Final Report to the Pesticide Program Dialogue Committee on the Activities of the Inert Disclosure Stakeholder Workgroup - March 2000 - April 2002
Proposals - Introduction
Discussion Paper 1
Discussion Paper 2
Discussion Paper 3
Discussion Paper 4
Discussion Paper 4(a)
Discussion Paper 5
Discussion Paper 6
Discussion Paper 7
Discussion Paper 7(a)
Discussion Paper 8
Discussion Paper 8(a)
Discussion Paper 9
Discussion Paper 10
Discussion Paper 11
Discussion Paper 12
Summary of Concerns
To investigate viable avenues to enhance disclosure of the identity of inert ingredients in pesticides products, EPA requested the Pesticide Program Dialogue Committee (PPDC) to consider establishing a workgroup. This new workgroup would advise the Committee on ways of making information on inert ingredients more available to the public while working within the mandates of Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and related trade secret or confidential business information (CBI) concerns. The Committee acknowledged that examination of current policy and practice in this area would be valuable. With the approval of the Committee, and after a formal solicitation period in June of 1999 (64 FR 33078, June 21, 1999), EPA established a diverse workgroup with members from public health, environmental, industry, academic, and state government organizations.
In March of 2000, EPA sponsored the first meeting of the Inert Disclosure Stakeholder Workgroup (IDSW). Workgroup meetings were conducted in a manner consistent with EPA policies on public participation. EPA sought to facilitate informational exchange to understand the issues, problems, values, perceptions, and affected parties and theirs needs. The workgroup process also provided an incubator for group proposals. Over a two year period, the workgroup held sixteen meetings. Workgroup meetings were open to the public. Background materials, meeting materials, and a record of the public comments received are archived in Public Docket "OPP-00439A" in the Office of Pesticides Programs Public Docket 1. Through this series of discussions, the workgroup developed this report. The report is a compilation of the workgroup's activities and contains background information, a description of the workgroup's mission, a description of the workgroup's process, copies of discussion papers and proposals for enhancing public information on inert ingredients in pesticide products.
Pesticide products contain both "active" and "inert"
ingredients. These terms are defined in the Federal Insecticide, Fungicide
and Rodenticide Act (FIFRA). An active ingredient is one that prevents,
destroys, repels or mitigates a pest, or is a plant regulator, defoliant,
desiccant or nitrogen stabilizer. By law, the active ingredient must be
identified by name on the label together with its percentage by weight.
Inert ingredients are defined in FIFRA §2(m) as any ingredients which
are not active. FIFRA does not, as a general matter, require inert ingredients
to be identified by name and percentage on the label, but the total percentage
of such ingredients must be declared. Although seven List 1 inerts (highly
toxic) are required to be identified. Most inert ingredients are not identified
on pesticide product labels.
FIFRA prohibits EPA from disclosing CBI to the public. Pesticide registrants frequently assert CBI and other trade secret claims to protect the "recipe" for their pesticide products. Often these claims are specifically made for the inert ingredients. Public requests for inert ingredient information are generally submitted to the Agency through the Freedom of Information Act (FOIA) process. As part of the FOIA process, the Agency contacts the registrant first to see if the registrant will disclose the information. Unless the registrant authorizes the immediate release of ingredient information, Agency must evaluate appropriate CBI claims. This substantiation process can be a slow, labor-intensive process. However, the Agency is granted statutory discretion to disclose CBI in limited circumstances, such as when necessary to treat illness or injury, or to prevent imminent harm to persons, property or the environment. Even then, release of the information is limited to "qualified persons" such as medical personnel.
EPA requested the workgroup members to consider potential measures to increase the availability of information to the public about inerts ingredients under FIFRA. EPA also asked the workgroup to factor into any workgroup proposals:
informational needs for a variety of stakeholders;
current Agency processes and policies for disseminating inert ingredient information to the public, including procedures for the protection of Confidential Business Information;
commercial considerations regarding the disclosure of inert ingredient information;
barriers and constraints in existing law and policy; and
relevant principles and benefits of right-to-know.
The workgroup members agreed on a process to evaluate proposals for disclosure that might be introduced by workgroup members. The workgroup established the following general evaluation criteria:
1. Who are the audiences?
2 What are their information needs?
3. How can their needs be met effectively?
4. How can commercial interests be protected?
5. What other regulatory policies and schemes may be relevant?
For evaluation criteria 1, "Who Are the Audiences," who would benefit from enhanced ingredient information the group created Chart 1, below. These audience groups were then summarized into five general audience groups.
WHO ARE THE AUDIENCES?
Commercial and Industrial entities
Emergency Response Officials
-epidemiologists (e.g., efficacy and health)
-applied technology (e.g., protective clothing)
-universities (e.g., toxicology)
-institutional (e.g., schools/hospitals)
-sensitive/susceptible populations (chain)
State/Local Public Health Agencies
GENERAL GROUPING OF AUDIENCES
Federal/State/Local Regulatory Government Agencies
Health Care Providers
Those who may be exposed who didn't use the product
Those who work with the product directly
For evaluation criteria number 2, "What Are Their Informational Needs," the workgroup created a matrix summary chart which identifies the informational needs of the audience groups as well as some related concerns, see Chart 2 below.
Informational Needs For Inert
|Federal/State/Local Regulatory Agencies||identity (chemical name),
|restrictions on dissemination of information
to other governmental/non-regulatory entities
variations between states/local entities
|Health Care Providers||identity (chemical name),
|timely (fast) information to assist
for the product
varies: non-industry research but may require
identity (chemical name),
|Do we need to query
|Those who may be exposed who did not use the product||
2) identity (chemical name),
Diverse group includes (but not limited to):
some or all user groups have a responsibility or legal obligation to share information (e.g., lawn care service and clients)
homeowners and less technically oriented users may need educational framework to make choices
redundancy needs to be built-into the system
|Those who work directly with the product||
1) identity (common name), hazard information (to take to health provider or government entity).
Diverse group includes (but not limited to):
some or all user groups have a responsibility or legal obligation to share information (e.g., lawn care service and clients)
homeowners and less technically oriented users may need educational framework to make choices
redundancy needs to be built-into the system
Appendix A contains summary documents that have been prepared for the purpose of highlighting some issues of concern for the IDSW. The summary documents are intended to give the reader a sense of the differing opinions that existed in the group. The summaries are not intended to be a comprehensive discussion of all the important issues addressed by the IDSW during its deliberations. The summaries are not endorsed by the IDSW as a group, but are endorsed by the authors and any sponsors.
1 The Docket is located in Room 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. The Docket is open from 8:30 a.m. to 4:00 p.m., Monday through Friday, excluding federal holidays. The Docket telephone number is 703-305-5805 or refer to http://www.epa.gov/pesticides/docket/ .
2 Susceptible Poplutations include the young, the elderly, those with disabilities and chronic health conditions.
3 Vulnerable Populations include those with asthma; allergies; chemical/multiple chemical sensitivities; those sick, injured or poisoned by pesticides; and those with immunological, neurological and related health problems.
4 Ibid, footnote number 2.
5 Ibid, footnote number 3.
The proposals and supplemental considerations that follow represent different approaches to enhancing inert ingredient information to the public that have emerged from this workgroup process. It should be noted that the proposals are not the result of a consensus process but suggestions from individuals within the group. A range of proposals has been introduced by individual members of the workgroup. The IDSW requests the Committee to submit this report to the Environmental Protection Agency's Office of Pesticide Programs for the Agency's use in increasing the availability of information about inert ingredients in pesticide products.
May 14, 2001
Proposal for Disclosure of Ingredient Information for Pesticide Products:
Proposed and endorsed by IDSW Members: J. Spagnoli, R. McAllister, S. Crescenzi, S. Kellner, C. Collins, W. Puckett, I. Tinsley, J. Jacoby, and A. James.
EPA regulations (40 CFR Sec. 156.10) require that pesticide product labels list the identity and percentage of the active ingredient(s). (See also FIFRA §2(n).) Inert ingredient(s) need not be listed separately on the label unless the Agency has determined that they specifically pose a hazard to man or the environment. This determination is made on an ingredient-by-ingredient basis, and includes the inerts EPA has classified "of toxicological concern" (List 1). Additionally, FIFRA §10(d)(1) specifically precludes the Agency from disclosing "the identity or percentage quantity of any deliberately added inert ingredient . . . unless [it is] first determined that disclosure is necessary to protect against an unreasonable risk of injury to health or the environment."
To address concerns regarding availability of information on pesticide product ingredients, EPA formed the Inerts Disclosure Stakeholders Workgroup in 2000 under the Pesticide Program Dialogue Committee. The Workgroup's mission is to advise the Agency on ways to make information on pesticide product ingredients more available, while working within the mandates of FIFRA and related concerns over confidential business information.
From the registrants' viewpoint, the desire for confidentiality is based on (1) who requests the information and for what purpose; (2) the level of detail requested; and (3) the uniqueness or critical nature of the function of the ingredient(s) in the performance or other desirable attribute of a product. Taking into account these considerations and the workgroup's directive to work within the current provisions of FIFRA, we present the following proposal for improving availability of pesticide product ingredient information.
We believe that adoption of this proposal will meet the goals of the workgroup's mission and will provide the Agency with the most expeditious and easily implemented means of making ingredient information more available. This proposal presents two ways that registrants can voluntarily provide additional ingredient information. If a registrant chooses to provide additional information, either or both means could be used.
GENERAL AVAILABILITY OF INGREDIENT INFORMATION
The Agency can develop a form (an example is attached) for pesticide registrants and applicants to provide information they authorize for public release about the inert ingredients in their registered end-use pesticide products. The form is designed to permit the registrant to provide this information while protecting the identity of proprietary inert ingredients. This information can be specified by the registrant in a number of ways, ranging from general description of an ingredient to full disclosure.
Three alternate approaches to incorporating this type of document into the pesticide registration process are presented below:
Releasable Product Summary EPA's regulations (40 CFR § 152.50(c)) require a publicly releasable summary of data submitted in support of a pesticide registration. Through a PR Notice, EPA could suggest that registrants utilize this proposed form (example attached) to provide product chemistry information as part of their releasable product summaries.
Non-Confidential Formula Description Form - EPA could create a non-confidential formula description that would be submitted voluntarily along with a Confidential Statement of Formula, EPA form 8570-4. Such a form would be subject to OMB approval.
Pesticide Product Technical Data Form - EPA in the past required registrants to submit a Label Technical Data form (EPA form 8570-10), providing check boxes for application sites, pest types, modes of action, user types, and formulation type. This form could be revised and restyled as a Pesticide Product Technical Data form and could include the ingredients information in the attached sample form. Use of this form also would require OMB approval.
Any of these forms can then be utilized by the Agency to respond to FOIA requests for ingredient information on products and ultimately be made accessible on EPA's website by EPA Reg. No., like the current Pesticide Product Label System. This website could be listed on the product label as a source of ingredient information (see below).
INGREDIENT INFORMATION ON LABELS
EPA could issue a PR Notice indicating that registrants will be allowed to amend their product labels (subject to Agency review and approval) to:
List on the product label information on "other ingredients," individually or by groups (e.g., petroleum distillates), as appropriate. Percentage information should not be needed for most inert ingredients. Ingredients not specifically listed should be lumped together under "other ingredients," showing their combined percentage. A fragrance should be identified specifically as "fragrance." To avoid confusion, known ingredient names that protect proprietary information should be used, if possible. The ingredient name used on the Material Safety Data Sheet (MSDS) should be used where applicable, though a more commonly known term or other acceptable name could be substituted. Chemical names, generally recognized common names, or other acceptable descriptive terms could be used, as appropriate, so long as they are not false or misleading (per EPA's consideration in the label approval process). Standard nomenclature for many if not most inert ingredients is available in reference works for other industries (pharmaceuticals, cosmetics, food, etc.), such as U.S. Pharmacoepia, National Formulary, Food Chemicals Index, Cosmetic Ingredient Dictionary, USAN and USP Dictionary. EPA could provide guidance to registrants on preferred terminology and sources of names. Reliance on these existing authoritative sources promotes consistency with other product labeling programs.
Include a statement on the label (back panel or other panel is acceptable) referencing another source of inert ingredients information, such as a company website, an EPA website, a toll-free telephone number, or a combination of sources. If the product contains a fragrance, the label should also state "Contains fragrance." A website would provide the publicly releasable product information summary noted above. Washington State has already adopted a similar approach in its fertilizer regulations. Such options would especially help address limited label space.
To facilitate the inclusion of other ingredient information, EPA should include in this PR Notice specific criteria for allowable label placement of ingredient information based on package type/size. We recommend:
On bottles, boxes, bags, and cans that are easily picked up and turned around (less than 1 gallon or 5 lb or less) or where information would otherwise unduly clutter the front panel (explanation provided by registrant), all ingredient information could be placed on the back or side panel. These criteria would be important: (1) the front panel should state where ingredients information is located; (2) ingredient information on the back or side panel must be easily located and legible to a person with normal vision.
On larger packages, the front panel will list the active ingredient(s) and percentage(s) and total percentage of other ingredients, with a referral to where additional ingredient information can be found. The additional ingredient information on the back or elsewhere must be easily located and should repeat the active ingredient(s) and percentage information from the front panel.
OTHER SUGGESTED ACTIONS
Through the Consumer Labeling Initiative or other appropriate effort, EPA should conduct further research to determine what specific needs, if any, are not satisfied by the information provided and identify how to best provide for these needs. This could likely be by means other than labeling.
EPA should expand the "Read the Label FIRST!" campaign to provide information to consumers about ingredient information on labels, such as the meaning of "active" and "other" and the function of the various types of "other" ingredients. (For example, "What are surfactants and why are they used?") This education campaign could also inform the public about ways to obtain additional health and safety information. Information is most useful if its meaning and relevance are understood. Striving to help people understand ingredient information is as important as providing it to them.
Registrants should have flexible options for providing additional ingredients information to the public, if they choose to do so. Labeling can be one option, but a summary on a website (whether the registrant's or EPA's) should be another option.
A voluntary process avoids many pitfalls and delays of rulemaking. It can be implemented much more quickly and better meets the goal of the IDSW. A rulemaking process would likely take years and would require demonstration that disclosure of ingredient identity is necessary to protect against unreasonable risk of injury to health or the environment.
EPA is currently considering revisions to its CBI regulations. Any rulemaking regarding disclosure of inert ingredients would have to be consistent with the CBI regulations that are developed, which would likely delay implementation even further.
|PRODUCT NAME||REGISTRATION NO.|
1.Active Ingredient(s): (Chemical/generic/common name(s) and percentage(s))
2. Other Ingredients
3. Other Ingredients of Toxicological Concern (List 1 Inerts)
4. Other Ingredients Associated with Physical or Health Hazards (from MSDS)
INSTRUCTIONS FOR COMPLETING FORM:
Section 1. Active Ingredient(s): Provide the chemical and common name of each active ingredient and its percentage in the formulation, as listed on the approved pesticide label.
Section 2. Other Ingredients: List each other ingredient in the product. The following options are available: (1) chemical or common name; (2) generic chemical classification; (3) function in the formulation (for example, emulsifier, solvent, diluent, binder, antifoamer, preservative, fragrance, dye or color, propellant, corrosion inhibitor, dispersant); (4) both generic chemical classification and function; or (4) a combination of any of these four options, as appropriate for the formulation, as long as the information is not false or otherwise misleading.
Section 3. Other Ingredients of Toxicological Concern (List 1 Inerts): Provide the chemical identity of any List 1 inert in the formulation; indicate if none.
Section 4. Other Ingredients Associated with Physical or Health Hazards: Identify each component that is required to be listed on the pesticide product's Material Safety Data Sheet (MSDS) on the basis of its physical or chemical hazard. The identification should be consistent with the identification of the component on the pesticide product's MSDS.
Section 5. Comments: May include any additional relevant information about this product.
A PROPOSAL FOR LABEL DISCLOSURE OF INERT INGREDIENTS
Proposed and endorsed by Michael Surgan, Caroline Cox, Shelley Davis, Mary Lamielle, and Carolyn Brickey who are Members of the Inerts Disclosure Stakeholders Workgroup (IDSW) For Transmission to the Pesticide Program Dialogue Committee (PPDC)
June 21, 2001
We propose that EPA initiate rulemaking to modify the labeling requirements for pesticides by adding a requirement that the name of each inert ingredient be listed on the pesticide product label, and that the term "inert ingredients" be replaced on the label with the more appropriate term "other ingredients". Specifically, we propose that 40 C.F.R § 156.10(g) be amended as follows (proposed new language in bold/italic; deletions in strikeout):
40 C.F.R. § 156.10 Labeling requirements.
(g) Ingredients statement-
(1) General. The label of each product must bear a statement
which contains the name and percentage by weight of each active
ingredient; the common chemical name of each inert ingredient,
total percentage by weight of all
each inert ingredients; and if the pesticide contains
arsenic in any form, statement of the percentages of total
and water-soluble arsenic calculated as elemental arsenic.
The active ingredients must be designated by the term "active
ingredients" and the inert ingredients must be designated
by the term "other inert ingredients,"
or the singular forms of these terms when appropriate. Both
terms shall be in the same type size, be aligned to the same
margin and be equally prominent. The statements "Other
Inert Ingredients, none" is not required
for pesticides which contain 100 percent active ingredients.
Unless the ingredient statement is a complete analysis of
the pesticide, the term "analysis" shall not be
used as a heading for the ingredient statement.
. . .
(7) Inert ingredients. The Administrator may require the name
of any inert ingredient(s) to be listed in the ingredient
statement if he determines that such ingredients may pose
a hazard to man or the environment.
This recommendation would result in mandatory label modifications to disclose the name and amount of each inert ingredient in pesticide products. EPA would implement this recommendation by immediately initiating rulemaking so that the proposed amendment could take effect in 180 days, or as soon thereafter as permitted under applicable notice, comment and review requirements.
The recommendation would require the modification of pesticide product labels.
3. Audiences Addressed by the Recommendation
By making the identity of inert ingredients available on the label, the information will be available to all audience groups. Once disclosed on the label, the information would also be available on various easily accessible databases, such as EPA's Pesticide Product Label System and similar databases maintained by State governments, universities and cooperative extension services. It would also be available through the National Pesticide Telecommunications Network and Poison Control Centers.
4. Nature of Information to be Disclosed
This proposal would require the disclosure on the label of the identity of each inert ingredient and its percentage by weight in each pesticide product. It would not require disclosure any other information about the formulation of the product.
5. Confidential Business Information
This proposal preserves the protection of confidential business information relating to formulation procedures and manufacturing processes. Registrants would not be required to reveal information such as the order of addition of ingredients, the identity of reactants and catalysts which are consumed or removed during production (and hence do not appear in the final product), or the reaction conditions and manufacturing processes.
The revelation of the identity of most inert ingredients is not information whose disclosure will cause competitive harm to manufacturers, since such information is already available to knowledgeable persons in the field through publicly available sources. Material Safety Data Sheets (MSDS's), for example, are required by the Emergency Planning and Community Right to Know Act, 42 U.S.C. §11021, and OSHA's Hazard Communication Standards, 29 C.F.R. §1910.1200(g), and are available to the public under 42 U.S.C. §11021(c)(2) and 11044. The identities of inert ingredients are frequently disclosed on these MSDS's. Manufacturers themselves frequently release ingredient information in response to public requests, although again this is a cumbersome and laborious process. In addition, many inert ingredients can be easily identified by individuals and companies well versed in pesticide formulation and with access to analytical laboratories. Business competitors might seek to produce a comparable product, but need not produce an identical one. Therefore, in some instances it may not be necessary for a competitor to use such reverse engineering analyses to precisely identify each inert ingredient to be able to formulate a similar product. The label disclosure of the identity of inert ingredients may offer little competitive advantage over what is already available or readily accessible to competitors.
Any financial burden to manufacturers from label modification will be negligible, and in fact disclosure of inert ingredients on product labels may actually benefit manufacturers. The Consumer Labeling Initiative Report cites research finding that consumers look positively upon detailed safety information on labels: they view the manufacturer as more concerned with consumer safety and are more likely to buy products with explicit warnings. In addition, full disclosure of inert ingredients would encourage pesticide manufacturers to conduct complete toxicological profiles on each inert they use. With this information in hand, manufacturers could reassure the public that product risk has been fully assessed and disclosed.
6. Additional Considerations
EPA should establish a list of standardized common names for inert ingredients.
A PROPOSAL FOR LABEL DISCLOSURE OF INERT INGREDIENTS
Prepared and endorsed by RoseMarie Cazeau,
Michael Surgan, Caroline Cox,
Shelley Davis, Mary Lamielle, Carolyn Brickey and Sheldon Wagner
who are Members of the Inerts Disclosure Stakeholders Workgroup (IDSW)
For Transmission to the Pesticide Program Dialogue Committee (PPDC)
November 16, 2001
We propose that the Environmental Protection Agency ("EPA") exercise its regulatory discretion contained in 40 C.F.R. §156.10(g)(7) and require the name of each inert ingredient be listed on the pesticide product label. Further, that the term "inert ingredient" be replaced on the label with the more appropriate term "other ingredient."
This recommendation would result in mandatory label modification
to disclose the names of each "other
in pesticide products. However, any registrant seeking to
protect the identity of an inert ingredient would have to
secure a determination of confidential business information
or trade secret status before the product is registered or,
for currently registered products, within three (3) years
of the effective date of the issuance of this new policy.
Through a PR notice issued within the next 180 days, EPA can
exercise its discretion authorized by statute, and require
such label disclosure, given the abundant evidence supporting
the conclusion that many "other inert ingredients"
do or may pose a hazard to man or the environment.
If however, EPA determines that such label modification can only be accomplished through rule making, then we propose that EPA initiate rulemaking and amend 40 C.F.R § 156.10(g) as follows (please note, proposed new language is in bold/italic; deletions in strikeout):
40 C.F.R. § 156.10 Labeling requirements.
(g) Ingredients statement-
(1) (A) General. The label of each pesticide product bear a
statement which contains the name and percentage by weight
of each active ingredient; the common chemical name of
each inert ingredient in descending order of concentration
by weight, and total percentage by weight of all inert
ingredients; and if the pesticide contains arsenic in any
form, statement of the percentages of total and water-soluble
arsenic calculated as elemental arsenic. For inert ingredients,
the common name could be used without the chemical name only
if it is well known and is accompanied by the CAS registry
number. If no common name has been accepted, the registrant
must secure and use a CAS registry chemical name and number.
