Docket Number: EPA-HQ-OPP-2011-0173 www.regulations.gov



## Cryolite Summary Document Registration Review: Initial Docket
March 201123 

### TABLE OF CONTENTS

Page #

I. Preliminary Work Plan (PWP) 4

II. Fact Sheet 12

III. Summary of Data Gaps 18

______________________ __________________

Please Note

This Preliminary Work Plan and Fact Sheet su mmarize the Environmental Protection Agency's current position based on the following documents:

1. Registration Review – Preliminary Problem Formulation for the Ecological Risk and Drinking Water Exposure Assessments for Cryolite. March 8, 2011.

2. Cryolite. Human Health Scoping Document in Support of Registration Review. March 16, 2011.

3. Sulfuryl Fluoride – Revised Human Health Risk Assessment for Fluoride to Incorporate New Hazard and Exposure Information. Janua ry 7, 2011. Available in the sulfuryl fluoride docket EPA-HQ-OPP-2005-0174.

4. Updated Review of Cryolite Inci dent Reports. November 30, 2010.

5. Chemical Profile for Registration Re view: Cryolite. November 10, 2010.

6. Screening Level Use Analysis (SLUA) for Cryolite. June 21, 2010.

7. Appendix A for Cryolite. September 2, 2010.

Additional supporting documents for cryolite may be found in the cryolite registration review

docket located on the internet at: www.regulations.gov4 I. Preliminary Work Plan – Cryolite

Introduction:

The Food Quality Protection Act (FQP A) of 1996 mandated a registration review program. All pesticides sold or distributed in the United States generally must be registered by the Environmental Protection Agency (EPA), based on scientific data showing that they will not

cause unreasonable risks to human health or the environment when used as directed on product labeling. The registration review program is intende d to make sure that, as the ability to assess risk evolves and as policies and practices change, all registered pesticides continue to meet the statutory standard of no unreasonable adverse eff ects to human health or the environment. Changes in science, public policy, and pesticide use practices will occur over time. Through the registration review program, the Ag ency periodically reevaluates pest icides to make sure that as change occurs, products in the marketplace can be used safely. Information on this program is provided at: http://www.epa.gov/ oppsrrd1/registration_review/.

The Agency is implementing the registration revi ew program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and will review each registered pesticide every 15 years to determine whether it continues to meet th e FIFRA standard for registration. The Agency will consider benefits information and data as required by FIFRA. The public phase of registration review begins when the initial docket is opened for each case. The docket is the Agency’s opportunity to state what it knows about the pesticide and what additional risk analyses and data or information it belie ves are needed to make a registration review decision. After reviewing and responding to co mments and data received in the docket during this initial comment period, the Agency will de velop and commit to a final work plan and schedule for the registration review of cryolite.

Cryolite is a naturally-occurring mineral of sodi um aluminum fluoride, and is part of the inorganic fluorine chemical famil y. Products included in this re gistration review case include both natural and synthetic sources. Cryolite is re gistered for use in agricultural settings on various fruits and vegetables, as well as for some uses on ornamental plants. There are no residential or public recrea tional uses of cryolite.

Furthermore, cryolite's toxicity is attributed to its dissociation into fluoride ions in the environment. The only residue of concern for th e tolerance expression for cryolite is fluoride. Therefore, all cryolite food tolerances are expresse d in terms of fluoride. Cryolite was subject to a Reregistration Eligibility D ecision (RED), which was completed in June 1996. The 1996 RED evaluated data on both cryolite and fluoride. Cr yolite tolerances were reassessed in 1997 in conjunction with a registration action.

On January 19, 2011, EPA published a proposed orde r granting objections to tolerances and a stay request with regard to su lfuryl fluoride and fluoride tole rances promulgated in 2004 and 2005 under section 408(d) of the Federal F ood, Drug, and Cosmetic Act (FFDCA) (FRL–8857– 9). The objections and stay request were filed by the Fluoride Action Network (FAN), the5 Environmental Working Group (EWG), and Beyond Pe sticides. The Objectors argue that the

fluoride tolerances should not have been es tablished by EPA because aggregate exposure to

fluoride is unsafe under FFDCA section 408. EPA is currently seeking public comment on all aspects of the proposed resolution of objections , including the scientific evaluations and the flouride aggregate risk assessment (EPA Dock et No. EPA–HQ–OPP–2005–0174). This action is relevant to cryolite because, lik e sulfuryl fluoride, cryolite br eaks down into fluoride. The aggregate fluoride risk assessment, which served as the basis for EPA’s proposed order to withdraw the sulfuryl fl uoride tolerances, consid ered all sources of fl uoride exposure including fluoride exposure as a result of the use of cryolite . Therefore, this action may affect cryolite’s registration review ti meline and decision.

