ࡱ> EGDG  0(bjbjَ ">+$]88888 $$$$$777$~ r N7377788$$$7|8R$$88887"$ `"md  OVERVIEW OF CONSUMER PRODUCTS AND CHILDREN'S HEALTH Most consumer products, in order to be successful, must be purchased and used by many consumers. Therefore, the ingredients of these products are routinely evaluated for toxicity to ensure that the levels of exposure from product use or foreseeable misuse are far below the level that would pose risks. In addition, chemical specialty products are comprehensively regulated by numerous federal agencies. Various federal statutes and regulations apply to manufacture, distribution, use and disposal of these products. The U.S. Consumer Product Safety Commission (CPSC) and the U.S. Environmental Protection Agency (EPA) are the primary regulators, but the Department of Transportation, the Food & Drug Administration, and the Occupational Safety & Health Administration play significant roles. Two of the primary provisions to which chemical specialty products are subject are summarized below. The Federal Hazardous Substances Act (FHSA) is described in some detail, while the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) is briefly discussed. The FHSA applies to most consumer products used in the home or school other than pesticides, foods, drugs, cosmetics, fuels, and tobacco products. Among the key provisions relating to children are consideration of any foreseeable use including ingestion by children and labeling guidelines for chronic hazards such as cancer, neurotoxicity, and developmental or reproductive toxicity. FIFRA covers all pesticides, which include not only insecticides and herbicides but also disinfectants and other antimicrobials. Among the provisions relating to children are child-resistant closures and application of a differential safety margin based on potential pre-natal and post-natal toxicity. FHSA The FHSA, enacted in 1960 and subsequently amended, is administered by the CPSC and requires labeling of "hazardous substances" if they are "intended, or packaged in a form suitable, for use in the household or by children." A hazardous substance that does not bear the labeling specified by section 2(p)(1) of the FHSA is misbranded and its introduction or receipt in interstate commerce is a prohibited act under the FHSA, subjecting the violator to penalties. A hazardous substance under the FHSA includes "any substance or mixture of substances which (i) is toxic . . . if such substance or mixture of substances may cause substantial personal injury or substantial illness during or as a proximate result of any customary or reasonably foreseeable handling or use, including reasonably foreseeable ingestion by children." This definition encompasses two components: that the substance be "toxic" and that its reasonably foreseeable or customary use may cause substantial personal injury or illness. Section 2(g) of the FHSA defines the term "toxic" very broadly as "any substance . . . which has the capacity to produce personal injury or illness to man through ingestion, inhalation, or absorption through any body surface." This broad statutory definition covers both acute and chronic toxicity. The CPSC's regulatory definitions that interpret and supplement the statutory definitions provide specific tests that can be used to determine whether a product is acutely toxic by oral ingestion, inhalation, and skin contact. The CPSC issued a supplemental definition in 1992 under the authority of section 10 of the FHSA that authorizes the Commission to issue regulations "for the efficient enforcement of this Act." The definition clarified that chronically toxic substances are "toxic" (and must be labeled appropriately) under the FHSA. Guidelines promulgated concurrently with the supplemental definition discuss the particular chronic hazards of cancer, neurotoxicity, and developmental or reproductive toxicity. However, the definition is not limited to only these hazards. The guidelines present exhaustive discussions of the chronic hazards of cancer, neurotoxicity, and reproductive and developmental