  Required OPP to re-evaluate over 10,000 pesticide tolerances

•  Required more advanced assessment methods –  Aggregate pesticide exposure

Diet + Residential + Water

–  Cumulative effects of pesticides with common mode of toxicity Evaluate exposure to multiple OP pesticides, rather than individual compounds

–  Special sensitivity of infants and children

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Health Effects Division Office of Pesticide Programs

EPA Sets Tolerances To Ensure Food Safety

•  Before allowing the use of a pesticide on food crops, EPA sets a tolerance, or maximum residue limit, which is the amount of pesticide residue allowed to remain in or on each treated food commodity.

–  The tolerance is the residue level that triggers enforcement actions. That is, if residues are found (by either FDA, USDA FSIS, TTB, or NOAA) above that level, the commodity will be subject to seizure by the government.

•  In setting the tolerance, EPA must make a safety finding that the pesticide can be used with "reasonable certainty of no harm." To make this finding, EPA considers

–  the toxicity of the pesticide and its break-down products –  how much of the pesticide is applied and how often –  how much of the pesticide (i.e., the residue) remains in or on food by the time it is

marketed and prepared

•  EPA ensures that the tolerance selected will be safe. The tolerance applies to food imported into this country, as well as to food grown here in the U.S.

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Health Effects Division Office of Pesticide Programs

Tolerance Setting Requires Numerous Scientific Studies

•  Pesticide companies, or registrants, must submit a wide variety of scientific studies for review before EPA will set a tolerance. –  The data are designed to identify possible harmful

effects the chemical could have on humans (its toxicity), –  the amount of the chemical (or breakdown products)

likely to remain in or on food, and –  other possible sources of exposures to the pesticide

(e.g., through use in homes or other places).

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Health Effects Division Office of Pesticide Programs

OPP’s Assessment Rely on a Series of Guideline Requirements

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AVAILABLE AT: http://www.epa.gov/ocspp/pdfs/OCSPP-TestGuidelines_MasterList.pdf

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Health Effects Division Office of Pesticide Programs

Residue Chemistry Guidelines

•  OPPTS Harmonized 860 Series Guidelines [http://www.epa.gov/ocspp/pubs/frs/publications/Test_Guidelines/series860.htm ]

•  1000 – Background •  1100 – Chemical Identity •  1200 – Directions for Use •  1300 – Nature of the Residue in Plants

and Livestock •  1340 – Residue Analytical Method •  1360 – Multiresidue Method •  1380 – Storage Stability Data •  1400 – Water, Fish, and Irrigated Crops •  1460 – Food Handling

•  1480 – Meat, Milk, Poultry, and Eggs •  1500 – Crop Field Trials •  1520 – Processed Food and Feed •  1550 – Proposed Tolerances •  1560 – Reasonable Grounds •  1650 – Submittal of Standards •  1850 – Confined Accumulation in

Rotational Crops •  1900 – Field Accumulation in

Rotational Crops

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Health Effects Division Office of Pesticide Programs

Nature of the Residue in Plants and Livestock

•  “What’s there?” & “What happens to the chemical?” –  metabolism

•  Radiolabel studies –  Plants: 3 dissimilar crops –  Livestock: goats & chickens

•  Method validation

GDLN 860.1300

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Crop Field Trials •  Determine maximum pesticide residues that can be

expected in foods and feeds. –  Conducted in the field –  Maximum application rate –  Shortest pre-harvest interval

•  How Are Crop Field Trial Magnitude of Residue Studies Used? –  To quantify the maximum levels of residues of concern identified in

plant metabolism studies –  To set tolerances (aka Maximum Residue Limits) in crops –  To estimate and refine dietary exposure for risk assessment

purposes

GDLN 860.1500

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Meat, Milk, Poultry, and Eggs •  Conducted with cows,

chickens, and pigs Interested in:

–  Primary Residues •  Direct treatment of livestock

or premises –  Secondary Residues

•  Residue in livestock from feed

•  How Are Livestock Magnitude of Residue Studies Used? –  To quantify the maximum levels of residues of concern identified in

livestock metabolism studies –  To set tolerances in meat, fat, meat byproducts, eggs, and milk –  To estimate and refine dietary exposure for risk assessment

purposes GDLN 860.1480 March 6, 2017

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Residue Analytical Method •  Enforcement

–  Accurate –  Specific –  Universal –  Repeatable

GDLN 860.1340

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Health Effects Division Office of Pesticide Programs

Storage Stability

•  Support FT/residue studies –  Determine if samples change during storage –  Provide information for adjusting residue values for

losses, if necessary

860.1380

March 6, 2017

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Processed Food and Feed •  Determine whether or not residue levels change

with processing.

