Docket Number: EPA-HQ-OPP-2010-0215 www.regulations.gov



## Fosamine Ammonium Summary Document Registration Review: Initial Docket
June 2010

# Registration Review Document for

Fosamine Ammonium



# Case No

. 2355

Approved By :

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Richard P. Ke igwin, 

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, Direc tor
Pesticide Re -evaluation Division

Date

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### TABLE OF CONTENTS

I. Preliminary Work Plan (PWP) 4

II. Fact Sheet 10

______________________ __________________

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 Fosamine Ammonium. May 19, 2010.

2. Fosamine Ammonium. Human Health A ssessment Scoping Document in Support of Registration Review. March 25, 2010.

3. Fosamine Ammonium: Review of Human Incidents. February 25, 2010.

4. Appendix A for Fosamine Ammonium. June 3, 2009.

Supporting documents for Fosamine Amonium may be found in the docket (EPA-HQ-OPP2010-0215) located on the internet at www.regulations.gov

.4 of 13 I. Preliminary Work Plan – Fosamine Ammonium

Introduction:

The Food Quality Protection Act of 1996 mandated a registration review program

. All pesticides
sold or distributed in the United Stat es (U.S) generally must be registered by the Environmental Protection Agency (EPA or the Agency), 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/oppsrr d1/registration_review/

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The Agency is implementing the registration revi ew program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), a nd 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 fosamine ammonium.

Fosamine ammonium is an herbicide register ed for use on non-agricultural rights-of way, industrial sites, fencerows, pine plantations, and sewage disposal areas. Formulated as a water soluble liquid, fosamine ammonium functions as a plant growth regulator. There are no residential uses and no residential exposures from th e registered uses are anticipated. Tolerances are not currently established for fosamine ammoni um since there are no registered food or feed
uses. Fosamine ammonium was fi rst registered in 1975 and the re registration eligibility decision (RED) was issued in 1995.

Anticipated Risk Assessment and Data Needs:

The Agency anticipates conducting a comprehens ive ecological risk assessment, including an endangered species assessment and updating the o ccupational exposure and risk assessment for all uses of fosamine ammonium and degradates of concern. A drinking water exposure and risk assessment is also anticipated in order to support registration review. Below is a summary of the issues relevant to the registration re view process of fosamine ammonium.5 of 13 Ecological Risk:

• The most recent ecological risk assessment for fosamine ammonium was completed in 1994 to support the RED.

• The Agency has not conducted a risk asse ssment that supports a complete endangered species determination for fosamine ammonium . The ecological risk assessment planned during registration review will allow the Agency to determine whether fosamine ammonium’s use has “no effect” or “may affect” federally listed threatened or endangered species (listed species) or their designated critical habitats. 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 Wildlife Service and/or
National Marine Fisheries Service (the Services), as appropriate.

• Based upon the use pattern and fosamine ammonium’s current ecotoxicity and environmental fate database, the Agency anticipates requiring the following data in order to conduct a complete ecological risk asse ssment, including an endangered species assessment, for all uses:

o GLN 850.2100 Avian acute oral toxic ity study (passerine species)

o GLN 850.1400 Fish early life-stage (freshwat er) (Rainbow trout, Bl uegill sunfish)

o GLN 850.1300 Aquatic invertebrate life-c ycle (freshwater) (Water flea)

• Please refer to the document, Registration Review – Preliminary Problem Formulation for the Ecological Risk and Drinking Wate r Assessments for Fosamine Ammonium,
located in the docket for a deta iled discussion of the anticipate d risk assessment and data

needs.

Human Health Risk:

• The most recent human health risk assessmen t for fosamine ammonium was completed in 1994 to support the RED.

• A dietary (food only) exposure assessment is not anticipated for fosamine ammonium because there are no registered food or feed uses. However, a new drinking water exposure and risk assessment is an ticipated for registration review.

• Based on the registered uses, the Agency does not anticipate conducting a residential exposure assessment for this registra tion review of fosamine ammonium.