toxicity, as well as the principles of exposure and risk assessment. The guidelines clearly recommend a risk level of 10-6 for carcinogens and certain safety factors for neurotoxins and reproductive and developmental toxicants. The guidelines provide that these levels should generally be followed in making labeling decisions, but they recognize that sound scientific data may warrant deviation from these levels. Rather than requiring set risk levels, the final supplemental definition defines "toxic" as including such chronic toxicants as carcinogens, neurotoxins and reproductive and developmental toxicants. The FHSA does not require manufacturers to use a particular, federally approved label; instead, the FHSA requires the use of specific signal words (e.g., "CAUTION" or "DANGER"). Section 2(p)(1) of the FHSA requires hazardous substances to bear certain types of label messages. Included within the types of labeling required are: The name of each component that contributes substantially to the hazard, A signal word (in the case of chronic hazards, "WARNING" or "CAUTION"), An affirmative statement of the hazard(s) (e.g., "Vapor harmful"), Precautionary statements describing the action(s) to be taken or avoided, Any necessary or appropriate instruction for first aid treatment, Any required instruction for special handling or storage of the package, and The statement "Keep out of the reach of children," or its equivalent. Except for the signal word, the FHSA generally does not require particular label language and permits manufacturers to decide on the specific language. (In addition, the CPSC may, by rule, require different or additional labeling where required by a special hazard presented by the substance. Where labeling cannot adequately protect the public, the CPSC may ban a hazardous substance.) In this regard, it should be noted that the term "label" is broadly defined by FHSA and expansively interpreted by the CPSC to include all written, printed or graphic matter upon the immediate container of any substance, and in any accompanying literature as designated by the Commission. "Accompanying literature" is defined as "any placard, pamphlet, booklet, book, sign, or other written, printed or graphic matter or visual device that provides directions for use, written or otherwise, and that is used in connection with the display, sale, demonstration, or merchandising of a hazardous substance intended for or packaged in a form suitable for use in the household or by children." Under the FHSA's labeling requirements for a hazardous substance that is intended or packaged for household use or for children, it is the manufacturers' responsibility to determine if their products are or contain a hazardous substance and must be labeled under the FHSA. Section 3(a)(1) of the FHSA provides for the CPSC to declare a particular substance to be a "hazardous substance" under the act in order to avoid or resolve uncertainty. However, the CPSC is not required to designate a substance as hazardous before enforcing the labeling requirements of section 2(p). Other Regulatory Requirements Child-resistant closures are required for products under two statutes. For products under the jurisdiction of the CPSC, the Poison Prevention Packaging Act (PPPA) requires such closures for twenty-nine types of materials or chemicals. For products governed by the EPA, FIFRA requires child-resistance closures based on the toxicity of the product. FIFRA references the PPPA protocol for the testing of child-resistant closures. This protocol was amended in 1995 to require that the closures used are both child-resistant and senior-friendly. The CPSC regularly reviews these requirements and is currently examining whether to require child-resistant closures across the board for household products containing certain levels of hydrocarbons. EPA regulates the sale and use of all pesticides under FIFRA. Prior to any manufacture, formulation, or distribution, each pesticide must be registered with EPA. In order to obtain or maintain a registration, each product must be