Anticipated Risk Assessment and Data Needs:

The Agency anticipates updating and revising th e ecological risk assessment (including an endangered species risk assessment) and the hum an health risk assessment for all uses of cryolite. Below is a summary of the issues releva nt to the registration re view of cryolite and the data the Agency anticipates requiring:

Ecological Risk:

• The most recent ecological risk assessment fo r cryolite was completed in 1996 in support

of the RED.

• The Agency has not conducted an ecological risk assessment that supports a complete endangered species determination for cryolite. The ecological risk assessment planned during registration review will allow the Agen cy to determine whether cryolite’s use has “no effect” or “may affect” federally liste d threatened or endangered species (listed species) or their designated critical habita ts. When an assessment concludes that a pesticide’s use “may affect” a listed species or its designated critical habitat, the Agency

will consult with the U.S. Fish and Wildli fe Service (FWS) and/or National Marine Fisheries Service (NMFS) (the Services), as appropriate.

• The Agency does not anticipate requiring en vironmental fate data during registration review. However, the Agency anticipates re quiring the following environmental effects data for use in conducting a complete eco logical risk assessment, including an endangered species assessment, for all uses:

o Guideline (GLN) No. 850.2100 – Avia n Oral Toxicity (Passerine)

o GLN No. 850.1025 – Acute Toxicity Estu arine/Marine Organisms (Oyster)

o GLN No. 850.1075 – Freshwater Fish Toxicity (Estuarine/Marine)6 o GLN No. 850.4100 – Nontarget Area Phytot oxicity Tier II, Seedling Emergence 1

o GLN No. 850.4150 – Nontarget Area Phyt otoxicity Tier II, Vegetative Vigor 1
GLN No. 850.4400 – Nontarget Area Phytotoxi city Tier II, Aquatic Plant Growth (Vascular Plants) 1

o GLN No. 850.5400 – Nontarget Area Phytotoxi city Tier II, Aquatic Plant Growth (Algal Plants) 1

• Please refer to Registration Review – Preliminar y Problem Formulation for the Ecological Risk and Drinking Water Ex posure Assessments for Cryolite, March 8, 2011, located in the docket, for a detailed discussi on of these anticipated risk assessment and

data needs.

Human Health Risk:

• A comprehensive human health risk asse ssment was completed in 1996 in support of reregistration, which assessed dietary (food and water) and occupational exposures. The 1996 RED evaluated data on both cryolite and fluoride because cryol ite’s toxicity is

attributed to its dissociation into fluoride ions.

• On January 7, 2011, the Office of Pesticide Prog rams and the Office of Water completed an aggregate risk assessment for all dietar y exposure sources of fluoride in food and drinking water, including the pesticid e cryolite and sulfur yl fluoride.

• Based on an endpoint of severe dental fluorosis, exposures for some sub-populations exceeded the Agency’s level of concern particul arly for children living in areas with high levels of naturally-occurring fluoride in thei r drinking water. The Agency is currently seeking comment on this risk assessme nt (EPA Docket No. EPA-HQ-OPP-2005-0174).

• Since fluoride is the only residue of concern from cryolite applications, the Agency will: 1) review all the comments received on the January 2011 fluoride aggregate risk assessment; 2) determine if a new aggregate ri sk assessment for cryolite is needed; and 3) determine whether cryolite meets the FFDCA sa fety standard. The registration review timeline for cryolite, described on page 8 of this document, is contingent upon the Agency’s safety standard determination for cryolite following the review of comments received on the January 2011 fluorid e aggregate risk assessment.

• Currently, there are no registered uses for cryolite that would result in residential exposure. However, residential bystander i nhalation exposures resulting from off-site transport (e.g., spray drift) may occur as a resu lt of applications of cryolite. The Agency

1 A Tier II study is expected to be required. The DCI expected to be issued will provide that a Tier I plant study may be conducted in lieu of a Tier II study with the understanding that any adverse effects observed by the Tier I study would necessitate conduct and submission of a Tier II study as well.7 is in the process of examining its policies and refining the methods used to complete residential exposure assessments. Therefore, the potential need for a bystander inhalation risk assessment for cryolite will be examined during registration review.