In no case would the use of a trademark or proprietary name
be permitted unless such name has been accepted as a common
name by the EPA Administrator. See 40 C.F.R. §156.10(g)(3)
and PR Notice 97-5. The active ingredients must be designated
by the term "active ingredients" and the inert ingredients
must be designated by the term "other
or the singular forms of these terms when appropriate. Both
terms shall be in the same type size, be aligned to the same
margin and be equally prominent. The statements "Other
Inert Ingredients, none" is not required for pesticides
which contain 100 percent active ingredients. Unless the ingredient
statement is a complete analysis of the pesticide, the term
"analysis" shall not be used as a heading for the
(B) Prior to the registration of a pesticide product, any registrant that wishes to withhold the identity of an inert ingredient in a pesticide product must petition the Administrator for an exemption from disclosure on the grounds of confidential business information or trade secret status. The Administrator will deny such a petition where s/he finds that the information is not entitled to treatment as confidential business information or a trade secret or because the ingredient may pose a hazard to man or the environment.
(C) Currently registered pesticide products must be relabeled in accordance with the provisions of 40 C.F.R. § 156.10(g)(1)(A) supra, within three (3) years of the issuance of this regulation, unless prior to that time the Administrator determines that the identity of an inert ingredient may be withheld from public disclosure in accordance with the provisions of 40 C.F.R. § 156.10(g)(1)(D), infra.
(D ) In making a determination of confidential business information or trade secret status, the Administrator will consider:
(a) The extent to which the identity of the ingredient is known outside petitioner's business;
(b) The extent to which the identity of the ingredient is known by employees and others involved in petitioner's business;
(c) The extent of measures taken by the petitioner to guard the secrecy of the information;
(d) The value of the information about the identity of the claimed trade secret ingredient to the petitioner and its competitors;
(e) The amount of effort or money expended by petitioner in developing the ingredient; and
(f) The ease or difficulty with which the identity of the ingredient could be properly acquired or duplicated by others.
In no event shall the Administrator accord confidentiality to the identity of an inert ingredient where the Administrator determines that the inert ingredient may pose a hazard to man or the environment.
. . .
(7) Inert ingredients. The Administrator may require the name
of any inert ingredient(s) to be listed in the ingredient
statement if he determines that such ingredients may pose
a hazard to man or the environment.
This recommendation would result in mandatory label modifications
to disclose the name of each inert ingredient in pesticide
products, unless the registrant secures an exemption from
disclosure prior to the registration of a new product or within
three years of the promulgation of this regulation for an
existing product. EPA would implement this recommendation
by immediately initiating rulemaking so that the proposed
amendment could take effect in 180 days, or as soon thereafter
as permitted under applicable notice, comment and review requirements.
The recommendation would require the modification of pesticide product labels.
3. Audiences Addressed by the Recommendation
By making the identity of inert ingredients available on the label, the information will be available to most audience groups. Once disclosed on the label, the information would also be available on various easily accessible databases, such as EPA's Pesticide Product Label System and similar databases maintained by State governments, universities and cooperative extension services. It would also be available through the National Pesticide Telecommunications Network and Poison Control Centers.
Some people, health care providers and researchers for example, might require additional information, such as the percentage by weight of individual inert ingredients. Under this recommendation, they would have to obtain that information from sources other than the label.
4. Nature of Information to be Disclosed
This proposal would require the disclosure on the label of the identity of each inert ingredient in each pesticide product and an indication of its relative concentration by weight. It would not require disclosure of the exact percentage of an inert ingredient in the product or any other information about the formation of the product.
5. Confidential Business Information
This proposal preserves the protection of confidential business information relating to formulation procedures and manufacturing processes. Registrants would not be required to reveal information such as the order of addition of ingredients, the identity of reactants and catalysts which are consumed or removed during production (and hence do not appear in the final product), or the reaction conditions and manufacturing processes. Furthermore, registrants would not be required to reveal the precise quantity of individual inert ingredients.
This new procedure is warranted to ensure timely public disclosure of inert ingredient information that is not entitled to confidentiality. Under the current procedure, by contrast, the vast majority of inert ingredient information is withheld for long time periods or indefinitely, even though few ingredients are entitled to confidential business information or trade secret status.
The procedure proposed here is modeled after that used by the Food and Drug Administration (FDA), for approving cosmetics labels. The FDA has found that few of the 20,000 inert ingredients used in cosmetics qualify for confidential treatment. Similarly, the Occupational Health and Safety Administration (OSHA) has found that it can maximize public disclosure of ingredient information without sacrificing valid business concerns by making an "up front" determination of confidential business information or trade secret status, since such confidential treatment is rarely warranted. Indeed, for this reason, some inert ingredients in pesticides are already publicly disclosed on Material Safety Data Sheets, which are required under the Emergency Planning and Community Right to Know Act, 42 U.S.C. §11021, and OSHA's Hazard Communication Standard, 29 C.F.R. §1910.1200(g), and available to the public under 42 U.S.C. §11021(c)(2) and 11044.
Maximizing public disclosure of inert ingredient information on pesticide labels is necessary because many inerts are toxic, cause allergic reactions or provoke chemical sensitivities. This is true even of some chemicals classified by EPA as List 4 Inerts, such as peanuts and peanut-derived products, which can cause potentially fatal reactions in sensitive individuals exposed by contact, inhalation or ingestion. Under the current regulatory scheme, persons who may have been injured by exposure to an inert ingredient must often wait months or even years to discover the identity of the ingredient. This is the case, even though the manufacturer may ultimately agree to disclosure or confidential treatment may finally be denied when such a claim is tested before the Agency or upon judicial review. Moreover disclosure on the label is the only way that persons who are aware of allergies or chemical sensitivities could protect themselves from exposure to a particular inert ingredient.
Few inert ingredients in pesticides would be entitled to confidential business information or trade secret status because the identity of most, if not all, such ingredients can be discovered through reverse engineering. As a consequence, revealing the identity of most inert ingredients is not information whose disclosure will cause competitive harm to manufacturers, since such information is already available or discoverable to knowledgeable persons in the field or those with access to analytical laboratories. Nor is it always necessary for a competitor to use reverse engineering analyses to precisely identify each inert ingredient to be able to formulate a similar product. For all these reasons, the label disclosure of the identity of inert ingredients will offer little competitive advantage over what is already available or readily accessible to competitors.
Finally, any financial burden to manufacturers from label modification will be negligible, and in fact disclosure of inert ingredients on product labels may actually benefit manufacturers. The Consumer Labeling Initiative Report cites research finding that consumers look positively upon detailed safety information on labels: they view the manufacturer as more concerned with consumer safety and are more likely to buy products with explicit warnings.
7. Additional Considerations
(a) EPA should establish a policy which ensures that its review and decision-making process gets completed within prescribed deadlines so that a registrant is not prejudiced by a lengthy waiting period for its decision.
(b) EPA should establish a list of standardized common names
for inert ingredients.
Supplemental Considerations for Proposals
on Pesticide Inert Disclosure
Brad Mitchell, Massachusetts Dept of Food and Agriculture
Initiatives Requiring Minimal Resources/Time to Implement
Many proposals suggested by Workgroup members will require a significant amount of time and/or other resources before these proposals may be implemented. Rulemaking would be required before some suggestions may be put in place. However a number of initiatives can be undertaken which would not require significant time or other resources to implement. Such initiative could be either interim, or complementary to those actions proposed in position papers. Such measures should not be expected to provide all inert information to all who need it, in all situations. However, they could provide more inert information than is currently being provided. Potential initiatives that would not require significant time or resources to implement include:
Label Contacts Numbers for Inert Information
Many registrants have customer service departments or equivalent
systems that provide product information to customers. Such
systems could be adapted to provide inert information to customers
or others who need such information. The most direct and effective
means of putting customers and other in touch with customer
service providers would be to publish a contact number on
the product label.
Protocols would need to be developed to determine how much inert information should be disclosed, and under what circumstances. In some cases, registrants may choose to have customer service personnel divert inert questions to other individuals in the company. It would be preferable for industry to adopt a single set of protocols. Input from EPA and other stakeholders should be obtained in the development of the protocols.
Database of Inert Information for Health Care Providers
Health care clinicians are arguably the audience with the greatest need for information on inert ingredients. Accurately identifying inert ingredients to which patients have been exposed can be as critical as identifying active ingredients to which they have been exposed. For clinicians to accurately diagnosis and treat a patient, they must know all elements of exposure.
The Micromedics database is currently available to all poison control systems. There are two major complaints with the system:
1. Not all pesticide products are listed in the system. While large registrants participate in the Micromedics system, many smaller registrants and re-formulators do not.
2. The system sometimes sends clinicians to industry contractors or employees to obtain information. This additional "link" between the clinician and the information sometimes results in unacceptable delays. Such delays are particularly problematic in emergencies.
It would be extremely helpful to have Micromedics-type database that includes all pesticide products. A web-based database would virtually guarantee access to those with authorized access, such as poison control systems. Direct access to information would remove unacceptable delays. It is possible to achieve a significant level of security through password-based systems, user agreements, and use tracking. Similar systems are in use in financial systems and other situations where database information is sensitive.
Label Recognition for Voluntary Full Disclosure
In some cases, the disclosing the identity of an inert ingredient contained in a product will not compromise the "trade security" of the product. Where inert information is not sensitive, registrants should be encouraged to disclose such information.
In some cases, it may be feasible to disclose all inert information in a product without compromising product security. Again, where it is feasible to list all inert ingredients in a product, registrants should be encouraged to do so. Furthermore, where all inerts are listed on the label, there should be an easily recognizable statement or symbol on the label indicating that all inert ingredients are listed. Knowledge that all inert ingredients are listed would be of potential value to health care providers as well as to consumers.
Disclosure of Inerts on the Label using "General Descriptors"
In some situations where information on inert ingredients is needed, the specific identity of an inert ingredient need not be disclosed to adequately meet a particular need. A reference to the chemical class, category or function will often suffice. For example, persons with sensitivities to fragrances would benefit greatly simply to know that a product contains a fragrance. The disclosure of such information would in no way result in the disclosure of trade secrets.
In the absence of other measures, registrants should be encouraged to provide as much information on inert ingredients as possible. General descriptors of inert ingredients should be as specific as possible, without compromising product security.
Ingredient Nomenclature Additional Work Needed
There was considerable discussion concerning the appropriateness of various nomenclatures that may be used to reference chemical ingredients. The group discussed the potential strengths and weaknesses of IUPAC nomenclature, common chemical names, CAS Number and several other systems.
It became clear to the group that no particular system of nomenclature was more appropriate than another. Rather, the system to be used is best determined by the audience, and their ability to recognize and utilize a system. Where common name is probably the most appropriate for the lay consumer, CAS number may be a more appropriate identifier for researchers or regulators. Where feasible, listing multiple names (acronyms) to identify inerts would be preferable. This is frequently done in computer databases.
Development of Discussion Papers
Early in the deliberations of the workgroup the members thought it would be useful to target specific questions, or topics for attention. As background and to focus on important issues, a number of informational papers were generated by workgroup members, EPA staff or guest experts. It should be noted that the discussion papers are the thoughts and opinions of the individual authors are not the result of a consensus process of the workgroup as a whole. The discussion papers generated attempt to address questions such as:
- How does EPA currently disclose information about inerts?
- What are the regulatory differences between disclosure required on cosmetic labels and pesticide products?
- How is information about inerts provided to health care providers? ("Poisindex" - a database software used by health care professionals)
- To what extent can the ingredients in a pesticide product be "reverse engineered" to reveal the chemical components of the product?
- What is the role of patents in protecting industry proprietary interests?
- What are the regulatory requirements for ingredient disclosure for cosmetics, over the counter drugs, and prescription drugs?
- What are the informational needs of sensitive and vulnerable populations such as persons with multiple chemical sensitivities?
- What barriers or restrictions for sharing inert ingredient information exist between the federal government and the states or, within the states?
- What support system does some of the industry use for providing information to the public when 1-800 numbers are called?
- What ingredient information is provided on the Material Safety Data Sheets (MSDS)?
- To what extent is there standard nomenclature and/or common names for inert ingredients?
- What are some of the relevant parameters of EPA labeling requirements?
Discussion Paper 1
EPA staff, March 20, 2000
Background Information About Disclosure of Information About Inerts
The Inert Disclosure Stakeholder Workgroup will advise the Pesticide Program Dialogue Committee (PPDC) on ways to make information on pesticide inert ingredients more available to the public while working within the mandates of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the related Confidential Business Information concerns. The advice we receive from the advisory committee process as well as information we receive from the public and other sources will greatly assist our efforts to develop our policy and approaches in this area. This paper provides certain background information relevant to the issue of disclosure of information about inerts.
A. Ingredients in Pesticide Products
Pesticide products contain "active" and "inert" ingredients. The terms "active ingredient" and "inert ingredient" are defined under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). An active ingredient is one that prevents, destroys, repels or mitigates a pest, or is a plant regulator, defoliant, desiccant or nitrogen stabilizer. By law, the active ingredient must be identified by name on the label together with its percentage by weight. The statute defines the term "inert ingredient" merely as an ingredient which is not active. The law does not require individual inert ingredients to be identified by name and percentage on the label, but the total percentage of all inert ingredients must be declared.
Historically, EPA has considered a substance to be "active" based largely on the label claim of the pesticide product. For example, a chemical that is intended to control a target pest, such as an insect, would be considered an active ingredient in an insecticide formulation. However, when the same chemical is used in a herbicide product, the chemical might perform the function of a solvent and would therefore be considered an inert ingredient in that particular formulation.
In September 1997, EPA issued Pesticide Regulation Notice 97-6 requesting registrants of pesticide products to voluntarily substitute the term "other ingredients" in lieu of the term "inert ingredients" on the label. EPA made this change after listening to comments from the public, and learning the results of a consumer survey on the use of household pesticides which indicated that many consumers are misled by the term "inert," believing it to mean "harmless." Since neither the federal law nor the regulations define the term "inert ingredients" on the basis of risk to humans, non-target species, or the environment, it should not be assumed that all inert ingredients are non-toxic. For convenience and consistency, the term"inert" will be used in this paper.
B. Historical Background: Regulation of Inert Ingredients Before 1987
Prior to the establishment of the EPA, the Department of Agriculture (USDA) was responsible for the registration of pesticides under FIFRA. The Food and Drug Administration (FDA) was responsible for establishing tolerances or safe levels of pesticide residues in raw agricultural commodities and food.
In 1961, FDA published a Federal Register notice (26 FR 10640; November 14, 1961) stating that USDA had determined that each component of registered pesticide products, including the inert ingredients, were pesticide chemicals. This determination meant that a tolerance (maximum legal levels for pesticide residues in raw agricultural commodities) or an exemption from the requirement of a tolerance had to be established for inert ingredients as required by the Federal Food, Drug, and Cosmetic Act (FFDCA).
By 1969, the FDA had established a policy regarding data requirements and review procedures for inert ingredients (34 FR 6041; April 3, 1969). This notice set forth general toxicity data requirements and stated that residue data requirements would depend on the toxicity of the chemical. The policy also allowed a simplified review process if FDA concluded that the inert ingredient was generally recognized as safe for the stated purpose. Likewise, the process to exempt an inert from the tolerance requirement generally occurred through an informal request procedure, rather than the formal petition process required for active ingredients.
In 1970, the authority to register a pesticide and to establish tolerances or exemptions to a tolerance for pesticide chemicals was transferred to EPA. However, since most of the data requirements and regulatory activities under FIFRA focused on the active ingredient, EPA exerted little regulatory control over inert ingredients. By 1984, there were two exceptions to this general policy. First, acute toxicity testing on the pesticide formulation, which generally includes both active and other ingredients, was routinely required for registration of end-use products. End-use products are the form of pesticide product which the public is most likely to purchase for use. Acute toxicity tests are used to determine short term effects. Second, certain labeling requirements for hazardous inert ingredients were imposed (49 FR 37980; September 26, 1984).
II. EPA's 1987 POLICY FOR INERTS
In 1987, EPA announced a comprehensive policy to "reduce the potential
for adverse effects from the use of pesticide products containing toxic
inert ingredients" (52 FR 13305; April 22, 1987). The policy also
established criteria for the types of information needed to evaluate the
impacts to human health and the environment from the use of the inert
ingredients in pesticide formulations. The Agency concluded that some
inert ingredients had potentially significant long-term health and environmental
hazards associated with their use in pesticide products. The policy emphasis
on the long-term health and environmental effects of inert ingredients
requires pesticide registrants to specifically consider these effects
when developing new pesticide formulations.
The 1987 notice and the current Agency policy establish data requirements for new inert ingredients and categorize all inert ingredients into four categories (or lists), including:
Considered to be of "toxicological concern," 57 chemicals were originally placed on List 1 because they demonstrated the potential to cause either: cancer, nerve damage, adverse developmental and reproductive effects, or adverse ecological effects. All List 1 inert ingredients are required to be disclosed on the product label. OPP also issued Data Call-In notices (DCIs) for these chemicals which required registrants to submit additional data. The data requested were equivalent to the data required for a new active ingredient to demonstrate that these chemicals can be safely used in pesticide formulations. There are now only seven List 1 inert ingredients currently in use.
There are 52 chemicals classified as List 2 inerts. Ingredients on this list are classified as potentially toxic with a high priority for testing. Agency review indicated that many of these chemicals had structural similarities to List 1 inert ingredients, or there were data suggesting a degree of toxicity or hazard. The Agency continues to evaluate the available data to determine whether a sufficient basis exists to allow these substances to be reclassified to List 1 or List 4.
List 3 inerts includes chemicals of unknown toxicity. There are about 1700 chemicals on this list. OPP is currently developing toxicological and ecological assessments for these inerts. In 1995, 146 inert ingredients, previously classified on List 3, were moved to List 4B (60 FR 35396; July 7, 1995). The moves were based on SAT reviews showing the substances were of low concern to human health and posed minimal environmental effects and were already approved for use by the FDA as direct food additives, or were low risk polymers that met the criteria established by the polymer exemption rule at 40 CFR 723.250.
This list includes 430 chemicals of minimal concern. In 1989, this list
was further divided into List 4A, minimal risk inerts, and List 4B, inerts
for which the Agency had sufficient information to conclude that their
current use patterns in pesticide products would not adversely affect
public health and the environment. In 1994, List 4A, ingredients of minimal
risk, was amended to include all commonly consumed foods used as inerts
(59 FR 49400; September 28, 1994).
A. Chemicals Removed from the Inert List
In 1998, the Agency removed certain chemicals from the inert list because
they had not
been used in pesticide formulations for at least two years (63 FR 34384; June 28, 1998). Some of the List 1 inert ingredients removed were no longer used as a direct result of the DCI's issued under FIFRA. A total of 251 chemicals were removed (32 List 1, 12 List 2, and 207 List 3).
B. Evaluation of Existing Inert Ingredients
The Agency is also evaluating existing inert ingredients. This effort is primarily focused on examining information available on List 2 and 3 inert ingredients to support decisions to reclassify these ingredients as either List 1 or List 4 inert ingredients.
C. Review of Other Scientific Data
Review of scientific literature and other data bases that contain information related to pesticides can, at times, provide relevant information for pesticide regulation. While data from these sources do not always meet EPA's strict standards (e.g., Good Laboratory Practices, evaluation criteria uses risk based standards) some do and are directly used for regulatory purposes when appropriate. Sometimes these sources are helpful because they direct the need for additional data when they suggest a potential concern with a pesticide ingredient. At other times, these sources provide supporting evidence for a decision that is based primarily on data meeting Agency standards.
In the last several years, OPP has re-analyzed considerable existing data on List 2 and 3 inerts and obtained some data through the of review of scientific literature and other data bases. The Structure Activity Team (SAT) of the Office of Pollution, Prevention, and Toxics conducted a review of available data on all 1700 List 3 inert ingredients to predict the effects of these chemicals on human health and the environment. The SAT review uses both existing information and predictions of a substance's likely toxicity and environmental effects. The SAT effort is being incorporated with existing OPP analysis and will be reviewed to determine if any reclassification for listing can be made. OPP has also been reviewing the data used for listing and delisting chemicals on EPA's Toxic Release Inventory (TRI). Like the SAT reviews, TRI reviews will be used to supplement the existing OPP data base.
III. BACKGROUND: REQUIREMENTS OF THE FOOD QUALITY PROTECTION ACT
The Food Quality Protection Act (FQPA) of 1996 requires reassessment of all food use inert ingredients which have tolerances or exemptions from the requirement of a tolerance to ensure that they meet the safety standards in the new law. In the past, consideration of tolerances or exemptions from a tolerance for inert ingredients were based solely on risk associated with their use in pesticide products. As of August 3, 1996, new tolerances are to be calculated for food use inert ingredients by assessing the aggregate exposure of the pesticide chemical residue including all dietary and non-dietary exposures resulting from their use in pesticide formulations, as well as exposures from non-pesticidal uses. The new tolerance reassessment process must now also focus explicitly on exposures and risks to infants and children, and possible disruptive endocrine effects. In addition to the new health standards, FQPA mandates data compensation and exclusive use rights for inert data submitters who submit data in support of a tolerance or exemptions to a tolerance. FQPA also directs EPA to establish a 15-year cycle review program to re-evaluate all registered pesticide products. This re-evaluation will include review of the pesticide formulations including any inert ingredients in the formulation.
IV. CONFIDENTIALITY OF PESTICIDE DATA AND THE FREEDOM OF INFORMATION ACT
A. The Freedom Of Information Act Process
The Freedom of Information Act (FOIA) allows the public to request copies of records in the possession of federal agencies. EPA is required to provide the fullest possible disclosure of information to the public unless the information falls into one of the exemptions under the FOIA (e.g., personal privacy, confidential business information, trade secrets, sensitive information, etc.). Most of the Office of Pesticide Programs's (OPP) records not specifically prepared for routine public distribution fall within the scope of the FOIA. The types of pesticide program records handled under FOIA include, but are not limited to, FIFRA health and safety data, internal data reviews or memoranda, and administrative files for registered products. Like the substantiation process, FOIA regulations provide a comprehensive series of procedures governing public access to information. If a FOIA request involves asserted CBI claims, the timeliness of the Agency's response is dependent upon the substantiation process.
A formula or "recipe" for each pesticide product is submitted to the Agency as part of the registration requirements. The formula information submitted includes the identity and percentage of the individual active and inert ingredients in the formula. The identity of inert ingredients is frequently asserted as confidential business information (CBI) by pesticide registrants. The current Agency process to substantiate an asserted CBI claim requires that each claim be evaluated on a case by case basis. This process can be slow. By law, EPA is prohibited from disclosing CBI to the public. However, the Agency may disclose CBI in limited circumstances, such as when necessary to treat illness or injury, or to prevent imminent harm to persons, property or the environment. Even then, release of the information must often be limited to certain "qualified persons" such as medical personnel, who may not disseminate the information more broadly. Agency regulations related to CBI and public information are found in 40 CFR part 2.