thoroughly tested, being subject to well over 100 tests, depending on use. The tests include data requirements for product chemistry, physical and chemical characteristics, toxicology, reentry protection, and environmental fate. EPA also conducts an extensive risk assessment, including any possible risks associated with exposure following an application of the end-use product. In 1996 FIFRA was amended by passage of the Food Quality Protection Act (FQPA). FQPA provided heightened health protections for infants and children from pesticide risks by requiring the application of a ten-fold margin of safety (or a different margin based on reliable data) to take into account potential pre-natal and post-natal toxicity and completeness of the data with respect to exposure and toxicity to infants and children. FQPA created a need for new techniques and methods that can provide quantitative data leading to comprehensive assessments of aggregate and cumulative exposure to pesticides, and the calculation of potential health risks associated with their use.   MO * 0(H*>* CJOJQJjCJOJQJU 89:cd     !"#QR=> $ !$$$89:cd     !"#QR=>dC  * + ##*(+(,(/(0(5dC  * + ##*(+(,(-(.(/(0($$ / =!"#$%Dd`c0 \  c 8Afibal.tifb.֐4Wgzp: Dn֐4Wgzp: PNG  IHDRJgAMA pHYsNIDATx_hwdX]hohXmz ~-WCL󢀃w_\pRb˝qbrOY%Z,9DXlҮ6j=HI3Ҍo~`+vAD,DD'GD#"a0q|D8 >"r9GD#"a0q|D8 >"r9GD#"a ":~.žGD]Au5t:AֵZ >"(.\o vZ >"#N; ىu\i#w"qwGD}qwGD'#/mGD4`ёrgg >":6bѡtB o^+ >":E: >"j W5#"C]x*5S1HS1芾Z|DNze|DvP!@\.GHh;P.\.#rE^%WGnY#zyۅaGd N˼a:731N 0N2%dipZީuba,5.0N*Ow+[r4`Tn<}w,W.6aإr[f{=}T)Kvb\n[Tn %~/i/Z-  ( ۼW1KA\ ;0uvN/ sA#;vG}!A iv>]Fqy7+䲢nvF >g\.`G~,4xzP4s jmb0հr%[on@̜p5tKt.?CEᱚz_ R\\d6 @ch5fl1tn+Aٸo1*ёM-`Ox?klfo7gl<>PoCȘ]S6|tjGt$\n;~X)( ܶ\+0kGfİ5m"ݛmm)|Sܦ0=lӍQt籲 ޶Vqf*kUūs]HdpZ B hGtݪ\)oPk6tUJ2׍N*~tP|#%q3ثK.}`o۱W~ yjqojmOQ|ɳ/Lk%>v黭(l {q42Lf@NMWTKŌᓷ+^m7CFbYe&='Ž^ܺݪGP"䚓_7&4OBlme)Yz5ݷdt+W]7F蝦bYa1F~_>|voA8|D250>]Q3PO2M ukiC OhGdC}ifydIT.n_>?lN]@lXGfUV,F ei=2Nފ3m ).|0nH뿶\es\=sE@e3&Jr[3kXħfz0հr9#Ǭgx7lU@5/t`\Ǟlx1+Oo[xj|ƞv0 0L|MW#RVKx6s|0.ww^ڻ  6ì^'pANl- 5tW+軰4GݮZ:HI&Ġm\estUZ+(nn_[=i0eBxϬ5?J&n  >j]^;Cg]m:$D<U\ڲAͪ*u6ZtsM_%i7ppZ]3)Ôr_*=/ ŏ(xGu Rޣk6?'/5jWlԦ&pGݩ['+e%aFWqlA|kz'6mhzV&p08+CC3]rS鹉m2 2 (\]˽bP-2˸ѕ*j.KXdܰg)X'h8zLHd^ʥD=ϕeZG6XXRW_N͜15.7y/*ߧ u wOosR~LE++9T|[~1Z)pxr[4.|&taW0ٳ^]NkkhxAJo'Io& #!},U:kԫ}-19UO_*iYH3~Ig-/$źIќa]vsx"1- >h,}> (f2Ŵ>A[(":#>:4Ay:kbQrд TYǯR?{{*sYT^(f1MbZ"aS >LNh]'_?-Gz` >@Zd,<=-j >4ˠC $N[wE=࣎ n;> > blY\6 ٙӆ(iQ/ _/06?'&/ZsߏJ?ޡp8 #5-q7ޡϣkl#Ɇ@t*s,]1վ>w9 9/:Lc:w'OKv]h{Br[[^={o84T+ɺ'Vt;כ?- 3gzyB~uQ4yegJeJ!ajļe<Nj@JdCX # 5d262[8PÈW ii>9DCJx} d|*`{ѥ% br+T4daUdau}J R"5+@S9.?Hha;.!v%XڞVׯ)_lu>+ aiI~i˙a.;3t~^G8V1ږaU,N/"O0"EBr:ió7㤄w;o+a.4}K.ҫ7˯FݐEH:'X ,BFҁrHW'V>L4oFw`~5咦FvΌ%UƐ&ƴgV/ qp"E ܹ#z~M2*-$C..{P-Iӳ+a`Xc=2VHj[Ls̟٘awW:ЮsRpf\% kNuA~u*;kh" @}2uS(Q[Wig62Ptuڈjss2P~ lu#ٜL-oAhmBa3Pw||r:\Ak-3)V7vɣ~oy]h#"0|Dw>"GDa; y#"V_a+IENDB` [4@4NormalCJOJPJQJmH <A@<Default Paragraph Font8Y8 Document Map-D OJQJ,@,Header  !, @,Footer  !0$0$>0(0(0(l,2$ӚU;5f)8lʃ"N@0( 0/P 0/ B S  ?0$5@L M ? E ,$1$?CZ fsEH3  !/#,$1$ Ogilvy PR)\\NT-2\SHARED\Z\WP\CSPA\cspa template.doc Ogilvy PR)\\NT-2\SHARED\Z\WP\CSPA\cspa template.doc Ogilvy PR)\\NT-2\SHARED\Z\WP\CSPA\cspa template.doc Ogilvy PR)\\NT-2\SHARED\Z\WP\CSPA\cspa template.docJanet Kreizman(C:\CommDept\New Folder\cspa template.dot Barry Ziman>\\CSMA_NT\USERS\Staff\CSPA Logo & Letterhead\cspa template.dot Barry Ziman6C:\windows\TEMP\AutoRecovery save of cspa template.asd Barry Ziman6C:\windows\TEMP\AutoRecovery save of cspa template.asd Barry Ziman6C:\windows\TEMP\AutoRecovery save of cspa template.asdEmployee"C:\My Documents\CHoverview1002.dot@  xl 0$p@G:Times New Roman5Symbol3& :ArialU hD X Stone SansCourier NewSTimesTimes New Roman5"Geneva"qh9j&9j&.WF;?!20d$ Ogilvy PREmployee Oh+'0t  $ 0 < HT\dl ss Ogilvy PR gilCHoverview1002 Employeew102plMicrosoft Word 8.0@@*@ m@ m; ՜.+,D՜.+,, hp|  .?$   Title(RZ _PID_GUID _PID_HLINKSAN{EDE93873-BEF0-11D4-B9BA-00805F4343F1}ALO fibal.tif !"#$%&'()*+-./012356789:;=>?@ABCFRoot Entry F !m!&"mHData  1Table,WordDocument">SummaryInformation(4DocumentSummaryInformation8<CompObjj  FMicrosoft Word Document MSWordDocWord.Document.89q