• The Agency does not intend to conduct an aggregate risk assessment as there are no
food/feed uses and no residentia l uses of fosamine ammonium.6 of 13 • The most recent occupational exposure and risk assessments for fosamine ammonium were conducted in 1994 to support the RED. An updated occupational exposure and risk assessment, that incorporates updated assessment methodologies, will be conducted during this registration review.

• Based on the current use pattern, the Agency an ticipates requiring the following data in order to support a human health risk assessment for fosamine ammonium:

o GLN 870.3465 90-Day Inhalation Toxicity (rat)

o GLN 870.3700b Developmental Toxicity (rabbit)

o GLN 870.7800 Immunotoxicity

• Following submission of the additional toxicolo gical data, the Agency plans to update the human health toxicity profile.

• Please refer to the document, Fosamine Ammonium. Hum an Health Assessment Scoping Document in Support of Registration Review, located in the docket for a detailed discussion of the anticipated risk asse ssment and data needs for human health.

Other Anticipated Data Needs:

• GLN 830.7050 UV/Visible Light Ab sorption – this study is a new data requirement under 40 CFR part 158 (Product Chemistry Data Requi rements) for registration of a pesticide (food and non-food uses). The Agency antici pates requiring this study to obtain basic information about the compound’s identity/com position and the wavelengths at which the compound may be susceptible to photochemical degradation.

Endocrine Disruptor Screening Program:

As required under FFDCA section 408(p), EP A has developed the Endocrine Disruptor Screening Program (EDSP) to determine whether certain substances (inc luding pesticide active and other ingredients) may have an effect in humans or wildlife si milar to an effect produced by a “naturally occurring estrogen, or other such endocrine effects as the Administrator may designate.” The EDSP employs a two-tiered ap proach to making the 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 quantitative relationship betw een the dose and the E, A, or T effect.

Between October 2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 chemicals, which contains 58 pesticid e active ingredients and 9 inert ingredients.
This list of chemicals was selected based on th e potential for human exposure through pathways7 of 13 such as food and water, residen tial activity, and certain post-applic ation agricultural scenarios.

This list should not be construed as a lis t of known or likely endocrine disruptors.

Fosamine ammonium is not among the group of 58 pesticide active ingredie nts on the initial list
to be screened under the EDSP. Under FFDCA sec. 408(p) the Agen cy must screen all pesticide chemicals. Accordingly, EPA anticipates i ssuing future EDSP orders/data call-ins for all registration review cases, in cluding those for which EPA ha s already opened a registration review docket for a pesticide active ingredient.

For further information on the status of the ED SP, the policies and procedures, the list of 67 chemicals, the test guidelines and the Tier 1 screening battery, pleas e visit our website: http://www.epa.gov/endo/

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Timeline:

EPA has created the following estimated timeline for the completion of the fosamine ammonium registration review.

Registration Review for Fosamine Ammonium – Projected Registra tion Review Timeline

Activities Estimated Date Opening the docket Open Docket and Public Comment Period 2010 – June Close Public Comment 2010 – August Case Development

Final Work Plan 2010 – November Issue DCI 2011 – July – Sept. Data Submission 2013 – July – Sept. Open Public Comment Period for Preliminary Risk Assessments 2015 – Jan. – March Close Public Comment Period 2015 – April - June Registration Review Decision Open Public Comment Period for Proposed Registration Review

Decision 2015 – July - Sept.

Close Public Comment Period 2015 – Oct. – Dec. Final Registration Review Decision a nd Begin Post-Decision Follow-up 2016 Total (years) 6

Guidance for Commenters:

The public is invited to comme nt on EPA’s preliminary regist ration review work plan and rationale. The Agency will carefully consid er all comments as well as any additional information or data provided in a timely manner pr ior to issuing a final work plan for fosamine

ammonium.8 of 13 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 nature of the concern.