B. Assertion of CBI Claims
Prior to releasing business information to the public, the Agency must determine whether the information is subject to a confidentiality claim. If there is no indication whether the submitter claims the information as CBI, EPA must inquire whether the submitter wishes to assert a claim if either of two circumstances apply: (1) the information was submitted before October 1, 1976, or (2) the information is such that the submitter might be expected to object to its release (generally, when there is a history of CBI claims for this type of information e.g., inert ingredients). However, the Agency need not make such an inquiry if the submitter has received prior notice that information not claimed as confidential may be disclosed without further notice.
C. Substantiation of CBI Claims
Once the Agency has established that information is claimed as CBI, EPA confidentiality regulations impose a series of procedures governing whether and how such information may be disclosed. For pesticide registrants, part of this procedure means responding to an Agency letter requesting that the CBI claim be substantiated. The Agency letter seeks responses to such questions as to whether the information has been disclosed to the public, what measures the submitter has taken to ensure non-disclosure of the information, and whether disclosure of the information is likely to cause substantial competitive harm. Normally, the submitter has 15 working days after the receipt of the Agency letter to respond. However, the submitter can request an extension.
D. EPA Determines Whether Information Is Entitled to Confidential Treatment
After the submitter has responded to the Agency's substantiation letter, EPA makes a final administrative determination whether the information is entitled to confidential treatment. Once a determination is made, notice of the Agency's final action is furnished to the submitter. If the Agency determines the information not to be entitled to confidential treatment, the final notice states that EPA will make the information publicly available within 31 days after receipt of the final action. Final Agency actions may be subject to injunctive relief and full judicial review.
E. Request for Disclosure of Inert InformationOPP processes approximately 1100 FOIA requests annually. Less than 1% of these requests seek information about the identities of pesticide product inert ingredients. These requests can take as little as six weeks to complete. However, some requests seek disclosure on thousands of products involving hundreds of registrants and can take several years to complete. Since 1996, using the substantiation process, OPP has disclosed the identity of some or all of the inert ingredients in over 250 products. Currently, over 30 appeal requests seeking disclosure for inert ingredients are awaiting final confidentiality determinations at EPA.
V. ENHANCING PUBLIC ACCESS TO PESTICIDE INFORMATION
EPA information about inert ingredients and labeling information is available via the INTERNET by logging on to:
- OPP created a Web site, Inert Ingredients in Pesticide Products, http://www.epa.gov/opprd001/inerts/ which allows the user to search the list of approximately 2500 inerts by CAS number, chemical name, or inert category listing. The site also provides users access to the Federal Register and Pesticide Registration notices applicable to inert ingredients.
- OPP created the web site, Read the Label First, http://www.epa.gov/pesticides/label/ EPA has created a label with pop-up text that explains the basic statements found on pesticide product labels, including inert or other ingredients.
- Consumer Labeling Initiative information regarding the study recommendations and findings, fact sheets and other consumer information is located at, www.epa.gov/oppt/labeling.
- OPP's Labeling Manual is located at http://www.epa.gov/oppfead1/labeling/lrm/.
- The National Pesticide Telecommunications Network is located at http://npic.orst.edu.
Discussion Paper 2
Guest Speaker: Richard Jewel, FDA
EPA staf drafted paper, July 25, 2000
Cosmetic Labeling under the Fair Packaging and Labeling Act (FLPA) and Federal Food Drug and Cosmetic Act (FFDCA)
This paper discusses certain regulations and policies pertaining to the labeling of cosmetic products as background for discussion in the Inert Disclosure Stakeholder Workgroup of the Pesticide Program Dialogue Committee. Office of Pesticide Programs staff worked with staff from the U.S. Food and Drug Administration, Office of Cosmetics and Colors to create this document.
Broad differences exist between the regulation of cosmetic products under the Fair Packaging and Labeling Act (FLPA) and Federal Food Drug and Cosmetic Act (FFDCA), and the regulation of pesticide products under the Federal, Insecticide, Fungicide, and Rodenticide Act (FIFRA). Unlike FIFRA, cosmetic products registration requirements are voluntary. However, both industries are regulated by mandatory labeling requirements. Cosmetics marketed directly to the public in the United States must have label declarations which identify the name and place of business or distributor, a net quantity statement, warning statements if appropriate or required by regulation, a product identity statement and an ingredient statement which designates all the products' ingredients that are not exempt from public disclosure or considered "incidental ingredients." Cosmetic products used by professionals (e.g., beauty salons) and free samples are not required to bear an ingredient statement.
Cosmetic ingredients are listed on the label in descending order of predominance with no requirement as to the percentage of the ingredients. Fragrances and flavors are allowed to be listed in general terms "as long as the meaning of such term is commonly understood by consumers" (21 CFR 701.3(a)).
Pesticide labeling requirements include an ingredient statement which contains the name and percentage by weight of each active ingredient and the total percentage by weight of all inert ingredients. Policy guidance in the EPA Label Review Manual, 2nd Edition, December 1996 states that "After July 1, 1997, all pesticide ingredient statements must be expressed as nominal concentration."
Exemptions to Ingredient Listing
Both industries, pesticides and cosmetics, are permitted certain exemptions from disclosure of ingredients if the industry meets the appropriate regulatory requirements. What is noteworthy is that while both statutes require the administering agency to protect trade secrets neither statute specifies a specific organizational process. Although the burden of proof in both cases is on the person seeking trade secret protection, the administration of confidentiality requests in the two agencies is very different.
Under the FFDCA, the Food and Drug Administration (FDA) has established an "up front" process which requires the petitioner to request and receive approval of the request for confidentiality before an exemption is granted. If a request for confidentiality is approved, cosmetic products may bear the phrase "and other ingredients." The identity of the other ingredients is treated as a trade secret not subject to public disclosure. If the request for confidentiality is denied, the petitioner is granted appeal rights, the right to withdraw the request without disclosure of the information and ultimately judicial review of the agency decision.
Under Agency confidentiality regulations and due to the fact that the current Confidential Statement of Formula (CSF) does not provide for specific designation of confidentiality claims, EPA has in effect a "back end" process where (1) before disclosing inert ingredient information, the Agency must normally consult with registrants concerning whether such information is claimed as confidential, and (2) if a registrant or applicant does assert a claim of confidentiality, the information is protected from disclosure until EPA takes formal action to determine that the information is not entitled to confidential treatment. The determination of the legality of the claim of confidentiality is not directly tied to acceptance or denial of the pesticide product application or label. Note that EPA is contemplating revising the CSF to require specific identification of CBI claims for future formulations.
As a result of these differences, EPA protects an unknown amount of information without knowing whether the information is in fact entitled to confidential treatment under the law. On the other hand, of an estimated 20,000 FDA registered cosmetic products, only a few have ingredients with approved trade secret status.
Incidental Ingredients and Inert Ingredients
Both EPA and FDA allow certain ingredients not to be listed on the label.
The FDA allows cosmetic manufacturers and distributors not to disclose
"incidental ingredients," which are "...present in a cosmetic
at insignificant levels and ... have no technical or functional effect
in the cosmetic," (21 CFR sec.701.3(l). An example of an incidental
ingredient could be a processing aid that may have been used during product
formulation but has no technical or functional effect in the final product.
FDA regulations do not cite a "de minimis" policy defining the
term "insignificant" for these ingredients. If brought before
the attention of the FDA, FDA will evaluate on a case-by-case basis whether
or not the industry has properly exercised the nondisclosure privilege
for incidental ingredients. FDA does not maintain a list of the number
and type of incidental ingredients used in cosmetic products. However,
FDA officials believe they have a sense of which incidental ingredients
are used by the industry. Many of the incidental ingredients are used
in flavors and fragrances which the FDA has allowed to be listed on the
label in general term. 6
Ease of Public Assess to Undisclosed Information
The public may obtain a listing of the approximately 2500 inert ingredients used in pesticide products without filing a Freedom of Information Act (FOIA) request but no cross reference to a specific product is available without filing a FOIA request for that product. Such a request usually triggers EPA action for a legal determination of the claim of confidentiality.
Although, not identified on the label of a pesticide product, a consumer can tell that inerts are present because the percentage of both active and inert ingredients must be listed. With cosmetic products the incidental ingredients are not required to be listed on the label nor is there a requirement to account for unlisted ingredients. Unless the consumer were familiar with FDA cosmetic labeling regulations, the consumer might assume that all ingredients were listed on the label.
6 Discussion with the FDA, Office
of Cosmetics and Colors, revealed that flavors and fragrances
were allowed to be grouped under general terms, "as long as
the meaning of such term is commonly understood by consumers,"
because the list of ingredients tended to be very long.
Discussion Paper 3
Guest Speaker: Doug Fast, Micromedex
September 12, 2000
1. How many FIFRA registered products are listed in POISINDEX? What proportion of all active FIFRA-registered products does this represent? Which products are not listed, and why were they not included?
At present, MICROMEDEX does not collect or index information on whether a product is FIFRA-registered and therefore does not know the proportion of all active FIFRA-registered products contained in the POISINDEX system. The system, however, contains approximately 20,300 pesticide products which are likely FIFRA-registered. Manufacturers voluntarily submit information for use in the POISINDEX system and, if submitted to Micromedex, they are included in the POISINDEX system. MICROMEDEX is open to the idea of receiving additional information on FIFRA-registered products so that the POISINDEX system provides comprehensive and complete information.
2. What specific information are registrants asked to provide on various products? How complete are the submissions received from various manufacturers? Do registrants pay a fee to have product information listed? What obligation/incentive do registrants have to provide product information data?
There are two primary pieces of information that are obtained from manufacturers. The first is company emergency contact information. This is basic contact information pertaining to the company, including: company name, address, business phone numbers, emergency numbers, e-mail, and non-emergency contact information.
The second is product specific information. This may include the following information for each product: Trade name, synonyms, countries of distribution, type/use of product, ingredients and amounts, physical description, product/formula identification codes, availability size and type, and date the specific formula was released, changed/updated, or discontinued.
As stated above, manufacturers voluntarily submit information to Micromedex. Therefore, the scope of the submitted information is subject to the manufacturers' discretion. At present, MICROMEDEX does not charge the manufacturers for listing or maintaining emergency contact and product specific information in the POISINDEX system. While manufacturers are not obligated to provide MICROMEDEX this information, their incentive may include the use of the information, in combination with MICROMEDEX' treatment protocols, by over 1,300 poison centers, hospital emergency departments and other health care professionals.
3. What is the process for updating information on a specific product? How often does this happen? Who initiates it? How is a registrant reminded that formulation update information is needed?
The majority of information updates occur as a result of product changes and, therefore, the frequency of updated information is largely dependent on the manufacturer. MICROMEDEX updates the POISINDEX system when it receives notice of product changes from manufacturers. MICROMEDEX also updates the POISINDEX system if a poison control center learns about a new product or change to an existing product. Upon notice from the poison center, MICROMEDEX contacts the manufacturer for the new/updated information.
4. Does the POISINDEX database contain information on cancelled products? Would the presence of older products cause any problems?
Yes, the POISINDEX system includes information on products that have been discontinued. Any product that has been discontinued is referenced as such in the system.
5. Who can subscribe to POISINDEX? Who are all the subscribers? What proportion of all poison control centers, hospitals, other entities subscribe to POISINDEX? What are the costs? Are there different access levels to information for the products?
Currently, MICROMEDEX licenses the POISINDEX system to a variety of end users. Poison centers and hospitals are the two primary customers. Within the United States, nearly 100% of the practicing poison control centers have access to the POISINDEX system. Other end users include medical personnel engaged in medical emergency preparedness, planning, and prevention. MICROMEDEX also licenses the system to companies for use in creating MSDSs, clinical research, etc. Numerous factors impact the POISINDEX system subscription fees, such as the type of media (e.g., CD ROM, network, intranet) and type of facility and its use within the facility. As a consequence, the subscription fees for the POISINDEX system vary. POISINDEX has different levels of access to the information contained in the system.
6. What problems does MICROMEDEX experience in obtaining the pesticide formulation information from registrants? In distributing to health care providers? What types of complaints come from POISINDEX users? What problems do health care providers encounter in obtaining product information for treating pesticide exposure?
The primary problem MICROMEDEX encounters in obtaining and distributing pesticide formulation information is manufacturers deciding to not provide any product data to MICROMEDEX. Complaints from POISINDEX users were recently reviewed as part of a market research study of the poison control centers, as well as other health care customers. This study indicated a higher level of concern with customer communication, such as appropriate billing and technical support, as well as the interest in having new data available more frequently. Since this time, MICROMEDEX has made internal changes to address these customer issues.
7. Does MICROMEDEX record statistics on the types of information requested from POISINDEX? Frequency of access? By category of subscriber? Are such statistics made available to registrants?
Due to the fact that POISINDEX is primarily delivered via a CD-ROM, MICROMEDEX currently is not able to track various usage information. MICROMEDEX has on occasion completed market research to obtain usage information, but the results would be too inconclusive to send registrants. MICROMEDEX also indexes each product in the POISINDEX system with an AAPCC code based on a particular substance and how it is used. This code is then submitted by participating poison centers to AAPCC to fulfill TESS reporting requirements, which may be able provide extensive exposure information.
8. Does POISINDEX include treatment protocol information for individual products? How is such information developed and provided to POISINDEX? What level of treatment detail is provided to healthcare providers?
POISINDEX contain over 1,100 toxicological treatment protocols. Each product contained within POISINDEX is either assigned an existing treatment protocol(s), or a new one is created. A product is assigned a specific protocol(s) based on the active/inactive ingredients contained in the product, concentration levels, and the form of the product. If a new protocol is needed, MICROMEDEX' editorial staff researches and writes the treatment protocol, and it is then reviewed by top authorities within the toxicology field. Each treatment protocol contains detailed information such as clinical effects, range of toxicity, treatment, and more.
Discussion Paper 4
October 17, 2000
Inert Disclosure Stakeholder Workgroup
Response to Questions about Reverse Engineering
To obtain some basic information about the analytical process for determining the composition of ingredients a pesticide product, (a.k.a. "Reverse Engineering"), the Inert Disclosure Stakeholder Workgroup created the list of questions below. EPA's Analytical Chemistry Branch (ACB), Biological & Economic Analysis Division, Office of Pesticide Programs, and Chip Collins, Agricultural Senior Research Manager, Stepan Company, who in coordination with analytical chemists from four multinational pesticide manufacturing companies, provided the following responses to the IDSW questions on reverse engineering.
1. Can the composition of all or most ingredients (active and inert)
in a pesticide product be determined by reverse engineering?
Reverse engineering would probably determine most, but not all of the ingredients in a mixture. Good science tends to cost money. Here you are talking very good science in a well equipped state-of-the-art laboratory staffed with highly trained chemists. The composition of all active ingredients as listed on the label, or on the Confidential Statement of Formula can be determined by "reverse engineering." Registrants are generally required to identify only ingredients above 0.1% (or less than 0.1% if the impurity is toxicologically significant) on the Confidential Statement of Formula, thus most , but not necessarily all, inert ingredients could be determined by reverse engineering.
What do you mean by reverse engineering? Determination of a chemically equivalent composition, while still prohibitively expensive, may be possible. Determination of an exact chemical composition is impossible. These differences, while related to issues such as chemical feedstock, basic chemical manufacturing iterations, complex mixtures used, etc, often give the registrant the toxicological and pesticide delivery competitive advantages needed to market his product.
The pesticide industries' analytical labs use good science everyday with the high priced instruments and experts used to conduct the product chemistries need to register today's pesticide formulas. Good science, for reverse engineering to the extent you are talking, would not cut it; it would take spectacular science. Separation screening, with these complex pesticide formulations, would be absolutely overwhelming.
FIFRA requires that all intentionally added ingredients(even if below
0.1% by weight) be identified on the CSF.
Many inert ingredients are listed by trade name on a pesticide registrant's CSFs. These trade named inerts, while compositions are identified in supplier's confidential files at EPA, are complex mixtures and not identified on the CSF.
Complex mixtures of in many cases 4 iterations/oligomers of the same chemical family would be impossible separated and identified when mixed with other anionic and nonionic surfactants with the active pesticide with it's isomers and solvents as well as defoamers and other formulation aids. Most formulated pesticides fit into this category. The value to the registrant is these iterations. When they are identified, the registrant in essence gives his competitors the $1MM plus put into developing the ideal combination of inert ingredients to give his product the competitive advantage needed to recoup his investment.
The pesticide and inert industry's well trained analytical, organic synthesis, and formulation chemists all agree that pesticide formulations can not be reverse engineered to a point at which they are exact chemical compositions. These chemists would be the most capable group to reverse engineer an exact chemical pesticide formulation composition and they universally agree that it can not be done. Identifying some components present in a complex chemical mixture does not produce a formula for recreating the mixture.
2. What degree of "engineering" is required for quantitative analysis of a pesticide product and what degree of "engineering" is required for qualitative analysis of a pesticide product?
The degree of "engineering" required for qualitative analysis of a pesticide formulation whether for the active ingredients or the inerts does require a well equipped laboratory having a wide variety of state-of-the-art analytical instruments. The most difficult part of the process is the qualitative identification. This is the part of the process that will take time and require well trained chemists who understand pesticide formulation chemistry. Once an ingredient has been isolated and identified, it is relatively easy to quantitate. In other words, once you can see it you can quickly measure it.
Most inert ingredients identified qualitatively are not considered easy to quantitate. There are no analytical standards for most inert ingredients and they would be very difficult to prepare. Nonionic surfactants, or polymers, are major inert ingredients and the analytical standards, for instance, an ethoxylated castor oil, are not available. The castor oil raw material used as the feedstock for ethoxylation is typically 87% ricinoleic acid (a natural fatty acid). The other 13% is natural but varies in composition. To truly identify the castor oil used in a specific pesticide formulation, there would need to be analytical standards for all of the various ethoxylate polymer chains plus the variations of the castor oil feed stock. The matrix would be impossible. But, the key to the performance of the pesticide formulations, and thus the commercial value, is those exact variations and ratios. This could not be determined by reverse engineering, but inert disclosure would eliminate the competitive, commercial value.
3. What are the estimated cost ranges for quantitative analysis and qualitative analysis of a pesticide product?
Cost estimates will vary all over the map. For what's reasonable if I might suggest you should contact someone in Superfund and ask what's the cost for a complete dioxin analysis, and what's the cost to identify the composition of an unknown "material" from a Superfund site. This should give you a working range. Also inquire how much of the time/cost is involved in quality assurance/quality control (QA/QC). A round figure for QA/QC time would be in the 20% range. Good QA/QC is critical in this time and age.
Hazardous material identification should not be used for cost estimates and linked to reverse engineering of the complex mixtures used in pesticides where most inert ingredients are not hazardous? There are readily available methods to identify most hazardous ingredients - few exist for the inert ingredients found in pesticide formulations. Development of analytical methods and standards for inert ingredient qualitative and quantitative analysis would be prohibitively expensive.
Have we considered the court's findings in the 1996 NCAP vs Browner? The court agreed with defendants statement that "it is costly and impracticable to reverse engineer pesticide formulas." Of the twenty-three inert ingredients used in the six pesticide formulations in the case, only two referred to reverse engineering. Neither was anyway close to identifying the inert chemicals that differentiated the formulations and neither reverse engineering argument resulted in a ruling that the inert should be disclosed.
Most analytical chemists consider NMR and NMR/MS when they talk about qualitative identification being easy to quantitate. What about the many water based systems where LC and LC/MS are the only options? These are not easily quantified.
4. Are the techniques used in reverse engineering widely available?
The analytical techniques used to identify the active ingredients are widely available. OPP Guidelines require enforcement analytical chemistry methods for each active ingredient, the States have copies of many analytical chemistry methods to identify active ingredients, many of the chemistry methods for active ingredients are published in scientific journals such as the Journal of the Association of Official Analytical Chemists, various journals of the American Chemical Society, the Journal of Chromatography, and the list goes on. Since the enforcement analytical methods for pesticide formulations are non-CBI, our lab routinely distributes copies of the method(s) to the various State enforcement labs once the pesticide receives a registration.
Analytical chemistry techniques to identify the inert ingredients in pesticide end-use formulations will required much more literature searching. One of the many source documents to be searched could be the Farm Chemicals Handbook 2000 published by Meister Publishing Company. There are two lists of inerts in this publication that are of concern to EPA. We are not aware of general analytical chemistry screening procedures available to determine inert ingredients in pesticide formulations.
Inert ingredients identified in Farm Chemical Handbook 2000 on page D23 are List 1 and List 2 Inerts. A majority of these are solvents and have potential hazards making them targets for analytical methods. Most inert ingredients used in pesticide formulations are not identified in Farm Chemical Handbook 2000. Development of analytical methods for these inert ingredients for reverse engineering analyses would be prohibitively expensive and would not be capable of identifying pesticide formulations to a point at which they are exact chemical compositions.
5. Would pesticide manufacturers generally have the capability to "reverse engineer" a competitor's product to find out the inert ingredients (all or most)?
It depends on the manufacturer. Some pesticide manufacturers have excellent well equipped labs with state-of-the-art equipment and experienced pesticide formulations chemists who could easily do "reverse engineering." Other pesticide manufacturers will have labs to determine the active ingredients only and rely more on technicians than on retaining experienced chemists. While these labs can turn out very high quality data they can be limited in what they can do to determine any unknowns. Again, the "reverse engineering" process will determine most, but not necessarily all inert ingredients in a pesticide formulation.
Pesticide manufacturers' well equipped analytical labs are dedicated to doing product chemistries required for pesticide registrations. They do not have the methods or expertise to identify the complex mixtures of inert ingredients in pesticide formulations. Pesticide manufacturers are experienced at analyzing pesticide formulations to separate the active ingredients from the inerts to quantify the active ingredients, not to identify and quantify the inert ingredients.
Why, if a few pesticide manufacturers are capable of reverse engineering the inerts in a pesticide formulation, don't they do so? The answer lies in the reason for doing reverse engineering. In order to commercialize a product the reverse engineering would have to result in a formulation that could be shown to be "substantially similar" to a currently registered pesticide formulation. Otherwise there is no advantage to reverse engineer since lacking the "substantially similar" claim would require a new registration process; hence time and expense. Surmounting the "substantially similar" hurdle makes reverse engineering impractical for the purpose of quickly and profitably commercializing a "me too" pesticide product. However, disclosure of the inert ingredients in a pesticide formulation significantly reduces the need for chemical expertise, state of the art equipment, time and the expense of seeking "me too" registrations. Disclosure of the inert ingredients of a registered pesticide removes the "substantially similar" hurdle for competitors.
6. For a pesticide manufacturer would the cost of reverse engineering generally be high? low?
The cost generally is the same whether it is a government lab (Federal or state), private, or a manufacturer's lab. Please remember that the analytical instruments cost the same as do the supplies, reagents, and overhead. Generally, the cost of good "reverse engineering" will be on the high side.