• If an applicable endpoint is identified in th e anticipated 90-Day Inha lation Toxicity study, the Agency intends to conduct a quantitative risk assessmen t for occupational exposure. The Agency is currently evaluating the Ma rch 2, 2010 Scientific Advisory Panel (SAP) final report on issues relate d to volatilization of pestic ides and may, as appropriate, develop policies and procedures to identif y whether to incorporate post-application inhalation exposure into the Agency’s risk assessments, and methods to assess postapplication inhalation exposure. If new po licies or procedures are implemented, the Agency would anticipate revisiting the need for a quantitative occupational postapplication inhalation exposur e assessment for cryolite.

• Since the residue of concern fo r cryolite applications is fl uoride, tolerance levels and residue definition may need to be modified or revoked in the future based on a determination of fluoride aggregate risks a nd whether cryolite meets the FFDCA safety

standard.

• For a discussion of tolerances, see Cryolite: Registration Review Scoping Document for Human Health Assessments, dated March 16, 2011.

• The toxicity database is complete except for the following studies, which the Agency anticipates requiring in order to conduc t a complete human health assessment:

o GLN No. 870.3465 - 90-Day Inhalation Toxicity

o GLN No. 870.7800 - Immunotoxicity

• Please refer to the Cryolite. Human Health Scoping Docume nt in Support of Registration
Review, March 16, 2011

, located in the docket, for a detail ed discussion of the anticipated

risk assessment and data needs for human health.

Endocrine Disruptor Screening Program:

As required by FIFRA and FFDCA, EPA reviews num erous studies to asse ss potential adverse outcomes from exposure to chemicals. Collectiv ely, these studies includ e acute, subchronic and chronic toxicity, including asse ssments of carcinogenicity, ne urotoxicity, developmental, reproductive, and general or systemic toxicity. These studies include endpoints which may be susceptible to endocrine influe nce, including effects on endocri ne target organ histopathology, organ weights, estrus cyclicity, sexual maturatio n, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess gr owth, developmental and reprod uctive effects in different taxonomic groups. As part of its most recent re gistration decision, EPA re viewed these data and selected the most sensitive endpoi nts for relevant risk assessment scenarios from the existing8 hazard database. However, as required by FFDCA section 408(p), cryolite is subject to the endocrine screening part of the Endocrine Disruptor Screenin g Program (EDSP).

EPA has developed the EDSP to determine whet her certain substances (including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect produced by a “naturally occurring estrogen, or ot her such endocrine effect s as the Administrator may designate.” The EDSP employs a two-tiered approach to making th e statutorily required

determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a chemical substance to interact with the estrog en, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go th rough Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stag e of the EDSP where EPA will determine which, if any, of th e Tier 2 tests are necessary base d on the available data. Tier 2 testing is designed to identify a ny adverse endocrine-related eff ects caused by the substance, and establish a dose-response relationship between the dose and the E, A, or T effect.

Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Between October 2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 chemicals, which contains 58 pest icide active ingredients and 9 inert ingredients. Cryolite is not among the group of 58 pesticide active ingredients on the initial list to be screened under the EDSP. EPA may issue future EDSP orders/data cal l-ins as part of regi stration review requiring

the submission of EDSP screening assays for cryolite. Th is action will be contingent on the regulatory safety determination of cryolite fo llowing the review of comments on the January 2011 fluoride aggregate risk assessment. For furt her information on the status of the EDSP, the policies and procedures, the list of 67 chemicals, future lists, th e test guidelines and the Tier 1 screening battery, please visit our website: http://www.epa.gov/endo/

.

Timeline:

EPA has created the following estimated timeline for the completion of th e cryolite registration

review. It should be noted that this timelin e will be contingent on the regulatory safety determination of cryolite following the revi ew of comments on the January 2011 fluoride aggregate risk assessment.