860.1520

March 6, 2017

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Processed Food and Feed •  (b) Purpose. Processing studies are required to determine

whether residues in raw commodities may be expected to degrade or concentrate during food processing.

860.1520

March 6, 2017

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Processed Food and Feed •  However, if residues do not concentrate in processed

commodities, the tolerance for the raw agricultural commodity (RAC) itself applies to all processed food or feed derived from it.

860.1520

March 6, 2017

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Health Effects Division Office of Pesticide Programs

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Fitting the Pieces Together

Conducting a Dietary Exposure Assessment …

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Health Effects Division Office of Pesticide Programs

Tolerance Setting Requires Numerous Scientific Studies…

•  And all of this information -- and then some -- is used in EPA's risk assessment process. –  The risk assessment includes consideration of the

amounts and types of food people eat and how widely the pesticide is used (that is, how much of the crop is actually treated with the pesticide), as well as chemistry, toxicity, and exposure information.

–  EPA also uses data from USDA on what foods people eat and the quantity they eat, collected through the Pesticide Data Program.

–  Through these evaluations, EPA is ensuring the overall safety of proposed pesticide uses, as required by FQPA.

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Health Effects Division Office of Pesticide Programs

Dietary Exposure Assessment Approach •  Combine food consumption data and residue

concentrations to develop distribution of dietary exposures

•  Assessments range from simple to complex, but

based on same general exposure algorithm •  Tiering process used to refine exposure estimates to

reflect more realistic assumptions

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= All Residue Values

All Consumption Values

Range of Dietary Exposures

March 6, 2017

consumed s)commoditie food(or foods unique ofnumber n here w

) Residue ConversionUnit nConsumptio( ExposureDietary n

1i food) ai/kg (mgifood) gm food/1000 kg (1bwt) food/kg (gm

ibwt) ai/kg (mg

=

∑=

××=

X

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Health Effects Division Office of Pesticide Programs

Dietary Risk Assessment Models •  Exposure assessment models based on

nationally-representative monitoring surveys

Key data surveys and databases: –  NHANES/”What We Eat in America” (2003-2008)

Nationally representative food consumption survey

–  U.S. EPA’s Food Commodity Intake Database (FCID)

Nationally representative food commodity consumption database

–  USDA’s Pesticide Data Program (PDP) and/or Field Trial Data -PDP is Nationally representative commodity residue sampling program -Field Trials represent “high-end” concentrations used to establish tolerances/MRLs

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JIFSANWebsiteUpdatewww.fcid.foodrisk.org

•  JIFSAN FCID Website has updated their data from 2003-2008 to 2005-2010.

•  The 2005-2010 data provides improved water consumption data for our risk assessments in OPP.

•  The 2005-2010 consumption data are more recent. •  Next consumption update would not occur for at

least another 2 years.

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Health Effects Division Office of Pesticide Programs

Dietary Risk Assessment Models

Food Consumption (NHANES/WWEIA)

Food Recipe Database http://fcid.foodrisk.org/recipes/

Raw Ingredient Consumption

(FCID) http://

fcid.foodrisk.org/dbc/

Ingredient Pesticide Residue

(PDP or FT)

+=

Dietary Exposure

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RiskAcceptableLevelaPAD,cPAD,etc.

March 6, 2017

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Health Effects Division Office of Pesticide Programs

Exposure Assessment Software and Modeling

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•  OPP uses a number of software models to perform its risk assessments:

•  All models incorporate food commodity

consumption data •  http://www.epa.gov/opp00001/science/deem •  http://thelifelinegroup.org/lifeline/index.php •  http://www.ilsi.org/researchfoundation/pages/cares.aspx •  http://www.epa.gov/heasd/products/sheds_multimedia/sheds_mm.html

DEEM-FCID/Calendex

SHEDS-Multimedia

March 6, 2017

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Health Effects Division Office of Pesticide Programs

