Document ID: EPA-HQ-OPP-2010-0707-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2010-09-23T04:00Z

EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE
PETITIONS PUBLISHED IN THE FEDERAL REGISTER   

 

Summary of Petition 

 

EPA has received a pesticide petition ([insert petition number]) from
Productos Químicos y Alimenticios OSKU S.A. (OSKU), 5212 El Guanaco,
Huechuraba,  Santiago, Chile proposing, pursuant to section 408(d) of
the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to
amend 40 CFR part 180 by establishing a tolerance for residues of sulfur
dioxide (from sodium metabisulfite) in or on the raw agricultural
commodity blueberries at 10 parts per million (ppm).  Adorno & Yoss, LLP
of Washington, D.C. serves as the agent for OSKU.  EPA has determined
that the petition contains data or information regarding the elements
set forth in section 408 (d)(2) of  FDDCA; however, EPA has not fully
evaluated the sufficiency of the submitted data at this time or whether
the data supports granting of the petition. Additional data may be
needed before EPA rules on the petition. 

 

A. Residue Chemistry 

 

1. Plant metabolism. 

     

Residues studies (OPPTS 860.1300) were conducted in postharvest
blueberries in order to characterize the fate of sulfur dioxide in the
fruit.  The residue of concern is sulfur dioxide released from sodium
metabisulfite which is contained in pads as a sole active ingredient. 
The active ingredient sodium metabisulfite in the pads releases sulfur
dioxide when it absorbs moisture generated by blueberries.  Sulfur
dioxide generating pads have been registered for use on post-harvest
table grapes as a fungicide.  The metabolism of sulfur dioxide is well
known in the literature. (See Reregistration Eligibility Decision (RED)
– Inorganic Sulfites, May 2007, which is available at the following
EPA web site: http://www.epa.gov/oppsrrd1/REDs/inorganicsulfites.pdf.) 

 

2. Analytical method.  

 

An adequate residue analytical method is available for enforcement
purposes.  The modified Monier-Williams method, which is the official
method of analysis approved by the Association of Official Analytical
Chemists (AOAC), is listed in 40 CFR Appendix B to Part 425. 

 

3. Magnitude of residues.  

 

The residue studies were performed in the United States under laboratory
and commercial conditions in order to determine the magnitude of the
residue in blueberries. 

 

 

B. Toxicological Profile 

 

Sulfiting agents have been used for centuries in food processing as
sanitizing agents, preservatives, inhibitors of undesirable
microorganisms in fermentation, inhibitors of browning and discoloration
during the preparation, storage, and distribution of many foods, and in
other uses.  Sulfiting agents, including sulfur dioxide (SO2) and SO2
generating sodium metabisulfite, are listed as the Generally Recognized
As Safe (GRAS) status by the Food and Drug Administration (FDA), with
limitations, as food preservatives, while the pesticidal use of
sulfating agents on grapes falls under EPA’s jurisdiction.  EPA
established a tolerance limit of 10 ppm for sulfur dioxide.  40 CFR
180.444.  Under section 408(q) of the Federal Food, Drug, and Cosmetic
Act (FFDCA), EPA reassessed this tolerance in May 2007.  Sufficient data
were available to support the reassessment of the tolerance.  An
assessment of the toxic effects caused by sulfur dioxide is discussed in
the Reregistration Eligibility Decision (RED) – Inorganic Sulfites,
EPA, May 2007, which is available at the following EPA web site:
http://www.epa.gov/oppsrrd1/REDs/inorganicsulfites.pdf.    

 

1. Animal metabolism. 

 

The metabolism of sulfur dioxide in mammals is adequately understood. 
(See Toxicological Profile for Sulfur Dioxide, U.S. Department of Health
and Human Service, December 1998, which is available at the following
web site: http://www.atsdr.cdc.gov/toxprofiles/tp116.pdf.) 

                                                                        
                                                                        
                                                              

2. Metabolite toxicology.  

 

The metabolism of sulfur dioxide is adequately known.  (See
Toxicological Profile for Sulfur Dioxide, U.S. Department of Health and
Human Service, December 1998, which is available at the following web
site: http://www.atsdr.cdc.gov/toxprofiles/tp116.pdf.) 