Registration Review for Cryolite– Projected Registration Review Timeline

Activities Estimated Date Opening the Docket Open Docket and Public Co mment Period 2011 – March Close Public Comment 2011 – May Case Development Final Work Plan 2011 – August Issue DCI 2012 – April – June Data Submission 2014 – April – June Open Public Comment Period for Draft Risk Assessments 2015 – Oct. – Dec.9 Registration Review for Cryolite– Projected Registration Review Timeline

Close Public Comment Period 2016 – Jan. – March Registration Review Decision Open Public Comment Period for Proposed Registration Review

Decision 2016 – April – June

Close Public Comment Period 2016 – July – Sept. Registration Review Decision and Begin Post-Decision Follow-up 2017 Total (years) 6

Guidance for Commenters:

The public is invited to comment on EPA’s preliminary work plan and rationale. The Agency will carefully consider all comments as well as any additional information or data provided in a timely manner prior to issuing a fina l work plan (FWP) for cryolite.

Trade Irritants:

Through the registration review process, the Ag ency intends to solicit information on trade irritants and, to the extent feas ible, take steps toward facilitating irritant resolution. Growers and other stakeholders are asked to comment on any tr ade irritant issues resulting from lack of Maximum Residue Limits (MRLs) or disparitie s between U.S. tolerances and MRLs in key export markets, providing as much specificity as possible regarding the na ture of the concern.

Water Quality:

Neither cryolite nor fluoride are id entified as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act 2 . In addition, no Total Maximum Daily Loads (TMDL) have been developed for cryolite 3 . More information on impaired water bodies and TMDLs can be found on the Agency’s website 4 . The Agency invites submission of water quality data for this pesticide. To the extent possible, data should conform to the quality standards in Appendix A of the OPP Standard Operating Procedur e: Inclusion of Impaired Water Body and Other Water Quality Data in OPP’s Regist ration Review Risk Assessment and Management Process 5 in order to ensure they can be us ed quantitatively or qualitatively in pesticide risk assessments.

Environmental Justice:

EPA seeks to achieve environmenta l justice, the fair tr eatment and meaningful involvement of all people, regardless of race, color, national origi n, or income, in the deve lopment, implementation,

2 http://iaspub.epa.gov/tmdl_waters10/attains _nation_cy.cause_detail_30 3d?p_cause_group_id=885

3 http://iaspub.epa.gov/tmdl_waters10/attain s_nation.tmdl_pollutant_detail ?p_pollutant_group_id=885&p_ pollutant_group_name=PESTIC IDES

4 http://www.epa.gov/owow/tmdl/

5 http://www.epa.gov/oppsrrd1/regist ration_review/water_quality_sop.htm10 and enforcement of environmental laws, regulati ons, and policies. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of thei r location, cultural practices, or other factors, may have atypical, unusually high exposure to cryolite, compared to the genera l population. Please comment if you are aware of any sub-populatio ns that may have atypical, unusually high exposure compared to th e general population.

Other Information:

Stakeholders are also specifically asked to prov ide information and data that will assist the Agency in refining the risk assessments, incl uding any species-specific ecological effects determinations. The Agency is interested in receiving the following information:

1. confirmation on the following label information;

a. sites of application

b. formulations

c. application methods and equipment

d. maximum application rates in units rela ted to mass per unit area of treatment

zone

e. frequency of application, applicati on intervals and maximum number of applications per season

f. geographic limitations on use

2. use or potential use distri bution (e.g., acreage and geogr aphical distribution of relevant crops);

3. use history;

4. median and 90 th percentile reported use rates (lbs. a.i./acre) from usage data – national, state, and county;

5. application timing (date of first applica tion and application intervals) by crop – national, state and county;

6. sub-county crop location data;

7. directly acquired county-level usage data (not derived from state level data);

a. maximum reported use rate (lbs. a.i. /acre) from usage data – county

b. percent crop treated – county

c. median and 90 th percentile number of applications – county

d. total pounds per year – county

e. the year the pesticide was last us ed in the county/sub-county area

f. the years in which the pesticide was applied in the county/sub-county area

8. typical interval (days);

9. state or local use restrictions;

10. ecological incidents (non-target plant dama ge and avian, fish, reptilian, amphibian and mammalian mortalities) not alre ady reported to the Agency;

11. pests controlled by cryolite and what are the chemical and non-chemical alternatives to cryolite for these pest(s);11 12. barriers for adopting chemical and non-chemical alternatives for pe st(s) controlled by cryolite (e.g., price, relative efficacy, use restrictions, application methods, etc.);

Next Steps:

After the 60-day comment period closes, the Ag ency will review and respond to any comments received in a timely manner, and then issu e its Final Work Plan (FWP) for cryolite.12 II. FACT SHEET

Background Information:

• Cryolite PC code: 075101, CAS No.: 15096-52-3.

