Web-Distribution of Labeling Wo rk Group Discussion P a per: Container-Affixed Label and Web-Distributed Labeling

Issues

When considering a system that could dynam i cally deliver state-specific and crop/site-specific labeling to pesticide users via the Internet or a toll-free num ber, what labeling elem ents 1. must appear on the lab e l affi xed to the container? 2. should appear in the labeling affixed to or accompanying the container? 3. could benefit the user by being delivere d using a stream lined, dynam i c method?

Premis e
FIFRA § 2(p) clearly al lows for both a “label” and “labeling.” The term “label” m eans “the written, printed, or graphic m a tter on, or attached to, the pestic ide or device or any of its containers or wrappers.” “Labeling ” 1 m eans “all labels and all othe r written, printed, or graphic

m a tter acco mpanying th e pesticide o r device at any tim e; or to which reference is m a de on the label o r in litera ture acc ompanying the pesticide or device, except to current official p ublica tions of the [EPA, USDA, DoI

, DHHS], St ate experim e nt station s , State ag ricu ltural college

, and other sim ilar Fede ral or S t ate institu tion s o r agenc i es a u thorized by law to cond uct res ear ch in the f i e l d of pesticides.” Although not comm on, current labeling som e tim es uses a reference to other enforceable docum ents that do not accomp any the container, as eviden ced by the Worker Protection S t andard and Bulleti ns Live (for threatened a nd endangered species and their habita ts).

Many people have voiced criticism s of the qual ity of the labeling currently on m a ny pesticide products. In particular, critics no te th at, b ecau se the labeling of a single p r oduct m a y contain precau tions and detailed use dire ctio ns for m u ltiple uses, the labeling is often quite long –

som e ti m e s exceeding 50 pages in len g th. More o v er, pesticid e comp anies do not all follow a consistent approach to the organization and presen tation of infor m ation in labeling. Further, to reduce printing costs, the labeling inf o rm ation can appear in sm aller font sizes. Critics argue therefore that users m a y have trouble finding a nd reading all relevant portions of a product’s labeling. They further argue that, if the current sy stem could be changed to address these factors, users’ comp lianc e with labeli ng requirem ents could improve.
A new web-distributed labeling syst em could provide simp lified labe ling to users. Under the new system the user would be require d to obtain a copy of labeling fo r the product from an alternate source, either the internet or a toll-free phone service that would m a il or fax a copy of the labeling to the user. The user would be required to comp ly not only with restrictions appearing in the label affixed to th e container and in la belin g accomp anying the con t ainer, but also with those in the additional labeling av ailable from a referenced intern et source or toll-free num ber. The user would be expected to obtain and follo w labeling referenced on th e container potentially generating that labeling using a search function for querying item s such as state and site.

1 Wh ile th e stat u t ory d e fin ition o f “lab eling ” en co m p asses b o t h attach ed an d un attach ed materials, th e re m a in d e r o f th is p ap e r g e n e rally u s es “labelin g ” as tho s e lab e lin g m a terials th at are d i st in gu ish a b l e from th e attach ed lab e l on the
cont ai ne r.

Sep t em b e r 24 , 2 008 Pag e 1 of 6Additional queries, such as c ounty of application or applicat ion m e thod, can generate greatly simp lified labeling since most labeling could then contain relatively brief, very specific use directions and precau tio ns that would not be obs cured by inf o rm ation applicab le to u s e on other sites or by other applications m e thods. This web-distributed labeling system should improve

comp liance with protective m easures and proper us e. The users ultim a tely would have in their possession all pertinent labeling inform ation.

This new system requires decisions be m a de rega rding which types of inform ation would appear on the label affixed to the container, whic h would appear in labeling accompanying the container, and which would be available through ot her sources (i.e. internet, m a il, and fax). This issue paper proposes a p a rtition i ng o f label and labeling elem ents according to whether they would be either “affixed to the con t ainer,” “phys ically accompanying the contain e r,” or in “web

distributed” labeling. It presents a proposed breakdown of the location of different labeling elem ents that m i ght best serve the user, registra nt, or EPA. The proposed approach is guided by the f o llowin g princ i ples :

• The location of label andlabeling ele m ents required by statute and current regulations would not change;

• Both the lab e l affixed to the containe r and lab e lin g physically accomp anying the contain e r w ould contain all inform at ion neces sary for the safe storag e, handling, and disposal of the container;

• Both the lab e l affixed to the containe r and lab e lin g physically accomp anying the container w ould contain basic inform ation necessary to offer safety to any person who

m i ght com e into con t act with the p r o duct, for example through handling the container or by using the product;

• The label affixed to the container and labe ling physically accomp anying the container would contain little or no additional inform ation so that the types of inform ation described above would be prom in ent and easy to understand; and

• Basic identif ying and safety inform ation on the label or in the labeling phy sica lly

accomp anying the container would b e repeated in the lab e ling available from the referenced s ources.