Water Quality:

Fosamine ammonium is not identified as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act, based on information provided at http://iaspub.epa.gov/tmdl_waters10/attains_ nation_cy.cause_detail_303d?p_cause_group_id=88

5 . In addition, no Total Maximum Daily Loads (TMDL) have been developed for fosamine ammonium, based on information provided at http://iaspub.epa.gov/tmdl_waters10/attains_ nation.tmdl_pollutant_de tail?p_pollutant_group_id =885&p_pollutant_group_name=PESTICIDES . More information on impaired water bodies and

TMDLs can be found at http://www.epa.gov/owow/tmdl/ . The Agency invites submission of water quality data for this pesticide. To the exte nt 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 (see: http://www.epa.gov/oppsrrd1/regist ration_review/water_quality_sop.htm ) in order to ensure they can be used quantitatively or qualitati vely 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, 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 fosamine ammonium, compared to the general population. Please comment if you are aware of any sub-populations that may have atypical, unusually high exposure compared to the 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. suggestions from stakeholders on ways to reduce non-target organism exposures to

fosamine ammonium

2. confirmation on the following label information9 of 13 a. maximum application rates in units rela ted to mass per unit area of treatment

zone b. geographic limitations on use

3. use or potential use distribu tion (e.g., acreage and geogra phical distribution of use sites)

4. use history

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

6. application timing (date of first applicati on and application inte rvals) by use site – national, state and county

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

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

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

c. total pounds per year – county

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

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

8. state or local use restrictions

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

10. monitoring data

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 issue its Final Work Plan (FWP) for the fosamine ammonium registration review.10 of 13 II. FACT SHEET

Background Information :

• Fosamine Ammonium PC Code: 106701, CAS#: 25954-13-6

• Technical registrant: E.I. DuPont de Nemours and Co., Inc. (EPA No. 352)

• First registered for use in 1975

• Reregistration Eligibility Deci sion issued in December, 1995

• There is one active FIFRA section 3 registration: EPA Reg. No. 352-395

• Pesticide Re-evaluation Divi sion Chemical Review Manager (CRM): Rusty Wasem wasem.russell@epa.gov

• Registration Division Contact: Eugene Wilson wilson.eugene@epa.gov

Use & Usage Information: For additional details, please refer to the BEAD Appendix A

document in the fosamine ammonium docket.

• Fosamine ammonium is a non-food use herbic ide registered for use on non-agricultural rights-of way, industrial sites, fencerows, pine plantations, and sewage disposal areas.

• Fosamine ammonium is formulat ed as a water soluble liquid.

• The Agency currently lacks data on the esti mated nationwide use (in pounds) of fosamine
ammonium.

Recent Actions:

• There are no recent regulatory actions for fosamine ammonium.

Ecological Risk Assessment Status :

The following are key findings of the most recen t ecological risk assessments for fosamine ammonium. Please refer to the document, Registration Review – Preliminary Problem Formulation for the Ecological Risk and Drinki ng Water Assessments for Fosamine Ammonium

, located in the docket for a detailed discu ssion of the ecological risk assessment.

• Fosamine ammonium is classified as pract ically non-toxic to freshwater fish and
invertebrates and estuarine/marine fish and invertebrates on an acute exposure basis. Fosamine ammonium is also classified as prac tically non-toxic to terrestrial invertebrates, mammals and birds on an acute exposure basis.

• While fosamine ammonium is classified as slightly toxic to practically non-toxic to aquatic plants, applications of fosamine ammonium at th e registered rates may pose a significant risk to endangered terrestrial plan t species inhabiting treated rights-of-way. The Agency was unable to assess plant risk s at the time of the RED due to lack of acceptable terrestrial plant data. Terrestrial plant toxicity data received since the RED will be reviewed during registration review to inform the potential risk of fosamine ammonium to endangered and non-endangered plant species.11 of 13 • Previously completed risk assessments indi cate that registered uses of fosamine ammonium do not produce risk quotients (RQs) that exceed the Agency’s level of concern (LOC) for animal species. Use of fosamine ammonium may, however, directly affect terrestrial plants, especially from th e right-of-way use (RQs = 4 and 57 for seedling emergence and vegetative vigor, respectively), and th rough loss of food source, indirectly affect animals depending on terrestrial plants fo r food or habitat. Due to a short half-life (<4 days), chronic risks to aquatic organisms are not expected from registered uses

of fosamine ammonium.