Staffing costs with experienced analytical chemists having organic synthesis and formulation knowledge would be the most expensive costs but analytical instruments are also very expensive. Pesticide manufacturers today are setup with analytical labs having no extra capacity. Reverse engineering a single formulation would take massive staffing and, as seen in the past, be incapable of determining an exact chemical composition. Pesticide manufacturer's resources today are focused on developing new products with true competitive advantages.
7. Would reverse engineering allow one to determine the relative weight of the inert ingredients (i.e., to list them in descending order of magnitude)?
Probably. The key factor here is how precise will be the "reverse engineering; i.e., will you be satisfied if you get to the nearest 10%?, the nearest 1%?, the nearest 0.1%?, the nearest part per million? Wherever you pick your cut off impacts your cost - the lower the number the higher your cost, but the better you can determine the inerts in descending order of magnitude.
Reverse engineering would not be capable of identifying pesticide formulations to a point at which they are exact chemical compositions, so relative weights are not an issue.
Though they are normally used at such low levels to thwart detection by reverse engineering, how can total inert disclosure protect pesticide processing aids, key to producing a toxicological and competitively superior pesticide delivery system, from becoming known? Case in point might be the processing aids used in the production of Trifluralin to prevent the formation of nitrosoamines.
8. If an inert ingredient was a mixture, would reverse engineering identify some or all components of the mixture?
Again, "reverse engineering" would probably determine most, but not necessarily all of the ingredients in a mixture. A lot will depend on the lab, i.e. how well it is equipped, and the training and experience of the chemists in analyzing pesticide formulations, and how precisely you want to identify the components in a mixture.
Again, reverse engineering can not be expected to identify all of the inert ingredient components of a complex pesticide formulation to a point at which they are chemically equivalent. This is the essence of our inert disclosure discussions. Reverse engineering can identify some inert chemical families in a pesticide formulation, but it is impossible to totally identify and reproduce these complex chemical mixtures. Inert disclosure would remove this barrier and prevent pesticide registrants from recouping their massive investment in developing unique pesticide delivery systems. This is the reason the confidential nature of pesticides formulations is recognized in law.
Additional Collins Question:
Why, if reverse engineering a complex chemical mixture is so simple, is a generic coke not on the market? The coke formula has always been held trade secret and protected even to the extent that parts of the formula are commercially prepared at separate manufacturing sites and then mixed together. Since the invention of analytical instruments, competitors have been trying to duplicate the coke formula. Individual elements of coke's formula can be analytically determined, but no one to date has reverse engineered the formula to a point at which it can be duplicated.
Discussion Paper 4(a)
Chip Collins, October 3, 2000
Inert Disclosure Stakeholders Workgroup
Reverse Engineering and NCAP v. Browner
October 3, 2000
The decision in NCAP v. Browner, see Northwest Coalition for Alternatives to Pesticides v. Carol Browner, Civil Action No. 94-1100 (DDC Cir. 1996), is sometimes mis-cited as it applies to the relevance of reverse engineering. The case stands for the proposition that reverse engineering is a relevant consideration in determining whether the identity of an inert ingredient is disclosable under the FOIA. The court found that the test is "whether the release of the requested information, given its commercial value to competitors and the cost of acquiring it through other means, will cause substantial competitive harm to the business that submitted it." The court concluded that each inert ingredient therefore must be evaluated on a case by case basis in order to determine whether, in light of the cost to competitors of acquiring the identity of the inert ingredient through reverse engineering, the disclosure of its identity would cause substantial competitive harm. One must focus on "the question of how difficult and costly it is or would be to learn the identity of the inert ingredients of the . . . pesticides in question by reverse engineering." There are no simple or general answers to this question - the facts in each situation must be specifically examined. This decision upholds the law. Disclosure under the provisions of FIFRA Section 10 must be done on a case by case basis.
There were 23 inert ingredients cited in the 6 pesticide formulations
that were part of the case. Only 2 of them referred to analytical
reverse engineering. Of the 19 inert ingredients that were
ruled releasable under the FOIA requests, 10 were ruled releasable
because the defendant "fails to make the necessary showing
of competitive harm." The other 9 were ruled releasable
because the "ingredient has been publicly disclosed and
therefore is not subject to confidentiality" in either
MSDSs or company correspondence on the products. Of the 23
inert ingredients, 4 were ruled non-releasable either because
the defendant showed "competitive harm as to disclosure"
or the inert ingredients are identified by trade name and
the "common name and CAS number do not appear on the
CSF, there is nothing to disclose under FOIA."
Neither of the 2 inert ingredients referred to by the plaintiffs as analytically reverse engineered was chemically identified sufficiently to relate it to a common name or CAS number on the CSF. These 2 ingredients provide good illustrations of the difficulties with reverse engineering. Both were components of the WEEDONE-LV4 formulation. The first was identified as "a surfactant chemically similar to dodecyl benzene sulfonate". The second was identified as "'benzene derivatives' and napthalene' as part of the ingredient in question."
Reverse Engineering and NCAP v. Browner
Chip Collins 10-3-00
However, the identity of the specific inert ingredient in an actual formulation such as the WEEDONE-LV4 would be very difficult and costly and probably not commercially feasible to reverse engineer. Dodecyl benzene sulfonate (DDBS) is one of the most common chemicals found in our society. It is a component of a great many laundry detergents, dish washes, and other cleaning products, and even here the plaintiff's reverse engineering would not have identified and produced a comparable cleaning product. DDBS is a chemical family approved under 40 CFR 180.1001 as an inert ingredient and used in pesticide formulations. Variations in the carbon chain and isomer distribution are key to the performance of this chemical family but so are the solvent combinations used with it to make a commercially viable product. These details would be impossible to determine in the complex chemical mixtures where they are used.
Similarly, aromatic solvents are commonly used in pesticide formulations, and they do contain some petroleum distillates and napthalene that can be identified. All aromatic solvents used today are complex hydrocarbon mixtures that, when added to a pesticide formulation containing other hydrocarbon mixtures, can not be distinguished. That is not to say that elements of that aromatic solvents are not identifiable, but the true identity of the aromatic solvent mixture would be, for all practical purposes, unidentifiable. The values to the pesticide registrant of any particular aromatic solvent would potentially include solvency, crystal inhibition, tank mix compatibility, flash point increases, odor control, etc. Disclosure of the specific aromatic solvent and/or CAS number would be financially devastating to the registrant's market for the product and invalidate any competitive advantage or value the registrant may have gained.
As a separate note, the Regulatory Background statement in NCAP v. Browner states that "OSHA's Hazard Communications Standards require chemical manufacturers to produce Material Safety Data Sheets (MSDS) listing the identity of all the ingredients." This is incorrect. Chemical manufacturers are required to identify only hazardous ingredients(29 CFR 1910.1200(g)).
7 Chip Collins is a senior manager in Ag formulations at Stepan Company. He is past chairman of the American Society for Testing Materials (ASTM) Pesticide Formulations Committee, current chairman of the Chemical Producers and Distributors Association (CPDA) Adjuvants and Inerts Committee, and an ASTM Fellow.
Discussion Paper 5
Wallace Puckett, October 17, 2000
Definition- A Patent is a written legal instrument issued by the U.S. Government that grants to the patent owner, for a term of 20 years from the filing date, an exclusive right to exclude others from making, using, selling, and/or offering for sale his/her invention as defined in the claims of the patent.
Purpose- One of the primary purposes of the patent system is to promote the dissemination of technology to the public, so that the public may benefit from this knowledge. In return and as an incentive, the U.S. Government grants the exclusive right for a term of years, which is currently 20 years from the filing date in the United States. With the disclosure of such technology, other inventors will hopefully improve on such knowledge; in other words, the technology shall advance with such knowledge.
Requirements for Patentable Inventions:
- An invention must be useful;
- The invention must be novel; and
- The invention cannot be obvious to one of ordinary skill in the art;
- The description of the invention in the patent application must be enabling to one skilled in the technology. In other words, the description of the invention must be sufficient to make and use the invention;
- The description of the invention must also include the inventor's best way of making and using the invention (e.g., preferred amounts, preferred starting materials, preferred components, etc. . . .). This requirement is known as the best mode.
Parts of a Patent - A patent is usually composed of two major parts. In the main body of the patent, known as the "specification," the inventor describes the invention in detail using text, graphics, and/or data. The inventor can optionally describe relevant prior patents and publications (known as "prior art") as background to his/her invention and to show why the present invention is an improvement. In the second part of the patent, the inventor sets forth the claims of the patent. It is the claims that define the scope of the invention for purposes of the rights of exclusivity granted by the U.S. Government. The claims are a very important part of the patent and determine where the patent is valid or not in view of previous patents and publications and moreover, determine whether someone is infringing one or more claims of the patent.
Types of Patents - Patents can be obtained for compositions of matter, methods of manufacture, methods of using, machines, articles, and any improvements thereof.
For chemical product patents the most desirable claims are for a new "composition of matter." In order words, a patent that has claims for a new chemical compound, such as a molecule or substance that is novel and unobvious. Since the composition of matter claims will dominate over any subsequent claims directed to the use of the composition or the making of the composition, or final products including the composition, the composition of matter claims are very important to any business. Thus, anyone using the composition in the United States will infringe the patent claims for the composition. This type of patent can be very difficult to invent around without violating the claims of the composition of matter patent.
Another type of chemical patent is one that discloses and claims a new use or application for a known substance or mixture. The use patent generally claims a method of using a substance or mixture to obtain a desirable result. Unlike the composition of matter patent, the use patent can be more successfully invented around. The same substance or mixture can be used but in a sufficiently altered method so as to fall outside the claims of the existing use patent. Nonetheless the use or application patent is generally robust and defendable.
Another type of chemical patent is one that discloses and claims a novel mixture or formulation of existing substances. This type of patent most useful when an inventor has exclusive access to one or more of the substances in the mixture. Like the use patent, the formulation patent can be successfully invented around as the claims of the patent are usually sufficiently narrow to allow others to formulate similar mixtures that fall outside the claims of the existing formulation patent.
However, patents on formulations are routinely granted, assuming the patentability requirements are satisfied. As an example, U.S. Patent Number 5,091,400: "Clathrate compound" discloses and claims a clathrate compound comprising 2,2'-bis(alpha-hydroxydiphenylmethyl)biphenyl as a host compound and an antimicrobial effective amount of 5-chloro-2-methyl-4-isothiazolin-3-one as a guest compound. This patent was issued on February 25, 1992. Then, on June 4, 1996, another similar patent was issued that invented around the claims of the previous art. U.S. Patent Number 5,523,020: "Clathrate compound including water-soluble microbicide" discloses and claims a clathrate compound composed of 5-choro-2-methyl-4-isothiazoline-3-one as a water soluble microbicide and a phenolic compound selected from a group consisting of 4,4'-ethylidenebisphenol, 2,4'-isopropylidenebisphenol, 2,2'-vinylidenebisphenol, 4,4'-isobutylidenebisphenol, 2,6'-secbutylidenebisphenol 2,4-di-tertbutylphenol, 2,6-di-tertbutylphenol, 2,4-di-propylphenol and 2-propyl-4-tert-butylphenol. The patent has a total of ten claims. The nine claims following the first (independent) claim further define the first claim by giving different limiting ratios of the two substances of the first claim.
Defending Patents - Beyond the challenges of crafting sufficiently broad claims so as to discourage similar inventions, patents must be defended by and at the expense of the patent holder. However, patent infringement if proven can be exceedingly expensive for the infringing party as demonstrated in the famous case involving Polaroid and Kodak.
Global Protection - Since patents divulge their information publicly, inventors wishing to protect their intellectual property globally must file patents in many countries all over the world. Unfortunately this strategy is only partially successful as there are a number of countries that still do not honor or defend the intellectual property rights of inventors.
In addition, filing a patent in numerous countries raises the cost of gaining and maintaining the patent to tens of thousands of dollars (depending on the number of countries involved) over the life of the patent. Just as an example, to obtain and maintain a patent in the United States, Europe, Russia, China, Japan, Canada, Australia, Taiwan, and one or two other countries could cost, in attorney fees, filing fees, and maintenance fees, over $ 150,000 (U.S.D.) over the full life of the patent.
For these reasons inventors must carefully weigh the advantages and disadvantages of filing and maintaining a patent with the advantages and disadvantages of keeping their invention as a trade secret. A trade secret by definition is any information that is not in the public domain and offers an advantage over the competition. However, a trade secret is only as good as it can be kept a secret. Thus, businesses or the inventor must take the necessary precautions in preserving the trade secret. After all, if the trade secret becomes public, even by accident or by someone's improper acts, the trade secret is no longer a trade secret. If someone else independently invents or reverse engineers the same trade secret, that person is free to use the trade secret for free. There is no expiration on a trade secret, just as long as it is kept as a trade secret.
Thus, there are benefits and disadvantages to patents and trade secrets. Each invention needs to be weighed against these benefits and disadvantages. In some instances, patents are the clear choice; in other instances, the choices may be more difficult. Sometimes, a business will have no alternative but to keep the improvement as a trade secret. It is important to keep in mind, that all industrialized countries (including the United States starting in a few months) automatically publish patent applications whether they are patentable or not. Accordingly, there is a risk that an invention will be disclosed to the public and yet the inventor may not obtain a granted patent due to not satisfying the obvious requirements. This could be the worse result, since the invention is known and the inventor has no protection. This risk needs to be considered prior to filing the application.
Julie Spanoli, October 9, 200
|Prescription/ OTC Drugs||Pesticide Products||Non-Pesticide Household Products||Cosmetics||Food|
|Federal Agency Overseeing Labeling Requirements
|CFR Citations for labeling||21 CFR Part 201||40 CFR Part 156||16 CFR Part 1500||21 CFR Part 701||21 CFR Part 101|
|Ingredient Identification Labeling Requirements||
OTC: Active and Inactive Ingredients
Prescription: Disclosure of inactive ingredients is required for drugs NOT for oral use
Inactive: Not required except as specified, e.g. List 1 and Petroleum Distillates>10%
|Required only for "hazardous"
substances (as defined)
For mixtures, the product's ingredients that contribute significantly to the product's hazard(s) are required to be identified
All ingredients with exceptions
If cosmetic is also OTC drug, must designate active ingredient (e.g. sunscreen, antibacterial)
|All ingredients with exceptions|
|% of ingredients required?||Actives: Not % but actual wt in dose.
|How are ingredients listed||Active and Inactive: Alphabetical Order||
Active: no requirement for order
Inactive: if provided, in order of predominance
|Ingredient(s) presenting hazard with the hazard||
Order of predominance
can use terms "may contain" for ingredients that are colorants and products that are "shades" as defined by regulation
For "shaded" products, ingredients need not be on label if on display in "chart" on rack where products are held.
Alternative ingredients can be listed if appropriate (separated by designation "OR" )
Assortments of products which share the majority of ingredients (e.g. eyeshadow) can be declared in a single, composite list.
|Order of predominance except for ingredients
less than 2% if so designated
(i.e. "Contains less than 2% of A, B , C and D" then A, B, C and D do not need to be in order of predominance)
Established common names or proprietary names
Ingredients cannot portray a feature or impression of greater value than its role in the formulation
|Common and/or chemical names for active ingredients||Common or "usual" name, chemical name if no common name exists. Generic name can be used if previously approved.||
Flavors and fragrances can be designated by their function.
For all other ingredients:
|Common or "usual" name of ingredient or mixture.|
Flavorings, perfumes and colorants are designated as such without
naming of their components.
Information can be deemed confidential via request and approval.
|Inert Ingredients not requiring identification||
None indicated for substances in products meeting "hazardous" criteria
No disclosure required for any ingredients not deemed hazardous or primary contributor to hazard.
|If identity is accepted as trade secret per 21CFR Part 720.8*** (see below), label designation is then "and other ingredients"||
Spices fitting definition do not need to be specifically identified.
Artificial flavors or natural flavors as defined can be so described and not specifically identified as to their composition.* (see below)
Artificial color fitting definition need not be identified except for those specified by regulation.* (see below)
Preservatives need to be identified only as such along with their function. (e.g. "To retard spoilage")
Incidental additives and certain processing aids.
|Trade secrets||A trade secret may consist of any commercially valuable plan, formula, process, or device that is used for the making, preparing, compounding, or processing of trade commodities and that can be said to be the end product of either innovation or substantial effort. There must be a direct relationship between the trade secret and the productive process. (Per 21 CFR 20.61(a)**** see below)||Any inert ingredient, not disclosed elsewhere||Not specified||
If requested per criteria given in 21 CFR Part 720.8.*** (Confidentiality of Statements - see below)
Confidentiality granted if trade secret within the meaning of 21CFR Part 20.61. Subject to judicial review.****(see below)
|Flavorings, spices (do not need to be specifically identified)|
*Sec. 101.22 Foods; labeling of spices, flavorings, colorings and chemical
(a)(1) The term artificial flavor or artificial flavoring means any substance, the function of which is to impart flavor, which is not derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf or similar plant material, meat, fish, poultry, eggs, dairy products, or fermentation products thereof. Artificial flavor includes the substances listed in Secs. 172.515(b) and 182.60 of this chapter except where these are derived from natural sources.
(2) The term spice means any aromatic vegetable substance in the whole, broken, or ground form, except for those substances which have been traditionally regarded as foods, such as onions, garlic and celery; whose significant function in food is seasoning rather than nutritional; that is true to name; and from which no portion of any volatile oil or
other flavoring principle has been removed. Spices include the spices listed in Sec. 182.10 and part 184 of this chapter, such as the following:
Allspice, Anise, Basil, Bay leaves, Caraway seed, Cardamon, Celery seed,
Chervil, Cinnamon, Cloves, Coriander, Cumin seed, Dill seed, Fennel seed,
Fenugreek, Ginger, Horseradish, Mace, Marjoram, Mustard flour, Nutmeg,
Oregano, Paprika, Parsley, Pepper, black; Pepper, white; Pepper, red;
Rosemary, Saffron, Sage, Savory, Star aniseed, Tarragon, Thyme, Turmeric.
Paprika, turmeric, and saffron or other spices which are also colors,
shall be declared as "spice and coloring" unless declared by
their common or usual name.
(3) The term natural flavor or natural flavoring means the essential oil, oleoresin, essence or extractive, protein hydrolysate, distillate, or any product of roasting, heating or enzymolysis, which contains the flavoring constituents derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf or similar plant material, meat, seafood, poultry, eggs, dairy products, or fermentation products thereof, whose significant function in food is flavoring rather than nutritional. Natural flavors include the natural essence or extractives obtained from plants listed in Secs. 182.10, 182.20, 182.40, and 182.50 and part 184 of this chapter, and the substances listed in Sec. 172.510 of this chapter.
(4) The term artificial color or artificial coloring means any "color additive" as defined in Sec. 70.3(f) of this chapter.
(5) The term chemical preservative means any chemical that, when added to food, tends to prevent or retard deterioration thereof, but does not include common salt, sugars, vinegars, spices, or oils extracted from spices, substances added to food by direct exposure thereof to wood smoke, or chemicals applied for their insecticidal or
**(c) A cosmetic ingredient shall be identified in the declaration of ingredients by:
(1) The name specified in Sec. 701.30 as established by the Commissioner for that ingredient for the purpose of cosmetic ingredient labeling pursuant to paragraph (e) of this section;
(2) In the absence of the name specified in Sec. 701.30, the name adopted for that ingredient in the following editions and supplements of the following compendia, listed in order as the source to be utilized:
(i) CTFA (Cosmetic, Toiletry and Fragrance Association, Inc.) Cosmetic Ingredient Dictionary, Second Ed., 1977 (available from the Cosmetic, Toiletry and Fragrance Association, Inc. 1110 Vermont Ave. NW., Suite 800, Washington, DC 20005, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408), which is incorporated by reference, except for the following deletions and revisions:
(a) The following names are not adopted for the purpose of cosmetic ingredient labeling:
Acid Black 58 Acid Black 107
Acid Black 139 Acid Blue 168
Acid Blue 170 Acid Blue 188
Acid Blue 209 Acid Brown 19
Acid Brown 30 Acid Brown 44
Acid Brown 45 Acid Brown 46
Acid Brown 48 Acid Brown 224
Acid Orange 80 Acid Orange 85
Acid Orange 86 Acid Orange 88
Acid Orange 89 Acid Orange 116
Acid Red 131 Acid Red 213
Acid Red 252 Acid Red 259
Acid Violet 73 Acid Violet 76
Acid Violet 99 Acid Yellow 114
Acid Yellow 127 Direct Yellow 81
Solvent Black 5 Solvent Brown 43
Solvent Yellow 63 Solvent Yellow 90
(b) The following names are adopted for the purpose of cosmetic ingredient labeling, provided the respective monographs are revised to describe their otherwise disclosed chemical compositions, or describe their chemical compositions more precisely, and such revised monographs are published in supplements to this dictionary edition by July 18, 1980.
Acid Black 2 Benzophenone-11
Carbomer 934 Carbomer 934P
Carbomer 940 Carbomer 941
Carbomer 960 Carbomer 961
Chlorofluorocarbon 11S Dimethicone Copolyol
Disperse Red 17 Pigment Green 7
Polyamino Sugar Condensate SD Alcohol (all 27 alphanumeric designations)
Sodium Chondroitin Sulfate Synthetic Beeswax
(c) The following names are adopted for the purpose of cosmetic ingredient labeling until January 19, 1981.
Amphoteric (all 20 numeric designations)
Quaternium (all 49 numeric designations)
(ii) United States Pharmacopeia, 19th
Ed., 1975, and Second Supplement to the USP XIX and NF XIV, 1976. (Copies
are available from the U.S. Pharmacopeial Convention, Inc., 12601 Twinbrook
Parkway, Rockville, MD 20852, or available for inspection at the Office
of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington,
(iii) National Formulary, 14th Ed., 1975, and Second Supplement to the USP XIX and NF XIV, 1976. (Copies are available from the U.S. Pharmacopeial Convention, Inc., 12601 Twinbrook Parkway, Rockville, MD 20852, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408).
(iv) Food Chemicals Codex, 2d Ed., 1972; First Supplement, 1974, and Second Supplement, 1975, which are incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition, Food
and Drug Administration, 200 C St. SW., Washington, DC 20204, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., Suite 700, Washington, DC 20408.
(v) USAN and the USP dictionary of drug names, USAN 1975, 1961-1975 cumulative list. (Copies are available from the U.S. Pharmacopeial Convention, Inc., 12601 Twinbrook Parkway, Rockville, MD 20852, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408.)
(3) In the absence of such a listing, the name generally recognized by consumers.
(4) In the absence of any of the above, the chemical or other technical name or description.