What information must appear on th e label a f fixed to the container?

In FIFRA § 2(q) and 40 CFR Part 156, specific label elem ents are defi ned as being required to be affixed to the container without which the product is considered m i sbranded. Thus, the following elem ents m u st be found in the label affixed to the container. (* required only by regulation, ** required by statute a nd regulation).

Sep t em b e r 24 , 2 008 Pag e 2 of 6Required by statute and/or regulation a nd m u st be affixed to the container

. 2 1. *Directions for use or a reference statem en t to directions for use found elsewhere in labeling 2. *Use classification (Restric ted Use Product statem ent) 3. *Violation o f f

e deral law statem ent 4. *Product registration number 5. *Signal word 6. *W PS referral statem ents 7. *Storage and disposal requirem e nts 8. **Product establishm ent num b er 9. **Brand/product/tradem arked Nam e 10. **Ingredient statem ent 11. **Net weight or contents 12. **Skull & crossbones/POISON and statem ent of practical treatm ent if highly toxic 13. **Na m e and address of producer, regist rant or person for whom produced 14. **W a rning or caution statem ent adequate to protect health and the environm ent (by regulation th is requ ires p hysical and chem i cal hazard inform ation, and h u m a n health and environm ental precautio n ary statem ents)

In addition to the existing requirem e nts out lined above, under web-distributed labeling a container label would include a reference statem ent, likely under the heading “Directions for Use” where the violation of federal law statem en t appears, that rem i nds users they are bound by the direction s on the con t ainer as well as those include in the web-distri buted labeling. This
statem ent should be obvious to any person handli ng a pesticide in order to ensure comp liance with both label and labeling requirem ents. Fo llowing is an example of what such language requiring users to obtain and comp ly with web-distributed labeling m a y look like:

15. You must obtain additio nal labeling from http://pesticidelabeling.gov or by calling 1

- 866-LABELING. You must possess a copy of th is addition a l labeling at the time of application. It is a violation of federal law to use this product in a manner inconsistent with its attached label or the additional labeling obtained in one of the m e thods listed above.

In addition, to facilitate state-EPA-registrant reg i stration sy n c hronicity, it m a y be necessary to include a un ique iden tifier in add itio n to the p r od uct reg i stration num b er; this is no t re quired today. (A unique identifier m a y be necessary if the registrant decided, for m a rketing or other reasons, to sell or distribute a re gistered pesticide with m o re than one version of its labeling for the sam e registration number. Logically it shou ld appear with the registration num ber on the product container label.)

2 Additional requirem e nt for labels of products for export only ** “Not Registered for Use in the United S t ates of Am erica. ”

Sep t em b e r 24 , 2 008 Pag e 3 of 6What other types of in formation should be pa rt of the lab e ling affi xed to or physically accompanying the container?

Since pes ticides in th eir contain e rs are in the ch a nnels of trad e, it is important to provide basic safety and handling inform ation about the product that is available to anyone who m a y com e in
contac t with the pes tic id e, such as distributors, applicators, handl ers, m e dical providers, or first responders. Having basic handling infor m ati on related to stream lined inform ation for environm ental protection, storage and spills is also important. This is an important liability issue for registran t s.
Additionally, in order to m i ni m i ze costs of reprinting product labels, pesticide comp anies would not want to put inform ation in the label or in the labeling physically ac companying the container that would be likely to change frequently.

The following elem ents would be recommended to be in the label af f i xed to the con t a i ner, bu t at

a m i ni m u m should appear in the labeli ng physically accomp a nying the container

.

16. In case of sp ill – CHEM TREC a nd m a nufacturer phone numbers

For m a rketing or liability purposes, there m a y be reasons to include m a nuf acturer inform ation or
stream lined sections from use directions.