• Registration review case number: 0087.

• Technical registrants: AMVAC Chemical Company; United Phosphorous, Incorporated; and Gowan Company.

• First registered for use in the U.S. in 1957.

• The RED for cryolite was completed in June, 1996.

• Cryolite product reregistration is complete, and the mitigation specified in the 1996 RED

is on current labels.

• Cryolite tolerances were reassessed in December 5, 1997 in conjunction with a registration action (62 FR 64294-64301).

• There are currently four e nd-use products and two tec hnical products registered.

• There are multiple tolerances for use of cryolite in or on food crops under 40 CFR §

180.1045.

• Pesticide Re-evaluation Di vision Chemical Review Manager: Molly Clayton, clayton.molly@epa.gov.

• Registration Division Co ntact: Venus Eagle, eagle.venus@epa.gov

.

Use & Usage Information: (For additional details, please refer to the Appendix A, SLUA, and Chemical Profile documents in the cryolite docket.)

• Cryolite is an inorganic fluorine compound regist ered for use as an insecticide and used primarily on raisins and table grapes to cont rol leafrollers, leaffolders, worms, and mites.

• Cryolite is formulated as bait/solid, wettable powder/dust, and dust a nd dry flowable. It may be applied as a broadcast foliar sp ray in early summer and late spring, as chemigation with sprinkler irrigation, and as a dust or spray with aircraft.

• The agricultural usage for cryolite from 1998-2008 averaged almost 2 million pounds active ingredient for use in about 300,000 acres per year.

• From 1998-2008, the largest markets in terms of total pounds of active ingredient applied were: raisin grapes (71%), table gr apes (12%), and wine grapes (9%).

Recent and Pending Actions:

• On January 19, 2011, EPA published a proposed or der granting objections to tolerances and a stay request with regard to sulfuryl fluoride and fluor ide tolerances promulgated in 2004 and 2005 under section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA) (FRL–8857–9). The objections and st ay request were filed by the Fluoride Action Network, the Environmental Working Group, and Beyond Pesticides. The Objectors argue that the fluoride tolerances should not have been established by EPA because aggregate exposure to fluoride is unsafe under FFDCA section 408. EPA is13 currently seeking public comment on all aspect s of the proposed resolution of objections, including the scientific eval uations and the aggregate risk assessment (EPA Docket No. EPA–HQ–OPP–2005–0174).

Ecological Risk Assessment Status:

The following are key findings of the most recent ecological risk assessment for cryolite. Please

refer to the Registration Review – Preliminary Problem Formulation for the Ecological Risk and Drinking Water Exposure Assessments for Cryolite, March 8, 2011, located in the docket, for a

detailed discussion of the ecological risk assessment.

Environmental Fate:

• Cryolite is a naturally-occurring mineral; how ever, most present day supplies of cryolite pesticide products are synthetically produce d. Open-literature data were used in conjunction with registrant submitted data in the 1996 ecological assessment to address the environmental chemistry of cryolite. The fate of the elemental components in cryolite (Na, Al, and F) is dependent on the natural biogeochemical cycles influenced by the soil chemical and mineralogical properties.

Risk Estimates:

• While some acute avian and mammalian risk quotients (RQs) exceeded the Agency’s level of concern (LOC) in the 1996 assessment, risk to birds and mammals was not expected from any registered use of cryol ite based on the likelihood of the species to receive significant dietary exposure at the an ticipated low exposure levels. Similarly, risks to terrestrial invertebrates and plan ts (i.e., foliage) were not expected.

• In the 1996 assessment, risk to aquatic or ganisms was not quantitatively assessed. Ground or surface water effects were expected to be negligible. No significant difference

in the accumulation of aluminum or fluoride moieties in plan ts or animals was expected

to occur.