(1) The extent to which the identity of the ingredient is known outside petitioner's business;
(2) The extent to which the identity of the ingredient is known by employees and others involved in petitioner's business;
(3) The extent of measures taken by the petitioner to guard the secrecy of the information;
(4) The value of the information about the identity of the claimed trade secret ingredient to the petitioner and to its competitors;
(5) The amount of effort or money expended by petitioner in developing the ingredient; and
(6) The ease or difficulty with which the identity of the ingredient could be properly acquired or duplicated by others.
****Sec. 20.61 Trade secrets and commercial or financial information which is privileged or confidential.
(a) A trade secret may consist of any
commercially valuable plan, formula, process, or device that is used for
the making, preparing, compounding, or processing of trade commodities
and that can be said to be the end product of either innovation or substantial
effort. There must be a direct relationship between the trade secret and
(b) Commercial or financial information that is privileged or confidential means valuable data or information which is used in one's business and is of a type customarily held in strict confidence or regarded as privileged and not disclosed to any member of the public by the person to whom it belongs.
(c) Data and information submitted or divulged to the Food and Drug Administration which fall within the definitions of a trade secret or confidential commercial or financial information are not available for public disclosure.
(d) A person who submits records to the Government may designate part or all of the information in such records as exempt from disclosure under exemption 4 of the Freedom of Information Act. The person may make this designation either at the time the records are submitted to the Government or within a reasonable time thereafter. The designation must be in writing. Where a legend is required by a request for proposals or request for quotations, pursuant to 48 CFR 352.215-12, then that legend is necessary for this purpose. Any such designation will expire 10 years after the records were submitted to the Government.
Discussion Paper 7
Mary Lamielle, November 8, 2000
"Chemical Sensitivities(CS)/Multiple Chemical Sensitivities(MCS)"
Ubiquitous nature of pesticides and the health threat that they pose.
Who's affected? Nature of the condition.
Health problems and disabling symptoms caused by pesticide exposures, including inert ingredients, for those with CS/MCS.
Information needs of those sick or disabled by pesticides. Need for immediate access to active ingredients, individual inerts, all chemicals in fragrances (potentially 4000 chemicals) and masking chemicals, natural substances in the mix, and the chemical make-up in the final mixture. It is not sufficient, for example, to list petroleum distillates. Xylene must be listed as an ingredient, not just on a separate MSDS. Fragrances are debilitating for most with MCS. Fragrances in pesticides also cover up chemical odors which may otherwise alert those with MCS to an exposure that should be avoided.
Critical need for immediate access to information, particularly
for those sick or disabled by exposure to pesticides. History
of inadequate or inconsistent assistance and response from
Poison Control, National Pesticide Telecommunications Network
(NPTN), physicians and others to meet the information needs
of those with CS/MCS and related disorders. Manufacturers's
800 numbers not generally useful. Web would not be sufficient
for these purposes.
Educate EPA and other government agencies, medical and public health professionals, and others regarding the effect of pesticides on those who are susceptible to or sick from pesticide exposures including all ingredients in individual products.
Discussion Paper 7(a)
Guest Speaker: Dr. William Meggs, November 8, 2000
- My name is William Joel Meggs, MD, PhD, FACEP. I am a physician licensed to practice medicine in the states of North Carolina, New Jersey, and New York. I completed a residency in internal medicine at Rochester General Hospital, a teaching hospital of the University of Rochester School of Medicine and Dentistry. I was a medical staff fellow at the National Institute of Allergy and Infectious Diseases. I completed a fellowship in Medical Toxicology at the New York City Poison Center, New York University, and Bellevue Hospital Center. I am board certified in Internal Medicine, Emergency Medicine, Allergy and Immunology, and Medical Toxicology. I practice medicine in Greenville, North Carolina. I am Chief of the Division of Toxicology, Professor, and Vice-Chair for Clinical Affairs, Emergency Department, Brody Medical School at East Carolina University. As a practicing medical toxicologist, I am qualified to render an opinion on medical aspects of pesticide poisoning.
- I see patients in the Emergency Department, intensive care units, and out patient clinic who have illness in association with an exposure to pesticides. There are a number of mechanisms by which chemical exposures can lead to disability, disease, and even death. Toxicity can occur at a wide variety of doses. Susceptibility to a toxin can result from deficiencies of detoxifying enzymes and mechanisms. Allergic reactions and chemical sensitivities can occur to both primary and secondary ingredients. Adverse reactions can occur through other and sometimes poorly understood mechanisms. Individuals with chronic diseases such as asthma and chronic rhinosinusitis often have enhanced susceptibility to exposures. Prior exposures can alter responses.
- When a person becomes ill after being exposed to a product, the overriding concern is the chemical composition of the product. The label for that product is consulted. Material safety data sheets supplied by the manufacturer are also consulted. Reference sources such as the Poison Index, toxicology texts, and electronic data bases such as Tox-Line and Med-Line are consulted. Often the data supplied by these sources do not give the composition of the product. Sometimes ingredients are listed by class, such as petroleum distillates, detergents, or surfactants. Sometimes the listed ingredients do not explain the toxicity experienced by the poisoned individuals. The active ingredient listed in the composition given does not explain the toxicity of the product.
- Both the physician and the poisoned individual are left in a quandary. For pesticide exposures, several possibilities exist. Labels of products list "inert" ingredients as constituents of the product. Inert is not synonymous with non-toxic, and inert ingredients are often very toxic. In addition, inert ingredients may be allergenic. Finally, individuals may have adverse reactions or intolerances to inert ingredients by other mechanisms. Could these "inert" ingredients be the cause of the symptomatology? Other possibilities for the toxicity include impurities accompanying the manufacture of active ingredients and degradation of active ingredients in storage and transport (for example, degradation of -thion forms of organophosphorus pesticides into -oxon forms that may be more toxic).
- What ingredient causes illness after exposure to a complex mixture often involves detective work and longnitudinal study. The person who often figures out what is making them ill is most often the patient. Hence, the general public needs to have full disclosure of every thing they are exposed to.
- As a medical toxicologist, it is impossible for me to properly evaluate and treat an individual who becomes ill after exposure to a pesticide without knowing fully the composition of the product, including inert ingredients.
- As a medical toxicologist, I strongly support the full disclosure of all ingredients in commercial products. I believe that the health of the citizens of our nation greatly overrides the protection of trade secrets in the formulation of inert ingredients. Often unanticipated problems arise when humans are exposed to chemicals. It is impossible to build our knowledge base on the effects of products on human health if the consumer and medical professionals are denied knowledge of the composition of these products.
- Ideally, every pesticide formulation as delivered on the shelf should undergo an independent chemical analysis to determine every constituent, including so-called inert ingredients, contaminants in the manufacturing process, and degradation products that might occur in transport and storage. There should be full disclosure on the label and in the material safety data sheets of the inert ingredients for any product with the possibility of human exposure. In a democratic society, there should be full and open disclosure of every chemical that is in products that people use in their homes, yards, farms, and on their food. In addition, there are overriding public health reasons for full disclosure. We develop knowledge of adverse consequences of chemical products through individual cases, case series, and comparing case reports.
Discussion Paper 8
Eileen Mahoney, October 10, 2000
October 10, 2000
Inert Disclosure Stakeholder Workgroup
United States Environmental Protection Agency
A discussion paper submitted by
Eileen M. Mahoney, Program Specialist
Pesticide Registration Branch
California Department of Pesticide Regulation
INERT INGREDIENTS ISSUES AT THE STATE LEVEL:
This was an informal survey of several states during September and October 2000 in preparation for the Inert Disclosure Stakeholder Workgroup conference call meeting scheduled October 17, 2000. These interviews are not representative of all state agency views and reflect only a segment of state agencies that deal directly with state pesticide regulation.
The original question was to determine the level of registration
information being shared between U.S. EPA and the States,
with the subsidiary question of what were the limits on pesticide
information that could be shared by the lead State agencies
with others within the State.
While the survey is not a complete one, among the states surveyed, NONE receive ANY registration information from U.S. EPA. Any information they receive is submitted by the registrants/applicants at the time they request registration in that state. Most registrants simply submit copies of information or documentation they submitted to U.S. EPA or copies of documentation they received from U.S. EPA.
I confined my survey to the western half of the country in order to reduce time-zone collisions. Of the dozen states I tried to contact, I spoke with staff in seven states:
Arizona (Environmental Services Division, Department of Agriculture),
Colorado (Division of Plant Industry, Department of Agriculture),
Idaho (Division of Agricultural Resources, Department of Agriculture),
Iowa (Pesticide Bureau, Department of Agriculture),
Oregon (Pesticide Division, Department of Agriculture),
Texas (Department of Agriculture), and
Washington (Department of Agriculture).
The general feeling from the various states was that U.S. EPA should be looking at the inert ingredients in the product formulations, so the states shouldn't have to. California, Colorado, Iowa and Washington are the only states surveyed who require submission of either U.S. EPA's Confidential Statement of Formula (CSF) or the equivalent state form for all pesticide product applications. Idaho does not require the CSF for Section 3 products, but does require it for Section 24(c) and Section 18 products. Arizona MAY require submission of inert ingredients information, but have not done so to any extent.
When the lead state agencies receive telephone inquiries about inert ingredients from medical professionals, if they have the information, they share it without hesitation, as long as the request comes in during regular business hours. None of the states maintain a 24-hour telephone "hot-line" for these types of questions. Most states refer questioners to the registrants' 24-hour telephone numbers for specific information, or to the poison control center in the area.
For other questions about inert ingredients, state agencies referred questioners to the registrants first. States that have any inert ingredients information take confidentiality very seriously, and will not divulge that information without a court order or permission from the registrant.
Arizona was the only state I surveyed that required submission of Material Safety Data Sheets (MSDS) for each product registered in the state. Others refer to online MSDS providers, saying that these sources were faster and more reliable than paper files anyway.
As a side note, several states are investigating digital imaging technology to capture the labels of registered products, as a way of easing information transfer to remote sites (regional offices, field offices, field investigators, etc.). They are hoping that U.S. EPA will also embrace this technology.
While the survey was admittedly a small sample, it does raise some interesting questions for further discussion:
Do people know what agency/office/department in their state
handles pesticide questions?
Do people know whether or not this agency has inert ingredient information?
Are most "poisoning" or "exposure" questions directed to poison control centers instead?
What is the real need among various audiences for inert ingredient information?
How can we measure the need for information, or CAN we measure it?
Discussion Paper 8(a)
January 2, 2002 (revised draft)
SURVEY FOR INERT DISCLOSURE WORKSHOP
Surveys were conducted of 12 State Lead Agencies (SLAs) for pesticide programs from the eastern half of the country. Eight responded to the survey. SLAs are those state agencies which have agreements with EPA to administer federally-mandated programs including Enforcement, Groundwater, Worker Protection, and Certification and Training.
SLAs are typically charged with administering state-mandated pesticide programs, including pesticide product registration. All agencies queried within this survey administer state product registration programs. All were queried on whether their state law requires submission of Confidential Statement of Formula (CSF), either as part of, or outside of the state registration program.
All individual respondents were senior pesticide officials within their agency. Respondents included:
Rhode Island - Elizabeth Lopes-Duguay, Senior Environmental Scientist
Maine - Labelle Hicks, Toxicololgist
New Jersey - Ralph Smith, Chief
Delaware - Grier Stayton, Pesticide Compliance Supervisor
North Carolina - Jim Burdett, Pesticide Administrator
Virginia - Marvin Lawson, Program Manager
Connecticut - Brad Robinson, Supervising Environmental Analyst
Massachusetts - Lee Corte-Real, Product Registration Coordinator
The questions asked were:
- Does your state ever find that you need to know about inert ingredients that are not listed on the label? If you do how do you obtain the information?
- Does your state ever receive requests/questions about inert ingredients? If you do what type of people?
- Does you state require MSDS or Confidential Statement of Formula to accompany the product registration?
- Is there a requirement for disclosure of inert ingredients outside of product registration?
- Have you ever been unable to obtain information on an inert ingredient?
- Do you have any suggestions/comments on how the EPA should be handling the issue of disclosure of inert ingredients?
2. They do receive calls from the general public who are generally very well educated on the subject
3. Rhode Island requires a MSDS to accompany a registration
4. Do not require any disclosure of inert ingredients outside of registration
5. Ms. Duguay believes that it would be helpful to have information on inert ingredients readily available so it would be easier to answer questions that are asked by the public
Virginia (Marv Lawson)
1. Have not needed to know about inert ingredients that are not on the label except when people call in questions.
2. It is not often, but they do get calls from concerned citizens about exposure/ accident related questions. When this occurs the registrant is contacted for information. There has not be a time when they were unable to obtain the information
3. Virginia does not require MSDS/CFS but they highly recommend that it be included
4. There is no requirement for disclosure of inert ingredients outside of registration
5. Dr. Lawson believes that it is good to have as much disclosure as possible, but confidentiality should be taken into account
New Jersey (Ralph Smith)
1. There is rarely a need information, but when they do it is for an unknown in a lab analysis. In order to find the information they go to the registrant and by law the registrant must give the information out to them. Consequently there has not been a problem obtaining need to know information.
2. It is rare but when the public does ask questions they will not supply the answers due to confidentiality. They refer the public to the registrant.
3. NJ does not require MSDS/CSF.
4. There are no requirements for disclosure of inert ingredients outside the registration.
5. Mr. Smith feels that all inert ingredients should be registered as active ingredients and put on the label.
North Carolina (Jim Burdett)
1. Have not needed to know any inert ingredients that are not on the label
2. They do receive calls from the general public about allergic reactions/calling on behalf of the health care person. N. Carolina also has some of the most active anti-pesticide groups, so many calls come from them.
3. N. Carolina requires MSDS for registration.
4. There is no requirement for disclosure of inert ingredients outside of registration
5. Although, people may be reluctant to give information about an inert ingredient they have always been able to obtain the information.
6. Mr. Burdett feels that if an inert ingredient is of toxicological concern it should be listed on the label.
Delaware (Grier Stayeton)
1. Have not needed to know about inert ingredients beside the ones listed on the labels
2. The public does request information
3. Delaware does not require MSDS/CSF for registration
4. There are no requirements for inert disclosure outside of registration
5. Mr. Stayeton feels that the information should be available
Connecticut (Brad Robinson)
1. Although not often, when they do need to find information on an inert ingredient they ask the registrant or look at the MSDS/CSF sheets. There has not been any problems obtain information on an inert ingredient.
2. The calls they receive are usually on active ingredients but when asked about inert ingredients, they are obligated to keep the information confidential
3. Conn. Requires MSDS and it is sometimes requested to add the CSF to the registration
4. There are no requirements for inert disclosure outside of registration.
5. Mr. Robinson believes that inert ingredients should not be listed on the label, but available on a website or program of some sort.
Massachusetts (Lee Corte-Real)
1. It is not often but when a health/environmental issue arises additional info is needed. It is found out by the manufacturer. Although it can be difficult depending upon the company information is able to be obtained.
2. It is rare, but the general public usually asks for information when a health issue arises resulting from exposure
3. Mass. Requires a MSDS for product registration.
4. Mass requires inclusion of products on rights-of-way approved herbicide list for application in sensitive areas.
5. Mr. Corte-Real feels that inert ingredient information should be accessible to the states via some secure password protected data system that would facilitate access to information.
Maine (Labelle Hicks)
1. Have required information on inert ingredients other than what is on label. To obtain this information they look at the MSDS/CSF, so they have always been able to obtain information
2. Usually it is the general public that requests additional information
3. Maine requires MSDS for product registration
4. There is no requirement for disclosure of inert ingredients outside of registration
5. Ms. Hicks believes that inert ingredients should be listed on the label
Discussion Paper 8(a)
January 2, 2002 (revised draft)
|Rhode island||Virginia||New Jersey||North Carolina||Delaware||Maine||Conn.||Massachusetts|
|Have you ever needed
to find inert
ingredients other than
what is on label?
|No||No||Yes -go to
|Do you receive
|Do you require
|Do you require
disclosure of inert
|No||No||No||No||No||No||No||Yes -inclusion of
products in the ROW
list for application in
|Have you ever been
unable to obtain
information on an inert
|No||No||No||No||No||No||No||No but can be difficult|
Discussion Paper 9
Ray McAllister, October 26, 2000
How the Pesticide Industry Supplies Emergency Medical
Information to Medical Personnel
Anecdotal Responses to an Informal Survey for the Inerts Disclosure Stakeholders Work Group
Octover 26, 2000
Ray S. McAllister
Senior Director, Science & Regulatory Policy
American Crop Protection Association
Information for this position paper was derived from a limited, informal, and admittedly unscientific survey of pesticide registrants regarding how they provide emergency medical information when inadvertent overexposure to their products occurs. These responses give insights into some approaches taken by registrants to provide emergency treatment information, but not a comprehensive catalogue of all approaches used.
The responses are reported anecdotally rather than quantitatively, as there was no statistical sampling method. The summary of survey responses has not been reviewed by other industry personnel. Before pursuing additional follow-up, input is sought from public health personnel, advocacy groups, and others about questions and concerns they may have about how emergency information is provided to users of pesticide products.
The following questions were distributed to several trade associations representing manufacturers and formulators of FIFRA-registered products, requesting responses from their member companies. Replies were received from 22 companies. Individual companies' responses are not identified here.
1. Does your company list a toll-free number for emergency contact on all its pesticide product labels? A non-toll-free number? If not, why not?
2. Who answers such calls placed to the company? Is the number answered 24 hours a day? How are emergency calls (concern about hazardous exposure to the product) handled? By your company directly, or contracted to a poison control center (PCC) or other organization? What other organizations handle such calls under contract?
3. What information is provided to medical personnel calling for assistance with a hazardous exposure? (Treatment protocol? Ingredient information? What level of detail?)
4. How do you keep track of calls for information, the reasons for the calls, and what information is provided?
5. What is the training and expertise of those who handle emergency calls?
6. What product information do you provide to Micromedex for inclusion in the Poisindex system used widely by poison control centers? Does it include complete inert ingredients information? Is such information supplied by your company to any other repository of product information so that it is available to medical personnel? If you do not provide full information to Micromedex, does the Poisindex database have a way of referring inquiries directly to your company or a separate service that you use?
7. What other questions should I be asking?
8. Who else should I be talking to?
These are representative responses, rather than a comprehensive
listing. I have tried to include the range of responses, without
categorizing or quantifying the individual responses. I have
avoided commentary on the issues and responses. Where a response
was particularly illustrative, I have quoted directly, as
indicated. There is no particular order to the responses under
each question. Each individual response applies to one or
more responding companies, but is not
necessarily generally characteristic of all or most registrants.
Question 1: Does your company list a toll-free number for emergency contact on all its pesticide product labels?
1. Many companies list a toll-free number on each product label and on the MSDS for the product.
2. Some list a regular telephone number (toll call) on the label, but indicate there that the company will accept collect calls.
3. A few companies reported they do not put a telephone number
on the label, as it has not been required. There is some concern
over the volume of non-emergency calls that would be received.
4. Some companies have provided an emergency number on the MSDS but not on the product label.
5. Some list the number for the CHEMTREC program on the MSDS.
6. Some list multiple numbers on the label for health emergencies, transportation emergencies, and MSDS information.
Question 2a: Is the number answered 24 hours a day?
1. Most companies report that calls are answered 24 hours a day.
2. Assigned staff answer the calls during normal or extended business hours (which may vary according to growing season), while security personnel answer the calls after hours.
3. An answering service or recording after hours gives the number for a PCC in case of emergency.
Questions 2b: Who answers such calls placed to the company?
1. Some companies handle the calls for emergency and general information internally. Some contract with a PCC to handle such calls, and the toll-free number on the label goes directly to the PCC.
2. Security personnel forward calls to designated person with expertise in area of concern, from a checklist of names.
3. Trained call recipients redirect incoming calls, depending on their nature, to contract PCC for human or animal exposure.
4. From a company physician: "I will talk directly to patients
and do so perhaps 20-30 times a year. Most often they want
to talk to the company'- we rarely have additional information
for the lay public, as the PCC is so capable and familiar
with our products. Occasionally I will need to discuss an
issue in more detail with either a physician or a patient
who is more knowledgeable (say, a toxicologist or physician).
The PCC makes an effort to notify us immediately of any serious
outcome, desire to talk to the company (we respond to all
of these requests), or threat of litigation or other action
by the caller, as well as any other circumstance where they
feel we could assist the consumer
[A Ph.D. regulatory
toxicologist] is on call as backup to the animal PCC. [We]
cross-cover to some extent and I have physician backup I can
turn to for vacations, etc."
5. Toxicologists handle calls for medical/environmental incidents. Transportation specialists handle transportation incidents. Senior chemists in Product Safety handle calls about chemical reactions.
6. A combination of distribution personnel and security monitor the phones, distribution team coordinators or poison control center provide information.
7. Other organizations providing emergency response: CHEMTREC, CHEM-TEL, INFOTRAC.
8. The 24-hour number is answered by company personnel or after hours by a contracted answering service. The calls are then directed to a designated individual for response, who contacts the appropriate corporate Toxicologists or the Corporate Medical Director.
9. "If you call our toll free number you will hear a menu with several choices. The first choice is for a spill, the second for a human health emergency, the third for an animal health emergency, and there are a few other choices for customer service type calls. [Company] personnel handle the spill calls; the health calls are handled by a [contract PCC] and the animal health calls are handled by an animal poison control center."
10. "The line is staffed 24/7 by trained nurses. If the nurses need additional information, we have company personnel with pagers giving 24/7 coverage "
11. The contract PCC refers spill information to CHEMTREC. If additional response is necessary, the PCC has an emergency contact list of company personnel.
12. "[Company] handles all calls for human incidents/exposures within it's toxicology department. The staff rotates call and provides 24-hour/day coverage."
13. "During normal working hours [calls are] answered by one of three ER professionals. Off hours the guards answer the calls and pages one of our on call volunteers who responds. If not answered in ten minutes, a second page is sent and handled by one of the three ER professionals on backup. We have contracts with both human and animal poison control centers for exposure calls."
14. The 800 number is managed by an outside service that forwards emergency calls to a contract PCC. After business hours a message tells callers with medical emergencies to remain on the line, and they are automatically transferred to the contract PCC.
Questions 3: What information is provided to medical personnel calling for assistance with a hazardous exposure?
1. PCC has web access to company's MSDS, also spreadsheet of product formulations.
2. Company personnel on call are knowledgeable about product ingredients and are authorized to provide this information if needed in a medical emergency.
3. The PCC's source of information is primarily the MSDS. They have confidential statements of formula which they are allowed to divulge in cases of medical emergency. However, specific ingredient information is rarely requested by medical providers. Generally the PCC will characterize the inerts in a generic sense, and that is usually sufficient.