 

3. Endocrine disruption.  

 

Reproductive effects were not observed in rats exposed to 5-30 ppm
sulfur dioxide for a period from 9 days prior to mating until 12-14 days
of pregnancy; or in mice exposed to 25 ppm sulfur dioxide 7 hours/day on
gestation days 6-15; or in rabbits exposed to 70 ppm sulfur dioxide 7
hours/day on gestation days 6-18.  (See Toxicological Profile for Sulfur
Dioxide, U.S. Department of Health and Human Service, December 1998,
which is available at the following web site:
http://www.atsdr.cdc.gov/toxprofiles/tp116.pdf.) 

                                                                        
                                                                        
                            

C. Aggregate Exposure 

 

Based on the use pattern of sulfur dioxide and sodium metabisulfite, EPA
has determined that aggregate exposure to sulfites does not pose a risk
concern.  (See Reregistration Eligibility Decision (RED) – Inorganic
Sulfites, EPA, May 2007, which is available at the following EPA web
site: http://www.epa.gov/oppsrrd1/REDs/inorganicsulfites.pdf.) 

 

1. Dietary exposure.  

 

i. Food.  

 

Sulfur dioxide (21 CFR 182.3862) and sodium metabisulfite (21 CFR
182.3766) are listed as GRAS by the FDA, with limitations, as food
preservatives.  Sulfiting agents are found in many foods, primarily as a
result of the GRAS preservative use.  It is estimated the sulfite
concentrations of >100 ppm may be found in dried fruits (excluding dark
raisins and prunes), lemon and lime juices, wine, molasses and
sauerkraut juice.  Dried potatoes, grape juice, wine vinegar, gravies,
fruit topping, and maraschino cherries may contain between 50 and 100
ppm sulfur dioxide.  Foods containing between 10 ppm and 50 ppm include
pectin, fresh shrimp, corn syrup, sauerkraut, pickled foods, corn
starch, hominy, frozen potatoes, maple syrup, imported jams and jellies
and fresh mushrooms. 

 

The World Health Organization (WHO) has emphasized the use of
appropriate labeling for alerting individuals who cannot tolerate
sulfites.  After receiving and reviewing reports of adverse reactions in
certain individuals following ingestion of sulfating agents used as
preservatives in food products, beverages, and fresh fruits and
vegetables, the FDA required ingredient labels to list sulfite
concentrations in excess of 10 ppm. 

 

The uses of products containing inorganic sulfites are limited to use as
indoor fumigants and as fungicidal control agents on grapes. A tolerance
limit of 10 ppm (expressed as sulfite) for sulfur dioxide is established
in 40 CFR 180.444, and sufficient date are available to support the
reassessment of this tolerance.  This 10 ppm tolerance is relatively low
compared to concentrations of sulfites in many common foods and viewed
as GRAS by FDA.  Further this level for which FDA requires labeling to
alert sulfite-sensitive individuals.  Therefore, residues resulting from
the postharvest use of sulfur dioxide and sodium metabisulfite on grapes
are not expected to be at a level of concern for the general population
or any population subgroups.  OSKU believes the proposed 10 ppm
tolerance for sulfur dioxide on blueberries would not constitute a level
of concern for the general population or any population subgroups. 

 

ii. Drinking water.  

 

Based on the use pattern and fate characteristics of these chemicals,
EPA has concluded that it does not have any drinking water concerns for
sulfur dioxide and sodium metabisulfite.  (See Reregistration
Eligibility Decision (RED) – Inorganic Sulfites, EPA, May 2007, which
is available at the following EPA web site:
http://www.epa.gov/oppsrrd1/REDs/inorganicsulfites.pdf.) 