17. Comp any logo, graphics, or other identifiers

18. General m a rketing referral to target sites a nd pests (e.g., for use in landscapes for chinch bugs)

19. Warranty s t atem ent

What types of information coul d benefit from being delivered using a streamlined , dynamic method (W eb-Distributed Labelin g - referenced by URL)

One benefit of web-distributed la beling is to provide the user w ith a strea m lined container labe l as well as labeling that contains only the pertinent info rm ation for a particular site of application, in a specific state, when using a particular application m e thod. W h en a pesticide user mu st read through 40 plus pages of sites/cr ops, 10 plus pages of applicati on equipm ent directions, and 5 plus pages o f drif t m itigation m easures when th e y are using one piece of applic ation equipm ent on one crop, the lab e ling becom e s “War and Peace.”

By allowing the user to run through a database query, a use-specific label is generated that should be much m o re readable. For example a sear ch by: 1) Unique identif ier, 2) State, 3) Crop/site and 4) Application Method or treatm ent type (air, ground, chem i g ation, backpack/hand, shank injection) generates m u ch-re duced user-specific labe ling that is specific for the direc tions, m itiga tions and p r ecautions ne eded for that particularu s e. The sear ch could be further refined by adding other search values, su ch as county for endangered species with access to Bulle tins Live.

Sep t em b e r 24 , 2 008 Pag e 4 of 620. Engineering Controls- expa nded section, if warranted

21. Environm ental Hazards – expa nded section, if warranted

a. Endangered species b. Site spe c if ic concerns

22. Resistance Managem e nt identifiers

23. Storage and Disposal – expanded section, if warranted

24. Use Directions (sample list, not exhaustive)

a. Worker Protection S t andard – apart from the Agr i cultural Use Box i. REI , especially if m u ltipl e crop or application type ii. Early entry worker PPE iii. Prohibition of any entr y prior to 4 hours b. Allowable S ites, Crops, Hosts

c. Use Requirem e nts i. Type of treatm ent (band, broadcast, injection, chem igation) ii. Product application rate and lim its 1. Rates f o r tar g et pes t s 2. Maxim u m num ber of applications or annual use-rate lim its 3. Tim i ng (growth stage, degree days) iii. Restricted E n try In terv al, if m u ltiple iv. Preharvest, grazing/haying, compost i ng, replant, rainfast intervals

v. Required adjuvants (buffers, spreaders, antifoam i ng agents) vi. Form ulation and m i xing instructions vii. Tank agitation requirements viii. Order of m i xing m u ltiple products /adjuvants

ix. Spray tank/boom decontam ination d. Use Prohibitions i. Tank m i xing (Buffers, adjuvants, products, fertilizer) ii. Crop rotation, water usage, iii. Greenhouse applications

e. Use Restrictions i. Who m a y apply (supervised trained technicians, trained handlers) ii. “Do not” statem ents 1. hum a n exposures, water contam ination, edible plants, frozen ground, sens itiv e sites/crops 2. 1,000 others where known problems ex ist (air temp erature lim its, sensitive o r n a m e ntals, etc.) iii. Application equipm ent specific (coul d be restrictive or advisory) – generate only those precautions by the m e thod they selected. 1. aerial, ground boom

, ground injection, chem igation, hand-held high volum e/spot

Sep t em b e r 24 , 2 008 Pag e 5 of 6a. set up (output, droplet size, gallonage, nozzle angle, boom length, boom height) b. drif t m itigation m easures (dif f

e rs with equipm ent), such as wind direction, temp erature inve rsions, wind speed, lack of wind, pressure lim its and requirem e nt for higher pressures

c. water source protection m eas ures (check valves for chem igation) d. efficacy req u irem ents (d roplet siz e ) f. Advisory Statem ents i. Storage and disposal assistance ii. Tank m i xing with known com b inations iii. Spray adjuvants iv. Off-target managem e nt strategies 1. based on application equipm en t, volum es applied, active ingred ient, location of se nsitiv e ar eas 2. assessing nearby areas

v. Resistance Managem e nt 1. Mode of action 2. Managem e nt approaches vi. Term s and Conditions of Use 1. Inherent Risks of Use 2. Lim itations of Re m e dies

The last three elem ents that could b e included as part of web-distributed labeling would be new to labe ls.

25. Highlighted, recen t chan ges to web-d i stributed labeling

26. Download date and expiration date f o r we b-distributed labeling (See issue paper on Lifespan of Web-Distributed Labeling.)

27. Existing stock provision dates if use is no longer supported or planned cancellation

Sep t em b e r 24 , 2 008 Pag e 6 of 6