Human Health Risk Assessment Status:

The following are key findings of the most recent human health risk assessments for fosamine ammonium. Please refer to the document, Fosamine Ammonium. Human Health Assessment Scoping Document in Support of Registration Review

, located in the docket for a detailed

discussion of the human health risk assessment.

Hazard Characterization:

• Fosamine ammonium has low acute oral and inhalation toxicity and moderate dermal toxicity. It is not an acute dermal irritant or a dermal sensitizer. It is a moderate-to-severe eye irritant.

• An acute neurotoxicity study in rats showed possible neurotoxic effects at the higher

doses. A subchronic neurotoxi city study showed no evidence of neurotoxic effects.

• The Agency has not received chronic oral toxi city or carcinogenicity studies for fosamine ammonium. The anticipated da ta requirement for a developmental toxicity study will inform the Agency about the possible chro nic toxic effects of fosamine ammonium.

Dietary (Food and Drinking Water):

• Because fosamine ammonium has no food or feed uses, dietary exposure and risk were
not estimated in the 1994 human health risk assessment. Dietary an alysis (from drinking water) has not been previously performed.

Residential:

• There are no residential uses for fosamine ammonium, therefore, a residential exposure
risk assessment has not been conducted.

Aggregate:

• No aggregate exposure assessment had been previously performed because dietary exposure to fosamine ammonium was not e xpected and there are no residential uses.12 of 13 Occupational :

• An occupational exposure assessment was last conducted for fosamine ammonium in 1994 to support the 1995 RED. Toxicity e ndpoints for occupationa l exposures through dermal and inhalation pathways were not selected for the 1994 assessment because the toxicity endpoints from the av ailable toxicity studies did no t trigger risk concern based on expected exposure (i.e., the No Observed E ffect Levels were considered sufficiently high).

• Occupational post-application exposure and risk has not been quantitatively assessed because the potential for post-application e xposure to fosamine ammonium residues was determined to be low based on use patterns.

• A quantitative assessment of risk to handler s was determined to be unnecessary since a qualitative review of results of acceptable toxicity studies combined with expected exposure did not trigger risk concerns.

• Past fosamine ammonium risk assessments re ly in part on data from studies in which adult human subjects were inte ntionally exposed to a pesticid e to determine their dermal and inhalation exposure. Many such studies , involving exposure to many different pesticides, comprise generic pe sticide exposure databases such as the Pesticide Handlers Exposure Database (PHED) and the Agricultur al Reentry Task Force (ARTF) Database. EPA has reviewed all the studies suppor ting these multi-pesticide generic exposure databases, and has found no clear and convinc ing evidence that the conduct of any of them was either fundamentally unethical or si gnificantly deficient relative to the ethical standards prevailing at the time the research was conducted. All appl icable requirements
of EPA’s Rule for the Protection of Human S ubjects of Research (40 CFR Part 26) have been satisfied, and there is no regulatory barrier to conti nued reliance on these studies.

Cumulative:

• The Agency has not determined whether fosamine ammonium shares a common mechanism of toxicity with other chemical substances. If, in the future, the Agency
determines that new information on fosamine ammonium is available that could potentially impact a cumulative risk assessment and result in a risk of concern, the Agency will revisit a cumulative risk assessment.

Incidents:

• The Office of Pesticide Programs Incident Data System (IDS) was reviewed for reports
of fosamine ammonium human incidents. No human incidents have been reported from 2002 to the present associ ated with the use of fosamine ammonium.

• A preliminary review of the Ec ological Incident Informati on System (EIIS) indicated one terrestrial plant incident that has been cl assified as “possibl y” caused by fosamine13 of 13 ammonium use and, The American Bird Conser vancy database did not list any incidents
associated with fosamine ammonium use.

Data Call-In (DCI) Status:

• DCI’s were issued for fosamine ammonium as part of the reregistration process, and all data requirements have been satisfied.

Tolerances and International Harmonization:

• There are no food or feed uses for fosamine ammonium. Therefore, no tolerances have been established for this pesticide.

Labels :

• The label for fosamine ammonium (EPA Reg. No. 352-395) can be obtained from the Pesticide Product Label System (PPLS) website: http://oaspub.epa.gov/pestlabl/ppls.home

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