4. The company provides a genericized' formula for PCC use listing "anionic surfactant from 1-3%" rather than specific ingredient name and exact percentage. The label and brief acute toxicology summaries are also provided. Any special safety/tox information is mentioned such as "mechanical' eye irritation, incompatibility with another agent, or antidote details.
5. "MSDS are provided. In some cases, special fact sheets. When appropriate, treatment protocols. They also have access to the CSF [confidential statement of formula], if needed. We also provide MSDS for all ingredients, if requested. On a request basis, we have provided specific information from animal studies. In short, we give them whatever they need."
6. Medical consultant will provide immediate treatment suggestions. He has basic information on effects caused by the active ingredient and suggested medical treatment. He does not have details on inert ingredients.
7. "Full range of information necessary to mitigate the concern and/or treat a patient."
8. "Ingredient information is provided once we confirm it is a physician calling. Ingredient information is provided in appropriate, relevant ranges."
II. "Ingredients not publicly disclosed would be made available to medical personnel on a need to know basis."
10. "The main information provided to medical personnel
is an MSDS, which in our case is fairly detailed. For example,
the MSDS specifies if a product is water-based or solvent-based,
as well as the type of and the approximate amount of the solvent,
generic descriptors of other principal inerts, etc."
11. "We answer their questions and provide any treatment protocol we are aware of. We tend to have them call the poison control centers so that they can confer with other medical professionals. If a medical professional requests it we will give them the total ingredient information for the product. This rarely happens."
12. "[The contract PCC] provides first aid information and recommends medical intervention, when necessary. They do follow-up on cases where individuals are recommended for medical treatment or seem to have "more serious" alleged injuries."
Question 4: How do you keep track of calls?
1. All calls are recorded for adverse effects reporting required by FIFRA.
2. "[Contract service] completes and faxes the company a report on any and all calls taken by them on our behalf. This report is very detailed and includes every individual spoken to, information collected, information passed on, etc. If [second contract service], is involved, they also complete a written report advising the situation and their recommendation to resolve. Ultimately, these incidents make their way to a complaint system within our company to ensure that they are properly followed up on and resolved."
3. "[Contract PCC] will record verbatim what the caller said and what the PCC response was. The PCC will gladly work with companies to record reasonable info specific to each companies needs."
4. The contract PCCs log and document each call. Level of detail depends on forthrightness of caller. PCC sends documentation and summary reports to company. Company also maintains its own database for all emergency calls. Calls are reviewed daily by product stewardship personnel. For allegation of adverse effects, FIFRA 6(a)(2) reporting is initiated. Sales person must review incident with customer to prevent recurrences. Yearly analysis for senior management to prevent recurrences.
5. For calls requesting information only, no specific records are kept. For actual exposures, all calls are recorded, and computer records of the call are saved. The information taken includes product involved, circumstances of the event, symptoms, medical treatment, and follow-up until the case is resolved.
Questions 5: What is the training and expertise of those
who handle emergency calls?
1. People who handle these call are degreed professionals with substantial experience in the industry. The calls are assigned to individuals based on their respective expertise.
2. Registered nurses, Ph.D. toxicologists, medical doctors, veterinarians (for animal emergencies), technical reps trained and supervised by clinical toxicologists.
3. "We train continuously." "For the most part, very well trained."
4. "The best training for answering emergency calls is probably a PharmD or Doctor of Pharmacy. Most PCCs have several on staff. Next most frequent is nurses (BSN, not the 2 yr degree type). There are a few other academic disciplines used such as paramedics, Med techs, pharmacologists, etc. By rule, all PCCs have at least one (usually more than one) MD on payroll to advise others on difficult cases. There is a certification exam for MDs and Pharm Ds and others given by several groups including the American Academy of Clinical Toxicologists, American Assoc. of PCCs, and American Academy of Medical Toxicology. There is also a continuing education requirement for all of these."
5. Sufficient training to understand where call needs to be routed. Call routing driven by key words and phrases.
Questions 6: What product information do you provide to Micromedex
for inclusion in the
Poisindex system used widely by poison control centers?
1. "We also provide a copy of this data to Micromedex for restricted access use by the Iowa PCCs and any other users of Micromedex under password encryption."
2. "We report to Micromedex. We also supply formula information to our contract PCC. We include complete inert ingredient info. We do not supply exact percentages of ingredients; rather we present ranges."
3. A few companies have expressed concern about Poisindex data and information being out of date.
4. Some companies provide MSDS to Poisindex, which do not include complete inert ingredients information.
5. Several companies report they do not provide product information to Poisindex.
6. " the complete "genericized" formula. We also provide labels and acute tox summaries We supply this info to our contract PCC, Micromedix, and our in-house emergency panel as a back up (and to handle some calls when needed). Poisindex has a spot where the caller can be directed to call a number specified by the company."
7. "We do not provide information to Micromedex. Only hazardous inerts are disclosed to our PCC. If there is a question about an inert that requires additional information, the PCC has company contacts to call directly."
Question 7: What other questions should I be asking?
1. Measure response time of companies and services to calls for emergency medical information.
2. What is the extent of geographic coverage for supplying emergency
3. How much money do companies spend on calls for emergency information, whether handled in house of by a contract PCC?
4. What percentage of calls to toll-free numbers are product related? True emergencies?
5. Focus also on veterinary medical services, not just human health concerns.
6. How often are inert ingredients a problem in human or animal exposures to pesticide products?
7. What percentage of calls are rated as serious?
8. Can most consumers or medical doctors make beneficial use of complete inert ingredients information?
9. Are the largest marketers covered by this survey?
Question 8: Who else should I be talking to?
1. " people who receive the calls. [M]y experience is that many callers simply want reassurance that an odor or a postapplication situation is okay."
2. Those who are responsible for corporate and product stewardship.
3. Individuals in the American Association of Poison Control Centers.
4. Emergency response, industrial hygiene, and medical personnel at the pesticide manufacturers.
Discussion Paper 10
EPA Staff, November 20, 2000
Names for Inert (Other) Ingredients
As part of the requirements for pesticide registration, an
applicant must provide the Office of Pesticide Programs (OPP)
with a Confidential Statement of Formula (CSF). The registrant
must list all components of a pesticide formulation, including
the inert ingredients on the CSF. Applicants are required
to identify the components of the formulation by the
"... product name, commonly accepted chemical name, the trade name, and the Chemical Abstract registry number (CAS Reg. No.) for each identifiable ingredient present in that product."
The most distinct naming convention for chemicals involves the use of the Chemical Abstracts Service (CAS) Registry System. The CAS Registry System is an international resource for chemical substance identification for scientists, industry, and regulatory bodies. Each of some 16 million chemical substances is assigned a CAS Registry Number and a Chemical Abstracts (CA) index name. CA index names are considered to be unambiguous and unique, however, they are often long complicated technical terms. CA index names can also be referred to as the chemical name. Other possible methods of naming chemicals are:
- A generic chemical class name may identify a chemical
as part of a class of chemicals but does not necessarily
identify a specific chemical within the class.
- Trade and proprietary names are given to a chemical by the manufacturer or supplier of the chemical. Trade names generally do not provide information as to the specific chemical structure or reveal the chemical class and are generally chosen for marketing purposes and/or to protect the identity of the chemical.
- A commonly used name is often used to represent chemical substances. Common names are often a shorter, possibly acronym-like name often based on combinations of the chemical name or family to which the chemical belongs, but not always. Sometimes common names can include code names, code numbers and synonyms for commonly used chemicals. "Common" names may be more recognizable and understandable than the corresponding CA index name but may not uniquely identify a specific chemical.
- Chemical substances can also be described for their "function" or "purpose." This name describes the function or purpose of the ingredient in the product, e.g., solvent, surfactant, dye.
Pesticide Registration (PR) Notice 97-5 provides
guidance on how active ingredients should be named for the
purposes of pesticide product labeling. This notice also encourages
the development and use of common names on consumer products.
The policy states that the EPA will accept common names approved
by the American National Standards Institute (ANSI), and other
acceptable common names not established by ANSI including,
names adopted by EPA for use on labels, shorter more familiar
chemical name variants, names that have become well known
through wide usage, and names that have been approved by other
recognized standards-setting organizations such as the International
Standards Organization (ISO) and the British Standards Institute
(BSI). However, this policy does not apply to inert ingredients.
Inert or "other" ingredients encompass a wide variety of materials such as organic substances, inorganic substances, minerals, foods and their by-products, and polymers. OPP has not issued a PR Notice issuing guidance on how inert ingredients are to be named. However, Agency personnel generally prefer to use a CAS index name when specificity is required, or a common name that has become well-known through wide usage.
The following table lists some inert ingredients with their
CA index name, other "common" names, CAS Reg. No.,
and, in some cases, the "purpose" or "function"
in formulation name.
|CA Index Name|| Common
|CAS Reg. No.|
|Denatonium benzoate||Bitrex||Aversive agent||3734-33-6|
|Sorbitan, mono-(9Z)-9-octadecenoate, poly(oxy-1,2-ethanediyl) derivatives||Polysorbate 80||POE sorbitan monooleate||Surfactant||9005-65-6|
|C.I. Acid Yellow 3||
D&C Yellow No. 10
products with methylquinoline and
|Benzenemethanaminium, ar-dodecyl-ar,N,N,N-tetra-methyl-, chloride||
Dodecylmethylbenzyl trimethyl ammonium chloride
Alkylbenzyl trimethyl ammonium chloride
|Quaternary ammonium compound||28855-27-8|
catalytic reformer fractionator residue,
|Aromatic petroleum hydrocarbon solvent||
|Perboric acid (HBO(O2)), sodium salt||Sodium perborate||Sodium peroxoborate||7632-04-4|
|Magnesium-aluminum silicate||Solid diluent, carrier||1302-78-9|
|Poly(oxy-1,2-ethanediyl), -(4-nonylphenyl)- -hydroxy-||p-Nonylphenyl polyoxyethylene ether||Nonoxynol||Nonionic surfactant||26027-38-3|
|Poly(oxy-1,2-ethanediyl), -(nonylphenyl)- -hydroxy-||Polyoxyethylene nonylphenol||POE-nonylphenol||Surfactant||9016-45-9|
|Lignosulfonic acid, sodium salt||Sodium lignosulfonate||Lignosulfate Surfactant||Surfactant||8061-51-6|
|Benzenesulfonic acid, 2,5-dichloro-4-[4,5-dihydro-3-methyl-5-oxo-4-[(4-
sulfophenyl)azo]-1H-pyrazol-1-yl]-, disodium salt
|Acid Yellow 17||Lissamine fast yellow||Dye||6359-98-4|
|Terpenes and terpenoids, grapefruit - oil||distilled grapefruit oil||Fragrance||68917-32-8|
Discussion Paper 11
Guest Speaker: Jennifer Silk, OSHA
November 20, 2000
Material Safety Data Sheet Requirements
Occupational Safety and Health Administration (OSHA)
Requirements for material safety data sheets (MSDSs) can be found in OSHA's Hazard Communication Standard (HCS)(29 CFR 1910.1200). The HCS gives workers the right-to-know the identities and hazards of chemicals in their workplaces. First promulgated in 1983, the HCS requires chemical manufacturers and importers to evaluate the health and physical hazards of the chemicals they produce or import. They are then required to relay those hazards to users or handlers downstream via labels on containers and MSDSs. All employers with hazardous chemicals in their workplaces must have a hazard communication program, including labels on containers, MSDSs for each hazardous chemical, and worker training. When workers have access to information about the chemicals, they can take steps to protect themselves. When employers have such information, they can implement the appropriate protective measures. Together, these actions will reduce the incidence of chemical source illnesses and injuries in the workplace.
Each of the three hazard communication elements-labels, MSDSs, and training-are interdependent, and serve a different role in the workplace right-to-know system. MSDSs are seen as a reference document for both workers and employers, as well as those who provide occupational health services to exposed employees (physicians, industrial hygienists, occupational health nurses, etc.) They are basically a compendium of everything that is known about the hazards of the chemicals, the chemical's characteristics, and precautions for safe handling and use. This information includes the identity of the hazardous chemical or the identity of the components of a hazardous chemical mixture.
OSHA and its State Plan partners enforce the requirements of this and all other OSHA standards. The chemical manufacturer or importer is responsible for the completion of the MSDS, and the accuracy of the information. The downstream employer may rely on their evaluations. MSDSs are examined by OSHA compliance safety and health officers in the course of workplace inspections. The chemical manufacturer or importer may be cited if information is missing or incorrect.
The text of the standard itself, as well as the compliance directive, interpretations, and other information on hazard communication, may be found on OSHA's web page at http://www.osha.gov. Go to the subject index and click on "Hazard Communication". The MSDS and trade secret provisions are attached as Annex I and Annex II to this paper.
Under the HCS requirements, the MSDS is the focus for specific chemical identity information. Based on information in the literature that indicates the more you put on a label, the less likely it is that anyone will read or understand it, there was some concern that loading a label with chemical names would detract from its utility. Thus the label may refer to a product or common name (referred to as the "identity"), as long as that name also appears on the MSDS and a link can be made between the two. On the MSDS, all hazardous ingredients must be identified by their "specific chemical identity". These terms are defined in the standard.
Pesticides are not treated differently than any other products covered by the HCS. There is an exemption for labeling when the product is labeled in accordance with the requirements of EPA. However, where MSDSs are required (e.g., in pesticide manufacturing and formulation facilities), pesticides are subject to the same requirements as other hazardous chemicals.
Where the specific chemical identity of a hazardous component is a legitimate trade secret, the HCS allows it to be withheld from the MSDS. However, it must be indicated that it is being withheld, and there are requirements in the standard for disclosing the information to safety and health professionals or worker representatives for health and safety reasons. Such reasons are indicated in the standard, and would include activities such as doing exposure monitoring or providing occupational health services. A confidentiality agreement may be required. There is an adjudication process in the trade secret provisions regarding disclosure, with the Assistant Secretary of OSHA being the ultimate arbiter. In the 17 years the standard has been in effect, this provision has never been invoked.
The HCS covers both single substances and mixtures. Disclosure of ingredient identity applies to both. The standard sought to achieve a balance between the need of employers to protect legitimate trade secrets, and the need to have specific chemical identity information to protect exposed workers. The discussion of trade secret protection occupied much of the hearings on the original rule, as well as being the subject of a court remand at a later date.
We consider the approach ultimately included in the standard to have been quite successful. While the rulemaking focused on this issue extensively, the trade secret requirements are among the least cited for the standard. There are many factors that contribute to this. First, before the HCS was promulgated, trade secret claims were broad and frequent, which led to little information being available to workers. After the standard was published, many employers reconsidered their claims, and found that many were not legitimate trade secrets under US common law. This led to a reduction in claims. In addition, since claims were limited to specific chemical identity, workers and worker representatives found that they were getting much more information about the chemicals than they had been previously, and thus there was less need to pursue disclosure of specific chemical identity.
Perhaps the most significant trade secret limitation involves reverse engineering. If the components of a product can be readily identified through reverse engineering, they are not legitimate trade secrets. OSHA has a very sophisticated analytical laboratory itself, and in some cases, has reverse engineered samples of products taken by our compliance officers when inspecting workplaces. A component cannot be considered a trade secret in such a situation.
In order to properly protect people exposed to hazardous chemicals, the specific chemical identity of individual components must be available to safety and health professionals providing occupational health services. After an extended rulemaking process, OSHA promulgated disclosure provisions related to MSDSs, with additional provisions regarding the protection of legitimate trade secrets. These provisions have proven to be successful in the implementation process, resulting in the disclosure of necessary information along with the protection of confidential business information.
"Material safety data sheets."
Chemical manufacturers and importers shall obtain or develop a material safety data sheet for each hazardous chemical they produce or import. Employers shall have a material safety data sheet in the workplace for each hazardous chemical which they use.
Each material safety data sheet shall be in English (although the employer may maintain copies in other languages as well), and shall contain at least the following information:
The identity used on the label, and, except as provided for in paragraph (i) of this section on trade secrets:
If the hazardous chemical is a single substance, its chemical and common name(s);
If the hazardous chemical is a mixture which has been tested as a whole to determine its hazards, the chemical and common name(s) of the ingredients which contribute to these known hazards, and the common name(s) of the mixture
If the hazardous chemical is a mixture which has not been tested as a whole:
The chemical and common name(s) of all ingredients which have been determined to be health hazards, and which comprise 1% or greater of the composition, except that chemicals identified as carcinogens under paragraph (d) of this
section shall be listed if the concentrations are 0.1% or greater; and,
The chemical and common name(s) of all ingredients which have been determined to be health hazards, and which comprise less than 1% (0.1% for carcinogens) of the mixture, if there is evidence that the ingredient(s) could be released from the mixture in concentrations which would exceed an established OSHA permissible exposure limit or ACGIH Threshold Limit Value, or could present a health risk to employees; and,
The chemical and common name(s) of all ingredients which have been determined to present a physical hazard when present in the mixture;
Physical and chemical characteristics of the hazardous chemical (such as vapor pressure, flash point);
The physical hazards of the hazardous chemical, including the potential for fire, explosion, and reactivity;
The health hazards of the hazardous chemical, including signs and symptoms of exposure, and any medical conditions which are generally recognized as being aggravated by exposure to the chemical;
The primary route(s) of entry;
The OSHA permissible exposure limit, ACGIH Threshold Limit Value, and any other exposure limit used or recommended by the chemical manufacturer, importer, or employer preparing the material safety data sheet, where available;
Whether the hazardous chemical is listed in the National Toxicology Program (NTP) Annual Report on Carcinogens (latest edition) or has been found to be a potential carcinogen in the International Agency for Research on Cancer (IARC) Monographs (latest editions), or by OSHA;
Any generally applicable precautions for safe handling and use which are known to the chemical manufacturer, importer or employer preparing the material safety data sheet, including appropriate hygienic practices, protective measures during repair and maintenance of contaminated equipment, and procedures for clean-up of spills and leaks;
Any generally applicable control measures which are known to the chemical manufacturer, importer or employer preparing the material safety data sheet, such as appropriate engineering controls, work practices, or personal protective
Emergency and first aid procedures;
The date of preparation of the material safety data sheet or the last change to it; and,
The name, address and telephone number of the chemical manufacturer, importer, employer or other responsible party preparing or distributing the material safety data sheet, who can provide additional information on the hazardous chemical and appropriate emergency procedures, if necessary.
If no relevant information is found for any given category on the material safety data sheet, the chemical manufacturer, importer or employer preparing the material safety data sheet shall mark it to indicate that no applicable information
Where complex mixtures have similar hazards and contents (i.e. the chemical ingredients are essentially the same, but the specific composition varies from mixture to mixture), the chemical manufacturer, importer or employer may prepare
one material safety data sheet to apply to all of these similar mixtures.
The chemical manufacturer, importer or employer preparing the material safety data sheet shall ensure that the information recorded accurately reflects the scientific evidence used in making the hazard determination. If the chemical
manufacturer, importer or employer preparing the material safety data sheet becomes newly aware of any significant information regarding the hazards of a chemical, or ways to protect against the hazards, this new information shall be
added to the material safety data sheet within three months. If the chemical is not currently being produced or imported the chemical manufacturer or importer shall add the information to the material safety data sheet before the chemical is
introduced into the workplace again.
Chemical manufacturers or importers shall ensure that distributors and employers are provided an appropriate material safety data sheet with their initial shipment, and with the first shipment after a material safety data sheet is updated;
The chemical manufacturer or importer shall either provide material safety data sheets with the shipped containers or send them to the distributor or employerprior to or at the time of the shipment;
If the material safety data sheet is not provided with a shipment that has been labeled as a hazardous chemical, the distributor or employer shall obtain one from the chemical manufacturer or importer as soon as possible; and,
The chemical manufacturer or importer shall also provide distributors or employers with a material safety data sheet upon request.
Distributors shall ensure that material safety data sheets, and updated information, are provided to other distributors and employers with their initial shipment and with the first shipment after a material safety data sheet is updated;
The distributor shall either provide material safety data sheets with the shipped containers, or send them to the other distributor or employer prior to or at the time of the shipment;
Retail distributors selling hazardous chemicals to employers having a commercial account shall provide a material safety data sheet to such employers upon request, and shall post a sign or otherwise inform them that a material safety
data sheet is available;
Wholesale distributors selling hazardous chemicals to employers over-the-counter may also provide material safety data sheets upon the request of the employer at the time of the over-the-counter purchase, and shall post a sign or otherwise inform such employers that a material safety data sheet is available;
If an employer without a commercial account purchases a hazardous chemical from a retail distributor not required to have material safety data sheets on file (i.e., the retail distributor does not have commercial accounts and does not use
the materials), the retail distributor shall provide the employer, upon request, with the name, address, and telephone number of the chemical manufacturer, importer, or distributor from which a material safety data sheet can be obtained;
Wholesale distributors shall also provide material safety data sheets to employers or other distributors upon request; and,
Chemical manufacturers, importers, and distributors need not provide material safety data sheets to retail distributors that have informed them that the retail distributor does not sell the product to commercial accounts or open the sealed
container to use it in their own workplaces.
The employer shall maintain in the workplace copies of the required material safety data sheets for each hazardous chemical, and shall ensure that they are readily accessible during each work shift to employees when they are in their work area(s). (Electronic access, microfiche, and other alternatives to maintaining paper copies of the material safety data sheets are permitted as long as no barriers to immediate employee access in each workplace are created by such
Where employees must travel between workplaces during a workshift, i.e., their work is carried out at more than one geographical location, the material safety data sheets may be kept at the primary workplace facility. In this situation, the
employer shall ensure that employees can immediately obtain the required information in an emergency.
Material safety data sheets may be kept in any form, including operating procedures, and may be designed to cover groups of hazardous chemicals in a work area where it may be more appropriate to address the hazards of a process
rather than individual hazardous chemicals. However, the employer shall ensure that in all cases the required information is provided for each hazardous chemical, and is readily accessible during each work shift to employees when they are in in their work area(s).
Material safety data sheets shall also be made readily available, upon request, to designated representatives and to the Assistant Secretary, in accordance with the requirements of 29 CFR 1910.1020(e). The Director shall also be given access to material safety data sheets in the same manner.
The chemical manufacturer, importer, or employer may withhold the specific chemical identity, including the chemical name and other specific identification of a hazardous chemical, from the material safety data sheet, provided that:
The claim that the information withheld is a trade secret can be supported;
Information contained in the material safety data sheet concerning the properties and effects of the hazardous chemical is disclosed;
The material safety data sheet indicates that the specific chemical identity is being withheld as a trade secret; and,
The specific chemical identity is made available to health professionals, employees, and designated representatives in accordance with the applicable provisions of this paragraph.