• There is sufficient information to characte rize cryolite as practic ally nontoxic to honey

bees based on data evaluated from an acute bee contact study. Cr yolite’s insecticidal mode of action requires ingestion and non-target terrestrial invertebra tes are not expected to be sensitive to this pesticide via a contac t route of exposure. A dditionally, insects with piercing/sucking mouthparts (i ncluding bees) are not expected to be affected by cryolite via an oral route because they cannot ingest crystals.

Human Health Risk Assessment Status:

The following are key findings of the most recent human health risk assessments for cryolite.

Please refer to the Cryolite. Human Health Assessmen t Scoping Document in Support of14 Registration Review, March 16, 2011

, located in the docket, for a detailed discussion of the

human health risk assessment.

• The most recent human health risk assessm ent for cryolite was completed in 1996 in support of reregistration. An aggregate risk assessment th at included contributions from all sources of fluoride, including exposure s from cryolite, was completed in January

2011.

Hazard Characterization:

• The 1996 RED evaluated data on both cryolite a nd fluoride because cryolite's toxicity is

attributed to its dissociation into fluoride ions . Data evaluated included guideline toxicity studies with cryolite, carcinoge nicity studies with fluoride, and assessments by several government agencies on fluoride in drinking water.

• Currently, severe dental fluorosis, including enam el pitting and other effects, is the effect of concern from dietary exposure. The Office of Water has recently completed a benchmark dose analysis in order to select a point of departure based on severe dental fluorosis from exposure to fluoride.

• Dental lesions in rats and mi ce cryolite toxicity studies were due to enamel fluorosis and included effects such as attrition, deform ity, mottling, and degeneration. Fluoride can also accumulate in bone, and increased bone de nsity in rats after tr eatment with cryolite has been noted in toxicity studies.

• The recent aggregate risk assessment for fl uoride included an analysis for potential sensitivity of children to fluoride. Give n the relative completeness of the fluoride toxicology database; the use of a child-specifi c endpoint (i.e., the most sensitive effect

and well-documented outcome in the literatu re); the data indicating a U-shaped doseresponse curve for oral hea lth; and the understanding of the potential exposures to fluoride, the Agency reduced the FQPA Sa fety Factor for fluoride to 1X.

• The Agency did not require a dermal toxic ity study for its 1996 reregistration decision. Given the chemical properties of parent cr yolite and degradate (fluoride ions), the Agency considered dermal absorption unlikely.

• As it is well-known that cryolite dissociates in to fluoride, the Agency did not require a metabolism study.

• Cryolite was classified as “not classifi able as to human carcinogenicity.”

Dietary (Food and Water):

• The Agency has recently completed a dietary exposure assessment for all sources of15 fluoride in food and drinking water, includi ng the pesticides cr yolite and sulfuryl

fluoride.

• Monitoring data were used to account for re sidues of fluoride as a result of cryolite application; residues in grapes and raisins we re higher than other crops (consistent with the usage assessment).

Residential:

• Cryolite is not registered for use in resident ial or public recreationa l settings. Therefore, a standard residential exposure risk as sessment was not conducted for the 1996 RED.

Aggregate:

• In January 2011, the Agency completed an aggregate risk assessment for exposure to fluoride, including the following sources of fluor ide: dietary exposure from the pesticides cryolite and sulfuryl fluoride; water exposure from naturally occurring sources of fluoride

in the environment as well as the intenti onal addition of fluoride to drinking water sources to prevent dental caries; incidental ingestion of fluoride while brushing teeth; and soil ingestion by children.

• This aggregate assessment iden tified some sub-populations whose exposure exceeded the Agency’s level of concern for fluoride, part icularly children living in areas with high levels of naturally-occurr ing sources of fluoride in their drinking water.

Occupational :

• In the most recent occupational risk a ssessment (1996), no dermal or inhalation toxicological endpoints were id entified; therefore, a quant itative occupational risk assessment for occupational e xposures was not conducted.

• Toxicity via the dermal route was not expected due to the ionic nature of cryolite.

Cumulative:

• Unlike other pesticides for which EPA has fo llowed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to cryolite and any other substances . As described in the aggregate section above, fluoride is a degradate of cryolite, a nd has been previously assessed. For the purposes of this registration review assessmen t of data needs, EPA has not assumed nor determined that cryolite has a common mechanis m of toxicity with other substances. For information regarding EPA’s efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA’s Office of Pesticide Programs concerning common16 mechanism determinations and procedures fo r cumulating effects from substances found

to have a common mechanism on EPA’s website at: http://www.epa.gov/pesticides/cumulative/ . If, in the future, the Agency determines that new information on cryolite is available that could potentially impact a cumulative risk assessment and result in a risk of concern, the Agency will revisit the need for a

cumulative risk assessment.