 

2. Non-dietary exposure.  

 

Since sulfur dioxide is primarily present in gaseous form, the general
public is exposed to it mostly by inhaling contaminated air.  Exposures
would be expected to be highest near industrial activities that involve
fuel combustion.  Occupational exposures to sulfur dioxide are
associated with workers in steel processing, refinery, and chemical
plants.  It has been estimated that approximately 600,000 American
workers may be occupationally exposed to sulfur dioxide.  Some of the
highest exposures occur when it is a by-product, as in the metal
smelting industry, and in the processing or combustion of high-sulfur
coal 

or oil.  (See HSDB 1998, Hazardous Substances Data Bank, National
Library of Medicine, National Toxicology Information Program, February
1998.)  

 

Levels of occupational exposure vary from industry to industry.  Sulfite
pulp worker exposure fluctuates but reaches levels greater than 10 ppm
(26 mg/m3) in the 1950´s (studies in Finland, Norway, and the United
States).  (See IARC. 1992. IARC monographs on the evaluation of the
carcinogenic risk of chemicals to man: Occupational exposures to mists
and vapours from strong inorganic acids, and other industrial chemicals.
Vol. 54. Lyon, France: World Health Organization, International Agency
for Research on Cancer.)  Because of modernization of facilities and
processes, these levels have been falling. Roasting of ores and the
combustion of sulfur-containing fuels in the metal industries have
resulted in workplace exposure concentration means of 1-10 ppm (2.6-26
mg/m3) in copper smelters and 1 ppm (2.6 mg/m3) or less in other
operations. Occupational exposure levels with a mean >1 ppm (2.6 mg/m3)
have been measured during sulfuric acid and superphosphate fertilizer
manufacture as well as during firefighting. 

 

No information was found regarding the number of people potentially
exposed in the vicinity of hazardous waste sites. However, since sulfur
dioxide has been found near hazardous waste sites, people living near
them may be exposed to higher than background levels. 

 

 

D. Cumulative Effects 

 

Section 408 (b)(2)(D)(v) of the FFDCA requires that,  when considering
whether to establish, modify, or revoke a tolerance,  the Agency
consider “available information” concerning the cumulative effects
of a particular pesticide residues and “other substances that have a
common mechanism of toxicity”.  EPA does not have, at this time,
available data to determine whether inorganic sulfites, including sulfur
dioxide, have a common mechanism of toxicity with other substances. 
Unlike other pesticides for which EPA has followed a cumulative risk
approach based on a common mechanism of toxicity,  EPA has not made a
common mechanism of toxicity finding as to inorganic sulfites, including
sulfur dioxide, and any other substances,  and inorganic sulfites do not
appear to produce a toxic metabolite produced by other substances. 

 

 

E. Safety Determination 

 

1. U.S. population.  

 

EPA has determined that taking into consideration of all available
information on sulfur dioxide and sodium metabisulfite, including the
specific use pattern and limited exposure potential, FDA’s
classification of GRAS, as well as the historical presence of sodium
metabisulfite in cosmetics and hair care products, the use of sulfur
dioxide and sodium metabisulfite on postharvest grapes is unlikely to
pose a significant risk to the general 

population or any population subgroup.  (See Reregistration Eligibility
Decision (RED) – Inorganic Sulfites, EPA, May 2007, which is available
at the following EPA web site:
http://www.epa.gov/oppsrrd1/REDs/inorganicsulfites.pdf

.)   OSKU believes that the use of sulfur dioxide and sodium
metabisulfite on postharvest blueberries would not pose a significant
risk to the general population. 

 

2. Infants and children.  

 

There is sufficient toxicological information for sulfur dioxide and
sodium metabisulfite to address FQPA considerations.  The available
information indicates that there is no evidence of increased
quantitative or qualitative susceptibility of the offspring after in
utero or post-natal exposure. Based on this information, OSKU believes
that there is no concern, at this time, for increased sensitivity to
infants and children to sulfur dioxide and sodium metabisulfite when
used on posthaverst blueberries.  

 

 

F. International Tolerances 

 

There is currently no Maximum Residue Level (MRL) established for sulfur
dioxide on blueberries by the Codex Alimentarius Commission.  However,
OSKU is aware that New Zealand and the European Community are
considering the inclusion of the use of sulfur dioxide on blueberries
with permitted sulfur dioxide residues of up to 10 ppm.