Where a treating physician or nurse determines that a medical emergency exists and the specific chemical identity of a hazardous chemical is necessary for emergency or first-aid treatment, the chemical manufacturer, importer, or
employer shall immediately disclose the specific chemical identity of a trade secret chemical to that treating physician or nurse, regardless of the existence of a written statement of need or a confidentiality agreement. The chemical
manufacturer, importer, or employer may require a written statement of need and confidentiality agreement, in accordance with the provisions of paragraphs (i)(3) and (4) of this section, as soon as circumstances permit.
In non-emergency situations, a chemical manufacturer, importer, or employer shall, upon request, disclose a specific chemical identity, otherwise permitted to be withheld under paragraph (i)(1) of this section, to a health professional (i.e.
physician, industrial hygienist, toxicologist, epidemiologist, or occupational health nurse) providing medical or other occupational health services to exposed employee(s), and to employees or designated representatives, if:
The request is in writing;
The request describes with reasonable detail one or more of the following occupational health needs for the information:
To assess the hazards of the chemicals to which employees will be exposed;
To conduct or assess sampling of the workplace atmosphere to determine employee exposure levels;
To conduct pre-assignment or periodic medical surveillance of exposed employees;
To provide medical treatment to exposed employees;
To select or assess appropriate personal protective equipment for exposed employees;
To design or assess engineering controls or other protective measures for exposed employees; and,
To conduct studies to determine the health effects of exposure.
The request explains in detail why the disclosure of the specific chemical identity is essential and that, in lieu thereof, the disclosure of the following information to the health professional, employee, or designated representative, would not satisfy the purposes described in paragraph (i)(3)(ii) of this section:
The properties and effects of the chemical;
Measures for controlling workers' exposure to the chemical;
Methods of monitoring and analyzing worker exposure to the chemical; and,
Methods of diagnosing and treating harmful exposures to the chemical;
The request includes a description of the procedures to be used to maintain the confidentiality of the disclosed information; and,
The health professional, and the employer or contractor of the services of the health professional (i.e. downstream employer, labor organization, or individual employee), employee, or designated representative, agree in a written
confidentiality agreement that the health professional, employee, or designated representative, will not use the trade secret information for any purpose other than the health need(s) asserted and agree not to release the information under
any circumstances other than to OSHA, as provided in paragraph (i)(6) of this section, except as authorized by the terms of the agreement or by the chemical manufacturer, importer, or employer.
The confidentiality agreement authorized by paragraph (i)(3)(iv) of this section:
May restrict the use of the information to the health purposes indicated in the written statement of need;
May provide for appropriate legal remedies in the event of a breach of the agreement, including stipulation of a reasonable pre-estimate of likely damages; and,
May not include requirements for the posting of a penalty bond.
Nothing in this standard is meant to preclude the parties from pursuing non-contractual remedies to the extent permitted by law.
If the health professional, employee, or designated representative receiving the trade secret information decides that there is a need to disclose it to OSHA, the chemical manufacturer, importer, or employer who provided the information shall be informed by the health professional, employee, or designated representative prior to, or at the same time as, such disclosure.
If the chemical manufacturer, importer, or employer denies a written request for disclosure of a specific chemical identity, the denial must:
Be provided to the health professional, employee, or designated representative, within thirty days of the request;
Be in writing;
Include evidence to support the claim that the specific chemical identity is a trade secret;
State the specific reasons why the request is being denied; and,
Explain in detail how alternative information may satisfy the specific medical or occupational health need without revealing the specific chemical identity.
The health professional, employee, or designated representative whose request for information is denied under paragraph (i)(3) of this section may refer the request and the written denial of the request to OSHA for consideration.
When a health professional, employee, or designated representative refers the denial to OSHA under paragraph (i)(8) of this section, OSHA shall consider the evidence to determine if:
The chemical manufacturer, importer, or employer has supported the claim that the specific chemical identity is a trade secret;
The health professional, employee, or designated representative has supported the claim that there is a medical or occupational health need for the information; and,
The health professional, employee or designated representative has demonstrated adequate means to protect the confidentiality.
If OSHA determines that the specific chemical identity requested under paragraph (i)(3) of this section is not a "bona fide" trade secret, or that it is a trade secret, but the requesting health professional, employee, or designated representative has a legitimate medical or occupational health need for the information, has executed a written confidentiality agreement, and has shown adequate means to protect the confidentiality of the information, the chemical manufacturer, importer, or employer will be subject to citation by OSHA.
If a chemical manufacturer, importer, or employer demonstrates to OSHA that the execution of a confidentiality agreement would not provide sufficient protection against the potential harm from the unauthorized disclosure of a trade secret specific chemical identity, the Assistant Secretary may issue such orders or impose such additional limitations or conditions upon the disclosure of the requested chemical information as may be appropriate to assure that the
occupational health services are provided without an undue risk of harm to the
chemical manufacturer, importer, or employer.
If a citation for a failure to release specific chemical identity information is contested by the chemical manufacturer, importer, or employer, the matter will be adjudicated before the Occupational Safety and Health Review Commission in
accordance with the Act's enforcement scheme and the applicable Commission rules of procedure. In accordance with the Commission rules, when a chemical manufacturer, importer, or employer continues to withhold the information
during the contest, the Administrative Law Judge may review the citation and supporting documentation "in camera" or issue appropriate orders to protect the confidentiality of such matters.
Notwithstanding the existence of a trade secret claim, a chemical manufacturer, importer, or employer shall, upon request, disclose to the Assistant Secretary any information which this section requires the chemical manufacturer, importer, or employer to make available. Where there is a trade secret claim, such claim shall be made no later than at the time the information is provided to the Assistant Secretary so that suitable determinations of trade secret status can be made and the necessary protections can be implemented.
Nothing in this paragraph shall be construed as requiring the disclosure under any circumstances of process or percentage of mixture information which is a trade secret.
Discussion Paper 12
EPA Staff, June 5, 2001
Inert Disclosure Stakeholder Workgroup
EPA Response to Labeling Questions Raised
By Workgroup Members
May 30, 2001
Question 1. Currently, does EPA allow all ingredients, active and inert, to be listed on the product label?
Answer: Yes. Registrants have always been allowed to list all ingredients on the label, if they so choose. This position was reiterated in a memorandum on Interim Guidance on Handling CLI Labeling Recommendations, June 7, 1999 signed by Marcia E. Mulkey, Director, Office of Pesticide Programs:
"...list all the other ingredient information on the label, as long as all of the inerts are represented in some way, e.g., by specific name or functional category, if they wish. This is not intended to allow circumvention of the requirement to include references to any List 1 inerts. If several specific inerts all act as "surfactants" for example, they would only have to list "surfactants" once, but the percentage associated with it would have to represent all the surfactants, not just one or a few. They should be able to do the same thing for a proprietary mixture (if the mixture is their solvent, for example, they would only have to say "solvent" and include the appropriate percentage). See the examples below. In addition, OGC has expressed an interest in retaining the percentages for each functional category, although we currently do have labels listing inerts that don't show the percentages by category, just the "total." Keep in mind many states register as individual products a product in which the registrant has varied the percentages of the inert ingredients."
|2-(1-Methylethoxy) phenol methylcarbamate||.50%|
|Piperonyl butoxide technical||.50%|
Other ingredients are: Water, Butane/Propane (spray propellent), petroleum-based solvent (to dissolve active ingredients), emulsifiers (to keep product from separating), perfume, corrosion inhibitor (stop can from rusting)
Alkyl (C12 40%; C14 50%; C16 10%) dimethyl benzyl ammonium chloride 1.55%
|Solvents (including water)||xx.x%|
Question 2. Could pesticide manufacturers list only part of the other ingredients on the label?
Answer: Maybe. Partial ingredient listings have the potential of being misleading. Case-by-case determinations must be made depending upon how the label is drafted. EPA requires the product label to represent all of the other ingredients in some way, e.g., by total percentage weight, specific name or functional category. Under FIFRA a pesticide product is considered misbranded if its labeling is false and misleading in any (pesticidal and non-pesticidal) of its claims. 40 CFR 156.10(a)(5)(i) through (x), provide examples of claims or representations which constitute misbranding. The first example in 40 CFR 156.10(a)(5)(i) clearly states:
"a false and misleading statement concerning the composition of the product;"
Question 3. Are there requirements for placement of the ingredient statement?
Answer: Yes. There are requirements regarding the placement and prominence of the ingredient statement for pesticide labels. Generally, the preferred location for the ingredient statement is on the front panel immediately below the product name. However, case-by-case determinations must be made depending upon a number of variables. For example, if the pesticide package is extremely small or is irregular in shape making it difficult to place the ingredient statement on the front panel of the label, permission may be granted, upon written request for the ingredient statement to appear on the back or side panel of the label. For consumer products, the preferred location is after the front panel hazard warnings. The text of the statement must run parallel with and be clearly distinguished from other text on the front panel. See EPA Label Review Manual 2nd Edition, EPA 737-B-96-001; see also http://www.epa.gov/oppfead1/labeling/lrm/.
Summary of Concerns
Summary of Concerns Statements
Appendix A contains summary documents that have been prepared for the purpose of highlighting some issues of concern for the IDSW. The summary documents are intended to give the reader a sense of the differing opinions that existed in the group. The summaries are not intended to be a comprehensive discussion of all the important issues addressed by the IDSW during its deliberations. The summaries are not endorsed by the IDSW as a group, but are endorsed by the authors and any sponsors.
Summary of Concerns as submitted by IDSW members;
Michael Surgan, Shelley Davis, Rose Marie Cazeau and Mary Lamielle
Identification of All Pesticide Ingredients
Product Labels is Sound Public Policy
This paper has been prepared to highlight issues where there were strongly divergent viewpoints held by IDSW members. The summary is not endorsed by the IDSW as a group, but endorsed by the author and its' sponsors.
This statement highlights information and testimony presented to the Inert Disclosure Stakeholder Workgroup (IDSW) in support of the label disclosure of the identity of "inert" ingredients in pesticides. Members of the workgroup put forth two different proposals which would require such disclosure, one would require full disclosure for all ingredients in all pesticide products, and the other would allow the opportunity for a registrant to petition EPA, as part of the pesticide registration process, to grant confidentiality for certain ingredients, if they atisfied specific criteria. These proposals would resolve, in large part, the problems created by the current practice of holding the identity of inert ingredients confidential.
Inert ingredients pose hazards to human and environmental health, yet they are only minimally tested as part of the pesticide registration process.
Inerts are regulated by EPA very differently than active ingredients. Under amendments to our national pesticide law passed in 1972, active ingredients are required to be tested for a battery of toxicological and ecological problems. For decades, EPA has been attempting to bring testing for ach registered active ingredient up to these standards.
Inert ingredients, on the other hand, were not subject to testing requirements until 1987. The requirements for health and safety testing of inerts which EPA established at that time were called "minimal" even by EPA. They did not include tests for the following serious hazards: the ability to cause cancer; the ability to adversely affect fertility and reproduction; and the ability to damage the nervous system. (For a complete list of the testing requirements, see U.S. EPA. 1987. Inert ingredients in pesticide products; Policy statement. Fed. Reg. 52(77):13305-13309. See www.epa.gov/opprd001/inerts/fr52.htm.)
No tests at all were required of inerts already in use in 1987; testing requirements apply only to inerts first used in pesticides since that date.
In addition, EPA requires very little testing for the potential hazards of the combination of active and inert ingredients, even though humans and the environment are actually exposed to these combinations of chemicals when a pesticide is used. A few acute toxicity tests are required for pesticide products, the combination of active and inert ingredients that are actually sold and used. These include, for example, tests of whether the pesticide product irritates skin or eyes. But no tests are required for the full product for the potentially more serious, long-term health problems. Does the combination cause cancer? Does the combination cause birth defects or other reproductive problems? Does the combination cause adverse effects following long-term exposure? None of these questions can be answered based on current testing requirements. (For a complete list of these testing requirements, see Code of Federal Regulations 40 § 158.340.)
This lack of testing requirements means that EPA has very little information about the hazards posed by inerts. Of the over 2300 substances used as inerts in pesticide products, EPA classifies almost three-quarters (over 1700) as "unknown toxicity" because EPA's Office of Pesticide Programs concludes that it does not have adequate information about their hazards. This percentage has not changed much since the first toxicity categories were assigned in 1987. (For a complete list of substances used as inert ingredients and their toxicity categories see U.S. EPA. Office of Pesticide Programs. Undated. Lists of other [Inert] pesticide ingredients. www.epa.gov/opprd001/inerts/lists.html.)
Despite the lack of systematic testing requirements for their use in pesticides, many inerts are actually known to be hazardous. A comparison of EPA's inert ingredient lists with lists of hazardous chemicals maintained by state, federal, and international agencies demonstrates that 26 percent of them (610 chemicals) are already classified as hazardous under the Clean Air Act, the Clean Water Act, the Safe Drinking Water Act, and other federal statutes. Over 350 "inerts" are also registered as active ingredients, but qualify as "inert" when their function in a pesticide product is something other than the control of the target pest. (For complete information about this study, see S. Marquardt, C. Cox, and H. Knight. 1998. Toxic secrets: "Inert" ingredients in pesticides: 1987-1997. Northwest Coalition for Alternatives to Pesticides. http://www.pesticide.org/)
Inert ingredients may pose a variety of special hazards to human health and the environment:
(1) Inert ingredients may disrupt the endocrine system. Over the last decade, there has been serious public concern about the ability of synthetic chemicals to disrupt the normal functions of human and wildlife hormone systems. Since these systems guide growth, development, behavior, and reproduction, disrupting them can have significant results. EPA is developing protocols to test pesticides for these effects, but has not yet finished that process. In the meantime, however, university researchers have completed a few such studies.
One such study involved polyethoxylated tallow amines and their
chemical relatives, which are surfactants often used in Roundup
products. (Roundup herbicides are among the most commonly
used herbicides in the U.S., both for agricultural and residential
purposes.) Researchers at Texas Tech University looked at
the production of sex hormones in the testes of laboratory
animals. They identified a protein whose function is to deliver
cholesterol to the site inside the cell where cholesterol
is used to synthesize sex hormones. They found that Roundup
interferes with this
process, and decreases hormone production by more than 90%.
When they tested Roundup's active ingredient, glyphosate,
it had no such effect. The authors conclude the inhibition
of hormonal synthesis is caused by either a surfactant (inert)
in the product, or by an interaction between the inerts and
the active ingredient. (See Walsh, L.P. et al. 2000. Roundup
inhibits steroidogenesis by disrupting steroidogenic acute
regulatory (StAR) protein expression. Environ. Health Persp.
108:769-776.) This study was published in an internationally
recognized, peer reviewed journal published by a federal agency.
The senior author of the study is the Robert A. Welch Professor
of Biochemistry at Texas Tech University Health Sciences and
has authored or co-authored over 150 peer-reviewed publications
and is a preeminent scientist in his field.
(2) Inert ingredients may be carcinogenic and have other significant chronic effects. Naphthalene is used as an active ingredient in moth balls, but is also used as an inert ingredient in other products, as a component of solvent mixtures. While EPA classifies naphthalene as an inert of "unknown toxicity," it has been long recognized as a cause of anemia, especially in children. In tests conducted by the National Toxicology Program, inhaled naphthalene (as might arise from the use of pesticide products containing naphthalene as a solvent) caused lung cancer. (See National Toxicology Program. 2000. Target organs and levels of evidence for NTP ... Technical Report Number 500. http://ntp-server.niehs.nih.gov.)
(3) Inert ingredients may be allergenic. Although classified by EPA as List 4A and 4B Inerts (those inert ingredients that are of least toxicological concern to EPA) a variety of peanut products are highly allergenic to certain people. According to the National Institutes of Health, these allergies can be "exquisitely severe, causing life-threatening reactions with the most minimal of exposures."
Sodium sulfite, classified by EPA as an inert ingredient of unknown toxicity (List 3), is also highly allergenic to certain people. According to the Hazardous Substance Data Bank maintained by the National Library of Medicine, exposure to small amounts, can cause "bronchoconstriction, diaphoresis, flushing, urticaria, tachycardia, hypotension, and anaphylaxis." In both these cases, allergic individuals may suffer acute life-threatening reactions, as a result of exposure to products whose label fails to warn them of the potential for exposure to these potent allergens.
Health professionals need information about inert ingredients in order to effectively treat their patients.
In any pesticide poisoning incident, quick identification of
the inert ingredients in the pesticide product can be crucial
for effective, timely treatment. At the opening meeting of
the IDSW workgroup member Rose Ann Soloway, Associate Director
of the American Association of Poison Control Centers, described
an incident that illustrated in a compelling way the need
that physicians have for this kind of information and the
difficulty they have in obtaining it. A family that lived
in an apartment building set off aerosol insecticide foggers
in their apartment, and then left the building. The fumes
from the foggers moved through the building's ventilation
system causing a number of neighbors to became ill. Their
treating physician determined that their symptoms were inconsistent
with those that would be expected to be caused by the active
ingredient of the product. The identity of the inert ingredients
was not available from the product label, the poison control
center's electronic toxicology database, nor the product's
Dr. William Meggs, MD addressed this point in his presentation to the IDSW. Dr. Meggs said, "When a person becomes ill after being exposed to product, the overriding concern is the chemical composition of the product." As a physician, he currently has several sources of this information, including labels, material safety data sheet, and various print and electronic references. However, none are complete. As Dr. Meggs told the IDSW, "Often data supplied by these sources do not give the composition of the product." As a result, he added, "both the physician and the poisoned individual are left in a quandary."
The pesticide product label is the most direct method for getting ingredient information to health professionals who need it. Currently they must rely upon alternatives such as telephone inquiries to poison control centers, manufacturers and/or their representatives. The IDSW learned that these sources may not always have or share full ingredient information. Other possible alternatives for accessing ingredient information, such as web-based and electronic databases could be useful sources of information but should complement, not replace, information on labels. Under most circumstances using these resources would require more time than is required if ingredient information is provided on product labels. Label disclosure avoids potential confusion when there are multiple products with similar names but different ingredients, or if product composition changes over time. In addition, most consumers know that they should provide labels to health professionals if a poisoning incident occurs because of public education campaigns conducted by poison control centers and similar organizations.
Pesticide consumers, and others exposed to pesticides, need information about the identity of inert ingredients.
"Consumers" of pesticides constitute a large and diverse audience. They may be individuals naive about the chemical toxicity, farmers or pest control professionals. They may be small businesses or major corporations, governmental agencies, housing authorities, hospitals, public schools, colleges or universities. They may purchase pesticides directly, or indirectly by contracting for pest control services. All have a right and responsibility to make informed choices. In order to accurately evaluate the risks of using a particular pesticide product, to protect themselves from potentially dangerous exposures, and to participate in their own health care, pesticide users need to know the identity of all of the ingredients in pesticide products. Beyond this group of "consumers" is the general public, who may be unknowingly exposed to pesticides applied by others.
Some IDSW members argued that consumers do not understand long chemical names and are ill-prepared to use the information. Even if that were true, it would not diminish the importance of those naive consumers having the information available to consult with health professionals and others who could advise them. Moreover, institutional consumers (as identified above) would have, or could obtain, the resources necessary to evaluate technical information. Some of these "consumers" are required by federal law (the National Environmental Policy Act) or state and/or local policies to conduct environmental impact evaluations of potential pesticide use, but cannot conduct complete assessments in the absence comprehensive ingredient information. Among those state pesticide regulatory agencies surveyed by IDSW members, 3/4 of those agencies that addressed the question supported increased public access to the identity of inert ingredients.
As the IDSW heard, some governmental agencies, particularly those that do not regulate pesticide use, are unable to obtain information on the identity of inerts. For example, there's the experience of the Washington Department of Health (WDOH) during a 2000 spray program:
"WDOH received a number of requests for disclosure of product inerts during this spray program. We tried to respond to these requests in several ways, none of which completely addressed community concern." (OPP-Docket -00439A,1/25/01, number 0120, Morrissey, Washington State Department of Health) In San Francisco (California), employees have had difficulty implementing their landmark integrated pest management ordinance without accurate ingredient information. (OPP-Docket -00439A,1/25/01, number 0148, Raphael, Department of the Environment, City and County of San Francisco)
In both of these examples, the state agency that regulated pesticides (the Washington Department of Agriculture and the California Department of Pesticide Regulation) had complete ingredient information, but held confidentiality concerns above the valid needs of others to know the complete list of ingredients in specific pesticide products. These are not isolated problems; regulatory agencies nationwide hold this information confidential.
Individual pesticide consumers (the lay public), also need, and want, full ingredient information.The quantitative research in EPA's Consumer Labeling Initiative (the mail and phone questionnaire) found that 27 - 41% of the pesticide purchasers surveyed who looked for ingredient information were looking for the names of specific ingredients on pesticide product labels because they wanted to avoid using certain chemicals. Their concerns were health-related. Between 30 and 38% of these consumers were looking for the name of a specific ingredient. These responses were clarifies in focus groups, the qualitative part of the survey. In the focus groups, "even though most participants did not know the purpose of the ingredients in outdoor pesticides and indoor insecticides, they wanted full disclosure of ingredients in case of an emergency. By having this information on the label they felt that they would be able to quickly obtain the correct medical advice for dealing with a possible problem."
Many individual consumers do not find complex chemical names useful. However, the common name of an inert ingredient provides the necessary information to consumers without being overly complex.
Finally, label identification of inert ingredients would help protect consumers from deceptive advertising practices. As reported to the IDSW, the New York State Attorney General's office has taken action on numerous occasions when pesticide producers and pest control services used the secrecy surrounding "inerts" to their advantage by making deceptive claims about the health and environmental impacts of pesticides. Claims made for the total product were sometimes supported only in respect to the active ingredients but were false or misleading in respect to the inerts, a fact consumers could not recognize in the absence of full disclosure of ingredients.
For example, one manufacturer claimed that a product was not toxic to fish although one inert ingredient in the formulation is "highly toxic" to some fish, according to data the manufacturer submitted to EPA. The implication that claims for the product can be based on the characteristic of a single component is blatantly misleading.
The NYS Attorney General's office has also obtained more than
one hundred Assurances of Discontinuance from pest control
services that made advertising claims about the health and
environmental impacts of their services, including that the
products applied. Those claims were deceptive for a number
of reasons, including that the applicators could not substantiate
them since they, like the rest of the public, were ignorant
of the full composition of the pesticide
Researchers need identification of inert ingredients in order to complete pesticide-related research.
Toxicologists, risk assessors, chemists and materials scientists are among those whose research may be inhibited by the lack unfettered availability of full ingredient information. Toxicological problems of pesticides can result from either the active ingredient, the inert ingredient(s), or a combination of the two. (see Walsh, L.P. et al. 2000. Roundup inhibits steroidogenesis by disrupting steroidogenic acute regulatory (StAR) protein expression. Environ. Health Persp. 108:769-776 ) Without accurate inert ingredient information, toxicologists studying pesticide products face barriers in conducting and interpreting their research.
