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Dimitri.Karakitsos@hklaw.com [Dimitri.Karakitsos@hklaw.com] 6/16/2017 8:46:28 PM Beck, Nancy [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=168ecb5184ac44de95a913297f353745-Beck, Nancy] FW: FYI for call today
FYI this is what I sent over to Byron today. I believe this is the language the regional folks are interpreting to mean the labels have to be identical.
(4)Placement of Label -
{i)General. The label shall appear on or be securely attached to the immediate container of the pesticide product. For purposes of this section, and the misbranding provisions of the Act, "securely attached" shall mean that a label can reasonably be expected to remain affixed during the foreseeable conditions and period of use. If the immediate container is enclosed within a wrapper or outside container through which the label cannot be clearly read, the label must also be securely attached to such outside wrapper or container, if it is a part of the package as customarily distributed or sold.
Dimitrios Karakitsos | H olland & Knight
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Holland & Knight LLP
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From: Karakitsos, Dimitrios J (WAS - X75132) Sent: Friday, June 16, 2017 11:07 AM To: 'Brown, Byron' <brown.byron@epa.gov>; 'traylor.patrick@epa.gov' <traylor.patrick@epa.gov> Subject: FYI for call today
Gentlemen,
Happy Friday and appreciate you all making some time for us this afternoon. Just wanted to give you both a heads up on what Bissel is thinking after having a lot of internal discussions. Look forward to the discussion and please let me know if I can be of help with anything.
Thanks!
1. Beyond Adding a Second EPA Establishment Number, the Products are Not Misbranded Region 10 has interpreted 40 CFR 156.10(a)(4) to require that the labels on interior bottle and exterior box be an exact match; that interpretation is not supported by the FI FRA statute or regulations.
Sierra Club v. EPA 18cv3472 NDCA
Tiers 8&9
ED 002061 00043838-00001
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Discussion of Point 1: Beyond the addition of a second EPA establishment number (to reflect that the antibacterial cleaning solution, which was manufactured in Grand Rapids, was placed into a box in China), BISSELL contends that the products are not misbranded.
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exterior of the box must be an exact match to the label on the pesticide bottle within. 40 C.F.R. 156.10(a),
reproduced below, describes the elements that must be on a pesticide label. BISSELL maintains that the label
oeisnsatatphbpelrisoehvxmetederinootnrnotuhfmethbEeePbrAoisxMamadedsteeetdsr)Laaalrlbeoefnl tofhotermtrhieseqburpairrnoedddeuecdlt.e. mAecnctosrdoifn4g0ly,CtFhRe
156.10(a) and consists of language products (once the second EPA
that
40 CFR 156.10(a)
[l)Contents of the label. Every M5tLd.de poduct shall bear a label cqntajnjn the information specified by the Act and the regulations in this part. The contents of a label must show clearly and prominently the following:
(i) The name, brand, or trademark under which the product is sold as prescribed in par3grap|L(bj of this section;
m The name and address of the producer, registrant, or person for whom pjoduced as prescribed in paragraph (c) of this section;
(iii) The net contents as prescribed in Mri&riP.h|d). of this section;
Ov) The product registration number as prescribed in paragraph (e) of this section;
(v) The producing establishment number as prescribed in paragraph (f) of this section;
(vi) An ingredient statement as prescribed in paragraph (g) of this section;
(vii) Hazard and precautionary statements as prescribed in subpart D of this part for human and domestic animal hazards
and subpart E of this part for environmental hazards.
(viii) The directions for use as prescribed in paragraph (S) of this section; and
(ix) The use classification(s) as prescribed in paragraph (j) of this section.
ADsisscuursasnicoen"olef tPteor,initd2e:nItfifyniencgesthsearpya, rEticPuAlaHr Qprohdauscetnafnodrcleomt neunmt dbiescr rientfioornmaantidonmfaoyr tihsesuceovae"rNedo Action products. BISSELL would add an additional EPA establishment number to any boxes requiring it, but BISSELL would be able to sell and distribute products in the defined set without other relabeling. The no action aitssesluf,rathnecreebleyttaepr pcloyuinldg btoe tdhreafpteroddtuocat praptlyhetor tthhaensapepcairfitcicuplraordupactrsty.and lots at issue rather than to BISSELL In response to possible state enforcement concerns, BISSELL's believes this is just a theoretical risk and one for which BISSELL will bear the cost of any consequence to its customers under its indemnity agreements with wbitseitahcriuninsgttohmoenier rspstra.etveAueennorfaoatrhccteeiormntheaansntsopuforsastnsacitbeelellaecwtotenarcnferdornmBsisEwsPeitlhAl bsreetallaiteetveeldaswtoEs.PfeAdesrhaolueldnfotarkceemaectniotnunbdaesredFIoFnRAfedhearsalnolaws
Dimitrios Karakitsos | H olland & Knight
Partner
Sierra Club v. EPA 18cv3472 NDCA
Tiers 8&9
ED 002061 00043838-00002
Holland & Knight LLP 800 17th Street N.W., Suite 1100 | Washington, DC 20006
-- ~ j| Fax 202.955.5564 dimitri.karakitsos@hklaw.com | www.hklaw.com
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Sierra Club v. EPA 18cv3472 NDCA
Tiers 8&9
ED 002061 00043838-00003