Incidents:

Ecological:

• The Ecological Incident Information Syst em (EIIS) was consulted for reports of ecological incidents associated with cryolite. There is on e 1992 reported incident in Delaware in which a wettable powder contai ning cryolite was sprayed on potatoes. One

thousand fish were killed from the runoff. The certainty code is unlikely and the legal status of the particular use in relation to the product label is unknown.

Human Health:

• No cryolite poisoning incident s were reported in the Office of Pesticide Programs Incident Data System (IDS) since 2002.

Tolerances and International Harmonization:

• The residue of concern for th e tolerance expression for cryol ite is fluoride. All food tolerances are expressed in te rms of fluoride. Although uses of cryolite are registered for animal feed commodities, the Agency had previously determined that there is no reasonable expectation of finite residues in livestock; therefore, livestock commodity

tolerances are not needed.

• No maximum residue limits (MRLs) have b een established by Codex or Canada for residues of cryolite or fluoride. Mexico adopt s US tolerances and/or Codex MRLs for its
export purposes.

Data Call-In Status :

• Generic data call-ins (GDC I-075101-16283, GDCI-075101-15979, and GDCI-075101- 16944) were issued in January 1980, January 1991, and November 1996, respectively. All of these data requirements have been fulfilled.

Labels :

• The labels for cryolite can be obtained from the Pesticide Product Label System (PPLS)
website at: http://oaspub.epa.gov/pestlabl/ppls.home

.17 Cryolite Registrations as of March 4, 2011

Registration No. Product Name Company Name

5481-132 Cryolite 93 AMVAC Chemical Corporation

10163-41 PROKIL Cryolite 96 Gowan Company

10163-185 PROKIL Cryolite Water Dispersable Granular Gowan Company

10163-225 Gowan Cryolite Bait Gowan Company

10163-242 PROKIL Cryolite 75 Dust Gowan Company

10163-243 PROKIL Cryolite 50 Dust Gowan Company

70506-172 Kryocide Insecticide United Phosphorus, Inc.18 III. Summary of Data Gaps

The table below summarizes the anticipat ed data requirements for cryolite.

Guideline

Number Study Title Test

Material Estimated

Timeframe (Measured in Months)

850.2100 Avian Oral Toxicity (Passerine) TGAI 6 12
850.1075 Freshwater Fish Toxicity (Estuarine/Marine) TGAI 12

850.1025 Acute Toxicity Estuarine/Marine Organisms (Oyster) TGAI 12

850.4100 Nontarget Area Phytotoxicity Tier II, Seedling Emergence 7 TGAI 12

850.4150 Nontarget Area Phytotoxicity Tier II, Vegetative Vigor 7 TGAI 12

850.4400 Nontarget Area Phytotoxicity Tier II, Aquatic Plant Growth (Aquatic Vascular Plants) 7 TGAI 12

850.5400 Nontarget Area Phytotoxicity Tier II, Aquatic Plant Growth (Algal Plants) 7 TGAI 12

870.3465 90-Day Inhalation Toxicity TGAI 24
870.7800 Immunotoxicity TGAI 12

6 Technical Grade Active Ingredient (TGAI).

7 A Tier II study is expected to be required. The DCI expe cted to be issued will provide that a Tier I plant study may be conducted in lieu of a Tier II study with the understanding that any adverse effects observed by the Tier I study would necessitate conduct and submission of a Tier II study as well. The purpose of a Tier II study is to

establish both a definitive No Observed Adverse Effect Con centration (NOAEC), or alternatively, a concentration at
which there is a 5% observed inhibition effect (IC 05 ) to be used in a risk assessment and effects determination for endangered or threatened species (listed species), and a definitive IC 25 (concentration at wh ich there is a 25% observed inhibition effect) for assessing risk to non-listed nontarget plants. If any adverse effects are observed in a Tier I study and neither a definitive NOAEC nor a definitive IC 05 value is available, then the Agency may have to presume in its effects determination, that cryolite "may affe ct" and is “likely to adversely affect” listed plant species.