Industrial hygienists, material scientists and others conduct
important research to assess the efficacy of protective clothing.
Because inert ingredient information is not readily available,
some of these scientists have had to obtain this information
through laboratory analysis, or have been unable to fully
complete their research. (See Harville, J. and S.S. Que Hee.
1989. Permeation of a 2,4-D isooctyl ester formulation through
neoprene, nitrile, and Tyvek protection
materials. Am. Ind. Hyg. Assoc. J. 50:438-446.)
Identifying ingredient information on pesticide labels makes pesticide labels similar to those on other consumer products.
A summary prepared by an IDSW member showed that food, cosmetics, and over-the-counter drugs all have labeling requirements that specify that most product ingredients be identified on the product label. This provides consumers with the opportunity to make informed purchasing decisions at the time they are making their purchase. Pesticides should be no different than these other products.
Although some IDSW members felt that the health and safety testing requirements for pesticides should exempt them from labeling requirements similar to those imposed upon these other consumer products, requirements to identify inert ingredients are appropriate and reasonable. In fact it can be argued that stricter requirements are reasonable. The balance between risks and benefits is fundamentally different for pesticides on one hand and food, cosmetics, and medicines on the other. While food, cosmetic, and medicine consumers receive both the risks and the benefits of what they consume, the people who bear the risks of pesticide hazards are often not the people who receive the benefits.
Identification of inert ingredients on pesticide labels would not be burdensome on the pesticide industry or EPA.
Prioritizing tasks and allocating resources is important in any regulatory process or commercical endeavor. However, identifying all pesticide ingredients on product labels will not be overly burdensome for either registrants or EPA. Because of ongoing reregistration and FQPA requirements, many labels are being revised and reapproved for other reasons, and inert ingredient identification could be done at the same time. EPA already has a general list of inert ingredients and also a list of food-use inerts which will be revised to meet FQPA requirements in the next few years. Thus, the job of creating a list of "standard" names for inerts has already been initiated.
Identifying inert ingredients on product labels will free registrants and EPA from other time-consuming tasks. Currently, both the agency and registrants use an extremely resource-intensive process for responding to Freedom of Information Act requests for information about the identity of inert ingredients. This would not be necessary if all pesticide ingredients were identified on product labels.
The Federal Insecticide Fungicide and Rodenticide ACt (FIFRA) does not prohibit disclosure of the identitiy of inert ingredients.
Some IDSW members have suggested that FIFRA gives inert ingredients unconditional protection from disclosure. This point has been recently litigated [No. 94-110 (JR) (941 F. Supp. 197) (D.D.C. Oct. 11, 1996)]. In that case, the court held that "FIFRA § 10 does not prohibit the disclosure of inert ingredients in the absence of the Administrator's judgment." FIFRA § 10 does protect information that "contains or relates to trade secrets or confidential or financial information," but inert ingredients are protected only in so far as they are legitimately confidential business information.
Most inert ingredients in pesticides do not qualify for protection as confidential business information.
For the majority of pesticide products, information about the identity of inert ingredients is not legitimate confidential business information. Most of the identities are already public or can be obtained through laboratory analysis (reverse engineering). As the IDSW heard from EPA's Analytical Chemistry Branch on October 4, 2000 (see Discussion Paper 4), "Most, but not necessarily all, inert ingredients could be determined by reverse engineering." Both public interest groups and researchers have successfully used reverse engineering to identify inert ingredients in pesticide products. Since EPA's regulations (40 CFR 2.208) require that confidential business information is information which is not "reasonably obtainable without the business's consent by other persons by use of legitimate means" (including reverse engineering), most inert ingredient information should not be given confidential status. Notwithstanding claims by some IDSW members to the contrary, a court ruling [No. 94-110 (JR) (941 F. Supp. 197) (D.D.C. Oct. 11, 1996)] has already established that "reverse engineering to identify ingredients is common practice." The court ruled that all of the identities of inert ingredients that were at issue in that case should be disclosed. Only the Chemical Abstract Services number of one inert ingredient was deemed to qualify for protection as confidential business information.
Label disclosure of the identity of all ingredients does not reveal the "exact chemical composition" of a pesticide product nor is it a recipe for manufacture of the product. Labels need not reveal the precise quantities of individual ingredients. Critical manufacturing information such as mixing and reaction conditions and the identity of catalysts and reactants that are consumed or removed would still be remain with the registrant.
It is worth noting that besides reverse engineering, there is currently another avenue for the public to obtain information about inert ingredients. The U.S. Congress, in the Freedom of Information Act, gives the public the right to access most government documents, including many that provide information about the identity of inert ingredients. The intent of the law is to promote the free flow of information that is essential to a democracy. Public interest organizations, state agencies, and individuals have used this right to obtain information about the identity of inert ingredients, but this in no way makes any judgment about the feasibility of reverse engineering. It is simply another approach made available under U.S. law to the general public.
"Summary of Concerns as submitted by Wallace E. Puckett, Buckman Laboratories International Incorporated and sponsors: Stephen Kellner, Consumer Specialty Products Association; Sue Crescenzi, Steptoe & Johnson LLP; Chip Collins, Stepan Company; Warren Stickle, Chemical Producers and Distributors Association."
This paper has been prepared to highlight issues where there were strongly divergent viewpoints held by IDSW members. The summary is not endorsed by the IDSW as a group, but endorsed by the author and its' sponsors.
1. Who Needs Information about the Identity of Inert Ingredients?
a. Health Professionals
The workgroup discussed the issue of providing information about the identity of inert ingredients, particularly when treating emergency exposure cases, although differences were noted as to the best manner to provide such information to this audience. Industry and trade group representatives supported a flexible enhancement of label information, such as use of generic descriptors of pesticide formulants, that would allow for the protection of confidential business information (CBI) while providing, in many instances, sufficient information for the health professional. These representatives countered the public interest groups' position by citing in proper context the Consumer Labeling Initiative (CLI) Phase II Recommendations as one of the factors that support this approach. Specifically, with respect to Ingredients Recommendations and Product Label Changes the CLI in its Phase II Recommendations took the following actions to:
1. Recommend that the EPA not make any across-the-board label changes for ingredients at the present time.
2. Recommend that the EPA allow manufacturers the flexibility to voluntarily provide "other ingredient" information on the label in a way that consumers in the study expressed they wanted (i.e., listed by category, perhaps with some explanation of purpose).
3. Recommend that the EPA allow manufacturers more flexibility in where they provide ingredient information (e.g., back panel versus front panel). (See chapter 9: CLI Phase II Recommendations Page 170-171).
Industry and trade group representatives presented several ways that health professionals might currently gain access to detailed inert ingredient information including 800 telephone numbers, company websites and others. Industry and trade representatives suggested that alternate means (i.e. databases, websites, etc.) of disclosing specific pesticide formulants information should be developed in cooperation with EPA for use by health professionals and that such a system be implemented industry wide.
b. Pesticide Consumers and the General Public
Representatives from industry and trade groups demonstrated that pesticide consumers and the general public did not need or want information about the identity of inert ingredients in the form of specific chemical or trade names because the general public and many pesticide consumers are unfamiliar with those types of terms. The Consumer Labeling Initiative and its Phase II Recommendations were given as example of research on which representatives from industry based their opinion. Again, industry and trade representatives supported a more flexible approach to enhanced pesticide formulation disclosure in which CBI is protected and useful generic ingredient information is provided on the label or in a Releasable Summary.
Industry and trade group representatives would be interested in reviewing the actual documentation supporting the anecdotal experience of the Washington State Department Of Health as related by public interest group representatives in which that State agency purportedly had difficulty in gaining access to pesticide formulation information. Industry representatives would also point out that full ingredient disclosure is in fact provided to the Washington State Department of Agriculture along with each and every registration application. It is hard to imagine how that information might be made more readily and appropriately available to the various branches of the Washington State government. Industry and trade group representatives also assert that consumers such as schools, municipal governments and land management agencies can gain this information by means other than the label. Interestingly, a survey conducted by Brad Mitchell and Eileen Mahoney, both members of the IDSW, was submitted as a paper for one of our many discussions. This survey found that the state agency representatives contacted reported no problems in obtaining ingredient information should they need it. Thus, inert ingredient information appears sufficiently available to State authorities, as documented by the survey.
As for claims by public interest group representatives that inert ingredients are not evaluated for toxicity, industry and trade group representatives disagreed. They pointed out that all inert ingredients in currently registered pesticides have been evaluated for mammalian and environmental toxicology since the formulated commercial pesticide product (the product available to the consumer) including all chemical constituents thereof is required to be tested according to EPA standards, evaluated and approved by EPA before a registration is issued. They also encouraged EPA to deploy the resources required to issue a data call-in for list 2 inerts and urged EPA to take action on list 3 inerts as well.
c. Pesticide Researchers
Industry and trade group representatives felt that scientists can obtain information about inert ingredients if needed for research projects by contacting manufacturers, particularly when the researchers are willing to sign non-disclosure agreements.
2. What Is the Best Way to Provide Inert Ingredient Information to the Public?
Industry/trade group representatives demonstrated that while the label is an important vehicle in disseminating product information it is not the only means of doing so. Moreover, the label is, in many cases, already crowded with required information (especially for small pesticide containers). In fact, the issue of "label clutter" and how it detracts from label readership and comprehension was the fundamental reason that the much-touted CLI came into being. Industry and trade group representatives also assert that meaningful and useful information can be communicated by a variety of methods in addition to the label. A consideration is to present the information in a way that is free of "label clutter" and provides meaningful information. For these reasons the group supports any of several methods of providing the public with inert ingredient information including placing label information on back panels (currently not allowed by EPA), use of EPA and company websites, and others. In fact a previous EPA workgroup, the Rodenticide Task Force, strongly recommended significant changes in the format and content of labels, without regard to ingredients, for rodenticides because the existing labels were confusing and unclear. Industry and trade group representatives continue to support generic descriptors of the formulants for the label (though the issue of label space is still in question) or the releasable summary.
3. Is Information about the Identity of Inert Ingredients Legitimately Confidential Business Information?
Public interest representatives purported that the identity of inert ingredients in pesticides is not confidential business information (CBI) because they contend that formulations of pesticides are easy to reverse engineer and/or already in the public domain.
Industry and trade group representatives countered by showing
that the determination of exact chemical composition is not
easily accomplished using reasonable means thus leading to
the opposite conclusion. The question is not whether or not
sufficiently robust technology exists to reverse engineer
"most, but not necessarily all, inert ingredients"
in a pesticide formulation. The question is whether or not
the exact chemical composition of a pesticide formulation
can be determined using reasonable means. For instance, in
the case of a fragrance the compound may be composed of multiple
numbers of inerts that would not be identifiable and further
the formulator will not be advised of the names of the inerts
due to CBI protections. Industry and trade group representatives
argued that if most inert ingredients were already public
information and if formulations were easy to reverse engineer
using reasonable means then there would be no reason to have
formed the IDSW in the first place. Moreover, there would
be no reason for the continuing broad ranging FOIA requests
for inert ingredient information from various public interest
groups such as that filed by the Northwest Coalition for Alternatives
to Pesticides in January 2001. Industry and trade groups believe
that public interest representatives contradict themselves
when they state that inert ingredient information must be
disclosed because the information is not available and/or
easy to obtain while on the other hand they argue that inert
ingredient information does not qualify for confidential business
information status because it is already public information
and/or is easy to obtain. Since the IDSW continues to argue
this matter and since FOIA requests for inert information
are still being filed it holds that the identity of inert
ingredients is neither in the public domain or "reasonably
obtainable by use of legitimate means."
In addition some members of IDSW embrace the District Court Case of Northwest Coalition for Alternatives to Pesticides v. Browner 941.F.Supp 197 (D.D.C. October 11, 1996 as the lynchpin for concluding that most inert ingredients information should not be given confidential status. This is not a proper conclusion. In fact the court found that:
(4) EPA's disclosure of chemical abstract numbers for inert Ingredients not previously disclosed could cause sufficient competitive harm to trigger FOIA exemption for confidential commercial information.
With respect to claims regarding the use of reverse engineering the District Court's opinion is also relevant:
Feasibility of reverse engineering is germane to the question of whether information is in the public domain, and thus to whether showing of competitive harm from disclosure can be made to trigger Freedom of Information Act (FOIA) exemption for confidential commercial information; test is whether release of requested information, given its commercial value to competitors and cost of acquiring it through other means, will cause substantial competitive harm to business that submitted it. 5 U.S.C.A. Section 552(b)(4).
Thus the District Court's decision is extremely limited in scope and was rendered on the basis of an individual factual examination of 6 pesticides and public disclosure of information by their registration owners. Thus the decision cannot be maneuvered to become the foundation of a disclosure doctrine.
From the very beginning of the IDSW industry and trade groups brought forth the fact that any program developed must be in compliance with statutory requirements of FIFRA or other statutes regulating pesticides. With respect to EPA disclosure of Inert Ingredients, Section 10(d) of FIFRA is abundantly clear in paragraph 10(d)(1)(C ) that the EPA administrator is not Authorized to disclose information that:
(C ) discloses the identity or percentage quantity of any deliberately added inert ingredient of a pesticide, unless the Administrator has
first determined that disclosure is necessary to protect against an
unreasonable risk of injury to health or the environment.
It was also noted that the Freedom of Information Act has safeguards with respect to protection of "trade secrets and commercial or financial information obtained from a person that are privileged or confidential. 5 U.S.C. Section 552(6)(4). A similar provision is also contained in 10(b) of FIFRA. EPA limited discussion of these points at the IDSW meetings in the hope that the Workgroup could agree to some sort of additional disclosure of inerts. Since this agreement was not achieved, the issue of statutory authority must be dealt with by EPA before any decision is made concerning disclosure of inerts.
In the recent July 2001 letter from EPA's Marcia Mulkey, Director of Pesticide Programs, to the authors of the petitions filed by public interest groups to Amend Pesticide Labeling Regulations to require that pesticide labels include the identities of all the inert ingredients, the lack of statutory authority in both FIFRA and the Freedom of Information Act was cited by EPA:
EPA lacks statutory authority to grant the specific relief requested,
as discussed below, and therefore must deny your petition.
The letter also states:
EPA is not aware of any authority that would require the
identities of all inert ingredients to be made public.1 Nor do the authorities
relied upon in support of the petition support the requested relief, because
they pertain to characteristics of individual inert ingredients, while the relief
requested would pertain to all inert ingredients in all products .
Finally, the footnote 1 contained in the above quoted statement is also pertinent to the determination by EPA of the lack of authority to require disclosure of all inert ingredients:
1Indeed, Congress contemplated that some inert ingredient identities would be confidential. Section 10(d)(1)( C ) provides that inert ingredient identities are exempted from the requirement that information in a safety and efficacy study be made publicly available. Although this does not mean that all inert ingredient identities are automatically confidential by operation of law, NCAP v. Browner, 941 F.Supp. at 201, it does strongly suggest that the publication of all inert ingredient identities on product labels is inconsistent with the statutory scheme enacted by Congress.
4. Implications of Full Disclosure on the Competitive Business Advantage in the US
A salient issue of discussion during the IDSW meetings has been that of confidential business information (CBI) as it is claimed for pesticide end-use product formulations in contrast to other chemical products like cosmetics, drugs and food. Mention has been made by some workgroup members that cosmetics manufacturers list all ingredients of their products and yet have not suffered competitive harm (a required tenant of CBI claims). This argument is made to cast doubt on pesticide producers claims that disclosing inert ingredient information about their products would cause competitive harm in the marketplace. During the meeting industry and trade group representatives presented a full comparison of chemical product types (or marketplaces). The comparison showed that for monograph drugs, cosmetics and foods ingredients are fully disclosed but new products in these markets are given immediate access to the market without required investment in toxicological studies or delay by agency review. New over the counter drugs (OTC) also fully disclose ingredients but are required to submit toxicology and efficacy studies and await agency review (prescription drugs are not required to fully disclose inert ingredients on the label though some disclose them in product literature). However, new drugs are given five years exclusive use (that is no competitor can simply copy the new drug and compete for a period of five years); after that time period competitors wishing to sell a similar drug product must complete an abbreviated new drug toxicology and efficacy studies package and await agency approval before going to market.
Similar to new drugs, pesticide end-use products registrants must complete a toxicology package and await agency review before going to market but are NOT given exclusive use of their product. Any competitor discovering a registered pesticide formulation can go to market by citing the original registrants toxicology package having made little investment in the pesticide end-use product. It is for this reason that pesticide makers take advantage of FIFRA section 10's protection of CBI as a means of competitive advantage.
It should be noted that new pesticide active ingredients are granted exclusive use for ten years. Unfortunately, most active ingredients currently registered are no longer within the ten-year exclusive use timeframe while many new end-use products based on these active ingredients have been and will be introduced. The reasons for the dwindling number of new active ingredients are many but are generally a reflection of the reduced investment in new pesticide actives by industry. The reduction in new pesticide active ingredient development stems from the increased regulatory burden to acquire and maintain a registration, global competition, legal liability, relatively small market size and reduced and chaotic profit margins to name a few.
In any case FIFRA section 10 recognized the need to protect CBI intrinsic to pesticide formulae and manufacturing processes with active ingredient exclusive use provisions clearly in view. That is, though the exclusive use timeframe for active ingredients would clearly provide competitive advantage, Congress nonetheless enacted CBI protections for formulants (inert ingredients) and manufacturing processes as well.
The key point to be made is that each of the regulatory requirements for each type of market discussed is unique to that market. The regulatory requirements of each type of market balances the notions of public and environmental protection with the competitive parameters of the marketplace in which each of these chemical products and their producers compete. One cannot compare the disclosure requirements of the cosmetic market to those of the pesticide market in ignorance of the other requirements that effect competitive advantage in that market. Specifically, while cosmetic producers are required to disclose every ingredient of the cosmetic products they sell, they are not subject to required toxicology studies or FDA review that would delay their entrance to the market. The cosmetic producer can begin to garner revenue from their cosmetic new products as quickly as they are able to produce and sell them. In contrast, pesticide producers must make a significant investment in toxicology and product chemistry and wait for EPA approval before they can begin to produce a revenue stream from a new end-use pesticide product. A similar comparison can be made between pesticides and food and between pesticides and monograph drug products.
Industry and trade group representatives encourage EPA in its role of gathering and evaluating appropriate toxicology and ecotoxicology data on inert ingredients. Though public interest group representatives make claims as to the "unknown toxicity" of inert ingredients, the fact is that data exists on many of the inert ingredients commonly used in pesticide formulations. The following discussion of polyethoxylated tallow amines (POEA) is exemplary.
Following a review of in vivo animal subchronic and developmental toxicity studies on POEA, conducted according to international guidelines and good laboratory practice, the authors Williams et al. concluded that based on no developmental effects or changes in reproductive tissues in any of the studies there is no evidence that the surfactant would adversely impact reproductive function (Williams, Gary M.; Kroes, Robert and Munro, Ian C. (2000). Safety evaluation and risk assessment of the herbicide Roundup and its active ingredient, Glyphosate, for humans. Regul. Toxicol. Pharmacol 31:117-165). In addition field ecosystem studies indicate that there were no unreasonable adverse effects in deer mice, birds and small mammals from the use of a glyphosate-based formulation containing POEA (Sullivan, Chapter 12 of " The Herbicide Glyphosate" Grossbard and Atkinson (eds), Butterworths, London, 1985 and Giesy, John P.; Dobson, Stuart and Solomon Keith R. (2000). Reviews of Environmental Contamination and Toxicology 167:35-120).
It is important to note that in vivo studies are recognized
by regulatory authorities throughout the world as being more
relevant than in vitro studies in the assessment of the potential
endocrine disrupting properties of chemicals. This is in part
due to discrepancies between the results of in vitro and in
vivo studies in identifying a relevant endocrine effect. This
is often as a result of high and unrealistic exposure in in
vitro studies and toxicokinetic factors such as uptake, body
distribution and metabolism in in vivo studies.
Indeed US EPA considers that to date it cannot conclude that
the results of in vitro endocrine studies translate into an
understanding of health or environmental hazards and risks
Some researchers have conducted such in vitro studies on certain inert ingredients. An example is the in vitro study conducted by Walsh et al. (2000). This study using mouse leydig tumor cells is inappropriate for hazard identification of POEA especially given: the large in vivo data base that is available; the many questions over the reliability of the study results due to the lack of appropriate positive and negative controls; the hormone levels were not normalized to the amount of protein in the metabolism experiments; tumor cells lines often behave differently than normal in vivo cells and cell viability/health was not properly assessed. In conclusion there is no credible evidence that the surfactant POEA is an endocrine disruptor.
5. Impact of Full Disclosure on US Global Competitiveness
Though industry and trade group representatives have made mention
of the effects of full disclosure on US global competitiveness
little time has been spent on this issue by the workgroup.
It is a fact that many registrants of pesticides in the US
compete both in the US and around the world. Full disclosure
of pesticide formulations in the US would enable competitors
outside the US to simply copy, produce and market "US
EPA registered pesticides" in their own countries. Such
an advantage would allow international competitors the "certification"
of US EPA approved pesticides without the investment in the
creation of the formulation or the expense of the toxicology
and product chemistry studies required by EPA. US registrants
would be at a significant return on investment disadvantage
vs. international competitors given that no investment would
be required by the international competitor. In other words,
the international competitor could price their copied product
below that of the US registrant in their country because their
return on investment requirement would be far less than that
of the US registrant. As an example, Buckman Laboratories
enjoys a dominant market share of the leather fungicide market
globally. It continues to hold its market share in a market
where many competitors have access to the fungicidal active
ingredient on which its leading fungicide product is based.
Buckman's competitive advantage comes, in part, from its superior
formulation technology. In the absence of patent law enforcement
in many parts of the world Buckman has gone to some effort
to maintain the secrecy of its formulations. Required disclosure
of its formulations in the US would seriously erode its market
advantage globally by enabling its competitors to easily copy
6. Violations of FIFRA and Deceptive Advertising of Pesticide Products
The representative of the New York State Attorney General's office discussed numerous instances in which action was taken when pesticide producers and pest control services used the secrecy surrounding "inerts" to their advantage when advertising claims about the health and environmental impacts of pesticides. According to this representative "As long as such secrecy is maintained, the public will remain illprepared to guard against this sort of deception, law enforcement agencies will face unnecessary difficulties in evaluating advertising claims and businesses will risk running afoul of the law, be that by intent or by ignorance."
While trade group and industry representatives understand that a few individuals or business enterprises may sometimes break the law and while it may be burdensome to enforce the law, it nonetheless must be enforced. In fact many FIFRA abiding registrants have asked EPA to increase its enforcement of/public education about FIFRA because those who do business outside of the requirements of FIFRA either "by intent or by ignorance" do so to the peril of the public and with business advantage over those that obey the law.