•  The modeling tools rely on probabilistic techniques (Monte-Carlo) to evaluate exposure

•  Techniques are routinely applied by OPP for virtually all of its pesticide risk assessments

•  More accurate estimates of entire range of exposures and their associated probabilities

•  Allow the Agency to characterize and quantify the variability in dietary exposure across various subgroups of interest

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Exposure Assessment Software and Modeling

March 6, 2017

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Health Effects Division Office of Pesticide Programs

Tolerances, eCFR, and www.globalmrl.com

•  Non-standard tolerance look-up methods can be resource & knowledge intensive. –  “Non-standard” = anything other than by pesticide active

ingredient –  eCFR reference

•  http://www.ecfr.gov/cgi-bin/text-idx?SID=b3890dda26481ee899bee522362cdaa8&c=ecfr&tpl=/ecfrbrowse/Title40/40cfrv25_02.tpl

•  We have been working closely with a firm that supports the web program ( 5 yr. EPA/USDA grant) –  https://www.globalmrl.com/db#query –  We are working to have other options provided on the web

for downloading such as an Excel spreadsheet with all the chemicals and MRLs. Many folks are more inclined to find information through the spreadsheet.

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https://www.globalmrl.com/

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Health Effects Division Office of Pesticide Programs

OECD MRL Calculator OECD-wide method to estimate MRLs

____________________

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Health Effects Division Office of Pesticide Programs

OECD MRL Calculator

•  OECD Workgroup formed in 2008 with the goal of harmonizing the calculation of MRLs across the OECD

–  Practical implementation of sound statistical methods

–  Simple to use –  Clear and unambiguous MRL proposal –  Harmonize EU and NAFTA procedures to extent

possible

•  Working Group on Pesticides approved draft OECD MRL calculator in 2010

•  Links to OECD User Guide, White paper, and draft calculator available at

http://www.epa.gov/pesticide-tolerances/oecd-maximum-residue-limit-calculator

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Health Effects Division Office of Pesticide Programs

OECD MRL Calculator

•  EPA and PMRA use OECD MRL calculator as standard practice EPA Exceptions: –  If Codex MRL exists, law requires EPA to harmonize with

Codex, if feasible/practical as per OECD MRL calculator result

•  Section 408(b)(4) of Federal Food, Drug, and Cosmetic Act (FFDCA)

•  Otherwise, reviewers need to describe reasons for non-harmonized tolerance

–  Harmonization with key trading partners (e.g., Canada) –  Specific peculiarities/oddities in field trial data

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Health Effects Division Office of Pesticide Programs

OECD MRL Calculator

•  Field trial issues may result in non-harmonized OECD Calculator results among different reviewers

•  For example, how to handle: –  replicate samples or non-independent field trials –  LOD or LOQ values –  specific peculiarities/oddities in field trial data or

conditions –  Outliers

•  EPA and PMRA working to develop common practices with respect to use of the OECD calculator

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Summary •  EPA’s Office of Pesticide Programs is responsible for

establishing the safety of pesticides, registering their use, and establishing tolerances/MRL’s.

•  OPP has published a number of Guidelines to guide pesticide registrants in meeting OPP registration requirements.

•  OPP Sets Tolerances to ensure the food supply is safe using a plethora of guideline studies to support their findings.

•  Depending upon the commodity, FDA, FSIS, TTB, or NOAA enforce these tolerances.

•  EPA’s Office of Pesticide Programs makes extensive uses probabilistic (Monte-Carlo) techniques to evaluate dietary exposure and ensure the safety of the food supply. –  these techniques make extensive use of both food consumption and

pesticide residue data that are publically available on the internet

March 6, 2017

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Questions?

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Health Effects Division Office of Pesticide Programs

Contactinforma5on:DavidHrdy

ChemistryandExposureBranchHealthEffectsDivision

OfficeofPes5cideProgramsPhone:703-305-6990

Email:[email protected]

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Health Effects Division Office of Pesticide Programs

Additional References Discussed in Presentation

Pesticides and Human Health Risk Assessment: Policies, Processes, and Procedures. Purdue University

Cooperative Extension Service Publication No. PPP-48. available at:

https://mdc.itap.purdue.edu/item.asp?item_number=PPP-48#.VaAM_a5VhBc

PDP Data Program background. Available at : http://www.ams.usda.gov/pdp

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